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Major reasons for the insufficient effects of current treatment options in bipolar disorder include delayed intervention for prodromal depressive and manic symptoms and decreased adherence to psychopharmacological treatment . The reliance on subjective information and clinical evaluations when diagnosing and assessing the severity of depressive and manic symptoms calls for less biased and more objective markers . By using electronic devices , fine-grained data on complex psychopathological aspects of bipolar disorder can be evaluated unobtrusively over the long term . Moreover , electronic data could possibly represent c and i date markers of diagnosis and illness activity in bipolar disorder and allow for early and individualized intervention for prodromal symptoms outside clinical setting s. The present dissertation concerns the use of electronic monitoring as a marker and treatment intervention in bipolar disorder and investigated the scientific literature and body of evidence within the area , which includes ten original study reports and two systematic review s , one of which included a meta- analysis , conducted by the author of the dissertation . Taken together , the literature presented in this dissertation illustrates that 1 ) smartphone-based electronic self-monitoring of mood seems to reflect clinical ly assessed depressive and manic symptoms and enables the long-term characterization of mood instability in bipolar disorder ; 2 ) preliminary results suggest that smartphone-based automatically generated data ( e.g. the number of text messages sent/day ; the number of incoming and outgoing calls/day ; the number of changes in cell tower IDs/day ; and voice features ) seem to reflect clinical ly assessed depressive and manic symptoms in bipolar disorder ; 3 ) smartphone-based electronic self-monitoring had no effects on the severity of depressive and manic symptoms in bipolar disorder , according to a r and omized controlled trial ; and 4 ) electronic monitoring of psychomotor activity and heart rate variability seems to reflect illness activity in bipolar disorder and differentiate between patients with bipolar disorder and healthy control individuals . These findings point toward the usefulness of electronic monitoring as a marker of illness in bipolar disorder . Using electronic monitoring as a treatment intervention could provide innovative and novel interventions on-dem and with a potential global reach , filling the gap between availability and the need for treatment . However , future studies using rigorous methodology and more r and omized controlled trials that carefully investigate the positive effects and possible harmful effects of electronic monitoring in bipolar disorder are needed . In addition , patient safety , privacy issues , data security and legal aspects are major concerns that must be considered and addressed when using electronic monitoring
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"Background In a recent exploratory r and omised trial we found that a novel , internet-based psychoeducation programme for bipolar disorder ( Beating Bipolar ) was relatively easy to deliver and had a modest effect on psychological quality of life . We sought to explore the experiences of participants with respect to feasibility , acceptability and impact of Beating Bipolar . Methods Participants were invited to take part in a semi-structured interview . Thematic analysis techniques were employed ; to explore and describe participants ’ experiences , the data were analysed for emerging themes which were identified and coded . Results The programme was feasible to deliver and acceptable to participants where they felt comfortable using a computer . It was found to impact upon insight into illness , health behaviour , personal routines and positive attitudes towards medication . Many participants regarded the programme as likely to be most beneficial for those recently diagnosed . Conclusions An online psychoeducation package for bipolar disorder , such as Beating Bipolar , is feasible and acceptable to patients , has a positive impact on self-management behaviours and may be particularly suited to early intervention . Alternative ( non-internet ) formats should also be made available to patients",
"Background Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed . Recently , the MONARCA I r and omized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms . The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purpose s , but had fewer manic symptoms during the trial . It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage , social activity , physical activity , and mobility . The Monsenso system , for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial . Methods The MONARCA II trial uses a r and omized controlled single-blind parallel-group design . Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder , Denmark are included and r and omized to either daily use of the Monsenso system including an feedback loop between patients and clinicians ( the intervention group ) or to the use of a smartphone for normal communicative purpose s ( the control group ) for a 9-month trial period . The trial was started in September 2014 and recruitment is ongoing . The outcomes are : differences in depressive and manic symptoms ; rate of depressive and manic episodes ( primary ) ; automatically generated objective data on measures of illness activity ; number of days hospitalized ; psychosocial functioning ( secondary ) ; perceived stress ; quality of life ; self-rated depressive symptoms ; self-rated manic symptoms ; recovery ; empowerment and adherence to medication ( tertiary ) between the intervention group and the control group during the trial . Ethical permission has been obtained . Positive , neutral and negative findings will be published . Discussion If the system is effective in reducing depressive and /or manic symptoms ( and other symptoms of bipolar disorder ) and the rate of episodes , there will be basis for extending the use to the treatment of bipolar disorder in general and in larger scale . Trial registration Clinical Trials.gov NCT02221336 . Registered 26th of September 2014",
"Introduction Electronic self-monitoring of affective symptoms using cell phones is suggested as a practical and inexpensive way to monitor illness activity and identify early signs of affective symptoms . It has never been tested in a r and omised clinical trial whether electronic self-monitoring improves outcomes in bipolar disorder . We are conducting a trial testing the effect of using a Smartphone for self-monitoring in bipolar disorder . Methods We developed the MONARCA application for And roid-based Smartphones , allowing patients suffering from bipolar disorder to do daily self-monitoring — including an interactive feedback loop between patients and clinicians through a web-based interface . The effect of the application was tested in a parallel-group , single-blind r and omised controlled trial so far including 78 patients suffering from bipolar disorder in the age group 18–60 years who were given the use of a Smartphone with the MONARCA application ( intervention group ) or to the use of a cell phone without the application ( placebo group ) during a 6-month study period . The study was carried out from September 2011 . The outcomes were changes in affective symptoms ( primary ) , social functioning , perceived stress , self-rated depressive and manic symptoms , quality of life , adherence to medication , stress and cognitive functioning ( secondary and tertiary ) . Analysis Recruitment is ongoing . Ethics Ethical permission has been obtained . Dissemination Positive , neutral and negative findings of the study will be published . Registration details The trial is approved by the Regional Ethics Committee in The Capital Region of Denmark ( H-2 - 2011 - 056 ) and The Danish Data Protection Agency ( 2013 - 41 - 1710 ) . The trial is registered at Clinical Trials.gov as NCT01446406",
"Background The Internet has potential as a medium for health behavior change programs , but no controlled studies have yet evaluated the impact of a fully automated physical activity intervention over several months with real-time objective feedback from a monitor . Objective The aim was to evaluate the impact of a physical activity program based on the Internet and mobile phone technology provided to individuals for 9 weeks . Methods A single-center , r and omized , stratified controlled trial was conducted from September to December 2005 in Bedfordshire , United Kingdom , with 77 healthy adults whose mean age was 40.4 years ( SD = 7.6 ) and mean body mass index was 26.3 ( SD = 3.4 ) . Participants were r and omized to a test group that had access to an Internet and mobile phone – based physical activity program ( n = 47 ) or to a control group ( n = 30 ) that received no support . The test group received tailored solutions for perceived barriers , a schedule to plan weekly exercise sessions with mobile phone and email reminders , a message board to share their experiences with others , and feedback on their level of physical activity . Both groups were issued a wrist-worn accelerometer to monitor their level of physical activity ; only the test group received real-time feedback via the Internet . The main outcome measures were accelerometer data and self-report of physical activity . Results At the end of the study period , the test group reported a significantly greater increase over baseline than did the control group for perceived control ( P higher level of moderate physical activity in the test group . The average increase ( over the control group ) in accelerometer-measured moderate physical activity was 2 h 18 min per week . The test group also lost more percent body fat than the control group ( test group : −2.18 , SD = 0.59 ; control group : −0.17 , SD = 0.81 ; P = .04 ) . Conclusions A fully automated Internet and mobile phone – based motivation and action support system can significantly increase and maintain the level of physical activity in healthy adults",
"CONTEXT Despite the availability of efficacious treatments , the long-term course of bipolar disorder is often unfavorable . OBJECTIVE To test the effectiveness of a multicomponent intervention program to improve the quality of care and long-term outcomes for persons with bipolar disorder . DESIGN R and omized controlled trial with allocation concealment and blinded outcome assessment . SETTING Mental health clinics of a group-model prepaid health plan . PATIENTS Of 785 patients in treatment for bipolar disorder who were invited to participate , 509 attended an evaluation appointment , 450 were found eligible to participate , and 441 enrolled in the trial . INTERVENTIONS Participants were r and omly assigned to a multicomponent intervention program or to continued care as usual . Three nurse care managers provided a 2-year systematic intervention program , including the following : a structured group psychoeducational program , monthly telephone monitoring of mood symptoms and medication adherence , feedback to treating mental health providers , facilitation of appropriate follow-up care , and as-needed outreach and crisis intervention . MAIN OUTCOME MEASURES In-person blinded research interviews every 3 months assessed mood symptoms using the Longitudinal Interval Follow-up Examination . Health plan administrative records were used to assess the use and cost of mental health services . RESULTS Intent-to-treat analyses demonstrated that the intervention significantly reduced the mean level of mania symptoms ( z = 2.09 , P = .04 ) and the time with significant mania symptoms ( 19.2 vs 24.7 weeks ; F(1 ) = 6.0 , P = .01 ) . There was no significant intervention effect on mean level of depressive symptoms ( z = 0.19 , P = .85 ) or time with significant depressive symptoms ( 47.6 vs 50.7 weeks ; F(1 ) = 0.56 , P = .45 ) . Benefits of the intervention were found only in a subgroup of 343 persons with clinical ly significant mood symptoms at the baseline assessment . The incremental cost ( adjusted ) of the intervention was 1251 dollars ( 95 % confidence interval , 55 - 2446 dollars ) , including approximately 800 dollars for the intervention program services and an approximate 500 dollars increase in the costs of other mental health services . CONCLUSIONS Population -based systematic care programs can significantly reduce the frequency and severity of mania in bipolar disorder , and cost increases are modest considering the clinical gains . The incorporation of more specific cognitive and behavioral content or more effective medication regimens may be necessary to significantly reduce the symptoms of depression",
"BACKGROUND The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence . Nevertheless , the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a r and omized controlled trial ( RCT ) . The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder . METHOD A total of 78 patients with bipolar disorder according to ICD-10 criteria , aged 18 - 60 years , and with 17-item Hamilton Depression Rating Scale ( HAMD-17 ) and Young Mania Rating Scale ( YMRS ) scores ≤17 were r and omized to the use of a smartphone for daily self-monitoring including a clinical feedback loop ( the intervention group ) or to the use of a smartphone for normal communicative purpose s ( the control group ) for 6 months . The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS , respectively , between the intervention and control groups . RESULTS Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms . There was a tendency towards more sustained depressive symptoms in the intervention group ( B = 2.02 , 95 % confidence interval -0.13 to 4.17 , p = 0.066 ) . Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group . CONCLUSIONS These results highlight that electronic self-monitoring , although intuitive and appealing , needs critical consideration and further clarification before it is implemented as a clinical tool",
"BACKGROUND Adjunctive psychosocial interventions are efficacious in bipolar disorder , but their incorporation into routine management plans are often confounded by cost and access constraints . We report here a comparative evaluation of two online programs hosted on a single website ( www.moodswings.net.au ) . A basic version , called MoodSwings ( MS ) , contains psychoeducation material and asynchronous discussion boards ; and a more interactive program , MoodSwings Plus ( MS-Plus ) , combined the basic psychoeducation material and discussion boards with elements of Cognitive Behavioral Therapy . These programs were evaluated in a head-to-head study design . METHOD Participants with Bipolar I or II disorder ( n=156 ) were r and omized to receive either MoodSwings or MoodSwings-Plus . Outcomes included mood symptoms , the occurrence of relapse , functionality , Locus of Control , social support , quality of life and medication adherence . RESULTS Participants in both groups showed baseline to endpoint reductions in mood symptoms and improvements in functionality , quality of life and medication adherence . The MoodSwings-Plus group showed a greater number of within-group changes on symptoms and functioning in depression and mania , quality of life and social support , across both poles of the illness . MoodSwings-Plus was superior to MoodSwings in improvement on symptoms of mania scores at 12 months ( p=0.02 ) but not on the incidence of recurrence . LIMITATIONS The study did not have an attention control group and therefore could not demonstrate efficacy of the two active arms . There was notable ( 81 % ) attrition by 12 months from baseline . CONCLUSION This study suggests that both CBT and psychoeducation delivered online may have utility in the management of bipolar disorder . They are feasible , readily accepted , and associated with improvement",
"The evaluation of the clinical outcome of patients enrolled in r and omised controlled studies should always be accurate and objective . The methods used to assess and report patients ' results must consequently be indicated a priori in the design of the clinical experimentation . Major ( hard ) individual end points currently constitute the gold st and ard in the definition of outcome measures , yet surrogate and composite end points are spreading diffusely as alternative/complementary outcome measures . Surrogate end points are minor outcome measures that are easier to record and are being adopted instead of major end points . They may be considered acceptable substitutes of hard end points when capable of predicting major events reliably , and when it may be demonstrated that the intervention on such surrogate end points consistently modifies the incidence of the event . In other cases they can not represent predictive elements of major clinical outcomes . Composite ( combined ) primary end points may contribute to improve the statistical precision of a clinical trial ; moreover , since clinical trials are particularly expensive , their identification permits more limited sample s of patients to be enrolled . Their limits include the possibility that the direction in which the different outcome measures composing the combined end point are modified is not the same . Biomedical research ers are called upon to design studies adopting major ( hard ) end points , rather than solitary surrogate end points , in order to provide really useful information for the care of patients . The selection of composite end points requires notable method ological attention so as to retrieve the most reliable estimates on the efficacy and the effectiveness of treatments",
"Background To our knowledge , no studies have evaluated whether weight loss can be promoted in overweight adults through the use of an intervention that is largely based on daily SMS ( Short Message Service : text ) and MMS ( Multimedia Message Service : small picture ) messages transmitted via mobile phones . Objective This paper describes the development and evaluation of a text message – based intervention design ed to help individuals lose or maintain weight over 4 months . Methods The study was a r and omized controlled trial , with participants being exposed to one of the following two conditions , lasting 16 weeks : ( 1 ) receipt of monthly printed material s about weight control ; ( 2 ) an intervention that included personalized SMS and MMS messages sent two to five times daily , printed material s , and brief monthly phone calls from a health counselor . The primary outcome was weight at the end of the intervention . A mixed-model repeated- measures analysis compared the effect of the intervention group to the comparison group on weight status over the 4-month intervention period . Analysis of covariance ( ANCOVA ) models examined weight change between baseline and 4 months after adjusting for baseline weight , sex , and age . Results A total of 75 overweight men and women were r and omized into one of the two groups , and 65 signed the consent form , completed the baseline question naire , and were included in the analysis . At the end of 4 months , the intervention group ( n = 33 ) lost more weight than the comparison group ( −1.97 kg difference , 95 % CI −0.34 to −3.60 kg , P = .02 ) after adjusting for sex and age . Intervention participants ’ adjusted average weight loss was 2.88 kg ( 3.16 % ) . At the end of the study , 22 of 24 ( 92 % ) intervention participants stated that they would recommend the intervention for weight control to friends and family . Conclusions Text messages might prove to be a productive channel of communication to promote behaviors that support weight loss in overweight adults . Trial Registration Clinical trials.gov NCT00415870 ; http:// clinical trials.gov/ct2/show/NCT00415870 ( Archived by WebCite at http://www.webcitation.org/5dnolbkFt",
"Background Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes , but delivery on a wide scale and at low cost is challenging . Some trials evaluating clinical interventions using short message service ( SMS ) text-messaging systems have shown important outcomes , although evidence is limited . We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-re source setting . We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care . Methods / design The SMS Text-message Adherence suppoRt trial ( StAR ) is a pragmatic individually r and omised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town , South Africa . The intervention is a structured programme of clinic appointment , medication pick-up reminders , medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages . Usual care is supplemented by infrequent non-hypertension related SMS text-messages . Participants are 1:1:1 individually r and omised , to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender , age , baseline systolic blood pressure , years with hypertension , and previous clinic attendance . The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation . Secondary outcomes include the proportion of patients with 80 % or more of days medication available , proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg , hospital admissions , health status , retention in clinical care , satisfaction with treatment and care , and patient related quality of life . Anonymised demographic data are collected on non- participants . Discussion The StAR trial uses a novel , low cost system based on widely available mobile phone technology to deliver the SMS-based intervention , manage communication with patients , and measure clinical ly relevant outcomes . The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-re source setting .Trial registration",
"Background R and omized controlled trials ( RCTs ) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes . However , with a prolonged duration from recruitment to publication , high-cost trial implementation , and a rigid trial protocol , RCTs are perceived as an impractical evaluation methodology for most mHealth apps . Objective Given the recent development of alternative evaluation method ologies and tools to automate mHealth research , we sought to determine the breadth of these methods and the extent that they were being used in clinical trials . Methods We conducted a review of the Clinical Trials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015 . Results Of the 137 trials identified , 71 were found to meet inclusion criteria . The majority used a r and omized controlled trial design ( 80 % , 57/71 ) . Study design s included 36 two-group pretest-posttest control group comparisons ( 51 % , 36/71 ) , 16 posttest-only control group comparisons ( 23 % , 16/71 ) , 7 one-group pretest-posttest design s ( 10 % , 7/71 ) , 2 one-shot case study design s ( 3 % , 2/71 ) , and 2 static-group comparisons ( 3 % , 2/71 ) . A total of 17 trials included a qualitative component to their methodology ( 24 % , 17/71 ) . Complete trial data collection required 20 months on average to complete ( mean 21 , SD 12 ) . For trials with a total duration of 2 years or more ( 31 % , 22/71 ) , the average time from recruitment to complete data collection ( mean 35 months , SD 10 ) was 2 years longer than the average time required to collect primary data ( mean 11 , SD 8) . Trials had a moderate sample size of 112 participants . Two trials were conducted online ( 3 % , 2/71 ) and 7 trials collected data continuously ( 10 % , 7/68 ) . Onsite study implementation was heavily favored ( 97 % , 69/71 ) . Trials with four data collection points had a longer study duration than trials with two data collection points : F4,56=3.2 , P=.021 , η2=0.18 . Single-blinded trials had a longer data collection period compared to open trials : F2,58=3.8 , P=.028 , η2=0.12 . Academic sponsorship was the most common form of trial funding ( 73 % , 52/71 ) . Trials with academic sponsorship had a longer study duration compared to industry sponsorship : F2,61=3.7 , P=.030 , η2=0.11 . Combined , data collection frequency , study masking , sample size , and study sponsorship accounted for 32.6 % of the variance in study duration : F4,55=6.6 , P<.01 , adjusted r2=.33 . Only 7 trials had been completed at the time this retrospective review was conducted ( 10 % , 7/71 ) . Conclusions mHealth evaluation methodology has not deviated from common methods , despite the need for more relevant and timely evaluations . There is a need for clinical evaluation to keep pace with the level of innovation of mHealth if it is to have meaningful impact in informing payers , providers , policy makers , and patients",
"BACKGROUND Bipolar Disorder ( BD ) is a common and severe form of mental illness . Pharmacotherapy is the main treatment offered , but has limited effectiveness , and there is increasing evidence that people with BD respond well to psychological interventions . Inequalities in access to face-to-face psychological interventions mean many people seek support outside of routine health services . AIM To assess a recovery informed web-based self-management intervention for BD to increase access to psychological support . METHOD A small online r and omised controlled trial ( RCT ) will evaluate the feasibility , acceptability and potential effectiveness of the intervention compared to treatment as usual ( TAU ) . Feasibility and acceptability will be assessed by recruitment , adherence and dropout rates , website usage statistics , user satisfaction scales and a series of qualitative interviews . Effectiveness will be assessed on a range of outcome measures including quality of life , mood symptoms , coping , recovery , and illness beliefs . ANALYSIS Rates of adherence and dropout will be analysed using logistic regression models with health , socioeconomic and treatment factors as explanatory variables . Changes in quality of life mean scores , contrasting between arms , will be assessed using r and om effects models . An exploratory analysis will be performed on the secondary outcomes . Thematic analysis ( Braun & Clarke , 2006 ) will be used to analyse the qualitative interviews . DISCUSSION The benefits , challenges and method ological challenges of developing a web-based intervention and conducting an RCT online are discussed . CONCLUSION The results of this trial will inform a definitive trial ; and the implementation phase will aim to assess the potential for use within the NHS",
"Abstract Objective : To determine the efficacy of teaching patients with bipolar disorder ( manic-depressive psychosis ) to identify early symptoms of relapse and seek prompt treatment from health services . Design : Single blind r and omised controlled trial with matching on four baseline variables using a minimisation algorithm . Setting : Mental health services in four NHS trusts ( one teaching , three non-teaching ) . Subjects : 69 patients with bipolar disorder who had had a relapse in the previous 12 months . Interventions : Seven to 12individual treatment sessions from a research psychologist plus routine care or routine care alone . Main outcome measures : Time to first manic or depressive relapse , number of manic or depressive relapses , and social functioning examined by st and ardised interviews every six months for 18 months . Results : 25th centile time to first manic relapse in experimental group was 65weeks compared with 17weeks in the control group . Event curves of time to first manic relapse significantly differed between experimental and control groups ( log rank 7.04 , df=1 , P=0.008 ) , with significant reductions in the number of manic relapses over 18months ( median difference 30 % ( 95 % confidence interval 8 % to 52 % ) , P=0.013 ) . The experimental treatment had no effect on time to first relapse or number of relapses with depression , but it significantly improved overall social functioning ( mean difference 2.0(0.7to 3.2 ) , P=0.003 ) and employment ( mean difference 0.7(0.1to 1.3 ) , P=0.030 ) by 18months . Conclusion : Teaching patients to recognise early symptoms of manic relapse and seek early treatment is associated with important clinical improvements in time to first manic relapse , social functioning , and employment",
"OBJECTIVES People in the late stage of bipolar disorder ( BD ) experience elevated relapse rates and poorer quality of life ( QoL ) compared with those in the early stages . Existing psychological interventions also appear less effective in this group . To address this need , we developed a new online mindfulness-based intervention targeting quality of life ( QoL ) in late stage BD . Here , we report on an open pilot trial of ORBIT ( online , recovery-focused , bipolar individual therapy ) . METHODS Inclusion criteria were : self-reported primary diagnosis of BD , six or more episodes of BD , under the care of a medical practitioner , access to the internet , proficient in English , 18 - 65 years of age . Primary outcome was change ( baseline - post-treatment ) on the Brief QoL.BD ( Michalak and Murray , 2010 ) . Secondary outcomes were depression , anxiety , and stress measured on the DASS scales ( Lovibond and Lovibond , 1993 ) . RESULTS Twenty-six people consented to participate ( Age M=46.6 years , SD=12.9 , and 75 % female ) . Ten participants were lost to follow-up ( 38.5 % attrition ) . Statistically significant improvement in QoL was found for the completers , t(15)=2.88 , 95 % CI:.89 - 5.98 , p=.011 , ( Cohen׳s dz=.72 , partial η(2)=.36 ) , and the intent-to-treat sample t(25)=2.65 , 95 % CI:.47 - 3.76 , ( Cohen׳s dz=.52 ; partial η(2)=.22 ) . A non-significant trend towards improvement was found on the DASS anxiety scale ( p=.06 ) in both completer and intent-to-treat sample s , but change on depression and stress did not approach significance . LIMITATIONS This was an open trial with no comparison group , so measured improvements may not be due to specific elements of the intervention . Structured diagnostic assessment s were not conducted , and interpretation of effectiveness was limited by substantial attrition . CONCLUSION Online delivery of mindfulness-based psychological therapy for late stage BD appears feasible and effective , and ORBIT warrants full development . Modifications suggested by the pilot study include increasing the 3 weeks duration of the intervention , adding caution s about the impact of extended meditations , and addition of coaching support/monitoring to optimise engagement",
"Heart rate variability ( HRV ) is a vali date d measure of sympato-vagal balance in the autonomic nervous system . HRV appears decreased in patients with bipolar disorder ( BD ) compared with healthy individuals , but the extent of state-related alterations has been sparingly investigated . The present study examined differences in HRV between affective states in BD . A heart rate and movement sensor weighing 8 g collected average acceleration , heart rate and the two slowest and fastest heart beats ( of the most recent 16 beats ) every 30 s over a period of at least three consecutive weekdays and nights in a prospect i ve longitudinal design from a total of 31 different affective states in 16 out patients with BD . A proxy measure of HRV was calculated as the difference between the second-shortest and the second-longest inter-beat-interval collected during each of the epochs . Analyses were based on over 100.000 HRV data -points . In unadjusted analyses and in analyses adjusted for age , gender and heart rate , during a manic state HRV was increased by 18 % compared with a depressed state ( eB = 1.18 , 95 % CI : 1.16 - 1.20 , p HRV appears to be altered in a state-dependent manner in bipolar disorder and could represent a c and i date state marker . Further studies with larger sample sizes are warranted",
"BACKGROUND Psychosocial interventions for bipolar disorder are frequently unavailable and re source intensive . Mobile technology may improve access to evidence -based interventions and may increase their efficacy . We evaluated the feasibility , acceptability and efficacy of an augmentative mobile ecological momentary intervention targeting self-management of mood symptoms . METHODS This was a r and omized single-blind controlled trial with 82 consumers diagnosed with bipolar disorder who completed a four-session psychoeducational intervention and were assigned to 10 weeks of either : 1 ) mobile device delivered interactive intervention linking patient-reported mood states with personalized self-management strategies , or 2 ) paper- and -pencil mood monitoring . Participants were assessed at baseline , 6 weeks ( mid-point ) , 12 weeks ( post-treatment ) , and 24 weeks ( follow up ) with clinician-rated depression and mania scales and self-reported functioning . RESULTS Retention at 12 weeks was 93 % and both conditions were associated with high satisfaction . Compared to the paper- and -pencil condition , participants in the augmented mobile intervention condition showed significantly greater reductions in depressive symptoms at 6 and 12 weeks ( Cohen׳s d for both were d=0.48 ) . However , these effects were not maintained at 24-weeks follow up . Conditions did not differ significantly in the impact on manic symptoms or functional impairment . LIMITATIONS This was not a definitive trial and was not powered to detect moderators and mediators . CONCLUSIONS Automated mobile-phone intervention is feasible , acceptable , and may enhance the impact of brief psychoeducation on depressive symptoms in bipolar disorder . However , sustainment of gains from symptom self-management mobile interventions , once stopped , may be limited",
"OBJECTIVES To examine the comparative effectiveness of an online psychoeducation program for people diagnosed with bipolar disorder within the previous 12 months , completed alone or with adjunctive peer support , on symptoms and perceived control over the illness . METHOD Participants were r and omly allocated to an eight-week online psychoeducation program ( n=139 ) , a psychoeducation program plus online peer support ( n=134 ) or an attentional control condition ( n=134 ) . RESULTS Increased perceptions of control , decreased perceptions of stigmatisation and significant improvements in levels of anxiety and depression , from pre- to post-intervention were found across all groups . There were no significant differences between groups on outcome measures , although a small clinical difference was found between the supported and unsupported conditions in depression symptoms and in functional impairment at the six-month follow-up . Adherence to the treatment program was significantly higher in the supported intervention than in the unsupported program . Gender and age were also significant predictors of adherence , with females and those over the age of 30 showing greater adherence . LIMITATIONS Mood state at study entry was measured by self-report rather than by clinical interview . CONCLUSIONS The pattern of outcomes suggests a primary influence of non-specific or common therapeutic factors across all three intervention groups . A personally tailored intervention may be more suitable for individuals recently diagnosed with bipolar disorder , and longer term coaching may increase program adherence and long-term improvement in symptoms and functioning",
"BACKGROUND The Internet is used to deliver information on many psychiatric disorders such as bipolar disorder . This paper reports on the results of a 12-months r and omised controlled trial , which examined the efficacy of an Internet-based preventive program for bipolar disorder , adjunctive to usual pharmacological management . METHODS Participants were recruited by completing an online screening question naire accessed through the Black Dog Institute and Sentiens websites based in Australia . The treatment was predominantly psycho-educational with cognitive behavioral therapy optional elements . The attention control treatment comprised directing subjects to a variety of websites focused on ' healthy living ' . Time to recurrence was determined using Kaplan-Meier survival analysis . The main outcome measures were recurrence as defined by : ( i ) depressive and /or hypomanic symptomatology and functional capacity ( using Beck Depression Inventory , Internal State Scale and Sheehan Disability Scale ) and ( ii ) hospitalization . RESULTS Two-hundred- and -thirty-three subjects were r and omized to the active or control treatment groups . There were no significant differences between the active and control treatment groups on any of the definitions of recurrence . LIMITATIONS Reliance on an online self-report tool to confirm diagnosis and hospitalization rates may have potentially allowed for inclusion of individuals with other diagnoses such as borderline personality disorder . The ' attention control ' treatment may have included more ' active ' components than intended . CONCLUSIONS This is the first report examining the efficacy of a r and omized controlled web-based psychological intervention in a large sample of subjects with bipolar disorder . The potential reasons for failing to demonstrate a significant difference compared to the active control are discussed",
"Background : Most programs addressing psychosocial concerns of cancer survivors are in-person programs that are expensive to deliver , have limited availability , and seldom deal with caregivers ’ concerns . Objective : This study examined the feasibility of translating an efficacious nurse-delivered program ( FOCUS Program ) for patients and their caregivers to a tailored , dyadic Web-based format . Specific aims were to ( 1 ) test the preliminary effects of the Web-based intervention on patient and caregiver outcomes , ( 2 ) examine participants ’ program satisfaction , and ( 3 ) determine the feasibility of using a Web-based delivery format . Methods : A phase 2 feasibility study was conducted with cancer patients ( lung , breast , colorectal , prostate ) and their family caregivers ( N = 38 dyads ) . The Web-based intervention provided information and support tailored to the unique characteristics of each patient , caregiver , and their dyadic relationship . Primary outcomes were emotional distress and quality of life . Secondary outcomes were benefits of illness/caregiving , communication , support , and self-efficacy . Analyses included descriptive statistics and repeated- measures analysis of variance . Results : Dyads had a significant decrease in emotional distress , increase in quality of life , and perceived more benefits of illness/caregiving . Caregivers also had significant improvement in self-efficacy . There were no changes in communication . Participants were satisfied with program usability , but recommended additional content . Conclusions : It was possible to translate a clinician-delivered program to a Web-based format that was easy to use and had positive effects on dyadic outcomes . Implication s for Practice : The Web-based program is a promising way to provide psychosocial care to more patients and caregivers using fewer personnel . It needs further testing in a larger r and omized clinical trial",
"BACKGROUND Several sleep laboratory studies suggest sleep abnormalities in bipolar disorder . However , this is the first study to compare remitted bipolar subjects with controls on actigraphic and subjective sleep parameters in a naturalistic setting over 5 nights . METHODS Nineteen subjects with Bipolar I Disorder and 19 age- and gender-matched healthy controls were included . Objective sleep parameters were estimated using wrist actigraphs . Subject-rated sleep diaries and mood ratings were also completed . Sleep data were averaged for each subject across nights , and raw score st and ard deviations were calculated as a measure of within-subject variability . RESULTS Multivariate analyses of variance found significant group differences for both actigraphic ( F(4,33)=3.80 , P=0.012 ) and subjective measures ( F(4,31)=3.18 , P=0.027 ) . Univariate analyses identified reliable differences in sleep onset latency ( subjective ) , sleep duration ( subjective ) , and variability of sleep duration and night wake time ( actigraphic ) . Binary backward stepwise logistic regression demonstrated that a combination of three sleep measures correctly predicted disorder status in 84 % of cases . LIMITATIONS Failure to match on sociodemographic and employment status is a limitation that may provide an alternative explanation for some findings . Furthermore , in the bipolar group 18 of 19 subjects were in receipt of psychotropic medication , compared to none of the healthy control group . Also , no information was recorded about family history of mental disorders in the control group . CONCLUSIONS The study suggests that the sleep of remitted bipolar out patients measured in naturalistic setting s is characteristically different from controls : bipolar subjects sleep longer , report longer onset latencies , and display greater variability across nights",
"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 Bipolar Disorder ( BD ) is a severe mental health problem . Psychological interventions are recommended by the National Institute for Health and Care Excellence ( NICE ) but patients experience severe inequalities in access . This study assessed the feasibility and potential effectiveness of a recovery informed web-based self-management intervention for people with BD . METHODS An online r and omised controlled trial ( n=122 ) compared treatment as usual ( TAU ) plus the ' Living with Bipolar ' ( LWB ) intervention with a waiting list control ( WLC ) group . RESULTS The study recruited to target and the retention rates were high . Participants engaged with the approach . Compared with the WLC , those receiving LWB showed the most robust improvement in psychological and physical domains of quality of life , wellbeing and recovery at the end of the intervention . LIMITATIONS The trial was not definitive and requires further investigation . CONCLUSIONS There is preliminary evidence that a web-based treatment approach in BD is feasible and potentially effective . Such interventions could form part of the Improving Access to Psychological Therapy ( IAPT ) initiative in severe mental health",
"OBJECTIVE A pilot study evaluated whether the addition of online coaching from a peer specialist increased participation in an online program featuring educational and interactive modules to promote self-management of bipolar disorder . METHODS A total of 118 participants with bipolar disorder recruited from online and in-person support groups and clinical setting s were enrolled in MyRecoveryPlan . Half the group was r and omly assigned to receive online coaching support from a certified peer specialist . RESULTS Participants offered online peer coaching were more likely to return to the program after registration ( 71 % versus 44 % , p=.005 ) and to continue using the program after three weeks ( 38 % versus 9 % , p online coaching from a peer specialist significantly increased engagement and retention in the program , but further research is needed to evaluate the program 's effects on clinical and recovery outcomes"
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Physical activity is beneficial for many chronic conditions . However , activity levels of Native Americans are not well known . This systematic review investigated if Native American population s achieve the recommended physical activity levels , compared current and past activity levels , and assessed the ability of exercise training programmes to improve health outcomes among this population . Electronic data bases ( e.g. MEDLINE , EMBASE ) were search ed and citations were cross-referenced . Included articles reported physical activity levels or investigations among Native Americans . This search identified 89 articles : self-report ( n = 61 ) , accelerometry and pedometry ( n = 10 ) , metabolic monitoring ( n = 10 ) and physical activity interventions ( n = 17 ) . Few adults were found to meet the physical activity recommendations ( 27.2 % [ 95 % confidence interval = 26.9 - 27.5 % ] self-report , 9 % [ 4 - 14 % ] accelerometry ) . Among children/youth , 26.5 % ( 24.6 - 28.4 % ) ( self-report ) to 45.7 % ( 42.3 - 49.1 % ) ( pedometry/accelerometry ) met the recommendations . Adults and children/youth were generally identified as physically inactive ( via doubly labelled water ) . Overall , Native American adults reported lower activity levels since 2000 , compared to 1990s , although similar to 1980s . Few physical activity interventions employed strong method ologies , large sample sizes and objective outcome measures . There is a clear need to increase Native American population s ' physical activity . Additional research is required to evaluate exercise training programmes among this population
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"BACKGROUND Childhood obesity is a major public health problem in the United States , particularly among American Indian communities . OBJECTIVE The objective was to evaluate the effectiveness of a school-based , multicomponent intervention for reducing percentage body fat in American Indian schoolchildren . DESIGN This study was a r and omized , controlled , school-based trial involving 1704 children in 41 schools and was conducted over 3 consecutive years , from 3rd to 5th grade s , in schools serving American Indian communities in Arizona , New Mexico , and South Dakota . The intervention had 4 components : 1 ) change in dietary intake , 2 ) increase in physical activity , 3 ) a classroom curriculum focused on healthy eating and lifestyle , and 4 ) a family-involvement program . The main outcome was percentage body fat ; other outcomes included dietary intake , physical activity , and knowledge , attitudes , and behaviors . RESULTS The intervention result ed in no significant reduction in percentage body fat . However , a significant reduction in the percentage of energy from fat was observed in the intervention schools . Total energy intake ( by 24-h dietary recall ) was significantly reduced in the intervention schools but energy intake ( by direct observation ) was not . Motion sensor data showed similar activity levels in both the intervention and control schools . Several components of knowledge , attitudes , and behaviors were also positively and significantly changed by the intervention . CONCLUSIONS These results document the feasibility of implementing a multicomponent program for obesity prevention in elementary schools serving American Indian communities . The program produced significant positive changes in fat intake and in food- and health-related knowledge and behaviors . More intense or longer interventions may be needed to significantly reduce adiposity in this population",
"OBJECTIVE Physical inactivity is common among older population s and American Indians . Our objective was to compare two methods for increasing physical activity and walking among American Indian elders . METHODS We conducted a two arm r and omized trial to increase physical activity in 125 American Indians aged 50 - 74 years at the Seattle Indian Health Board in 2005 . Participants were r and omized into either an activity monitoring ( N=63 ) or activity monitoring with a pedometer ( N=62 ) arm over a six-week period . Outcomes included self-reported physical activity and well-being , and the 6-min walk test . RESULTS There were no group differences in self-reported physical activities and well-being . The 6-min walk test yielded no between-group differences . All participants increased the frequency of leisure walking ( p frequency of all exercise-related activities ( p frequency of moderate-intensity exercise activities ( p improved weekly caloric expenditure for all exercise activities ( p<0.05 ) by the end of the trial . CONCLUSIONS Pedometers did not confer enhanced performance on the physical activity outcomes beyond those achieved through self-monitoring . Physical activity can be promoted among at-risk groups in a brief , inexpensive manner in primary care . Exercise prescription and culturally relevant enhancement strategies may optimize physical activity outcomes for elder American Indians",
"OBJECTIVE The Diabetes Prevention Program ( DPP ) showed that intensive lifestyle intervention reduced the risk of diabetes by 58 % . This paper examines demographic , psychosocial , and behavioral factors related to achieving weight loss and physical activity goals in the DPP lifestyle participants . RESEARCH METHODS AND PROCEDURES Lifestyle participants ( n = 1079 ; mean age = 50.6 , BMI = 33.9 , 68 % female , and 46 % from minority groups ) had goals of 7 % weight loss and 150 min/wk of physical activity . Goal achievement was assessed at the end of the 16-session core curriculum ( approximately week 24 ) and the final intervention visit ( mean = 3.2 years ) as a function of demographic , psychosocial , and behavioral variables . RESULTS Forty-nine percent met the weight loss goal and 74 % met the activity goal initially , while 37 % and 67 % , respectively , met these goals long-term . Men and those with lower initial BMI were more likely to meet activity but not weight loss goals . Hispanic , Asian , and Native Americans were more likely to meet the long-term activity goals , and whites were more likely to meet the initial weight loss goal . In multivariate analyses , meeting the long-term weight loss goal and both activity goals increased with age , while psychosocial and depression measures were unrelated to goal achievement . Dietary self-monitoring was positively related to meeting both weight loss and activity goals , and meeting the activity goal was positively related to meeting the weight loss goal . Participants who met initial goals were 1.5 to 3.0 times more likely to meet these goals long-term . DISCUSSION Success at meeting the weight loss and activity goals increased with age . Initial success predicted long-term success . Self-monitoring and meeting activity goals were related to achieving and sustaining weight loss",
"BACKGROUND Little is known about the rates of cardiovascular disease ( CVD ) , atherosclerosis , and their risk factors among Canada 's Aboriginal people . To establish the relative prevalence of risk factors , atherosclerosis , and CVD , we undertook a population -based study among people of Aboriginal and European ancestry in Canada . METHODS We r and omly recruited 301 Aboriginal people from the Six Nations Reservation , and 326 people of European origin from Hamilton , Toronto , and Edmonton , Canada . Clinical CVD was defined by history or electrocardiographic findings , atherosclerosis was measured by B-mode carotid ultrasonography , and conventional and new CVD risk factors were measured using st and ardised methods . FINDINGS Aboriginal people had significantly more carotid atherosclerosis ( mean of the maximum intimal-medial thickness 0.82 ( SD 0.20 ) mm vs 0.78 ( 0.20 ) mm , p=0.027 ) , and had a higher frequency of CVD ( 18.5 % vs 7.6 % , p=0.00002 ) compared with Europeans . Aboriginal people had significantly higher rates of smoking , glucose intolerance , obesity , abdominal obesity , and substantially higher concentrations of fibrinogen , and plasminogen activator inhibitor-1 . Aboriginal people had significantly higher rates of unemployment and a lower annual household income . For any given income level , Aboriginal people had higher rates of risk factors and CVD compared with the Europeans . INTERPRETATION A significant proportion of Aboriginal people live in poverty which is associated with high rates of CVD and CVD risk factors . Improvement of the socioeconomic status of Aboriginal people might be a key to reduce CVD in this group",
"OBJECTIVE To determine whether maternal participation in an obesity prevention plus parenting support ( OPPS ) intervention would reduce the prevalence of obesity in high-risk Native-American children when compared with a parenting support (PS)-only intervention . RESEARCH METHODS AND PROCEDURES Forty-three mother/child pairs were recruited to participate . Mothers were 26.5 + /- 5 years old with a mean BMI of 29.9 + /- 3 kg/m(2 ) . Children ( 23 males ) were 22 + /- 8 months old with mean weight-for-height z ( WHZ ) scores of 0.73 + /- 1.4 . Mothers were r and omly assigned to a 16-week OPPS intervention or PS alone . The intervention was delivered one-on-one in homes by an indigenous peer educator . Baseline and week 16 assessment s included weight and height ( WHZ score and weight-for-height percentile for children ) , dietary intake ( 3-day food records ) , physical activity ( measured by accelerometers ) , parental feeding style ( Child Feeding Question naire ) , and maternal outcome expectations , self-efficacy , and intention to change diet and exercise behaviors . RESULTS Changes in WHZ scores showed a trend toward significance , with WHZ scores decreasing in the PS condition and increasing among the OPPS group ( -0.27 + /- 1.1 vs. 0.31 + /- 1.1 , p = 0.06 ) . Children in the OPPS condition also significantly decreased energy intake ( -316 + /- 835 kcal/d vs. 197 + /- 608 kcal/d , p Scores on the restriction subscale of the Child Feeding Question naire decreased significantly in the OPPS condition ( -0.22+/- 0.42 vs. 0.08+/- 0.63 , p OPPS group were engaging in less restrictive child feeding practice s over time . DISCUSSION A home-visiting program focused on changing lifestyle behaviors and improving parenting skills showed promise for obesity prevention in high-risk Native-American children",
"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",
"OBJECTIVE To report dietary intake and physical activity among preschool-aged children living in rural American Indian communities before participation in a family-based healthy lifestyle intervention and to compare data to current age-specific recommendations . SUBJECTS/ DESIGN One hundred thirty-five preschool-aged children , living in rural American Indian communities , provided diet and physical activity data before participating in a 2-year r and omized healthy lifestyle intervention . Three 24-hour dietary recalls assessed nutrient and food and added sugar intake , which were compared to the National Academy of Science 's Dietary Reference Intakes , the US Department of Agriculture 's MyPyramid , and American Heart Association recommendations . Time watching television and moderate plus vigorous activity was compared to MyPyramid and American Academy of Pediatrics recommendations . STATISTICAL ANALYSIS Nutrient , food group , added sugar intake , and time watching television and in moderate or vigorous activity were compared to recommendations by computing the percent of recommendations met . Nonparametric tests identified differences in diet and physical activity among age groups and normal and overweight children ( body mass index or = 85th percentile ) . RESULTS Average nutrient intakes met recommendations whereas food group intakes did not . Mean fruit and vegetable intakes for 2- to 3-year-olds were 0.36 c/day fruit and 0.45 c/day vegetables and , for 4- to 5-year-olds , 0.33 c/day fruit and 0.48 c/day vegetables . Both age groups reported consuming more than 50 g added sugar , exceeding the recommendation of 16 g. Overweight vs normal weight children reported significantly more sweetened beverage intake ( 8.0+/-0.10 vs 5.28+/-0.08 oz/day , P watching television 2.0 hours/day and significant differences were observed for total television viewing and nonviewing time between overweight and normal weight children ( 8.52+/-0.6 vs 6.54+/-0.6 hours/day , P 20 minutes/day of moderate or vigorous activity . CONCLUSIONS Overall , children in this sample did not meet MyPyramid recommendations for fruits or vegetables and exceed added sugar intake recommendations . Television viewing time and time when the television was on in the home was highly prevalent along with low levels of moderate or vigorous activity . The Healthy Children Strong Families intervention we studied has potential for improving nutrition and physical activity among preschool-aged children living in rural American Indian communities",
"The purpose of this study was to evaluate the efficacy of a community-based exercise course applied to a group of American Indians ( AI ) who , because of physician recommendation and /or self-motivation , desired to increase their physical activity . Changes in physiological measurements and self-perceived measurements were determined following a moderate-intensity exercise program implemented through a r and omized controlled trial to a population of American Indian elders between the ages of 55 and 75 living in an urban area . It was hypothesized that the exercise subjects would show improvement in all of the study variables examined , including three subjective measurements in emotional health , seven subjective measurements in physical health , and several physiological indices . The subjects participated in a six-week exercise class design ed for healthy elderly persons as well as for those struggling from arthritis , heart disease , obesity , and /or non-insulin dependent diabetes . Results were measured using both subjective self-perceived and objective physiological measurements ; T-tests were used to analyze the data , using subjects as their own controls and using a separate control group . Following the intervention , the exercise participants significantly improved their self-perceived physical health ( p = 0.001 ) , emotional health ( p = 0.023 ) , and personal appearance ( p = 0.025 ) when compared with baseline values . The exercise subjects also significantly increased the self-perceived frequency with which they performed chores that gave them exercise ( p = 0.035 ) and significantly increased the self-perceived frequency that they participated in activities specifically for exercise ( p = 0.023 ) when compared with pre-intervention measurements . A corresponding trend in objective indices was also observed : following the intervention period , exercise participants were found to significantly lower their systolic blood pressure ( p = 0.046 ) and significantly lower their respirations ( p = 0.048 ) as compared with initial values . Findings of this study suggest that senior Al adults who participated in the exercise program subjectively and objective ly improved their health status . The authors think that this type of program would be an excellent re source for physicians to recommend to their eldrly patients in need of increased physical activity . A literature search found no previously published clinical data documenting the response of Al elders to excercises that developed flexibility , muscular strength , and muscular endurance",
"Objective . We assessed health status and behavioral risks in American Indians ( AIs ) from rural , northern plains reservation communities . Methods . AI interviewers from the communities administered the core and optional modules of the Behavioral Risk Factor Surveillance System ( BRFSS ) to 404 AI adults r and omly selected from housing lists from four AI tribal communities located on the northern plains of the U.S. The BRFSS interview assessed several health functioning areas including medical conditions , preventive screenings , and behavioral risks . We measured health disparities by comparing the AI sample data with a northern plains statewide ( North Dakota ) sample and a U.S. national sample . We compared outcomes with BRFSS statewide ( North Dakota ) and U.S. national data from telephone-based interviews . Results . AI participants showed a significantly greater prevalence of diabetes , coronary heart disease , myocardial infa rct ion , smoking , obesity , and heavy alcohol use than either the regional or national sample s. They also reported being less likely to engage in leisure-time physical activity and to have had age-appropriate preventive screenings for several diseases including colorectal cancer , prostate cancer , breast cancer , and cardiovascular disease . Conclusions . Face-to-face interviews conducted by AI community members are an effective means of gathering health information about AIs living in rural , reservation communities . AIs living in these communities on the northern plains have a much higher prevalence of many health-risk behaviors and some medical conditions than are found in the general population . Improved health-care access , better preventive screenings , and culturally appropriate community-based health promotion programs and policies should be examined as possible ways to reduce health disparities",
"A pilot trial was conducted to test adherence to specific lifestyle interventions among Pima Indians of Arizona , and to compare them for changes in risk factors for diabetes mellitus . Ninety-five obese , normoglycaemic men and women , aged 25 - 54 years , were r and omized to treatments named ' Pima Action ' ( Action ) and ' Pima Pride ' ( Pride ) , which were tested for 12 months . Action involved structured activity and nutrition interventions , and Pride included unstructured activities emphasizing Pima history and culture . Adherence to interventions , changes in self-reported activity and diet , and changes in weight , glucose concentrations , and other risk factors were assessed regularly . Thirty-five eligible subjects who had declined r and omization were also followed as an ' observational ' group and 22 members of this group were examined once at a median of 25 months for changes in weight and glucose concentration . After 12 months of intervention , members of both intervention groups reported increased levels of physical activity ( median : Action 7.3 h month(-1 ) , Pride 6.3 h month(-1 ) , p decreased starch intake ( 28 g , p = 0.008 ) . Body mass index , systolic and diastolic blood pressures , weight , 2-h glucose and 2-h insulin had all increased in Action members ( p waist circumference had decreased in Pride members ( p = 0.05 ) . Action members gained more weight than Pride members ( 2.5 kg vs 0.8 kg , p = 0.06 ) , and had a greater increase in 2-h glucose than Pride members ( 1.33 mM vs 0.03 mM , p = 0.007 ) . Members of the observational group gained an average of 1.9 kg year(-1 ) in weight and had an increase of 0.36 mM year(-1 ) in 2-h glucose . Sustaining adherence in behavioural interventions over a long term was challenging . Pimas may find a less direct , less structured , and more participative intervention more acceptable than a direct and highly structured approach",
"The purpose of this analytical review was to estimate the direct and indirect economic costs of physical inactivity and obesity in Canada in 2001 . The relative risks of diseases associated with physical inactivity and obesity were determined from a meta- analysis of existing prospect i ve studies and applied to the health care costs of these diseases in Canada . Estimates were derived for both the direct health care expenditures and the indirect costs , which included the value of economic output lost because of illness , injury-related work disability , or premature death . The economic burden of physical inactivity was $ 5.3 billion ( $ 1.6 billion in direct costs and $ 3.7 billion in indirect costs ) while the cost associated with obesity was $ 4.3 billion ( $ 1.6 billion of direct costs and $ 2.7 billion of indirect costs ) . The total economic costs of physical inactivity and obesity represented 2.6 % and 2.2 % , respectively , of the total health care costs in Canada . The results underscore the importance of public health efforts aim ed at combating the current epidemics of physical inactivity and obesity in Canada",
"BACKGROUND Existing evidence indicates that Inuit in A rct ic Canada are undergoing a lifestyle transition leading to decreased physical activity ( PA ) and increased body mass index ( BMI ) . Data specific to PA and BMI amongst Inuit in Nunavut , Canada , are currently limited . The present study aim ed to characterise current PA and BMI levels in a sample of Inuit adults . METHODS Inuit adults r and omly selected from a cross-sectional survey of three communities in Nunavut , Canada , completed an adapted International Physical Activity Question naire ( IPAQ ) and an anthropometric survey . Data were analysed by gender and age group using st and ardised IPAQ protocol . RESULTS Response rates ranged from 69 - 93 % . Two hundred and eighteen Inuit adults [ 180 women , 38 men ; mean ( st and ard deviation ( SD ) ) ages 42.3 ( 13.0 ) and 42.4 ( 14.8 ) years respectively ; age range 19 - 89 years ] completed the IPAQ . All men and 97 % of women allowed height and weight measurements ; the remainder were self-reported . Mean ( SD ) BMI was 27.7 ( 6.3 ) kg/m(2 ) for males and 30.3 ( 8.0 ) kg/m(2 ) for females . The largest proportion of women and participants in both age groups had a BMI in the obese category ; males were evenly split between the normal and obese categories . Self-reported PA was high , with most men , women and participants ≤50 years in the high category of PA . Participants > 50 years were evenly split across the medium and high categories . Most participants ( 72 % ) were classified as being overweight or obese , yet reported medium or high levels of PA ( 89 % ) . CONCLUSIONS The findings obtained in the present study indicate the co-existence of high BMI and high self-reported PA amongst Inuit adults",
"Cardiovascular disease rates vary greatly between ethnic groups in Canada . To establish whether this variation can be explained by differences in disease risk factors and sub clinical atherosclerosis , we undertook a population -based study of three ethnic groups in Canada : South Asians , Chinese and Europeans . A total of 985 participants were recruited from three cities ( Hamilton , Toronto and Edmonton ) by stratified r and om sampling . Clinical cardiovascular disease was defined by history or electrocardiographic findings . Carotid atherosclerosis was measured with B-mode ultrasonography . Conventional ( smoking , hypertension , diabetes , raised cholesterol ) and novel risk factors ( markers of a prothrombotic state ) were measured . Within each ethnic group and overall , the degree of carotid atherosclerosis was associated with a higher prevalence of cardiovascular disease . South Asians had the highest prevalence of this condition compared with Europeans and Chinese ( 11 % , 5 % and 2 % , respectively ; p=0.0004 ) . Despite this finding , Europeans had more atherosclerosis ( mean of the maximum intimal medial thickness 0.75 [ 0.16 ] mm ) than South Asians ( 0.72 [ 0.15 ] mm ) and Chinese ( 0.69 [ 0.16 ] mm ) . South Asians had an increased prevalence of glucose intolerance , higher total and low-density lipoprotein cholesterol , higher triglycerides and lower high-density lipoprotein cholesterol , and much greater abnormalities in novel risk factors including higher concentrations of fibrinogen , homocysteine , lipoprotein(a ) , and plasminogen activator inhibitor-1 . Although there are differences in conventional and novel risk factors between ethnic groups , this variation and the degree of atherosclerosis only partly explains the higher rates of cardiovascular disease among South Asians compared with Europeans and Chinese . The increased risk of cardiovascular events could be due to factors affecting plaque rupture , the interaction between prothrombotic factors and atherosclerosis , or as yet undiscovered risk factors",
"Developing a physically active lifestyle is critical for all children . This is especially relevant for Pima Indian children living in Native American communities in the southwestern United States . Since the 1950s , obesity and type II diabetes mellitus incidence rates in Pima communities have increased dramatically ( Kriska et al. , 2003 ) . These conditions are becoming prevalent in Pima children as well . A study of 1,704 Native American children revealed that 53.7 % and 27.3 % of Pima girls and boys , respectively , ( M age = 7.6 years , SD = 0.6 ) are above the 95th percentile for body mass index ( BMI ; Caballero et al. , 2003 ) . Also , Dabelea et al. ( 1998 ) found that the prevalence of type II diabetes mellitus in Pima children and adolescents ages 10–19 years increased from 1967 to 1996 . Specifically , type II diabetes rates for boys ages 10–14 years increased from 0 % in 1967–76 to 1.4 % in 1987–96 and in girls ages 10–14 years from 0.72 % in 1967–76 to 2.88 % in 1987–96 . More alarming are the increased prevalence rates in Pima adolescents ages 15–19 years . During the same time periods mentioned above , adolescent type II diabetes prevalence rates rose from 2.43 % to 3.78 % for boys and from 2.73 % to 5.31 % for girls . Several prospect i ve studies have shown that a physically active lifestyle can lessen the likelihood of acquiring type II diabetes mellitus ( Helmrich , Ragl and , Leung , & Paffenbarger , 1991 ; Manson et al. , 1991 ) . Specifically , Kriska et al. ( 2003 ) examined the relationship of leisure and occupational physical activity and BMI on type II diabetes mellitus incidence rates in 1,728 nondiabetic Pima Indians 15–59 years from 1987 to 2000 . Of the participants , 346 developed diabetes . Men and women in the high physical activity group had a lower diabetes incidence than men and women in the low physical activity group . After adjusting for age and BMI , the differences between the high and low activity groups were only statistically significant in women . Results from the study suggest that physical activity participation may be a defense against type II diabetes . The apparent protective effects of physical activity against type II diabetes warrants investigation into the current physical activity participation of Pima children living in Native American communities"
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Current guidelines recommend the use of probiotics to reduce the risk of eczema . It remains unclear which strain(s ) to use . We systematic ally evaluated data on the efficacy of Lactobacillus rhamnosus GG ( LGG ) supplementation prenatally and /or postnatally for the primary prevention of eczema . The Cochrane Library , MEDLINE , and EMBASE data bases were search ed up to August 2018 , with no language restrictions , for systematic review s of r and omized controlled trials ( RCTs ) and RCTs published afterwards . The primary outcome was eczema . For dichotomous outcomes , we calculated the risk ratio ( RR ) and 95 % confidence interval ( CI ) . A r and om-effects model was used to pool data . Heterogeneity was explored using the I2 statistics . The GRADE criteria were used to assess the overall quality of evidence supporting the primary outcome . Seven publications reporting 5 RCTs ( 889 participants ) were included . High to moderate certainty in the body of evidence suggests that LGG supplementation ( regardless of the timing of administration ) did not reduce the risk of eczema . There was also no consistent effect on other allergic outcomes . This meta- analysis shows that LGG was ineffective in reducing eczema . It does not support the general recommendation to use probiotics for preventing eczema , unless specific strains would be indicated
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"Perinatal administration of the probiotic Lactobacillus rhamnosus strain GG ( ATCC 53103 ) , reduces incidence of atopic eczema in at-risk children during the first 2 years of life ( infancy ) . We have therefore assessed persistence of the potential to prevent atopic eczema at 4 years . Atopic disease was diagnosed on the basis of a question naire and a clinical examination . 14 of 53 children receiving lactobacillus had developed atopic eczema , compared with 25 of 54 receiving placebo ( relative risk 0.57 , 95 % CI 0.33 - 0.97 ) . Skin prick test reactivity was the same in both groups : ten of 50 children previously given lactobacillus compared with nine of 50 given placebo tested positive . Our results suggest that the preventive effect of lactobacillus GG on atopic eczema extends beyond infancy",
"In this r and omized controlled trial , we examined the effect of early LGG infant supplementation in decreasing the risk of childhood eczema . OBJECTIVES : To determine if probiotic administration during the first 6 months of life decreases childhood asthma and eczema . METHODS : We conducted a r and omized , double-blind controlled trial of Lactobacillus rhamnosus GG ( LGG ) supplementation on the cumulative incidence of eczema ( primary end point ) and asthma and rhinitis ( secondary end points ) in high-risk infants . For the first 6 months of life , intervention infants ( n = 92 ) received a daily dose of 10 billion colony-forming units of LGG and 225 mg of inulin ( Amerifit Br and s , Cromwell , CT ) , and control infants ( n = 92 ) received 325 mg of inulin alone . We used survival analysis methods to estimate disease incidences in the presence or absence of LGG and to estimate the efficacy of LGG in delaying or preventing these diseases . RESULTS : Infants were accrued over a 6-year period ( median follow-up : 4.6 years ; 95 % retention rate at 2 years ) . At 2 years of age , the estimated cumulative incidence of eczema was 30.9 % ( 95 % confidence interval [ CI ] , 21.4%–40.4 % ) in the control arm and 28.7 % ( 95 % CI , 19.4%–38.0 % ) in the LGG arm , for a hazard ratio of 0.95 ( 95 % CI , 0.59–1.53 ) ( log-rank P = .83 ) . At 5 years of age , the cumulative incidence of asthma was 17.4 % ( 95 % CI , 7.6%–27.1 % ) in the control arm and 9.7 % ( 95 % CI , 2.7%–16.6 % ) in the LGG arm , for a hazard ratio of 0.88 ( 95 % CI , 0.41–1.87 ) ( log-rank P = .25 ) . CONCLUSIONS : For high-risk infants , early LGG supplementation for the first 6 months of life does not appear to prevent the development of eczema or asthma at 2 years of age",
"To cite this article : Boyle RJ , Ismail IH , Kivivuori S , Licciardi PV , Robins‐Browne RM , Mah L‐J , Axelrad C , Moore S , Donath S , Carlin JB , Lahtinen SJ , Tang MLK . Lactobacillus GG treatment during pregnancy for the prevention of eczema : a r and omized controlled trial . Allergy 2011 ; 66 : 509–516",
"BACKGROUND Data for trends in prevalence of asthma , allergic rhinoconjunctivitis , and eczema over time are scarce . We repeated the International Study of Asthma and Allergies in Childhood ( ISAAC ) at least 5 years after Phase One , to examine changes in the prevalence of symptoms of these disorders . METHODS For the ISAAC Phase Three study , between 2002 and 2003 , we did a cross-sectional question naire survey of 193,404 children aged 6 - 7 years from 66 centres in 37 countries , and 304,679 children aged 13 - 14 years from 106 centres in 56 countries , chosen from a r and om sample of schools in a defined geographical area . FINDINGS Phase Three was completed a mean of 7 years after Phase One . Most centres showed a change in prevalence of 1 or more SE for at least one disorder , with increases being twice as common as decreases , and increases being more common in the 6 - 7 year age-group than in the 13 - 14 year age-group , and at most levels of mean prevalence . An exception was asthma symptoms in the older age-group , in which decreases were more common at high prevalence . For both age-groups , more centres showed increases in all three disorders more often than showing decreases , but most centres had mixed changes . INTERPRETATION The rise in prevalence of symptoms in many centres is concerning , but the absence of increases in prevalence of asthma symptoms for centres with existing high prevalence in the older age-group is reassuring . The divergent trends in prevalence of symptoms of allergic diseases form the basis for further research into the causes of such disorders",
"BACKGROUND . The value of probiotics for primary prevention is controversial . Published trials vary considerably in study design and the applied probiotics , thereby limiting comparability of the results . OBJECTIVE . The purpose of this trial was to study the preventive effect of the probiotic Lactobacillus GG on the development of atopic dermatitis . METHODS . In a double-blind , placebo-controlled prospect i ve trial , 105 pregnant women from families with ≥1 member ( mother , father , or child ) with an atopic disease were r and omly assigned to receive either the probiotic Lactobacillus GG ( American Type Culture Collection 53103 ; 5 × 109 colony-forming units of Lactobacillus GG twice daily ) or placebo . Ninety-four families ( 89.5 % ) completed the trial . The supplementation period started 4 to 6 weeks before expected delivery , followed by a postnatal period of 6 months . The primary end point was the occurrence of atopic dermatitis at the age of 2 years . Secondary outcomes were severity of atopic dermatitis , recurrent episodes of wheezing bronchitis , and allergic sensitization at the age of 2 years . RESULTS . Atopic dermatitis was diagnosed in 14 ( 28 % ) of 50 in the Lactobacillus GG group and in 12 ( 27.3 % ) of 44 in the placebo group . The risk of atopic dermatitis in children on probiotics relative to placebo was 0.96 ( confidence interval 0.38–2.33 ) . Severity of atopic dermatitis was comparable between the 2 groups . Notably , children with recurrent ( ≥5 ) episodes of wheezing bronchitis were more frequent in the Lactobacillus GG group ( 26 % ; n = 13 ) , as compared with the placebo group ( 9.1 % ; n = 4 ) . No difference was observed between both groups in total immunoglobulin E concentrations or numbers of specific sensitization to inhalant allergens . CONCLUSIONS . Supplementation with Lactobacillus GG during pregnancy and early infancy neither reduced the incidence of atopic dermatitis nor altered the severity of atopic dermatitis in affected children but was associated with an increased rate of recurrent episodes of wheezing bronchitis . Therefore , Lactobacillus GG can not be generally recommended for primary prevention",
"The prevalence of atopic diseases is increasing throughout the Western world , and means of primary prevention are needed to reverse this trend . The role of breast-feeding , the best source of infant nutrition , in protection against atopic disease remains elusive . In this double-blinded , placebo-controlled study of 62 mother-infant pairs , it is shown that administering probiotics to the pregnant and lactating mother increased the immunoprotective potential of breast milk , as assessed by the amount of anti-inflammatory transforming growth factor beta2 ( TGF-beta2 ) in the milk ( 2885 pg/mL [ 95 % CI , 1624 - 4146 ] in mothers receiving probiotics vs 1340 pg/mL [ 95 % CI , 978 - 1702 ] in mothers receiving placebo ; P = .018 ) . The risk of developing atopic eczema during the first 2 years of life in infants whose mothers received probiotics was significantly reduced in comparison with that in infants whose mothers received placebo ( 15 % and 47 % , respectively ; relative risk , 0.32 [ 95 % CI , 0.12 - 0.85 ] ; P = .0098 ) . Maternal atopy was a clear risk factor for atopic eczema in the infant . The infants most likely to benefit from maternal probiotic supplementation were those with an elevated cord blood IgE concentration . Administering probiotics during pregnancy and breast-feeding thus offers a safe and effective mode of promoting the immunoprotective potential of breast-feeding and provides protection against atopic eczema during the first 2 years of life",
"Background Prevalence of allergic diseases in infants , whose parents and siblings do not have allergy , is approximately 10 % and reaches 20–30 % in those with an allergic first-degree relative . Intestinal microbiota may modulate immunologic and inflammatory systemic responses and , thus , influence development of sensitization and allergy . Probiotics have been reported to modulate immune responses and their supplementation has been proposed as a preventive intervention . Objective The World Allergy Organization ( WAO ) convened a guideline panel to develop evidence -based recommendations about the use of probiotics in the prevention of allergy . Methods We identified the most relevant clinical questions and performed a systematic review of r and omized controlled trials of probiotics for the prevention of allergy . We followed the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach to develop recommendations . We search ed for and review ed the evidence about health effects , patient values and preferences , and re source use ( up to November 2014 ) . We followed the GRADE evidence -to-decision framework to develop recommendations . Results Currently available evidence does not indicate that probiotic supplementation reduces the risk of developing allergy in children . However , considering all critical outcomes in this context , the WAO guideline panel determined that there is a likely net benefit from using probiotics result ing primarily from prevention of eczema . The WAO guideline panel suggests : a ) using probiotics in pregnant women at high risk for having an allergic child ; b ) using probiotics in women who breastfeed infants at high risk of developing allergy ; and c ) using probiotics in infants at high risk of developing allergy . All recommendations are conditional and supported by very low quality evidence . Conclusions WAO recommendations about probiotic supplementation for prevention of allergy are intended to support parents , clinicians and other health care professionals in their decisions whether to use probiotics in pregnancy and during breastfeeding , and whether to give them to infants",
"IN RESPONSE : We agree with Dr. Baldassarre that the regulatory model for approval of probiotics , prebiotics , and synbiotics could alter the evaluation of adverse events in r and omized controlled trials , which may cause study publications to omit some safety data . This regulatory model has remained ambiguous and complex and varies by region ( 1 , 2 ) . Probiotics that have a long historical use or are used as additives or processing aids have been subject to few or no regulations . In contrast , those intended for new therapeutic purpose s must follow a strict process for approval ( 3 ) . We recognize that the safety and efficacy findings associated with a specific probiotic formulation should not be generalized to a new formulation . Knowing the precise identity of a probiotic that was assessed in a r and omized controlled trial is fundamental to determine its exact safety profile . The identification methods typically used ( such as pulsed-field gel electrophoresis and r and omly amplified polymorphic DNA analysis ) allow for differentiation of individual strains but are otherwise inadequate for species recognition ( 2 ) . Inconsistencies in the bacterial identification for probiotics may lead to a biased safety profile and erroneous decision making and have major consequences for patients . It is crucial that toxicology of these products take into account the dose , formulation , bacterial species , and target population . That all stakeholdersincluding laboratories , government regulatory authorities , and scientistsbe prepared to address this important topic is critical . Nevertheless , problems with the regulatory model can not fully explain why 28 % of trials did not report any information on harms and 70 % inadequately reported harms-related data . Poor reporting of harms may be due to distorted reporting of adverse events in the trials , silencing the evidence on harms , or lack of knowledge on how to report adverse events in publications ( 4 ) . Inadequate reporting of adverse events in published articles of r and omized controlled trials remains a major problem in several medical areas . We need to promote more active implementation and endorsement of recommendations for st and ardizing the evaluation of these interventions and reporting harms-related data . The points raised by Dr. Baldassarre and the findings of our study highlight that a collective , international effort is urgently needed to improve the evaluation of these products"
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There is evidence that physical exercise training ( PET ) conducted at the workplace is effective in improving physical fitness and thus health . However , there is no current systematic review available that provides high-level evidence regarding the effects of PET on physical fitness in the workforce . To quantify sex- , age- , and occupation type-specific effects of PET on physical fitness and to characterize dose – response relationships of PET modalities that could maximize gains in physical fitness in the working population . A computerized systematic literature search was conducted in the data bases PubMed and Cochrane Library ( 2000–2019 ) to identify articles related to PET in workers . Only r and omized controlled trials with a passive control group were included if they investigated the effects of PET programs in workers and tested at least one fitness measure . Weighted mean st and ardised mean differences ( SMDwm ) were calculated using r and om effects models . A multivariate r and om effects meta-regression was computed to explain the influence of key training modalities ( e.g. , training frequency , session duration , intensity ) on the effectiveness of PET on measures of physical fitness . Further , subgroup univariate analyses were computed for each training modality . Additionally , method ological quality of the included studies was rated with the help of the Physiotherapy Evidence Data base ( PEDro ) Scale . Overall , 3423 workers aged 30–56 years participated in 17 studies ( 19 articles ) that were eligible for inclusion . Method ological quality of the included studies was moderate with a median PEDro score of 6 . Our analyses revealed significant , small-sized effects of PET on cardiorespiratory fitness ( CRF ) , muscular endurance , and muscle power ( 0.29 ≤ SMDwm ≤ 0.48 ) . Medium effects were found for CRF and muscular endurance in younger workers ( ≤ 45 years ) ( SMDwm = 0.71 ) and white-collar workers ( SMDwm = 0.60 ) , respectively . Multivariate r and om effects meta-regression for CRF revealed that none of the examined training modalities predicted the effects of PET on CRF ( R2 = 0 ) . Independently computed subgroup analyses showed significant PET effects on CRF when conducted for 9–12 weeks ( SMDwm = 0.31 ) and for 17–20 weeks ( SMDwm = 0.74 ) . PET effects on physical fitness in healthy workers are moderated by age ( CRF ) and occupation type ( muscular endurance ) . Further , independently computed subgroup analyses indicated that the training period of the PET programs may play an important role in improving CRF in workers
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"Objectives Occupational groups exposed to high occupational physical activity have an increased risk for cardiovascular disease ( CVD ) . This may be explained by the high relative aerobic workload . Enhanced cardiorespiratory fitness reduces the relative aerobic workload . Thus , the aim was to evaluate the 12-months effects of worksite aerobic exercise on risk factors for CVD among cleaners . Methods One hundred and sixteen cleaners aged 18–65 years were r and omized to a group performing aerobic exercise and a reference group receiving lectures . Outcomes were collected at baseline and after 12-months . A repeated measures 2 × 2 multi-adjusted mixed-model design was applied to compare the between-group differences using intention-to-treat analysis . Results Between-group differences ( p aerobic exercise group : cardiorespiratory fitness 2.15 ( SE 1.03 ) mlO2/min/kg , aerobic workload -2.15 ( SE 1.06 ) % HRR , resting HR -5.31 ( SE 1.61 ) beats/min , high sensitive C-reactive protein -0.65 ( SE 0.24 ) μg/ml . The blood pressure was unaltered . Stratified analyses on relative aerobic workload at baseline revealed that those with relative aerobic workloads ≥30 % of HRR seems to impose a notable adverse effect on resting and ambulatory blood pressure . Conclusion This long-term worksite aerobic exercise intervention among cleaners led to several beneficial effects , but also potential adverse effects among those with high relative aerobic workloads . Trial Registration Controlled-Trials.com IS RCT",
"Objective : To investigate the effect of two contrasting physical activity worksite interventions versus a reference intervention ( REF ) on various health outcomes . Methods : A 1-year r and omized controlled trial was conducted with specific resistance training ( SRT ) , all-round physical exercise ( APE ) , and REF . Results : SRT and APE compared with REF showed significant reductions in systolic blood pressure ( ∼6 mm Hg ) , body fat percentage ( ∼2.2 body fat% ) , as well as shoulder and back pain ( ∼30 % reduction in duration ) . Muscle strength ( APE and SRT ) and maximal oxygen uptake ( APE ) increased approximately 10 % . Conclusions : Worksite intervention with both SRT as well as APE is recommended , since these activities compared with REF result ed in clinical ly relevant reductions of cardiovascular and metabolic syndrome-related risk factors as well as musculoskeletal pain symptoms , in combination with minor increases in physical capacity",
"Objective : This pilot study questions the effects of a worksite physical activity program on health and fitness in tertiary employees . Methods : Ninety-five employees were r and omly assigned to Control ( CON ) ; Novice ( NOV ) ; Experienced group ( EXP ) . The NOV and EXP groups followed a 5-month worksite physical activity program ( at least two sessions/week ) . Body composition , physical activity level and physical fitness , eating habits , health perception , sleep quality , pain , and quality of life were assessed . Results : Fat mass decreased in NOV and EXP ; the distance covered during the 6-minute walking test , push-ups , squat jump increased for NOV and EXP group . Physical activity level , health perception , quality of sleep , and eating habits were improved in NOV . Conclusion : This study underlines for the first time the beneficial effects of such worksite programs among tertiary employees on overall health and the feasibility of its design",
"Purpose This study assessed the effects of a worksite aerobic exercise intervention among cleaners on : work ability , need for recovery , productivity , and rating of exertion . Methods In a monocentric r and omised controlled trial in Denmark , 116 , of 250 invited , cleaners were cluster-r and omised ( work location ; sex ; age ; length of service ) to aerobic exercise [ N = 57 , 44.9 years , 75.4 % female , body mass index ( BMI ) 26.2 ] , receiving 2 weekly aerobic exercise sessions during 12 months , or a reference group ( N = 59 , 45.7 years , 76.3 % female , BMI 27.1 ) , receiving health-promoting lectures . Self-reported data on outcomes and sociodemographic information were collected at baseline , and at 4 and 12 month follow-up . All outcomes were analysed in a linear repeated- measures 2 × 2 mixed-model by an intention-to-treat analysis approach . Results Drop-out was 26 and 33 % at 4 and 12 months , respectively . Aerobic exercise adherence was 51 % during the first 4 months . At 4 month follow-up no effects were found . At 12 month follow-up , work ability significantly increased by 0.59 on a 0–10 scale ( 95 % CI 0.05–1.13 ) and need for recovery significantly decreased by − 11.0 on a 0–100 scale ( 95 % CI − 19.8 to − 2.2 ) in the aerobic exercise group compared to the reference group . Productivity and rating of exertion were unaltered . Analysis stratified on age showed significant effects only among the participants aged ≤ 45 years . Conclusions After 12 months work ability improved and need for recovery decreased . A period of 4 months was insufficient to affect these outcomes emphasising that longer interventions may be needed to induce effects on work ability and need for recovery ",
"Effects of age , sex , race , and initial fitness on training responses of maximal O(2 ) uptake ( VO(2 max ) ) are unclear . Data were available on 435 whites and 198 blacks ( 287 men and 346 women ) , aged 17 - 65 yr , before and after st and ardized cycle ergometer training . Individual responses varied widely , but VO(2 max ) increased significantly for all groups . Responses by men and women and by blacks and whites of all ages varied widely . There was no sex difference for change ( Delta ) in VO(2 max ) ( ml . kg(-1 ) . min(-1 ) ) ; women had lower initial values and greater relative ( % ) increases . Blacks began with lower values but had similar responses . Older subjects had a lower Delta but a similar percent change . Baseline VO(2 max ) correlated nonsignificantly with DeltaVO(2 max ) but significantly with percent change . There were high , medium , and low responders in all age groups , both sexes , both races , and all levels of initial fitness . Age , sex , race , and initial fitness have little influence on VO(2 max ) response to st and ardized training in a large heterogeneous sample of sedentary black and white men and women",
"BACKGROUND It is a common belief that physical exercise at the workplace decreases subjective health complaints and reduces sickness absence , but this is not supported by previous r and omized studies . AIMS To evaluate the effectiveness of physical exercise at the workplace . METHODS One hundred and twenty-nine employees in a community-based nursing home for the elderly were r and omized into physical exercise or control groups . A weekly exercise class consisting of light aerobic exercise , muscle strengthening and stretching was held for a 6-month period . The control group was told to continue their ordinary activity . The main outcome measures were aerobic fitness ( UKK , walking test ) , health-related quality of life ( COOP/WONCA ) and sickness absence . Blinded assessment s were carried out at baseline and following the 6-month intervention . Complete sickness absence data were collected from a community register for two comparable 7-month periods . RESULTS The average number of exercise sessions was 12 ( 0 - 26 ) . Self-reported physical activity increased in the intervention group compared with the control group ( P Aerobic fitness improved in both groups ( P Mean sickness absence increased from 6.8 to 15.6 days in the exercise group and from 10.4 to 14.5 in the control group . No differences between groups were found for aerobic fitness , health-related quality of life or sickness absence . CONCLUSION The intervention neither improved health-related quality of life nor reduced sickness absence",
"Background Up-to- date research on musculoskeletal- and neuromotor fitness ( MSMF ) is lacking . The aims of the present paper were to a ) establish normative values of MSMF by gender and age , and b ) to assess how much of the variance in MSMF can be explained by obesity in adults . Methods A r and om selection of 726 Norwegians ( 20–65 years ) participated in a national cross-sectional study . Muscular endurance , muscular strength , explosive power , flexibility and balance were assessed in addition to waist circumference ( WC ) . Results Females displayed significantly higher scores compared to males on muscular endurance of the back extensors and on the flexibility tests ( p on h and grip strength , modified push-ups , and explosive power . An inverse association was found between age and all MSMF scores for females ( Beta:−0.06–(−0.92 ) , p ≤ 0.044 ) and males ( Beta:−0.15–(0.91 ) , p ≤ 0.006 ) , where younger participants displayed higher test scores on all MSMF tests , compared to older participants . Furthermore , participants showing higher scores on WC displayed lower scores on the following MSMF tests for both females and males : muscular endurance of the back extensors , balance , flexibility of the shoulder , and explosive power ( p male participants with higher WC scores showed lower scores on muscular endurance of the upper body and flexibility of the hamstrings compared to males with lower WC scores ( p MSMF for adults based on age and gender , and support an inverse relationship of MSMF to age and WC",
"Objective To evaluate the effectiveness of a worksite vitality intervention on vigorous physical activity ( VPA ) , fruit intake , aerobic capacity , mental health and need for recovery after work among older hospital workers ( ie , 45 years and older ) . Methods The 6-month intervention was evaluated using a r and omised controlled trial design . Workers who were r and omised to the intervention group ( n=367 ; control : n=363 ) received the Vital@Work intervention containing ( 1 ) a Vitality Exercise Program ( VEP ) combined with ( 2 ) three visits to Personal Vitality Coach . The VEP consisted of a weekly yoga session , a weekly workout session and weekly unsupervised aerobic exercising . Free fruit was provided at the VEP . Data on the outcome measures were collected ( ie , year 2009–2010 ) at baseline ( n=730 ) and 6 months of follow-up after baseline ( n=575 ) using question naires , accelerometers and 2 km walk tests . Effects were analysed according to the intention-to-treat principle with complete cases ( n=575 ) and imputed data ( n=730 ) using linear regression analyses . Additional analyses were performed for high yoga and workout compliance ( ie , > mean number of sessions ) . Results Effects were found for sports activities ( β=40.4 min/week , 95 % CI 13.0 to 67.7 ) and fruit intake ( β=2.7 pieces/week , 95 % CI 0.07 to 4.7 ) and were stronger for workers with high compliance to yoga ( sport : β=49.6 min/week , 95 % CI 13.9 to 85.2 ; fruit : β=3.8 pieces/week , 95 % CI 1.1 to 6.4 ) and workout sessions ( sport : β=72.9 min/week , 95 % CI 36.1 to 109.8 ; fruit : β=4.0 pieces/week , 95 % CI 1.1 to 6.4 ) . The intervention group lowered their need for recovery , when compared to controls ( β=−3.5 , 95 % CI −6.4 to −0.54 ) , with stronger effects for high workout compliance ( β=−5.3 , 95 % CI −9.3 to −1.3 ) . No effects were found on VPA , aerobic capacity or mental health . Conclusions Implementation of worksite yoga and workout facilities and minimal fruit interventions should be considered by employers to promote transitions into healthier lifestyles and thereby health",
"The aim was to determine the effect of one weekly hour of specific strength training within working hours , performed with the same total training volume but with different training frequencies and duration s , or with different levels of supervision , on compliance , muscle health and performance , behavior and work performance . In total , 573 office workers were cluster-r and omized to : 1 WS : one 60-min supervised session/week , 3 WS : three 20-min supervised sessions/week , 9 WS : nine 7-min supervised sessions/week , 3 MS : three 20-min sessions/week with minimal supervision , or REF : a reference group without training . Outcomes were diary-based compliance , total training volume , muscle performance and question naire-based health , behavior and work performance . Comparisons were made among the WS training groups and between 3 WS and 3 MS . If no difference , training groups were collapsed ( TG ) and compared with REF . Results demonstrated similar degrees of compliance , mean(range ) of 39(33 - 44)% , and total training volume , 13.266(11.977 - 15.096)kg . Musculoskeletal pain in neck and shoulders were reduced with approx . 50 % in TG , which was significant compared with REF . Only the training groups improved significantly their muscle strength 8(4 - 13)% and endurance 27(12 - 37)% , both being significant compared with REF . No change in workability , productivity or self-rated health was demonstrated . Secondary analysis showed exercise self-efficacy to be a significant predictor of compliance . Regardless of training schedule and supervision , similar degrees of compliance were shown together with reduced musculoskeletal pain and improved muscle performance . These findings provide evidence that a great degree of flexibility is legitimate for companies in planning future implementation of physical exercise programs at the workplace . Clinical Trials.gov , number NCT01027390",
"ISSUE ADDRESSED Physical activity and exercise participation is limited by a perceived lack of time , poor access to facilities and low motivation . The aim was to assess whether providing an exercise program to be completed at the workplace with or without direct supervision was effective for promoting health-related physical fitness and exercise participation . METHODS Fifty university employees aged ( Mean ± SD ) 42.5 ± 11.1 years were prescribed a moderate- to vigorous-intensity aerobic and resistance exercise program to be completed at an onsite facility for 8 weeks . Participants were r and omly allocated to receive direct exercise supervision or not . Cardiorespiratory fitness ( V̇O2max ) and maximal muscular strength were assessed at baseline and 8 weeks . Self-report physical activity was assessed at baseline , 8 weeks and 15 months post-intervention . RESULTS Attendance or exercise session volume were not different between groups . Cardiorespiratory fitness ( Mean ± 95 % CI ) ; + 1.9 ± 0.7 mL·kg·min-1 ; P ( + 7.4 ± 3.5 Nm·kg-1 % ; P ( + 7.4 ± 4.6 Nm·kg-1 % ; P strength increased , irrespective of intervention group . Self-reported vigorous-intensity physical activity increased over the intervention ( mean ± 95 % CI ; + 450 ± 222 MET·minutes per week ; P to improve health-related physical fitness in the short-term independent to the level of supervision provided , but does not influence long-term participation . SO WHAT ? : Lower cost onsite exercise facility supervision is as effective at improving physical health and fitness as directly supervised exercise , however ongoing support may be required for sustained physical activity behaviour change",
"BACKGROUND Reduced muscular strength , as measured by grip strength , has been associated with an increased risk of all-cause and cardiovascular mortality . Grip strength is appealing as a simple , quick , and inexpensive means of stratifying an individual 's risk of cardiovascular death . However , the prognostic value of grip strength with respect to the number and range of population s and confounders is unknown . The aim of this study was to assess the independent prognostic importance of grip strength measurement in socioculturally and economically diverse countries . METHODS The Prospect i ve Urban-Rural Epidemiology ( PURE ) study is a large , longitudinal population study done in 17 countries of varying incomes and sociocultural setting s. We enrolled an unbiased sample of households , which were eligible if at least one household member was aged 35 - 70 years and if household members intended to stay at that address for another 4 years . Participants were assessed for grip strength , measured using a Jamar dynamometer . During a median follow-up of 4.0 years ( IQR 2.9 - 5.1 ) , we assessed all-cause mortality , cardiovascular mortality , non-cardiovascular mortality , myocardial infa rct ion , stroke , diabetes , cancer , pneumonia , hospital admission for pneumonia or chronic obstructive pulmonary disease ( COPD ) , hospital admission for any respiratory disease ( including COPD , asthma , tuberculosis , and pneumonia ) , injury due to fall , and fracture . Study outcomes were adjudicated using source documents by a local investigator , and a subset were adjudicated central ly . FINDINGS Between January , 2003 , and December , 2009 , a total of 142,861 participants were enrolled in the PURE study , of whom 139,691 with known vital status were included in the analysis . During a median follow-up of 4.0 years ( IQR 2.9 - 5.1 ) , 3379 ( 2 % ) of 139,691 participants died . After adjustment , the association between grip strength and each outcome , with the exceptions of cancer and hospital admission due to respiratory illness , was similar across country-income strata . Grip strength was inversely associated with all-cause mortality ( hazard ratio per 5 kg reduction in grip strength 1.16 , 95 % CI 1.13 - 1.20 ; p cardiovascular mortality ( 1.17 , 1.11 - 1.24 ; p non-cardiovascular mortality ( 1.17 , 1.12 - 1.21 ; p myocardial infa rct ion ( 1.07 , 1.02 - 1.11 ; p=0.002 ) , and stroke ( 1.09 , 1.05 - 1.15 ; p Grip strength was a stronger predictor of all-cause and cardiovascular mortality than systolic blood pressure . We found no significant association between grip strength and incident diabetes , risk of hospital admission for pneumonia or COPD , injury from fall , or fracture . In high-income countries , the risk of cancer and grip strength were positively associated ( 0.916 , 0.880 - 0.953 ; p middle-income and low-income countries . INTERPRETATION This study suggests that measurement of grip strength is a simple , inexpensive risk-stratifying method for all-cause death , cardiovascular death , and cardiovascular disease . Further research is needed to identify determinants of muscular strength and to test whether improvement in strength reduces mortality and cardiovascular disease . FUNDING Full funding sources listed at end of paper ( see Acknowledgments )",
"Purpose The aim was to assess 1-year cardiovascular health effects of Intelligent Physical Exercise Training , IPET . Methods Office workers from six companies were r and omized 1:1 to a training group , TG ( N = 194 ) or a control group , CG ( N = 195 ) . TG received 1-h supervised high intensity IPET every week within working hours for 1 year , and was recommended to perform 30-min of moderate intensity physical activity 6 days a week during leisure . The training program was based on baseline health check measures of cardiorespiratory fitness ( CRF ) , body composition , blood pressure , blood profile , and musculoskeletal health . Results There were no baseline differences between groups . CRF assessed as VO2max in absolute values and relative to body weight was ( mean ± SD ) : 3.0 ± 0.8 l/min and 35.4 ± 10.9 ml/min/kg for females , 3.9 ± 1.0 l/min and 37.9 ± 11.79 ml/min/kg for males . Intention to treat analysis demonstrated a significant almost 5 % increase in VO2max in TG compared with CG . A per protocol analysis of those with an adherence of ≥70 % demonstrated a significant increase in CRF of more than 10 % compared with CG , and a significant reduction in systolic blood pressure ( −5.3 ± 13.7 mm Hg ) compared with CG . Conclusion High intensity IPET combined with the recommendations of moderate intensity physical activity demonstrated significant clinical relevant improvements in CRF and systolic blood pressure . This underlines the effectiveness of health promotion by implementing physical exercise training at the workplace",
"Background Cleaners constitute a job group with poor health and low socioeconomic re sources . Therefore , there is a great need for scientifically documented health promoting initiatives for cleaners . However , both workplace initiatives and high quality intervention studies are lacking . The aim of this study was to evaluate the effects of a 3-month workplace trial with interventions to improve physical or cognitive behavioural re sources among cleaners . Methods A cluster r and omised controlled trial was conducted among 294 female cleaners from 9 workplaces . The participants were allocated to three groups : Physical coordination training ( PCT , n = 95 ) , Cognitive behavioural theory-based training ( CBTr , n = 99 ) and Reference group ( REF , n = 100 ) . Interventions were conducted during work hours for an average of 1 hour/week . Muscle strength was measured by maximal voluntary contractions in trunk/extension , and shoulder abduction/elevation . Postural balance was measured on a force platform . Kinesiophobia was measured with Tampa Scale for Kinesiophobia . Test and question naires were completed at baseline and at 3-month follow-up and analyses followed the intention-to-treat ( ITT ) principle with last observation carried forward in case of missing data at follow-up . Reports and analyses are given on true observations as well . Results ITT-analyses revealed that PCT improved strength of the trunk ( p and postural balance ( p strength and balance improvements corresponded to ~20 % and ~16 % , respectively . ITT-analyses showed that CBTr reduced kinesiophobia compared to PCT and REF ( p including PCT and CBTr among cleaners improved strength and postural balance from PCT , and kinesiophobia from CBTr . The improved strength , postural balance and kinesiophobia may improve the cleaners ' tolerance for high physical work dem and s. Future studies should investigate the potential in the combination of PCT and CBTr in a workplace intervention . Trial registration Current controlled trials IS RCT",
"Objective . To provide a comprehensive underst and ing of the motivational factors and barriers that are important for compliance with high-intensity workplace physical exercise that is aim ed at reducing musculoskeletal disorders . Method . The present study , which used semideductive , thematic , and structured in-depth interviews , was nested in a 20-week cluster r and omised controlled trial among office workers . Interviews were conducted with 18 informants with diverse fields of sedentary office work who participated in strength training at the workplace for 20 minutes , three times per week . Organisational , implementational , and individual motives and barriers were explored . Results & Discussion . The results show that attention should be given to the interaction between the management , the employees , and the intervention , as the main barrier to compliance was the internal working culture . The results emphasised the need for a clear connection between the management 's implementational intentions and the actual implementation . The results emphasise the importance of ensuring the legitimacy of the intervention among managers , participants , and colleagues . Moreover , it is important to central ly organise , structure , and ensure flexibility in the working day to free time for participants to attend the intervention . Recommendations from this study suggest that a thorough intervention mapping process should be performed to analyse organisational and implementational factors before initiating workplace physical exercise training",
"ABSTRACT This 9-month r and omised controlled workplace physical activity trial investigated the effects of soccer and Zumba exercise , respectively , on muscle strength , maximal jump height , sit- and -reach flexibility and postural sway among female workers . A total of 107 female hospital employees aged 25–63 were cluster-r and omised to a soccer group , a Zumba group or a control group . Training was conducted outside working hours as two to three 1-h weekly sessions the first 3 months and once a week the last 6 months . Tests were conducted at baseline , after 3 and 9 months . The soccer group improved maximal neck extension strength both after 3 ( 1.2 kg ; P improved maximal trunk extension strength ( 3.1 kg ; P = 0.04 ) after 3 months , with improvements in postural sway velocity moment ( −9.2 mm2/s ; P 0.05 ) and lower limb lean mass ( 0.4 kg ; P in vertical jump height or sit- and -reach flexibility . The present study indicates that workplace-initiated soccer and Zumba exercise may be beneficial for improvement of the neck and trunk strength , which may have preventive effects with regard to future perceived muscle pain in the respective body regions . Furthermore , the Zumba group revealed positive effects on lower limb lean mass and postural sway compared to the control group",
"Purpose To assess effects of 1-year Intelligent Physical Exercise Training ( IPET ) on musculoskeletal health . Methods Office workers were r and omized 1 : 1 to a training group , TG ( N = 193 ) , or a control group , CG ( N = 194 ) . TG received 1 h supervised high intensity IPET every week within working hours for 1 year and was recommended to perform 30 min of moderate intensity physical activity for 6 days a week during leisure . The IPET program was based on baseline health measures . Results No baseline differences were present . An intention-to-treat analysis showed significant between-group effect for muscle strength but not for musculoskeletal pain . However , a per- protocol analysis of those with an adherence of ≥70 % demonstrated a significant between-group effect for neck pain during the past three months . Several significant within-group changes were present , where TG and TG ≥ 70 % demonstrated clinical ly relevant pain reductions whereas minimal reductions were seen for CG . Conclusion IPET and recommendations of moderate intensity physical activity demonstrated significant between-group effect on muscle strength . Interestingly , significant within-group reductions in musculoskeletal pain were seen not only in TG but also in CG . This may underlie the lack of such between-group effect and shows that a possible positive side effect of merely drawing attention can improve musculoskeletal health",
"The aim of the study was to investigate the effectiveness of a resistance-training program on muscle strength of the back and neck/shoulder muscles , relative physical workload , muscle fatigue and musculoskeletal discomfort during a simulated assembly and lifting task . Twenty-two workers were r and omized over an 8-week resistance-training group , and a control group . Isokinetic muscle strength was assessed using the Cybex dynamometer , muscle fatigue was measured using EMG , and perceived discomfort was measured using a 10-point scale . At the follow-up , we found no effect of the resistance-training program on isokinetic muscle strength of the back and shoulder muscles . Furthermore , we did not find any effect on EMG data , nor on musculoskeletal discomfort during the simulated work tasks . However , trained workers performed the lifting tasks for a longer time before reporting considerable discomfort than those in the control group",
"Objective : The aim of this study was to investigate the effect of individually tailored intelligent physical exercise training ( IPET ) on presenteeism and absenteeism among office workers . Methods : In a 1-year r and omized controlled trial ( RCT ) , employees were allocated to a training group TG ( N = 193 ) or control group CG ( N = 194 ) . TG received 1-hour high-intensity IPET once a week within working hours , and was recommended to perform 30 minutes of moderate-intensity physical activity ( PA ) 6 days a week during leisure-time . Results : An intention-to-treat analysis showed no effect on absenteeism , but a significant 4 % increase in workability and 9 % increase in general health in TG compared with CG . A per- protocol analysis [ adherence of ≥70 % ( N = 89 ) ] in addition showed a significant 6 % increase in productivity and a 29 % reduction in absenteeism compared with CG . Conclusion : IPET combined with recommendations of leisure-time PA significantly improved presenteeism and decreased absenteeism if following the protocol",
"Objective : To investigate the effects of a workplace fitness and education program intervention on physical fitness of workers . Methods : Employees from a chemical plant ( n = 60 ) participated in a 4-month longitudinal study . They were r and omly distributed in control and experimental groups . The experimental group had 4 months of exercise training in 15-minute sessions . The following evaluations were performed before and after the training period : body composition , localized muscle strength , and flexibility . Results : The experimental group showed a significant decrease in body fat ( 24.7 % ) and a significant increase in lean mass ( 6.1 % ) , flexibility ( 17.9 % ) , sit-up test performance ( 39.8 % ) , and push-up test performance ( 29.8 % ) after the workplace fitness and education program compared with initial values . Conclusions : A structured program of physical exercise was effective in improving body composition , abdominal strength , upper limb strength , and flexibility in workers",
"Abstract The purpose of this study was to investigate the time course of skeletal muscle adaptations result ing from high-intensity , upper and lower body dynamic resistance training ( WT ) . A group of 17 men and 20 women were recruited for WT , and 6 men and 7 women served as a control group . The WT group performed six dynamic resistance exercises to fatigue using 8–12 repetition maximum ( RM ) . The subjects trained 3 days a week for 12 weeks . One-RM knee extension ( KE ) and chest press ( CP ) exercises were measured at baseline and at weeks 2 , 4 , 6 , 8 , and 12 for the WT group . Muscle thickness ( MTH ) was measured by ultrasound at eight anatomical sites . One-RM CP and KE strength had increased significantly at week 4 for the female WT group . For the men in the WT group , 1 RM had increased significantly at week 2 for KE and at week 6 for CP . The mean relative increases in KE and CP strength were 19 % and 19 % for the men and 19 % and 27 % for the women , respectively , after 12 weeks of WT . Resistance training elicited a significant increase in MTH of the chest and triceps muscles at week 6 in both sexes . There were non-significant trends for increases in quadriceps MTH for the WT groups . The relative increases in upper and lower body MTH were 12%–21 % and 7%–9 % in the men and 10%–31 % and 7%–8 % in the women respectively , after 12 weeks of WT . These results would suggest that increases in MTH in the upper body are greater and occur earlier compared to the lower extremity , during the first 12 weeks of a total body WT programme . The time-course and proportions of the increase in strength and MTH were similar for both the men and the women",
"Purpose . Low back pain is a leading cause of disability in firefighters and is related to poor muscular endurance . This study examined the impact of supervised worksite exercise on back and core muscular endurance in firefighters . Design . A cluster r and omized controlled trial was used for this study Setting . The study occurred in fire stations of a municipal fire department ( Tampa , Florida ) . Subjects . Subjects were 96 full-duty career firefighters who were r and omly assigned by fire station to exercise ( n = 54 ) or control ( n = 42 ) groups . Intervention . Exercise group participants completed a supervised exercise targeting the back and core muscles while on duty , two times per week for 24 weeks , in addition to their usual fitness regimen . Control group participants continued their usual fitness regimen . Measures . Back and core muscular endurance was assessed with the Biering-Sorensen test and plank test , respectively . Analysis . Changes in back and core muscular endurance from baseline to 24 weeks were compared between groups using analysis of covariance and linear mixed effects models . Results . After 24 weeks , the exercise group had 12 % greater ( p = .021 ) back muscular endurance and 21 % greater ( p= .0006 ) core muscular endurance than did the control group . The exercise intervention did not disrupt operations or job performance . Conclusion . A supervised worksite exercise program was safe and effective in improving back and core muscular endurance in firefighters , which could protect against future low back pain",
"OBJECTIVES The combination of high physical work dem and s and low physical capacity has been shown to increase the risk for cardiovascular disease and musculoskeletal disorders . The aim of this study was to assess the physical capacity of construction workers and evaluate the effect of individually tailored exercise programs on their physical fitness and muscular capacity . METHOD The study was a r and omized controlled trial of male constructions workers allocated to either an exercise or control group . The intervention lasted 12 weeks , and the exercise group trained 3 x 20 minutes a week . The participants completed health checks before and after the intervention period . Data from the first health check were used to tailor the exercise in the interventions . RESULTS At baseline , participants had maximal oxygen consumption ( VO(2max ) ) of 2.9 [ st and ard deviation ( SD ) 0.7 ] l/min and body mass index ( BMI ) of 28.3 ( SD 4.7 ) . Compared to representative data on employees in Denmark ( N=78 ) , this study population ( N=67 ) had significantly lower relative aerobic capacity [ difference in z-score -1.13 , st and ard error ( SE ) 0.1 , P higher BMI [ difference in z-score 1.10 , SE 0.2 , P VO(2max)of 0.4 l/min for the exercise group and 0.0 l/min for the control group ( P Body mass and other general health measures remained unchanged . CONCLUSION Training for 20 minutes , 3 times a week significantly increased VO(2max)with a clinical ly relevant magnitude regarding risk of cardiometabolic disorders . This study demonstrates a good effectiveness for integrating short exercise bouts into organizational routines among constructions workers",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"Objective : The aim of this study was to assess the effectiveness of a workplace leg-strengthening program on self-reported function , physical capacity , and work-related outcomes among desk-based workers . Methods : Forty-three desk-based workers were r and omized to a 12-week exercise program or no exercise control . The primary outcome was change in self-reported physical function on the Lower Extremity Functional Scale ( LEFS ) from baseline to follow-up . Secondary outcomes were physical capacity ( mobility , strength ) , self-reported outcomes ( pain , depressive symptoms ) , and work-related outcomes ( resilience , work ability ) . Results : The exercise group showed greater improvements in LEFS and mobility . No significant between-group differences existed in knee strength or remaining self-reported and work-related outcomes . Conclusion : Workplace implemented leg-strengthening exercises are effective at improving self-reported and physical health outcomes of desk-based workers . Moving forward , occupational exercise interventions may be essential to enhance worker longevity among the aging , sedentary workforce",
"Purpose The present study examined changes in body composition , maximum oxygen uptake , and physical activity in sedentary office employees prescribed with two different walking programs during a 10-week intervention . Methods 68 sedentary employees were r and omly assigned to one of three groups : multiple bouts of walking ( n = 24 ( 5 male , 19 female ) Age = 46±9 , BMI = 30.5±5.78 kg/m2 ) , continuous walking ( n = 22 ( 6 male , 16 female ) Age = 48±9 , BMI = 30.6±6.2 kg/m2 ) and the control group ( n = 22 ( 5 male , 17 female ) Age = 42±10 , BMI = 27.5±5.23 kg/m2 ) . Dual-energy X-ray absorptiometry ( iDXA ) assessed body composition and a Bruce protocol treadmill test assessed aerobic fitness at baseline and week 11 . At baseline , week 6 and week 11 a waist worn accelerometer measured physical activity and sedentary behavior . Physical activity was measured throughout the program with a wrist worn accelerometer . Results The results from the mixed- design ANOVA show that fat mass ( p fat percentage ( p time . Sedentary behavior did not change ( p>0.05 ) for all three groups . Moderate intensity physical activity increased significantly from pre-test to week 6 ( p0.05 ) for all groups . No changes in VO2 were observed ( p>0.05 ) for all groups . Conclusions Continuous or intermittent walking activity produce similar benefits on body weight , fat mass and body fat percentage in sedentary employees . Meanwhile , intermittent walking allowed these sedentary employees to increase lean mass and fat free mass . Intermittent walking could provide at least similar benefits on body composition compared to a continuous walking program",
"This r and omized controlled study investigated the effectiveness of soccer and Zumba on fitness and health indicators in female participants recruited from a workplace . One hundred seven hospital employees were cluster-r and omized to either a soccer group ( SG ) , Zumba group ( ZG ) , or control group ( CG ) . Intervention effects for the two training groups were compared with CG . The training was conducted outside working hours as 2 - 3 1-h sessions per week for 12 weeks . Peak oxygen uptake ( VO2peak ) , fat percentage , fat mass , bone mineral content , and plasma osteocalcin were measured before and after the intervention period . Based on intention-to-treat-analyses , SG significantly improved the VO2peak relative to body mass ( 5 % ; P = 0.02 ) and decreased heart rate during 100-W cycle exercise ( -7 bpm ; P = 0.01 ) , total body fat percentage ( -1.1 % ; P = 0.002 ) , and total body fat mass ( -1.0 kg ; P = 0.001 ) compared with CG . ZG significantly improved the VO2peak relative to body mass ( 5 % ; P = 0.03 ) and decreased total fat mass ( -0.6 kg ; P Plasma osteocalcin increased in SG ( 21 % ; P short-term soccer training as well as Zumba outside working hours may result in fitness and modest health benefits among female hospital employees"
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Objectives The aim of this systematic review and meta- analysis was to evaluate fissure sealant retention in clinical studies in which investigators used flowable composites as pit and fissure sealants compared with conventional resin-based pit and fissure sealants . Data sources and data selection The authors conducted a literature search ( all articles published until April 13 , 2017 ) to identify studies for inclusion in this systematic review . They assessed the quality of the evidence provided by using the modified Jadad scale and performed meta-analyses by using a r and om-effects model . Data extraction and data synthesis The authors found 11 studies that met the inclusion criteria for the systematic review and nine studies that could be used for the meta- analysis . Of the 11 studies identified in the systematic review , four scored as having a low risk of bias , and seven scored as having a medium risk of bias . Our meta- analysis showed a significant positive effect of using flowable composites as a fissure sealant material ( odds ratio , 2.387 [ 95 % CI , 1.047 , 5.444 ; P = 0.039 ] ) . Conclusion It seems that the use of flowable composite as a fissure sealing material can slightly increase the retention rate of sealants compared with conventional resin-based sealants
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"Abstract Unfilled resins are commonly in use as sealant material . In addition , there are filled sealants available . Helioseal F is a newly developed filled material with fluoride release . In this clinical trial , Helioseal F has been evaluated in one lower molar versus Delton opaque as an unfilled control in lower molars . After 12 months there were no significant differences in retention , porosities , and the number of clinical ly unacceptable margins between the material s. The complete retention was 30 out of 31 examined teeth for Delton and 28 out of 31 for Helioseal F. After 1 year of clinical testing , these results indicate that a sealant containing fluoride-releasing particles did not show a significant difference in retention rate compared to an unfilled conventional sealant . However , long-term results concerning marginal adaptation should be evaluated",
"Objective : The purpose of this clinical study was to compare the retention rates of two flowable restorative systems ( Admira Flow and Gr and io Flow ) with that of a conventional resin-based sealant ( Fissurit F ) . Material s and Methods : The study was planned as a clinical trial with a split-mouth design . A total of 122 sealants ( 38 Admira Flow , 41 Gr and io Flow , 43 Fissurit F ) were r and omly applied to completely erupted permanent molars in 35 patients aged 9–20 years and followed up for 24 months . Data were analyzed using Pearson ’s χ2 and multiple comparison tests . Results : At the end of the follow-up period , Fissurit F had higher retention rates ( 81.0 % ) than both Admira Flow ( 60.5 % ) and Gr and io Flow ( 57.1 % ) , with p significant difference in caries development among groups ( p > 0.05 ) . Conclusion : The two flowable composite resin material s used as fissure sealant were less retentive than the conventional resin sealant ",
"Aim and Objectives : Fissure caries is most common in children due to deep pit and fissures . Pit and fissure areas on the occlusal surface of the teeth make them susceptible to dental caries , which need to be prevented or restored . Fissures sealant reduces the risk of occlusal caries . The present study was done to evaluate microleakage and shear bond strength of various fissure sealants . Material s and Methods : Thirty-six extracted molars were r and omly allocated equally ( n = 12 ) into three groups with three different sealants to evaluate shear bond strength and microleakage at sealant space . The shear bond strengths was evaluated with one-way analysis of variance and microleakage by Kruskal-Wallis nonparametric test using the Statistical Package for the Social Sciences version 18.0 ( Chicago : SPSS Inc , 2009 ) . Results : Tetric flow ( 16.8 MPa ) recorded the highest shear bond strength and the difference was statistically significant with enamel loc ( 12.8 MPa ) . There was no statistically significant difference in relation to microleakage ( P > 0.05 ) in the tested groups . Conclusions : Tetric flow recorded the highest shear bond strength and the difference was statistically significant with enamel loc . However , there was no statistically significant difference among the groups regarding microleakage",
"This study evaluates the caries-preventive potential in permanent teeth of dental sealants when combined with an ongoing , school-based fluoride program . The investigation was design ed as a sequential , cross-sectional comparison . Dental caries findings in 1987 for 416 children ages 7 - 11 and 14 - 17 who received dental sealants and fluorides were compared with corresponding data derived from 1983 baseline examinations of children who received fluoride therapy only . In addition , sealant retention status was determined . Overall mean DMFS scores in 1987 for children in two age groups combined were 51 % lower than in 1983 . Also , a surface-specific treatment effect was demonstrated in pit and fissures for both older and younger age groups . The overall proportion of sealants retained on occlusal surfaces of first molars after an average of 2 yr ( 92 % ) compared favorably with similar figures cited in the scientific literature . The results of this study suggest that pit and fissure sealants confer additional caries-preventive benefits beyond those of fluoride therapy alone",
"PURPOSE The aim of this work is to study and compare the retention rate , caries-preventing and antibacterial effects of resin-modified glass ionomer and flowable composite in comparison to conventional fissure sealant . METHODS Forty-five children aged 7 - 10 years with newly erupted lower first permanent molars were r and omly divided into three equal treatment groups . Group I : sealed by a conventional resin sealant ; Group II : sealed by resin modified glass ionomer ( RMGI ) ; and Group III : sealed by flowable composite . Retention and caries status of the sealed teeth were recorded after 1 month , 6 months , year and 2 years . In addition , Streptococcus mutans counts were assessed at baseline , 1 day , 1 month , 6 months , 1 year and 2 years after sealant application . Data were analyzed by Fisher exact , chi-square and ANOVA tests . RESULTS Group III and Group I showed significantly higher retention rates than Group II fissure sealant ( p caries-preventive effects between the tested sealant material s throughout the duration of the study . Streptococcus mutans counts were significantly lower in group II compared to group I or group III up to 6 months of the study ( p Streptococcus mutans counts were not significant ( p>0.05 ) . CONCLUSION This study indicated a lower retention of RMGI compared to flowable composite and resin sealant without significant difference in caries prevention or long-term bacterial inhibition",
"PURPOSE The purpose of this study was to compare microbial leakage of a new hydrophilic sealant with that of a conventional hydrophobic resin-based sealant . METHODS One hundred extracted , caries-free , human maxillary premolars were r and omly divided into five groups . Those in Groups 1 , 2 , and 3 had dry , wet , and artificial saliva-contaminated occlusal surfaces , respectively , and were sealed with a hydrophilic sealant , while those in Groups 4 and 5 had dry and wet occlusal surfaces , respectively , and were sealed with a hydrophobic sealant . A newly design ed microbial penetration method utilizing Streptococcus mutans as an indicator was tested for leakage assessment . Data were analyzed using SPSS 15.0 software , and the significance level was set at α=0.05 . RESULTS The log rank test indicated a statistically significant difference in leakage rates among the five groups . Mantel-Cox log-rank test findings showed that Group 3 had the highest leakage rate , with Groups 2 and 4 having the lowest . There was no statistically significant difference in leakage rate between Groups 2 and 4 . CONCLUSIONS With respect to the limitations of an in vitro study , our findings suggest that hydrophilic sealants are an acceptable alternative to hydrophobic sealants",
"Aim : This was to compare 3 different material s for fissure sealing ( FS ) after a clinical use during a 24 month period and to assess the use of flowable composite resins in combination with dentine adhesives as sealing material s. Study Design : There were 41 patients aged from 7–17 years , for whom 100 permanent molars were sealed with 3 different sealing material s. Methods : Group A , 33 teeth were sealed material Helioseal Clear Chroma ( Vivadent , Schaan , Liechtenstein ) ; Group B , 33 teeth were sealed with Teethmate F1 ( Kuraray , Kurashiki , Japan ) , and in Group C , 34 teeth were sealed with the flowable composite Tetric Flow ( Vivadent , Schaan , Liechtenstein ) . For the analysis of the degree of retention , the criteria used were : 0-complete retention , 1-loss of 1/3 of material , 2-loss of 2/3 of material , 3-complete loss of material . Clinical criteria for appearance of a new caries lesion included following values : Caries present ( + ) or caries absent ( − ) . Statistics : Chi-Square test was used for statistical analysis of retention rates between groups . Results : After the 24 month period , the highest retention rate of complete retention was established for the material Tetric Flow of 76.5 % , Helioseal Clear Croma 66.7 % , and Teethmate F1 60.6 % . The incidence of caries with Helioseal Clear Croma was 6.1 % , for Teethmate F1 3 % , with no statistically significant difference after the 24 months period ( p=0.656 ) . In the group of teeth sealed with Tetric Flow , there was not a single case of caries noted . Conclusions : The use of flowable composite resins as sealing material s is equal to other material s for fissure sealing",
"This l and mark study of a pit and fissure sealant found 27.6 percent complete retention and 35.4 percent partial retention on permanent first molars . In the matched pair analysis , carious or restored surfaces made up 31.3 percent of the surfaces in the sealed group and 82.8 percent in the unsealed group",
"OBJECTIVES The aim of this clinical study was to evaluate the retention rate and caries-prevention effect of a flowable composite compared to a conventional resin-based sealant in a young population over a 24-month period . METHODS Thirty-four patients , ranging in age from 16 to 22 years , diagnosed with at least 2 non-cavitated pit- and -fissure caries in the first and second molars were selected for this r and omized split-mouth design trial . A total of 220 sealants , were placed in 117 upper molars and 103 lower molars . The teeth were sealed with a flowable resin composite ( Tetric Evo Flow ) or a sealant material ( Helioseal F ) . Each restoration was independently evaluated in terms of retention and the presence of caries at baseline and at 1 , 6 , 12 , and 24 months . Data were analyzed using non-parametric Mann-Whitney U and Friedman 1-way ANOVA tests at p Tetric Evo Flow showed complete retention with 100 % , 95.5 % , 93.8 % , and 88.5 % at 1 , 6 , 12 , and 24-month evaluations , respectively , while Helioseal F retention rates were 98.1 % , 95.5 % , 94.8 % , and 85.4 % , respectively , for the same evaluation periods . At the 24-month recall , 4 ( 4.2 % ) total losses were observed in subjects treated with Tetric Evo Flow and 2 total losses ( 2.1 % ) for Helioseal F , respectively . No significant differences were observed between the material s in retention rates or caries incidence for each evaluation period ( p>0.05 ) . CONCLUSION Placement of flowable composite as fissure sealants in the younger population seems to be as effective as conventional fluoride containing fissure sealants for the prevention of fissure caries . CLINICAL RELEVANCE The use of a flowable composite as a fissure sealant material , in conjunction with a total-etch , single bottle adhesive , yielded better retention than did the conventional fluoride containing resin-based fissure sealant over a 24-month period in young patients",
"This clinical study evaluated the retention and caries protection of a flowable resin composite ( Flow Line ) and a flowable compomer ( Dyract Flow ) used in preventive resin restorations as compared to the conventional preventive resin technique which uses a resin composite ( Brilliant ) and a sealant ( Concise ) . This study observed 205 permanent molars with small carious cavities less than 1.5 mm in width , which were obtained from 165 children aged 7 to 15 years . Flowable resin composite was used to treat 75 teeth , and 71 teeth were treated with flowable compomer in both cavities and caries-free fissures . For the control group , 59 teeth were treated with resin composite in cavities and sealant in caries-free fissures . The teeth were evaluated at 3 , 6 , 12 , 18 and 24-month intervals . After three months , all 205 treated teeth were completely intact . After six months , 66 of the 71 teeth treated with flowable resin composite and 65 of the 70 teeth treated with flowable compomer were complete , compared to 57 of the 58 teeth treated with the conventional preventive resin technique . After 12 months , 60 of the 67 teeth treated with flowable resin composite and 61 of the 67 teeth treated with flowable compomer were complete , compared to 51 of the 55 teeth treated with the conventional preventive resin technique . After 18 months , 53 of the 61 teeth treated with flowable resin composite and 54 of the 62 teeth treated with flowable compomer were complete , compared to 47 of the 53 teeth treated with the conventional preventive resin technique . After 24 months , 49 of the 58 teeth treated with flowable resin composite and 45 of the 57 teeth treated with flowable compomer were complete , compared to 42 of the 52 teeth treated with the conventional preventive resin technique . There were no statistically significant differences in retention rates among all groups after 3 , 6 , 12 , 18 or 24-months ( p>0.05 ) . One tooth treated with flowable resin composite and one tooth treated with flowable compomer developed caries after 18 and 24 months , respectively , result ing from partial loss at \" caries-free fissures . \" Five teeth developed caries in the conventional preventive resin group ; one after 12 months , two after 18 months and one after 24 months , due to loss at cavities . The final caries occurred after 24 months , result ing from partial loss at \" caries-free fissures . \" The differences in caries development among the three groups were not statistically significant ( p>0.05 ) . This study suggested that flowable resin composite and flowable compomer could be used for preventive resin restorations . Meanwhile , a vigilant recall should be followed-up due to the risk of failure for flowable material s in \" caries-free \" fissures . The repair should be performed immediately , in case the preventive resin restoration develops a fracture or loss",
"This clinical study evaluated the retention rate and caries protection of a medium-filled ( 46 % volume ) flowable restorative material ( CuRay-Match , OMNII Oral Pharmaceuticals , West Palm Beach , FL 33409 , USA ) compared to an unfilled sealant ( Delton , Dentsply Caulk , Milford , DE 19963 , USA ) . Using a half-mouth design , sealants were applied on r and omly assigned caries-free first and /or second permanent molars of 32 children ranging in age from 6 - 11 years . A total of 118 teeth were etched , dried and sealed . Teeth were evaluated at one , six and 18-month intervals . After one month , 52 teeth sealed with unfilled sealant were intact compared with 46 sealed with a medium-filled resin , and after six months , 36 teeth sealed with an unfilled sealant were intact compared with 27 that were sealed with a medium-filled resin . After 18 months , 29 teeth were still fully sealed with an unfilled sealant , whereas 18 were sealed with a medium-filled resin . The difference between the two groups was not statistically significant . Regarding caries development , four teeth sealed with a medium-filled material and five teeth sealed with an unfilled sealant were decayed after 18 months . These results indicate that a medium-filled flowable restorative material did not perform better in retention rate and caries increment when compared to an unfilled conventional sealant . However , the effect of the additional techniques , such as the use of bonding agent and fissurotomy on retention rates should be evaluated in further studies",
"Bacteriologic and clinical studies suggest that sealants can be used therapeutically on incipient caries of the enamel . The present study was design ed to explore this approach further by determining whether there is a difference in retention rates on sound or carious tooth surfaces sealed for the first time as well as resealed surfaces . A total of 1766 teeth were sealed for subjects 12 - 14 yr of age of which 120 were judged to be carious . Mouths were divided sagittally on a r and om basis and an ultraviolet light activated resin with a filler or an autopolymerizing resin without a filler was placed on contralateral surfaces of all molar and premolar teeth . The effects of sealant type , caries status , arch and tooth type on retention over a 2-yr period were tested using Mantel-Haenszel statistics . At the end of 1 yr , 88 % of the teeth sealed with the autopolymerizing resin were judged to be completely intact compared to 82 % of the teeth filled with the ultraviolet light resin . At the end of the second year the retention rates were 84 % and 75 % respectively . The retention rates for carious and sound teeth at the end of both years were almost identical . Overall , premolars had a 15 % more favorable retention rate than molars . There were minimal differences between arches although maxillary premolars had approximately a 5 % higher retention rate than m and ibular premolars . The reverse was true for molar teeth . Retention of sealants at the end of the second year ( resealed after 1 yr ) was 4 % less than comparable teeth sealed initially",
"Aim : To evaluate the effect of application a new-generation bulk-fill flowable composite resin as an intermediate material between composite resin and dental substrates on micro-leakage in Class V composite restorations . Material s and Methods : A total of 144 Class V cavities were prepared in 72 human molars . Specimens were then r and omly distributed among three groups according to adhesive system applied ( Group 1 : Clearfil SE Bond ; Group 2 : Adper Easy One ; Group 3 : Adhesive 200 T ) , and each group was divided into three subgroups according to liner material used ( Group A : No liner-control group ; Group B : Aelite Flo LV , low viscosity microhybrid composite ; Group C : Smart dentin replacement ) . All cavities were restored using resin composite ( Aelite LS , low shrinkage posterior composite ) . Specimens were stained with 0.5 % basic fuchsin and evaluated dye penetration . Results : There was no significant difference in dye penetration was found between the control and the experimental groups . Conclusions : Micro-leakage is not affected by the application of either conventional or new-generation flowable composite resin as an intermediate material between composite resin and dental substrates",
"BACKGROUND This article presents evidence -based clinical recommendations for the use of pit- and -fissure sealants on the occlusal surfaces of primary and permanent molars in children and adolescents . A guideline panel convened by the American Dental Association ( ADA ) Council on Scientific Affairs and the American Academy of Pediatric Dentistry conducted a systematic review and formulated recommendations to address clinical questions in relation to the efficacy , retention , and potential side effects of sealants to prevent dental caries ; their efficacy compared with fluoride varnishes ; and a head-to-head comparison of the different types of sealant material used to prevent caries on pits- and -fissures of occlusal surfaces . TYPES OF STUDIES REVIEW ED This is an up date of the ADA 2008 recommendations on the use of pit- and -fissure sealants on the occlusal surfaces of primary and permanent molars . The authors conducted a systematic search in MEDLINE , Embase , Cochrane Central Register of Controlled Trials , and other sources to identify r and omized controlled trials reporting on the effect of sealants ( available on the U.S. market ) when applied to the occlusal surfaces of primary and permanent molars . The authors used the Grading of Recommendations Assessment , Development , and Evaluation approach to assess the quality of the evidence and to move from the evidence to the decisions . RESULTS The guideline panel formulated 3 main recommendations . They concluded that sealants are effective in preventing and arresting pit- and -fissure occlusal carious lesions of primary and permanent molars in children and adolescents compared with the nonuse of sealants or use of fluoride varnishes . They also concluded that sealants could minimize the progression of non-cavitated occlusal carious lesions ( also referred to as initial lesions ) that receive a sealant . Finally , based on the available limited evidence , the panel was unable to provide specific recommendations on the relative merits of 1 type of sealant material over the others . Conclusions and practical implication s : These recommendations are design ed to inform practitioners during the clinical decision-making process in relation to the prevention of occlusal carious lesions in children and adolescents . Clinicians are encouraged to discuss the information in this guideline with patients or the parents of patients . The authors recommend that clinicians re-orient their efforts toward increasing the use of sealants on the occlusal surfaces of primary and permanent molars in children and adolescents"
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BACKGROUND Obesity induced low- grade chronic inflammation disrupts proper immune and metabolic function . Vitamin D deficiency increases inflammation , which is associated with cardiometabolic risk . This systematic review examines the association between oral vitamin D ( VD ) supplementation and circulating inflammatory biomarkers and glycemic outcomes from r and omized controlled trials ( RCTs ) of overweight and /or obese adults . METHODS MEDLINE OVID , EMBASE and the Cochrane Central Register of Controlled Trials were search ed according to a predefined protocol . Eligible RCTs included adults r and omized to receive either oral VD or placebo . Two review ers independently assessed RCTs for inclusion . Bias was assessed using the Cochrane Collaboration risk of bias tool . Mean differences were calculated comparing end-of- study sample means between the independent VD and placebo groups . RESULTS Eleven unique RCTs met inclusion criteria from a total of 3,383 identified citations , including 79 screened articles and 14 full text data extraction s. Inflammatory and glycemic measures were reported in 7 and 10 RCTs , respectively . Most trial findings were non-significant with considerable heterogeneity in design , participants and outcomes . All but one trial was rated as either high or unclear risk of bias . Two RCTs reported significant changes in inflammatory biomarkers ; however , the mean difference between groups was not statistically significant : C-reactive protein 0.19 mg/L ( p = 0.88 ) ; Tumor Necrosis Factor -0.54 pg/ml ( p = 0.20 ) . Two other trials found significant mean differences in fasting plasma glucose -0.32 mmol/L ( p = 0.03 ) , Hemoglobin A1c -0.13 % ( p = 0.04 ) , and Homeostatic Model Assessment -0.86 ( p = 0.02 ) following VD supplementation . CONCLUSIONS Overall , there is no clear established benefit of VD supplementation on inflammatory biomarkers among overweight/obese adults . Baseline serum VD possibly influences the effect of VD repletion on inflammatory markers . Risk of bias was present in most studies , thus supporting the need for higher quality studies in this area to more conclusively underst and the role VD supplementation has on inflammatory pathways
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"OBJECTIVE —Accumulating epidemiological evidence suggests that hypovitaminosis D may be associated with type 2 diabetes and related metabolic risks . However , prospect i ve data using the biomarker serum 25-hydroxyvitamin D [ 25(OH)D ] are limited and therefore examined in the present study . RESEARCH DESIGN AND METHODS —A total of 524 r and omly selected nondiabetic men and women , aged 40–69 years at baseline , with measurements for serum 25(OH)D and IGF-1 in the population -based Ely Study , had glycemic status ( oral glucose tolerance ) , lipids , insulin , anthropometry , and blood pressure measured and metabolic syndrome risk ( metabolic syndrome z score ) derived at baseline and at 10 years of follow-up . RESULTS —Age-adjusted baseline mean serum 25(OH)D was greater in men ( 64.5 nmol/l [ 95 % CI 61.2–67.9 ] ) than women ( 57.2 nmol/l [ 54.4,60.0 ] ) and varied with season ( highest late summer ) . Baseline 25(OH)D was associated inversely with 10-year risk of hyperglycemia ( fasting glucose : β = −0.0023 , P = 0.019 ; 2-h glucose : β = −0.0097 , P = 0.006 ) , insulin resistance ( fasting insulin β = −0.1467 , P = 0.010 ; homeostasis model assessment of insulin resistance [ HOMA-IR ] : β = −0.0059 , P = 0.005 ) , and metabolic syndrome z score ( β = −0.0016 , P = 0.048 ) after adjustment for age , sex , smoking , BMI , season , and baseline value of each metabolic outcome variable . Associations with 2-h glucose , insulin , and HOMA-IR remained significant after further adjustment for IGF-1 , parathyroid hormone , calcium , physical activity , and social class . CONCLUSIONS —This prospect i ve study reports inverse associations between baseline serum 25(OH)D and future glycemia and insulin resistance . These associations are potentially important in underst and ing the etiology of abnormal glucose metabolism and warrant investigation in larger , specifically design ed prospect i ve studies and r and omized controlled trials of supplementation",
"OBJECTIVE Low vitamin D levels predict the development of diabetes . This double-blind , r and omized , control study in subjects with prediabetes and hypovitaminosis D evaluated whether high doses of vitamin D for 1 year affected insulin secretion , insulin sensitivity , and the development of diabetes . RESEARCH DESIGN AND METHODS A total of 1,551 subjects ≥40 years of age not known to have diabetes were screened with A1C levels . Subjects with A1C levels of 5.8–6.9 % underwent an oral glucose tolerance test ( OGTT ) . Subjects with prediabetes and 25-OH vitamin D ( 25-OHD ) levels were r and omized to receive weekly placebo ( n = 53 ) or vitamin D ( n = 56 ) with doses based on body weight and baseline 25-OHD levels . OGTTs were performed 3 , 6 , 9 , and 12 months later . Insulin secretion and sensitivity were measured , and the proportion of subjects developing diabetes was assessed . RESULTS 25-OHD levels rapidly rose from 22 to nearly 70 ng/mL after vitamin D supplementation with a mean weekly dose of 88,865 IU . There were no differences between the placebo and vitamin D groups regarding fasting plasma glucose , 2-h glucose , or insulin secretion and sensitivity or in the percent developing diabetes or returning to normal glucose tolerance . No subjects experienced increased serum or urinary calcium levels . At 12 months , A1C levels were significantly slightly less ( 0.2 % ) in the vitamin D group . CONCLUSIONS In individuals with prediabetes and hypovitaminosis D , doses of vitamin D supplementation design ed to raise serum 25-OHD levels into the upper-normal range for 1 year had no effect on insulin secretion , insulin sensitivity , or the development of diabetes compared with placebo administration",
"BACKGROUND Since inflammation is believed to have a role in the pathogenesis of cardiovascular events , measurement of markers of inflammation has been proposed as a method to improve the prediction of the risk of these events . METHODS We conducted a prospect i ve , nested case-control study among 28,263 apparently healthy postmenopausal women over a mean follow-up period of three years to assess the risk of cardiovascular events associated with base-line levels of markers of inflammation . The markers included high-sensitivity C-reactive protein ( hs-CRP ) , serum amyloid A , interleukin-6 , and soluble intercellular adhesion molecule type 1 ( sICAM-1 ) . We also studied homocysteine and a variety of lipid and lipoprotein measurements . Cardiovascular events were defined as death from coronary heart disease , nonfatal myocardial infa rct ion or stroke , or the need for coronary-revascularization procedures . RESULTS Of the 12 markers measured , hs-CRP was the strongest univariate predictor of the risk of cardiovascular events ; the relative risk of events for women in the highest as compared with the lowest quartile for this marker was 4.4 ( 95 percent confidence interval , 2.2 to 8.9 ) . Other markers significantly associated with the risk of cardiovascular events were serum amyloid A ( relative risk for the highest as compared with the lowest quartile , 3.0 ) , sICAM-1 ( 2.6 ) , interleukin-6 ( 2.2 ) , homocysteine ( 2.0 ) , total cholesterol ( 2.4 ) , LDL cholesterol ( 2.4 ) , apolipoprotein B-100 ( 3.4 ) , HDL cholesterol ( 0.3 ) , and the ratio of total cholesterol to HDL cholesterol ( 3.4 ) . Prediction models that incorporated markers of inflammation in addition to lipids were significantly better at predicting risk than models based on lipid levels alone ( P levels of hs-CRP and serum amyloid A were significant predictors of risk even in the subgroup of women with LDL cholesterol levels below 130 mg per deciliter ( 3.4 mmol per liter ) , the target for primary prevention established by the National Cholesterol Education Program . In multivariate analyses , the only plasma markers that independently predicted risk were hs-CRP ( relative risk for the highest as compared with the lowest quartile , 1.5 ; 95 percent confidence interval , 1.1 to 2.1 ) and the ratio of total cholesterol to HDL cholesterol ( relative risk , 1.4 ; 95 percent confidence interval , 1.1 to 1.9 ) . CONCLUSIONS The addition of the measurement of C-reactive protein to screening based on lipid levels may provide an improved method of identifying persons at risk for cardiovascular events",
"OBJECTIVE The aim of the study was to evaluate the expression of tumor necrosis factor (TNF)-alpha protein in the subcutaneous and visceral adipose tIssue in correlation with adipocyte cell Volume , serum TNF-alpha , soluble TNF-receptor-2 ( sTNFR-2 ) and indirect parameters of insulin resistance in overweight/obese and lean healthy persons . DESIGN A cross-sectional case-control study was used . PATIENTS Twenty-eight overweight/obese prob and s with normal glucose tolerance ( BMI > 27 kg/m(2 ) ) and 15 lean people ( BMI , participated in the study . METHODS Two to four grams of subcutaneous and visceral adipose tIssue were removed and studied using semi-quantitative immunohistochemical staining of the TNF-alpha protein . Serum TNF-alpha , sTNFR-2 ( ELISA ) and fasting C-peptide ( RIA ) were measured . RESULTS TNF-alpha protein was expressed in adipocytes of both depots . The expression was evaluated visually and found to be greater in the obese patients . Significantly higher serum TNF-alpha ( 5.58+/-0.87 pg/ml vs 4.21+/-0.55 , mean+/-s.d . , P sTNFR-2 levels ( 7.84+/-3.56 ng/ml vs 4.59+/-1.35 , P=0.005 ) were found in the obese subgroup in correlation with the fasting C-peptide level ( r=0.49 , P=0.003 ; and r=0.74 , P=0.001 ) and the C-peptide/ blood glucose ratio ( r=0.47 , Spearman , P=0.005 ; and r=0.70 , P=0.001 ) . The cell Volume of both adipocyte depots was found to have a significant positive correlation with serum TNF-alpha and sTNFR-2 levels in the total group of patients ( subcutaneous : r=0.52 , P=0.0003 ; r=0.69 , P sTNFR-2 production and obesity-linked insulin resistance",
" The objective of the present trial was to assess the effects of vitamin D supplementation on serum 25-hydroxyvitamin D [ 25(OH)D ] and high-density lipoprotein cholesterol ( HDL-C ) in subjects with high waist circumference . Subjects were r and omly assigned a daily multivitamin and mineral ( MVM ) supplement or a MVM supplement plus vitamin D 1,200 IU/day ( MVM+D ) for 8 weeks . There was a significant difference in mean change for 25(OH)D between the MVM and MVM+D treatment groups ( − 1.2 ± 2.5 nmol/l vs. 11.7 ± 3.0 nmol/l , respectively ; P = 0.003 ) . Vitamin D 1,200 IU/day did not increase 25(OH)D to a desirable level ( ≥ 75 nmol/l ) in 61 % of participants . There were no significant changes in cardiovascular disease risk markers . Thus , vitamin D supplementation with 1,200 IU/day was insufficient to achieve desirable serum 25(OH)D in most participants and did not affect cardiovascular disease risk markers ",
"Background Recent evidence suggests that higher calcium and /or vitamin D intake may be associated with lower body weight and better metabolic health . Due to contradictory findings from intervention trials , we investigated the effect of calcium plus vitamin D3 ( calcium+D ) supplementation on anthropometric and metabolic profiles during energy restriction in healthy , overweight and obese adults with very-low calcium consumption . Methods Fifty-three subjects were r and omly assigned in an open-label , r and omized controlled trial to receive either an energy-restricted diet ( −500 kcal/d ) supplemented with 600 mg elemental calcium and 125 IU vitamin D3 or energy restriction alone for 12 weeks . Repeated measurements of variance were performed to evaluate the differences between groups for changes in body weight , BMI , body composition , waist circumference , and blood pressures , as well as in plasma TG , TC , HDL , LDL , glucose and insulin concentrations . Results Eighty-one percent of participants completed the trial ( 85 % from the calcium + D group ; 78 % from the control group ) . A significantly greater decrease in fat mass loss was observed in the calcium + D group ( −2.8±1.3 vs.-1.8±1.3 kg ; P=0.02 ) than in the control group , although there was no significant difference in body weight change ( P>0.05 ) between groups . The calcium + D group also exhibited greater decrease in visceral fat mass and visceral fat area ( P for changes in metabolic variables ( P>0.05 ) . Conclusion Calcium plus vitamin D3 supplementation for 12 weeks augmented body fat and visceral fat loss in very-low calcium consumers during energy restriction . Trial registration Clinical Trials.gov ( NCT01447433 , http:// clinical trials.gov/ )",
"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 purpose of this study was to examine the effects of vitamin D supplementation on inflammatory biomarkers in overweight and obese adults participating in a progressive resistance exercise training program . Twenty-three ( 26.1 ± 4.7 years ) overweight and obese ( BMI 31.3 ± 3.2 kg/m2 ) adults were r and omized into a double-blind vitamin D supplementation ( Vit D 4,000 IU/day ; female 5 , male 5 ) or placebo ( PL , female 7 ; male 6 ) intervention trial . Both groups performed 12 weeks ( 3 days/week ) of progressive resistance exercise training ( three sets of eight exercises ) at 70–80 % of one repetition maximum . Whole-blood lipopolysaccharide (LPS)-stimulated tumor necrosis factor ( TNF ) α production as well as circulating C-reactive protein ( CRP ) , TNFα , interleukin 6 ( IL-6 ) , and alanine aminotransferase ( ALT ) were assessed at baseline and after the 12-week intervention . No main effects of group or time were detected for circulating CRP , TNFα , IL-6 , and ALT . As expected , when PL and Vit D groups were combined , there was a significant correlation between percent body fat and CRP at baseline ( r = 0.45 , P = 0.04 ) , and between serum 25OHD and CRP at 12 weeks ( r = 0.49 , P = 0.03 ) . The PL group had a significant increase in 25 μg/ml LPS + polymixin B-stimulated TNFα production ( P = 0.04 ) , and both groups had a significant reduction in unstimulated TNFα production ( P . Vitamin D supplementation in healthy , overweight , and obese adults participating in a resistance training intervention did not augment exercise-induced changes in inflammatory biomarkers ",
"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",
"Insufficient vitamin D status has been linked to autoimmune diseases , cancer and metabolic disorders , like obesity and insulin resistance . In vitro and animal studies suggest that vitamin D may play a crucial role in immune activation and inflammation . The relation between vitamin D and pro-inflammatory cytokines is not completely established . Furthermore , it is not known if the effect of vitamin D on entities of metabolic syndrome is mediated through its effect on cytokines or other biomarkers . The objectives of this study were to investigate if there is a relationship between vitamin D status and such pro-inflammatory cytokines as tumor necrosis factor-alpha ( TNF-α ) , interleukin 6 ( IL-6 ) and high sensitive C-reactive protein ( hs-CRP ) in patients with overweigh and obesity . We also proposed that the intervention with high dose of cholecalciferol may have effect on the cytokine levels and result in corresponding changes in the measures of insulin resistance ( HOMA-IR and QUICKI ) . Serum levels of IL-6 , TNF-α and hs-CRP were measured in 332 overweight and obese subjects who completed a 1-year r and omised intervention with either 40,000 IU vitamin D ( cholecalciferol ) per week or 20,000 IU vitamin D per week , or placebo . We found significant associations between IL-6 , TNF-α , vitamin D and insulin resistance indices at baseline . One year intervention with vitamin D decreased serum IL-6 levels ; however hs-CRP levels were significantly increased . Neither measures of insulin resistance , nor TNF-α were influenced by a 1-year vitamin D supplementation",
"The aims of the present study was to examine how overweight and obesity affect serum concentrations nitric oxide ( NO ) metabolites and to determine whether there is association between serum concentrations tumor necrosis factor (TNF)-alpha and TNF soluble receptors ( sTNF-R ) in subjects with overweight and obesity . The study groups involved 154 women : 102 obese ( 81 obese with body mass index [ BMI ] 30 to 40 kg/m2 and 21 obese with BMI > 40 kg/m2 ) , 24 overweight patients , and 28 lean controls . Serum concentrations of NO metabolites and of TNF-alpha and its soluble receptors ( sTNF-R1 , sTNFR-2 ) were measured by enzyme-linked immunosorbent assay ( ELISA ) kits . Serum concentration of insulin was measured by radioimmunoassay ( RIA ) . Plasma glucose , cholesterol , high-density lipoprotein (HDL)-cholesterol , and triglicerydes were determined by enzymatic procedure . Body composition was determined by impedance analysis using Bodystat ( Douglas , British Isles ) . Serum concentrations of NO in the overweight group ( 35.1 + /- 12.1 micromol/L ) and the obese groups with BMI 30 to 40 kg/m2 ( 32.8 + /- 9.3 micromol/L ) and with BMI greater than 40 kg/m2 ( 33.3 + /- 8.5 micromol/L ) were significantly higher when compared to controls ( 28.2 + /- 8.1 micromol/L ) : P levels of NO between the overweight group and both obese groups . Serum concentration of TNF-alpha was also significantly higher in the group with overweight ( 6.5 + /- 3.1 pg/mL ) , in the obese group with BMI 30 to 40 kg/m2 ( 6.8 + /- 3.1 pg/mL ) , and in the obese group with BMI greater than 40 kg/m2 ( 7.4 + /- 2.6 pg/mL ) when compared to controls ( 2.9 + /- 2.2 pg/mL ) : P serum concentrations of sTNF-R1 and -R2 did not differ significantly between the overweight group , both obese groups , and controls . In conclusion , we observed increased serum concentrations of TNF-alpha and NO in overweight and obese women . It seems that there is an association between serum concentrations of TNF-alpha and NO ; however , this relationship depends on the degree of obesity",
"BACKGROUND & AIMS The impact of vitamin D supplementation in overweight and obese adults during resistance training on body composition , muscle function , and glucose tolerance was investigated . METHODS Twenty-three overweight and obese ( age : 26.1±4.7 y ; BMI : 31.3±3.2 kg/m(2 ) ; 25-hydroxyvitamin D : 19.3±7.2 ng/mL ) adults were recruited for participation in a double-blind , placebo-controlled trial . Participants were r and omly divided into vitamin D ( VitD , 4000 IU/d ; 5 females , 5 males ) and placebo ( PL ; 7 females , 6 males ) groups . Both groups completed 12 weeks of resistance training . 25-hydroxyvitamin D , parathyroid hormone , body composition , and glucose tolerance were assessed at baseline and 12 weeks . Muscle function ( strength and power ) was assessed at baseline , 4 , 8 , and 12 weeks . RESULTS During the intervention , 25-hydroxyvitamin D increased and parathyroid hormone decreased in the VitD group ( P ) . Peak power was significantly increased at 4 weeks in the VitD group only ( P in 25-hydroxyvitamin D with the change in waist-to-hip ratio ( R(2)=0.205 , P=0.02 ) . No other improvements were observed with supplementation . CONCLUSIONS Vitamin D supplementation in overweight and obese adults during resistance training induced an early improvement in peak power , and elevated vitamin D status was associated with reduced waist-to-hip ratio . CLINICAL TRIAL REGISTRATION NUMBER NCT01199926",
"OBJECTIVE Adiponectin inhibits vascular inflammation and increases IL-10 mRNA expression in human macrophages . Thus , we investigated the possible relationship between plasma adiponectin and IL-10 levels and the effects of a diet-induced moderate weight loss on both cytokines . PATIENTS AND STUDY DESIGN Plasma adiponectin and IL-10 levels were analyzed in 64 and roid [ body mass index ( BMI ) , > 28 kg/m2 ; waist to hip ratio ( WHR ) , > or = 0.86 ] and 20 gynoid [ BMI , > 28 kg/m2 ; WHR , In 15 and roid obese women , measurements were repeated after a 12-wk diet period ( 1200 kcal/d ) . RESULTS Median adiponectin [ 5.2 ( range , 3.3 - 7.8 ) vs. 12.1 ( 9.7 - 13.9 ) vs. 15.0 ( 12.6 - 18.2 ) microg/ml ; P IL-10 [ 1.8 ( 1.2 - 3.3 ) vs. 3.5 ( 2.9 - 4.3 ) and vs. 4.1 ( 3.5 - 4.8 ) pg/ml ; P adiponectin levels were independently related ( P IL-10 levels , independently of BMI , WHR , or insulin resistance . No significant change in either median adiponectin or IL-10 levels was observed after body weight reduction ( 8 + /- 4 kg ; P changes in adiponectin paralleled those in IL-10 ( P IL-10 and adiponectin levels . However , the antiinflammatory status of obesity might require prolonged periods of energy-restricted diets to revert to normal",
"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",
"This article summarizes the new 2011 report on dietary requirements for calcium and vitamin D from the Institute of Medicine ( IOM ) . An IOM Committee charged with determining the population needs for these nutrients in North America conducted a comprehensive review of the evidence for both skeletal and extraskeletal outcomes . The Committee concluded that available scientific evidence supports a key role of calcium and vitamin D in skeletal health , consistent with a cause- and -effect relationship and providing a sound basis for determination of intake requirements . For extraskeletal outcomes , including cancer , cardiovascular disease , diabetes , and autoimmune disorders , the evidence was inconsistent , inconclusive as to causality , and insufficient to inform nutritional requirements . R and omized clinical trial evidence for extraskeletal outcomes was limited and generally uninformative . Based on bone health , Recommended Dietary Allowances ( RDAs ; covering requirements of ≥97.5 % of the population ) for calcium range from 700 to 1300 mg/d for life-stage groups at least 1 yr of age . For vitamin D , RDAs of 600 IU/d for ages 1–70 yr and 800 IU/d for ages 71 yr and older , corresponding to a serum 25-hydroxyvitamin D level of at least 20 ng/ml ( 50 nmol/liter ) , meet the requirements of at least 97.5 % of the population . RDAs for vitamin D were derived based on conditions of minimal sun exposure due to wide variability in vitamin D synthesis from ultraviolet light and the risks of skin cancer . Higher values were not consistently associated with greater benefit , and for some outcomes U-shaped associations were observed , with risks at both low and high levels . The Committee concluded that the prevalence of vitamin D inadequacy in North America has been overestimated . Urgent research and clinical priorities were identified , including re assessment of laboratory ranges for 25-hydroxyvitamin D , to avoid problems of both undertreatment and overtreatment",
"AIM To determine the short-term effect of vitamin D(3 ) supplementation on insulin sensitivity in apparently healthy , middle-aged , central ly obese men . SUBJECTS AND METHODS A double-blind r and omized controlled trial was conducted at a tertiary care facility in which 100 male volunteers aged > or = 35 years received three doses of vitamin D(3 ) ( 120,000 IU each ; supplemented group ) fortnightly or placebo ( control group ) . Hepatic fasting insulin sensitivity [ homeostasis model assessment ( HOMA ) , quantitative insulin-sensitivity check index , HOMA-2 ] , postpr and ial insulin sensitivity [ oral glucose insulin sensitivity ( OGIS ) ] , insulin secretion ( HOMA%B , HOMA2-%B ) , lipid profile and blood pressure were measured at baseline and at 6 weeks ' follow-up . RESULTS Seventy-one of the recruited subjects completed the study ( 35 in supplemented group , 36 in control group ) . There was an increase in OGIS with supplementation by per protocol analysis ( P = 0.038 ; intention-to-treat analysis P = 0.055 ) . The age- and baseline 25-hydroxyvitamin D level-adjusted difference in change in OGIS was highly significant ( mean difference 41.1 + /- 15.5 ; P = 0.01 ) . No changes in secondary outcome measures ( insulin secretion , basal indices of insulin sensitivity , blood pressure or lipid profile ) were found with supplementation . CONCLUSION The trial indicates that vitamin D(3 ) supplementation improves postpr and ial insulin sensitivity ( OGIS ) in apparently healthy men likely to have insulin resistance ( central ly obese but non-diabetic )",
"BACKGROUND A suboptimal vitamin D and calcium status has been associated with higher risk of type 2 diabetes in observational studies , but evidence from trials is lacking . OBJECTIVE We determined whether vitamin D supplementation , with or without calcium , improved glucose homeostasis in adults at high risk of diabetes . DESIGN Ninety-two adults were r and omly assigned in a 2-by-2 factorial- design , double-masked , placebo-controlled trial to receive either cholecalciferol ( 2000 IU once daily ) or calcium carbonate ( 400 mg twice daily ) for 16 wk . The primary outcome was the change in pancreatic β cell function as measured by the disposition index after an intravenous-glucose-tolerance test . Other outcomes were acute insulin response , insulin sensitivity , and measures of glycemia . RESULTS Participants had a mean age of 57 y , a body mass index ( BMI ; in kg/m(2 ) ) of 32 , and glycated hemoglobin ( Hb A(1c ) ) of 5.9 % . There was no significant vitamin D × calcium interaction on any outcomes . The disposition index increased in the vitamin D group and decreased in the no-vitamin D group ( adjusted mean change ± SE : 300 ± 130 compared with -126 ± 127 , respectively ; P = 0.011 ) , which was explained by an improvement in insulin secretion ( 62 ± 39 compared with -36 ± 37 mU · L(-1 ) · min , respectively ; P = 0.046 ) . Hb A(1c ) increased less , but nonsignificantly , in the vitamin D group than in the no-vitamin D group ( 0.06 ± 0.03 % compared with 0.14 ± 0.03 % , respectively ; P = 0.081 ) . There was no significant difference in any outcomes with calcium compared with no calcium . CONCLUSION In adults at risk of type 2 diabetes , short-term supplementation with cholecalciferol improved β cell function and had a marginal effect on attenuating the rise in Hb A(1c ) . This trial was registered at clinical trials.gov as NCT00436475",
"CONTEXT Vitamin D receptors are present in many tissues . Hypovitaminosis D is considered to be a risk factor for atherosclerosis . OBJECTIVE This study explores the effects of vitamin D replacement on insulin sensitivity , endothelial function , inflammation , oxidative stress , and leptin in vitamin D-deficient subjects . DESIGN , SETTING , AND PATIENTS Twenty-three asymptomatic vitamin D-deficient subjects with 25-hydroxyvitamin D [ 25(OH)D ] levels below 25 nmol/liter were compared with a control group that had a mean 25(OH)D level of 75 nmol/liter . The vitamin D-deficient group received 300,000 IU i m monthly for 3 months . The following parameters were evaluated before and after treatment : vitamin D metabolites , leptin , endothelial function by brachial artery flow mediated dilatation ( FMD ) , insulin sensitivity index based on oral glucose tolerance test , and lipid peroxidation as measures of thiobarbituric acid reactive substances ( TBARS ) . RESULTS FMD measurements were significantly lower in 25(OH)D-deficient subjects than controls ( P = 0.001 ) and improved after replacement therapy ( P = 0.002 ) . Posttreatment values of TBARS were significantly lower than pretreatment levels ( P FMD and 25(OH)D ( r = 0.45 ; P = 0.001 ) and a negative correlation between FMD and TBARS ( r = -0.28 ; P leptin levels after therapy , and the leptin levels were positively correlated with 25(OH)D levels ( r = 0.45 ; P vitamin D has favorable effects on endothelial function . Vitamin D deficiency can be seen as an independent risk factor of atherosclerosis . Hypovitaminosis D-associated endothelial dysfunction may predispose to higher rates of cardiovascular disease in the winter",
"BACKGROUND AND AIM Cross-sectional studies indicate vitamin D to be of importance for glucose tolerance , blood pressure and serum lipids , but whether supplementation with vitamin D would improve cardio-vascular risk factors is not known . DESIGN AND SETTING The study was a 1 year , double blind placebo-controlled intervention trial performed at the University Hospital of North Norway from November 2005 to October 2007 . Subjects . A total of 438 overweight or obese subjects , 21 - 70 years old , were included and 330 completed the study . INTERVENTIONS The subjects were r and omized to vitamin D ( cholecalciferol , vitamin D(3 ) ) 40 000 IU per week ( DD group ) , vitamin D 20 000 IU per week ( DP group ) , or placebo ( PP group ) . All subjects were given 500 mg calcium daily . MAIN OUTCOME MEASURES Fasting serum lipids and blood pressure were measured and an oral glucose tolerance test performed at start and end of the study . RESULTS At baseline the mean serum 25(OH)D levels were 58 nmol L(-1 ) ( all subjects ) and increased to 140 and 101 nmol L(-1 ) in the DD and DP groups , respectively . No significant differences were found between the three groups regarding change in measures of glucose metabolism or serum lipids . In the DP group , there was a slight but significant increase in systolic blood pressure compared with the placebo group . CONCLUSIONS Our results do not support a positive effect of vitamin D on glucose tolerance , blood pressure or serum lipids . Further studies in subjects with low serum 25(OH)D levels combined with impaired glucose tolerance , hypertension or dyslipidaemia are needed",
"CONTEXT We previously showed that a single high dose of oral ( po ) cholecalciferol ( D₃ ) sharply increases serum 25-hydroxyvitamin D [ 25(OH)D ] . OBJECTIVE We evaluated the long-term bioavailability and metabolism of a single po or intramuscular ( i m ) high dose of ergocalciferol ( D₂ ) or D₃. DESIGN This was a prospect i ve intervention study . SETTING The study was conducted in an ambulatory care setting . PATIENTS Participants were 24 subjects with hypovitaminosis D. INTERVENTIONS A single dose of 600,000 IU of po or i m D₂ or D₃ was administered . MAIN OUTCOME MEASURES Serum 25(OH)D and 1,25-dihydroxyvitamin D [ 1,25(OH)₂D ] were measured at baseline and at days 30 , 60 , 90 , and 120 by RIA . Serum 1,25(OH)₂D₂ , 1,25-dihydroxyvitamin D₃ [ 1,25(OH)₂D₃ ] , 24,25-hydroxyvitamin D₂ [ 24,25(OH)D₂ ] , and 24,25-hydroxyvitamin D₃ [ 24,25(OH)D₃ ] were measured by liquid chromatography-t and em mass spectrometry in a subgroup of patients receiving the po formulations . RESULTS The areas under the curve of 25(OH)D after D₃ were significantly higher than those after D₂ ( P basal difference significantly increased at day 30 with po D₂ and D₃ ( P in 1,25(OH)₂D at day 30 ( P produced increases in 24,25(OH)D₂ and 24,25(OH)D₃ , respectively , at day 30 ( P of D₂ or D₃ is initially more effective in increasing serum 25(OH)D than the equivalent i m dose and is rapidly metabolized . Our RIA assay for 1,25(OH)₂D may not recognize"
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BACKGROUND Infant formulas containing hydrolysed proteins have been widely advocated for preventing allergic disease in infants , in place of st and ard cow 's milk formula ( CMF ) . However , it is unclear whether the clinical trial evidence supports this . OBJECTIVES To compare effects on allergic disease when infants are fed a hydrolysed formula versus CMF or human breast milk . If hydrolysed formulas are effective , to determine what type of hydrolysed formula is most effective , including extensively or partially hydrolysed formula ( EHF/PHF ) . To determine whether infants at low or high risk of allergic disease , and whether infants receiving early short-term ( first few days after birth ) or prolonged formula feeding benefit from hydrolysed formulas . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL 2017 , Issue 11 ) , MEDLINE ( 1948 to 3 November 2017 ) , and Embase ( 1974 to 3 November 2017 ) . We also search ed clinical trials data bases , conference proceedings , and the reference lists of retrieved articles and previous review s for r and omised controlled trials and quasi-r and omised trials . SELECTION CRITERIA We search ed for r and omised and quasi-r and omised trials that compared use of a hydrolysed formula versus human milk or CMF . Outcomes with ≥ 80 % follow-up of participants from eligible trials were eligible for inclusion . DATA COLLECTION AND ANALYSIS Two review authors independently selected trials , assessed trial quality and extracted data from the included studies . Fixed-effect analyses were performed . The treatment effects were expressed as risk ratio ( RR ) and risk difference ( RD ) with 95 % confidence intervals and quality of evidence using the GRADE quality of evidence approach . The primary outcome was all allergic disease ( including asthma , atopic dermatitis , allergic rhinitis and food allergy ) . MAIN RESULTS A total of 16 studies were included . Two studies assessed the effect of three to four days infant supplementation with an EHF while in hospital after birth versus pasteurised human milk feed . A single study enrolling 90 infants reported no difference in all allergic disease ( RR 1.43 , 95 % CI 0.38 to 5.37 ) or any specific allergic disease up to childhood including cow 's milk allergy ( CMA ) ( RR 7.11 , 95 % CI 0.35 to 143.84 ) . A single study reported no difference in infant CMA ( RR 0.87 , 95 % CI 0.52 to 1.46 ; participants = 3559 ) . Quality of evidence was assessed as very low for all outcomes .No eligible trials compared prolonged hydrolysed formula versus human milk feeding . Two studies assessed the effect of three to four days infant supplementation with an EHF versus a CMF . A single study enrolling 90 infants reported no difference in all allergic disease ( RR 1.37 , 95 % CI 0.33 to 5.71 ; participants = 77 ) or any specific allergic disease including CMA up to childhood . A single study reported a reduction in infant CMA of borderline significance ( RR 0.62 , 95 % CI 0.38 to 1.00 ; participants = 3473 ) . Quality of evidence was assessed as very low for all outcomes .Twelve studies assessed the effect of prolonged infant feeding with a hydrolysed formula compared with a CMF . The data showed no difference in all allergic disease in infants ( typical RR 0.88 , 95 % CI 0.76 to 1.01 ; participants = 2852 ; studies = 8) and children ( typical RR 0.85 , 95 % CI 0.69 to 1.05 ; participants = 950 ; studies = 2 ) , and no difference in any specific allergic disease including infant asthma ( typical RR 0.57 , 95 % CI 0.31 to 1.04 ; participants = 318 ; studies = 4 ) , eczema ( typical RR 0.93 , 95 % CI 0.79 to 1.09 ; participants = 2896 ; studies = 9 ) , rhinitis ( typical RR 0.52 , 95 % CI 0.14 to 1.85 ; participants = 256 ; studies = 3 ) , food allergy ( typical RR 1.42 , 95 % CI 0.87 to 2.33 ; participants = 479 ; studies = 2 ) , and CMA ( RR 2.31 , 95 % CI 0.24 to 21.97 ; participants = 338 ; studies = 1 ) . Quality of evidence was assessed as very low for all outcomes . AUTHORS ' CONCLUSIONS We found no evidence to support short-term or prolonged feeding with a hydrolysed formula compared with exclusive breast feeding for prevention of allergic disease . Very low- quality evidence indicates that short-term use of an EHF compared with a CMF may prevent infant CMA . Further trials are recommended before implementation of this practice .We found no evidence to support prolonged feeding with a hydrolysed formula compared with a CMF for prevention of allergic disease in infants unable to be exclusively breast fed
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"We examined the prevent effect of a whey hydrolyzed formula ( NAN H.A. ) on the development of allergic disease from new born infants . A hundred thirty three pregnant women were divided into the NAN H.A. group and the control group . Mothers , who agreed to use the whey hydrolyzed formula to their infant , were classified into the NAN H.A. group . We examined laboratory date such as IgE levels of these infants as well as clinical symptoms for evaluating of the preventive effect of NAN H.A. The serum IgE levels from infants of the NAN H.A. group were lower than those of the control group . The incidance of the infants who showed allergic clinical symptoms was significant lower in the NAN H.A. group . The odds ratio to skin symptom at 3 years of age with multiple logistic regression was 5.32 between the control group and the NAN H.A. group ( p mother 's history of allergy was positive and negative ( p NAN H.A. can prevent the development of allergic symptoms in infants",
"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 )",
"OBJECTIVE To determine the effect of brief early exposure to cows ’ milk on atopy in the first 2 years of life . DESIGN Double blind , placebo controlled , r and omised feeding intervention trial ( Bokaal study ) . SETTING Dutch midwifery practice s. PARTICIPANTS 1533 breast fed neonates . INTERVENTION Exposure to cows ’ milk protein ( n = 758 ) or a protein free placebo ( n = 775 ) during the first 3 days of life . MAIN OUTCOME MEASURES Clinical atopic disease and any positive radioallergosorbent ( RAST ) tests at 1 year of age . RESULTS Atopic disease in the first year was found in 10.0 % ( cows ’ milk)v 9.3 % ( placebo ) of the children , with a relative risk of 1.07 ; in the second year , atopic disease was found in 9.6 % v 10.2 % , respectively , with a relative risk of 0.94 . Per protocol analysis showed similar results . Any RAST positive test was found in 9.4 % ( cows ’ milk)v 7.9 % ( placebo ) of children , with a relative risk of 1.19 . Stratified analysis for high family risk of allergy showed a doubled incidence of atopic disease but no effect from the intervention . CONCLUSION Early and brief exposure to cows ’ milk in breast fed children does not increase the risk of atopic disease in the first 2 years",
" A group of 130 healthy term infants were r and omly assigned at birth to one of three feeding regimens for the first 3 days of life : human milk ( HM ) , cow-milk formula ( CMF ) , or a casein hydrolysate formula ( CHF ) . The formula-fed infants received no human milk during the study days . After day 3 , all infants were exclusively breast-fed . Blood sample s were taken at 4 days and at 2 and 4 months of age during outpatient visits . Macromolecular absorption was analyzed 60 min after a feed of human milk by measuring the serum α-lactalbumin ( S-αLA ) concentrations by a competitive radioimmunoassay . Total serum IgE ( S-lgE ) was assayed by radioimmu-noassay . The median S-IgE value was significantly lower at 2 months of age in the CHF group than in the HM group . The values remained significantly lower , even at 4 months of age , in the CHF group than in either the HM or the CMF group . The median S-αLA concentration at 2 months of age was significantly higher in the CHF group than in either the HM group or the CMF group . No significant differences could be found between the CMF and HM groups at any time . One infant in the HM group and one infant in the CMF group developed infantile colic . Two infants in the CHF group developed symptoms of cow-milk allergy . All other infants were healthy at 4 months of age",
"AIM AND OBJECTIVE The aim of the study was to evaluate the effectiveness of massage , sucrose solution , herbal tea or hydrolysed formula , each used individually in the treatment of infantile colic . BACKGROUND The term colic describes a group of symptoms that occur frequently in infants , consisting of paroxysmal abdominal pain and severe crying . Infant colic is of importance for both parents and the community health services that provide families with care , and is therefore an important clinical problem that is amenable to nursing interventions . DESIGN This prospect i ve and r and omised-controlled study involved 175 infants in Turkey . METHODS Data were gathered by using Wessel criteria ; parents wrote a daily structured diary , recording the onset and duration of crying . Patients were assigned r and omly into four different intervention groups ( massage , sucrose solution , herbal tea and hydrolysed formula ) and control group . Duration of crying following each intervention was recorded in the diary by parents for a one week period . RESULTS There was a significant reduction in crying hours per day in all intervention groups . The difference between mean duration of total crying ( hours/day ) before and after the intervention infants in hydrolysed formula group was found higher than massage , sucrose and herbal tea group . The difference between mean duration of total crying(hours/day ) before and after the intervention infants in massage group was found lower than other intervention groups and all groups . CONCLUSION Our findings demonstrated that varied interventions such as administration of massage , sucrose solution , herbal tea and hydrolysed formula are effective in the treatment of colic . The difference between mean duration of total crying ( hours/day ) before and after the intervention in hydrolysed formula group was found higher than other intervention groups . Hydrolysed formula was the most effective in reducing the duration of crying ( hours/day ) when compared with the other intervention groups . Massage intervention yielded the least symptomatic improvement among all the interventions . RELEVANCE TO CLINICAL PRACTICE Colic treatment models used in this study can be used by nurses in neonatal and primary healthcare setting s as an aid to families for the treatment of infantile colic",
"Background : Recent increases in the prevalence of asthma and atopy emphasise the need for devising effective methods for primary prevention in children at high risk of atopy . Method : A birth cohort of genetically at risk infants was recruited in 1990 to a r and omised controlled study . Allergen avoidance measures were instituted from birth in the prophylactic group ( n=58 ) . Infants were either breast fed with mother on a low allergen diet or given an extensively hydrolysed formula . Exposure to house dust mite was reduced by the use of an acaricide and mattress covers . The control group ( n=62 ) followed st and ard advice as normally given by the health visitors . At age 8 , all 120 children completed a question naire and 110 ( 92 % ) had all assessment s ( skin prick test , spirometry , and bronchial challenges ) . Results : In the prophylactic group eight children ( 13.8 % ) had current wheeze compared with 17 ( 27.4 % ) in the control group ( p=0.08 ) . Respective figures were eight ( 13.8 % ) and 20 ( 32.3 % ) for nocturnal cough ( p=0.02 ) and 11 of 55 ( 20.0 % ) and 29 of 62 ( 46.8 % ) for atopy ( p=0.003 ) . After adjusting for confounding variables , the prophylactic group was found to be at a significantly reduced risk for current wheeze ( odds ratio ( OR ) 0.26 ( 95 % confidence interval ( CI ) 0.07 to 0.96 ) ) , nocturnal cough ( OR 0.22 ( 95 % CI 0.06 to 0.83 ) ) , asthma as defined by wheeze and bronchial hyperresponsiveness ( OR 0.11 ( 95 % CI 0.01 to 1.02 ) ) , and atopy ( OR 0.21 ( 95 % CI 0.07 to 0.62 ) ) . Conclusion : Strict allergen avoidance in infancy in high risk children reduces the development of allergic sensitisation to house dust mite . Our results suggest that this may prevent some cases of childhood asthma",
"A total of 105 “ high‐risk ” infants born in 1988 were studied prospect ively from birth to 18 months of age . The infants were recommended breastfeeding and /or hypoallergenic formula ( Nutramigen or Profylac ) combined with avoidance of solid foods during the first 6 months of life . All mothers had unrestricted diet . Avoidance of daily exposure to tobacco smoke , furred pets and dust‐collecting material s in the bedroom were advised . This prevention group was compared with a control group consisting of 54 identically defined “ high‐risk ” infants born in 1985 in the same area . All infants had either severe single atopic predisposition combined with cord blood IgE ≥ 0.5 KU/1 or biparental atopic predisposition . The control group had unrestricted diet and was not advised about environmental factors . Apart from the prevention programme and year of birth the prevention group and the control group were comparable . The parents were highly motivated and compliance was good . The rate of participation was 97 % , and 85 % followed the dietary measures strictly . The cumulative prevalence of atopic symptoms was significantly lower at 18 months in the prevention group ( 32 % ) , as compared with the control group ( 74 % ) ( p prevalence of recurrent wheezing ( 13 % , versus 37 % ; p ) , atopic dermatitis ( 14 % versus 31 % ; p ) , vomiting/diarrhoea ( 5 % versus 20 % ; p and infantile colic ( 9 % versus 24 % ; p The cumulative prevalence of food allergy was significantly lower in the prevention group ( 6 % versus 17 % ; p groups daily exposure to tobacco smoke increased the risk of recurrent wheezing significantly ( p with breastmilk and /or hypoallergenic formula combined with avoidance of solid foods until the age of 6 months appeared to reduce the cumulative prevalence of atopic symptoms during the first 18 months of life",
"A total of 105 infants at \" high risk \" for developing allergy born in 1988 were studied prospect ively from birth to 18 months of age . The infants were recommended breastfeeding and /or hypoallergenic formula ( Nutramigen or Profylac ) combined with avoidance of solid foods the first six months of life . All mothers had unrestricted diet . Avoidance of daily exposure to tobacco smoking , furred pets and dust collecting material s in the bedroom was advised . This prevention group was compared to a control group consisting of 54 identically defined \" high-risk \" infants born in 1985 in the same area . All the infants had either severe single atopic predisposition combined with cord blood IgE > or = 0.5 KU/l or biparental atopic predisposition . The control group had unrestricted diet and was not advised about environmental factors . The cumulative incidence of atopic symptoms was significantly lower at 18 months in the prevention group ( 32 % ) compared with the control group ( 74 % ) ( p incidence of recurrent wheezing ( 13 % versus 37 % ; p atopic dermatitis ( 14 % versus 31 % ; p vomiting/diarrhoea ( 5 % versus 20 % ; p infantile colic ( 9 % versus 24 % ; p cumulative incidence of food-allergy was significantly lower in the prevention group ( 6 % versus 17 % ; p < 0.05 ) . In both high-risk groups exposure to daily tobacco smoking increased the risk of recurrent wheezing significantly ( p < 0.01 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Abstract Objectives : To investigate the association between the duration of exclusive breast feeding and the development of asthma related outcomes in children at age 6 years . Design : Prospect i ve cohort study . Setting : Western Australia . Subjects : 2187 children ascertained through antenatal clinics at the major tertiary obstetric hospital in Perth and followed to age 6 years . Main outcome measures : Unconditional logistic regression to model the association between duration of exclusive breast feeding and outcomes related to asthma or atopy at 6 years of age , allowing for several important confounders : sex , gestational age , smoking in the household , and early childcare . Results : After adjustment for confounders , the introduction of milk other than breast milk before 4 months of age was a significant risk factor for all asthma and atopy related outcomes in children aged 6 years : asthma diagnosed by a doctor ( odds ratio 1.25 , 95 % confidence interval 1.02 to 1.52 ) ; wheeze three or more times since 1 year of age ( 1.41 , 1.14 to 1.76 ) ; wheeze in the past year ( 1.31 , 1.05 to 1.64 ) ; sleep disturbance due to wheeze within the past year ( 1.42 , 1.07 to 1.89 ) ; age when doctor diagnosed asthma ( hazard ratio 1.22 , 1.03 to 1.43 ) ; age at first wheeze ( 1.36 , 1.17 to 1.59 ) ; and positive skin prick test reaction to at least one common aeroallergen ( 1.30 , 1.04 to 1.61 ) . Conclusion : A significant reduction in the risk of childhood asthma at age 6 years occurs if exclusive breast feeding is continued for at least the 4 months after birth . These findings are important for our underst and ing of the cause of childhood asthma and suggest that public health interventions to optimise breast feeding may help to reduce the community burden of childhood asthma and its associated traits . Key messages Asthma is the leading cause of admission to hospital in Australian children and its prevalence is increasing Whether breast feeding protects against asthma or atopy , or both , is controversial Asthma is a complex disease , and the relative risks between breast feeding and asthma or atopy are unlikely to be large ; this suggests the need for investigation in a large prospect i ve birth cohort with timely assessment of atopic outcomes and all relevant exposures Exclusive breast feeding for at least 4 months is associated with a significant reduction in the risk of asthma and atopy at age 6 years and with a significant delay in the age at onset of wheezing and asthma being diagnosed by a doctor Public health interventions to promote an increased duration of exclusive breast feeding may help to reduce the morbidity and prevalence of childhood asthma and",
"Abstract Extensively hydrolyzed ( EH ) formula with Lactobacillus rhamnosus GG ( LGG ) was demonstrated to alleviate cow ’s milk allergy ( CMA ) symptoms and promote faster acquisition of tolerance to cow ’s milk protein . We previously demonstrated that partially hydrolyzed ( PH ) and EH formulas with LGG supported normal growth in healthy-term infants through 120 days of age . The objective of the current study was to evaluate growth , development , and specific adverse events through 5 years of age in participants from that cohort who continued receiving study formula . Infants who completed a double-blind , r and omized growth and tolerance study were eligible to continue receiving the assigned study formula through 1 year of age ( control : EH casein formula , EHF , or one of two investigational formulas : EH casein formula with LGG ( EHF-LGG ) or a PH formula with LGG ( PHF-LGG ) ) and participate in follow-up through 5 years of age . Anthropometric measures , behavior development , and specific adverse events were recorded . No significant differences in achieved weight and height or behavioral development outcomes at 3 or 5 years of age were observed among study groups . Few statistically significant differences in the incidence of specific infection-related events through years 3 or 5 were observed among study groups , none of which were considered clinical ly relevant . Conclusion : Extensively and partially hydrolyzed formulas with LGG were associated with normal growth and development and long-term safety through 5 years of age . What is Known:• Infants with cow ’s milk allergy often experience allergic manifestations that can lead to poor nutrition status and poor growth.• Providing partially hydrolyzed ( PH ) and EH formulas with or without LGG in infants can support normal growth in healthy-term infants . What is New:• This study provides long-term safety data for the first 5 years of life on the use of extensively and partially hydrolyzed formulas with LGG when fed through 1 year of age.• Extensively and partially hydrolyzed formulas with LGG are associated with normal growth , development , and long-term safety through 5 years of age",
"BACKGROUND Partially hydrolyzed whey formula ( pHWF ) has been recommended for infants with a family history of allergic disease at the cessation of exclusive breast-feeding to promote oral tolerance and prevent allergic diseases . OBJECTIVE To determine whether feeding infants pHWF reduces their risk of allergic disease . METHODS A single-blind ( participant ) r and omized controlled trial was conducted to compare allergic outcomes between infants fed a conventional cow 's milk formula , a pHWF , or a soy formula . Before birth , 620 infants with a family history of allergic disease were recruited and r and omized to receive the allocated formula at cessation of breast-feeding . Skin prick tests to 6 common allergens ( milk , egg , peanut , dust mite , rye grass , and cat d and er ) were performed at 6 , 12 , and 24 months . The primary outcome was development of allergic manifestations ( eczema and food reactions ) measured 18 times in the first 2 years of life . RESULTS Follow-up was complete for 93 % ( 575/620 ) at 2 years and 80 % ( 495/620 ) at 6 or 7 years of age . There was no evidence that infants allocated to the pHWF ( odds ratio , 1.21 ; 95 % CI , 0.81 - 1.80 ) or the soy formula ( odds ratio , 1.26 ; 95 % CI , 0.84 - 1.88 ) were at a lower risk of allergic manifestations in infancy compared with conventional formula . There was also no evidence of reduced risk of skin prick test reactivity or childhood allergic disease . CONCLUSION Despite current dietary guidelines , we found no evidence to support recommending the use of pHWF at weaning for the prevention of allergic disease in high-risk infants",
"Partially hydrolyzed formulas ( pHF ) represent a significant percentage of the infant formula market . A new whey-based , palm olein oil (PO)–free pHF was developed and a masked , r and omized , parallel growth study was conducted in infants fed this formula or a commercially available whey-based pHF with PO . Infants between 0 and 8 days were to be enrolled and studied to 119 days of age . Growth and tolerance of infants were evaluated . Mean weight gain from 14 to 119 days of age was similar between groups . There were no significant differences between groups in weight , length , head circumference ( HC ) , or length or HC gains . Infants fed the new PO-free pHF had significantly softer stools than those fed the PO-containing formula except at 119 days of age . This study demonstrates that whereas growth of infants fed different formulas during the first 4 months of life may be similar , infants may tolerate individual formulas differently",
"Abstract Objective : To describe the incidence and prognosis of wheezing illness from birth to age 33 and the relation of incidence to perinatal , medical , social , environmental , and lifestyle factors . Design : Prospect i ve longitudinal study . Setting : Engl and , Scotl and , and Wales . Subjects : 18 559 people born on 3 - 9 March 1958 . 5801 ( 31 % ) contributed information at ages 7 , 11 , 16 , 23 , and 33 years . Attrition bias was evaluated using information on 14 571 ( 79 % ) subjects . Main outcome measure : History of asthma , wheezy bronchitis , or wheezing obtained from interview with subjects ' parents at ages 7 , 11 , and 16 and reported at interview by subjects at ages 23 and 33 . Results : The cumulative incidence of wheezing illness was 18 % by age 7 , 24 % by age 16 , and 43 % by age 33 . Incidence during childhood was strongly and independently associated with pneumonia , hay fever , and eczema . There were weaker independent associations with male sex , third trimester antepartum haemorrhage , whooping cough , recurrent abdominal pain , and migraine . Incidence from age 17 to 33 was associated strongly with active cigarette smoking and a history of hay fever . There were weaker independent associations with female sex , maternal albuminuria during pregnancy , and histories of eczema and migraine . Maternal smoking during pregnancy was weakly and inconsistently related to childhood wheezing but was a stronger and significant independent predictor of incidence after age 16 . Among 880 subjects who developed asthma or wheezy bronchitis from birth to age 7 , 50 % had attacks in the previous year at age 7 ; 18 % at 11 , 10 % at 16 , 10 % at 23 , and 27 % at 33 . Relapse at 33 after prolonged remission of childhood wheezing was more common among current smokers and atopic subjects . Conclusion : Atopy and active cigarette smoking are major influences on the incidence and recurrence of wheezing during adulthood . Key messages Incidence of wheezing illness at all ages was strongly and consistently related to a history of hay fever or eczema ( atopy ) . Associations with maternal smoking during pregnancy , abdominal pain , and migraine were largely confined to those without atopy Active smoking was a powerful and potentially avoidable risk factor for wheeze starting in adult life among both atopic and non-atopic subjects A quarter of the children with a history of asthma or wheezy bronchitis by age 7 reported wheeze in the past year at age 33 Recurrence of wheezing after prolonged remis- sion during late adolescence was strongly associ- ated with atopy and cigarette smoking",
"Aims /hypothesisThe Trial to Reduce IDDM in the Genetically at Risk ( TRIGR ) study was design ed to establish whether weaning to a highly hydrolysed formula in infancy subsequently reduces the risk of type 1 diabetes . Methods The study population comprises newborn infants who have first-degree relatives with type 1 diabetes and meet the increased risk HLA inclusion , but not exclusion criteria . The study is being performed in 15 countries in three continents . First-degree relatives of patients with type 1 diabetes were identified from diabetes clinics , diabetes registries , and from other endocrinology or obstetrics offices and websites . HLA typing was performed at birth from cord or heel stick blood , and the results sent to the study ’s Data Management Unit within 2 weeks for communication of eligibility to the clinical study centre . All mothers recruited were encouraged to breastfeed . The intervention lasted for 6 to 8 months , and weaning formulas based on hydrolysed casein and st and ard cow ’s milk were compared . Results TRIGR recruited 5,606 infants , of whom 2,160 were enrolled as eligible participants , 6 % more than the target of 2,032 . Of those enrolled , 80 % were exposed to the study formula . The overall retention rate over the first 5 years is 87 % , with protocol compliance at 94 % . The r and omisation code will be opened when the last recruited child turns 10 years of age , i.e. in 2017 . Conclusions /interpretationThe TRIGR experience demonstrates the feasibility and successful implementation of an international dietary intervention study . TRIGR is the first ever primary prevention trial for type 1 diabetes and , if completed successfully , will provide a definite answer to the research question .Trial registration Clinical Trials.gov NCT00179777 Funding The study was funded by the National Institute of Child Health and Development ( NICHD ) and National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) , National Institutes of Health ( NIH ) ( grant numbers HD040364 , HD042444 and HD051997 ) , Canadian Institutes of Health Research , the Juvenile Diabetes Research Foundation International and the Commission of the European Communities ( specific RTD programme ‘ Quality of Life and Management of Living Re sources ’ , contract number QLK1 - 2002 - 00372 ‘ Diabetes Prevention ’ . Other funding came from the EFSD/JDRF/Novo Nordisk Focused Research Grant , Academy of Finl and , Dutch Diabetes Research Foundation and Finnish Diabetes Research Foundation )",
"Importance Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility . There are no intact proteins in extensively hydrolyzed formulas . Objective To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children . Design , Setting , and Participants An international double-blind r and omized clinical trial of 2159 infants with human leukocyte antigen – conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries ; 1081 were r and omized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula . The follow-up of the participants ended on February 28 , 2017 . Interventions The participants received either a casein hydrolysate or a conventional adapted cow ’s milk formula supplemented with 20 % of the casein hydrolysate . The minimum duration of study formula exposure was 60 days by 6 to 8 months of age . Main Outcomes and Measures Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria . Secondary outcomes included age at diabetes diagnosis and safety ( adverse events ) . Results Among 2159 newborn infants ( 1021 female [ 47.3 % ] ) who were r and omized , 1744 ( 80.8 % ) completed the trial . The participants were observed for a median of 11.5 years ( quartile [ Q ] 1-Q3 , 10.2 - 12.8 ) . The absolute risk of type 1 diabetes was 8.4 % among those r and omized to the casein hydrolysate ( n = 91 ) vs 7.6 % among those r and omized to the conventional formula ( n = 82 ) ( difference , 0.8 % [ 95 % CI , −1.6 % to 3.2 % ] ) . The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group , duration of breastfeeding , duration of study formula consumption , sex , and region while treating study center as a r and om effect was 1.1 ( 95 % CI , 0.8 to 1.5 ; P = .46 ) . The median age at diagnosis of type 1 diabetes was similar in the 2 groups ( 6.0 years [ Q1-Q3 , 3.1 - 8.9 ] vs 5.8 years [ Q1-Q3 , 2.6 - 9.1 ] ; difference , 0.2 years [ 95 % CI , −0.9 to 1.2 ] ) . Upper respiratory infections were the most common adverse event reported ( frequency , 0.48 events/year in the hydrolysate group and 0.50 events/year in the control group ) . Conclusions and Relevance Among infants at risk for type 1 diabetes , weaning to a hydrolyzed formula compared with a conventional formula did not reduce the cumulative incidence of type 1 diabetes after median follow-up for 11.5 years . These findings do not support a need to revise the dietary recommendations for infants at risk for type 1 diabetes . Trial Registration clinical trials.gov Identifier :",
"BACKGROUND Protein hydrolysate formulas are used for infants with food allergy . Most studies of such formulas focus on their effect on allergy and rarely evaluate their capacity to provide normal nutritional status . OBJECTIVE We compared plasma aminograms , serum urea nitrogen , and trace element status in breastfed infants , infants fed hydrolysate formulas , and infants fed milk formula . DESIGN From 6 wk to 6 mo of age , infants were breastfed or fed regular milk formula ( RF ) , 1 of 2 casein-hydrolysate formulas ( CH-1 or CH-2 ) , or whey-hydrolysate formula ( WH ) . Anthropometric measures were taken monthly , and blood sample s were collected at 6 wk and 6 mo . Plasma amino acids , serum urea nitrogen , hematologic indexes , plasma zinc , and plasma copper were analyzed . RESULTS There were no significant differences in hemoglobin , serum transferrin receptor , copper , or zinc among groups . Serum ferritin was significantly lower in infants fed the CH formulas than in the other groups . Infants fed CH-2 had significantly higher serum urea nitrogen than did all other groups . Plasma threonine , valine , phenylalanine , methionine , and tryptophan were significantly higher in the hydrolysate formula groups than in the breastfed group . Plasma tyrosine was significantly lower in infants fed the CH formulas than in the breastfed group , whereas arginine was significantly higher in the WH group than in all other groups . Plasma proline was lower , whereas threonine and tryptophan were higher , in the WH group than in the CH groups . CONCLUSIONS The iron status of infants fed CH formula was lower than that of all other groups . The amounts of amino acids provided by hydrolysate formulas appear excessive compared with regular formula , which is reflected by high serum urea nitrogen ( CH-2 ) and high plasma amino acid concentrations . A reduced and more balanced amino acid content of hydrolysate formulas may be beneficial",
"IMPORTANCE The disease process leading to clinical type 1 diabetes often starts during the first years of life . Early exposure to complex dietary proteins may increase the risk of β-cell autoimmunity in children at genetic risk for type 1 diabetes . Extensively hydrolyzed formulas do not contain intact proteins . OBJECTIVE To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of diabetes-associated autoantibodies in young children . DESIGN , SETTING , AND PARTICIPANTS A double-blind r and omized clinical trial of 2159 infants with HLA-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries ; 1078 were r and omized to be weaned to the extensively hydrolyzed casein formula and 1081 were r and omized to be weaned to a conventional cows ' milk-based formula . The participants were observed to April 16 , 2013 . INTERVENTIONS The participants received either a casein hydrolysate or a conventional cows ' milk formula supplemented with 20 % of the casein hydrolysate . MAIN OUTCOMES AND MEASURES : Primary outcome was positivity for at least 2 diabetes-associated autoantibodies out of 4 analyzed . Autoantibodies to insulin , glutamic acid decarboxylase , and the insulinoma-associated-2 ( IA-2 ) molecule were analyzed using radiobinding assays and islet cell antibodies with immunofluorescence during a median observation period of 7.0 years ( mean , 6.3 years ) . RESULTS The absolute risk of positivity for 2 or more islet autoantibodies was 13.4 % among those r and omized to the casein hydrolysate formula ( n = 139 ) vs 11.4 % among those r and omized to the conventional formula ( n = 117 ) . The unadjusted hazard ratio for positivity for 2 or more autoantibodies among those r and omized to be weaned to the casein hydrolysate was 1.21 ( 95 % CI , 0.94 - 1.54 ) , compared with those r and omized to the conventional formula , while the hazard ratio adjusted for HLA risk , duration of breastfeeding , vitamin D use , study formula duration and consumption , and region was 1.23 ( 95 % CI , 0.96 - 1.58 ) . There were no clinical ly significant differences in the rate of reported adverse events between the 2 groups . CONCLUSIONS AND RELEVANCE Among infants at risk for type 1 diabetes , the use of a hydrolyzed formula , when compared with a conventional formula , did not reduce the incidence of diabetes-associated autoantibodies after 7 years . These findings do not support a benefit from hydrolyzed formula . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00179777",
"BACKGROUND & AIMS Feeding during the first months of life might affect risk for celiac disease . Individuals with celiac disease or type 1 diabetes have been reported to have high titers of antibodies against cow 's milk proteins . Avoidance of cow 's milk-based formula for infants with genetic susceptibility for type 1 diabetes reduced the cumulative incidence of diabetes-associated autoantibodies . We performed a r and omized controlled trial in the same population to study whether weaning to an extensively hydrolyzed formula reduced the risk of celiac disease autoimmunity or celiac disease . METHODS We performed a double-blind controlled trial of 230 infants with HLA-defined predisposition to type 1 diabetes and at least 1 family member with type 1 diabetes . The infants were r and omly assigned to groups fed a casein hydrolysate formula ( n = 113 ) or a conventional formula ( control , n = 117 ) whenever breast milk was not available during the first 6 - 8 months of life . Serum sample s were collected over a median time period of 10 years and analyzed for antibodies to tissue transglutaminase ( anti-TG2A ) using a radiobinding assay , to endomysium using an immunofluorescence assay , and antibodies to a deami date d gliadine peptide using an immunofluorometry assay . Duodenal biopsies were collected if levels of anti-TG2A exceeded 20 relative units . Cow 's milk antibodies were measured during the first 2 years of life . RESULTS Of the 189 participants analyzed for anti-TG2A , 25 ( 13.2 % ) tested positive . Of the 230 study participants observed , 10 ( 4.3 % ) were diagnosed with celiac disease . We did not find any significant differences at the cumulative incidence of anti-TG2A positivity ( hazard ratio , 1.14 ; 95 % confidence interval , 0.51 - 2.54 ) or celiac disease ( hazard ratio , 4.13 ; 95 % confidence interval , 0.81 - 21.02 ) between the casein hydrolysate and cow 's milk groups . Children who developed celiac disease had increased titers of cow 's milk antibodies before the appearance of anti-TG2A or celiac disease . CONCLUSIONS In a r and omized controlled trial of 230 infants with genetic risk factors for celiac disease , we did not find evidence that weaning to a diet of extensively hydrolyzed formula compared with cow 's milk-based formula would decrease the risk for celiac disease later in life . Increased titers of cow 's milk antibody before anti-TG2A and celiac disease indicates that subjects with celiac disease might have increased intestinal permeability in early life . Clinical Trials.gov Number : NCT00570102",
"Objective To determine if use of paracetamol in early life is an independent risk factor for childhood asthma . Design Prospect i ve birth cohort study . Setting Melbourne Atopy Cohort Study . Participants 620 children with a family history of allergic disease , with paracetamol use prospect ively documented on 18 occasions from birth to 2 years of age , followed until age 7 years . Main outcome measures The primary outcome was childhood asthma , ascertained by question naire at 6 and 7 years . Secondary outcomes were infantile wheeze , allergic rhinitis , eczema , and skin prick test positivity . Results Paracetamol had been used in 51 % ( 295/575 ) of children by 12 weeks of age and in 97 % ( 556/575 ) by 2 years . Between 6 and 7 years , 80 % ( 495/620 ) were followed up ; 30 % ( 148 ) had current asthma . Increasing frequency of paracetamol use was weakly associated with increased risk of childhood asthma ( crude odds ratio 1.18 , 95 % confidence interval 1.00 to 1.39 , per doubling of days of use ) . However , after adjustment for frequency of respiratory infections , this association essentially disappeared ( odds ratio 1.08 , 0.91 to 1.29 ) . Paracetamol use for non-respiratory causes was not associated with asthma ( crude odds ratio 0.95 , 0.81 to 1.12 ) . Conclusions In children with a family history of allergic diseases , no association was found between early paracetamol use and risk of subsequent allergic disease after adjustment for respiratory infections or when paracetamol use was restricted to non-respiratory tract infections . These findings suggest that early paracetamol use does not increase the risk of asthma",
"BACKGROUND Early exposure to complex dietary proteins may increase the risk of beta-cell autoimmunity and type 1 diabetes in children with genetic susceptibility . We tested the hypothesis that supplementing breast milk with highly hydrolyzed milk formula would decrease the cumulative incidence of diabetes-associated autoantibodies in such children . METHODS In this double-blind , r and omized trial , we assigned 230 infants with HLA-conferred susceptibility to type 1 diabetes and at least one family member with type 1 diabetes to receive either a casein hydrolysate formula or a conventional , cow's-milk-based formula ( control ) whenever breast milk was not available during the first 6 to 8 months of life . Autoantibodies to insulin , glutamic acid decarboxylase ( GAD ) , the insulinoma-associated 2 molecule ( IA-2 ) , and zinc transporter 8 were analyzed with the use of radiobinding assays , and islet-cell antibodies were analyzed with the use of immunofluorescence , during a median observation period of 10 years ( mean , 7.5 ) . The children were monitored for incident type 1 diabetes until they were 10 years of age . RESULTS The unadjusted hazard ratio for positivity for one or more autoantibodies in the casein hydrolysate group , as compared with the control group , was 0.54 ( 95 % confidence interval [ CI ] , 0.29 to 0.95 ) , and the hazard ratio adjusted for an observed difference in the duration of exposure to the study formula was 0.51 ( 95 % CI , 0.28 to 0.91 ) . The unadjusted hazard ratio for positivity for two or more autoantibodies was 0.52 ( 95 % CI , 0.21 to 1.17 ) , and the adjusted hazard ratio was 0.47 ( 95 % CI , 0.19 to 1.07 ) . The rate of reported adverse events was similar in the two groups . CONCLUSIONS Dietary intervention during infancy appears to have a long-lasting effect on markers of beta-cell autoimmunity -- markers that may reflect an autoimmune process leading to type 1 diabetes . ( Clinical Trials.gov number , NCT00570102 . )",
"Aims : To investigate the effect of caesarean section on gastrointestinal symptoms , atopic dermatitis , and sensitisation to nutritional allergens in infants . Methods : A total of 865 healthy full term neonates with parental history of allergy participating in the prospect i ve German Infant Nutritional Intervention Program ( GINI ) were exclusively breast fed during the first four months of life and had a one year follow up . Data were obtained by follow up visits at age 1 , 4 , 8 , and 12 months , weekly diaries for the first six months , and measurement of total and specific IgE at birth and 12 months . Results : Infants born by caesarean section ( 147/865 , 17 % ) had a greater risk of diarrhoea ( ORadj 1.46 , 95 % CI 1.022 to 2.10 ) and sensitisation to food allergens , both in adjusted ( ORadj 2.06 , 95 % CI 1.123 to 3.80 ) and stratified analyses ( by cord blood IgE ) . Caesarean delivery was not associated with colicky pain and atopic dermatitis . Conclusion : Caesarean delivery might be a risk factor for diarrhoea and sensitisation in infants with family history of allergy . Further research in this area seems warranted as choosing caesarean section becomes increasingly popular",
"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",
"BACKGROUND Some breastfed infants with atopic eczema benefit from elimination of cow milk , egg , or other antigens from their mother 's diet . Maternal dietary antigens are also known to cross the placenta . OBJECTIVES To assess the effects of prescribing an antigen avoidance diet during pregnancy or lactation , or both , on maternal and infant nutrition and on the prevention or treatment of atopic disease in the child . SEARCH METHODS We search ed the Cochrane Pregnancy and Childbirth Group 's Trials Register ( 6 July 2012 ) . SELECTION CRITERIA All r and omized or quasi-r and omized comparisons of maternal dietary antigen avoidance prescribed to pregnant or lactating women . We excluded trials of multimodal interventions that included manipulation of the infant 's diet other than breast milk or of non-dietary aspects of the infant 's environment . DATA COLLECTION AND ANALYSIS We extracted data from published reports , supplemented by additional information received from the trialists we contacted . MAIN RESULTS The evidence from five trials , involving 952 participants , does not suggest a protective effect of maternal dietary antigen avoidance during pregnancy on the incidence of atopic eczema during the first 18 months of life . Data on allergic rhinitis or conjunctivitis , or both , and urticaria are limited to a single trial each and are insufficient to draw meaningful inferences . Longer-term atopic outcomes have not been reported . The restricted diet during pregnancy was associated with a slightly but statistically significantly lower mean gestational weight gain , a non-significantly higher risk of preterm birth , and a non-significant reduction in mean birthweight . The evidence from two trials , involving 523 participants , did not observe a significant protective effect of maternal antigen avoidance during lactation on the incidence of atopic eczema during the first 18 months or on positive skin-prick tests to cow milk , egg , or peanut antigen at one , two , or seven years . One crossover trial involving 17 lactating mothers of infants with established atopic eczema found that maternal dietary antigen avoidance was associated with a non-significant reduction in eczema severity . AUTHORS ' CONCLUSIONS Prescription of an antigen avoidance diet to a high-risk woman during pregnancy is unlikely to reduce substantially her child 's risk of atopic diseases , and such a diet may adversely affect maternal or fetal nutrition , or both . Prescription of an antigen avoidance diet to a high-risk woman during lactation may reduce her child 's risk of developing atopic eczema , but better trials are needed . Dietary antigen avoidance by lactating mothers of infants with atopic eczema may reduce the severity of the eczema , but larger trials are needed",
"Background Parents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional . Up to one-half of formula-fed infants experience a formula change during the first six months of life . Methods The objective of this study was to assess discontinuance due to study physician-assessed formula intolerance in healthy , term infants . Infants ( 335 ) were r and omized to receive either a st and ard intact cow milk protein formula ( INTACT ) or a partially hydrolyzed cow milk protein formula ( PH ) in a 60 day non-inferiority trial . Discontinuance due to study physician-assessed formula intolerance was the primary outcome . Secondary outcomes included number of infants who discontinued for any reason , including parent-assessed . Results Formula intolerance between groups ( INTACT , 12.3 % vs. PH , 13.7 % ) was similar for infants who completed the study or discontinued due to study physician-assessed formula intolerance . Overall study discontinuance based on parent- vs. study physician-assessed intolerance for all infants ( 14.4 vs.11.1 % ) was significantly different ( P = 0.001 ) . Conclusion This study demonstrated no difference in infant tolerance of intact vs. partially hydrolyzed cow milk protein formulas for healthy , term infants over a 60-day feeding trial , suggesting nonst and ard partially hydrolyzed formulas are not necessary as a first-choice for healthy infants . Parents frequently perceived infant behavior as formula intolerance , paralleling previous reports of unnecessary formula changes . Trial Registration clinical trials.gov :",
"BACKGROUND Early feeding with cow 's milk ( CM ) may increase the risk of cow 's milk allergy ( CMA ) . OBJECTIVE We sought to examine prospect ively whether supplementary feeding of CM at the maternity hospital would increase the risk when compared with feeding with pasteurized human milk or hydrolyzed formula . METHODS We studied 6209 unselected healthy , full-term infants , of whom 5385 ( 87 % ) required supplementary milk while in the hospital . The infants were r and omly assigned to receive CM formula ( 1789 infants ) , pasteurized human milk ( 1859 infants ) , or whey hydrolysate formula ( 1737 infants ) . The comparison group ( 824 infants ) was composed of infants who were exclusively breast-fed . The infants were followed for 18 to 34 months for symptoms suggestive of CMA . The primary endpoint was a challenge-proven adverse reaction to CM after a successful CM elimination diet . RESULTS The cumulative incidence of CMA in the infants fed CM was 2.4 % compared with 1.7 % in the pasteurized human milk group ( odds ratio [ OR ] , 0.70 ; 95 % confidence interval [ CI ] , 0 . 44 - 1.12 ) and 1.5 % in the whey hydrolysate group ( OR , 0.61 ; 95 % CI , 0 . 38 - 1.00 ) . In the comparison group , CMA developed in 2.1 % of the infants . Among the infants who required supplementary feeding at hospital , both exposure to CM while in the hospital ( OR , 1.54 ; 95 % CI , 1.04 - 2.30 ; P = .03 ) and obvious parental atopy ( OR , 2.32 ; 95 % CI , 1.53 - 3.52 ; P CMA . CONCLUSIONS Our data indicate that feeding of CM at maternity hospitals increases the risk of CMA when compared with feeding of other supplements , but exclusive breast-feeding does not eliminate the risk",
"The aim of this study was to assess the preventive effect of exclusive breast-feeding and early solid food avoidance on atopic dermatitis ( AD ) in infancy . This study is part of a dietary clinical trial in a prospect i ve cohort of healthy term newborns at risk of atopy . It was recommended to breast-feed for at least 4 months and to avoid solid food in the same time-period . Eight hundred and sixty-five infants exclusively breast-fed , and 256 infants partially or exclusively formula-fed , were followed-up until the end of the first year following birth . AD and sensitization to milk and egg were considered as study end-points . The 1-year incidence of AD was compared between the two study groups . Adjusted odds ratios ( OR ) with 95 % confidence intervals ( CI ) were calculated by multiple logistic regression . The incidence of AD was calculated in relation to age at introduction of solid food and amount of food given . In the breast-fed group , the adjusted OR for AD was 0.47 ( 95 % CI 0.30 - 0.74 ) . The strongest risk factor was the occurrence of AD in the subject 's core family . The risk of infants with AD to be sensitized to milk was four times higher , and to egg eight times higher , than in infants without AD . Age at first introduction of solid food and diversity of solid food showed no effect on AD incidence . We conclude that in infants at atopic risk , exclusive breast-feeding for at least 4 months is effective in preventing AD in the first year of life",
"Prevention guidelines for infants at high risk of allergic disease recommend hydrolysed formula if formula is introduced before 6 months , but evidence is mixed . Adding specific oligosaccharides may improve outcomes",
"BACKGROUND Recommendations for primary prevention of allergic diseases in high-risk children include feeding with hydrolyzed formulas if breast-feeding is insufficient . OBJECTIVE The primary objective of the German Infant Nutritional Intervention study was to investigate the allergy preventive effect of 3 hydrolyzed formulas compared with cow 's milk formula in the first 3 years of life in a r and omized , double-blind trial . METHODS Between 1995 and 1998 , 2252 newborns with atopic heredity were allocated to a group receiving cow 's milk formula , partially or extensively hydrolyzed whey formula , or extensively hydrolyzed casein formula as a milk substitute for the first 4 months if breast-feeding was insufficient . Main outcome parameters were allergic manifestations , atopic dermatitis ( AD ) , and asthma . RESULTS After 3 years , 396 of 2252 children ( 17.6 % ) had dropped out . Breast-fed infants without formula feeding during the intervention ( n = 889 ) were considered separately . A significant reduction of the incidence of AD was achieved with the extensively hydrolyzed casein formula in the intention-to-treat ( ITT ; n = 1363 ) and per protocol ( PP ; n = 904 ) analyses ( ITT : population odds ratio [ 95 % CI ] , 0.67 [ 0.45 - 0.99 ] ; PP : adjusted odds ratio [ OR(adj ) ] , 0.53 [ 0.32 - 0.88 ] ) , and with the partially hydrolyzed whey formula in the PP analysis ( ITT : population odds ratio , 0.76 [ 0.52 - 1.11 ] ; PP : OR(adj ) , 0.60 [ 0.37 - 0.97 ] ) . None of the formulas reduced the incidence of asthma . CONCLUSION The risk for AD , but not for asthma , can be reduced with certain cow 's milk hydrolyzates in high-risk infants when breast-feeding is insufficient . CLINICAL IMPLICATION S Early nutritional intervention in high-risk children has significant influence on the incidence of AD , but not of asthma",
"This prospect i ve , long-term study assessed the effects of a protein hydrolysate formula on allergy prevention in infants with a family history of allergy . Infants were r and omly assigned to receive either the hydrolysate formula ( n = 92 ) or an adapted cow milk formula ( n = 85 ) alone or with breast-feeding for 4 months . The groups did not differ in family allergy history scores or cord blood IgE levels . After 4 months , total IgE levels and allergic reactions did not differ significantly between groups , although the hydrolysate group had a lower prevalence of eczema . At 12 months of age , neither IgE levels nor allergic reactions were significantly different . At 2 years of age , however , 18 allergic reactions had occurred in the hydrolysate group and 31 had occurred in the control group ; the differences were significant for eczema ( p asthma . At 4 years of age , allergic signs were found in 11 children in the hydrolysate group and in 17 children in the control group ; the difference was significant only for eczema ( p protein hydrolysate formula to infants at risk for allergies had a long-term preventive effect on the prevalence of eczema but not of asthma",
"A recent increase in the prevalence of atopic disorders and the enormous costs of management of atopic patients have prompted attempts at prevention . We have examined the effect of exclusive breast feeding and of feeding different infant formulas on incidence of atopic disease in a prospect i ve r and omized controlled study . Seventy-two infants were recruited into each of the following groups : cow milk whey hydrolysate formula ( NAN/HA ) conventional cow milk formula ( Similac ) , soy-based formula ( Isomil ) , and exclusive breast feeding for greater than 4 months . The cumulative incidence of atopic eczema , recurrent wheezing , rhinitis , gastrointestinal symptoms , and colic were noted . Skin prick tests and radioallergosorbent tests for IgE antibodies to milk and soy were performed . At 12 and 18 months of age , the incidence of atopic eczema as also that of all atopic symptoms was significantly lower and similar in the breast-fed and whey hydrolysate groups , compared with the cow milk and soy formula groups . IgE antibodies were detected more often in the cow milk and soy formula groups , especially the former . Among symptomatic infants , fewer skin positive prick tests were seen in the soy group compared with the cow milk group . Our observations show that among infants at high risk of developing atopic disease because of positive family history , exclusive breast feeding or whey hydrolysate formula is associated with a lower incidence and thus a delay in the occurrence of allergic disorders compared with groups fed conventional cow milk or soy formulas",
"In a prospect i ve study of a 1-year birth cohort of 158 high-risk infants the effect of feeding breastmilk , a casein hydrolysate ( Nutramigen ) or a new ultrafiltrated whey hydrolysate ( Profylac ) on the development of cow milk protein allergy/intolerance ( CMPA/CMPI ) was assessed and compared . All the infants had biparental or severe single atopic predisposition , the latter combined with cord blood IgE > or = 0.5 kU/L. At birth all infants were r and omized to Nutramigen or Profylac , which was used when breastfeeding was insufficient or not possible during the first 6 months of life . During the same period this regimen was combined with avoidance of solid foods and cow milk protein . All mothers had unrestricted diets and were encouraged to do breastfeeding only . Moreover , avoidance of daily exposure to tobacco smoking , furred pets and dust-collecting material s in the bedroom was advised . The infants were followed prospect ively from birth to 18 months of age . All possible atopic symptoms were registered and controlled elimination/challenge studies were performed when symptoms suggested CMPA/CMPI . A total of 154 ( 97 % ) were followed up and 141 followed the diet strictly . Eighty-eight ( 62 % ) of the infants were breastfed for at least 6 months , 20 ( 14 % ) were breastfed exclusively , 59 and 62 had varying amounts of Nutramigen or Profylac respectively . CMPA/CMPI was diagnosed in 1/20 , 1/59 and 3/62 in the breastfed , the Nutramigen and Profylac groups respectively , but 1 of the latter also had Nutramigen . None of the infants showed reactions against Nutramigen or Profylac . In 4 infants symptoms were provoked by breastmilk when the mother ingested cow milk and in 1 only by cow milk . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND Allergy is a common cause of illness . The effect of feeding different infant formulas on the incidence of atopic disease and food allergy was assessed in a prospect i ve r and omized double-blind study of high-risk infants with a family history of atopy . METHODS 216 high-risk infants whose mothers had elected not to breast-feed were r and omized to receive exclusively a partial whey hydrolysate formula or a conventional cow 's milk formula or a soy formula until 6 months of age . Seventy-two high risk infants breast-fed for > or = 4 months were also studied . RESULTS Follow-up until 5 years of age showed a significant lowering in the cumulative incidence of atopic disease in the breast-fed ( odds ratio 0.422 [ 0.200 - 0.891 ] ) and the whey hydrolysate ( odds ratio 0.322 [ 0.159 - 0.653 ) groups , compared with the conventional cow 's milk group . Soy formula was not effective ( odds ratio 0.759 [ 0.384 - 1.501 ] ) . The occurrence of both eczema and asthma was lowest in the breast-fed and whey hydrolysate groups and was comparable in the cow 's milk and soy groups . Similar significant differences were noted in the 18 - 60 month period prevalence of eczema and asthma . Eczema was less severe in the whey hydrolysate group compared with the other groups . Double-blind placebo-controlled food challenges showed a lower prevalence of food allergy in the whey hydrolysate group compared with the other formula groups . CONCLUSIONS Exclusive breast-feeding or feeding with a partial whey hydrolysate formula is associated with lower incidence of atopic disease and food allergy . This is a cost-effective approach to the prevention of allergic disease in children",
"For comparison of the antigenicity and allergenicity of three cow 's milk formulas , serum IgE antibodies to cow 's milk , β‐lactoglobulin and casein , and IgG antibodies to β‐lactoglobulin were analyzed in 94 infants with a family history of allergy . They were participating in a r and omized trial comparing the allergy prophylactic effect of feeding an extensively hydrolyzed ( N ) , a partially hydrolyzed ( PH ) , and a regular cow 's milk formula ( RM ) . Only infants who had been formula‐fed for 3 months or more were included . IgE antibodies to cow 's milk proteins were more common in the RM group ( 22/34 ) than in the N ( 2/31 ) and PH groups ( 3/29 ) . There was a strong correlation between sensitization to cow 's milk and β‐lactoglobulin ( r=0.85 , P The IgG responses to β‐lactoglobulin were low in the N group , intermediate in the PH group , and high in the RM group . High responses , as well as detection of IgE antibodies , were associated with development of atopic disease . The low antigenicity and allergenicity of the extensively hydrolyzed formula support its use in allergy prophylaxis . The partial hydrolysate seemed to be less suitable for this purpose",
"Background Infant feeding practice s , particularly the type of milk feeding , have been associated with the development of type 1 diabetes . Aim of the study We studied the relationship between early infant feeding ( during the first year of life ) and diabetes in a large population -based cohort . Methods In 1994–1995 , 6,209 healthy full-term newborns participated in a study examining the effect of supplementary feeding , on development of allergy to cow ’s milk , in maternity hospitals . All supplements in the maternity hospitals were known . Mothers recorded the feeding of infants prospect ively at home . In August 2006 , from a nationwide diabetes registry , 45 children from our cohort were listed as having type 1 diabetes . Results The distribution of cases was similar in the r and omized feeding groups : 9/1,789 in the group that received adapted cow ’s milk-based formula ; 12/1,737 in those who received extensively hydrolyzed formula ; 16/1,859 in those who received banked human milk ; and 8 among those 824 exclusively breast-fed in the hospital . When children who had received cow ’s milk-based formula in the maternity hospital were compared with those without such exposure , less number of children in the former group had diabetes by age 8 ( P = 0.026 ) , but by the end of the follow-up ( 11.5 years ) the difference disappeared ( P = 0.16 ) . Length of breast-feeding and introduction of cereals and other solid foods were similar among those developing type 1 diabetes and those remaining healthy , while early regular daily feeding with cow ’s milk-based formula tended to associate with lower risk for type 1 diabetes ( OR 0.66 ; 95 % confidence interval 0.38–1.13 ; P = 0.08 ) . Conclusions In an extended , secondary analysis of a population -based cohort , very early exposure to cow ’s milk is not a risk factor for type 1 diabetes ; it may in fact diminish its appearance before age 8",
"BACKGROUND Breast milk contains immune factors that compensate for the underdeveloped defenses of the gut of the newborn infant . OBJECTIVE We sought to study the importance of these factors in the immune responses of infants with cows ' milk allergy ( CMA ) to the proteins in cows ' milk ( CM ) . METHODS We prospect ively followed the development of CMA in 6209 healthy infants and collected sample s of colostrum from mothers . Sample s from mothers of infants with CMA and from control subjects were analyzed for immunoglobulins , CM-specific antibodies , and cytokines . In infants with CMA , correlations between the concentration of transforming growth factor (TGF)-beta1 in colostrum and the extent of the immune response to CM proteins were studied . RESULTS The concentration of TGF-beta1 in colostrum sample s from mothers of infants with IgE-mediated CMA ( n = 65 ) was lower ( mean , 589 pg/mL ; 95 % confidence interval [ CI ] , 413 - 840 ) than from mothers of infants with non-IgE-mediated CMA ( n = 37 ; mean , 1162 pg/mL ; 95 % CI , 881 - 1531 ; t = 2.57 , P = .012 ) . In 126 control subjects the mean concentration was 807 pg/mL ( 95 % CI , 677 - 963 ) . In the infants with CMA ( n = 96 - 100 ) , the concentration of TGF-beta1 in colostrum was positively correlated with IgA antibodies to beta-lactoglobulin and IgG antibodies to alpha-casein and whole formula and negatively with the diameter of a skin prick test response to CM and lymphocyte stimulation indices to alpha-casein and beta-lactoglobulin . CONCLUSIONS In an infant prone to having CMA , the TGF-beta1 content of mother 's colostrum may promote IgG-IgA antibody production and inhibit IgE- and cell-mediated reactions to CM",
"Early feeding with cows ' milk ( CM ) may cause cows ' milk allergy ( CMA ) . Breast milk contains many immune factors which compensate for the undeveloped defence mechanisms of the gut of the newborn infant . We studied the effect of supplementary CM feeding at the maternity hospital on the subsequent incidence of CMA , the effects of formula and breast feeding on the subsequent immunologic types of CMA , and the importance of immune factors present in colostrum in the immune responses of infants with CMA . In a cohort of 6209 infants , 824 were exclusively breast-fed and 87 % required supplementary milk while in the maternity hospital : 1789 received CM formula , 1859 pasteurized human milk , and 1737 whey hydrolysate formula . The cumulative incidence of CMA , verified by a CM elimination-challenge test , was 2.4 % in the CM , 1.7 % in the pasteurized human milk and 1.5 % in the whey hydrolysate group . Among these infants , exposure to CM at hospital and a positive atopic heredity increased the risk of CMA . Of the exclusively breast-fed infants , 2.1 % had CMA . Risk factors for the development of IgE-mediated CMA were : exposure to CM at hospital , breast-feeding during the first 8 weeks at home either exclusively or combined with infrequent exposure to small amounts of CM and long breast-feeding . The content of transforming growth factor-beta1 ( TGF-beta1 ) in colostrum from mothers of infants with IgE-mediated CMA was lower than from mothers of infants with non-IgE-mediated CMA . In infants with CMA , TGF-beta1 in colostrum negatively correlated with the result of skin prick test and the stimulation of peripheral blood mononuclear cells to CM , but positively with infants ' IgA and IgG antibodies to CM proteins . Feeding of CM formula at maternity hospital increases the risk of CMA , but exclusive breast-feeding does not eliminate the risk . Prolonged breast-feeding exclusively or combined with infrequent exposure to small amounts of CM during the first 8 weeks induces the development of IgE-mediated CMA . Colostral TGF-beta1 may inhibit IgE- and cell mediated reactions and promote IgG-IgA antibody production to CM in infants prone to developing CMA",
"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 One hundred twenty children , identified before birth as being at high risk for atopy , were prenatally assigned to prophylactic or control groups . METHODS The infants in the prophylactic group either received breast milk from mothers on an exclusion diet or an extensively hydrolyzed formula . Their bedrooms and living rooms were treated repeatedly with an acaricide , and they used polyvinyl-covered mattresses with vented head areas . The infants in the control group were fed conventionally , and no environmental control was recommended . RESULTS A significant advantage , first demonstrated at 1 year of age , persists for children in the prophylactic group . They have less of any allergy or eczema , but the reduced prevalence of asthma is no longer significant . Only three children in the prophylactic group had positive skin prick test results compared with 16 in the control group , suggesting a significant reduction in sensitization . CONCLUSION A dual approach to allergen avoidance , focusing on foods and aeroallergens , appears to be beneficial in selected high-risk infants . Avoidance of potent allergens in early life increases the threshold for sensitization in these high-risk infants . Whether sensitization has been avoided or merely deferred has yet to be proved",
"BACKGROUND By using the response to protein hydrolysate formula ( PHF ) as a model system , we discovered the existence of a sensitive period , before 4 mo , when exposure determines the hedonic tone to flavors . OBJECTIVE We aim ed to characterize the timing and duration of this sensitive period . DESIGN Healthy infants , whose parents had chosen formula feeding , were r and omly assigned into 1 of 6 groups at age 0.5 mo : 2 control groups , one fed cow milk-based formula ( CMF ) and the other fed PHF for 7 mo ; 2 groups fed PHF for either 1 or 3 mo beginning at 1.5 mo and CMF otherwise ; and 2 groups fed PHF for 1 mo beginning at either 2.5 or 3.5 mo and CMF otherwise . Brief access taste tests were conducted monthly , and complete \" meals \" of both formulas occurred at the end of the study . RESULTS Three months of PHF exposure led to acceptance similar to that at 1 mo of exposure . Although these infants were more accepting than were infants with no exposure , they were less accepting than were infants with 7 mo of exposure , which suggests a dosing effect . The time when flavor experiences began was also significant . Among infants exposed to PHF for 1 mo , those who were first fed PHF at 3.5 mo rejected PHF relative to CMF more than did infants exposed at younger ages . CONCLUSION The general principles observed are likely of broader significance , indicating a fundamental feature of mammalian development and reflecting the importance of familiarizing infants with flavors that their mothers consume and transmit to breast milk . This trial was registered at clinical trials.gov as NCT00994747",
"ABSTRACT A prospect i ve case‐control study is presented to assess an allergy prevention programme in children up to 36 months of age . Infants born at three maternity hospitals were followed from birth : 279 infants with high atopic risk ( intervention group ) were compared with 80 infants with similar atopic risk but no intervention ( non‐intervention group ) . The intervention programme included dietary measures ( exclusive and prolonged milk feeding diet followed by a hypoantigenic weaning diet ) and environmental measures ( avoidance of parental smoking in the presence of the babies , day care > 2 years of life ) . Mothers in this group who had insufficient breast milk were r and omly assigned to one of two coded formulas : either a hydrolysed milk formula ( Nidina HA , Nestlé ) or a conventional adapted formula ( Nan , Nestlé ) . Other environmental measures remained the same as for the breastfeeding mothers . The non‐intervention group were either breastfed or received the usual Italian milk feeding and weaning diet , without environmental advice . The main outcome measures were anthropometric measurements and allergic disease manifestations . Normal anthropometric data were observed both in the intervention group and in the nonintervention group . The incidence of allergic manifestations was much lower in the intervention group than in the nonintervention group at 1 year ( 11.5 versus 54.4 % , respectively ) and at 2 years ( 14.9 versus 65.6 % ) and 3 years ( 20.6 versus 74.1 % ) . Atopic dermatitis and recurrent wheezing were found in both the intervention group and the non‐intervention group from birth up to the second year of life , while urticaria and gastrointestinal disorders were only present in the non‐intervention group in the first year of life . Conjunctivitis and rhinitis were present after the second year in both the intervention group and the non‐intervention group . Relapse of the same allergic symptom was less in the intervention group ( 13.0 % ) than in the non‐intervention group ( 36.9 % ) . In comparison to the non‐intervention group , there were fewer intervention group cases with two or more different allergic symptoms ( 8.7 versus 32.6 % ) , and they were more likely to avoid steroid treatment ( 0 versus 10.8 % ) and hospital admission ( 0 versus 6.5 % ) . Babies in the non‐intervention group fed with adapted formula were more likely to develop allergies than breastfed babies in the same group . In the intervention group the breastfed infants had the lowest incidence of allergic symptoms , followed by the infants fed the hydrolysed formula ( ns ) . Infants in the intervention group fed the adapted formula had significantly more allergies than the breastfed and hydrolysed milk fed infants , although less than their counterparts in the non‐intervention group . Of the affected subjects in the intervention group , 80.4 % were RAST and /or Prick positive to food or inhalant allergens . Total serum IgE values detected at birth in the intervention group were not predictive , but at 1 and 2 years of age , IgE values more than 2 SD above the mean in asymptomatic babies were found to predictive for later allergy . In breastfed babies the total IgE level at 1 and 2 years of age was lower than in the other two feeding groups . Of the various factors tested in the non‐intervention group , the following were the most important in the pathogenesis of allergic symptoms : ( i ) formula implementation begun in the first week of life ; ( ii ) early weaning ( ; ( iii ) feeding beef ( ; ( iv ) early introduction of cow 's milk ( parental smoking in the presence of the babies and early day care admission ( ( exclusive breastfeeding and /or hydrolysed milk feeding , delayed and selective introduction of solid foods , and environmental advice ) were effective at the third year of follow‐up , greatly reducing allergic manifestations in high atopic risk babies in comparison with those not receiving these interventions",
"BACKGROUND The prevalence and natural history for food protein-induced enterocolitis syndrome ( FPIES ) have not been determined . OBJECTIVE We sought to determine the prevalence , clinical manifestations , and rate of recovery for FPIES in a large-scale , population -based prospect i ve study . METHODS In a prospect i ve study the feeding history of 13,019 infants was obtained . Infants with probable adverse reactions to cow 's milk protein ( CMP ) were clinical ly examined , skin prick tested , and challenged orally . Diagnostic criteria for CMP-induced FPIES included age less than 9 months , delayed recurrent vomiting ( usually with nausea ) , and lethargy after exposure to CMP in the absence of other IgE-mediated symptoms , such as rash , urticaria , and respiratory symptoms . In addition , a positive challenge response to milk result ed in the above-mentioned gastrointestinal symptoms , removal of milk from the diet result ed in the resolution of those symptoms , or both . RESULTS Ninety-eight percent of the cohort participated in the study . The cumulative incidence for FPIES was 0.34 % ( 44/13,019 patients ) . The most common symptoms were recurrent vomiting ( 100 % ) , lethargy ( 77 % ) diarrhea ( 25 % ) , pallor ( 14 % ) , and bloody diarrhea ( 4.5 % ) . All patients had FPIES within the first 6 months of life . By the age of 3 years , 90 % of the patients had recovered . We did not detect any concomitant reaction to soy . Eight patients with FPIES had IgE-mediated cow 's milk allergy ( IgE-CMA ) . CONCLUSIONS The prevalence of FPIES is significant , and its clinical presentation is distinct from that of IgE-CMA . Most patients with FPIES recover , although a proportion might convert to IgE-CMA . The likelihood for a cross-reactivity to soy in this population was less than previously estimated",
"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 Asthma is a chronic disease that often starts in childhood . The key risk factors are a child 's environment and their genetic characteristics . The aim of this study was to evaluate the efficacy of environmental modification in the first 12 months of life on the prevalence of asthma in high-risk individuals . Methods Children ( n=120 ) considered at high risk of allergic disorders ( either dual heredity or single heredity and a high cord total IgE ) , were enrolled in a single-blinded , r and omised controlled trial . Infants in the intervention arm were either breast fed with the mother on a low allergen diet or given an extensively hydrolysed formula . Exposure to house dust mite allergen was reduced . The control group followed st and ard advice . Children were assessed at ages 1 , 2 , 4 , 8 and 18 years for the presence of asthma and atopy . Results At 18 years of age , there was a significantly lower prevalence of asthma in the prevention group compared with the control group ( OR : 0.23 , 95 % CI 0.08 to 0.70 , p=0.01 ) , primarily due to asthma that developed during childhood but persisted until age 18 years . Repeated-measure analysis showed that there was an overall reduction in asthma prevalence from 1 to 18 years ( OR : 0.51 , CI 0.32 to 0.81 , p=0.04 ) . Prevalence of atopy was not significantly different between the two groups at age 18 . Conclusion Comprehensive allergen avoidance in the first year of life is effective in preventing asthma onset in individuals considered at high risk due to heredity . The effect occurs in the early years , but persists through to adulthood",
"Aims : To determine the effect of brief early exposure to cows ' milk on the expression of atopy during the first five years of life . Methods : Follow up analysis of a double blind , placebo controlled , r and omised feeding intervention trial ( BOKAAL study ) . Subjects were 1108 children from 1533 initially r and omised breast fed neonates in the Netherl and s. Atopic disease and prevalence of allergic symptoms at age 1 , 2 , and 5 , and specific IgE at age 1 and 5 were determined . Results : Atopic disease in the first year was found in 10.0 % ( cows ' milk ) versus 9.3 % ( placebo ) of the children , with a relative risk ( RR ) of 1.07 . No differences were found in the second year either . At age 5 , atopic disease was found in 26.3 % ( cows ' milk ) versus 25.0 % ( placebo ) , RR 1.05 . There was no difference in the prevalence of allergic symptoms . Specific IgE to cows ' milk ( RAST positive 2 + or more ) was 5.8 % ( cows ' milk ) versus 4.1 % ( placebo ) at age 1 ( RR 1.43 ) , and 5.3 % versus 3.0 % at age 5 ( RR 1.77 ) . There was no difference in sensitisation to other common allergens between the two groups . Conclusion : Early , brief exposure to cows ' milk in breast fed children is not associated with atopic disease or allergic symptoms up to age 5",
"OBJECTIVE To test whether weaning to a bovine insulin-free cow 's milk formula ( CMF ) reduces type 1 diabetes mellitus-associated autoantibodies in children at genetic risk . DESIGN R and omized , double-blind pilot trial ( Finnish Dietary Intervention Trial for the Prevention of Type 1 Diabetes [ FINDIA ] ) . SETTING Three pediatric hospitals in Finl and from May 15 , 2002 , to November 22 , 2005 . PARTICIPANTS A total of 1113 infants with HLA-conferred susceptibility to type 1 diabetes were r and omly assigned to receive study infant formulas ; 908 children provided at least 1 follow-up blood sample ( last follow-up , June 2009 ) . INTERVENTION The CMF ( n = 389 ) , whey-based hydrolyzed formula ( WHF ) ( n = 350 ) , or whey-based FINDIA formula essentially free of bovine insulin ( n = 365 ) during the first 6 months of life whenever breast milk was not available . MAIN OUTCOME MEASURES Primary outcome was beta-cell autoimmunity monitored at ages 3 , 6 , and 12 months and then annually until age 3 years . Autoantibodies to insulin , the 65-kDa isoform of glutamic acid decarboxylase , and the tyrosine phosphatase-related IA-2 molecule were screened , and islet cell autoantibodies and autoantibodies to zinc transporter 8 were analyzed in infants whose primary screening test results were positive . RESULTS In the intention-to-treat analysis , 6.3 % of children in the CMF group , 4.9 % of those in the WHF group , and 2.6 % of children in the FINDIA group were positive for at least 1 autoantibody by age 3 years . The odds ratios were 0.75 ( 95 % CI , 0.37 - 1.54 ) in the WHF group and 0.39 ( 0.17 - 0.91 ) in the FINDIA group when compared with the CMF group . In the treatment-received analysis , the corresponding odds ratios were 0.81 ( 95 % CI , 0.37 - 1.76 ) and 0.23 ( 0.08 - 0.69 ) . CONCLUSION In comparison with ordinary CMF , weaning to an insulin-free CMF reduced the cumulative incidence of autoantibodies by age 3 years in children at genetic risk of type 1 diabetes mellitus . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01055080",
"Abstract Little research has focused on infant developmental effects , other than growth , of formulas that differ substantially in the form of protein . To examine development of infants fed formulas differing in free amino acid content , we r and omized 0.5-month-old infants ( n = 79 ) to either a control group who fed only cow milk formula ( CMF ) during the first 8 months ( CMF8 ) , or to one of two experimental groups : one experimental group fed extensively protein hydrolyzed formula ( EHF ) for 1–3 months during first 4.5 months ( EHF1 - 3 ) of life , and the other fed EHF for 8 months ( EHF8 ) . The Mullen Scales of Early Learning were administered monthly from 1.5 to 8.5 months to assess fine ( FM ) and gross ( GM ) motor control , receptive ( RL ) and expressive ( EL ) language , visual reception ( VR ) , and an early learning composite ( ELC ) . Across the 5.5–8.5-month time period , when compared to CMF8 infants , GM scores in EHF1 - 3 infants averaged 1.5 points higher ( 95 % CI 0.1 , 3.0 ) and in EHF8 infants 2.2 points higher ( 95 % CI 0.3 , 4.0 ) . Similarly , VR scores averaged 1.9 points higher ( 95 % CI 0.1 , 3.8 ) in EHF1 - 3 infants and 2.2 points higher ( 95 % CI −0.2 , 4.5 ) in EHF8 infants . EHF8 infants ’ RL scores averaged 1.8 points lower ( 95 % CI 0.1 , 3.6 ) than CMF8 infants . These data suggest that the form of protein in infant formula may impact cognitive development and that the higher free amino acid content in breast milk may be a contributing factor to the differential cognitive development between breastfed and CMF-fed infants . Clinical Trial Registration : clinical trials.gov NCT00994747",
"Aims /hypothesisWe aim ed to assess the feasibility of a dietary intervention trial with weaning to hydrolysed formula in infants at increased risk of type 1 diabetes and to study the effect of the intervention on the emergence of diabetes-associated autoantibodies in early childhood . Methods We studied 242 newborn infants who had a first-degree relative with type 1 diabetes and carried risk-associated HLA-DQB1 alleles . After exclusive breastfeeding , the infants underwent a double-blind , r and omised pilot trial of either casein hydrolysate ( Nutramigen ; Mead Johnson ) or conventional cow ’s milk-based formula until the age of 6–8 months . During a mean observation period of 4.7 years , autoantibodies to insulin , anti-glutamic acid decarboxylase and insulinoma-associated antigen-2 were measured by radiobinding assays , and islet cell antibodies ( ICA ) by immunofluorescence . Results The feasibility of screening and identifying a cohort of first-degree relatives with HLA-conferred disease susceptibility , enrolling them in a dietary intervention trial and following them for seroconversion to autoantibody positivity is established . The cumulative incidence of autoantibodies was somewhat smaller in the casein hydrolysate vs control formula group , suggesting the need for a larger well-powered study . After adjustment for duration of study formula feeding , life-table analysis showed a significant protection by the intervention from positivity for ICA ( p=0.02 ) and at least one autoantibody ( p=0.03 ) . Conclusions /interpretationThe present study provides the first evidence ever in man , despite its limited power , that it may be possible to manipulate spontaneous beta cell autoimmunity by dietary intervention in infancy",
"Aims : To assess maternal compliance with nutritional recommendations in an allergy preventive programme , and identify factors influencing compliance behaviour . Methods : R and omised double-blind intervention study on the effect of infant formulas with reduced allergenicity in healthy , term newborns at risk of atopy . Maternal compliance with dietary recommendations concerning milk and solid food feeding was categorised . Results : A total of 2252 newborns were r and omised to one of four study formulas . The drop out rate during the first year of life was 13.5 % ( n = 304 ) . The rates of high , medium , and low compliance to milk feeding during weeks 1–16 were 83.4 % , 4.0 % , and 7.5 % ; the corresponding rates to solid food feeding during weeks 1–24 were 60.0 % , 12.1 % , and 22.9 % . In 5.1 % of subjects no nutritional information was available . Low compliance was more frequent among non-German parents , parents with a low level of education , young mothers , smoking mothers , and those who weaned their infant before the age of 2 months . Conclusions : Evaluation of allergy preventive programmes should take into account non-compliance for assessing the preventive effectiveness on study outcome",
"BACKGROUND The natural history of allergic disease and its potential for prevention merit close examination because of the explosive worldwide increase in the prevalence and morbidity of atopic disorders . This study examines the development of atopy at age 7 years in 165 children in a high-risk cohort , previously reported from birth to age 4 years . METHODS In this prospect i ve , r and omized , controlled study of food allergen avoidance in infancy , the prophylactic-treated group consisted of infants whose mothers avoided cow 's milk , egg , and peanut during the last trimester of pregnancy and lactation and who , themselves , avoided cow 's milk until age 1 year ( casein hydrolysate supplementation before age 1 ) , egg until age 2 years , and peanut and fish until age 3 years . The control group consisted of maternal/infant pairs who followed st and ard feeding practice s. RESULTS Despite a significant reduction in food allergy and milk sensitization before age 2 years , none of the following differed between the groups at age 7 years : food allergy , atopic dermatitis , allergic rhinitis , asthma , any atopic disease , lung function , food or aeroallergen sensitization , serum IgE level , or presence of nasal eosinophils or nasal basophilic cells . Children with food allergy by 4 years evidence d higher 7-year ( current ) prevalences of allergic rhinitis and asthma ( p Atopic diseases/parameters at age 7 years were shown , by multivariate analysis ( p ( elevated serum IgE level ; egg , cow 's milk , and peanut sensitization ; and nasal eosinophils and nasal basophilic cells ) . CONCLUSIONS These findings help to : ( 1 ) eluci date the natural history of atopic disease in high-risk children ; ( 2 ) document the progression of allergy from atopic dermatitis , food allergy , and food sensitization to respiratory allergy and aeroallergen sensitization despite food allergy prevention in infancy ; ( 3 ) identify allergy predictive markers ; and ( 4 ) exp and our appreciation of the interactions of genetic and environmental factors in the development of atopy",
"The possible role of cows milk intolerance in the aetiology of infant colic was evaluated in 19 babies presenting to their health visitor or general practitioner in one town . Over a three week period a st and ard modified cows milk formula was compared with a soya milk formula on a double blind basis . The duration of colic symptoms was significantly reduced during the week on soya milk ( P less than 0.01 ) , with 11 out of 19 babies fulfilling the diagnostic criteria for cows milk intolerance . Four babies whose symptoms failed to improve either spontaneously or with soya milk were given a hydrolysed protein milk with a positive response in two , confirmed by challenge testing . Thus in 13 out of 19 babies ( 68 % ) the symptoms of infant colic resolved almost completely with dietary change",
"BACKGROUND Only a few studies have analyzed the value of early sensitization in predicting the development of atopic disease . The relevance of low immunoglobulin ( Ig ) E antibody levels in this respect also remains unclear . OBJECTIVE To investigate the relevance of sensitization in 12-month-old children in the development of atopic disease by the age of 6 years . METHODS We analyzed data for 1290 children with a positive family history of atopy from the prospect i ve , multicenter German Infant Nutritional Intervention ( GINIplus ) study and investigated the relationship between the presence of detectable specific IgE antibodies at the age of 12 months and the development of atopic disease by the age of 6 years . RESULTS In all , 10.9 % of children analyzed developed sensitization . At the age of 6 years , 20.6 % of children with early sensitization had eczema compared to 9.4 % of those without ( odds ratio [ OR ] , 2.31 ; 95 % confidence interval [ CI ] , 1.42 - 3.74 ) . The corresponding figures were 15.4 % vs 7.3 % for allergic rhinitis ( OR , 2.22 ; CI , 1.31 - 3.78 ) and 10.2 % vs 2.6 % ( OR , 3.93 ; 95 % CI , 1.98 - 7.76 ) for asthma . Children with early sensitization to aeroallergens had the greatest risk of subsequent atopic disease . Early sensitization did not increase risk in children without eczema within the first year of life . Very low specific IgE levels ( 0.18 - 0.34 kU/L ) were not significantly associated with any of the outcomes analyzed . CONCLUSION Sensitization to common food allergens and to aeroallergens in particular during the first year of life was found to be a strong predictor for the development of atopic disease by the age of 6 years in children with a positive family history of atopy",
"Screening of total IgE in 1189 cord blood sample s was conducted by Phadebas IgE PRIST in a one-year birth cohort 1983 - 1984 in Viborg , Denmark . 113 children with cord blood IgE levels > or = 0.5 kU/l and 138 children chosen at r and om among those with cord blood IgE levels at 5 years of age . Based upon history and physical examination a diagnosis of definite atopy or no atopy was established . Allergy ( IgE mediated ) was defined as atopic disease combined with increased total IgE levels at 5 years of age . The cumulative prevalence of atopic disease was not influenced by cord blood IgE levels or atopic predisposition . Cord blood IgE levels had a low sensitivity as a predictor of atopic disease . A statistically significant correlation between serum levels of IgE at birth and at 5 years was however found ( p elevated cord blood IgE levels developed allergic disease before 5 years of age ( p total IgE level > 63 kU/l ( geometric mean + 1 SD ) at the age of 5 years can be regarded as being an elevated level . A cord blood IgE level > or = 0.3 kU/l in combination with atopic predisposition was predictive of allergic disease , especially allergic bronchial asthma . With regard to allergic disease , the positive predictive value was 26 % , the sensitivity 33 % and the rate ratio for development of allergic disease 4 . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND Hydrolysates are used in the treatment and prevention of cows milk protein allergy . Hydrolysis might alter the plasma level of amino acids . METHODS Forty-five infants were included in a double-blind prospect i ve study and were r and omized in two groups : one receiving a whey predominant formula ( n = 20 ) and the second group receiving a whey hydrolysate formula ( n = 25 ) . Weight and length gain was evaluated up to the age of 13 weeks , when blood was sample d for determination of fasting plasma amino acids . RESULTS Four infants of the hydrolysate group dropped out because refusal to ingest the formula . Weight and length gain at 13 weeks of age were extremely comparable . Significant differences in plasma concentrations were observed for a number of nonessential and essential amino acids ( p = .035 to .0001 ) . Threonine and lysine were both higher in the hydrolysate group , and aspartic acid , cystine , methionine , tyrosine , phenylalanine , histidine , and arginine were lower in the hydrolysate group . CONCLUSIONS These differences in plasma amino acid levels have to be regarded with care because all concentrations were within normal ranges , with the exception of threonine . Weight and length gain of the hydrolysate and the whey predominant formula were identical",
"A masked , r and omized , parallel growth study was conducted in infants fed an amino acid – based formula ( AF ) or an extensively hydrolyzed casein-based formula ( HF ) . Infants were enrolled between 0 and 9 days and studied to 112 days of age . Growth , formula intake , stool patterns , and serum albumin concentrations were assessed . There were no significant differences between groups in weight , length , or head circumference , gains in weight or length , or study formula intake . The number of stools parents rated as being formed , and the mean daily number of stools were greater in the HF than in the AF group at 14 and 28 days of age . Mean serum albumin concentrations were not significantly different between groups and were within the normal range . This study demonstrates that AF supports normal growth of infants comparable to that of infants fed HF during the critical first 4 months of life",
"Summary Aim of the study . An allergen-reduced dietary intervention programme with strict dietary requirements was implemented over the first four months of life in an unselected population -based infant cohort and compared to a non-intervention cohort ( the ZUFF study ) . Recommendations for the dietary programme in the intervention cohort were extended , but not strictly implemented , until the end of month six . The intervention was based on breastfeeding , a moderate whey hydrolysate formula ( pHF ) , and delayed introduction of weaning foods with a high allergenicity . This study was a prospect i ve , controlled , and unblinded study , the first to assess the effects of an allergen-reduced , pHF-based early nutritional programme in a broad unselected infant population . Because overall healthy development of the infant is a major objective of any nutritional programme , the study evaluated the effects of the dietary intervention on infant growth and general health status rather than specific allergic manifestations . Part I of this paper gave results for nutritional behaviour only , and Part II gives results for growth and general health status during the intervention period through the sixth month of life . Methods . Assignment of study infants was to demographically comparable intervention ( Z ) or control ( FF ) cohorts according to place of birth . In the intervention cohort ( Z=564 ) , the recommended dietary regimen was breastfeeding and – if exclusive breastfeeding was not possible – supplementation with a moderately hydrolysed , allergen-reduced infant formula ( pHF ) . Weaning foods were delayed until four months of age or later in case of weaning foods with high allergenicity . In the control cohort ( FF=566 ) , there was no specific intervention . Imbalances between cohorts in confounding ( adjuvant ) factors that could influence health related outcomes were integrated as covariates into the logistic regression of the main analyses . Growth parameters included weight , length , head circumference , BMI , and Z scores ( SDS ) . General health status was assessed by clinical ly significant findings in gastrointestinal , respiratory , or skin symptoms . Results . Growth at 6 weeks and at 3 and 6 months was similar for Z and FF . Significantly fewer Z than FF infants had clinical ly noteworthy health findings at 3 months ( Z=27 % versus FF=37 % , odds ratio=0.63 , CI=0.48–0.82 ) and 6 months ( Z=33 % versus FF=49 % , odds ratio=0.51 , CI=0.40–0.66 ) . This corresponds to a 30 % reduction in overall health concerns at 6 months for the intervention cohort . At 3 and 6 months , differences between cohorts in most measures of general health status were strongly influenced by a lower incidence of skin symptoms in the Z cohort . Within FF , there were fewer exclusively breastfed ( eBF ) infants with health problems at 3 months compared with those who were partially ( pBF ) or non-breastfed ( nBF ) ( eBF=31 % , pBF=40 % , nBF=39 % , p number of infants with health concerns was similar for exclusively breastfed infants and for those in whom mother 's milk was supplemented or replaced by pHF ( eBF=29 % , pBF=25 % , nBF=26 % , ns ) . In a sub analysis of overall health findings in infants without a family risk of allergies , there were again significantly fewer Z than FF infants with any health or any skin problem . Conclusion .An allergen-reduced dietary recommendation that includes a moderate whey hydrolysate infant formula ( pHF ) has no negative effects on growth parameters up to 6 months of life in an infant population unselected for atopic risk . The dietary intervention produced improvements in general health status when compared with a control cohort that received infant formula with unhydrolysed proteins ( IF ) , and high allergenic weaning foods at an earlier age . The difference between cohorts was principally due to fewer adverse skin findings . In infants following our allergen-reduced feeding recommendation , 3-month general health status was comparable between those who were exclusively breastfed and those in whom breastfeeding was supplemented or replaced by pHF . Our results demonstrate that a pHF feeding recommendation during the first 4 to 6 months of life – when exclusive breestfeeding is not possible – is a safe and feasible regimen not only in high-allergic risk population s but in general unselected infant population . The general use of pHF formula in non- or partly breastfed infants could therefore be considered an important contribution to optimised infant nutrition",
"There is much evidence that the development of allergic disorders may be related to early exposure of allergens , including those in breastmilk . We have tried to find out whether avoidance of food and inhaled allergens in infancy protects against the development of allergic disorders in high-risk infants . In a prenatally r and omised , controlled study 120 infants with family history of atopy and high ( greater than 0.5 kU/l ) cord-blood concentrations of total IgE were allocated r and omly to prophylactic and control groups . In the prophylactic group ( n = 58 ) , lactating mothers avoided allergenic foods ( milk , egg , fish , and nuts ) and avoided feeding their infants these foods and soya , wheat , and orange up to the age of 12 months ; the infants ' bedrooms and living rooms were treated with an acaricidal powder and foam every 3 months , and concentrations of Dermatophagoides pteronyssinus antigen(Der p l ) in dust sample s were measured by enzyme-linked immunosorbent assay . In the control group ( n = 62 ) , the diet of mothers and infants was unrestricted ; no acaricidal treatment was done and Der p l concentrations were measured at birth and at 9 months . A paediatric allergy specialist unaware of group assignment examined the infants for allergic disorders at 10 - 12 months . Odds ratios were calculated by logistic regression analysis for various factors with control for other confounding variables . At 12 months , allergic disorders had developed in 25 ( 40 % ) control infants and in 8 ( 13 % ) of the prophylactic group ( odds ratio 6.34 , 95 % confidence intervals 2.0 - 20.1 ) . The prevalences at 12 months of asthma ( 4.13 , 1.1 - 15.5 ) and eczema ( 3.6 , 1.0 - 12.5 ) were also significantly greater in the control group . Parental smoking was a significant risk factor for total allergy at 12 months whether only one parent smoked ( 3.97 , 1.2 - 13.6 ) or both parents smoked ( 4.72 , 1.2 - 18.2 )",
"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 ",
"BACKGROUND The importance of the inflammatory response in allergic disease has warranted investigation of two of the more integral cells in the pathogenesis of allergic rhinitis , namely , nasal basophilic cells ( NBCs ) and nasal eosinophils ( NEs ) . In the present study the natural history of NBCs and NEs was studied from birth through 4 years of age in infants of atopic parents to better underst and their relationship to the development of various atopic disorders . METHODS During a prospect i ve , r and omized , controlled trial of the effect of maternal and infant food avoidance on the development of atopic disorders in 288 infants of atopic parents , NBCs and NEs were determined semiquantitatively on Wright-Geimsa stained nasal mucosal scrapings and related to each other and to various atopic parameters . RESULTS In these infants who are at high risk NBCs developed in both those becoming atopic and those remaining nonatopic , but they occurred with increased frequency and quantity in those children in whom most allergic disorders and food or inhalant sensitization developed . NEs , rare at 4 months in all infants , increased in atopic children from 1 to 4 years , and remained infrequent and nominal in nonatopic children . Levels of NBCs and NEs ( 1 ) correlated with each other strongly , directly , and with increasing magnitude in children from ages 4 months to 4 years and ( 2 ) correlated with log serum IgE levels weakly and moderately in children from ages 2 to 4 years . Stepwise linear regression analyses revealed that allergic rhinitis accounted for most of the variance seen in the level of NBCs and NEs during early childhood , reaching 50 % by age 4 years . Asthma , atopic dermatitis , food allergy , food and inhalant sensitization , serum IgE level , and IgG beta-lactoglobulin level accounted for a small proportion of the variance in NBCs and NEs from ages 4 months to 4 years . CONCLUSIONS These findings help to eluci date the natural history of NBCs and NEs in infants at risk for atopic disorders and document the temporal association of these cells with the development of atopic disease , principally allergic rhinitis",
"BACKGROUND The prevalence of asthma has increased in developed countries in the past 2 decades . The effectiveness of intervention measures on the primary prevention of asthma has not been well studied . OBJECTIVE To assess the effectiveness of a multifaceted intervention program in the primary prevention of asthma in high-risk infants ( in this study , infants are defined as persons from birth to the age of 1 year ) . DESIGN Prospect i ve , prenatally r and omized , controlled study with follow-up through the age of 1 year . SETTING University hospital-based setting s at 2 Canadian centers : Vancouver , British Columbia , and Winnipeg , Manitoba . PARTICIPANTS A total of 545 high-risk infants ( at least 1 first-degree relative with asthma or 2 first-degree relatives with other IgE-mediated allergic diseases ) identified before birth . INTERVENTIONS Avoidance of house dust mite and pet allergens and environmental tobacco smoke , encouragement of breastfeeding , and supplementation with a partially hydrolyzed formula . MAIN OUTCOME MEASURES Probable or possible asthma , rhinitis without apparent colds , and a prick skin test result positive for common inhalant allergens . RESULTS Thirty-eight ( 15.1 % ) of the 251 infants available for assessment in the intervention group and 49 ( 20.2 % ) of the 242 infants available for assessment in the control group fulfilled the criteria for possible or probable asthma ( adjusted relative risk , 0.66 ; 90 % confidence interval , 0.44 - 0.98 ) . Also , 16.7 % of the infants in the intervention group and 27.3 % of the infants in the control group developed rhinitis without colds ( adjusted relative risk , 0.51 ; 90 % confidence interval , 0.35 - 0.74 ) . The incidence of positive skin test results to 1 or more inhalant allergens was similar in both groups ( 4.4 % in the intervention group and 4.6 % in the control group ) . CONCLUSIONS Our multifaceted intervention program result ed in a modest but significant ( P= .04 ) reduction in the risk of possible or probable asthma and rhinitis without apparent colds at the age of 12 months in high-risk infants . In the absence of a vali date d definition of asthma at the age of 12 months , follow-up studies are needed to determine the effectiveness of the intervention program in the primary prevention of asthma in high-risk infants",
"The aim of this study was to compare the allergy-preventive effect of a partially hydrolyzed formula with two extensively hydrolyzed formulas , in infants with a high risk for development of allergic disease . High-risk infants from four Danish centres were included in the period from June 1994 to July 1995 . Five-hundred and ninety-five high-risk infants were identified . High-risk infants were defined as having biparental atopy , or a single atopic first-degree relative combined with cord blood immunoglobulin E ( IgE ) > or = 0.3 kU/l . At birth all infants were r and omized to one of three different blinded formulas . All mothers had unrestricted diets during pregnancy and lactation and were encouraged to breast-feed exclusively . If breast-feeding was insufficient , one of the three formulas , according to r and omization , was given during the first 4 months . It was recommended not to introduce cow 's milk , cow 's milk products . and solid foods until the age of 4 months . After the age of 4 months a normal unrestricted diet and conventional cow 's milk-based formula were given when needed . All infants were followed-up prospect ively with interview and physical examination at the age of 6 , 12 , and 18 months , and if any possible atopic symptoms were reported . If food allergy was suspected , controlled elimination/challenge procedures were performed in a hospital setting . Of 550 infants included in the study , 514 were seen at all visits and 36 were excluded owing to noncompliance . Of 478 infants who completed the study , 232 were exclusively breast-fed , 79 received an extensively hydrolyzed casein formula ( Nutramigen ) , 82 an extensively hydrolyzed whey formula ( Profylac ) , and 85 a partially hydrolyzed whey formula ( Nan HA ) , during the first 4 months of life . These four groups were identical in regard to atopic predisposition , cord blood IgE , birthplace , and gender . Exclusively breast-fed children were exposed less to tobacco smoke and pets at home and belonged to higher social classes , whereas the three formula groups were identical concerning environmental factors . The frequency of breast-feeding was high ; only eight ( 2 % ) children were not breast-fed at all . The three formula groups were identical in regard to duration of breast-feeding and age at introduction of formula and solid foods . No significant differences were found in the three groups of infants receiving formula milk regarding the cumulative incidence of atopic dermatitis or respiratory symptoms . The cumulative incidence of parental-reported cow 's milk allergy was significantly higher in children fed partially hydrolyzed formula ( Nan HA ) compared with extensively hydrolyzed formula ( Nutramigen or Profylac ) at 12 and 18 months ( NanHA , 7.1 % ; Nutramigen , 2.5 % ; Profylac , 0 % ; p=0.033 ) . The cumulative incidence of confirmed cow 's milk allergy was 1.3 % ( three of 232 ) in exclusively breast-fed infants , 0.6 % ( one of 161 ) in infants fed extensively hydrolyzed formula ( Nutramigen or Profylac ) , and 4.7%(four of 85 ) in infants fed partially hydrolyzed formula ( Nan HA ) . Partially hydrolyzed formula was found to be less effective than extensively hydrolyzed formula in preventing cow 's milk allergy , 0.6 % vs. 4.7 % ( p=0.05 ) , but because of the small number of cases the results should be interpreted with caution . Compared with other similar studies the frequency ofatopic symptoms was low , even though the dietetic intervention did not include either maternal diet during lactation or dietary restrictions to the children after the age of 4 months",
"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",
"Serum levels of IgE , IgE antibodies to egg white ( EW ) and cow 's milk ( CM ) , IgG , and IgA antibodies to ovalbumin ( OA ) and beta-lactoglobulin ( BLG ) were measured in a group of 115 infants with a family history of atopy/allergy at birth and at 3 , 6 , 9 , 12 , and 18 months of age . The mothers of 65 infants avoided eggs , CM , and fish during the first 3 months of lactation ( maternal antigen avoidance diet , D group ) , whereas the remaining 50 mothers had no diet restrictions ( no maternal antigen avoidance diet , ND group ) . CM was introduced after 6 months of age and EW after 9 months . The only statistically significant difference between the D and ND group infants was a lower rate of specimens with IgE antibodies to EW and /or CM in the infants at 3 months of age ( p = 0.008 ) . IgE antibodies to EW and /or CM appeared in 62 infants during the study period and often during complete breast-feeding . In 40 of the infants , IgE antibodies appeared before the introduction of EW and CM into the diet . The IgE concentrations of the D and the ND group infants were similar . Cord-blood IgE was a poor predictor of atopy/allergy ; for example , only seven of 103 infants with double heredity for atopy/allergy had values above the 90th percentile of our normal reference . The concentrations of IgG antibodies to OA and BLG were similar in the two groups . The levels decreased significantly ( p less than 0.001 ) from birth to 6 months of age , indicating a passive placental transfer . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Forty-five healthy infants were included in a double-blind r and omized prospect i ve study comparing the nutritional value of two formulas . One group received a whey-predominant formula ( n = 20 ) ; the other group received a whey hydrolysate formula ( n = 25 ) . Four infants of the whey hydrolysate group were dropped because they refused the formula . Although the mean daily volume intake was smaller with the whey hydrolysate formula compared with the whey-predominant formula ( p weight gain in the two groups after 13 weeks was identical ( 27.2 g/day in both groups ; the mean difference in weight gain between the groups after 13 weeks was only 8 g ) . Length gain at 13 weeks was 10.4 cm in the whey-predominant formula group and 10.8 cm in the whey hydrolysate formula group ( p = NS ) . After 13 weeks , blood was sample d for hemoglobin , hematocrit , red blood cell count , white blood cell count , lymphocytes , glycemia , proteins , albumin , prealbumin , calcium , phosphorus , urea , creatinine , iron , iron-binding capacity , zinc , and vitamins A and E. Except for the iron-binding capacity , zinc , urea ( in plasma as well as in urine ) ( all three were higher in the whey hydrolysate group ) , no significant differences were found . According to these results , exclusive feeding of the whey hydrolysate formula from birth to 3 months of age to healthy infants appears to result in an adequate nutritional status , as assessed at 3 months of age",
"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",
"OBJECTIVE In study 1 , to compare the effect on growth in healthy infants of a new amino acid-based formula ( AAF ) and a control extensively hydrolyzed formula ( EHF ) , with both docosahexaenoic acid ( DHA ) and arachidonic acid ( ARA ) at levels similar to those in human milk worldwide . In study 2 , to evaluate the hypoallergenicity of this new AAF in infants and children with confirmed cow 's milk allergy ( CMA ) . STUDY DESIGN In study 1 , a total of 165 healthy , full-term , formula-fed infants r and omly received the new AAF or control formula . Anthropometric measurements , tolerance , and adverse events were recorded throughout the study . Plasma amino acid profiles were evaluated in a subset of the infants . In study 2 , the hypoallergenicity of the new AAF was evaluated in 32 infants and children using a double-blind , placebo-controlled food challenge ; an open challenge ; and a 7-day feeding . RESULTS In study 1 , overall growth , tolerance , and safety outcomes were similar in both groups . In study 2 , 29 of the 32 subjects completed both challenges ; no allergic reaction was seen in any of the 32 subjects . CONCLUSIONS The new AAF with DHA and ARA at levels similar to those in human milk worldwide is hypoallergenic . It also is safe and supports growth in healthy , term infants",
"BACKGROUND The long-term effect of nutritional intervention with hydrolyzed infant formulas on allergy development has not been sufficiently evaluated . OBJECTIVE We performed a follow-up of the German Infant Nutritional Intervention study until 6 years of life to investigate the long-term allergy-preventive effect of 3 hydrolyzed infant formulas compared with cow 's milk formula ( CMF ) in a r and omized , double-blind trial . METHODS Between 1995 and 1998 , 2252 newborns with atopic heredity were r and omly assigned at birth to receive one of 4 blinded formulas : partially or extensively hydrolyzed whey formula , extensively hydrolyzed casein formula , or CMF as milk substitute for the first 4 months when breast-feeding was insufficient . The cohort was followed from birth until 6 years of age with yearly question naires . Outcomes were physician-diagnosed allergic diseases ( atopic dermatitis , food allergy , allergic urticaria , asthma , and hay fever/allergic rhinitis ) . Log-binomial regression modeled with generalized estimation equations was used for the statistical analysis . RESULTS In the intent-to-treat analysis the relative risk of a physician 's diagnosis of allergic manifestation ( AM ) compared with CMF was 0.82 ( 95 % CI , 0.70 - 0.96 ) for partially hydrolyzed whey formula , 0.90 ( 95 % CI , 0.78 - 1.04 ) for extensively hydrolyzed whey formula , and 0.80 ( 95 % CI , 0.69 - 0.93 ) for extensively hydrolyzed casein formula . The corresponding figures for atopic eczema were 0.79 ( 95 % CI , 0.64 - 0.97 ) , 0.92 ( 95 % CI , 0.76 - 1.11 ) , and 0.71 ( 95 % CI , 0.58 - 0.88 ) , respectively . In the per- protocol analysis all effects were stronger and significant . No significant effect on other AMs was found . CONCLUSION The data confirm a long-term allergy-preventive effect of hydrolyzed infant formulas on AM and atopic eczema until 6 years of age",
"BACKGROUND & AIMS Emerging research has revealed the existence of periods in which the developing brain has heightened sensitivity to environmental influences . We discovered a sensitive period , age , when exposure to the flavor of extensively hydrolyzed protein hydrolysate formulas ( ePHF ) determines its hedonic tone . This formula has pronounced bitter , sour , and savory tastes compared to cow-milk-based formulas ( CMF ) . This study aim ed to determine the effects of duration of exposure during the sensitive period on a food containing an exemplar of the savory flavor . METHODS Formula-fed infants were r and omized into four groups at age 0.5 months : one control group fed the CMF for 8 months , and three groups fed ePHF for 1 , 3 , or 8 months and CMF otherwise . When infants were 8.5 months , their acceptance of a savory and plain broth was measured . RESULTS Infants fed hydrolysate formula for 3 or 8 months , but not 1 month , showed greater acceptance of the savory broth relative to the plain broth ( p consumed it at a faster rate ( p = 0.01 ) . CONCLUSIONS The duration of flavor exposure affects infants ' earliest responses to foods : a 3-month exposure to ePHF shifted the hedonic tone for savory flavor",
"BACKGROUND The diversity in the perceived prevalence , recovery , and risk factors for cow 's milk allergy ( CMA ) necessitated a large-scale , population -based prospect i ve study . OBJECTIVE We sought to determine the prevalence , cross-reactivity with soy allergy , and risk factors for the development of CMA . METHODS In a prospect i ve study the feeding history of 13,019 infants was obtained by means of telephone interview ( 95.8 % ) or question naire ( 4.2 % ) . Infants with probable adverse reactions to milk were examined , skin prick tested , and challenged orally . RESULTS Ninety-eight percent of the cohort participated in the study . The cumulative incidence for IgE-mediated CMA was 0.5 % ( 66/13,019 patients ) . The mean age of cow 's milk protein ( CMP ) introduction was significantly different ( P days ) and those with IgE-mediated CMA ( 116.1 + /- 64.9 days ) . Only 0.05 % of the infants who were started on regular CMP formula within the first 14 days versus 1.75 % who were started on formula between the ages of 105 and 194 days had IgE-mediated CMA ( P IgE-mediated CMA among infants with exposure to CMP at the age of 15 days or more ( P Sixty-four patients with IgE-mediated CMA tolerated soy , and none had a proved allergy to soy . CONCLUSIONS IgE-mediated CMA is much less common than generally reported . Early exposure to CMP as a supplement to breast-feeding might promote tolerance . Finally , soy is a reasonable feeding alternative in patients with IgE-mediated CMA",
"Ninety-one high atopy-risk infants were prospect ively followed up to 18 months of age with regard to the development of allergic/atopic manifestations and sensitization . They were r and omized into one of two feeding groups , i.e. , a hydrolyzed , ultrafiltered cow 's milk whey formula , Profylac ( n = 32 ) , or an ordinary cow 's milk formula ( n = 39 ) , for 12 months , started after exclusive breast-feeding for 0 - 9 ( median 6.0 ) months . Lactating mothers avoided milk , egg , and fish , as did the infants up to 12 months of age . Twenty of the 91 infants were breast-fed exclusively for more than 9 months and regarded as a control group . All infants were followed-up by question naires , physical examinations , skin prick tests , and determination of serum total IgE and cow ' milk-specific IgE. The frequency of allergic/atopic disease was similar in the three groups . However , all three infants who developed cow 's milk allergy with skin symptoms belonged to the cow 's milk formula group . The skin prick test with whey hydrolysate was negative in all , while with cow 's milk it was positive in eight infants . Growth was similar in the three groups . The study comprises too few infants to allow us to make statistically based statements . However , the difficulties encountered and the limited effects obtained by the use of whey hydrolysate at weaning at about 6 months of age made us conclude that we can spare high atopy-risk families this extra burden",
"BACKGROUND Avoidance of individual risk factors have not been successful in preventing the development of asthma . OBJECTIVE We sought to determine the effectiveness of a multifaceted intervention program in primary prevention of asthma in high-risk infants . METHODS We identified 545 high-risk infants on the basis of an immediate family history of asthma . Families were r and omized into intervention or control groups . Intervention measures included avoidance of house dust mite , pet allergen , and environmental tobacco smoke . Breast-feeding was encouraged with formula supplementation if necessary , and introduction of solid foods was delayed . RESULTS At 2 years of age , 19.5 % of the children had asthma , and 14.7 % had atopy ( positive skin test response to one or more common allergens ) . Significantly fewer children had asthma in the intervention group compared with in the control group ( 16.3 % vs 23.0 % ) , with 60 % less persistent asthma at 2 years . There was a 90 % reduction for recurrent wheeze in the intervention group compared with that seen in the control group . Exposure to maternal environmental tobacco smoke during pregnancy or the first year was a risk factor for asthma at 2 years of age . A positive skin test response , particularly to food , at 12 months predicted asthma at 2 years . There was no significant difference for atopy between the intervention and control groups , but daycare reduced atopy at 2 years . CONCLUSION This multifaceted intervention program during a window of opportunity in the first year of life was effective in preventing asthma in high-risk children at 2 years of age . Future studies with this cohort at school age are important",
"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",
"Objective : To evaluate growth , tolerance and plasma biochemistries in infants fed an experimental rice protein-based infant formula . Design : R and omized , blinded , 16 week parallel feeding trial of 65 healthy infants fed either an experimental partially hydrolyzed rice protein-based infant formula fortified with lysine and threonine ( RPF , n = 32 ) , or a st and ard intact cow ’s milk protein-based formula ( CMF , n = 33 ) as a control . Assessment s occurred at enrollment ( average 2 days ) , 2 , 4 , 8 , and 16 weeks of age . Results : Growth as indicated by weight , length , and head circumference was not different between the 2 formula groups . All plasma biochemistries for both groups were within reference normal range . However , RPF group had lower phosphorus and urea nitrogen , lower essential amino acids except threonine , which was higher , and lower ratio of essential ( including semi-essential ) to non-essential amino acids . Differences in the concentrations and ratios of amino acids became less as feeding progressed with age . Plasma total protein , albumin , prealbumin , calcium , magnesium , and alkaline phosphatase were not different between groups . Conclusion : Healthy infants fed an experimental partially hydrolyzed rice protein-based formula had normal growth , tolerance , and plasma biochemistry comparable to those of infants fed a st and ard intact milk protein-based formula , despite some differences in amino acid profiles",
"Incidence and clinical manifestation of cow 's milk protein intolerance ( CMPI ) were studied in 1158 unselected newborn infants followed prospect ively from birth to 1 year of age . No food changes were required in 914 infants who were used as healthy controls . When CMPI was suspected ( 211 infants ) , diagnostic dietary interventions according to a st and ard protocol were performed . After exclusion of lactose intolerance , two positive cow 's milk elimination/challenge tests were considered diagnostic of CMPI . Two hundred and eleven symptomatic infants were examined for possible CMPI . A large group of 80 infants improved on a lactose reduced formula . In 87/211 infants CMPI was excluded ( sick controls ) . Finally CMPI was proven in 26 infants . The calculated incidence rate for CMPI was 2.8 % . The principal symptoms in infants with CMPI were gastrointestinal , dermatological and respiratory in 50 % , 31 % and 19 % respectively . A positive family history for atopy ( first or second degree relatives ) was more frequent in either CMPI infants ( 65 % ) , or sick controls ( 63 % ) when compared to either healthy controls ( 35 % ) or infants improving on a low lactose formula ( 51 % ) . Differences between patients with CMPI and sick controls were only found for the presence of atopy in at least 2 first degree relatives [ ( 5/26 in CMPI infants and 4/87 in sick controls ( P multiorgan involvement [ 10/26 infants with CMPI as opposed to 12/87 in the sick control group ( P<0.02 ) ] . These statistical differences are too weak to be of clinical value",
"Extensively hydrolyzed formulas present a complex matrix subject to adverse conditions during manufacture that could influence growth and tolerance of infants fed these formulas . A masked , r and omized , parallel growth study was conducted in infants fed a ready-to-feed ( RTF ) or powdered ( PWD ) form of an extensively hydrolyzed casein-based formula . Infants were enrolled between 0 and 9 days and studied to 112 days of age . Growth , formula intake , and stool patterns were assessed . There were no significant differences between groups in weight , length , head circumference , or their respective gains . Tolerance was similar between groups except that the RTF group had greater formula intakes and passed more stools/day compared to the PWD group . This study demonstrates that the PWD formulation of this RTF formula supports similar growth and tolerance in infants during the first 4 months of life",
"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",
"Weight-gain in 35 slightly undernourished Australian Aboriginal infants was studied in hospital ( 49 admissions ) during a blind controlled trial of a pre-hydrolysed low-lactose milk preparation and reconstituted full-cream milk powder . Infants fed the lactose hydrolysed milk gained 70 % more weight than those receiving normal milk . Better weight-gains were achieved in those on the lactose hydrolysed milk irrespective of percentage st and ard weight for age , the presence of diarrhoea on admission to the trial , and stool sugar concentrations . The use of low-lactose milk should be considered in nutritional aid programmes for undernourished children throughout the world",
"Partialy hydrolyzed formulas have been proposed for term and preterm infants , but decreased nitrogen and calcium intestinal absorption rates , together with plasma amino acid imbalances have been reported in preterm infants . We evaluated a new formula with modified nitrogen and calcium sources ( glycerophosphate ) . During their second week of life , 16 preterm infants were r and omly assigned to 1 of 2 groups : 9 were fed the new partially hydrolyzed formula and 7 a conventional formula . A nutrient balance was performed at the end of the first month of life . Amino acid concentrations and whole-body mineralization were measured at the end of study period ( theoretical term ) . Birth weight and gestational age ( mean + /- SD ) were similar in the 2 groups ( 28.9 + /- 7.0 wks and 1,183 + /- 242 g v 27.7 + /- 1.0 wks and 1,139 + /- 162 g ) . Median nitrogen absorption rate ( 85 % v 89 % ; P = .03 ) was lower in infants fed the new formula than in those fed the conventional one . After correction for difference in nitrogen intake , there was no significant difference in N retained between the 2 groups ( P = .11 ) . Plasma amino acid concentrations were also similar in the 2 groups . At theoretical term , median bone mineral content was not significantly different between the 2 groups ( 50 g/kg v 55 g/kg ; P = .17 ) and it was close to the reference values obtained in term neonates just after birth . As long as nitrogen content is 10 % higher in protein hydrolyzed formula than in entire protein formula , appropriate nitrogen retention , plasma amino acid profile can be achieved with the new partially hydrolyzed formula . In both groups , bone mineralization at theoretical term was close to the mineralization observed term neonates just after birth",
"Background : Exposure to cow ’s milk protein in early infancy could lead to increased rates of allergic diseases later in life . We investigated whether feeding a protein-hydrolyzed formula ( HF ) in the first 6 months of life decreased allergic diseases up to 36 months later . Methods : Newborns who had at least 1 first-degree family member with a history of atopy and could not breast-feed were enrolled . They were fed with HF or cow ’s milk infant formula ( CM ) for at least 6 months via an open-label protocol and were monitored prospect ively at 6 , 18 and 36 months of age to assess allergy sensitization and allergic diseases . Results : A total of 1,002 infants were enrolled and 679 infants were consistently fed the same formula for the first 6 months of life ( 345 HF and 334 CM ) . The percentage of food sensitization ( especially to milk protein ) was significantly lower in the HF group than in the CM group at 36 months ( 12.7 vs. 23.4 % , p = 0.048 ) . There was no significant difference in the prevalence of aeroallergen sensitization between the groups . Occurrence of allergic diseases during the first 3 years of life was significantly correlated with aeroallergen sensitization , but not to food allergen sensitization , parental atopy or feeding types . Conclusions : Infants fed with HF during the first 6 months of life had a significantly lower percentage of sensitization to milk protein allergens , but not allergic diseases during the first 3 years of life . Avoidance of cow ’s milk protein alone in infancy is not enough to decrease rates of allergic diseases",
"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 effect of different feeding regimens , notably the use of hydrolysed cow 's milk formulas , on the development of allergic reactions and the development of cow 's milk protein-IgG antibodies is still disputed . We prospect ively compared the development of allergic manifestations and cow 's milk protein-IgG antibodies in a total of 702 infants who were divided into six groups:1.exclusively breast milk for at least 4 weeks (n=206).2.Breast milk plus initial partially hydrolysed formula (n=104).3.Breast milk plus extensively hydrolysed formula (n=50).4.Breast milk plus initial conventional cow 's milk formula (n=73).5.Conventional cow 's milk with or without breast milk throughout (n=187).6.Extensively hydrolysed cow 's milk formula for 2 months , followed by conventional cow 's milk (n=82).Cow 's milk protein antibodies were determined by an indirect immuno-fluorescent test . Antibody titres rose slowly in groups 1 , 3 and 6 . Children in group 5 showed two high peaks . There were no significant differences in the frequency and type of allergic manifestations between the groups . Introduction of cow 's milk formula during the first trimenon result ed in elevated antibody titres in all breast fed infants compared with introduction at a later date . Conclusion : In contrast to a previous study from the same laboratory , there is no diagnostic significance of cow 's milk protein-IgG antibodies for allergic manifestations . The occurrence of these antibodies is a physiological phenomenon : the shorter the breast feeding period and the earlier cow 's milk formula is introduced , the higher the antibody levels",
"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",
"BACKGROUND The potential of extensively or partially hydrolyzed formulas to reduce the risks for allergies is controversial . OBJECTIVE We sought to assess the preventive effect of differently hydrolyzed formulas compared with cow 's milk formula ( CMF ) in high-risk infants . METHODS Between 1995 and 1998 , 2252 infants with a hereditary risk for atopy were enrolled in the German Infant Nutritional Intervention Study and r and omly assigned at birth to one of 4 blinded formulas : CMF , partially hydrolyzed whey formula , extensively hydrolyzed whey formula , and extensively hydrolyzed casein formula ( eHF-C ) . The primary end point at 1 year of age was the presence of allergic manifestation , which was defined as atopic dermatitis ( AD ) , gastrointestinal manifestation of food allergy , allergic urticaria , or a combination of these factors . RESULTS At 12 months per protocol , analysis was performed on 945 infants exposed to study formula : 304 ( 13.5 % ) infants had left the study , 138 ( 6.1 % ) infants were excluded because of noncompliance , and 865 infants were exclusively breast-fed the first 4 months of life . The incidence of allergic manifestation was significantly reduced by using eHF-C compared with CMF ( 9 % vs 16 % ; adjusted OR , 0.51 ; 95 % CI , 0.28 - 0.92 ) , and the incidence of AD was significantly reduced by using eHF-C ( OR , 0.42 ; 95 % CI , 0.22 - 0.79 ) and partially hydrolyzed whey formula ( OR , 0.56 ; 95 % CI , 0.32 - 0.99 ) . Family history of AD was a significant risk factor and modified the preventive effect of the hydrolysates . CONCLUSIONS Prevention of allergic diseases in the first year of life is feasible by means of dietary intervention but influenced by family history of AD . The preventive effect of each hydrolyzed formula needs to be clinical ly evaluated",
"A cohort of 1749 newborns from the municipality of Odense born during 1985 in the University Hospital of Odense were followed prospect ively for the development of cow 's milk allergy (CMA)/cow 's milk protein intolerance ( CMI ) during their first year . The diagnosis of CMA/CMI was based on elimination/open milk challenge procedures according to generally accepted criteria . Thirty nine infants ( 2.2 % ) developed CMA/CMI . Infants with CMA/CMI were fed cow 's milk formula daily during the first month of life significantly more often than infants in the study population ( p less than .001 ) . All 39 infants with CMA/CMI had ingested cow 's milk formula ( 40 - 830 mL ) neonatally , whereas none of the 210 neonates without supplements of cow 's milk formula developed CMA/CMI ( p less than .05 ) . Based on a positive skin-prick test ( 2 + or more ) and /or specific serum IgE antibody to cow 's milk ( AL-RAST class 2 or more ) 16 infants were classified as having CMA . In infants solely breast-fed for greater than 1 month CMA was as frequent ( 1 % [ 14/1414 ] as in cow 's milk formula fed infant ( 0.6 % [ 2/335 ] ) . In infants with CMI , a significant majority ( 3.9 % [ 13/335 ] versus 0.7 % [ 10/1414 ] , p less than .001 ) had been cow 's milk formula fed during the first month . These data indicate an association between early cow 's milk formula feeding and development of reproducible adverse reactions to cow 's milk protein . Early neonatal intake of cow 's milk protein is probably a condition of sensitization and later adverse reactions to cow 's milk protein",
"OBJECTIVE To determine the effect of a partially hydrolysed formula on genetically predisposed children , with respect to the development of atopic clinical manifestations and in vitro testing of serum IgE levels ( total and milk-specific ) . METHODS One hundred and ten infants were r and omly assigned to receive either partially hydrolysed formula or st and ard infant formula , and were prospect ively monitored from birth for clinical atopic symptoms and serum IgE levels . RESULTS Eczema occurred less frequently in infants receiving partially hydrolysed formula . This was significant ( P wheezing occurred less frequently in infants receiving partially hydrolysed formula , compared to those receiving st and ard infant formula , the difference did not reach statistical significance ( P > 0.05 ) . CONCLUSIONS Exclusive feeding of hypoallergenic milk formula in the first 4 months of life has a protective effect in terms of the development of atopic dermatitis in the first 2 years of life , compared to feeding with cow 's milk formula",
"Type 1 diabetes is considered to be a T-cell-mediated autoimmune disease in which insulin-producing beta-cells are destroyed . Immunity to insulin has been suggested to be one of the primary autoimmune mechanisms leading to islet cell destruction . We have previously shown that the first immunization to insulin occurs by exposure to bovine insulin ( BI ) in cow 's milk ( CM ) formula . In this study , we analyzed the development of insulin-specific T-cell responses by proliferation test , emergence of insulin-binding antibodies by enzyme immunoassay , and insulin autoantibodies by radioimmunoassay in relation to CM exposure and family history of type 1 diabetes in infants with a first-degree relative with type 1 diabetes and increased genetic risk for the disease . The infants were r and omized to receive either an adapted CM-based formula or a hydrolyzed casein (HC)-based formula after breast-feeding for the first 6 - 8 months of life . At the age of 3 months , both cellular and humoral responses to BI were higher in infants exposed to CM formula than in infants fully breast-fed ( P = 0.015 and P = 0.007 ) . IgG antibodies to BI were higher in infants who received CM formula than in infants who received HC formula at 3 months of age ( P = 0.01 ) , but no difference in T-cell responses was seen between the groups . T-cell responses to BI at 9 months of age ( P = 0.05 ) and to human insulin at 12 ( P = 0.014 ) and 24 months of age ( P = 0.009 ) as well as IgG antibodies to BI at 24 months of age ( P = 0.05 ) were lower in children with a diabetic mother than in children with a diabetic father or a sibling , suggesting possible tolerization to insulin by maternal insulin therapy . The priming of insulin-specific humoral and T-cell immunity occurs in early infancy by dietary insulin , and this phenomenon is influenced by maternal type 1 diabetes",
"Objectives : The aim of this study was to evaluate the efficacy on crying episodes owing to infantile colic of a new infant formula containing partially hydrolysed whey proteins , prebiotic oligosaccharides ( OS ) , with a high β-palmitic acid content . Design : Prospect i ve r and omized controlled study . Setting : Italy . Subjects : Two hundred and sixty-seven formula-fed infants , aged less than 4 months , with infantile colic , were r and omized to receive either the new infant formula ( study treatment ( ST ) ) or a st and ard formula and simethicone ( 6 mg/kg twice a day ) ( control treatment ( CT ) ) . A question naire was given to parents to evaluate for 14 days the daily number of colic episodes and crying time . Results : Out of the 199 infants who completed the study , 96 were treated with the new formula and 103 were not treated . Infants receiving the new formula had a significant decrease in colic episodes after 1 week ( 2.47±1.94 at day 7 vs 5.99±1.84 at the study entry ) compared to infants receiving the CT ( 3.72±1.98 at day 7 vs 5.41±1.88 at the study entry ) ( P the crying episodes were significantly different between the two groups of infants ( 1.76±1.60 in ST vs 3.32±2.06 in CT ) ( P partially hydrolysed formula supplemented with fructo- and galacto-OS induces a reduction of crying episodes in infants with colic after 7 and 14 days when compared with a st and ard formula and simethicone . Sponsorship : The study was supported by funds from Numico , Italy",
"Objectives The aim of this study was to evaluate the nutritional efficacy and bifidogenic characteristics of a new infant formula containing partially hydrolyzed whey protein , modified vegetable oil with a high & bgr;-palmitic acid content , prebiotic oligosaccharides , and starch . Methods In a double-blind study , healthy formula-fed term infants aged younger than 2 weeks were r and omized to receive either the new infant formula ( NF ) or a st and ard formula ( SF ) until the age of 12 weeks . Anthropometric measurements were taken at enrollment , 6 weeks , and 12 weeks . In a sub sample of infants , blood sample s were taken at 6 weeks and stool sample s were taken at enrollment and 6 weeks . Blood sample s were analyzed for biochemical measures of protein status and amino acids , and stools were analyzed for total bacteria and bifidobacteria . Mothers completed a feeding diary and question naire at 6 and 10 weeks . Results One hundred fifty-four infants were enrolled in the study ; 102 completed the trial . The growth of infants in both formula groups was in line with published growth curves . During the first 6 weeks , NF girls gained more weight and head circumference than the SF girls . These velocity differences were not maintained throughout the 12-week study period . The NF stools had a higher proportion of bifidobacteria at 6 weeks compared with the SF stools , and they were softer . There were no clinical ly significant differences in the blood biochemical and amino acid values between groups . Both formulas were well tolerated by the infants . Conclusions When compared with a st and ard infant formula , the new formula supported satisfactory growth , led to higher counts of bifidobacteria in the feces , produced blood bio-chemical values typical of formula-fed infants , and was well tolerated",
"BACKGROUND & AIMS Gastric emptying ( GE ) is influenced by the type of nutrition . The objective of this study was to compare GE in infants fed an intact protein formula ( IPF ) , a partially hydrolysed formula ( PHF ) , and an extensively hydrolysed formula ( EHF ) . METHODS This was a double-blind , r and omized , cross-over study . Following a fasting period of > or = 3 h , 20 healthy newborns were fed IPF , PHF , and EHF containing 50 microl (13)C-octanoic acid ( OA ) . Breath sample s were taken before feeding and every 15 min for 4 h thereafter . (13)C-OA breath test was assessed by isotope-ratio mass spectrometry , and GE half-times ( t(1/2 ) ) were determined . RESULTS Seventeen infants with a mean gestational age of 37 wk ( range 28 - 40 wk ) and birth weight of 2698 g ( range 720 - 3690 g ) completed the study . At study initiation , the mean age was 31 d ( range 6 d-13 wk ) and the mean weight was 3466 g ( range 2100 - 5700 g ) . EHF emptied significantly faster than IPF and PHF ( medians 46 vs. 55 and 53 min , respectively , Wilcoxon , P significant difference between GE of PHF and IPF ( Wilcoxon , P=0.2 ) . CONCLUSIONS EHF may be better tolerated by infants with GE problems",
"BACKGROUND Previous analysis in a prospect i ve , population -based cohort reported reduced weight gain in children fed extensively hydrolyzed casein ( eHF-C ) formula during the first year of life but showed no effect on growth between 1 and 6 y of life . No studies have been conducted in children up to the age of 10 y. OBJECTIVE The objective was to investigate potential differences in body mass index ( BMI ) over the first 10 y of life between infants fed within the intervention period of the first 16 wk of life with partially hydrolyzed whey ( pHF-W ) , extensively hydrolyzed whey ( eHF-W ) , eHF-C , or cow-milk formula ( CMF ) and infants exclusively breastfed ( BF ) within the intervention period . DESIGN This was a prospect i ve , r and omized , double-blind trial in full-term neonates with atopic heredity in the German birth cohort German Infant Nutritional Intervention ( GINI ) followed through the first 10 y of life . Analyses of absolute and World Health Organization (WHO)-st and ardized BMI trajectories for 1840 infants [ pHF-W ( n = 253 ) , eHF-W ( n = 265 ) , eHF-C ( n = 250 ) , CMF ( n = 276 ) , and BF ( n = 796 ) ] were conducted according to intention-to-treat principles . RESULTS Except for the previously reported slower BMI gain in infants fed with eHF-C formula within the first year of life , no significant differences in absolute or WHO-st and ardized BMI trajectories were shown between the pHF-W , eHF-W , eHF-C , CMF , and BF groups thereafter up to the age of 10 y. CONCLUSIONS Extension of the follow-up period from 6 to 10 y for this r and omized controlled trial showed no long-term consequences on BMI for the 4 infant formulas considered . These data need to be confirmed in future studies",
"It has been reported that the feeding of cow 's milk may enhance the development of atopy in predisposed infants . A prospect i ve study following children from birth through 15 years of age in a private pediatric practice was design ed to determine if the food ingested during the first months of life is related to the development of atopy in the offspring of allergic families . Each of 328 children with a positive family history of allergy was assigned to one of three groups . according to the feeding preference of the parents : 48 were fed breast milk ; 79 , soy-based formula ; and 201 , cow 's milk formula . All groups had egg , citrus , tomato , and wheat restrictions as well as inhalant allergen avoidance . These were compared to a control group of 580 children with no family history of allergy . Breast fed infants were found to have approximately one-half the incidence of atopy of cow 's milk or soy formula fed infants from atopic families when followed for up to 15 years . Soy feeding produced no advantage over cow 's milk in the prophylaxis of allergic disease . There was a threefold increase in clinical ly apparent atopic disease in offspring of allergic families when compared to controls but only a two-fold increase if the infant was breast fed . These results support the hypothesis that breast feeding and delay of exposure to known allergens may reduce the frequency of clinical allergic disease in the offspring of allergic families",
"OBJECTIVE To prospect ively investigate the association of high levels of immunoglobulin E ( IgE ) sensitization to foods and the presence of atopic dermatitis ( judged by reported topical steroid use during the first 16 months of life ) in a birth cohort of 620 Australian children \" at risk \" of allergic disease because of family history . RESULTS A total of 559 of the children in the cohort were fully evaluated , and the cumulative prevalence of atopic dermatitis was 24 % . More children in the cohort who had atopic dermatitis had strongly positive skin test results ( > or = 4 + , histamine equivalent units , > or = approximately 6-mm wheal ) , consistent with IgE food sensitization to either cow 's milk , egg , or peanut at 6 months ( 22 % vs 5 % , chi(2 ) = 35 ; P attributable risk percent for IgE food sensitization as a cause of atopic dermatitis was 65 % and 64 % at these times . In a separate group of infants with severe atopic dermatitis , the equivalent rates of IgE food sensitization at 6 months was 83 % and at 12 months , 65 % . CONCLUSION IgE food sensitization is a major risk factor for the presence of atopic dermatitis in infancy",
"The effect of feeding different infant formulas on incidence of atopic disease was assessed in a prospect i ve double-blind r and omized controlled trial among \" high risk \" infants with family history of atopy among first-degree relatives . The incidence of atopic eczema , wheezing , rhinitis , gastrointestinal symptoms , and colic was noted and serum IgE antibodies to milk were estimated . Seventy-two infants were recruited into each of the following groups : cow milk whey hydrolysate formula ( NAN/HA ) , conventional cow milk formula ( Similac ) , soy-based formula ( Isomil ) , and exclusive breast feeding for greater than or equal to 4 months . The number of infants who exited for reasons other than atopy and were excluded from analysis were 4 , 5 , 4 , and 12 in the four groups , respectively . The incidence of one or more symptoms of possible allergic etiology was five of 68 infants fed NAN/HA , 24 of 67 infants fed Similac , 25 of 68 infants fed Isomil , and 12 of 60 breast-fed infants . Among symptomatic infants , skin prick test to milk proteins was positive in four out of five infants fed NAN/HA , 16 of 24 fed Similac , 2 of 25 fed Isomil , and 7 of 12 breast-fed . IgE antibodies to milk were found in 2 of 68 , 9 of 67 , 0 of 68 , and 6 of 60 infants in the four groups , respectively . It is concluded that exclusive breast feeding for more than 4 months is partially protective against the development of atopic disease among high risk infants . ( ABSTRACT TRUNCATED AT 250 WORDS",
"A prospect i ve r and omized study of growth and digestive tolerance in a cohort of 60 healthy infants with no history for allergic disease is reported . A milk-based formula and a formula of identical composition whose proteins had undergone hydrolysis were fed successively to the study infants according to a crossover design , for eight weeks . Intake , weight gain and length gain were comparable and satisfactory with both diets . With the hydrolyzed protein formula , stools were greener in color and significantly more numerous , although both parameters remained within normal limits . The most noteworthy result was the significantly greater rate of regurgitations in the group given the hydrolyzed protein formula , i.e. , 26 % versus 8 % in the group fed a conventional modified milk formula . These results show that use of partial protein hydrolysate formulas is associated with minor digestive adverse effects",
"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",
"At the age of 5 years , the prevalence of atopic manifestations was analysed in 58 formula-fed “ at risk ” infants because of a history of atopic disease in at least two first degree relatives . Infants were r and omly assigned to receive either a partial whey-hydrolysate formula ( n : 28 ) or a regular cow 's milk formula ( n : 30 ) during the first 6 months of life ; thereafter , feeding was unrestricted . Only non-breastfed infants were included . The groups did not differ in risk factors or in known confounding factors possibly influencing the incidence of manifestations suggestive of atopic disease . At 6 months , the prevalence of cow 's milk protein ( CMP ) sensitivity was significantly decreased in the hydrolysate group ( 7 % versus 43%;P : 0.002 ) . At the age of 12 ( 21 % versus 53%;P : 0.029 ) , 36 ( 25 % versus 57%;P : 0.018 ) and 60 months ( 29 % versus 60%;P : 0.016 ) there was still a significant difference in the number of atopic manifestations , if calculated cumulatively . There was no difference between the groups if only the new cases after the age of 6 months were considered . Eczema was less frequent in the whey-hydrolysate group , but only during the 1st year of life , suggesting a decreased prevalence of CMP sensitivity . During the first 6 months , diarrhoea of non-infectious origin occurred in 8/30 infants ( 27 % ) of the adapted formula group , and in no infant in the hydrolysate group . “ Colic as single manifestation ” was considered of “ allergic ” origin in 1/28 infants in the hydrolysate group , and in 4/30 infants in the adapted formula group . If gastro-intestinal symptoms such as “ diarrhoea and colic as single manifestation ” are not considered , the number of infants with CMP sensitivity remains only significant for the first 6 months ( P : 0.004 ) . At 12 , 36 and 60 months , differences are not significant ( 0.106 , 0.116 and 0.07 , respectively ) . The results of this study support the hypothesis that allergy prevention is antigen specific . Conclusion If mother 's milk is not available and other studies confirm these results , there might be an indication for partial hydrolysates in infants with a family history of atopy , since these formulae reduce the incidence of CMP sensitivity",
"Children ’s weight/growth development is age-specific and may be influenced by breastfeeding . We therefore assessed velocities of weight , length , body-mass-index and overweight/obesity development from birth up to age 6 years overall and in relation to breastfeeding . The method of this study is based on pooled data of the birth-cohorts GINI-plus and LISA-plus and follows 7,643 healthy full-term neonates in four study -centers in Germany . Up to nine anthropometric measurements are available . Overweight/obesity is percentile-defined according to WHO-Child-Growth-St and ards . Fully-breastfed is defined as breastfed for at least 4 months . Piecewise-linear-r and om-coefficient-models were applied to assess growth trajectories and velocities between 0–3 , 3–6 , 6–12 , 12–24 and beyond 24th months . Velocities for weight- , length- and BMI -development are highest in the first 3 months after birth and diminish , with differing pace , in the periods that follow . For overweight and obesity , peak-velocities are estimated in periods 6–12 and 3–6 months . The difference in the velocity of weight gain for breastfed vs. other children is −18 g/month in the first 3 month , −93 g/month between month 3 and 6 , −14 g/month between month 6 and 12 and −3 g/month beyond the 24th month . Velocities in length are not different between breastfed and non-breastfed children . Over time , a slightly lower risk ( difference being overweight was estimated for breastfed children , after adjustment for study -center , socio-economic-status and maternal smoking in pregnancy . Infants fully-breastfed gain less weight , but grow equally in length in the first 12 months of life versus mixed or formula-fed children . The protective effect of breastfeeding on becoming overweight is related to its weight-velocity-modifying-effect in early infancy",
"Oral administration of foreign proteins , e.g. cow 's milk ( CM ) proteins , stimulates the immune system and induces humoral and cellular immune response against these antigens in infants . Up-regulation of adhesion molecules is known to be associated with activation of the immune system . The purpose of the study was to examine whether orally administered CM proteins induce elevation in soluble adhesion molecules , i.e. intercellular adhesion molecule-1 ( ICAM-1 ) and L-selectin , in infants . In a double-blind trial , 10 infants received CM-based formula and 10 infants casein hydrolysate formula until the age of 9 mo . The infants of mothers with insulin-dependent diabetes mellitus ( IDDM ) were recruited into a pilot study of a trial for primary prevention of IDDM by elimination of CM proteins from the diet during early infancy . A cord blood sample and peripheral blood sample s were taken at the ages of 3 , 6 , 9 , and 12 mo of age . The levels of soluble ICAM-1 and L-selectin were measured by ELISA . The levels of soluble ICAM-1 were higher at the ages of 3 , 6 , 9 , and 12 mo in infants who received CM-based formula than in infants who received hydrolyzed formula ( p = 0.05 ) . Instead , no difference was found in the the levels of soluble L-selectin . The levels of soluble ICAM-1 and L-selectin were higher in all infants when compared with the levels reported in adults or to the levels seen in cord blood . Orally fed CM proteins induce an elevation in soluble ICAM-1 in infants . This may reflect the generation of an immune response against these proteins , because ICAM-1 has an important costimulatory role in lymphocyte activation",
"BACKGROUND A recent cohort study suggested that intake of soy milk or soy formula was associated with peanut allergy . If this finding is confirmed , it suggests an avenue for modification of diet as a peanut allergy prevention strategy . OBJECTIVE To investigate the relationship between soy consumption and peanut sensitization in a prospect i ve cohort study of children . METHODS A total of 620 babies with a family history of allergic disease were recruited . Dietary information was obtained from telephone interviews every 4 weeks from birth until 15 months and then again at 18 months and 2 years . Skin prick tests to peanut , milk , and egg were performed at 6 , 12 , and 24 months . A wheal size > or = 3 mm was considered positive for sensitization . RESULTS Children whose parents elected to introduce soy formula or soy milk into their children 's diet were more likely to be sensitized to peanuts at 2 years ( odds ratio , 2.02 ; 95 % CI , 1.04 - 3.92 ; P = .039 ) . However , this relationship was explained by feeding of soy to children who had siblings with milk allergy or were themselves sensitized to milk . After adjusting for these factors , there was no evidence of an association between soy consumption and peanut sensitization ( odds ratio , 1.34 ; 95 % CI , 0.64 - 2.79 ; P = .434 ) . CONCLUSION The association between soy consumption and peanut sensitization is not causal but merely a result of preferential use of soy milk in infants with a personal or family history of cow 's milk allergy . Future studies should take the confounding effects related to dietary modifications by parents into account when investigating the association between diet and childhood allergic diseases",
"OBJECTIVE To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherl and s. STUDY DESIGN R and omized , double-blind , parallel trial with a 1-week qualification period and a 1-week intervention period . Participants . Forty-three healthy , thriving , formula-fed infants , 3 hours per day on at least 3 days per week . Infants were r and omized to whey hydrolysate formula ( n = 23 ) or st and ard formula ( n = 20 ) . MAIN OUTCOME MEASURE Difference in duration of crying ( minutes per day ) between qualification week and intervention week . RESULTS Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [ 95 % confidence interval : 1 - 127 minutes per day ] in favor of the whey hydrolysate formula . Five infants did not complete the trial . The scope of the study was not sufficient to expect significant differences in the subgroup analyses . CONCLUSIONS An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting",
"BACKGROUND Development of humoral and cellular immune responses to orally administered antigens in human beings is poorly understood , although antigen administration has been suggested as a treatment for hypersensitivity disorders and autoimmune diseases . OBJECTIVE The purpose of the study was to investigate the development of systemic immune response in infants fed with formula containing whole cow 's milk proteins or hydrolyzed formula containing casein peptides . METHODS In a double-blind trial , 10 infants received cow 's milk-based formula , and 10 infants received a casein hydrolysate formula until the age of 9 months . Blood sample s were taken at the ages of 6 , 9 , and 12 months . Cellular responses were assessed by proliferation assay of peripheral blood mononuclear cells to cow 's milk proteins ( beta-lactoglobulin , bovine serum albumin , and alpha-casein ) . Humoral responses to the same proteins were measured by ELISA for IgG antibodies . RESULTS Feeding infants with cow 's milk-based formula induced systemic humoral and cellular responses to cow 's milk proteins . T-cell response later declined , supporting the concept of oral tolerization . Exposure to cow 's milk proteins after the age of 9 months result ed in depressed cellular and humoral responsiveness to these proteins . CONCLUSION Our results support the view that induction of oral tolerance in human beings is an age-dependent phenomenon",
"Treating the infant colic syndrome by counseling the parents concerning more effective responses to the infant crying is compared to the elimination of soy or cow 's milk protein from the infant 's diet in a r and omized clinical trial . Because symptoms of vomiting and diarrhea are not part of the infant colic syndrome , infants with these gastrointestinal symptoms were excluded from the study . Dietary changes were accomplished by either feeding the infants a hydrolyzed casein formula or by requiring mothers to eliminate milk from their diets . In phase 1 of the study , the group receiving counseling ( n = 10 ) had a decrease in crying from 3.21 + /- 1.10 h/d to 1.08 + /- 0.70 h/d ( P = .001 ) . The crying in the group that received dietary changes ( n = 10 ) decreased from 3.19 + /- 0.69 h/d to 2.03 + /- 1.07 h/d ( P = .01 ) , a level still greater than twice normal . The decrease in those receiving counseling was faster and greater than that of those given dietary changes ( P less than .02 ) . In the second phase of the study , group 2 infants were reexposed to cow 's milk or soy protein and the parents received counseling . In this phase , counseling again decreased crying significantly from 2.09 + /- 1.07 h/d to 1.19 + /- 0.60 h/d ( P = .05 ) . No infant in the study who improved with changes in his or her diet had a significant increase in crying , with reexposure to soy or cow 's milk protein . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Whey hydrolysate formulas are a recent and important innovation in infant feeding . This study compared clinical tolerance and acceptability of a whey hydrolysate formula ( WH ) with those of a whey-predominant formula ( WF ) in 45 infants . Four infants ( 16 % ) who refused to drink WH formula were eliminated from the study . Mean volume intake was significantly lower for WH ( 120 mL/kg/day ) than for WF ( 147 mL/kg/day ; P mean caloric intake was also significantly different : 80 kcal/kg/day ( WF ) vs 97 kcal/kg/day ( WF ; P weight gain from birth to 13 weeks of age was nearly identical in both groups ( 171 % for WH vs 178 % for WF ) . No significant differences were noted in duration of feeding , number of pauses during feeding , number of stools per day , or number of regurgitations per day . The lower rate of caloric intake and the dropout rate of 16 % for WH raise questions about the use of WH formula in normal infants , as has become the case in some Western European regions",
"Summary Background : The best nutritional option for newborn infants is mother 's milk . However , some newborn babies may not be exlusively breastfed during the first months of life , potentially leading to reduced overall health status and the early onset of allergic diseases in some infants . Considerable research has been devoted to the development and assessment of infant nutrition programmes , particularly to the prevention of allergies in high-risk infants . However , equal numbers of infants with and without an elevated familial risk of allergies will eventually develop allergic diseases . Therefore , optimizing nutritional programmes for the early infant population as a whole is an important – but as yet insufficiently studied – area of investigation . Moreover , although safe and effective nutrition must primarily support healthy development of the infant , few studies have evaluated the overall health benefits of nutritional interventions , but have focussed on specific allergic manifestations . In animal models , an allergen-reduced moderate whey hydrolysate formula ( pHF , Nestlé Beba HA ) induces the development of oral tolerance towards cow 's milk proteins , without inducing sensitization . In infants with a high risk for allergies , pHF formulae reduce the early onset of allergic disease during the first 5 years of life by approximately 50 % compared with a dietary regimen of unaltered proteins . At present , very little is known about the overall health benefits of such a dietary intervention on the unselected infant population as a whole . Aim of the study : The aim of our prospect i ve , controlled study was to investigate the overall health benefits of an allergen-reduced nutritional programme in a newborn infant population unselected for atopic risk factors . The population in our study was a comparable as possible to the general population of healthy newborn infants . Our study included exclusive breastfeeding , use of a moderate whey hydrolysate formula ( pHF , Nestlé Beba HA ) if infant formula was needed , and delayed introduction of low-allergenic weaning foods . The study included assessment s of compliance with the dietary programme , and evaluated nutritional habits , growth , and overall health status for 24 months . The health evaluation included allergic manifestations but die – by purpose – not define or evaluate them specifically . Part I of this paper gives results for nutritional habits during the first 6 months of life , Part II gives results for growth and general health status for the same time period , Part III will present feeding habits during the second half of the first year of life , and Part IV will present results to 24 months of age . The complete study report is published as a supplement to this journal . Methods : Nuritional assignment was to demographically comparable intervention ( Z ) or control ( FF ) cohorts according to the infant 's place of birth . In the intervention cohort ( Z , n=564 ) , the recommended dietary regimen was breastfeeding and /or the pHF formula , with no weaning food before 4 months of age . In the control cohort ( FF , n=566 ) , there was no intervention . Longitudinal diet groups , defined for 4 months , excluding dropouts and noncompliants , were exclusive breastfeeding ( eBF , Z , n=201 , FF , n=162 ) , partial breastfeeding ( pBF , Z , n=222 , FF , n=311 ) , or non-breastfeeding ( nBF , Z , n=42 , FF , n=62 ) . Imbalances between groups and cohorts in confounding factors that could influence health-related symptoms were integrated as covariates into the main analyses using logistic regression . Nutritional surveillance was carried out using continuous prospect i ve monitoring . Results : The overall rate of breastfeeding , irrespective of partial or excluive breastfeeding or the additional use of weaning foods , was similar in both cohorts at 4 and 6 months . However , from ages 3 to 6 month , significantly more Z than FF infants were excluively breastfed ( p different kinds of weaning foods compared with FF ( 2 versus 10 ; p Six-month rates of dropout were very low in both groups ( Z=4.3 % , FF=1.8 % ) and compliance with the programme was excellent over the strict intervention period of 4 months ( Z=86.9 % ) until the sixth month . Conclusions : A dietary recommendation that promotes breastfeeding , includes a moderate whey hydrolysate formula ( Nestlé Beba HA ) , and delays the introduction of highly allergenic weaning foods ( an allergen-reduced dietary regimen ) significantly increases breastfeeding and delays weaning in a normal infant population without any compliance problem to the moderate hydroysate formula that is quite often seen in the eHF . The regimen was followed closely , with a high degree of compliance and a low dropout rate compared with previous allergy-prevention studies . Compliance with the dietary regimen was excellent over the 4 months of intervention and throughout the following 2 months",
"Clinical experience ( \" the dangerous bottle \" ) and experimental evidence indicate that the early life of an infant is particularly important for the development of the immune responses to food antigens . However , the clinical and immunologic consequences of a brief exposure to , or avoidance of , food antigens during the neonatal period in human infants are poorly understood and documented . We present the preliminary results of a prospect i ve controlled study of 256 normal breast-fed infants r and omly assigned to receive ( blind ) either an adapted formula ( Nidina ) or a partially hydrolyzed formula ( Nidal HA ) as a supplement to breast-feeding for a few days when necessary , and to be examined at days 5 , 90 , 150 , and 365 . The results indicated that ( 1 ) the prevalence of clinical symptoms and of total and specific IgE responses was not statistically different in the two groups of infants and ( 2 ) infants fed a hydrolyzed formula had median titers of specific IgG lower than those fed an adapted formula ; the difference was significant for alpha-lactalbumin at day 90 ( p immune responses of breast-fed infants to food antigens thus appear to be modulated by early , short-term exposure to them",
"Background : Hydrolyzed milk formulas are recommended to feed infants at high risk of atopy if breast‐feeding is not possible . We studied the specific cellular and humoral immune response to cow 's milk proteins and occurrence of atopic dermatitis under different feeding regimens : two hydrolyzed infant milk formulas ( partially [ pHF ] and extensively hydrolyzed [ eHF ] ) and under exclusive breast‐feeding ( BF )",
"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",
"BACKGROUND The role of exposure to dietary antigens through maternal milk is intriguing , because it may result either in immunization or in tolerance . Exposure to cow 's milk proteins results in antibody formation against bovine insulin in infants at risk for type 1 diabetes . OBJECTIVE To study the appearance of IgG antibodies to bovine and human insulin in infants with an atopic family history whose mothers followed a cow 's milk-free diet during the first 3 months of lactation . METHODS In a prospect i ve cohort study on prevention of food allergies , 123 infants were exclusively breast-fed or received supplementation with a hydrolyzed casein-based formula ( Nutramigen ) until the age of 6 months . The mothers either avoided cow 's milk during the first 3 months of lactation ( diet group ) or had an unrestricted diet ( nondiet group ) . The levels of IgG antibodies to bovine and human insulin were determined by enzyme immunoassay at 3 , 6 , 12 , and 18 months and at 4 years . In addition , cord blood was obtained at birth and a maternal sample at delivery . RESULTS At 3 months , IgG antibodies to bovine insulin were low in both dietary groups ( median levels 0.150 and 0 . 114 optical density units in the diet and nondiet groups ) . After exposure to dietary insulin , IgG antibodies to bovine insulin increased in both groups , reaching a peak at 12 months in the nondiet group and at 18 months in the diet group . At 18 months , IgG antibodies to bovine insulin were lower in infants in the nondiet group than in infants in the diet group ( 0.287 vs 0.500 , P antibodies no longer differed between the groups . CONCLUSION The exposure to cow 's milk proteins through breast milk during the first 3 months of life result ed in decreased levels of antibodies to dietary bovine insulin at 18 months of age , suggesting a role for breast milk antigens in early tolerance induction",
"Formulas containing proteins with reduced potential to sensitize might be effective in reducing the risk of atopic disease , but such products should be nutritionally adequate . We design ed a r and omized , double-blind study to evaluate nutritional adequacy and sensitization potential of a formula containing partially hydrolyzed whey-predominant milk proteins . Subjects were term infants enrolled at birth . Infants in group A were fed human milk , and group B received the partially hydrolyzed formula ; group C , fed a formula containing intact whey-predominant milk proteins , served as control subjects . We recorded anthropometric measurements and symptoms of formula intolerance at monthly intervals for 4 months in 205 infants . Milk IgE and IgG antibodies were measured until 8 months of age in 63 infants . Daily weight gain was not significantly different among the groups . Gastrointestinal symptoms attributed to feeding intolerance were also comparable . Increases in serum IgG antibodies were significantly greater in group C throughout the study . There were no significant differences in IgE antibodies . Thus a formula containing partially hydrolyzed whey-predominant milk protein promoted adequate growth and induced a lesser priming effect for IgG antibody response than did an intact whey-predominant formula",
"BACKGROUND The long-term effect of nutritional intervention with hydrolysate infant formulas on allergic manifestations in high-risk children is uncertain . OBJECTIVE We sought to investigate the effect of hydrolysate infant formulas on allergic phenotypes in children with family history of allergies at school age . METHODS We analyzed data from participants of the prospect i ve German Infant Nutritional Intervention study after 10 years of follow-up . At birth , children were r and omly assigned to receive , for the first 4 months , one of 4 blinded formulas as breast milk substitute , if necessary : partially hydrolyzed whey formula ( pHF-W ) , extensively hydrolyzed whey formula ( eHF-W ) , extensively hydrolyzed casein formula ( eHF-C ) , or st and ard cow 's milk formula . Outcomes were parent-reported , physician-diagnosed allergic diseases . Log-binomial regression models were used for statistical analysis . RESULTS The relative risk for the cumulative incidence of any allergic disease in the intention-to-treat analysis ( n = 2252 ) was 0.87 ( 95 % CI , 0.77 - 0.99 ) for pHF-W , 0.94 ( 95 % CI , 0.83 - 1.07 ) for eHF-W , and 0.83 ( 95 % CI , 0.72 - 0.95 ) for eHF-C compared with st and ard cow 's milk formula . The corresponding figures for atopic eczema/dermatits ( AD ) were 0.82 ( 95 % CI , 0.68 - 1.00 ) , 0.91 ( 95 % CI , 0.76 - 1.10 ) , and 0.72 ( 95 % CI , 0.58 - 0.88 ) , respectively . In the per- protocol analysis ( n = 988 ) effects were stronger . The period prevalence of AD at 7 to 10 years was significantly reduced with eHF-C in this analysis , but there was no preventive effect on asthma or allergic rhinitis . CONCLUSION The significant preventive effect on the cumulative incidence of allergic diseases , particularly AD , with pHF-W and eHF-C persisted until 10 years without rebound , whereas eHF-W showed no significant risk reduction . There is insufficient evidence of ongoing preventive activity at 7 to 10 years of age",
" A group of 129 infants were r and omly assigned at birth to one of three feeding regimens : human milk ( HM ) , cow 's milk formula ( CMF ) or a casein hydrolysate formula ( CHF ) during the first 3 days of life . Blood sample s were taken on at 4 days and at 2 , 4 , 8 , 12 and 24 months of age . Macromolecular absorption was analysed by measuring the serum concentration of human α‐lactalbumin ( S‐α‐LA ) with a competitive radioimmunoassay ( RIA ) . Total serum IgE was measured by RIA . A family history of allergy correlated to the proportion of infants with allergic symptoms both at 24 and 36 months of age ( p= 0.03 and p= 0.04 respectively ) . In none of the three groups did correlation exist between the duration of breastfeeding and serum α‐LA , serum IgE , family history of allergy , frequency of allergic symptoms and proportion of infants with infections ",
"BACKGROUND The short- and long-term effects of feeding with hydrolyzed formulas on growth are uncertain . OBJECTIVE Our aim was to investigate the potential differences in body mass index ( BMI ) over the first 6 y of life between infants fed with partially hydrolyzed whey ( pHF-W ) , extensively hydrolyzed whey ( eHF-W ) , extensively hydrolyzed casein ( eHF-C ) , or cow-milk formula ( CMF ) and infants exclusively breastfed for the first 16 wk of life . DESIGN We established a prospect i ve , r and omized , double-blind trial of full-term neonates with atopic heredity in the German birth cohort followed by the German Infant Nutritional Intervention Study through the first 6 y of life . Intention-to-treat and per- protocol analyses of absolute and World Health Organization-st and ardized BMI trajectories for 1840 infants ( pHF-W : n = 253 ; eHF-W : n = 265 ; eHF-C : n = 250 , CMF : n = 276 ; breastfed : n = 796 ) were performed . RESULTS No significant differences in absolute or World Health Organization-st and ardized BMI trajectories were found among the pHF-W , eHF-W , CMF , and breastfed groups during the 6-y follow-up . However , in the eHF-C group , both intention-to-treat and per- protocol analyses showed a significantly slower sex-adjusted BMI gain through the 8th to 48th week of life ( -0.1 to -0.2 lower BMI z score ) but not beyond . Analyses of weight and length revealed that this difference is due to a slightly diminished weight gain in the first year of life because growth in length did not differ among study groups for the entire follow-up . CONCLUSIONS To our knowledge , this is the first r and omized trial investigating both short- and long-term effects of partially and extensively hydrolyzed formula ( pHF-W , eHF-W , eHF-C ) , CMF , and breastfeeding on growth in one trial . Feeding with eHF-C led to a transient lower weight gain in the first year of life . No long-term consequences of different formulas on BMI were observed",
"In an attempt to prevent or reduce the manifestations of atopic disease , a group of infants considered to be genetically at high risk of atopy was entered in a prenatally r and omized , controlled study . A prophylactic group ( n= 58 ) was either breast‐fed with their mothers excluding foods regarded as highly antigenic from their diets , or given an extensively hydrolysed formula . In addition , strenuous efforts were made to reduce exposure to the house‐dust mite by application of acaricide to the bedroom and living room carpets and upholstered furniture . A control group ( n= 62 ) was fed conventionally by breast or on formula , and no specific environmental measures were taken . The results ( previously reported ) after 1 year showed significantly less total allergy , asthma , and eczema in the prophylactic group . Similar results were obtained at 2 years although the reduction in asthma no longer achieved statistical significance . However , there was significantly less sensitization , as shown by a battery of skin prick tests ( SPTs ) , to both dietary allergens and aeroallergens in the prophylactic group . A11 the children have now been review ed at the age of 4 years , and SPTs to a wide range of dietary allergens and aeroallergens have been performed . The control group continues to show more total allergy ( odds ratio [ OR ] 2.73 , 95 % confidence interval [ CI ] 1.21–6.13 , P definite allergy ( allergic symptoms plus positive SPT ) ( OR 5.6 , CI 1.8–17.9 , P and eczema ( OR 3.4 , CI 1.2–10.1 , P positive SPTs ( OR 3.7 , CI 1.3–10.0 , P reduces the risk of atopic disease . This should be reserved for infants considered at very high risk of atopy , and close medical and dietetic supervision must be available",
"BACKGROUND The effect of diet change in 38 bottle-fed and 77 breast-fed \" colicky \" infants , referred from community-based pediatric facilities was studied over a 1-week period in a double-blind ( within each feeding mode ) , r and omized , placebo-controlled trial . METHODS Bottle-fed infants were assigned to either casein hydrolysate or cow 's milk formula . All mothers of breast-fed infants were started on an artificial color-free , preservative-free , additive-free diet and also r and omized to an active low allergen diet ( milk- , egg- , wheat- , nut-free ) or a control diet . RESULTS The response to diet was assessed on day 1 and day 8 with the use of a previously vali date d infant distress chart on which parents recorded distress levels . If successful outcome was defined as a reduction in distress of 25 % or more , after adjusting for age and feeding mode , infants on active diet had a significantly higher rate of improvement than those on the control diet ( odds ratio , 2.32 ; 95 % confidence interval , 1.07 - 5.0 ; p = 0.03 ) . Analysis of the day 8 to day 1 distress ratio , again adjusted for age and feeding mode , showed that infants on the active diet had distress reduced by 39 % ( 95 % confidence interval , 26 - 50 ) compared with 16 % ( 95 % confidence interval , 0 - 30 ) for those on the control diet ( p = 0.012 ) . CONCLUSION The results suggest a period of dietary modification with a low allergen diet and appropriate nutritional support should be considered in healthy infants with colic",
"The effect of maternal and infant avoidance of allergenic foods on food allergy was examined in a prenatally r and omized , controlled trial of infants of atopic parents . The diet of the prophylactic-treated group ( N = 103 ) included ( 1 ) maternal avoidance of cow 's milk , egg , and peanut during the third trimester of pregnancy and lactation and ( 2 ) infant use of casein hydrolysate ( Nutramigen ) for supplementation or weaning , and avoidance of solid foods for 6 months ; cow 's milk , corn , soy , citrus , and wheat , for 12 months ; and egg , peanut , and fish , for 24 months . In the control group ( N = 185 ) , mothers had unrestricted diets , and infants followed American Academy of Pediatrics feeding guidelines . The cumulative prevalence of atopy was lower at 12 months in the prophylactic-treated ( 16.2 % ) compared to the control ( 27.1 % ) group ( p = 0.039 ) , result ing from reduced food-associated atopic dermatitis , urticaria and /or gastrointestinal disease by 12 months ( 5.1 % versus 16.4 % ; p = 0.007 ) , and any positive food skin test by 24 months ( 16.5 % versus 29.4 % ; p = 0.019 ) , caused primarily by fewer positive milk skin tests ( 1 % versus 12.4 % ; p = 0.001 ) . The prevalences of allergic rhinitis , asthma , and inhalant skin tests were unaffected . Serum IgE levels in the prophylactic-treated group were marginally lower only at 4 months . Thus , reduced exposure of infants to allergenic foods appeared to reduce food sensitization and allergy primarily during the first year of life",
"BACKGROUND Early exposure to dust mite allergens may be critical for primary sensitization . Reducing exposure may offer a realistic chance for primary prevention of sensitization and asthma , but it is essential to implement measures that can achieve and maintain the low-allergen environment . OBJECTIVE Our purpose was to assess the effectiveness of mite allergen avoidance measures in achieving and maintaining a low-allergen environment during pregnancy and in the first year of life . METHODS The Manchester Asthma and Allergy Study is a prospect i ve , prenatally r and omized study that follows the development of asthma and atopy in a cohort of infants at high risk ( both parents atopic ) who are r and omly allocated to full mite allergen avoidance or to a normal regimen . Avoidance measures comprise ( 1 ) mite-proof covers ( mattress , pillow , and quilt ) for parental bed , ( 2 ) high-filtration vacuum cleaner , ( 3 ) vinyl flooring in infant 's bedroom , ( 4 ) new crib and portable crib mattresses encased in mite-proof material , ( 5 ) benzyl benzoate ( Acarosan ) applied on carpets and soft furniture , ( 6 ) bed linens washed in hot water weekly , and ( 7 ) washable soft toys . Dust sample s from the parental bed , bedroom floor , living room floor , infant 's mattress , and nursery floor were collected between the 10th and 14th weeks of pregnancy , immediately after birth , and then at age 6 months and 1 year , and Der p 1 levels were determined by mAb-based ELISA . RESULTS Recovered Der p 1 from maternal mattress was reduced by 97 . 25 % ( 95 % confidence interval [ CI ] 95.25%-98.41 % ) during the second and third trimesters of pregnancy , with the effect persisting for 6 months ( 98 % reduction , 95 % CI 97.25%-99.1 % ) and 12 months ( 97.6 % reduction , 95 % CI 95.7%-98.6 % ) after the birth ( active vs control , P Total Der p 1 from bedroom floor in the active group was reduced by 53.7 % ( 95 % CI 25.7%-71.2 % ) in sample s collected within 4 weeks of the child 's birth , with the percentage reduction being 62 . 8 % ( 95 % CI 39.3%-77.2 % ) at 6 months and 26.5 % ( 95 % CI -24 % to 57.1 % ) at 1 year ( active compared vs control , P Der p 1 levels in crib mattress and nursery floor in the active group were extremely low ( crib mattresses geometric mean [ 95 % CI ] 2.3 ng [ 1.6 - 3.4 ] at birth , 6.8 ng [ 4.5 - 10 ] at age 6 months , and 15.6 ng [ 9.8 - 24.8 ] at age 1 year [ active vs control , P = .001 ] ; nursery 1 ng [ 0.9 - 1.1 ] at birth , 1.7 ng [ 1.2 - 2.5 ] at age 6 months , and 2 ng [ 1.3 - 3.5 ] at age 1 year [ active vs control , P total amount of allergen recovered at age 1 year was 29-fold ( 95 % CI 15.1- to 56.7-fold ) higher in the control group than in the active group . CONCLUSIONS The avoidance measures used in this study achieved and maintained a low mite allergen environment during pregnancy and in the first year of life in homes of infants at risk of atopy",
"STUDY OBJECTIVES We sought to identify early life factors ( ie , first 4 years ) associated with wheeze , asthma , and bronchial hyperresponsiveness ( BHR ) at age 10 years , comparing their relative influence for these conditions . METHODS Children were seen at birth , and at 1 , 2 , 4 , and 10 years of age in a whole- population birth cohort study ( 1,456 subjects ) . Information was collected prospect ively on genetic and environmental risk factors . Skin-prick testing was performed at 4 years of age . Current wheeze ( in the last 12 months ) and currently diagnosed asthma ( CDA ) [ ie , current wheeze and ever-diagnosed asthmatic subject ] were recorded at 10 years of age when BHR was measured at bronchial challenge . Independent significant risk factors for these outcomes were identified by logistic regression . RESULTS Independent significance for current wheeze occurred with maternal asthma ( odds ratio [ OR ] , 2.08 ; 95 % confidence interval [ CI ] , 1.27 to 3.41 ) and paternal asthma ( OR , 2.12 ; 95 % CI 1.29 to 3.51 ) , recurrent chest infections at 2 years ( OR , 3.98 ; 95 % CI , 2.36 to 6.70 ) , atopy at 4 years of age ( OR , 3.69 ; 95 % CI , 2.36 to 5.76 ) , eczema at 4 years of age ( OR , 2.15 ; 95 % CI , 1.24 to 3.73 ) , and parental smoking at 4 years of age ( OR , 2.18 ; 95 % CI , 1.25 to 3.81 ) . For CDA , significant factors were maternal asthma ( OR , 2.26 ; 95 % CI , 1.24 to 3.73 ) , paternal asthma ( OR , 2.30 ; 95 % CI , 1.17 to 4.52 ) , and sibling asthma ( OR , 2.00 ; 95 % CI , 1.16 to 3.43 ) , recurrent chest infections at 1 year of age ( OR , 2.67 ; 95 % CI , 1.12 to 6.40 ) and 2 years of age ( OR , 4.11 ; 95 % CI , 2.06 to 8.18 ) , atopy at 4 years of age ( OR , 7.22 ; 95 % CI , 4.13 to 12.62 ) , parental smoking at 1 year of age ( OR , 1.99 ; 95 % CI , 1.15 to 3.45 ) , and male gender ( OR , 1.72 ; 95 % CI , 1.01 to 2.95 ) . For BHR , atopy at 4 years of age ( OR , 5.38 ; 95 % CI , 3.06 to 9.47 ) and high social class at birth ( OR , 2.03 ; 95 % CI , 1.16 to 3.53 ) proved to be significant . CONCLUSIONS Asthmatic heredity , predisposition to early life atopy , plus early passive smoke exposure and recurrent chest infections are important influences for the occurrence of wheeze and asthma at 10 years of age . BHR at 10 years of age has a narrower risk profile , suggesting that factors influencing wheezing symptom expression may differ from those predisposing the patient to BHR",
"BACKGROUND Asthma places huge dem and s on health-care services , and its prevalence is increasing . Reduction of exposure to environmental allergens could offer a realistic chance for primary prevention . Our aim was to ascertain whether or not living in a low-allergen environment reduces the risk of asthma and atopic diseases in infants . METHODS We assigned infants to four risk groups according to parental atopic status . We enrolled 291 high-risk couples ( both parents atopic , no pets ) into a prospect i ve , prenatally r and omised , cohort study , and allocated them to environmental manipulation , in which measures to reduce prenatal and postnatal allergen exposure were undertaken ( active HRA ) ( n=145 ) or no intervention ( control HRC ) ( n=146 ) . Two further prospect i ve groups were studied : 161 high-risk infants with pets in the home ( HRP group ) and 168 low-risk infants , whose parents were both non-atopic ( LR group ) . The main outcome measures were signs and symptoms of atopic disease at 1 year of age . FINDINGS 103 families dropped out or were lost to follow up . At age 1 year we followed-up 133 HRA , 118 HRC , 140 HRP , and 126 LR infants . Children in the HRA group were less likely to have respiratory symptoms during the first year of life than those in the HRC group . The most pronounced differences were in the relative risks for severe wheeze with shortness of breath ( relative risk 0.44 [ 95 % CI 0.20 - 1.00 ] ) , prescribed medication for the treatment of wheezy attacks ( 0.58 [ 0.36 - 0.95 ] ) , and wheezing after vigorous playing , crying , or exertion ( 0.18 [ 0.04 - 0.79 ] ) . Probability of respiratory symptoms in HRC and HRP infants was similar , whereas it was much lower in the LR than in the HRC group . Cat ownership was significantly associated with sensitisation to cats ( 24.6 [ 3.04 - 199.05 ] ; p=0.003 ) . INTERPRETATION Environmental manipulation reduces some respiratory symptoms in the first year of life in high-risk infants . Further follow up is needed , however , to ascertain whether living in a low-allergen environment reduces allergy and asthma in later life",
"The ingestion of food antigens usually results in the induction of oral tolerance , but the clinical and immunologic consequences of brief exposure to cow 's milk proteins during the neonatal period are not well-documented . The aim of this work was to study immunoglobulin (Ig)E and IgG responses to cow 's milk proteins and ovalbumin after exposure during the first three days of life in infants who were otherwise exclusively breast-fed . A group of 129 infants was r and omly assigned at birth to one of three feeding regimens : human milk ( HM ) , cow 's milk formula ( CMF ) , or a casein hydrolysate formula ( CHF ) , during the first three days of life . They were then all exclusively breast-fed for a varying period of time and followed for two years . Serum IgG and IgE antibodies to cow 's milk proteins and ovalbumin ( OVA ) were analyzed in blood sample s obtained at birth , at 4 days and at 2 , 4 , 8 , 12 and 24 months of age . The levels of IgG antibodies to beta-lactoglobulin ( IgG-BLG ) and bovine serum albumin ( IgG-BSA ) were higher in the CMF and the HM groups than in the CHF group for up to two years . This was particularly obvious for IgG-BLG in infants who started weaning before two months . The levels of IgG antibodies to casein ( IgG-CAS ) were higher in the CMF group , as compared with the CHF group at 8 and 12 months . The levels of IgG antibodies to OVA were similar in all three feeding groups . The levels of IgE antibodies to CAS or OVA were similar in the three feeding groups . Exposure to cow 's milk during the first three days of life stimulated IgG antibody production to cow 's milk proteins and this was still obvious at 2 years of age , while feeding with a casein hydrolysate during the first three days of life was associated with low levels of IgG antibodies to cow 's milk proteins",
"Healthy , term infants received extensively hydrolyzed casein formula ( EHF ; control ) , the same formula supplemented with Lactobacillus rhamnosus GG ( EHF-LGG ) , or partially hydrolyzed whey : casein ( 60:40 ) formula supplemented with LGG ( PHF-LGG ) , in this double-blind , r and omized , controlled , parallel , prospect i ve study . Anthropometric measures and 24-hour dietary and tolerance recalls were obtained at 30 , 60 , 90 , 120 , and 150 days of age . Blood collected in a subset of infants was analyzed for fatty acid profiles in plasma and red blood cells and for markers of allergic sensitization . Adverse events were recorded throughout the study . Growth rates were not statistically different between EHF and PHF-LGG and between EHF and EHF-LGG from day 14 to day 30 , 120 , or 150 . No relevant differences in formula tolerance , adverse events , or allergic and immune markers were demonstrated between groups . The extensively and partially hydrolyzed formulas supplemented with LGG support normal growth in healthy , term infants and are well tolerated and safe",
"Retraction On 28 October 2015 , The BMJ retracted this article , published in 1989 : Ch and ra RK , Puri S , Hamed A. Influence of maternal diet during lactation and use of formula feeds on development of atopic eczema in high risk infants . BMJ 1989;299:228–30 . The BMJ has retracted the article after receiving a copy of an inquiry into the research of R K Ch and ra , which was conducted by the Memorial University of Newfoundl and and completed in August 1995 . The university did not publish the inquiry report at the time . Nor did it notify the editors of journals that had published articles by Ch and ra that were considered in the report . The BMJ obtained a copy of the report when it came into the public domain as a result of Ch and ra taking and losing a legal action against the Canadian Broadcasting Corporation ( CBC ) , which aired television programmes about Ch and ra in 2006 . The inquiring committee experienced great difficulty with its work , but its final conclusion was that “ scientific misconduct has been committed by Dr Ch and ra . ” It looked at three studies and found that : “ absolutely no raw data ( or files ) of any kind were exhibited ” “ the Committee can not identify anyone who did the recruiting , can not identify anyone who did or remembers a significant amount of work ” “ the coauathors had little or very likely nothing to do with the work ” “ it is unbelievable that there are essentially no hospital records to support the study in question ” “ the committee can not accept that the Carnation study was done anywhere near to completeness or with the accuracy reported in the Annals of Allergy and Journal of Clinical Nutrition , For that matter , the same can probably be said for the Mead Johnson work published in the British Medical Journal . ” When asked by The BMJ in 2015 why it had not published the report in 1995 , Memorial University of Newfoundl and said that the report “ was the product of a flawed investigation process and could not be relied upon . ” In the CBC programmes , however , a university spokesman said that the university had not acted on the report because of legal threats from Ch and ra . The university further told The BMJ : “ In the spirit of being helpful , we acknowledge that over the years serious questions have been raised about the 1989 publication , leading to much controversy . If [ The ] BMJ decides to retract the paper on the basis of evidence apart from the findings of the 1995 report , then we would underst and your decision in this regard . ” The BMJ is retracting the paper because of the 1995 report , and because of the convincing evidence given in the CBC television programmes and the court case that the work of R K Ch and ra is not to be trusted . For more information , see The BMJ 's feature article(1 ) and editorial,(2 ) published on 28 October 2015",
"Purpose To investigate whether specific IgA , IgG , IgG1 and IgG4 responses to cow ’s milk proteins differ between infants with cow ’s milk allergy and infants with cow ’s milk related symptoms ( control subjects ) , and whether early feeding affects these responses as well as specific IgE. Methods A cohort of 6,209 healthy , full-term infants in a double-blind r and omized trial received , as supplementary feeding at maternity hospitals ( mean duration 4 days ) , either cow ’s milk formula , extensively hydrolyzed whey formula or donor breast milk . Infants who developed cow ’s milk associated symptoms ( n = 223 ) underwent an open oral cow ’s milk challenge ( mean age 7 months ) , which confirmed cow ’s milk allergy in 111 and was negative in 112 . We measured in sera cow ’s milk specific IgE levels with UniCAP ( Phadia , Uppsala , Sweden ) , and β-lactoglobulin and α-casein specific IgA , IgG1 , IgG4 and IgG levels with enzyme-linked immunosorbent assay . Results Infants with IgE-mediated cow ’s milk allergy had lower β-lactoglobulin and α-casein specific IgG1 , IgG4 and IgG levels ( p cow ’s milk allergy or control subjects . Within the group of infants with cow ’s milk allergy , exposure to cow ’s milk during the first few days after birth led to higher β-lactoglobulin and α-casein specific IgG4 levels ( p infants who developed cow ’s milk allergy early exposure to cow ’s milk result ed in a heightened specific IgG4 response "
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Background To complete a systematic review and meta- analysis based on the clinical question : Is Deflazacort ( DFZ ) , a prednisolone derivative , an effective therapy for improving strength , with acceptable side effects , in children with Duchenne Dystrophy ( DD ) ? Methods MEDLINE , EMBASE , Current Contents , Dissertation Abstract s , Health Star , PsychINFO and Cochrane , were search ed using the following inclusion criteria : 1 ) A r and omized controlled trial comparing DFZ with placebo or another therapy ; 2 ) Male participants age 2–18 years with DD ; 3 ) Outcomes of ( a ) any form of strength or functional testing , or ( b ) any form of side effect . Results Fifteen studies of potential relevance were identified , with five meeting the inclusion criteria . These five studies included 291 children and were published in English language journals between 1994 and 2000 . Two studies compared DFZ versus placebo , two studies compared DFZ with prednisone and one study had both placebo and prednisone comparisions . Two large trials were identified that have not been published in article format . Due to the heterogeneity in outcome measures and the inconsistent reporting of summary statistics a meta-analytic approach could not be taken . Conclusions Examining individual studies it appears that DFZ improves strength and functional outcomes compared to placebo , but it remains unclear if it has a benefit over prednisone on similar outcomes . Two trials found that DFZ causes less weight gain than prednisone
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"We conducted a double blind controlled trial in 28 Duchenne muscular dystrophy ( DMD ) patients with Deflazacort ( DF ) , an oxazoline derivative of prednisolone which reduces its side-effects . Myometric muscle strength measurements , Scott Score and timed tests showed statistically significant improvement for the treated group ( P less than 0.05 ) . Side-effects after 9 months of treatment included mild cushingoid appearance in four patients ( 28 % ) and moderate in only one ( 7 % ) , increased appetite in seven ( 50 % ) , increased body hair in four ( 28 % ) , irritability and hyperactivity in three ( 21 % ) . Increased body weight was not prominent and was controlled with dietary measures . No patient had to be withdrawn from medication . More research and long-term follow-up are needed in order to establish the mechanism of improvement and the consequences of long-term steroid administration in DMD . In this regard DF appears as an alternative to prednisone preserving its benefits but with fewer side-effects",
"We r and omized 18 Duchenne muscular dystrophy ( DMD ) boys whose age ranged from 5.2 to 14.6 years ( mean , 7.3 years ) for treatment with either deflazacort ( 0.9 mg/kg/day ) or prednisone ( 0.75 mg/kg/day ) on the basis of age and functional score at the onset of treatment . We followed the patients every 3 months for 1 year , evaluating four limb muscles with the Medical Research Council scale and performance of four functions ( walking , climbing stairs , Gowers ' maneuver , and rising from a chair ) . Side effects were monitored by a question naire and by routine blood examination , and weight and height were recorded at each visit . At 12 months , the effect of both steroids was examined by comparing the status of the treated patients with another group of untreated DMD patients that served as natural history control . The two steroids were equally effective in improving motor function and functional performances . At 9 months , the average weight increase with respect to baseline value was 5 % ( 2 kg ) in the deflazacort group but 18 % in the prednisone group ( P side effects were observed . Steroid treatment with deflazacort appears to cause fewer side effects than with prednisone , particularly weight gain , which could be important to maximize motor performances",
"Several studies have demonstrated the slowing effect of corticosteroids on the decline of muscle strength in Duchenne muscular dystrophy ( DMD ) . Deflazacort ( DFC ) is supposed to have fewer side effects than prednisone ( PRED ) . An ongoing double blind multicenter study is comparing the effects and side effects of deflazacort ( 0.9 mg/kg/day ) and prednisone ( 0.75 mg/kg/day ) in DMD . This interim report includes data for 67 boys between age 5 years and loss of ambulation . Besides the common clinical and laboratory data for chronic corticoid treatment , motor performance has been tested . Interim results , 3 - 15 months after starting the medication , show some scattering but no grouping of data for all the functions tested : timed motor functions , sum of the strength of 20 muscles according to a 10-point scale on manual testing , weight gain , osteocalcin and alkaline phosphatase . Only the changes in CK activity after 3 months medication might reflect two equal groups without any correlation with the initial activity or with other parameters . On average , there was no clear-cut loss of muscle strength or performance . Except for in 4 patients , who were excluded due to unacceptable weight gain and /or loss of ambulation , there were no side effects considered to be serious . The results suggest that ( i ) DFC and PRED in equal anti-inflammatory dosage are similarly or equally efficient in slowing down the decline of muscle strength in DMD ; ( ii ) benefits outweigh the side effects . This allows the study to continue as design ed",
"A r and omized , controlled trial of daily prednisone was conducted in 99 boys ( aged 5 to 15 years ) with Duchenne dystrophy to define the time course of improvement and the dose response to treatment . Prednisone at 0.3 mg/kg ( n = 33 ) , prednisone at 0.75 mg/kg ( n = 34 ) , and placebo ( n = 32 ) were administered for 6 months . Patients were examined using manual muscle and myometry testing , timed functional testing , pulmonary function testing , and laboratory measurements at 10 days , 1 month , 2 months , 3 months , and 6 months of treatment . Boys treated with prednisone had stronger average muscle strength scores , than did boys treated with placebo as early as 10 days after starting therapy . At the 3-month visit , the boys in the group given 0.75 mg/kg of prednisone were significantly stronger than those in the group given 0.3 mg/kg of prednisone , indicating a dose response . At 6 months , significant side effects occurred in the group treated with 0.75 mg/kg of prednisone , including weight gain , cushingoid appearance , and excessive hari growth . Only weight gain was observed in the group taking prednisone at a dose of 0.3 mg/kg . Importantly , no side effects were evident at 10 days or 1 month of treatment , despite improvement in muscle strength and function . We conclude that prednisone produces a rapid increase in muscle strength in patients with Duchenne dystrophy and that this improvement is maximal at a prednisone dosage of 0.75 mg/kg or less",
"We previously reported the results of a r and omized , double-blind 6-month trial of prednisone therapy in which 102 boys aged 5 to 15 years with Duchenne muscular dystrophy received daily doses of 1.5 and 0.75 mg/kg per day and were compared with those receiving placebo . The strength and function in both prednisone-treated groups improved equally and were significantly better than in the placebo group . To compare alternate-day and daily dosing of prednisone with respect to benefits and adverse side effects , the placebo group was started on alternate-day prednisone therapy , and the treatment group regimens were changed to equivalent doses of alternate-day prednisone without breaking the double-blind nature . At the end of 6 months , the group that was changed from daily to alternate-day therapy had declined in strength back to levels observed 12 months previously , at the start of daily therapy . The group in which alternate-day therapy was started showed a significant improvement in strength at 3 months , similar in magnitude to the response of boys treated with daily therapy . However , their strength declined significantly in the subsequent 3 months compared with boys who received daily therapy . The frequency of side effects was not significantly different for alternate-day therapy compared with daily therapy . We conclude that alternate-day prednisone therapy effectively increases strength but does not sustain the improvement to the same extent as daily therapy or mitigate side effects",
"We performed a r and omized , double-blind , controlled six-month trial of prednisone in 103 boys with Duchenne 's muscular dystrophy ( age , 5 to 15 years ) . The patients were assigned to one of three regimens : prednisone , 0.75 mg per kilogram of body weight per day ( n = 33 ) ; prednisone , 1.5 mg per kilogram per day ( n = 34 ) ; or placebo ( n = 36 ) . The groups were initially comparable in all measures of muscle function . Both prednisone groups had significant improvement of similar degree in the summary scores of muscle strength and function . Improvement began as early as one month and peaked by three months . At six months the high-dose prednisone group , as compared with the placebo group , had improvement in the time needed to rise from a supine to a st and ing position ( 3.4 vs. 6.2 seconds ) , to walk 9 m ( 7.0 vs. 9.7 seconds ) , and to climb four stairs ( 4.0 vs. 7.1 seconds ) , in lifting a weight ( 2.1 vs. 1.2 kg ) , and in forced vital capacity ( 1.7 vs. 1.5 liters ) ( P less than 0.001 for all comparisons ) . There was an increase in urinary creatinine excretion ( 261 vs. 190 mg per 24 hours ) , which suggested an increase in total muscle mass . However , the prednisone-treated patients who had required long-leg braces ( n = 5 ) or wheelchairs ( n = 11 ) continued to require them . The most frequent side effects were weight gain , cushingoid appearance , and excessive hair growth . We conclude from this six-month study that prednisone improves the strength and function of patients with Duchenne 's muscular dystrophy . However , further research is required to identify the mechanisms responsible for these improvements and to determine whether prolonged treatment with corticosteroids may be warranted despite their side effects",
"A r and omized double-blind controlled trial of deflazacort was conducted in 28 Duchenne muscular dystrophy patients either treated with deflazacort 2.0 mg/kg alternate-day therapy or placebo . The deflazacort group showed significant improvement in climbing stairs ( P rising from a chair , Gower 's maneuver , and walking ( P MRC index was significantly better ( P MRC index : higher scores in walking , chair rising ( P grade and time of Gower 's maneuver ( P mean time for loss of ambulation for the treated group after we started the trial was 33.2 + /- 9 months ; for the placebo group it was 20.5 + /- 11 months ( deflazacort vs. placebo group , P lost their ambulation at a median age of 11.8 years vs. 10.5 years in the placebo group . Side effects were mild , consisting of moderate weight gain and slight behavioral changes",
"Prednisone has been shown to improve strength in Duchenne dystrophy . Azathioprine often benefits corticosteroid-responsive diseases and can reduce the dose of prednisone needed . The present study reports a r and omized , controlled trial of prednisone and azathioprine design ed to assess the longer-term effects of prednisone and to determine whether azathioprine alone , or in combination with prednisone , improves strength . Ninety-nine boys ( aged five to 15 years ) with Duchenne dystrophy were r and omized to one of three groups : ( I ) placebo ; ( II ) prednisone 0.3 mg/kg/d ; or ( III ) prednisone 0.75 mg/kg/d . After 6 months , azathioprine 2 to 2.5 mg/kg/d was added in groups I and II and placebo added in group III . The study showed that the beneficial effect of prednisone ( 0.75 mg/kg/d ) is maintained for at least 18 months and is associated with a 36 % increase in muscle mass . There was weight gain , growth retardation , and other side effects . Azathioprine did not have a beneficial effect . This study suggests that prednisone 's beneficial effect is not due to immunosuppression"
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4117d9da-06ff-11f0-808a-c43d1ab1c353
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AIM To determine the effects of different modality of exercise training programs on muscle oxygenation in older adults . METHODS Relevant articles were search ed in PubMed , Web of Science , Science Direct and Scopus , using the keywords : " Aged " AND " Muscle oxygenation " AND ( Exercise OR " Exercise therapy " OR " Exercise Movement Techniques " OR Hydrotherapy ) , without limitation concerning the publication date . To be included in the full analysis , the study had to be a r and omized controlled trial in which older adults participants ( mean age : 65 years at least ) were su bmi tted to an exercise-training program and muscle oxygenation assessment . RESULTS The search es result ed in 1238 articles from which 7 met all the inclusion criteria . The trials involved 370 older adults ( 68.7±1.7years ) , healthy and with peripheral arterial disease . Studies included resistance and endurance exercises as well as walking sessions . Training sessions were 2 - 6 time per week , lasted 3 - 24 months and with different training intensity throughout studies . After a long-term resistance training , healthy older adults showed enhanced muscle oxygen extraction capacity , regulation of vessels and vascular endothelium function ; endurance training is reported to improve microvascular blood flow and matching of oxygen delivery to oxygen utilization , muscle oxidative capacity and muscle saturation , and walking sessions results in better muscle oxygen availability and muscle oxygen extraction capacity in older adults with peripheral arterial disease . CONCLUSIONS This review supports the fact that depending on the clinical status of the participants and the modality , exercise training improves different aspects of the muscle oxygenation in older adults
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[
"In older humans , infusions of endothelial agonists suggest endothelial dysfunction , due in part to less nitric oxide (NO)- and prostagl and in (PG)-mediated vasodilatation , and a shift toward PG-mediated vasoconstriction . Ageing can also be associated with lower exercise blood flow ( exercise hyperaemia ) , but the vascular mechanisms mediating this remain unknown . Notably , in young adults , inhibition of NO and PGs during exercise decreases exercise hyperaemia by approximately 20 and approximately 12 % , respectively . We tested our first hypothesis that in older humans inhibition of NO would decrease hyperaemia , but that inhibition of PGs would increase hyperaemia by blocking vasoconstrictor PGs . Fifteen older subjects ( 65 + /- 3 years ) performed dynamic forearm exercise for 20 min ( 20 contractions min(-1 ) ) . Forearm blood flow ( FBF ) was measured beat-to-beat with Doppler ultrasound , while saline or drugs were infused sequentially via brachial artery catheter in the exercising forearm . After achieving steady-state exercise , L-NAME ( 25 mg ) was infused over 5 min to inhibit NO synthase . After a further 2 min of exercise ( saline ) , ketorolac ( 6 mg ) was infused over 5 min to inhibit PGs , followed by a further 3 min of exercise with saline . Drug order was reversed in seven subjects . L-NAME reduced steady-state exercise hyperaemia by 12 + /- 3 % in older subjects ( P blood flow ( 3 + /- 6 % , P>0.4 ) . The effects of l-NAME and ketorolac were independent of drug order . By comparing these results with our previous results in young adults , we tested our second hypothesis that in older humans inhibition of NO or PGs would have less impact on exercise hyperaemia due to less vasodilatation from these signals . Our results suggest that , compared with young adults , in older humans the relative contribution of NO to exercise hyperaemia is reduced approximately 45 % ( 22 + /- 4 versus 12 + /- 3 % ) , but the role of PG in mediating vasodilatation is lost in ageing human skeletal muscle . Lower exercise hyperaemia in older humans may be mediated in part by less NO- and PG-mediated vasodilatation during exercise",
"The objectives of this study were to examine the effects of opioid administration on the acute cardiorespiratory and muscle oxygenation responses during a repetitive lifting and lowering test ( RLL ) to voluntary fatigue in participants with chronic low back pain ( LBP ) . Written informed consent was obtained from 27 LBP participants ( mean age 50.9 ± 16.4 years ) who completed one testing session during which they were administered a saline placebo and opioid ( 1 μg/kg of fentanyl intravenously ) in r and om order . The participants performed the RLL at a rate that they felt that they could sustain for an 8-h working day . Acute opioid administration increased the total lifting time and total work done during RLL by 35 and 48 % , respectively ( p work capacity was accompanied by a significant ( p increase in oxygen cost of 22 % per unit amount of work done and significant ( p 0.05 ) increases in heart rate ( 7 % ) and ventilation rate ( 10 % ) . Near infrared spectroscopic analysis of erector spinae oxygenation and blood volume responses during RLL indicated no significant ( p > 0.05 ) differences between the opioid and placebo phases . These findings suggest that the increased energy cost of lifting as a result of opioid administration was due to enhanced central oxygen transport and not peripheral muscle oxygen extraction",
"BACKGROUND Aging is associated with increased cardiovascular risk and endothelial dysfunction . Since exercise can improve endothelium-dependent vasodilation , in the present study we tested whether long-term physical activity could prevent aging-related endothelial dysfunction . METHODS AND RESULTS In 12 young and elderly ( age 26.9+/-2.3 and 62.9+/-5.8 years , respectively ) healthy sedentary subjects and 11 young and 14 elderly matched athletes ( age 27.5+/-1.9 and 66.4+/-6.1 years , respectively ) , we studied ( with strain-gauge plethysmography ) forearm blood flow modifications induced by intrabrachial acetylcholine ( 0.15 , 0.45 , 1.5 , 4.5 , and 15 microg/100 mL per minute ) , an endothelium-dependent vasodilator , at baseline , during infusion of N(G)-monomethyl-L-arginine ( L-NMMA ) ( 100 microg/100 mL forearm tissue per minute ) , a nitric oxide-synthase inhibitor , vitamin C ( 8 mg/100 mL forearm tissue per minute ) , an antioxidant , and finally under simultaneous infusion of L-NMMA and vitamin C. The response to sodium nitroprusside ( 1 , 2 , and 4 microg/100 mL forearm tissue per minute ) was also evaluated . In young athletes and sedentary subgroups , vasodilation to acetylcholine was inhibited by L-NMMA and was not changed by vitamin C. In elderly subjects , vasodilation to acetylcholine was blunted as compared with young subjects in both control subjects and athletes , whereas the response to sodium nitroprusside was similar . Moreover , in elderly athletes , vitamin C did not change the vasodilation to acetylcholine . In contrast , in elderly sedentary subjects , the response to acetylcholine was resistant to L-NMMA . In this subgroup , vitamin C increased the vasodilation to acetylcholine and restored the inhibiting effect of L-NMMA . CONCLUSIONS These results suggest that regular physical activity can at least in part prevent the age-induced endothelial dysfunction , probably the restoration of nitric oxide availability consequent to prevention of production of oxidative stress",
"This systematic review examines the effectiveness of current exercise interventions for the management of frailty . Eight electronic data bases were search ed for r and omized controlled trials that identified their participants as “ frail ” either in the title , abstract , and /or text and included exercise as an independent component of the intervention . Three of the 47 included studies utilized a vali date d definition of frailty to categorize participants . Emerging evidence suggests that exercise has a positive impact on some physical determinants and on all functional ability outcomes reported in this systematic review . Exercise programs that optimize the health of frail older adults seem to be different from those recommended for healthy older adults . There was a paucity of evidence to characterize the most beneficial exercise program for this population . However , multicomponent training interventions , of long duration ( ≥5 months ) , performed three times per week , for 30–45 minutes per session , generally had superior outcomes than other exercise programs . In conclusion , structured exercise training seems to have a positive impact on frail older adults and may be used for the management of frailty",
"This r and omized trial proposed to determine if there were differences in calf muscle StO2 parameters in patients before and after 12 weeks of a traditional walking or walking-with-poles exercise program . Data were collected on 85 patients who were r and omized to a traditional walking program ( n = 40 ) or walking-with-poles program ( n = 45 ) of exercise training . Patients walked for 3 times weekly for 12 weeks . Seventy-one patients completed both the baseline and the 12-week follow-up progressive treadmill tests ( n = 36 traditional walking and n = 35 walking-with-poles ) . Using the near-infrared spectroscopy measures , StO2 was measured prior to , during , and after exercise . At baseline , calf muscle oxygenation decreased from 56 ± 17 % prior to the treadmill test to 16 ± 18 % at peak exercise . The time elapsed prior to reaching nadir StO2 values increased more in the traditional walking group when compared to the walking-with-poles group . Likewise , absolute walking time increased more in the traditional walking group than in the walking-with-poles group . Tissue oxygenation decline during treadmill testing was less for patients assigned to a 12-week traditional walking program when compared to those assigned to a 12-week walking-with-poles program . In conclusion , the 12-week traditional walking program was superior to walking-with-poles in improving tissue deoxygenation in patients with PAD",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"Arm cranking is a useful alternative exercise modality for improving walking performance in patients with intermittent claudication ; however , the mechanisms of such an improvement are poorly understood . The main aim of the present study was to investigate the effects of arm-crank exercise training on lower-limb O2 delivery in patients with intermittent claudication . A total of 57 patients with intermittent claudication ( age , 70+/-8 years ; mean+/-S.D. ) were r and omized to an arm-crank exercise group or a non-exercise control group . The exercise group trained twice weekly for 12 weeks . At baseline and 12 weeks , patients completed incremental tests to maximum exercise tolerance on both an arm-crank ergometer and a treadmill . Respiratory variables were measured breath-by-breath to determine peak VO2 ( O2 uptake ) and ventilatory threshold . Near-IR spectroscopy was used in the treadmill test to determine changes in calf muscle StO2 ( tissue O2 saturation ) . Patients also completed a square-wave treadmill-walking protocol to determine VO2 kinetics . A total of 51 patients completed the study . In the exercise group , higher maximum walking distances ( from 496+/-250 to 661+/-324 m ) and peak VO2 values ( from 17.2+/-2.7 to 18.2+/-3.4 ml.kg-1 of body mass.min-1 ) were recorded in the incremental treadmill test ( P time to minimum StO2 ( from 268+/-305 s to 410+/-366 s ) , a speeding of VO2 kinetics ( from 44.7+/-10.4 to 41.3+/-14.4 s ) and an increase in submaximal StO2 during treadmill walking ( P walking performance after arm-crank exercise training in patients with intermittent claudication is attributable , at least in part , to improved lower-limb O2 delivery",
"OBJECTIVES Near-infrared spectroscopy provides a noninvasive method of measuring tissue oxygen saturation and has been used to monitor extremity compartment syndrome . Tissue O(2 ) saturation ( StO(2 ) ) is potentially useful in assessing patients with peripheral arterial disease ( PAD ) . The purpose s of this feasibility study are to ( 1 ) explore the diagnostic sensitivity of StO(2 ) in subjects with PAD and symptoms of intermittent claudication ( IC ) compared with normal subjects , and ( 2 ) correlate the change in StO(2 ) during and after exercise with the ankle brachial index ( ABI ) in patients with IC . Material and methods Forty-nine subjects , 35 normal and 14 PAD , from two centers were evaluated in a prospect i ve cross-sectional analysis comparing StO(2 ) by using the InSpectra tissue spectrometer and ABI at rest ( baseline ) and after treadmill exercise . Measurements were obtained at baseline and peak exercise ( normal subjects ) and at baseline , initial claudication distance ( ICD ) and absolute claudication distance ( ACD ) in PAD subjects . Endpoint values were the mean of 15 data points . Times to 50 % of StO(2 ) recovery to baseline ( T(50 ) ) and complete recovery to baseline ( T(100 ) ) were measured . Receiver-operator characteristic curves were constructed to assess the sensitivity/specificity values associated with various StO(2 ) cut-points . RESULTS The PAD patients were older ( P = .0002 ) and 57 % were male , compared with 37 % males in the normal group . The ABI was 0.68 + /- 0.14 in PAD patients versus 1.14 + /- 0.08 in normal subjects ( P baseline StO(2 ) was 65 % in both groups . The peak exercise StO(2 ) was significantly lower and the absolute change in StO(2 ) and the percent change in StO(2 ) were significantly greater in PAD patients ( P T(50 ) and T(100 ) were longer in the PAD patients compared to normal subjects ( P = .0001 and .002 , respectively ) . A T(50 ) of > 70 seconds yielded a sensitivity of 89 % and a specificity of 85 % for PAD . CONCLUSIONS StO(2 ) is a new and potentially useful technique to evaluate patients with PAD . Resting StO(2 ) was similar in PAD-IC subjects and normals . There was a significantly greater drop in StO(2 ) and longer recovery times in PAD-IC subjects . Interestingly , StO(2 ) at the ICD and ACD was similar . StO(2 ) offers a different and perhaps more appropriate end point for diagnosis and monitoring of the management of patients with PAD , and may offer additional insight into the pathophysiology of exercise-induced muscle ischemia and its recovery",
"Selected near-infrared spectroscopy ( NIRS ) parameters were assessed in healthy untrained participants and in peripheral arterial disease ( PAD ) trained patients to evaluate their usefulness in rehabilitative outcome . Forty-five PAD and 15 healthy participants were studied at entry and at 34 ± 2 weeks . Healthy participants performed their usual activities . Patients with PAD performed 2 home-based programs : structured at prescribed pace ( S-pre , n = 31 ) and unstructured at free pace ( U-free , n = 14 ) . We measured ankle – brachial index ( ABI ) , NIRS calf oxygen consumption at rest , NIRS dynamic muscle perfusion during an incremental test , and walking capacity . In all patients with PAD the NIRS parameters significantly increased approaching the stable values of untrained healthy participants . Among PAD , only S-pre group showed significant improvements in hemodynamic , functional , and NIRS parameters with selective adaptations in the worse legs . The assessment of NIRS parameters , that were found stable without training in healthy and modified in PAD only following structured training , might outline the local exercise-induced adaptations"
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4117da20-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE This systematic review and meta- analysis of r and omized controlled trials ( RCTs ) was performed to summarize the effect of alpha-lipoic acid ( ALA ) supplementation on glycemic control and lipid profiles among patients with metabolic diseases . METHODS We search ed the following data bases till October 2017 : MEDLINE , EMBASE , Web of Science and Cochrane Central Register of Controlled Trials . The relevant data were extracted and assessed for quality of the studies according to the Cochrane risk of bias tool . Data were pooled using the inverse variance method and expressed as st and ardized mean difference ( SMD ) with 95 % confidence intervals ( 95 % CI ) . Heterogeneity between studies was assessed by the Cochran Q statistic and I-squared tests ( I2 ) . Twenty-four studies were included in the meta-analyses . RESULTS The findings of this meta- analysis showed that ALA supplementation among patients with metabolic diseases significantly decreased fasting glucose ( SMD -0.54 ; 95 % CI , -0.89 , -0.19 ; P = 0.003 ) , insulin ( SMD -1.01 ; 95 % CI , -1.70 , -0.31 ; P = 0.006 ) , homeostasis model assessment of insulin resistance ( SMD -0.76 ; 95 % CI , -1.15 , -0.36 ; P hemoglobin A1c ( SMD -1.22 ; 95 % CI , -2.01 , -0.44 ; P = 0.002 ) , triglycerides ( SMD -0.58 ; 95 % CI , -1.00 , -0.16 ; P = 0.006 ) , total- ( SMD -0.64 ; 95 % CI , -1.01 , -0.27 ; P = 0.001 ) , low density lipoprotein-cholesterol ( SMD -0.44 ; 95 % CI , -0.76 , -0.11 ; P = 0.008 ) . We found no detrimental effect of ALA supplementation on high density lipoprotein-cholesterol ( HDL-cholesterol ) levels ( SMD 0.57 ; 95 % CI , -0.14 , 1.29 ; P = 0.11 ) . CONCLUSIONS Overall , the current meta- analysis demonstrated that ALA administration may lead to an improvement in glucose homeostasis parameters and lipid profiles except HDL-cholesterol levels
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"OBJECTIVE To evaluate the potential body weight-lowering effects of dietary supplementation with eicosapentaenoic acid ( EPA ) and α-lipoic acid separately or combined in healthy overweight/obese women following a hypocaloric diet . METHODS This is a short-term double-blind placebo-controlled study with parallel design that lasted 10 weeks . Of the r and omized participants , 97 women received the allocated treatment [ Control , EPA ( 1.3 g/d ) , α-lipoic acid ( 0.3 g/d ) , and EPA+α-lipoic acid ( 1.3 g/d+0.3 g/d ) ] , and 77 volunteers completed the study . All groups followed an energy-restricted diet of 30 % less than total energy expenditure . Body weight , anthropometric measurements , body composition , resting energy expenditure , blood pressure , serum glucose , and insulin and lipid profile , as well as leptin and ghrelin levels , were assessed at baseline and after nutritional intervention . RESULTS Body weight loss was significantly higher ( P with α-lipoic acid . EPA supplementation significantly attenuated ( P in leptin levels that occurs during weight loss . Body weight loss improved lipid and glucose metabolism parameters but without significant differences between groups . CONCLUSIONS The intervention suggests that α-lipoic acid supplementation alone or in combination with EPA may help to promote body weight loss in healthy overweight/obese women following energy-restricted diets",
"AIM To determine an influence of alpha-lipoic acid to reduction of body weight and regulation of total cholesterol concentration , triglycerides and glucose serum levels in obese patients with diabetes mellitus type 2 . METHODS A prospect i ve study includes two groups of obese patients with diabetes mellitus and signs of peripheral polyneuropathia : examined group ( 30 patients ; 15 females and 15 males ) , and control group ( 30 patients ; 12 females and 18 males ) . All were treated with metformin ( 850 - 1700 mg/day ) . Examined patients were additionally treated with alpha-lipoic acid 600 mg/day during 20 weeks . Body mass index and concentrations of total cholesterol , triglycerides and glucose in serum were compared before and after the treatment . RESULTS The group treated with 600 mg alpha-lipoic acid lost significantly more weight , and had lower triglyceride level than the control group . There were no significant differences in total cholesterol and glucose serum levels between the groups . CONCLUSION Alpha-lipoic acid of 600 mg/day treatment have influenced weight and triglycerides loss in obese patients with diabetes mellitus type 2 . It should be considered as an important additive therapy in obese patients with diabetes mellitus type 2",
"Weight gain and other metabolic disturbances have now become discouraging , major side effects of atypical antipsychotic drugs ( AAPDs ) . The novel strategies required to counteract these serious consequences , however , should avoid modulating the activities of the neurotransmitter receptors involved because those receptors are the therapeutic targets of AAPDs . Adenosine monophosphate-activated protein kinase is an enzyme that plays a pivotal role in energy homeostasis . We hypothesized that & agr;-lipoic acid ( ALA ) , which is known to modulate adenosine monophosphate-activated protein kinase activity in the hypothalamus and peripheral tissues , would ameliorate AAPD-induced weight gain . We describe the case series of a 12-week ALA trial in schizophrenia patients treated with AAPDs . Two of 7 enrolled subjects were dropped from the study because of noncompliance and dem and for new medication to treat depressive symptoms , respectively . The mean ( SD ) weight loss was 3.16 ( 3.20 ) kg ( P = 0.043 , last observation carried forward ; median , 3.03 kg ; range , 0 - 8.85 kg ) . On average , body mass index showed a significant reduction ( P = 0.028 ) over the 12 weeks . During the same period , a statistically significant reduction was also observed in total cholesterol levels ( P = 0.042 ) , and there was a weak trend toward the reduction in insulin resistance ( homeostasis model assessment of insulin resistance ) ( P = 0.080 ) . Three subjects reported increased energy subjectively . The total scores on the Brief Psychiatric Rating Scale and the Montgomery-Asberg Depression Rating Scale did not vary significantly during the study . These preliminary data suggest the possibility that ALA can ameliorate the adverse metabolic effects induced by AAPDs . To confirm the benefits of ALA , more extended study is warranted",
"BACKGROUND Short-term continuous subcutaneous insulin infusion ( CSII ) in patients with newly diagnosed type 2 diabetes has been proved effective in improving metabolic control and β-cell function , thus inducing long-term drug-free remission . A r and omized controlled trial was conducted to investigate whether CSII in combination with rosiglitazone , metformin , or α-lipoic acid separately brings about extra benefits . PATIENTS AND METHODS One hundred sixty patients with newly diagnosed type 2 diabetes were r and omized to one of four treatment groups : CSII alone , CSII in combination with rosiglitazone or metformin for 3 months , or CSII with α-lipoic acid intravenous infusion for 2 weeks . Duration of CSII treatment was identical in the four groups . Glucose and lipid profiles , homeostasis model assessment ( HOMA ) indices , acute insulin response ( AIR ) , intramyocellular lipid ( IMCL ) level , and malondialdehyde level were compared before and after intervention . RESULTS The near-normoglycemia rate at the third month in CSII alone and that in combination with rosiglitazone , metformin , or α-lipoic acid was 72.5 % , 87.5 % , 90 % , and 75 % , respectively ( metformin group vs. CSII alone , P=0.045 ) . The metformin group achieved euglycemia in a shorter time ( 2.6 ± 1.3 vs. 3.7 ± 1.8 days , P=0.020 ) with less daily insulin dosage and was more powerful in lowering total cholesterol , increasing AIR and HOMA β-cell function , whereas reduction of IMCL in the soleus was more obvious in the rosiglitazone group but not in the metformin group . The efficacy of combination with α-lipoic acid was similar to that of CSII alone . CONCLUSIONS Short-term CSII in combination with rosiglitazone or metformin is superior to CSII alone , yet the efficacy of the two differs in some way , whereas that with α-lipoic acid might not have an additive effect",
"Several studies showed that impairment of endothelium-dependent arterial dilation ( EDAD ) exists in subjects with impaired fasting glucose ( IFG ) . The crucial mechanism of this endothelial dysfunction remains unclear . We hypothesized that oxidative stress may be partially responsible for the impairment in EDAD in subjects with IFG . Thus , the present study was design ed to assess whether the antioxidant α-lipoic acid can improve endothelial dysfunction in subjects with IFG . Sixty subjects with newly diagnosed IFG and 32 healthy individuals with normal glucose tolerance were enrolled . Subjects were r and omized into 2 groups : untreated experimental group ( n = 30 ) and α-lipoic acid treatment group ( n = 30 , α-lipoic acid 600 mg via intravenous infusion once a day for 3 weeks ) . We measured EDAD at baseline and after 3 weeks of intervention . At baseline , EDADs in α-lipoic acid and untreated experimental groups were 4.03 % and 4.14 % , respectively , which were significantly lower than that in controls ( 5.72 % ) ( P increase in EDAD ( reaching 5.10 % ; ΔEDAD , 26.5 % ) ( P decrease in plasma thiobarbituric acid reactive substances ( TBARS ) ( 29.1 % ) ( P α-lipoic acid . Endothelium-dependent arterial dilation and TBARS remained unchanged before and after intervention in the untreated experimental group . The absolute changes in EDAD showed a significant negative correlation with the changes in TBARS ( r = -0.444 , P = .014 ) . Our data showed that IFG subjects have impaired endothelial function and that antioxidant α-lipoic acid can improve endothelial function through a decrease of oxygen-derived free radicals ",
"The purpose of this study was to investigate the effects of α-lipoic acid on body weight and lipid profiles in Sprague-Dawley rats fed a high fat diet ( HFD ) . After 4 weeks of feeding , rats on the HFD were divided into three groups by r and omized block design ; the first group received the high-fat-diet ( n = 10 ) , and the second group received the HFD administered with 0.25 % α-lipoic acid ( 0.25LA ) , and the third group received the high-fat diet with 0.5 % α-lipoic acid ( 0.5LA ) . The high fat diet with α-lipoic acid supplemented groups had significantly inhibited body weight gain , compared to that in the HFD group ( P 0.05 ) . Organ weights of rats were also significantly reduced in liver , kidney , spleen , and visible fat tissues in rats supplemented with α-lipoic acid ( P in plasma lipid profiles , such as total lipids , total cholesterol , triglycerides , low-density lipoprotein , and high-density lipoprotein , were observed between the HFD and 0.5LA groups . The atherogenic index and the plasma high density lipoprotein-cholesterol/total cholesterol ratio improved significantly with α-lipoic acid supplementation in a dose-dependent manner ( P 0.05 ) . Total hepatic cholesterol and total lipid concentration decreased significantly in high fat fed rats supplemented with α-lipoic acid in a dose-dependent manner ( P whereas liver triglyceride content was not affected . In conclusion , α-lipoic acid supplementation had a positive effect on weight gain and plasma and liver lipid profiles in rats",
"Background and purpose Nonalcoholic fatty liver disease ( NAFLD ) is one of the causes of a fatty liver , occurring when fat is deposited ( steatosis ) in the liver not due to excessive alcohol use . It is related to insulin resistance and the metabolic syndrome . The purpose of the present study was to evaluate the impact of combination therapy with alpha-lipoic acid ( ALA ) and ursodeoxycholic acid ( UDCA ) on NAFLD . Methods Alpha-lipoic acid 400 mg/day plus UDCA 300 mg/day ( ALAUDCA ) was investigated in patients over a period of 12 months using a r and omized , placebo (PLA)-controlled study with four parallel groups . Serum concentration of gamma-glutamyl transpeptidase ( GGT ) , alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , albumin and platelets ( PLT ) were measured at the beginning and at the end of the treatment . Moreover , the AST/ALT ratio and the NAFLD fibrosis score were examined . Results A total of 120 patients were r and omly assigned to the four groups . ALA and UDCA were safe and well tolerated in the oral daily administration only . AST , ALT , GGT ( p ALAUDCA and other three groups . Besides , NAFLD fibrosis score underlined a significant reduction ( p ALAUDCA group , while AST/ALT ratio presented a moderate decline ( p > 0.05 ) . Conclusion ALAUDCA therapy reduced AST , ALT , GGT values and improved NAFLD fibrosis score and AST/ALT ratio , especially in patients who were on a hypocaloric diet . These findings will be useful in patient selection in future clinical trials with ALAUDCA in long-term studies",
"PURPOSE alpha-lipoic acid is an essential cofactor for mitochondrial respiratory enzymes that improves mitochondrial function . We previously reported that alpha-lipoic acid markedly reduced body weight gain in rodents . The purpose of this study was to determine whether alpha-lipoic acid reduces body weight in obese human subjects . METHODS in this r and omized , double-blind , placebo-controlled , 20-week trial , 360 obese individuals ( body mass index [ BMI ] ≥ 30 kg/m(2 ) or BMI 27 - 30 kg/m(2 ) plus hypertension , diabetes mellitus , or hypercholesterolemia ) were r and omized to alpha-lipoic acid 1200 or 1800 mg/d or placebo . The primary end point was body weight change from baseline to end point . RESULTS the 1800 mg alpha-lipoic acid group lost significantly more weight than the placebo group ( 2.1 % ; 95 % confidence interval , 1.4 - 2.8 ; P ) . Urticaria and itching sensation were the most common adverse events in the alpha-lipoic acid groups , but these were generally mild and transient . CONCLUSION alpha-lipoic acid 1800 mg/d led to a modest weight loss in obese subjects . Alpha-lipoic acid may be considered as adjunctive therapy for obesity",
"OBJECTIVE The aim of this study was to investigate the effect of alpha-lipoic acid ( ALA ) treatment on endothelium-dependent and -independent vasodilatation , assessed by forearm blood flow ( FBF ) , in patients with type 2 diabetes mellitus . RESEARCH DESIGN AND METHODS A total of 30 subjects with type 2 diabetes were included in this r and omized , controlled , double-blinded , parallel group study . FBF responses to intra-arterial acetylcholine ( ACh ) and glycerol trinitrate ( GTN ) were measured before and after 21 days of intravenous treatment with 600 mg alpha-lipoic acid or placebo . RESULTS FBF responses were comparable at baseline . After treatment , FBF reactivity to ACh and GTN was unchanged in subjects receiving placebo . By contrast , ALA treatment increased endothelium-dependent vasodilatation to ACh ( P ALA treatment improves endothelium-dependent vasodilatation in patients with type 2 diabetes , in the absence of effects on forearm vasomotor function . If this salutary action translates into vascular risk reduction remains to be established",
"OBJECTIVE This study aims to evaluate the efficacy and safety of α-lipoic acid in the treatment of aged type 2 diabetes mellitus ( T2DM ) complicated with acute cerebral infa rct ion . PATIENTS AND METHODS 90 patients were r and omly divided into two groups , on the basis of conventional treatment . The experiment group was administrated with α-lipoic acid , while only Vitamin C for the control group , for 3 consecutive weeks . Before and after the experiment , superoxide dismutase ( SOD ) , glutathione peroxidase ( GSH-Px ) and malondialdehyde ( MDA ) levels were measured and scored with the NIHSS ( National Institutes of Health Stroke Scale ) , and the changes of blood glucose , insulin function and other indicators were observed . RESULTS After the treatment , the plasma SOD and GSH-Px levels increased , while MDA decreased ( p ( p ) . NIHSS score , blood glucose , blood lipids and HOMA-IA of the experiment group decreased significantly ( p significant adverse reactions were found in both groups . CONCLUSIONS α-lipoic acid was safe and effective in the treatment of aged T2DM complicated with acute cerebral infa rct ion , significantly reducing the patient 's oxidative stress , blood glucose and lipid levels and being able to improve islet function",
"Background / Aims : Supplementation with antioxidants is of special interest in preventing or delaying the development and progression of age-related macular degeneration ( AMD ) . This investigation aim ed to assess the effect of α- lipoic acid ( LA ) on serum lipids , serum malondialdehyde ( MDA ) and superoxide dismutase ( SOD ) in patients with AMD . Methods : A total of 62 patients ( 50–75 years old ) with early and intermediate dry form of AMD were r and omly assigned to two groups , i.e. LA administration ( n = 32 ) and placebo ( n = 30 ) . The levels of serum lipids and MDA and SOD activity were measured before and after LA and placebo intervention . Results : Compared with the parameters at baseline , serum total cholesterol ( CHO ) , triglyceride and high- and low-density lipoprotein CHO ( HDL and LDL ) levels were not significantly different after LA and placebo intervention . There was a slight but statistically nonsignificant decrease in serum MDA levels and a statistically significant increase in serum SOD activity after LA intervention . There were no statistically significant differences in serum MDA levels or SOD activity after placebo intervention . Conclusion : The apparent increase in SOD activity caused by LA supplementation indicates that LA may have a possible preventive effect in the development of AMD through an antioxidant mechanism",
"Background / Aim : Endothelial dysfunction due to reduced nitric oxide ( NO ) availability precedes the development of atherosclerosis . Asymmetric dimethylarginine ( ADMA ) , an endogenous inhibitor of NO synthase , is not only a cause of endothelial dysfunction , but also a predictor of the cardiovascular outcome in end-stage renal disease ( ESRD ) patients on hemodialysis ( HD ) . α-Lipoic acid ( ALA ) , a strong antioxidant , increases NO-mediated vasodilation in diabetic patients . We investigated whether ALA could decrease the plasma level of ADMA in diabetic ESRD patients on HD . Methods : Fifty patients undergoing HD three times per week were r and omized to a treatment group receiving ALA 600 mg/day for 12 weeks or a control group . We measured the plasma levels of cholesterol , albumin , high-sensitivity C-reactive protein , oxidized low-density lipoprotein , hemoglobin A1c , and ADMA in both groups at baseline and at 12 weeks . Results : In the control group , the levels of total cholesterol , serum albumin , high-sensitivity C-reactive protein , oxidized low-density lipoprotein , hemoglobin A1c , and ADMA did not change . In the treatment group , the plasma levels of ADMA decreased significantly from a median of 1.68 ( range 0.45–3.78 ) µM to a median of 1.31 ( range 0.25–3.19 ) µM ( p = 0.001 ) . Conclusion : Considering that ADMA is an independent risk factor for cardiovascular outcome in ESRD patients , ALA may have the potential of a beneficial effect in them , in part by decreasing the plasma level of ADMA ",
"OBJECTIVE We examined the effects of alpha-lipoic acid ( ALA ) supplementation on inflammation , oxidative stress , and serum lipid profile levels in hemodialysis ( HD ) patients . DESIGN This was a double-blinded , r and omized , placebo-controlled clinical trial . SETTING The present study involved HD centers in Tabriz , Iran . PATIENTS Participants included 63 patients with end-stage renal disease ( 43 men and 20 women ; age range : 22 - 79 years ) undergoing maintenance HD . INTERVENTION HD patients were r and omly assigned into the supplemented group ( n = 31 ) , receiving a daily dose of ALA ( 600 mg ) , or a control group ( n = 32 ) , receiving placebo for 8 weeks . MAIN OUTCOME MEASURES High sensitivity C-reactive protein ( hsCRP ) , malondialdehyde , total antioxidant status , total cholesterol , triglyceride , high-density lipoprotein cholesterol ( HDL-C ) , and low-density lipoprotein cholesterol ( LDL-C ) were measured at baseline and after 8 weeks of supplementation . RESULTS At the end of intervention , 11 patients were excluded from the study . HsCRP levels decreased by 18.7 % in the supplemented group after 8 weeks of supplementation , and the reduction was significant in comparison with the placebo group ( P mean malondialdehyde and total antioxidant status levels did not change significantly in the 2 groups during the study . The mean high-density lipoprotein cholesterol concentrations increased significantly in the supplemented group at the end of the study ( P lipid profile parameters within each group during the study . CONCLUSION ALA supplementation significantly reduced hsCRP levels , which is a risk factor for cardiovascular disease in HD patients",
"OBJECTIVE We previously found that lipoic acid ( LA ) improved high-fat diet (HFD)-induced dyslipidemia in rats . To eluci date the molecular mechanisms of that effect , we carried out experiments aim ed at analyzing biochemical parameters and gene expression profiles . METHODS C57BL/6 mice were r and omly assigned to one of three groups ( n = 8) . The control group consumed an ordinary diet ( 4.89 % fat , w/w ) . The other two experimental groups were fed with an HFD ( 21.45 % fat , w/w ) or an HFD plus 0.1 % LA . After 6 wk , plasma lipid level and antioxidant status were examined . To investigate the molecular mechanisms underlying the effects of LA on lipid metabolism and oxidative stress , we examined gene expression profiles in liver using the GeneChip microarray system . The differential expression of genes of interest identified by microarray technique was vali date d by real-time reverse transcription-polymerase chain reaction . RESULTS HFD result ed in significant alterations in lipid profiles and a depressed antioxidant defense system . LA supplementation induced decreases in lipid peroxidation , plasma cholesterol , triacylglycerols , and low-density lipoprotein cholesterol and an increase in high-density lipoprotein in HFD-fed mice . DNA microarray analysis of the liver showed that LA ingestion upregulated the expression of genes related to beta-oxidation and free radical scavenger enzymes , whereas those involved in cholesterol synthesis were downregulated . CONCLUSION LA can prevent HFD-induced dyslipidemia by modulating lipid metabolism , especially by increasing beta-oxidation and decreasing cholesterol synthesis , and oxidative stress by increasing those of free radical scavenger enzyme gene expression",
"OBJECTIVES This study intended to assess the effects of the antioxidants ; Alpha Lipoic Acid ( ALA ) , omega 3 fatty acids and vitamin E on the parameters of insulin sensitivity , oxidative stress , lipid metabolism and glycaemic control in patients of type 2 diabetes mellitus . METHODS This was a prospect i ve , r and omized , double blind , placebo controlled , single centred study . One hundred four patients with type 2 diabetes mellitus with insulin resistance were recruited for the study . They were given ALA , omega 3 fatty acids , vitamin E or placebo . Their weight , Body Mass Index ( BMI ) and Waist circumference were measured . The investigations which were fasting glucose and fasting total cholesterol . The insulin resistance was calculated on the basis of the BMI and the waist circumference . RESULTS In the intra group analysis at the baseline ( V1 ) vs at the end of the treatment period ( V5 ) , we observed a significant decrease in the BMI , waist circumference and the total cholesterol in the three treatment groups . In the intergroup analysis at V5 , ALA , omega 3 fatty acids and vitamin E showed a significant improvement in the total cholesterol as compared to the placebo and vitamin E showed the maximum improvement . CONCLUSION ALA , omega 3 fatty acids and vitamin E showed the improvement in insulin sensitivity . Since they differ in improving different parameters all of these three can be used as an add on therapy in patients with type 2 diabetes mellitus to improve their insulin sensitivity and lipid metabolism",
"Despite well-controlled blood glucose levels , diabetic complications still inevitably take place via several mechanisms including excessive generation of free radicals in patients who suffer from diabetes mellitus ( DM ) . A r and omized double-blind placebo-controlled clinical trial to investigate the effectiveness of oral supplementation of DL-alpha-lipoic acid ( ALA ) on glycemic and oxidative status in DM patients was conducted . Thirty eight out patients with type 2 DM were recruited and r and omly assigned to either placebo or treatment in various doses of ALA ( 300 , 600 , 900 , and 1200 mg/day ) for 6 months . Following the treatment , all subjects were evaluated for glucose status and oxidative biomarkers . Results showed that fasting blood glucose , HbA1c trended to decrease in a dose-dependent manner . Increase of urinary PGF2α-Isoprostanes ( F2α-IsoP ) was noted in placebo but not ALA-treated groups , indicating possible suppressing action of ALA on lipid peroxidation in DM subjects . 8-Hydroxy-2'-deoxyguanosine ( 8-OHdG ) levels , however , were similar in both placebo and ALA groups as well as urinary microalbumin and serum creatinine . Safety evaluation was monitored and treatment was found to be well tolerated despite some minor side effects . Results from this study reflected the benefits of ALA in glucose status with slight efficiency on oxidative stress-related deterioration in DM patients",
"OBJECTIVE To examine the effects of alpha-lipoic acid ( ALA ) treatment over a period of 2 months on fasting blood glucose ( FBG ) , insulin resistance ( IR ) , and glutathione peroxidase ( GH-Px ) activity in type 2 diabetes ( T2DM ) patients . METHODS This study took place in Motahari Clinic , Shiraz , Iran , which is affiliated to Shiraz University of Medical Sciences from May to October 2006 . Type 2 DM patients ( n=57 ) were divided into 2 groups to receive either ALA ( 300 mg daily ) or placebo by systematic r and omization , and were followed-up for 8 weeks . After an overnight fasting and 2 hours after breakfast , patients ' blood sample s were drawn and tested for FBG , 2 hours PPG , serum insulin level , and GH-Px activity . RESULTS The result of the study showed a significant decrease in FBG and PPG levels , IR-Homeostasis Model Assessment ( IR-HOMA index ) and GH-Px level in the ALA group . The comparison of differences between FBG and IR at the beginning and at the end of study in the ALA treated group and the placebo group were also significant . CONCLUSION This study supports the use of ALA as an antioxidant in the care of diabetic patients",
"There is a growing evidence that excess generation of highly reactive free radicals , largely due to hyperglycemia , causes oxidative stress , which further exacerbates the development and progression of diabetes and its complications . The purpose of this study was to evaluate the impact of ALA on lipid profile , oxidative pattern and inflammation in patients with controlled non-insulin dependent diabetes mellitus ( NIDDM ) . ALA , 400mg/day was investigated in NIDDM patients over a period of 4 weeks using a r and omized , placebo-(PLA)-controlled study with two parallel groups . The marker of oxidative stress was the concentration of reactive oxygen metabolites , evaluated using a commercially available test , called d-ROMs test , and the biological antioxidant potential ( BAP ) ; besides , the lipid profile ( total cholesterol = TC , high-density lipoprotein-cholesterol = HDL-C ; low-density lipoprotein-cholesterol = LDL-C , and triglycerides = TG ) and the C-reactive protein ( CRP ) , marker of inflammation were measured at the beginning and at the end of the treatment . A total of 14 patients were r and omly assigned to the two groups . ALA was safe and well tolerated in the only oral daily administration . The d-ROMs test ( p=0.03 ) and HDL-C ( p=0.04 ) showed a significant difference between the two groups . BAP ( p=0.06 ) tended to be higher in the treated patients , while LDL-C ( p=0.07 ) presented a moderate decline . There were no significant differences in TC ( p=0.65 ) , TG ( p=0.78 ) and CRP ( p=0.96 ) between the ALA and PLA groups . ALA therapy appears to reduce significantly d-ROMs and to improve HDL-C value , especially in men with metabolic syndrome treated with oral hypoglycemic drugs . These findings will be useful in patient selection in future clinical trials with ALA in long term studies"
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OBJECTIVES to examine and synthesize the available knowledge in the literature about the effects of preterm birth on the development of school-age children . SOURCES this was a systematic review of studies published in the past ten years indexed in MEDLINE / Pubmed , MEDLINE /BVS ; LILACS /BVS ; IBECS/BVS ; Cochrane/BVS , CINAHL , Web of Science , Scopus , and PsycNET in three language s ( Portuguese , Spanish , and English ) . Observational and experimental studies that assessed motor development and /or behavior and /or academic performance and whose target- population consisted of preterm children aged 8 to 10 years were included . Article quality was assessed by the Strengthening the reporting of observational studies in epidemiology ( STROBE ) and Physiotherapy Evidence Data base ( PEDro ) scales ; articles that did not achieve a score of 80 % or more were excluded . SUMMARY OF FINDINGS the electronic search identified 3,153 articles , of which 33 were included based on the eligibility criteria . Only four studies found no effect of prematurity on the outcomes ( two articles on behavior , one on motor performance and one on academic performance ) . Among the outcomes of interest , behavior was the most search ed ( 20 articles , 61 % ) , followed by academic performance ( 16 articles , 48 % ) and motor impairment ( 11 articles , 33 % ) . CONCLUSION premature infants are more susceptible to motor development , behavior and academic performance impairment when compared to term infants . These types of impairments , whose effects are manifested in the long term , can be prevented through early parental guidance , monitoring by specialized professionals , and interventions
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"Objectives : 1 ) To investigate the comorbidity of verbal and nonverbal learning disability subtypes with several domains of behavior problems among 8-year-old children . 2 ) To determine whether receipt of an early intervention modified the association between childhood behavior problems and learning disabilities ( LD ) . Methods : This is a secondary data analysis of the Infant Health and Development Program ( IHDP ) , a r and omized clinical trial of an early intervention provided between ages 0 and 3 involving 985 children born low birthweight and premature . The findings are based on a prospect i ve follow-up of these children at 8 years of age . Results : Compared to children without verbal LD ( VLD ) , those with VLD were twice as likely to exhibit clinical levels of total behavior problems and 89 % more likely to exhibit externalizing behavior problems . Analysis of specific subscales of behavior revealed significant associations with anxious/depressed and withdrawn behaviors , as well as an increased likelihood of attention problems among children with VLD . No significant association was found between nonverbal LD ( NVLD ) and any type of behavior problem . Furthermore , there was a significant interaction between VLD and the intervention , in which the odds of internalizing behavior problems were greater among children with VLD . No interaction effect of the intervention occurred for any type of behavior problem among children with NVLD . Conclusions : These findings provide evidence that distinct differences exist for different learning disability subtypes with regards to behavioral outcomes and the effects of early intervention services among 8-year-old children",
"OBJECTIVE : To determine whether mild and severe growth restriction at birth among preterm infants is associated with neonatal mortality and cerebral palsy and cognitive performance at 5 years of age and school performance at 8 years of age . METHODS : All 2846 live births between 24 and 32 weeks ' gestation from 9 regions in France in 1997 were included in a prospect i ve observational study ( the EPIPAGE [ Étude Epidémiologique sur les Petits Ages Gestationnels ] study ) and followed until 8 years of age . Infants were classified as “ small-for-gestational-age ” ( SGA ) if their birth weight for gestational age was at the children born between 24 and 28 weeks ' gestation , the mortality rate increased from 30 % in the AGA group to 42 % in the M-SGA group and to 62 % in the SGA group ( P ) . Birth weight was not significantly associated with any cognitive , behavioral , or motor outcomes at the age of 5 or any school performance outcomes at 8 years . For the children born between 29 and 32 weeks ' gestation , SGA children had a higher risk for mortality ( adjusted odds ratio [ aOR ] : 2.79 [ 95 % confidence interval ( CI ) : 1.50–5.20 ] ) , minor cognitive difficulties ( aOR : 1.73 [ 95 % CI : 1.12–2.69 ] ) , inattention-hyperactivity symptoms ( aOR : 1.78 [ 95 % CI : 1.10–2.89 ] ) , and school difficulties ( aOR : 1.74 [ 1.07–2.82 ] ) compared with AGA children . Being born M-SGA was associated with an increased risk for minor cognitive difficulties ( aOR : 1.87 [ 95 % CI : 1.24–2.82 ] ) and behavioral difficulties ( aOR : 1.66 [ 95 % CI : 1.04–2.62 ] ) . CONCLUSIONS : In preterm children , growth restriction was associated with mortality , cognitive and behavioral outcomes , as well as school difficulties",
"OBJECTIVE To compare healthy late-preterm infants with their full-term counterparts from age 4 through 15 years for numerous st and ard cognitive , achievement , socioemotional , and behavioral outcomes . DESIGN Prospect i ve cohort study . SETTING National Institute of Child Health and Development Study of Early Child Care and Youth Development , 1991 - 2007 . PARTICIPANTS A total of 1298 children ( 53 born at 34 - 36 weeks ' gestational age ) , and their families , observed from birth through age 15 years . None of the infants had major health problems before or immediately following birth , and all the infants were discharged from the hospital within 7 days . MAIN EXPOSURE Preterm status : children born late preterm ( 34 - 36 weeks ) vs those born full term ( 37 - 41 weeks ) . MAIN OUTCOME MEASURES Eleven st and ard outcomes measuring cognition , achievement , social skills , and behavioral/emotional problems using the Woodcock-Johnson Psycho-Educational Battery-Revised and the Child Behavior Checklist , administered repeatedly through age 15 years . RESULTS No consistent significant differences were found between late-preterm and full-term children for these st and ard measures from ages 4 to 15 years . Through age 15 years , the mean difference of most of these outcomes hovered around 0 , indicating , along with small confidence intervals around these differences , that it is unlikely that healthy late-preterm infants are at any meaningful disadvantage regarding these measures . CONCLUSION Late-preterm infants born otherwise healthy seem to have no real burdens regarding cognition , achievement , behavior , and socioemotional development throughout childhood",
"OBJECTIVES . Our objective was to determine motor , cognitive , and behavioral outcome at school age in preterm children with periventricular hemorrhagic infa rct ion and to identify cerebral risk factors for adverse outcome . METHODS . This was a prospect i ve cohort study of all preterm infants who were Ultrasound scans were review ed for characteristics of periventricular hemorrhagic infa rct ion and other cerebral abnormalities . At 4 to 12 years of age , motor outcome was assessed by the Gross Motor Function Classification System and the Manual Ability Classification System , by a neurologic examination ( Touwen ) , an intelligence test ( Wechsler Intelligence Scale III/Wechsler Preschool and Primary Scale of Intelligence-Revised ) , and tests for visual-motor integration , visual perception , and verbal memory . Behavior was assessed by using the Child Behavior Checklist and the Behavior Rating Inventory of Executive Function . RESULTS . Of 38 infants , 15 ( 39 % ) died . Twenty-one of the 23 survivors were included in the follow-up . Four infants were neurologically normal , 1 had minor neurologic dysfunction , 13 had unilateral spastic cerebral palsy , and 3 had bilateral cerebral palsy . Coordination , associated movements , and fine manipulative abilities were affected most according to the neurologic examination . Gross Motor Function Classification System scores were level 1 ( 7 children ) , level 2 ( 7 children ) , level 3 ( 1 child ) , and level 4 ( 2 children ) . Manual Ability Classification System scores were normal ( 4 children ) , level 1 ( 8 children ) , level 2 ( 7 children ) , and level 3 ( 2 children ) . The mean and median total IQ was 83 . Visual perception was normal in 88 % of children , visuomotor integration was normal in 74 % , and verbal memory was normal in 50 % . Behavior was normal in 53 % of children , and executive functions were normal in 65 % and 29 % of children ( by parent and teacher report , respectively ) . Characteristics of the periventricular hemorrhagic infa rct ion were not related to functional motor outcome and intelligence . Posthemorrhagic ventricular dilatation was a risk factor for poorer total and performance intelligence and abnormal fine manipulative abilities . CONCLUSIONS . The majority of surviving preterm children with periventricular hemorrhagic infa rct ion had cerebral palsy with limited functional impairment at school age . Intelligence was within 1 SD of the norm of preterm children without lesions in 60 % to 80 % of the children . Verbal memory , in particular , was affected . Behavioral and executive function problems occurred slightly more than in preterm infants without lesions . The functional outcome at school age of preterm children with periventricular hemorrhagic infa rct ion is better than previously thought",
"OBJECTIVE To investigate neurodevelopment at school age in preterm infants treated with hydrocortisone for bronchopulmonary dysplasia ( BPD ) in the neonatal period . STUDY DESIGN Preterm infants ( n = 226 ; gestational age performed subtests of the Wechsler Intelligence Scale for Children-Revised , the Visual Motor Integration test , a 15-Word Memory Test and the Movement Assessment Battery for Children at school age . Conventional MRI of the brain was obtained . Sixty-two children who received hydrocortisone for BPD ( starting dose , 5 mg/kg/day ; median duration , 27.5 days ) were compared with 164 nontreated neonates . RESULTS Hydrocortisone-treated infants were younger , lighter , and sicker than their non-steroid-treated counterparts . Adjustments for gestational age , body weight , sex , mechanical ventilation , and small for gestational age were made . Adjusted mean Intelligence Quotient , Visual Motor Integration test , and memory test results were the same in the hydrocortisone-treated group and the non-steroid-treated group ( 99 versus 101 , P = .62 ; 97 versus 99 , P = .49 , 7.9 versus 7.5 , P = .42 , respectively ) . Motor function and incidence of cerebral palsy in both groups was not different ( 11 % versus 7 % , P = .97 ) . Occurrence of brain lesions on MRI was similar for the two groups . CONCLUSIONS Neonatal hydrocortisone treatment for BPD had no long-term effects on neurodevelopment",
"Objectives . To examine the prevalence , stability , and predictors of clinical ly significant behavior problems in 869 preterm low birth weight ( LBW ) infants at 3 , 5 , and 8 years of age . Methods . A prospect i ve cohort study was conducted . Clinical ly significant behavior problems were assessed using dichotomized total problem Child Behavior Checklist scores in LBW children at ages 3 , 5 , and 8 years . Baseline sociodemographic and obstetric data were collected . Maternal General Health Question naire performed at 40 weeks ' gestation was dichotomized at a score of 12 to give a measure of maternal psychological distress . Prevalence and stability of behavior problems at ages 3 , 5 , and 8 were determined and potential predictors of behavior problems at age 3 , 5 , and 8 were examined using multiple logistic regression . Results . Prevalence of behavior problems remained at ∼20 % at 3 , 5 , and 8 years . Stability of behavior problems between different ages was ∼50 % . Significant behavior problems at ages 3 , 5 , and 8 were predicted by maternal psychological distress at 40 weeks ( odds ratio [ OR ] : 1.59 ; 95 % confidence interval [ CI ] : 1.21–2.09 ) , maternal cigarette smoking during pregnancy ( OR : 1.57 ; 95 % CI : 1.20–2.04 ) , Hispanic ethnicity ( OR : 2.00 ; 95 % CI : 1.24–3.24 ) , and maternal age ( OR : 0.97 ; 95 % CI : 0.94–0.99 ) . Conclusions . This sample had double the prevalence of behavior problems expected in the general child population . These problems showed stability over time . Cigarette smoking in pregnancy , maternal psychological distress at 40 weeks ' gestation , maternal age , and Hispanic ethnicity all were significant predictors of the development of behavior problems from ages 3 to 8 . These findings have implication s for health policies on smoking and postnatal depression",
"CONTEXT The outcome into school age of regional cohorts of children born in the 1990s with birth weights less than 1000 g ( extremely low birth weight , ELBW ) or earlier than 28 weeks ' gestation ( very preterm ) is not known . OBJECTIVE To determine the cognitive , educational , and behavioral outcome of ELBW or very preterm infants born in the 1990s compared with normal birth weight ( NBW ) controls . DESIGN Regional cohort study . SETTING Victoria , Australia . PARTICIPANTS The ELBW or very preterm cohort was composed of 298 consecutive survivors born during 1991 - 1992 . The NBW cohort was composed of 262 r and omly selected children with birth weights of more than 2499 g. MAIN OUTCOME MEASURES Cognitive ability , educational progress , and behavioral problems . RESULTS The follow-up rates from birth to 8 years of age for survivors were 92.3 % ( 275/298 ) for the ELBW or very preterm cohort and 85.1 % ( 223/262 ) for the NBW cohort . The ELBW or very preterm children scored significantly below NBW controls on full-scale IQ ( mean difference , -9.4 ; 95 % confidence interval [ CI ] , -12.1 to -6.7 ; P indices of verbal comprehension ( mean difference , -6.8 ; 95 % CI , -9.5 to -4.2 ; P perceptual organization ( mean difference , -9.9 ; 95 % CI , -12.7 to -7.2 ; P freedom from distractibility ( mean difference , -8.1 ; 95 % CI , -10.8 to -5.5 ; P processing speed ( mean difference , -6.7 ; 95 % CI , -9.4 to -4.0 ; P tests of reading ( mean difference , -6.7 ; 95 % CI , -9.5 to -3.9 ; P spelling ( mean difference , -5.6 ; 95 % CI , -8.0 to -3.3 ; P arithmetic ( mean difference , -8.8 ; 95 % CI , -11.3 to -6.2 ; P Attentional difficulties , internalizing behavior problems , and immature adaptive skills were more prevalent in the ELBW or very preterm cohort . CONCLUSION School-aged ELBW or very preterm children born in the 1990s continue to display cognitive , educational , and behavioral impairments",
"OBJECTIVE To describe the educational status and special education services at 8 years among children who had threshold retinopathy of prematurity ( ROP ) . METHODS A prospect i ve study was conducted of a cohort of children who had birth weight of At age 5.5 years , visual status , functional skills , and social information were obtained . At 8 years , special education classes , developmental disabilities , rehabilitation therapies , and academic and social competencies were determined by question naire . Visual status was considered favorable/unfavorable on the basis of the better eye . RESULTS Of 255 survivors , 216 ( 85 % ) were evaluated at both 5.5 and 8 years . Major impairments were significantly more prevalent in children with unfavorable versus favorable visual status : cerebral palsy ( 39 % vs 16 % ) , developmental disability ( 57 % vs 22 % ) , autism ( 9 % vs 1 % ) , and epilepsy ( 23 % vs 3 % ) . Special education services ( 63 % vs 27 % ) , below- grade -level academic performance ( 84 % vs 48 % ) , and school-based rehabilitation services were significantly less common in children with favorable visual status . Favorable visual status , favorable functional ratings at 5.5 years , markers of higher socioeconomic status , and nonblack race were associated with significantly lower rates of both special education placement and below- grade -level academic performance at age 8 . On multivariate logistic regression , only favorable visual status and functional status remained significant predictors for decreasing special education placement . CONCLUSION Threshold ROP is associated with high rates of developmental , educational , and social challenges in middle childhood ; preserved vision was associated with a clear advantage , with more than half of the children with favorable visual status performing at grade level",
"The Movement Assessment Battery for Children-2 ( M-ABC-2 ) is one of the most commonly used tests for the diagnosis of specific developmental disorders of motor function ( F82 ) . The M-ABC-2 comprises eight subtests per age b and ( AB ) that are assigned to three dimensions : manual dexterity , aim ing and catching , and balance . However , while previous exploratory findings suggested the correctness of the assumption of factorial validity , there is no empirical evidence that the M-ABC-2 subtests allow for a valid reproduction of the postulated factorial structure . The purpose of this study was to empirically confirm the factorial validity of the M-ABC-2 . The German normative sample of AB2 ( 7 - 10 years ; N=323 ) was used as the study sample for the empirical analyses . Confirmatory factor analysis was used to verify the factorial validity of the M-ABC-2 ( AB2 ) . The incremental fit indices ( χ2=28.675 ; df=17 ; Bollen-Stine p value=0.318 ; RMSEA=0.046 [ 0.011 - 0.075 ] ; SRMR=0.038 ; CFI=0.960 ) provided evidence for the factorial validity of the M-ABC-2 ( AB2 ) . However , because of a lack of empirical verification for convergent and discriminant validity , there is still no evidence that F82 can be diagnosed using M-ABC-2 ( AB2 )"
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Abstract Anemia is the most frequent complication of inflammatory bowel disease ( IBD ) , but anemia , mostly due to iron deficiency , has long been neglected in these patients . The aim was to briefly present the pathophysiology , followed by a balanced overview of the different forms of iron replacement available , and subsequently , to perform a systematic review of studies performed in the last decade on the treatment of iron-deficiency anemia in IBD . Given that intravenous therapies have been introduced in the last decade , a systematic review performed in PubMed , EMBASE , the Cochrane Library , and the websites of WHO , FDA , and EMA covered prospect i ve trials investigating the management of iron-deficiency anemia in IBD published since 2004 . A total of 632 articles were review ed , and 13 articles ( 2906 patients ) with unique content were included . In general , oral supplementation in iron-deficiency anemia should be administered with a target to restore/replenish the iron stores and the hemoglobin level in a suitable way . However , in patients with IBD flares and inadequate responses to or side effects with oral preparations , intravenous iron supplementation is the therapy of choice . Neither oral nor intravenous therapy seems to exacerbate the clinical course of IBD , and intravenous iron therapy can be administered even in active disease stages and concomitantly with biologics . In conclusion , because many physicians are in doubt as to how to manage anemia and iron deficiency in IBD , there is a clear need for the implementation of evidence -based recommendations on this matter . Based on the data presented , oral iron therapy should be preferred for patients with quiescent disease stages and trivial iron deficiency anemia unless such patients are intolerant or have an inadequate response , whereas intravenous iron supplementation may be of advantage in patients with aggravated anemia or flares of IBD because inflammation hampers intestinal absorption of iron
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"Abstract Objective . The prevalence of anemia in inflammatory bowel disease ( IBD ) has been broadly described . The recurrence , type and burden of anemia remain unenlightened . The primary objective was to describe this . The secondary objective was to evaluate the implementation of European guidelines . Material s and methods . This longitudinal follow-up study included 300 IBD out patients from six centers in Sc and inavia . Patients were enrolled in a research cohort , in which each center included 5 % of their IBD cohort . The study was prospect ively planned , while data were retrospectively collected . The burden of anemia was calculated as number of months with anemia . A Markov model was used to calculate the probabilities of transitioning between stages . The European guidelines were used as the st and ard for anemia management . Results . Anemia affected > 50 % of IBD out patients during the 2-year observation period . Totally , 20 % of the total observation time was spent in anemia . Over the 7200 months of observation , anemia was found in 1410 months . The most frequent type was combined anemia ( 63 % ) . Combined anemia covers both anemia of chronic disease ( ACD ) and iron-deficiency anemia ( IDA ) . Pure ACD was present in 21 % of burden time , while pure IDA was present in 16 % of burden time . The European guidelines have mainly been implemented . Conclusion . Anemia affected a majority of the IBD out patients . One in five months , the patients were anemic . Anemia related to inflammation dominated the different types of anemia . Pure IDA was found in for 16 % . These findings , despite a fair implementation of guidelines",
"BACKGROUND Iron deficiency may impair aerobic performance . This study aim ed to determine whether treatment with intravenous iron ( ferric carboxymaltose ) would improve symptoms in patients who had heart failure , reduced left ventricular ejection fraction , and iron deficiency , either with or without anemia . METHODS We enrolled 459 patients with chronic heart failure of New York Heart Association ( NYHA ) functional class II or III , a left ventricular ejection fraction of 40 % or less ( for patients with NYHA class II ) or 45 % or less ( for NYHA class III ) , iron deficiency ( ferritin level were r and omly assigned , in a 2:1 ratio , to receive 200 mg of intravenous iron ( ferric carboxymaltose ) or saline ( placebo ) . The primary end points were the self-reported Patient Global Assessment and NYHA functional class , both at week 24 . Secondary end points included the distance walked in 6 minutes and the health-related quality of life . RESULTS Among the patients receiving ferric carboxymaltose , 50 % reported being much or moderately improved , as compared with 28 % of patients receiving placebo , according to the Patient Global Assessment ( odds ratio for improvement , 2.51 ; 95 % confidence interval [ CI ] , 1.75 to 3.61 ) . Among the patients assigned to ferric carboxymaltose , 47 % had an NYHA functional class I or II at week 24 , as compared with 30 % of patients assigned to placebo ( odds ratio for improvement by one class , 2.40 ; 95 % CI , 1.55 to 3.71 ) . Results were similar in patients with anemia and those without anemia . Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality -of-life assessment s. The rates of death , adverse events , and serious adverse events were similar in the two study groups . CONCLUSIONS Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency , with or without anemia , improves symptoms , functional capacity , and quality of life ; the side-effect profile is acceptable . ( Clinical Trials.gov number , NCT00520780 )",
"OBJECTIVES : Anemia is a frequent complication in patients with inflammatory bowel disease ( IBD ) . The optimal route for iron supplementation to replenish iron stores has not been determined so far . We therefore evaluated the efficacy and safety of intravenous iron sucrose as compared with oral iron sulfate for the treatment of iron deficiency anemia ( IDA ) in patients with IBD . METHODS : A r and omized , prospect i ve , open-label , multicenter study was performed in 46 patients with anemia and transferrin saturation ≤20 % and /or serum ferritin concentrations ≤20 μg/L. The intravenous group received a single dose of iron sucrose of 7 mg iron/kg body weight , followed by five 200 mg infusions for the following 5 wks . The oral group received iron sulfate 100–200 mg per day for 6 wks . RESULTS : While a comparable increase in hemoglobin was observed for both administration routes ( median increase 0.25 g/L in the intravenous group vs 0.21 g/L in the oral group ) , only iron sucrose led to a rise in serum ferritin concentrations . Intractable gastrointestinal adverse events caused permanent study drug discontinuation in five patients ( 20.8 % ) receiving iron sulfate , whereas only one patient ( 4.5 % ) had to be withdrawn because of side effects due to iron sucrose . CONCLUSIONS : Although being equal in short-term efficacy and overall tolerability our results suggest a better gastrointestinal tolerability for iron sucrose . Larger trials are m and atory to prove a possible advantage of iron sucrose in short- and long-term efficacy as well as in tolerability over iron sulfate in the management of IDA in IBD",
"BACKGROUND AND AIMS Infliximab ( IFX ) and iron sucrose ( FeS ) are of high value in inflammatory bowel disease ( IBD ) . We aim ed to assess the relative role of both therapies in IBD related anaemia and their safety when used in combination . METHODS IBD patients with anaemia receiving a first series of FeS infusions in addition to IFX were prospect ively followed . We investigated serum kinetics of erythropoietin ( EPO ) , soluble transferrin receptors ( sTFRs ) and vascular endothelial growth factor ( VEGF ) . RESULTS Data analysis included 87 patients of whom 49.4 % achieved the target Hb level of 12.0 g/dL. IFX result ed in a significant increase of EPO and sTFR compared to baseline pre-IFX levels ( p=0.029 and p=0.005 respectively ) and after a 12-week combined FeS and IFX treatment , EPO and sTFR levels dropped significantly compared to pre-FeS levels ( p Infusion related adverse events were recorded in 2 IFX treated patients ( 2.3 % , 0.7 % of the infusions ) and were mild . Disease activity and quality of life were not affected . CONCLUSIONS In anaemic IBD patients treated with IFX , combined administration of FeS is safe . Infliximab significantly increases serum EPO and sTFR levels result ing in an increased functional iron deficiency , which is restored after combined treatment with I.V. iron sucrose",
"OBJECTIVES : In the largest head-to-head comparison between an oral and an intravenous ( IV ) iron compound in patients with inflammatory bowel disease ( IBD ) so far , we strived to determine whether IV iron isomaltoside 1,000 is non-inferior to oral iron sulfate in the treatment of iron deficiency anemia ( IDA ) . METHODS : This prospect i ve , r and omized , comparative , open-label , non-inferiority study was conducted at 36 sites in Europe and India . Patients with known intolerance to oral iron were excluded . A total of 338 IBD patients in clinical remission or with mild disease , a hemoglobin ( Hb ) receive either IV iron isomaltoside 1,000 according to the Ganzoni formula ( 225 patients ) or oral iron sulfate 200 mg daily ( equivalent to 200 mg elemental iron ; 113 patients ) . An interactive web response system method was used to r and omize the eligible patient to the treatment groups . The primary end point was change in Hb from baseline to week 8 . Iron isomaltoside 1,000 and iron sulfate was compared by a non-inferiority assessment with a margin of −0.5 g/dl . The secondary end points , which tested for superiority , included change in Hb from baseline to weeks 2 and 4 , change in s-ferritin , and TSAT to week 8 , number of patients who discontinued study because of lack of response or intolerance of investigational drugs , change in total quality of life ( QoL ) score to weeks 4 and 8 , and safety . Exploratory analyses included a responder analysis ( proportion of patients with an increase in Hb ≥2 g/dl after 8 weeks ) , the effect of regional differences and total iron dose level , and other potential predictors of the treatment response . RESULTS : Non-inferiority in change of Hb to week 8 could not be demonstrated . There was a trend for oral iron sulfate being more effective in increasing Hb than iron isomaltoside 1,000 . The estimated treatment effect was −0.37 ( 95 % confidence interval ( CI ) : −0.80 , 0.06 ) with P=0.09 in the full analysis set ( N=327 ) and −0.45 ( 95 % CI : −0.88 , −0.03 ) with P=0.04 in the per protocol analysis set ( N=299 ) . In patients treated with IV iron isomaltoside 1,000 , the mean change in s-ferritin concentration was higher with an estimated treatment effect of 48.7 ( 95 % CI : 18.6 , 78.8 ) with P=0.002 , whereas the mean change in TSAT was lower with an estimated treatment effect of −4.4 ( 95 % CI : −7.4 , −1.4 ) with P=0.005 , compared with patients treated with oral iron . No differences in changes of QoL were observed . The safety profile was similar between the groups . The proportion of responders with Hb ≥2 g/dl ( IV group : 67 % ; oral group : 61 % ) were comparable between the groups ( P=0.32 ) . Iron isomaltoside 1,000 was more efficacious with higher cumulative doses of > 1,000 mg IV . Significant predictors of Hb response to IV iron treatment were baseline Hb and C-reactive protein ( CRP ) . CONCLUSIONS : We could not demonstrate non-inferiority of IV iron isomaltoside 1,000 compared with oral iron in this study . Based on the dose – response relationship observed with the IV iron compound , we suggest that the true iron dem and of IV iron was underestimated by the Ganzoni formula in our study . Alternative calculations including Hb and CRP should be explored to gauge iron stores in patients with IBD",
"Background Studies on the association between iron supplementation and mortality in dialysis patients are rare and conflicting . Methods In our observational single-center cohort study ( INVOR study ) we prospect ively studied 235 incident dialysis patients . Time-dependent Cox proportional hazards models using all measured laboratory values for up to 7.6 years were applied to study the association between iron supplementation and all-cause mortality , cardiovascular and sepsis-related mortality . Furthermore , the time-dependent association of ferritin levels with mortality in patients with normal C-reactive protein ( CRP ) levels ( was evaluated by using non-linear P-splines to allow flexible modeling of the association . Results One hundred and ninety-one ( 81.3 % ) patients received intravenous iron , 13 ( 5.5 % ) patients oral iron , whereas 31 ( 13.2 % ) patients were never supplemented with iron throughout the observation period . Eighty-two ( 35 % ) patients died during a median follow-up of 34 months , 38 patients due to cardiovascular events and 21 patients from sepsis . Baseline CRP levels were not different between patients with and without iron supplementation . However , baseline serum ferritin levels were lower in patients receiving iron during follow up ( median 93 vs 251 ng/mL , p ) . Iron supplementation was associated with a significantly reduced all-cause mortality [ HR ( 95%CI ) : 0.22 ( 0.08–0.58 ) ; p = 0.002 ] and a reduced cardiovascular and sepsis-related mortality [ HR ( 95%CI ) : 0.31 ( 0.09–1.04 ) ; p = 0.06 ] . Increasing ferritin concentrations in patients with normal CRP were associated with a decreasing mortality , whereas in patients with elevated CRP values ferritin levels>800 ng/mL were linked with increased mortality . Conclusions Iron supplementation is associated with reduced all-cause mortality in incident dialysis patients . While serum ferritin levels up to 800 ng/mL appear to be safe , higher ferritin levels are associated with increased mortality in the setting of concomitant inflammation",
"Background : Iron deficiency anemia ( IDA ) is frequently seen in inflammatory bowel disease . Traditionally , oral iron supplementation is linked to extensive gastrointestinal side effects and possible disease exacerbation . This multicenter phase-3 study tested the efficacy and safety of ferric maltol , a complex of ferric ( Fe3 + ) iron with maltol ( 3-hydroxy-2-methyl-4-pyrone ) , as a novel oral iron therapy for IDA . Methods : Adult patients with quiescent or mild-to-moderate ulcerative colitis or Crohn 's disease , mild-to-moderate IDA ( 9.5–12.0 g/dL and 9.5–13.0 g/dL in females and males , respectively ) , and documented failure on previous oral ferrous products received oral ferric maltol capsules ( 30 mg twice a day ) or identical placebo for 12 weeks according to a r and omized , double-blind , placebo-controlled study design . The primary efficacy endpoint was change in hemoglobin ( Hb ) from baseline to week 12 . Safety and tolerability were assessed . Results : Of 329 patients screened , 128 received r and omized therapy ( 64 ferric maltol-treated and 64 placebo-treated patients ) and comprised the intent-to-treat efficacy analysis : 55 ferric maltol patients ( 86 % ) and 53 placebo patients ( 83 % ) completed the trial . Significant improvements in Hb were observed with ferric maltol versus placebo at weeks 4 , 8 , and 12 : mean ( SE ) 1.04 ( 0.11 ) g/dL , 1.76 ( 0.15 ) g/dL , and 2.25 ( 0.19 ) g/dL , respectively ( P covariance ) . Hb was normalized in two-thirds of patients by week 12 . The safety profile of ferric maltol was comparable with placebo , with no impact on inflammatory bowel disease severity . Conclusions : Ferric maltol provided rapid clinical ly meaningful improvements in Hb and showed a favorable safety profile , suggesting its possible use as an alternative to intravenous iron in IDA inflammatory bowel disease",
"AIM OF THE STUDY To describe our 15-year experience on the patients ' response and safety to the use of EPO in IBD patients with refractory anemia . PATIENTS - METHODS Single center retrospective chart analysis of all IBD patients receiving EPO for the period 1994 - 2009 . Patients with resistant anemia not responding to I.V. iron therapy were enrolled . Concommitant medication , medical and laboratory data on short and long-term patients ' responses and safety were recorded . RESULTS In total 820 IBD files were review ed and among 78 patients treated with I.V. iron we identified 26 patients who received EPO in concordance to our inclusion criteria . Azathioprine or methotrexate was administered in 17 patients and 7 patients received concomitant Infliximab . After EPO , 22/26 patients ( 84.6 % ) responded and peripheral blood parameters were significantly improved and blood transfusions were significantly decreased ( p Erythropoietin dose was increased in three non-responders while two patients required emergency transfusions . No adverse events were recorded . CONCLUSIONS In anemic IBD patients who are refractory to I.V. iron monotherapy , administration of EPO significantly improved peripheral blood parameters with safety . Prospect i ve controlled trials are needed to confirm positive patients ' response to EPO and identify those patients who are more likely to benefit",
"Red blood cells ( RBC ) storage facilitates the supply of RBC to meet the clinical dem and for transfusion and to avoid wastage . However , RBC storage is associated with adverse changes in erythrocytes and their preservation medium . These changes are responsible for functional alterations and for the accumulation of potentially injurious bioreactive substances . They also may have clinical ly harmful effects especially in critically ill patients . The clinical consequences of storage lesions , however , remain a matter of persistent controversy . Multiple retrospective , observational , and single-center studies have reported heterogeneous and conflicting findings about the effect of blood storage duration on morbidity and /or mortality in trauma , cardiac surgery , and intensive care unit patients . Describing the details of this controversy , this review not only summarizes the current literature but also highlights the equipoise that currently exists with regard to the use of short versus current st and ard ( extended ) storage duration red cells in critically ill patients and supports the need for large , r and omized , controlled trials evaluating the clinical impact of transfusing fresh ( short duration of storage ) versus older ( extended duration of storage ) red cells in critically ill patients",
"BACKGROUND The hemoglobin threshold for transfusion of red cells in patients with acute gastrointestinal bleeding is controversial . We compared the efficacy and safety of a restrictive transfusion strategy with those of a liberal transfusion strategy . METHODS We enrolled 921 patients with severe acute upper gastrointestinal bleeding and r and omly assigned 461 of them to a restrictive strategy ( transfusion when the hemoglobin level fell below 7 g per deciliter ) and 460 to a liberal strategy ( transfusion when the hemoglobin fell below 9 g per deciliter ) . R and omization was stratified according to the presence or absence of liver cirrhosis . RESULTS A total of 225 patients assigned to the restrictive strategy ( 51 % ) , as compared with 61 assigned to the liberal strategy ( 14 % ) , did not receive transfusions ( P probability of survival at 6 weeks was higher in the restrictive- strategy group than in the liberal- strategy group ( 95 % vs. 91 % ; hazard ratio for death with restrictive strategy , 0.55 ; 95 % confidence interval [ CI ] , 0.33 to 0.92 ; P=0.02 ) . Further bleeding occurred in 10 % of the patients in the restrictive- strategy group as compared with 16 % of the patients in the liberal- strategy group ( P=0.01 ) , and adverse events occurred in 40 % as compared with 48 % ( P=0.02 ) . The probability of survival was slightly higher with the restrictive strategy than with the liberal strategy in the subgroup of patients who had bleeding associated with a peptic ulcer ( hazard ratio , 0.70 ; 95 % CI , 0.26 to 1.25 ) and was significantly higher in the subgroup of patients with cirrhosis and Child-Pugh class A or B disease ( hazard ratio , 0.30 ; 95 % CI , 0.11 to 0.85 ) , but not in those with cirrhosis and Child-Pugh class C disease ( hazard ratio , 1.04 ; 95 % CI , 0.45 to 2.37 ) . Within the first 5 days , the portal-pressure gradient increased significantly in patients assigned to the liberal strategy ( P=0.03 ) but not in those assigned to the restrictive strategy . CONCLUSIONS As compared with a liberal transfusion strategy , a restrictive strategy significantly improved outcomes in patients with acute upper gastrointestinal bleeding . ( Funded by Fundació Investigació Sant Pau ; Clinical Trials.gov number , NCT00414713 . )",
"BACKGROUND AIMS : Anemia is a common complication of inflammatory bowel diseases ( IBD ) This multicenter study tested the noninferiority and safety of a new intravenous iron preparation , ferric carboxymaltose ( FeCarb ) , in comparison with oral ferrous sulfate ( FeSulf ) in reducing iron deficiency anemia ( IDA ) in IBD . METHODS : Two hundred patients were r and omized in a 2:1 ratio ( 137 FeCarb:63 FeSulf ) to receive FeCarb ( maximum 1,000 mg iron per infusion ) at 1-wk intervals until the patients ' calculated total iron deficit was reached or FeSulf ( 100 mg b.i.d . ) for 12 wk . The primary end point was change in hemoglobin ( Hb ) from baseline to week 12 . RESULTS : The median Hb improved from 8.7 to 12.3 g/dL in the FeCarb group and from 9.1 to 12.1 g/dL in the FeSulf group , demonstrating noninferiority ( P = 0.6967 ) . Response ( defined as Hb increase of > 2.0 g/dL ) was higher for FeCarb at week 2 ( P = 0.0051 ) and week 4 ( P = 0.0346 ) . Median ferritin increased from 5.0 to 323.5 μg/L at week 2 , followed by a continuous decrease in the FeCarb group ( 43.5 μg/L at week 12 ) . In the FeSulf group , a moderate increase from 6.5 to 28.5 μg/L at week 12 was observed . Treatment-related adverse events ( AEs ) occurred in 28.5 % of the FeCarb and 22.2 % of the FeSulf groups , with discontinuation of study medication due to AEs in 1.5 % and 7.9 % , respectively . CONCLUSIONS : FeCarb is effective and safe in IBD-associated anemia . It is noninferior to FeSulf in terms of Hb change over 12 wk , and provides a fast Hb increase and a sufficient refill of iron stores",
"The treatment of anemia in hemodialysis patients is frequently hindered by the presence of suboptimal iron stores . Intravenous iron dextran is in common use to maintain iron stores in this population , but there are little published data regarding the incidence and type of adverse events . The purpose of this study was to evaluate the safety of this medication . Charts from four hemodialysis centers of all 573 patients treated with intravenous iron dextran ( INFeD ; Schein Pharmaceutical , Inc , Florham Park , NJ ) between July 1 , 1993 , and June 30 , 1995 , were studied . Twenty-seven patients ( 4.7 % ) had adverse reactions that were related to iron dextran . Four patients ( 0.7 % ) had reactions classified as serious ( one cardiac arrest ; three others required hospitalization ) . Ten patients ( 1.7 % ) had reactions classified as anaphylactoid . No patients died or developed permanent disability as a result of reactions . The most common adverse reactions included itching ( 1.5 % of patients ) and dyspnea or wheezing ( 1.5 % ) ; others included chest pain ( 1.0 % ) , nausea ( 0.5 % ) , hypotension ( 0.5 % ) , swelling ( 0.5 % ) , dyspepsia ( 0.5 % ) , diarrhea ( 0.5 % ) , skin flushing ( 0.3 % ) , headache ( 0.3 % ) , cardiac arrest ( 0.2 % ) , and myalgias ( 0.2 % ) . Five of all the reactions occurred during a test dose ; four of these were anaphylactoid . Several factors were studied as possible predictors of adverse reactions . A positive history of drug allergy ( odds ratio , 2.4 ; P = 0.03 ) and history of multiple drug allergy ( odds ratio , 5.5 ; P = 0.0004 ) were significant predictors of reactions . In summary , we found serious adverse reactions to be uncommon in hemodialysis patients treated with intravenous iron dextran . Future prospect i ve studies will help confirm this finding",
"BACKGROUND & AIMS Iron-deficiency anemia is the most common systemic complication of inflammatory bowel diseases ( IBD ) . Iron-deficiency anemia recurs frequently and rapidly after iron-replacement therapy in patients with IBD . We performed a r and omized , placebo-controlled trial to determine if administration of ferric carboxymaltose ( FCM ) prevents anemia in patients with IBD and low levels of serum ferritin . METHODS We performed a single-blind , multicenter study of nonanemic patients who had completed the FERGIcor study . Serum levels of ferritin were assessed every second month , and patients were given FCM ( total iron dose , 1181 ± 662 mg ; n = 105 ) or placebo ( n = 99 ) when levels decreased to less than 100 μg/L. The primary end point was time to recurrence of anemia within 8 months . Secondary end points included changes of quality of life , disease activity , results from laboratory tests , and adverse events . RESULTS Anemia recurred in 26.7 % of subjects given FCM and in 39.4 % given placebo . The time to anemia recurrence was longer in the FCM group ( hazard ratio , 0.62 ; 95 % confidence interval , 0.38 - 1.00 ; P = .049 ) . Markers of body levels of iron increased or remained at normal levels in subjects given FCM ( ferritin increased by 30.3 μg/L , transferrin saturation increased by 0.6 % ) but decreased in the group given placebo ( ferritin decreased by 36.1 μg/L , transferrin saturation decreased by 4.0 % ) . Changes in quality of life and disease activity were comparable between groups . Adverse events were reported in 59.0 % of the FCM group and 50.5 % of the placebo group , and serious adverse events were reported in 6.7 % and 8.1 % , respectively . CONCLUSIONS FCM prevents recurrence of anemia in patients with IBD , compared with placebo . Nevertheless , the high rate of anemia recurrence warrants optimization of the frequency and requirements for FCM treatment",
"BACKGROUND Anemia is a common and serious complication in patients with inflammatory bowel disease . The present study was dedicated to evaluate the therapeutic efficacy of erythropoietin ( EPO ) combined with enteral nutrition ( EN ) in anemic Crohn 's disease ( CD ) patients , in terms of hemoglobin level , treatment success rate , adverse events , and predictor of this therapy . MATERIAL S AND METHODS We performed a prospect i ve study in CD patients . On the basis of hemoglobin level , all enrolled patients were divided into anemic and nonanemic groups . The anemic group was further divided into EPO and non-EPO subgroups , depending on whether EPO was prescribed . Hematological and other parameters were measured initially and in the first 4 weeks after starting treatment . RESULTS In total , 109 patients ( 49 nonanemic and 60 anemic , including 38 EPO and 22 non-EPO ) were included . The prevalence of anemia in CD was 55.05 % . Age , disease behavior , Crohn 's Disease Activity Index scores , C-reactive protein , and erythrocyte sedimentation rate were significantly different between anemic and nonanemic groups . An increase in hemoglobin level and a significant decrease in C-reactive protein level were observed in the EPO treatment group . Treatment success rate was 63.16 % in the EPO group , whereas none of patients achieved treatment success in the non-EPO group . CONCLUSION EPO combined with EN can improve the hemoglobin level in anemic CD patients",
" SUMMARY Using a double-blind and placebo technics , the side-effects of tablets containing different iron compounds were compared in 1496 subjects . Three separate series , all of which included placebo and ferrous sulphate tablets were studied . The agreement between the results obtained in different series was very good . Ferrous sulphate , ferrous gluconate , ferrous fumarate , and ferrous glycine sulphate had almost the same incidence and type of side-effects . The incidence was significantly higher than when placebo tablets were given",
"Background Intravenous iron has been suggested as a safe and effective treatment of anemia complicating inflammatory bowel disease ( IBD ) . Low molecular weight ( LMW ) iron dextran has the ability to administer the patient ’s total iron requirement in a single infusion . Aims The aim of this study was to assess the safety and efficacy of the total dose of LMW iron dextran infusion for the treatment of iron deficiency in IBD . Methods Fifty IBD patients ( 27 female , 35 Crohn ’s disease , 15 ulcerative colitis ) were included in the study . Mean ± st and ard deviation ( SD ) hemoglobin and ferritin levels before the infusion were 9.88 ± 1.42 g/dl and 13.9 ± 10.9 ng/ml , respectively . A 25-mg test dose was followed by infusion of the total dose of LMW iron dextran based on the iron deficit . Several clinical and laboratory parameters were measured before and on week 4 after infusion . Results Four patients ( 8 % ) developed adverse reactions during the test infusion and did not receive the total-dose infusion . Only one patient developed an allergic reaction during the total-dose infusion . In the remaining 45 patients , the mean ± SD iron dose that was given was 1,075 ± 269 mg . The mean ± SD elevation of hematocrit and hemoglobin on week 4 was 4.9 ± 1.9 % and 1.7 ± 0.8 g/dl , respectively . Hematopoietic response was observed in 23 of 45 patients ( 51.1 % ) . Conclusion Total parenteral iron replacement with LMW iron dextran is an easy , safe , and effective alternative method for treating iron deficiency anemia in IBD . Harmless adverse reactions may develop in a minority of patients",
"Background : In patients with inflammatory bowel disease , oral iron is anecdotally reported to be less effective and less well tolerated than in those without inflammatory bowel disease , and to increase disease activity",
"Purpose Inflammation-induced anemia is frequent among critically ill patients and can be aggravated by true iron deficiency ( ID ) result ing from blood losses . The serum hepcidin level controls the availability of iron for erythropoiesis , and its determination offers new perspectives for the diagnosis of ID in the presence of inflammation . We conducted a prospect i ve observational study to determine the cutoff value and diagnostic accuracy of hepcidin levels for detecting ID in critically ill anemic patients . Methods Patients suffering from anemia ( hemoglobin determinations of hematological and iron parameters , including hepcidin levels ( ELISA test ) . The iron status for each set of measures was determined by the consensus of three experts , blinded to hepcidin values . Results Of 51 patients ( 36 male/15 female ) , 5 had ID at inclusion , while 8 developed ID during their stay . A total of 128 iron profiles were analyzed . Median hepcidin levels were 80.5 ( 0.05–548.3 ) and 526.6 ( 246.7–891.4 ) µg/l for ID and non-ID profiles , respectively . The onset of ID during the ICU stay led to a progressive decline in hepcidin levels , whereas a persistent inflammatory profile remained associated with high hepcidin concentrations . The optimal threshold for serum hepcidin for ID diagnosis was assessed by building 100 ROC curves using a resampling method and found at 129.5 µg/l [ 95 % CI = ( 115.5–143.4 ) ] . Conclusions Hepcidin levels may be suppressed by ID even in case of inflammation . Serum hepcidin of 129.5 µg/l was the most accurate threshold for ID diagnosis in critically ill patients with anemia",
"Objective . Patients with inflammatory bowel disease ( IBD ) often have low iron stores or anaemia . There is controversy about whether iron should be supplemented orally or intravenously ( i.v . ) . The purpose of this study was to investigate whether treatment with intravenous iron is superior to treatment with oral iron . The primary end-points were response and remaining anaemia at the end of treatment ( EOT ) . Material and methods . Ninety-one patients with IBD and anaemia ( B-Hb were r and omized to oral iron sulphate ( n=46 ) or intravenous iron sucrose ( n=45 ) treatment for 20 weeks . Results . Forty-three patients in the intravenous iron group completed the study compared to 35 patients in the oral iron group ( p=0.0009 ) . Only 22 patients ( 48 % ) tolerated the prescribed oral dose , and 52 % reduced the dose or withdrew from treatment because of poor tolerance . At EOT , 47 % patients in the oral iron group increased their B-Hb by ≥20 g/L , compared with 66 % in the intravenous iron group ( p=0.07 ) . In the oral iron group , 41 % still had anaemia versus 16 % of the patients in the intravenous iron group ( p=0.007 ) , and 22 % versus 42 % reached their reference B-Hb level ( p=0.04 ) . Treatment with intravenous iron sucrose improved iron stores faster and more effectively than oral iron ( p=0.002 ) . Under treatment with intravenous iron , 74 % of the patients had no anaemia and normal S-ferritin levels ( > 25 µg/L ) at EOT compared with 48 % of patients receiving oral iron ( p=0.013 ) . Conclusions . Treatment with intravenous iron sucrose is effective , safe , well tolerated and superior to oral iron in correcting haemoglobin and iron stores in patients with IBD",
"BACKGROUND & AIMS Iron deficiency anemia ( IDA ) is common in chronic diseases and intravenous iron is an effective and recommended treatment . However , dose calculations and inconvenient administration may affect compliance and efficacy . We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen ( FCM ) with individually calculated iron sucrose ( IS ) doses in patients with inflammatory bowel disease ( IBD ) and IDA . METHODS This r and omized , controlled , open-label , multicenter study included 485 patients with IDA ( ferritin Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron , or Ganzoni-calculated IS dosages in up to 11 infusions of 200 mg iron . Primary end point was Hb response ( Hb increase ≥ 2 g/dL ) ; secondary end points included anemia resolution and iron status normalization by week 12 . RESULTS The results of 240 FCM-treated and 235 IS-treated patients were analyzed . More patients with FCM than IS achieved Hb response ( 150 [ 65.8 % ] vs 118 [ 53.6 % ] ; 12.2 % difference , P = .004 ) or Hb normalization ( 166 [ 72.8 % ] vs 136 [ 61.8 % ] ; 11.0 % difference , P = .015 ) . Both treatments improved quality of life scores by week 12 . Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience . Deviations from scheduled total iron dosages were more frequent in the IS group . CONCLUSIONS The simpler FCM-based dosing regimen showed better efficacy and compliance , as well as a good safety profile , compared with the Ganzoni-calculated IS dose regimen",
"For nearly half a century , parenteral iron has been considered dangerous and for use only in extreme situations and when oral iron was not tolerated . This proscription was based largely on poorly characterised and infrequent anaphylactoid reactions to the high-molecular-weight dextran preparation ( Imferon ) that for most of this time was the only product available . Moreover , when parenteral iron was necessary , the recommended approach was small intramuscular doses ( ≤100 mg ) , even after intravenous administration of the total iron defi cit as a single dose or as repetitive boluses was shown to be as safe and eff ective as the intramuscular route . This mindset persists despite the subsequent introduction of low-molecular-weight iron dextran and two iron salt preparations , ferric gluconate and iron saccharate ( the latter is also known as iron sucrose ) , all of which are associated with fewer serious adverse events than the high-molecular-weight dextran . The introduction of recombinant erythropoietin for dialysis patients was associated with the development , in some individuals , of functional iron defi ciency that limited effi cacy . Intravenous iron , unlike oral iron , improves erythropoietic response in dialysis patients , and is now routinely used . The discovery of the iron regulatory peptide , hepcidin , has improved our underst and ing of the anaemia of chronic infl ammatory states , including cancer . Hepcidin is upregulated in these conditions , result ing in increased synthesis by the liver . Hepcidin inhibits iron transport across cell membranes , which decreases the accessibility of storage iron and gastrointestinal absorption of dietary iron , leading to an increased frequency of iron-restricted erythropoiesis , especially during therapy with recombinant erythropoietin . The most frequent laboratory fi ndings during the anaemia of chronic infl ammation are hypoferraemia and a low percent transferrin saturation , although these fi ndings are not always present . The increasing use of recombinant erythropoietin to treat anaemia in patients with chronic diseases has exp and ed the population of patients with functional iron defi ciency and increased interest in safe rational approaches to parenteral iron therapy . There is mounting evidence that anaemic patients with cancer undergoing chemotherapy and receiving recombinant erythropoietin respond better when parenteral iron is administered . This benefi t is independent of baseline iron variables , such as ferritin , low percentage transferrin saturation , and stainable marrow haemosiderin , leaving the clinician in need of laboratory variables to reliably detect iron-restricted erythropoiesis in patients with infl ammatory illnesses and to predict improvement of erythropoietic response to parenteral iron in the setting of infl ammatory illness . Two new laboratory measures look promising : percent hypochromic red blood cells and reticulocyte haemoglobin content . These tests are reliable and accurate correlates of functional iron defi ciency . Although these investigations are not yet widely available , their use will probably exp and and guide identifi cation of functional iron defi ciency and rational intervention with parenteral iron . Currently , four parenteral iron preparations are available ( table ) . No r and omised trials have compared the safety and effi cacy of any of these agents . The largest retrospective review of dialysis experience suggests that most serious adverse events have been associated with the high-molecular-weight iron dextrans ( Imferon , which is no longer available and the current preparation , Dexferrum ) and are rare ( iron dextran or the two iron salts ( fi gure ) . Adverse event rates might be somewhat higher in patients with infl ammatory diseases in which immune-mediated drug reactions may be observed more commonly than in dialysis patients . Some of the adverse clinical experience with parenteral iron is due to inappropriate supportive care . Myalgias , when they include chest and back discomfort , are mistakenly described as anaphylaxis , prompting Low – molecular – weight iron dextran Iron saccharate Ferric gluconate High – molecular – weight iron",
"Levels of hepcidin , a major regulator of iron homeostasis , may identify patients with iron deficiency anemia ( IDA ) who will not respond to oral iron therapy . In this study , IDA patients underwent a 14‐day trial ( run‐in ) course of ferrous sulfate therapy . Nonresponders ( Hgb increase r and omized to IV ferric carboxymaltose ( FCM ; two injections of 750 mg ) or further oral iron for 14 days . Screening hepcidin levels were 38.4 versus 11.3 ng/mL , P = 0.0002 in nonresponders versus responders to a trial of oral iron . Hepcidin of > 20 ng/mL , showed sensitivity of 41.3 % , specificity of 84.4 % , and positive predictive value of 81.6 % for predicting nonresponsiveness to oral iron . PPVs for ferritin > 30 ng/mL or transferrin saturation (TSAT)>15 % were 59.2 and 55 % , respectively . Negative predictive values for hepcidin , ferritin , and TSAT were 46.3 , 22.7 , and 19.7 , respectively . FCM versus oral iron showed Hgb increases of ≥1 gm/dL in 65.3 % versus 20.8 % ( P predicts nonresponsiveness to oral iron in patients with IDA and is superior to TSAT or ferritin for this purpose . Nonresponse to oral iron therapy does not rule out IDA , since two‐thirds of patients subsequently responded to intravenous iron . Am . J. Hematol . 88:97–101 , 2013 . © 2012 Wiley Periodicals ,",
"Background : The aim was to evaluate the efficacy and tolerance of oral and intravenous iron treatment in anemic inflammatory bowel disease ( IBD ) patients , considering both hematological and quality ‐of‐life outcomes . Methods : We performed a prospect i ve multicenter study in IBD patients with iron deficiency anemia . Patients having hemoglobin > 10 g/dL were prescribed oral ferrous sulfate . If hemoglobin intravenous ( sucrose ) iron was administered . Oral iron‐intolerant patients were changed to intravenous treatment . Clinical ( Truelove/Harvey – Bradshaw ) , hematological ( response defined as hemoglobin normalization ) , and quality ‐of‐life ( shortened CCVEII‐9 question naire ) evaluations were performed at baseline and at 3 and 6 months . Results : 100 IBD patients ( 59 Crohn 's disease , 41 ulcerative colitis ) were included . Mean basal hemoglobin levels were 10.8 ± 1.3 g/dL ( range , 6.6–12.9 ) . Seventy‐eight patients received oral treatment and 22 intravenous iron . Hemoglobin normalization was achieved in 86 % of patients : 89 % with oral , and 77 % with intravenous iron . An IBD activity increase was not demonstrated in any patient . Four patients ( 5.1 % ) showed oral iron intolerance leading to discontinuation of treatment . No adverse events were reported for intravenous iron . Hemoglobin correlated with CCVEII‐9 ( P . The CCVEII‐9 score increased in patients who normalized hemoglobin levels in 3 months ( from 58 ± 9 to 73 ± 10 ) or 6 months ( 54 ± 9 , 68 ± 12 , and 74 ± 10 ) ( P : Oral iron treatment is effective and well tolerated in most IBD patients , and does not exacerbate the symptoms of the underlying IBD . Intravenous iron , on the other h and , is an effective and safe alternative treatment for iron deficiency anemia in more severely anemic or intolerant patients . Anemia correction with iron treatment is associated with a relevant improvement in the patients ' quality of life . ( Inflamm Bowel Dis 2009"
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4117dad4-06ff-11f0-808a-c43d1ab1c353
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ABSTRACT While growing evidence suggests that microfinance is an effective approach for improved women ’s health , a significant gap remains in our underst and ing . The objective of this review is to synthesis e the findings from published literature focused on microfinance and health issues particularly affecting women , including HIV/AIDS , reproductive health , mental health , and violence . Forty-one articles that examine the impact of microfinance participation on women ’s health were identified through a systematic search of electronic data bases , coded using a structured abstract ion form , and synthesis ed . Review results indicate that the impact of microfinance on women ’s health is an area in great need of research and publication attention . Varied quality and reporting in the identified articles restricted the ability to draw concrete conclusions regarding the relationship between microfinance participation and women ’s health , but led to the identification of current gaps in existing published research . Future research should work to address the recommendations provided in order to offer additional evidence to better underst and the use of microfinance programming as a structural intervention to improve women ’s health
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"Objective : To assess effects of a combined microfinance and training intervention on HIV risk behavior among young female participants in rural South Africa . Design : Secondary analysis of quantitative and qualitative data from a cluster r and omized trial , the Intervention with Microfinance for AIDS and Gender Equity study . Methods : Eight villages were pair-matched and r and omly allocated to receive the intervention . At baseline and after 2 years , HIV risk behavior was assessed among female participants aged 14–35 years . Their responses were compared with women of the same age and poverty group from control villages . Intervention effects were calculated using adjusted risk ratios employing village level summaries . Qualitative data collected during the study explored participants ' responses to the intervention including HIV risk behavior . Results : After 2 years of follow-up , when compared with controls , young participants had higher levels of HIV-related communication ( adjusted risk ratio 1.46 , 95 % confidence interval 1.01–2.12 ) , were more likely to have accessed voluntary counseling and testing ( adjusted risk ratio 1.64 , 95 % confidence interval 1.06–2.56 ) , and less likely to have had unprotected sex at last intercourse with a nonspousal partner ( adjusted risk ratio 0.76 , 95 % confidence interval 0.60–0.96 ) . Qualitative data suggest a greater acceptance of intrahousehold communication about HIV and sexuality . Although women noted challenges associated with acceptance of condoms by men , increased confidence and skills associated with participation in the intervention supported their introduction in sexual relationships . Conclusions : In addition to impacts on economic well being , women 's empowerment and intimate partner violence , interventions addressing the economic and social vulnerability of women may contribute to reductions in HIV risk behavior",
"OBJECTIVE To explore whether adding a gender and HIV training programme to microfinance initiatives can lead to health and social benefits beyond those achieved by microfinance alone . METHODS Cross-sectional data were derived from three r and omly selected matched clusters in rural South Africa : ( i ) four villages with 2-year exposure to the Intervention with Microfinance for AIDS and Gender Equity ( IMAGE ) , a combined microfinance-health training intervention ; ( ii ) four villages with 2-year exposure to microfinance services alone ; and ( iii ) four control villages not targeted by any intervention . Adjusted risk ratios ( aRRs ) employing village-level summaries compared associations between groups in relation to indicators of economic well-being , empowerment , intimate partner violence ( IPV ) and HIV risk behaviour . The magnitude and consistency of aRRs allowed for an estimate of incremental effects . FINDINGS A total of 1409 participants were enrolled , all female , with a median age of 45 . After 2 years , both the microfinance-only group and the IMAGE group showed economic improvements relative to the control group . However , only the IMAGE group demonstrated consistent associations across all domains with regard to women 's empowerment , intimate partner violence and HIV risk behaviour . CONCLUSION The addition of a training component to group-based microfinance programmes may be critical for achieving broader health benefits . Donor agencies should encourage intersectoral partnerships that can foster synergy and broaden the health and social effects of economic interventions such as microfinance ",
"In northern Nigeria , interventions are urgently needed to narrow the large gap between international breastfeeding recommendations and actual breastfeeding practice s. Studies of integrated microcredit and community health interventions documented success in modifying health behaviors but typically had uncontrolled design s. We conducted a cluster-r and omized controlled trial in Bauchi State , Nigeria , with the aim of increasing early breastfeeding initiation and exclusive breastfeeding among female microcredit clients . The intervention had 3 components . Trained credit officers led monthly breastfeeding learning sessions during regularly scheduled microcredit meetings for 10 mo . Text and voice messages were sent out weekly to a cell phone provided to small groups of microcredit clients ( 5 - 7 women ) . The small groups prepared songs or dramas about the messages and presented them at the monthly microcredit meetings . The control arm continued with the regular microcredit program . R and omization occurred at the level of the monthly meeting groups . Pregnant clients were recruited at baseline and interviewed again when their infants were aged ≥6 mo . Logistic regression models accounting for clustering were used to estimate the odds of performing recommended behaviors . Among the clients who completed the final survey ( n = 390 ) , the odds of exclusive breastfeeding to 6 mo ( OR : 2.4 ; 95 % CI : 1.4 , 4.0 ) and timely breastfeeding initiation ( OR : 2.6 ; 95 % CI : 1.6 , 4.1 ) were increased in the intervention vs. control arm . Delayed introduction of water explained most of the increase in exclusive breastfeeding among clients receiving the intervention . In conclusion , a breastfeeding promotion intervention integrated into microcredit increased the likelihood that women adopted recommended breastfeeding practice s. This intervention could be scaled up in Nigeria , where local organizations provide microcredit to > 500,000 clients . Furthermore , the intervention could be adopted more widely given that > 150 million women , many of childbearing age , are involved in microfinance globally",
"Adolescent females in Zimbabwe are at high risk for HIV acquisition . Shaping the Health of Adolescents in Zimbabwe ( SHAZ ! ) was a r and omized controlled trial of a combined intervention package including life-skills and health education , vocational training , micro-grants and social supports compared to life-skills and health education alone . SHAZ ! was originally envisioned as a larger effectiveness trial , however , the intervention was scaled back due to context ual and economic conditions in the country at the time . SHAZ ! enrolled 315 participants r and omly assigned to study arm within blocks of 50 participants ( 158 intervention and 157 control ) . The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including ; reduced food insecurity [ IOR = 0.83 vs. COR = 0.68 , p-0.02 ] , and having their own income [ IOR = 2.05 vs. COR = 1.67 , p = 0.02 ] . Additionally , within the Intervention arm there was a lower risk of transactional sex [ IOR = 0.64 , 95 % CI ( 0.50 , 0.83 ) ] , and a higher likelihood of using a condom with their current partner [ IOR = 1.79 , 95 % CI ( 1.23 , 2.62 ) ] over time compared to baseline . There was also evidence of fewer unintended pregnancies among intervention participants [ HR = 0.61 , 95 % CI ( 0.37 , 1.01 ) ] , although this relationship achieved only marginal statistical significance . Several important challenges in this study included the coordination with vocational training programs , the political and economic instability of the area at the time of the study , and the difficulty in creating a true st and ard of care control arm . Overall the results of the SHAZ ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants , and lessons for further economic livelihoods interventions with adolescent females . Further work is needed to refine the intervention model , and test the impact of the intervention at scale on biological outcomes . Trial Registration Clinical Trials.gov",
"BACKGROUND HIV infection and intimate-partner violence share a common risk environment in much of southern Africa . The aim of the Intervention with Microfinance for AIDS and Gender Equity ( IMAGE ) study was to assess a structural intervention that combined a microfinance programme with a gender and HIV training curriculum . METHODS Villages in the rural Limpopo province of South Africa were pair-matched and r and omly allocated to receive the intervention at study onset ( intervention group , n=4 ) or 3 years later ( comparison group , n=4 ) . Loans were provided to poor women who enrolled in the intervention group . A participatory learning and action curriculum was integrated into loan meetings , which took place every 2 weeks . Both arms of the trial were divided into three groups : direct programme participants or matched controls ( cohort one ) , r and omly selected 14 - 35-year-old household co-residents ( cohort two ) , and r and omly selected community members ( cohort three ) . Primary outcomes were experience of intimate-partner violence -- either physical or sexual -- in the past 12 months by a spouse or other sexual intimate ( cohort one ) , unprotected sexual intercourse at last occurrence with a non-spousal partner in the past 12 months ( cohorts two and three ) , and HIV incidence ( cohort three ) . Analyses were done on a per- protocol basis . This trial is registered with Clinical Trials.gov , number NCT00242957 . FINDINGS In cohort one , experience of intimate-partner violence was reduced by 55 % ( adjusted risk ratio [ aRR ] 0.45 , 95 % CI 0.23 - 0.91 ; adjusted risk difference -7.3 % , -16.2 to 1.5 ) . The intervention did not affect the rate of unprotected sexual intercourse with a non-spousal partner in cohort two ( aRR 1.02 , 0.85 - 1.23 ) , and there was no effect on the rate of unprotected sexual intercourse at last occurrence with a non-spousal partner ( 0.89 , 0.66 - 1.19 ) or HIV incidence ( 1.06 , 0.66 - 1.69 ) in cohort three . INTERPRETATION A combined microfinance and training intervention can lead to reductions in levels of intimate-partner violence in programme participants . Social and economic development interventions have the potential to alter risk environments for HIV and intimate-partner violence in southern Africa",
"The Sonagachi Project was initiated in Kolkata , India in 1992 as a STD/HIV intervention for sex workers . The project evolved to adopt strategies common to women 's empowerment programs globally ( i.e. , community mobilization , rights-based framing , advocacy , micro-finance ) to address common factors that support effective , evidence -based HIV/STD prevention . The Sonagachi model is now a broadly diffused evidence -based empowerment program . We previously demonstrated significant condom use increases among female sex workers in a 16 month replication trial of the Sonagachi empowerment intervention ( n=110 ) compared to a control community ( n=106 ) receiving st and ard care of STD clinic , condom promotion , and peer education in two r and omly assigned rural towns in West Bengal , India ( Basu et al. , 2004 ) . This article examines the intervention 's impacts on 21 measured variables reflecting five common factors of effective HIV/STD prevention programs to estimate the impact of empowerment strategies on HIV/STD prevention program goals . The intervention which was conducted in 2000 - 2001 significantly : 1 ) improved knowledge of STDs and condom protection from STD and HIV , and maintained STD/HIV risk perceptions despite treatment ; 2 ) provided a frame to motivate change based on reframing sex work as valid work , increasing disclosure of profession , and instilling a hopeful future orientation reflected in desire for more education or training ; 3 ) improved skills in sexual and workplace negotiations reflected in increased refusal , condom decision-making , and ability to change work contract , but not ability to take leave ; 4 ) built social support by increasing social interactions outside work , social function participation , and helping other sex workers ; and 5 ) addressed environmental barriers of economic vulnerabilities by increasing savings and alternative income , but not working in other locations , nor reduced loan taking , and did not increase voting to build social capital . This study 's results demonstrate that , compared to narrowcast clinical and prevention services alone , empowerment strategies can significantly impact a broader range of factors to reduce vulnerability to HIV/STDs",
"A community r and omized pre-test/post-test design was used to compare the knowledge and behaviors of microfinance clients receiving malaria education ( n=213 ) to those receiving diarrhea education ( n=223 ) and to non-client controls ( n=268 ) . Comparisons assessed differences at follow-up as well as within-group changes over time . At follow-up , malaria clients had significantly better malaria knowledge than comparison groups : 48.4 % of malaria clients were able to identify groups most vulnerable to malaria compared with 39.2 % of diarrhea clients ( P=0.044 ) and 37.7 % of non-clients ( P=0.024 ) . Malaria clients were more likely than diarrhea clients ( P=0.024 ) ( P knowledge of malaria complications during pregnancy ; to own at least one bed net ; and to report at least one child or woman of reproductive age sleeping under a bed net . Malaria clients also experienced the greatest increases in ITN ownership/use ( 9 % vs. 2.9 % and 6.7 % among diarrhea clients and non-clients ) . Results indicate that , although significant barriers to malaria control remain , a malaria education program provided by microfinance institutions can effectively contribute to community and national malaria initiatives",
"OBJECTIVES We sought to obtain evidence about the scope of women 's empowerment and the mechanisms underlying the significant reduction in intimate partner violence documented by the Intervention With Microfinance for AIDS and Gender Equity ( IMAGE ) cluster-r and omized trial in rural South Africa . METHODS The IMAGE intervention combined a microfinance program with participatory training on underst and ing HIV infection , gender norms , domestic violence , and sexuality . Outcome measures included past year 's experience of intimate partner violence and 9 indicators of women 's empowerment . Qualitative data about changes occurring within intimate relationships , loan groups , and the community were also collected . RESULTS After 2 years , the risk of past-year physical or sexual violence by an intimate partner was reduced by more than half ( adjusted risk ratio=0.45 ; 95 % confidence interval=0.23 , 0.91 ) . Improvements in all 9 indicators of empowerment were observed . Reductions in violence result ed from a range of responses enabling women to challenge the acceptability of violence , expect and receive better treatment from partners , leave abusive relationships , and raise public awareness about intimate partner violence . CONCLUSIONS Our findings , both qualitative and quantitative , indicate that economic and social empowerment of women can contribute to reductions in intimate partner violence",
"Female sex workers have been central in India ’s HIV epidemic since it was first diagnosed among them in 1989 . Female sex workers ’ risk of HIV is primarily economically motivated . The Pi pilot study examined the feasibility and association of a microenterprise intervention , the tailoring of canvas bags , on sexual risk behaviors among female sex workers ( N = 100 ) in Chennai . Women were r and omized to an intervention or control arm . Between-group comparisons at baseline and at six-month follow-up were performed . Multivariate linear regression with bootstrapping was conducted to estimate the intervention effect . At baseline , women were a median of 35 years old , 61 % were married and they had an average of two children . Intervention participants reported a significantly lower number of sex partners and significant increases in income at the 6-month follow-up compared to control participants . In a multivariate model , intervention participants had a significantly lower number of paying clients per month at follow-up compared to control participants . By graduation , 75 % of intervention arm participants had made at least one sellable canvas bag and 6 months after the study ’s end , 60 % have continued involvement in bag production . The pilot study demonstrated that microenterprise interventions are successful in both providing FSWs with licit income opportunities and was associated with reductions in HIV risk behaviors",
"While much descriptive research has documented positive associations between social capital and a range of economic , social and health outcomes , there have been few intervention studies to assess whether social capital can be intentionally generated . We conducted an intervention in rural South Africa that combined group-based microfinance with participatory gender and HIV training in an attempt to catalyze changes in solidarity , reciprocity and social group membership as a means to reduce women 's vulnerability to intimate partner violence and HIV . A cluster r and omized trial was used to assess intervention effects among eight study villages . In this paper , we examined effects on structural and cognitive social capital among 845 participants and age and wealth matched women from households in comparison villages . This was supported by a diverse portfolio of qualitative research . After two years , adjusted effect estimates indicated higher levels of structural and cognitive social capital in the intervention group than the comparison group , although confidence intervals were wide . Qualitative research illustrated the ways in which economic and social gains enhanced participation in social groups , and the positive and negative dynamics that emerged within the program . There were numerous instances where individuals and village loan centres worked to address community concerns , both working through existing social networks , and through the establishment of new partnerships with local leadership structures , police , the health sector and NGOs . This is among the first experimental trials suggesting that social capital can be exogenously strengthened . The implication s for community interventions in public health are further explored",
"Abstract Microfinance can be used to reach women and adolescent girls with HIV prevention education . We report findings from a cluster-r and omized control trial among 55 villages in West Bengal to determine the impact of non-formal education on knowledge , attitudes and behaviors for HIV prevention and savings . Multilevel regression models were used to evaluate differences between groups for key outcomes while adjusting for cluster correlation and differences in baseline characteristics . Women and girls who received HIV education showed significant gains in HIV knowledge , awareness that condoms can prevent HIV , self-efficacy for HIV prevention , and confirmed use of clean needles , as compared to the control group . Condom use was rare and did not improve for women . While HIV testing was uncommon , knowledge of HIV-testing re sources significantly increased among girls , and trended in the positive direction among women in intervention groups . Conversely , the savings education showed no impact on financial knowledge or behavior change",
"OBJECTIVES We tested whether a structural intervention combining savings-led microfinance and HIV prevention components would achieve enhanced reductions in sexual risk among women engaging in street-based sex work in Ulaanbaatar , Mongolia , compared with an HIV prevention intervention alone . METHODS Between November 2011 and August 2012 , we r and omized 107 eligible women who completed baseline assessment s to either a 4-session HIV sexual risk reduction intervention ( HIVSRR ) alone ( n=50 ) or a 34-session HIVSRR plus a savings-led microfinance intervention ( n=57 ) . At 3- and 6-month follow-up assessment s , participants reported unprotected acts of vaginal intercourse with paying partners and number of paying partners with whom they engaged in sexual intercourse in the previous 90 days . Using Poisson and zero-inflated Poisson model regressions , we examined the effects of assignment to treatment versus control condition on outcomes . RESULTS At 6-month follow-up , the HIVSRR plus microfinance participants reported significantly fewer paying sexual partners and were more likely to report zero unprotected vaginal sex acts with paying sexual partners . CONCLUSIONS Findings advance the HIV prevention repertoire for women , demonstrating that risk reduction may be achieved through a structural intervention that relies on asset building , including savings , and alternatives to income from sex work"
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Summary Osteoporosis affects many aspects of daily life . The aim of this systematic review was to assess the effects of exercise interventions on functional outcomes in persons with osteoporosis , in comparison with controls . Methods Four data bases were search ed and yielded 1587 citations . Two review ers independently determined study eligibility , rated risk of bias , appraised method ological quality of studies , and resolved discordance by consensus . Results A total of 28 studies examining 2113 participants met inclusion criteria ; 25 studies were suitable for meta-analyses . Four categories of exercise were identified using the ProFaNE taxonomy . After removing studies with high risk of bias and sorting them into intervention sub-types , we were able to sufficiently reduce the heterogeneity . The st and ardized mean difference ( SMD ) favored multicomponent exercise for mobility ( − 0.56 , 95 % CI [ − 0.81 , − 0.32 ] , p = 0.06 , I2 = 51 % ) ; balance ( 0.50 , 95 % CI [ 0.27 , 0.74 ] , p = 0.28 , I2 = 21 % ) ; and self-reported measures of functioning ( − 0.69 , 95 % CI [ − 1.04 , − 0.34 ] , p = 0.02 , I2 = 61 % ) . Trials were judged at low or unclear risk of selection bias , indicating inadequate reporting and at high risk of performance bias due to lack of participant blinding . The mean method ological quality rating of the studies was 63.5 % indicating moderate quality . Conclusions A multicomponent exercise program of high-speed training combined with simulated functional tasks is promising to enhance functional outcomes . Due to substantial clinical heterogeneity of the target groups and specific dem and s of exercise modes , it is unclear which exercise program is optimal
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"Multimodal exercise programs incorporating traditional progressive resistance training ( PRT ) , weight-bearing impact training and /or balance training are recommended to reduce risk factors for falls and fracture . However , muscle power , or the ability to produce force rapidly , has emerged as a more crucial variable to functional decline than muscle strength or mass . The aim of this 12-month community-based r and omized controlled trial , termed Osteo-cise : Strong Bones for Life , was to evaluate the effectiveness and feasibility of a multimodal exercise program incorporating high-velocity (HV)-PRT , combined with an osteoporosis education and behavioral change program , on bone mineral density ( BMD ) , body composition , muscle strength and functional muscle performance in older adults . Falls incidence was evaluated as a secondary outcome . A total of 162 older adults ( mean ± SD ; 67 ± 6 years ) with risk factors for falls and /or low BMD were r and omized to the Osteo-cise program ( n = 81 ) or a control group ( n = 81 ) . Exercise consisted of fitness center-based HV-PRT , weight-bearing impact and challenging balance/mobility activities performed three times weekly . After 12 months , the Osteo-cise program led to modest but significant net gains in femoral neck and lumbar spine BMD ( 1.0 % to 1.1 % , p 0.05 ) , muscle strength ( 10 % to 13 % , p ( Timed Stair Climb , 5 % , p ) and dynamic balance ( Four Square Step Test 6 % , p on total body lean mass or mobility ( timed-up- and -go ) , and no difference in falls rate ( incidence rate ratio [ IRR ] , 1.22 ; 95 % confidence interval [ CI ] , 0.72 - 2.04 ) . In conclusion , this study demonstrates that the Osteo-cise : Strong Bones for Life community-based , multimodal exercise program represents an effective approach to improve multiple musculoskeletal and functional performance measures in older adults with risk factors for falls and /or low BMD . Although this did not translate into a reduction in the rate of falls , further large-scale trials are needed to evaluate the efficacy of this multimodal approach on reducing falls and fracture",
"Physical exercise has a favorable impact on bones , but optimum training strategies are still under discussion . In this study , we compared the effect of slow and fast resistance exercises on various osteodensitometric parameters . Fifty-three postmenopausal women were r and omly assigned to a strength training ( ST ) or a power training group ( PT ) . Both groups carried out a progressive resistance training , a gymnastics session , and a home training over a period of 12 mo . During the resistance training , the ST group used slow and the PT group fast movements ; otherwise there were no training differences . All subjects were supplemented with Ca and vitamin D. At baseline and after 12 mo , bone mineral density ( BMD ) was measured at the lumbar spine , proximal femur , and distal forearm by dual-energy X-ray absorptiometry . We also measured anthropometric data and maximum static strength . Frequency and grade of pain were assessed by question naire . After 12 mo , significant between-group differences were observed for BMD at the lumbar spine ( P total hip ( P BMD at the spine ( + 0.7 + /- 2.1 % , not significant ) and the total hip ( 0.0 + /- 1.7 % , not significant ) , the ST group lost significantly at both sites ( spine : -0.9 + /- 1.9 % ; P : -1.2 + /- 1.5 % ; P anthropometric data , maximum strength , BMD of the forearm , or frequency and grade of pain . These findings suggest that power training is more effective than strength training in reducing bone loss in postmenopausal women",
"OBJECTIVES To assess whether group exercise and coping classes reduce physical and psychological impairments and functional disability in older women with prevalent vertebral fractures ( VFs ) . DESIGN R and omized , controlled trial ( modified cross-over ) with site as unit of assignment ; testing at baseline and 3 , 6 , 9 , and 12 months . SETTING Nine North Carolina retirement communities . PARTICIPANTS One hundred eighty-five postmenopausal Caucasian women ( mean age 81 ) , each with at least one VFs . INTERVENTION The intervention group had 6 months of exercise ( 3 meetings weekly , 45 minutes each ) and coping classes ( 2 meetings weekly , 45 minutes each ) in Phase 1 , followed by 6 months of self-maintenance . The control group had 6 months of health education control intervention ( 1 meeting weekly , 45 minutes ) in Phase 1 , followed by the intervention described above . MEASUREMENTS Change in trunk extension strength , change in pain with activities , and change in psychological symptoms . RESULTS Between-group differences in the change in trunk extension strength ( 10.68 foot pounds , P psychological symptoms ( -0.08 , P=.011 ) were significant for Phase 1 . Changes in pain with activities did not differ between groups ( -0.03 , P=.64 ) ; there was no change in the pain endpoint . In Phase 2 , controls showed significant changes in trunk strength ( 15.02 foot pounds , P psychological symptoms ( -0.11 , P=.006 ) from baseline . Change in pain with activities was not significant ( -0.03 , P=.70 ) . During self-maintenance , the intervention group did not worsen in psychological symptoms , but improved trunk extension strength was not maintained . CONCLUSION Weak trunk extension strength and psychological symptoms associated with VFs can be improved in older women using group treatment , and psychological improvements are retained for at least 6 months",
"Background Tai Chi ( TC ) is a mind-body exercise that shows potential as an effective and safe intervention for preventing fall-related fractures in the elderly . Few r and omized trials have simultaneously evaluated TC 's potential to reduce bone loss and improve fall-predictive balance parameters in osteopenic women . Methods In a pragmatic r and omized trial , 86 post-menopausal osteopenic women , aged 45 - 70 , were recruited from community clinics . Women were assigned to either nine months of TC training plus usual care ( UC ) vs. UC alone . Primary outcomes were changes between baseline and nine months of bone mineral density ( BMD ) of the proximal femur and lumbar spine ( dual-energy X-ray absorptiometry ) and serum markers of bone resorption and formation . Secondary outcomes included quality of life . In a sub sample ( n = 16 ) , quiet st and ing fall-predictive sway parameters and clinical balance tests were also assessed . Both intent-to-treat and per- protocol analyses were employed . Results For BMD , no intent-to-treat analyses were statistically significant ; however , per protocol analyses ( i.e. , only including TC participants who completed ≥ 75 % training requirements ) of femoral neck BMD changes were significantly different between TC and UC ( + 0.04 vs. -0.98 % ; P = 0.05 ) . Changes in bone formation markers and physical domains of quality of life were also more favorable in per protocol TC vs. UC ( P = 0.05 ) . Changes in sway parameters were significantly improved by TC vs. UC ( average sway velocity , P = 0.027 ; anterior-posterior sway range , P = 0.014 ) . Clinical measures of balance and function showed non-significant trends in favor of TC . Conclusions TC training offered through existing community-based programs is a safe , feasible , and promising intervention for reducing multiple fracture risks . Our results affirm the value of a more definitive , longer-term trial of TC for osteopenic women , adequately powered to detect clinical ly relevant effects of TC on attenuation of BMD loss and reduction of fall risk in this population .Trial Registration Clinical Trials.gov :",
"Summary The EFOPS trial clearly established the positive effect of long-term exercise on clinical low-trauma fractures in postmenopausal women at risk . Bearing in mind that the complex anti-fracture exercise protocol s also affect a large variety of diseases of increased age , we strongly encourage older adults to perform multi purpose exercise programs . Introduction Physical exercise may be an efficient option for autonomous fracture prevention during increasing age . The aim of the study was to evaluate the effect of exercise on clinical overall fracture incidence and bone mineral density ( BMD ) in elderly subjects at risk . Methods In 1998 initially , 137 early-postmenopausal , osteopenic women living in Erlangen-Nuremberg , Germany , were included in the EFOPS trial . Subjects of the exercise group ( EG ; n = 86 ) conducted two supervised group and two home exercise sessions/week while the control group ( CG ; n = 51 ) was requested to maintain their physical activity . Primary study endpoints were clinical overall low-trauma fractures determined by question naires , structured interviews , and BMD at the lumbar spine and femoral neck assessed by dual-energy X-ray absorptiometry . Results In 2014 , 105 subjects ( EG : n = 59 vs. CG : n = 46 ) representing 1680 participant-years were included in the 16-year follow-up analysis . Risk ratio in the EG for overall low-trauma fractures was 0.51 ( 95 % confidence interval ( 95 % CI ) 0.23 to 0.97 , p = .046 ) , rate ratio was 0.42 ( 95 % CI 0.20 to 0.86 , p = .018 ) . Based on comparable baseline values , lumbar spine ( MV −1.5 % , 95 % CI −0.1 to −2.8 vs. −5.8 % , −3.3 to −7.2 % ) and femoral neck ( −6.5 % , −5.2 to −7.7 vs. −9.6 % , −8.2 to 11.1 % ) BMD decreased in both groups ; however , the reduction was more pronounced in the CG ( p ≤ .001 ) . Conclusion This study clearly evidence d the high anti-fracture efficiency of multi purpose exercise programs . Considering furthermore the favorable effect of exercise on most other risk factors of increasing age , we strongly encourage older adults to perform multi purpose exercise programs",
"How should health care professionals choose among the many therapies cl aim ed to be efficacious for treating specific disorders ? The practice of evidence -based medicine provides an answer . Advocates of this approach urge health care professionals to base treatment choices on the best evidence from systematic research on both the efficacy and adverse effects of various therapeutic alternatives . Ideally , health care professionals would compare different treatments by referring to r and omized , double-blind , head-to-head trials that compared the treatment options . Although individual medications are typically well research ed when these placebo-controlled studies are performed , studies that directly compare treatments are rare . In the absence of direct head-to-head trials , other evidence comes from indirect comparisons of two or more therapies by examining individual studies involving each treatment . This article provides an introductory review of methods of such indirect comparisons of therapies across studies , provides examples of how these methods can be used to make treatment decisions , and presents a general overview of relevant issues and statistics for readers interested in underst and ing these methods more thoroughly",
"Objectives To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older , high risk people living at home . Design Three arm , r and omised parallel trial ; assessment s at baseline and after six and 12 months . R and omisation done by computer generated r and om blocks , stratified by sex and fall history and concealed by an independent secure website . Setting Residents in metropolitan Sydney , Australia . Participants Participants aged 70 years or older who had two or more falls or one injurious fall in past 12 months , recruited from Veteran ’s Affairs data bases and general practice data bases . Exclusion criteria were moderate to severe cognitive problems , inability to ambulate independently , neurological conditions that severely influenced gait and mobility , resident in a nursing home or hostel , or any unstable or terminal illness that would affect ability to do exercises . Interventions Three home based interventions : Lifestyle integrated Functional Exercise ( LiFE ) approach ( n=107 ; taught principles of balance and strength training and integrated selected activities into everyday routines ) , structured programme ( n=105 ; exercises for balance and lower limb strength , done three times a week ) , sham control programme ( n=105 ; gentle exercise ) . LiFE and structured groups received five sessions with two booster visits and two phone calls ; controls received three home visits and six phone calls . Assessment s made at baseline and after six and 12 months . Main outcome measures Primary measure : rate of falls over 12 months , collected by self report . Secondary measures : static and dynamic balance ; ankle , knee and hip strength ; balance self efficacy ; daily living activities ; participation ; habitual physical activity ; quality of life ; energy expenditure ; body mass index ; and fat free mass . Results After 12 months ’ follow-up , we recorded 172 , 193 , and 224 falls in the LiFE , structured exercise , and control groups , respectively . The overall incidence of falls in the LiFE programme was 1.66 per person years , compared with 1.90 in the structured programme and 2.28 in the control group . We saw a significant reduction of 31 % in the rate of falls for the LiFE programme compared with controls ( incidence rate ratio 0.69 ( 95 % confidence interval 0.48 to 0.99 ) ) ; the corresponding difference between the structured group and controls was non-significant ( 0.81 ( 0.56 to 1.17 ) ) . Static balance on an eight level hierarchy scale , ankle strength , function , and participation were significantly better in the LiFE group than in controls . LiFE and structured groups had a significant and moderate improvement in dynamic balance , compared with controls . Conclusions The LiFE programme provides an alternative to traditional exercise to consider for fall prevention . Functional based exercise should be a focus for interventions to protect older , high risk people from falling and to improve and maintain functional capacity . Trial registration Australia and New Zeal and Clinical Trials Registry 12606000025538",
"Background This r and omised , single-blind controlled pilot trial aim ed to determine the effectiveness of a physiotherapy program , including exercise and manual therapy , in reducing impairments and improving physical function and health-related quality of life in people with a history of painful osteoporotic vertebral fracture . Methods 20 participants were r and omly allocated to an intervention ( n = 11 ) or control ( n = 9 ) group . The intervention group attended individual sessions with an experienced clinician once a week for 10 weeks and performed daily home exercises with adherence monitored by a self-report diary . The control group received no treatment . Blinded assessment was conducted at baseline and 11 weeks . Question naires assessed self-reported changes in back pain , physical function , and health-related quality of life . Objective measures of thoracic kyphosis , back and shoulder muscle endurance ( Timed Loaded St and ing Test ) , and function ( Timed Up and Go test ) were also taken . Results Compared with the control group , the intervention group showed significant reductions in pain during movement ( mean difference ( 95 % CI ) -1.8 ( -3.5 to -0.1 ) ) and at rest ( -2.0 ( -3.8 to -0.2 ) ) and significantly greater improvements in Qualeffo physical function ( -4.8 ( -9.2 to -0.5 ) ) and the Timed Loaded St and ing test ( 46.7 ( 16.1 to 77.3 ) secs ) . For the perceived change in back pain over the 10 weeks , 9/11 ( 82 % ) participants in the intervention group rated their pain as ' much better ' compared with only 1/9 ( 11 % ) participants in the control group . Conclusion Despite the modest sample size , these results support the benefits of exercise and manual therapy in the clinical management of patients with osteoporotic vertebral fractures , but need to be confirmed in a larger sample .Trail registration",
"BACKGROUND The authors ' objective was to evaluate the efficacy of a 6-month Tai Chi intervention for decreasing the number of falls and the risk for falling in older persons . METHODS This r and omized controlled trial involved a sample of 256 physically inactive , community-dwelling adults aged 70 to 92 ( mean age , 77.48 years ; st and ard deviation , 4.95 years ) who were recruited through a patient data base in Portl and , Oregon . Participants were r and omized to participate in a three-times-per-week Tai Chi group or to a stretching control group for 6 months . The primary outcome measure was the number of falls ; the secondary outcome measures included functional balance ( Berg Balance Scale , Dynamic Gait Index , Functional Reach , and single-leg st and ing ) , physical performance ( 50-foot speed walk , Up&Go ) , and fear of falling , assessed at baseline , 3 months , 6 months ( intervention termination ) , and at a 6-month postintervention follow-up . RESULTS At the end of the 6-month intervention , significantly fewer falls ( n=38 vs 73 ; p=.007 ) , lower proportions of fallers ( 28 % vs 46 % ; p=.01 ) , and fewer injurious falls ( 7 % vs 18 % ; p=.03 ) were observed in the Tai Chi group compared with the stretching control group . After adjusting for baseline covariates , the risk for multiple falls in the Tai Chi group was 55 % lower than that of the stretching control group ( risk ratio,.45 ; 95 % confidence interval , 0.30 to 0.70 ) . Compared with the stretching control participants , the Tai Chi participants showed significant improvements ( p functional balance , physical performance , and reduced fear of falling . Intervention gains in these measures were maintained at a 6-month postintervention follow-up in the Tai Chi group . CONCLUSIONS A three-times-per-week , 6-month Tai Chi program is effective in decreasing the number of falls , the risk for falling , and the fear of falling , and it improves functional balance and physical performance in physically inactive persons aged 70 years or older",
"PURPOSE Despite the decreased gravitational loading that is experienced in an aquatic environment , little research has been conducted on this exercise medium for women with osteoporosis ( OP ) . Aquatic exercise ( AE ) may improve function and balance , thus ultimately decreasing fall risk and the potential for hip fractures in this high-risk population . METHOD A total of 68 women with OP , aged 60 years or older , were recruited into a r and omized clinical trial evaluating the impact of AE , l and exercise ( LE ) , and no exercise ( NE ) on balance , functional mobility , and quality of life ( QOL ) . RESULTS Only one balance measure ( backward t and em walk ) significantly improved with AE compared to LE , but this did not translate into a greater improvement in self-report function . There were no significant differences between the exercise interventions and NE , except for in ratings of global change , where participants in the AE group were three times more likely to report improvement than those in the NE group . CONCLUSION There were no differences in balance , function , or QOL in women with OP who followed an AE or LE programme compared to those in an NE control group . However , the significant differences in backward t and em walk between the AE and LE groups and self-reported global change between the AE and NE groups warrant further investigation . Significant improvements in balance and global change suggest that AE is a viable alternative for older women with OP who have difficulty exercising on l and",
"The purpose of this study was to assess the effect of 18-week Tai Chi training on body balance in a dynamic trial among elderly men with dizziness . The study covered subjects aged 60 to 80 years . We identified 40 men who reported a history of dizziness . The subjects were recruited using direct mailings and a community information campaign . The participants were r and omly assigned to either the exercise intervention ( n = 20 ) or control group ( n = 20 ) . The Tai Chi group participated in an 18-week exercise class held for 45 minutes twice a week . Body balance was studied in two ways : using the \" 8 foot up and go test \" ( Rikli and Jones 2001 ) and using a Computer Posturographic System PE 90 ( manufactured by Military Institute of Aviation Medicine in Warsaw and outfitted with Pro-Med modified software ) . The ability to perform specific tasks ( maximal deflections in four directions ) was measured on the posturographic platform . The variation in results obtained on the first and second date of tests in the experimental and control groups was confirmed statistically using four parameters , i.e. \" 8 foot up to and go test ( H = 8.21;p = 0.003 ) , forward deflection ( H = 3.70;p = 0.050 ) , backward deflection ( H = 5.04;p = 0.024 ) and maximum sway area ( H = 8.86;p = 0.002 ) . Consequently , we found that the 18-week period of Tai-Chi exercises , with a frequency of twice a week for 45 minutes , is beneficial for dynamic balance , which is important for the reduction of fall risk factors among elderly men with dizziness",
"OBJECTIVE To determine how multiple risk factors for osteoporotic fractures could be modified by high-intensity strength training exercises in postmenopausal women . DESIGN R and omized controlled trial of 1-year duration . SETTING Exercise laboratory at Tufts University , Boston , Mass. POPULATION Forty postmenopausal white women , 50 to 70 years of age , participated in the study ; 39 women completed the study . The subjects were sedentary and estrogen-deplete . INTERVENTIONS High-intensity strength training exercises 2 days per week using five different exercises ( n = 20 ) vs untreated controls ( n = 19 ) . MAIN OUTCOME MEASURES Dual energy x-ray absorptiometry for bone status , one repetition maximum for muscle strength , 24-hour urinary creatinine for muscle mass , and backward t and em walk for dynamic balance . RESULTS Femoral neck bone mineral density and lumbar spine bone mineral density increased by 0.005 + /- 0.039 g/cm2 ( 0.9 % + /- 4.5 % ) ( mean + /- SD ) and 0.009 + /- 0.033 g/cm2 ( 1.0 % + /- 3.6 % ) , respectively , in the strength-trained women and decreased by -0.022 + /- 0.035 g/cm2 ( -2.5 % + /- 3.8 % ) and -0.019 + /- 0.035 g/cm2 ( -1.8 % + /- 3.5 % ) , respectively , in the controls ( P = .02 and .04 ) . Total body bone mineral content was preserved in the strength-trained women ( + 2.0 + /- 68 g ; 0.0 % + /- 3.0 % ) and tended to decrease in the controls ( -33 + 77 g ; -1.2 % + /- 3.4 % , P = .12 ) . Muscle mass , muscle strength , and dynamic balance increased in the strength-trained women and decreased in the controls ( P = .03 to High-intensity strength training exercises are an effective and feasible means to preserve bone density while improving muscle mass , strength , and balance in postmenopausal women",
"There is little evidence that home-based muscle training through exercise improves the muscle strength and QoL of elderly osteoporotic women . The efficacy of home-based daily exercise on muscle strength of the upper and lower extremities and QoL were examined in elderly osteoporotic women by means of a case-controlled study that was design ed and conducted between 2005 and 2006 . Sixty-three osteoporotic women over 60 years of age were r and omly assigned to 12 months of muscle exercise or to no intervention . The outcomes were changes in muscle strength and quality of life ( QoL ) . Ultimately , sixty-two participants completed the 12 months program . Before the start of home-exercise training , the lumbar spine bone mineral density ( BMD ) and femoral neck BMD values in the intervention group were significantly lower than those in the control group ( p Grip strength and maximum walking speed increased significantly in the intervention group ( p QoL , physical functioning was improved by home-based exercise in the intervention group ( p=0.05 ) , while there were no improvements in any of the categories of Short-Form 36 in the control group . Our results suggest that home-based training is effective for elderly osteoporotic women in improving not only muscle strength in upper and lower extremities but also physical functioning in",
"Summary R and omized controlled study in 80 postmenopausal women with osteoporosis was conducted to investigate the effect of a home-based , simple , low-intensity exercise . Low-intensity back-strengthening exercise was effective in improving the quality of life and back extensor strength . Introduction and hypothesisBack-strengthening exercise is effective in increasing back extensor strength and decreasing risk of vertebral fractures . We hypothesized that a home-based , simple , low-intensity exercise could enhance back extensor strength and improve the quality of life and /or spinal range of motion in postmenopausal women in a short-term follow-up . Methods Eighty postmenopausal women with osteoporosis were r and omly assigned to a control group ( n = 38 ) or an exercise group ( n = 42 ) . Subjects were instructed to lift their upper trunk from a prone position antigravity and maintain the neutral position . Isometric back extensor strength , spinal range of motion , and scores for quality of life were evaluated at baseline and 4 months . Results Back extensor strength significantly increased both in the exercise group ( 26 % ) and in the control group ( 11 % ) . Scores for quality of life increased in the exercise group ( 7 % ) , whereas it remained unchanged in the control group ( 0 % ) . There was a significant difference in quality of life score between the groups ( p = 0.012 ) . Conclusions Low-intensity back-strengthening exercise was effective in improving the quality of life and back extensor strength in patients with osteoporosis",
" Summary The aim of this r and omized controlled trial was to evaluate the effect of a 3-month course of exercises on mobility , balance , disease-specific , and generic health-related quality of life ( HRQOL ) for women with osteoporosis and a history of vertebral fractures . Our results showed that exercises improved their mobility , balance , and HRQOL . Introduction The aim was to evaluate the effect of a 3-month course of circuit exercises plus a 3-h lesson on how to cope with osteoporosis on mobility , balance , and the HRQOL for postmenopausal women ( 60–84 years ) with osteoporosis and a history of vertebral fracture . Our hypothesis was that a 3-month course would have a significantly positive effect on the women 's mobility and balance as well as on their HRQOL . Methods The participants ( 89 ) were r and omized to an intervention group ( IT ) or a control group ( CT ) and assessed at baseline at 3 months and at 12 months with measurement of maximum walking speed ( MWS ) , Timed Up and GO ( TUG ) , Functional Reach ( FR ) , the Quality of Life Question naire issued by the European Foundation for Osteoporosis ( ‘ QUALEFFO-41 ’ ) and the General Health Question naire ( GHQ-20 ) . The sample size was calculated with reference to walking speed ( primary outcome ) , and the statistical approaches used were Student 's t test or the chi-square test . Results At 3 months , better results were registered on the primary outcome , MWS as well as TUG , FR , sum score of GHQ-20 , and “ QUALEFFO-41 : mental function ” in the IT compared with the CT . At 12 months , those in the IT had a better result on the primary outcome , MWS as well as TUG , “ QUALEFFO-41 : total score ” “ QUALEFFO-41 : mental function ” , “ QUALEFFO-41 : physical function ” , and “ QULEFFO-41 : pain ” compared with CT . Conclusion Circuit exercises will improve mobility and health-related quality of life of elderly women with osteoporosis and a history of vertebral fractures",
"This r and omized controlled trial was design ed to investigate the effect of a 6-month home-based exercise program versus control ( usual activities ) on quality of life for postmenopausal women with osteoporosis who had at least one vertebral fracture . Twelve-month assessment s of outcomes were completed to determine if women would continue exercising with minimal supervision and if benefit could be sustained . The home exercise program followed a \" lifestyle exercise \" approach where participants completed exercises 60 min per day , 3 days a week and could complete exercises in small periods of time throughout the day . Exercise activities included stretching , strength training and aerobics ( i.e. walking ) . Participants were assessed at baseline , 6 months , and 12 months using the Osteoporosis Quality of Life Question naire ( OQLQ ) , the Sickness Impact Profile ( SIP ) , a balance test , and the Timed Up And Go test . Bone mineral density was assessed at baseline and 12 months for both the lumbar spine and femoral neck . Quality of life ( OQLQ ) improved over 6 months in the exercise group compared to the control group in the domains of symptoms ( P=0.003 ) , emotion ( P=0.01 ) and leisure ( P=0.03 ) . Results from the balance test indicated a greater effect in the exercise group over 12 months ( P measures of Timed Up and Go , SIP at 6 and 12 months , and femoral neck and lumbar spine bone mineral density at 12 months . Home-based exercise with minimal supervision improves quality of life in elderly women with vertebral fractures . Future research is needed to determine if home exercise programs reduce falls and fall-related injuries in the elderly",
"A r and omized , controlled , single-blinded 25-wk prospect i ve study was conducted to compare the effects of group-based resistance and agility training on bone , as measured by both dual-energy X-ray absorptiometry ( DXA ) and peripheral quantitative computed tomography ( pQCT ) , in older women with low bone mass . Ninety-eight community-dwelling women aged 75 - 85 yr were r and omized to one of three experimental groups : resistance training ( n = 32 ) , agility training ( n = 34 ) , or stretching ( sham exercise ) ( n = 32 ) . Total hip , femoral neck , and trochanteric bone mineral density ( BMD ) were measured by DXA . Peripheral QCT measurements were performed at the tibia and radius . The pQCT outcome measures at the shaft regions were cortical bone content , cortical bone cross-sectional area , cortical bone density , and density-weighted polar section modulus ( SSI ) . The pQCT outcome measures at the distal sites were total bone content , total bone cross-sectional area , and total bone density . At trial completion , the agility training group significantly increased cortical bone density by 0.5 + /- 0.2 % ( SE ) at the tibial shaft compared with a 0.4 + /- 0.3 % loss in the stretching group . The resistance training group significantly increased cortical bone density ( 1.4 + /- 0.6 % ) at the radial shaft compared , with a 0.4 + /- 0.5 % loss in the agility training group . No significant between-group differences were observed in the other bone outcome measures ( by DXA or pQCT ) . Future research is needed to determine the mechanism(s ) responsible for the observed adaptation of the cortical bone to mechanical loading",
"BACKGROUND The performance of daily tasks , such as stair climbing or lifting an object , requires both muscle strength and power . Age-associated reductions in strength and power can affect an older adult 's ability to complete daily tasks such as stair climbing and lifting a child . METHODS The purpose s of this study were to determine whether power training was more efficacious than strength training for improving whole-body physical function in older adults and to examine the relationship between changes in anaerobic power and muscle strength and changes in physical function . Thirty-nine men and women ( mean age + /- SD = 72.5 + /- 6.3 years ) with below-average leg extensor power were r and omly assigned to control ( C , n = 15 ) , strength-training ( ST , n = 13 ) or power-training ( PT , n = 11 ) groups . The ST and PT groups met 3 days per week for 16 weeks ; the C group maintained usual activity and attended three lectures during the course of the study . Primary outcome measures included the Continuous Scale Physical Functional Performance test , maximal strength , and anaerobic power . RESULTS After baseline was controlled for , the Continuous Scale Physical Functional Performance test total score was significantly greater for the PT group than for the ST ( p = .033 ) and C ( p = .016 ) groups . Maximal strength was significantly greater for the ST group than for the C group ( p = .015 ) after the intervention . There was no significant difference between groups for peak anaerobic power . CONCLUSIONS Power training was more effective than strength training for improving physical function in community-dwelling older adults",
"Objective : To evaluate the effects of tai chi exercise on risk factors for falls in postmenopausal women with osteopaenia through measurements of balance , gait , physical function and quality of life . Design : A r and omized , controlled , single-blinded , 24-week trial with stratification by age and bone mass . Setting : General community . Participants : Sixty-one independently living elderly females aged 65 years and older with low bone mass . Interventions : Subjects were recruited and r and omly assigned to 24 weeks of tai chi ( 60 minutes/session , three sessions/week , n = 30 ) or a control group ( n = 31 ) . Outcome measures : Computerized dynamic posturography , gait , ‘ timed up and go ’ , five-chair sit-to-st and and quality of life assessed at baseline , 12 and 24 weeks . Results : After 24 weeks , subjects in the tai chi group demonstrated an increase in stride width ( P = 0.05 ) and improvement in general health ( P = 0.008 ) , vitality ( P = 0.02 ) and bodily pain ( P = 0.03 ) compared with those in the control group . There was no significant difference in balance parameters , ‘ timed up and go ’ , five-chair sit-to-st and and other domains of quality of life . Conclusion : Tai chi exercise may reduce risk factors for falls by increasing the stride width , and may improve quality of life in terms of general health , vitality and bodily pain in postmenopausal women with osteopaenia",
"Objectives : To investigate whether a 12-week home-based programme of trunk-strengthening exercise could benefit spinal mobility , function and quality of life for osteoporotic and osteopenic postmenopausal women without fracture . Design s : R and omized controlled clinical trial . Setting : Department of Physical Therapy in National Taiwan University Hospital . Subjects : Twenty-eight postmenopausal women ( mean age 60.39=9.3 years ) diagnosed with osteoporosis or osteopenia without fracture history were recruited for this study . Subjects were r and omly assigned into exercise or control groups , each consisting of 14 subjects . Interventions : The 12-week exercise programme included strengthening routines for the trunk extensor and flexor muscles . The subjects performed three sets of 10 repetitions for each of the exercises , with programmes carried out three times per day at home . Main outcome measurements : Muscular strength , spinal range of motion ( ROM ) and motion velocity , Oswestry Disability Question naire ( ODQ ) and quality of life ( QOL ) were measured before the start and after completion of the exercise programme . Results : Statistically significant improvements were demonstrated in spinal ROM and motion velocity in the sagittal and frontal planes for the exercise group ( pB=0.05 ) . Further , the strength of the trunk flexors and extensors increased after exercise training ( pB=0.05 ) . ODQ measure was significantly reduced in the exercise group ( pB=0.05 ) , while the controls showed no significant change . Subjects in the exercise group showed better satisfaction in some domains of the Short-Form-36 Health Survey quality of life question naire ( pB=0.05 ) . Conclusions : This 12-week home-based trunk-strengthening exercise programme could improve trunk mobility and strength , and enhance QOL in osteoporotic and osteopenic postmenopausal women without vertebral fracture . Future study should recruit more cases or more severe subjects to verify the results",
"It is considered that skeletal mass in humans may respond to loading or the number of loading cycles . The aim of this study was to examine the effect of a 1 year progressive resistance training program on the bone mass of 56 postmenopausal women . Assignment was by block r and omization to one of two resistance training groups : a strength trained group ( 3 x 8 repetition maximum ) or an endurance group ( 3 x 20 repetition maximum ) . The resistance exercises were selected to stress the ipsilateral forearm and hip region . The exercising side was r and omly assigned with one side exercised while the alternate side acted as the nonexercise control . Bone mineral density ( BMD ) was measured every 3 months at the radial forearm and four hip sites using the Hologic QDR 2000 bone densitometer . A linear regression function was fitted for each individual 's bone density results , and the slope was compared for the exercise and control side using paired t-tests . The bone mass increase with the strength regimen was significantly greater at the trochanteric hip site ( control -0.6 + /- 2.2 % , exercise 1.7 + /- 4.1 % , p increase in BMD with the endurance regimen except at the radius midsite ( control -1.0 + /- 2.3 % , exercise 0.1 + /- 1.4 % , p muscle strength , tested by a one-repetition maximum ( 1RM ) test , increased significantly for all 10 exercises ( p change in BMD and the percentage increase in strength as follows : trochanter with leg press ; intertrochanter with leg press ( p resistance exercise in that although the trochanter and intertrochanter bone density was elevated by the resistance exercises undertaken , there was no effect on the femoral neck value . Postmenopausal bone mass can be significantly increased by a strength regimen that uses high-load low repetitions but not by an endurance regimen that uses low-load high repetitions . We conclude that the peak load is more important than the number of loading cycles in increasing bone mass in early postmenopausal women",
"INTRODUCTION Osteoporosis is a chronic disease that leads to bone fragility and is associated with fracture risks and serious consequences for mobility . OBJECTIVE To verify the effects of two linear programs of resistance training ( RT ) on bone mineral density ( BMD ) , functional autonomy ( FA ) , muscular strength and quality of life ( QoL ) of postmenopausal women in pharmacological treatment . STUDY DESIGN R and omized controlled trial , code : RBR-6bqsw8 . METHODS 52 volunteers were distributed into three groups , according to r and omly parallel form : RT3times-per-week ( RT3 , n=20 ) ; RT2times-per-week ( RT2 , n=16 ) and control group ( CG , n=16 ) . The following assessment tools were used : bone mineral density ( BMD ) by dual X-ray absorptiometry , ' Latin America Group for maturity ' ( GDLAM ) protocol for FA , 10RM test for leg exercises and the ' Osteoporosis Assessment Question naire ' ( OPAQ ) for QoL. The physical activities were planned for 13 months in cycles with different intensities . A two-way ANOVA with Bonferroni post-hoc test were used . RESULTS The results showed that the RT3/week was significantly more efficient ( p All BMD variables , FA ( Δ%=29.3 % ) , leg press at 45 ° ( Δ%=24.97 % ) and OPAQ ( Δ%=20.23 % ) . In addition , both RT3 and RT2 groups were more efficient ( p : total BMD ( Δ%=0.09 % ) and ( Δ%=0.06 % ) ; FA ( Δ%=7.1 % ) and RT2 ( Δ%=3.78 % ) ; Leg press at 45 ° ( Δ%=84.1 % ) and ( Δ%=59.1 % ) ; keen extension ( Δ%=15.28 % ) and ( Δ%=20.37 % ) ; OPAQ ( Δ%=57.61 % ) and ( Δ%=37.37 % ) , respectively . CONCLUSION The study showed that both experimental groups presented favorable results for BMD , strength , FA and QoL. However , the RT3 showed the best results compared to other groups after 13 months of intervention",
"OBJECTIVE To evaluate the effectiveness of three different training protocol s on physical function of older adults living in long-term care facilities . Emphasis was placed on feasibility in real-life situations . METHODS Subjects ( N=224 ) were r and omised to 6 months of twice weekly ( 1 ) resistance training ; ( 2 ) all-round functional-skills training ; ( 3 ) a combination of both ; or ( 4 ) a control program . Fitness and performance measures and self-reported disability were measured at baseline and after 24 weeks intervention . RESULTS Attendance to the strength training was 76 % , to the functional-skills training 70 % and to the combined training 73 % . In those who attended at least 75 % of all classes ( n=97 ) the functional-skills and combined training program improved several fitness and performance measures compared to the control group . CONCLUSION Twice weekly functional-skills training , or a combination of resistance and functional-skills training can improve several fitness and performance measures of institutionalised older people . PRACTICE IMPLICATION S An important finding from our study was that less than twice a week exercise training is not enough for functional improvement , while it proved difficult for the elderly subjects to exercise twice weekly . Education on the health benefits of regular exercise , and a larger availability of classes in long-term care facilities may improve attendance",
"OBJECTIVE To evaluate the efficacy of the Nijmegen Falls Prevention Program ( NFPP ) for persons with osteoporosis and a fall history in a r and omized controlled trial . Persons with osteoporosis are at risk for fall-related fractures because of decreased bone strength . A decrease in the number of falls therefore is expected to be particularly beneficial for these persons . DESIGN R and omized controlled trial . SETTING Hospital . PARTICIPANTS Persons with osteoporosis and a fall history ( N=96 ; mean ± SD age , 71.0±4.7y ; 90 women ) . INTERVENTION After baseline assessment , participants were r and omly assigned to the exercise ( n=50 ; participated in the NFPP for persons with osteoporosis [ 5.5wk ] ) or control group ( n=46 ; usual care ) . MAIN OUTCOME MEASURES Primary outcome measure was fall rate , measured by using monthly fall calendars for 1 year . Secondary outcomes were balance confidence ( Activity-specific Balance Confidence Scale ) , quality of life ( QOL ; Quality of Life Question naire of the European Foundation for Osteoporosis ) , and activity level ( LASA Physical Activity Question naire , pedometer ) , assessed posttreatment subsequent to the program and after 1 year of follow-up . RESULTS The fall rate in the exercise group was 39 % lower than for the control group ( .72 vs 1.18 falls/person-year ; risk ratio , .61 ; 95 % confidence interval , .40-.94 ) . Balance confidence in the exercise group increased by 13.9 % ( P=.001 ) . No group differences were observed in QOL and activity levels . CONCLUSION The NFPP for persons with osteoporosis was effective in decreasing the number of falls and improving balance confidence . Therefore , it is a valuable new tool to improve mobility and independence of persons with osteoporosis",
"PURPOSE To examine the effect of resistance exercises on self-reported physical function and activities of daily living ( ADL ) in older adults with osteoporosis or osteopenia . METHODS A search of available literature was conducted using PubMed , CINAHL , SPORTD iscus , PEDro , ProQuest Nursing and Allied Health Source , and Cochrane Controlled Trials Register . Studies were included if they involved ( 1 ) r and omized controlled trials ; ( 2 ) participants with osteoporosis or osteopenia ; ( 3 ) resistance exercise as an intervention ; and ( 4 ) self-report of physical function or ADL . Articles were independently review ed for quality by two authors using the Physiotherapy Evidence Data base ( PEDro ) scale . Cohen 's d effect size was calculated by dividing st and ardized mean differences by the st and ard deviation to determine treatment effect in terms of physical function or ADL . RESULTS Five full-text articles were selected for inclusion . PEDro scores ranged from 5 to 7 ( out of 10 ) . Effect size mean differences as a result of resistance intervention ranged from 0.08 to 1.74 , suggesting \" trivial \" to \" large \" effects on self-reported physical function and ADL . CONCLUSION RESULTS suggest that interventions using resistance training have a beneficial impact on the domains of physical function and ADL in participants with osteoporosis or osteopenia . More high- quality studies are needed to lend further validity to this supposition"
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4117db56-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES The first aim was to make an inventory of available instruments and question naires for the assessment of disabilities in personal care in patients with rheumatic disorders . The second aim was to investigate which of these instruments have acceptable , method ological quality with regard to reliability , validity and responsiveness . The third aim was to investigate the assumption that convergent validity results in stronger correlations when vali date d against a more similar construct . METHODS A computer-aided literature search ( 1982 - 2001 ) in several data bases was performed to identify studies focusing on the clinimetric properties of instruments to assess impairments in function in patients with rheumatic disorders . Data were extracted in a st and ardised way and compared to a priori defined criteria . RESULTS In total , 19 measurement instruments were included . Five out of these 19 were found to have acceptable reliability , while 12 had acceptable validity . Only three question naires met both criteria . Results concerning the responsiveness of these three question naires were conflicting . No difference was found in the strength of correlation between validation against the most similar construct versus validation against the least similar construct . CONCLUSION It is concluded that the Arthritis Impact Measurement Scale ( AIMS ) is the most suitable instrument for the assessment of disabilities in personal care
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"OBJECTIVE To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology ( ACR ) and the Outcome Measures in Clinical Trials ( OMERACT ) conference committee to be used in clinical trials of rheumatoid arthritis ( RA ) . METHODS Utilizing data from a multicenter r and omized double-blind clinical trial of low-dose cyclosporine and placebo in RA , we estimated the relative efficiency ( RE ) of measures to detect a treatment effect ( relative to tender joint count , which was assigned a value of 1 ) . Four pain measures ( 10-cm visual analog scale [ VAS ] , 5-point categorical scale , Health Assessment Question naire [ HAQ ] pain index , Arthritis Impact Measurement Scales [ AIMS ] pain score ) and 3 quality -of-life measures ( Problem Elicitation Technique [ PET ] , HAQ , AIMS ) were compared . RESULTS Physician and patient global measures were the most responsive instruments , although neither was statistically superior to tender joint count . Swollen joint count , grip strength , pain measured on a 10-cm VAS , and functional status as measured by the PET and HAQ were all of intermediate responsiveness . Morning stiffness , 5-point pain scale , and erythrocyte sedimentation rate were the least responsive instruments . CONCLUSION This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT",
"As an alternative to the calculation of change scores for health status question naires used in clinical trials or longitudinal studies , transitional questions have been developed for patients to assess changes directly themselves . Here the original Health Assessment Question naire ( HAQ ) is compared with a modified version of the HAQ ( MHAQ ) which contains transition questions used at follow up . These , together with a set of st and ard rheumatological tests , were all completed by 100 patients with rheumatoid arthritis on two occasions , three months apart . Change scores were calculated for the HAQ and for the clinical measures and compared with the MHAQ . The results were strikingly in favour of encouraging patients to assess their own degree of change through the use of transition questions in the MHAQ",
"The final development of the Sickness Impact Profile ( SIP ) , a behaviorally based measure of health status , is presented . A large field trial on a r and om sample of prepaid group practice enrollees and smaller trials on sample s of patients with hyperthyroidism , rheumatoid arthritis and hip replacements were undertaken to assess reliability and validity of the SIP and provide data for category and item analyses . Test-retest reliability ( r = 0.92 ) and internal consistency ( r = 0.94 ) were high . Convergent and discriminant validity was evaluated using the multitrait – multi method technique . Clinical validity was assessed by determining the relationship between clinical measures of disease and the SIP scores . The relationship between the SIP and criterion measures were moderate to high and in the direction hypotheszed . A technique for describing and assessing similarities and differences among groups was developed using profile and pattern analysis . The final SIP contains 136 items in 12 categories . Overall , category , and dimension scores may be calculated",
"Five health status instruments were administered in r and om order to 50 arthritis patients before and after total joint arthroplasty . Relative efficiency and sensitivity in measurement of change in pain , mobility and physical function , social role and social activity , and global health were assessed . The instruments had highly correlated scores , but had differences in certain dimensions . Inter-instrument differentials were larger for social and global outcomes than for pain or mobility . NO single instrument consistently outperformed the others . A method for determining relative efficiency is described",
"To assess the sensitivity of the Arthritis Impact Measurement Scales ( AIMS ) , we analyzed data from 3 clinical trials . One trial involving 255 patients with rheumatoid arthritis ( RA ) was a 12-week , r and omized controlled trail of diclofenac , naproxen , and aspirin . Two trials were open-label studies of 24 weeks duration that included 165 RA and 355 osteoarthritis ( OA ) patients , all of whom were treated with diclofenac . In addition to the AIMS , tender joint count , morning stiffness , and erythrocyte sedimentation rate were used as outcome measures in the trials . The AIMS results showed substantial improvements in Physical Function , Psychological Status , and Pain , as well as in overall Arthritis Impact . These improvements were detected by the time of the initial outcome assessment at 4 weeks or 8 weeks , and were detected in patients with either OA or RA . These AIMS results closely parallel improvements shown by traditional clinical measures , and demonstrate that the AIMS health status measure is sensitive to improvements in OA as well as in RA . The AIMS also detects responses produced by therapy with nonsteroidal antiinflammatory drugs ( NSAIDs ) , and these improvements can be demonstrated in as short a treatment time as 4 weeks . These findings confirm the utility of the AIMS for assessing outcome in rheumatic disease studies , and they have implication s for the design of future clinical trials of NSAIDs",
"Health status measures are being used with increasing frequency in clinical research . Up to now the emphasis has been on the reliability and validity of these measures . Less attention has been given to the sensitivity of these measures for detecting clinical change . As health status measures are applied more frequently in the clinical setting , we need a useful way to estimate and communicate whether particular changes in health status are clinical ly relevant . This report considers effect sizes as a useful way to interpret changes in health status . Effect sizes are defined as the mean change found in a variable divided by the st and ard deviation of that variable . Effect sizes are used to translate “ the before and after changes ” in a “ one group ” situation into a st and ard unit of measurement that will provide a clearer underst and ing of health status results . The utility of effect sizes is demonstrated from four different perspectives using three health status data sets derived from arthritis population s administered the Arthritis Impact Measurement Scales ( AIMS ) . The first perspective shows how general and instrument-specific benchmarks can be developed and how they can be used to translate the meaning of clinical change . The second perspective shows how effect sizes can be used to compare traditional clinical measures with health status measures in a st and ard clinical drug trial . The third application demonstrates the use of effect sizes when comparing two drugs tested in separate drug trials and shows how they can facilitate this type of comparison . Finally , our health status results show how effect sizes can supplement st and ard statistical testing to give a more complete and clinical ly relevant picture of health status change . We conclude that effect sizes are an important tool that will facilitate the use and interpretation of health status measures in clinical research in arthritis and other chronic diseases",
"Summary Three experimental question naires were compared with the Influence of Rheumatic Diseases on Health and Lifestyle ( IRGL ) question naire , a Dutch version of the Arthritis Impact Measurement Scales . Sixty-two patients with osteoarthritis ( OA ) and 35 patients with rheumatoid arthritis ( RA ) , all of whom underwent hip arthroplasty , completed the study . Results showed that visual analogue scales for pain , stiffness , fatigue , and anxiety were strongly correlated with a number of the IRGL scales . Patient preference scales were sensitive to change and provided additional information on aspects of the patients ' quality of life ( QOL ) that were felt to be important by the patients themselves . The question naire on performance in various roles in life was insensitive to change . In existing question naires , there is an attempt to represent the concept of QOL in terms of its most important aspects . Such realizations of the concept of QOL are not entirely suitable for application in clinical trials . The IRGL is overly complex , and its sometimes comprehensive scales do not deal with the possible effects of treatment . Neither of these properties is conducive to sensitivity to change . Visual analogue scales reduce the complexity . A simpler representation of QOL that can evaluate aspects relevant to treatment is recommended",
"OBJECTIVE To examine the value of the Health Assessment Question naire ( HAQ ) as an outcome measure in short term exercise trials . We studied the association of the objectives of exercise , namely joint mobility , muscle strength , and physical condition , with the HAQ . METHODS Data for 100 patients with rheumatoid arthritis ( RA ) included in a study to examine the effect of exercise therapy were used for secondary analysis . Disease activity was determined by the disease activity score ( DAS3 ) , pain was scored on a visual analog scale ( VAS ) , and depression was measured by the Dutch Arthritis Impact Measurement Scale . Aerobic capacity ( VO2max ) estimated from a submaximal ergometer test , grip strength ( kPa ) , isokinetic muscle strength of the knee ( Nm/kg ) , and the Escola Paulista de Medicina range of motion ( EPM-ROM ) score , a measure of general flexibility , were used as indicators for physical impairments . All variables were entered in a forward multiple regression analysis with the HAQ as dependent variable . RESULTS The HAQ was significantly correlated with the DAS3 score ( r = 0.53 ) , pain ( r = 0.51 ) , depression ( r = 0.40 ) , joint mobility ( r = 0.27 ) , quadriceps strength ( r = -0.35 ) , and grip strength ( r = -0.50 ) , but not with physical condition . The DAS3 score was first entered in the multiple regression analysis model , followed by pain , quadriceps strength , and grip strength ( R2 = 0.45 ) . After 12 weeks of exercise therapy changes in the HAQ were significantly correlated with changes in pain ( r = 0.41 ) , in depression ( r = 0.33 ) , and in quadriceps strength ( r = -0.25 ) , but not with changes in joint mobility or physical condition . CONCLUSION Physical impairments are weakly associated with the HAQ . The HAQ is not an appropriate instrument to detect changes in physical impairments due to short term exercise therapy",
"Exposure to environmental tobacco smoke ( ETS ) during fetal life and infancy is closely related to the smoking habits of the parents . Estimates of exposure to ETS require valid and detailed information on changes in cigarette smoking over time . The objective was to test the validity of self-reported smoking among parents during pregnancy and early childhood in a cohort of children at high risk for allergy development by measurement of exhaled carbon monoxide ( CO ) . The cohort comprised 117 families enrolled from the general population of pregnant women at admission to antenatal care . Data on parental tobacco smoking were obtained by interview and exhaled CO was measured ( Micro-Smokerlyzer(R ) ) in parents twice during pregnancy and when the child was 6 and 18 months old . The median ( range ) exhaled CO levels were 3 ( 0 - 10 ) parts per million ( ppm ) for non-smokers and 15 ( 1 - 39 ) ppm for smokers ( P areas under the ROC curve were high for both mothers ( between 0.88 and 0.99 ) and fathers ( between 0.87 and 0.89 ) , indicating exhaled CO as a good diagnostic tool for determining smoking status . Comparing the ROC areas obtained for mothers from late pregnancy and during infancy with the area from early pregnancy showed no statistical differences ( P = 0.21 , 0.43 and 0.44 respectively ) and the same was true for fathers during infancy ( P = 0.81 ) . The level of 8 ppm was used as the cut-off between smokers and non-smokers , based on data from a pilot study . Using CO as a diagnostic tool for smoker status showed very high specificity ( between 97 and 100 % ) , indicating that very few persons cl aim ing to be non-smokers had CO levels higher than 8 ppm . In conclusion , the validity of interview-obtained self-reported smoking among parents during pregnancy and early childhood was high . Repeated interviews and CO measurements in a prospect i ve study design did not change the validity , indicating a low risk of information bias . A structured interview combined with measurement of exhaled CO is a valid and reliable method for estimating ETS exposure to the fetus and young infant"
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4117db88-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Obsessive compulsive disorder ( OCD ) is a psychiatric disorder which has been shown to affect 2 to 3.5 % of people during their lifetimes . Inadequate response occurs in 40 % to 60 % of people that are prescribed first line pharmaceutical treatments ( selective serotonin reuptake inhibitors ( SSRIs ) ) . To date not much is known about the efficacy and adverse effects of second-generation antipsychotic drugs ( SGAs ) in people suffering from OCD . OBJECTIVES To evaluate the effects of SGAs ( monotherapy or add on ) compared with placebo or other forms of pharmaceutical treatment for people with OCD . SEARCH STRATEGY The Cochrane Depression , Anxiety and Neurosis Group 's controlled trial registers ( CCDANCTR- Studies and CCDANCTR-References ) were search ed up to 21 July 2010 . The author team ran complementary search es on Clinical Trials.gov and contacted key authors and drug companies . SELECTION CRITERIA We included double-blind r and omised controlled trials ( RCTs ) comparing oral SGAs ( monotherapy or add on ) in adults with other forms of pharmaceutical treatment or placebo in people with primary OCD . DATA COLLECTION AND ANALYSIS We extracted data independently . For dichotomous data we calculated the odds ratio ( OR ) and their 95 % confidence intervals ( CI ) on an intention-to-treat basis based on a r and om-effects model . For continuous data , we calculated mean differences ( MD ) , again based on a r and om-effects model . MAIN RESULTS We included 11 RCTs with 396 participants on three SGAs . All trials investigated the effects of adding these SGAs to antidepressants ( usually SSRIs ) . The duration of all trials was less than six months . Only 13 % of the participants left the trials early . Most trials were limited in terms of quality aspects . Two trials examined olanzapine and found no difference in the primary outcome ( response to treatment ) and most other efficacy-related outcomes but it was associated with more weight gain than monotherapy with antidepressants . Quetiapine combined with antidepressants was also not any more efficacious than placebo combined with antidepressants in terms of the primary outcome , but there was a significant superiority in the mean Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) score at endpoint ( MD -2.28 , 95 % CI -4.05 to -0.52 ) . There were also some beneficial effects of quetiapine in terms of anxiety or depressive symptoms . Risperidone was more efficacious than placebo in terms of the primary outcome ( number of participants without a significant response ) ( OR 0.17 , 95 % CI 0.04 to 0.66 ) and in the reduction of anxiety and depression ( MD -7.60 , 95 % CI -12.37 to -2.83 ) . AUTHORS ' CONCLUSIONS The available data of the effects of olanzapine in OCD are too limited to draw any conclusions . There is some evidence that adding quetiapine or risperidone to antidepressants increases efficacy , but this must be weighed against less tolerability and limited data
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"Background Although serotonin reuptake inhibitors are effective in the treatment of OCD , many patients fail to respond to these agents . Growing evidence from open-label and placebo-controlled trials suggests a role for augmentation of SRIs with atypical antipsychotics in OCD . Quetiapine is generally well tolerated and previous open-label data has produced mixed results in OCD and additional controlled data is needed . Methods We undertook a double-blind , r and omised , parallel-group , flexible-dose , placebo-controlled study of quetiapine augmentation in subjects who had responded inadequately to open-label treatment with an SRI for 12 weeks . Following informed consent and screening , forty-two subjects were r and omised to either placebo or quetiapine for six weeks . Results There was significant improvement from baseline to endpoint on the Yale-Brown Obsessive-Compulsive Scale in both the quetiapine and placebo groups ( quetiapine , n = 20 , p placebo , n = 21 , p = 0.001 ) with 40 % ( n = 8) of quetiapine and 47.6 % ( n = 10 ) of placebo treated subjects being classified as responders . Quetiapine did not demonstrate a significant benefit over placebo at the end of the six-week treatment period ( p = .636 ) . Similarly quetiapine failed to separate from placebo in the subgroup of subjects ( n = 10 ) with co-morbid tics . Quetiapine was generally well tolerated . Conclusions In this study , quetiapine augmentation was no more effective than placebo augmentation of SRIs . A number of limitations in study design make comparisons with previous studies in this area difficult and probably contributed to our negative findings . Future work in this important clinical area should address these limitations",
"BACKGROUND Although serotonin reuptake inhibitors ( SRIs ) are the first-line treatment for obsessive-compulsive disorder ( OCD ) , approximately half of patients with OCD do not respond adequately to SRI monotherapy . Patients with predominant obsessions are common in OCD and are often difficult to treat , necessitating adjunctive treatment . METHOD This was a 9-week , double-blind , placebo-controlled , crossover study comparing the benefits of 2-week adjunctive treatments with risperidone , haloperidol , and placebo in patients with OCD ( DSM-IV criteria ) who continued to have severe symptoms despite taking a stable dose of an SRI . Eligible patients must have been receiving a therapeutic dose of an SRI for at least 12 weeks and at the screening visit had a score > or = 10 on items 1 - 5 ( obsession ) and a total score > or = 16 on the Yale-Brown Obsessive Compulsive Scale ( YBOCS ) . Data were collected from January 1999 through April 2002 . RESULTS Sixteen patients were enrolled and 12 completed the study . On the YBOCS , both risperidone and haloperidol significantly reduced obsession ( p placebo . There was a tendency that haloperidol , and to a lesser degree risperidone , also reduced the compulsion and the total YBOCS scores . These results were accompanied by a reduction in the Hopkins Symptom Checklist 90-revised ( SCL-90R ) anxiety scale score . According to the 17-item Hamilton Rating Scale for Depression , the SCL-90R depression scale , and the Profile of Mood States , risperidone , but not halo-peridol , also improved depressed mood . Neither risperidone nor haloperidol changed neurocogni-tive function during the 2-week treatment . All 12 patients completed the 2-week risperidone treatment , but 5 of the 12 terminated haloperidol treatment early owing to intolerable side effects . CONCLUSION Adjunctive risperidone improved obsessions and depressed mood and was well tolerated in patients with SRI-refractory OCD",
"The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas",
"BACKGROUND To date , only 1 controlled study has found a drug ( haloperidol ) to be efficacious in augmenting response in patients with obsessive-compulsive disorder ( OCD ) refractory to serotonin reuptake inhibitor ( SRI ) monotherapy ; patients with comorbid chronic tic disorders showed a preferential response . This report describes the first controlled study of risperidone addition in patients with OCD refractory to treatment with SRI alone . METHODS Seventy adult patients with a primary DSM-IV diagnosis of OCD received 12 weeks of treatment with an SRI . Thirty-six patients were refractory to the SRI and were r and omized in a double-blind manner to 6 weeks of risperidone ( n = 20 ) or placebo ( n = 16 ) addition . Behavioral ratings , including the Yale-Brown Obsessive Compulsive Scale , were obtained at baseline and throughout the trial . Placebo-treated patients subsequently received an identical open-label trial of risperidone addition . RESULTS For study completers , 9 ( 50 % ) of 18 risperidone-treated patients were responders ( mean daily dose , 2.2 + /-0.7 mg/d ) compared with 0 of 15 in the placebo addition group ( P risperidone addition responded . Risperidone addition was superior to placebo in reducing OCD ( P , depressive ( P and anxiety ( P = .003 ) symptoms . There was no difference in response between OCD patients with and without comorbid diagnoses of chronic tic disorder or schizotypal personalty disorder . Other than mild , transient sedation , risperidone was well tolerated . CONCLUSION These results suggest that OCD patients with and without comorbid chronic tic disorders or schizotypal personality disorder may respond to the addition of low-dose risperidone to ongoing SRI therapy",
"Objective : Although many patients with obsessive-compulsive disorder ( OCD ) benefit from treatment with serotonin reuptake inhibitors ( SRIs ) , it is estimated that 40 % to 60 % of them do not respond . The objective of the present study was to evaluate the efficacy of quetiapine added to baseline treatment with SRIs for the treatment of OCD in severely ill adult subjects . Method : Forty patients ( 21 men , 19 women ) with primary OCD according to Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria participated in a 12-week , double-blind , placebo-controlled trial . They were r and omly assigned to dosages of quetiapine titrated up to 400 mg/d ( n = 20 ) or to placebo ( n = 20 ) in addition to their SRI treatment . During the continuation phase ( weeks 6 - 12 ) , subjects received different dosages between 400 and 600 mg/d depending on clinical response . At entry , all patients were unresponsive to at least 1 course of at least 12 weeks of treatment with SRIs at defined doses . The total Yale-Brown Obsessive-Compulsive Scale score was the primary efficacy parameter . Results : Intention-to-treat , last-observation-carried-forward analysis demonstrated a mean ± SD decrease in Yale-Brown Obsessive-Compulsive Scale score of 5.2 ± 5.4 in the quetiapine group and 3.9 ± 4.9 in the placebo group . The analysis of treatment effects between the 2 groups showed no significant difference . There were no significant group differences in any of the other self-rating scales or clinician-administered rating scales . Conclusions : In this study , augmentation of SRI treatment with quetiapine in severe OCD had no additional effect",
"BACKGROUND One of the few combination approaches to the treatment of obsessive-compulsive disorder ( OCD ) with encouraging support is the addition of an antipsychotic to a serotonin reuptake inhibitor . METHODS The study consisted of a 6-week , placebo-controlled addition of olanzapine 5 - 10 mg ( 6.1 + /- 2.1 mg , mean + /- SD ) to fluoxetine in OCD subjects who were partial or nonresponders to an 8-week , open-label fluoxetine trial ( 40 mg in 43 subjects , 20 mg in 1 subject ) . RESULTS Both the fluoxetine-plus-olanzapine ( n = 22 ) and fluoxetine-plus-placebo ( n = 22 ) groups improved significantly over 6 weeks [ F(3,113 ) = 11.64 , p Yale-Brown Obsessive Compulsive Scale scores with repeated- measures analysis of variance ; however , the treatment x time interaction was not significant for olanzapine versus placebo addition to fluoxetine . CONCLUSIONS These findings indicate no additional advantage of adding olanzapine for 6 weeks in OCD patients who have not had a satisfactory response to fluoxetine for 8 weeks , compared with extending the monotherapy trial",
"BACKGROUND The purpose of this study was to explore the efficacy of adding an atypical antipsychotic , olanzapine , to a serotonin reuptake inhibitor ( SRI ) in treatment-refractory obsessive-compulsive disorder ( OCD ) . METHOD Twenty-six patients aged between 18 and 65 ( mean = 41.2 , SD = 11.9 ) years meeting DSM-IV criteria for OCD , who had not responded to SRIs , were treated for 6 weeks in a double-blind , placebo-controlled augmentation study with either olanzapine ( up to 20 mg/day ) or placebo . Severity of illness was assessed biweekly by the Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) . Analysis of covariance with baseline Y-BOCS score included as a covariate was used to compare improvement in Y-BOCS scores in the 2 groups . Response was defined as a 25 % or greater improvement in Y-BOCS score . Data were collected between April 2001 and May 2003 . RESULTS Outcome was assessed for all patients using the last observation carried forward . Subjects in the olanzapine group had a mean decrease of 4.2 ( SD = 7.9 ) in Y-BOCS score compared with a mean increase in score of 0.54 ( SD = 1.31 ) for subjects in the placebo group ( F = 4.85 , df = 2,23 ; p = .04 ) . Six ( 46 % ) of 13 subjects in the olanzapine group showed a 25 % or greater improvement in Y-BOCS score compared with none in the placebo group . The final mean dose of olanzapine was 11.2 ( SD = 6.5 ) mg/day . Medication was well tolerated . Only 2 ( 15 % ) of 13 subjects who received olanzapine discontinued because of side effects : sedation ( N = 1 ) or weight gain ( N = 1 ) . CONCLUSION These results provide preliminary evidence that adding olanzapine to SRIs is potentially efficacious and well tolerated in the short-term treatment of patients with refractory OCD . Controlled studies with larger sample sizes are necessary to more definitively address this treatment strategy",
"According to previous data , the addition of risperidone in obsessive-compulsive patients refractory to serotonin reuptake inhibitors ( SRIs ) is shown to be a safe and effective treatment strategy . The aims of our study were to evaluate the efficacy of risperidone addition , in comparison to placebo , in fluvoxamine-refractory obsessive-compulsive patients and to investigate whether risperidone could boost the efficacy of fluvoxamine in fluvoxamine-responder patients . Subjects were 45 obsessive-compulsive in patients , consecutively recruited at the Department of Neurosciences at the San Raffaele Hospital , Milan . Thirty-nine patients completed the study . All patients received 12 weeks of a st and ardized open-label fluvoxamine monotherapy and then continued for 6 weeks with placebo or risperidone in a double-blind design . Results showed a significant effect of risperidone addition , at the end of the double-blind phase ( 18th week ) , only for fluvoxamine-refractory patients . Five patients on risperidone ( 50 % ) and two ( 20 % ) on placebo became responders , with a Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) decrease > or = 35 % . Risperidone was generally well tolerated , except for a mild transient sedation and a mild increase in appetite . This preliminary study suggests that even very low ( 0.5 mg ) risperidone doses are effective in OC patients who were nonresponders to a st and ardized treatment with fluvoxamine",
"The aim of the present pilot study was to investigate in a single-blind manner , over a period of 8 weeks , the comparative efficacy and tolerability of risperidone versus olanzapine addition in the treatment of OCD patients who did not show a > or=35 % decrease in the YBOCS score after 16-week SRI treatment ( defined as resistant ) . The study consisted of two different phases : a 16-week open-label prospect i ve phase to ascertain resistance to SRI treatment and an 8-week single-blind addition phase for resistant subjects only . Ninety-six subjects with DSM-IV OCD ( YBOCS > or=16 ) entered the open-label prospect i ve phase ; at the end of the 16-week period , 50 ( 52 % ) were judged to be resistant and were r and omized to receive risperidone ( 1 to 3 mg/d ) or olanzapine ( 2.5 to 10 mg/d ) addition for 8 weeks . Overall , patients in both groups responded significantly , without differences between the two treatment groups ; although no differences emerged for the proportion of patients reporting at least an adverse event , the profiles of adverse experiences differed significantly , being risperidone associated with amenorrhoea and olanzapine with weight gain",
"OBJECTIVE Although atypical antipsychotic agents have been found effective in the augmentation of serotonin reuptake inhibitors ( SRIs ) for treatment-resistant obsessive-compulsive disorder ( OCD ) in short-term trials , there are few data on the effectiveness and safety of these agents in clinical setting s over the long term . METHOD Subjects ( N = 46 ) who responded to selective SRIs ( SSRIs ) in an initial 12-week trial were continued on SSRI monotherapy plus cognitive-behavioral therapy ( CBT ) for 1 year . Subjects ( N = 44 ) who failed to respond to SSRIs were r and omly assigned to 1 of 3 atypical antipsychotics -- olanzapine , quetiapine , or risperidone -- and were consecutively treated using SSRI + atypical antipsychotics combined with CBT for 1 year . This study was conducted from January 2006 to November 2007 at Osaka City University Graduate School of Medicine Hospital , Japan . RESULTS Augmentation with atypical antipsychotics reduced mean + /- SD Yale-Brown Obsessive Compulsive Scale ( YBOCS ) total scores in SSRI-refractory OCD patients ( at initial assessment = 29.3 + /- 9.9 , after 1 year = 19.3 + /- 6.8 ) . However , compared to SSRI responders ( at initial assessment = 25.8 + /- 11.4 , after 1 year = 13.7 + /- 4.6 ) , total YBOCS scores in those who required atypical antipsychotic augmentation were initially higher , and they remained at higher levels than those of SRI responders after 1 year of the treatments . CONCLUSIONS Our work does not sufficiently support the long-term effectiveness of the atypical antipsychotics in the augmentation of SSRIs for treatment-resistant OCD patients . Even though this approach seems useful for some types of OCD patients , such as those with symmetry/ordering and hoarding symptoms , these data emphasize the limitations of the current pharmacotherapeutic options in treatment-refractory OCD , and their chronic use raises a number of safety concerns . TRIAL REGISTRATION ( Clinical Trials.gov ) Identifier NCT00854919",
"BACKGROUND Although serotonin reuptake inhibitors ( SRIs ) are the most effective pharmacologic treatment currently available for patients with obsessive-compulsive disorder ( OCD ) , 40 % to 60 % of patients do not respond to this treatment . This study was conducted to evaluate the efficacy and tolerability of quetiapine in addition to an SRI for treatment-refractory patients with OCD . METHOD Forty patients ( 10 men/30 women , mean + /- SD age = 35.2 + /- 12.1 years ; range , 18 - 60 years ) with primary OCD according to DSM-IV criteria who were recruited between February 2001 and December 2002 were r and omly assigned in an 8-week , double-blind , placebo-controlled trial to receive dosages titrated upward to 300 mg/day of quetiapine ( N = 20 ) or placebo ( N = 20 ) in addition to their SRI treatment . At entry , all patients were unresponsive to courses of treatment with at least 2 different SRIs at a maximum tolerated dose for 8 weeks . During the study , primary efficacy was assessed according to change from baseline on the Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) . A responder was defined as having a final Clinical Global Impressions-Improvement scale rating of \" very much improved \" or \" much improved \" and a decrease of > or = 35 % in Y-BOCS score . RESULTS An intent-to-treat , last-observation-carried-forward analysis demonstrated a mean + /- SD decrease in Y-BOCS score of 9.0 + /- 7.0 ( 31 % ) in the quetiapine group and 1.8 + /- 3.4 ( 7 % ) in the placebo group ( F=16.99 , df=1,38 ; p somnolence , dry mouth , weight gain , and dizziness . CONCLUSION The results of this study show that quetiapine in addition to an SRI is beneficial for patients with OCD who do not respond to SRI treatment alone",
"OBJECTIVE Although patients with obsessive-compulsive disorder ( OCD ) benefit from treatment with serotonin reuptake inhibitors ( SRIs ) , it is estimated that 40 % to 60 % of the patients remain unimproved . The objective of this study was to examine whether addition of the atypical antipsychotic quetiapine to SRIs is useful for patients with OCD who do not respond to SRI monotherapy . METHOD Ten patients with OCD ( DSM-IV criteria ) who had not responded to at least 3 previous treatments with an SRI at maximum dose and duration were assigned to receive quetiapine in addition to an SRI for 8 weeks . Treatment response was assessed using the Yale-Brown Obessive-Compulsive Scale ( YBOCS ) . RESULTS Seven of 10 patients responded to the quetiapine addition . The mean + /- SD baseline YBOCS score of 31.4 + /- 7.8 dropped to a mean of 20.8 + /- 8.4 at endpoint with a mean reduction of 35.4 % . CONCLUSION This is the first study to show that treatment-refractory OCD patients may benefit from addition of quetiapine to ongoing SRI therapy",
"This double-blind , placebo-controlled trial was performed to determine the efficacy and tolerability of 8 wk of risperidone augmentation of serotonin reuptake inhibitor ( SRI ) treatment in adult subjects with treatment-resistant obsessive-compulsive disorder ( OCD ) ( failure of at least two SRI trials ) . Sixteen adult treatment-resistant OCD patients were r and omly assigned to augmentation with 8 wk of either risperidone ( n=10 ) ( 0.5 - 3.0 mg/d ) or placebo ( n=6 ) following at least 12 wk of SRI treatment . Four patients on risperidone ( 40 % ) and none ( 0 % ) on placebo were responders with both a Clinical Global Impression - Improvement ( CGI-I ) score of 1 or 2 and a Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) decrease > /=25 % . Risperidone was generally well tolerated : there were 3 dropouts , 1 on risperidone and 2 on placebo . Better Y-BOCS insight score at baseline significantly correlated with a greater CGI-I score at endpoint on risperidone augmentation . Risperidone may be an effective and well-tolerated augmentation strategy in treatment-resistant OCD subjects , but larger sample size studies are required to demonstrate this",
"BACKGROUND Adding the atypical neuroleptic risperidone to a serotonin reuptake inhibitor ( SRI ) has benefited patients with treatment-refractory obsessive-compulsive disorder ( OCD ) . Since olanzapine and risperidone have similar serotonergic and dopaminergic receptor binding profiles , we tested the hypothesis that olanzapine augmentation would be beneficial in treatment-unresponsive OCD . METHOD For this 8-week trial , we recruited 10 adult OCD patients ( DSM-IV criteria ) unresponsive to fluoxetine ( > or = 60 mg/day ) for > or = 10 weeks , which was continued throughout the trial . Other psychotropic medications were discontinued . Subjects had OCD for > or = 1 year , a Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) score of > or = 18 , and no organic , psychotic , or other primary Axis I disorder . Two weeks after olanzapine , 2.5 mg/day , was added , and in the absence of responder status ( Y-BOCS score decrease > or = 25 % ) and limiting side effects , we increased the dose to 5 mg/day , and after 2 more weeks , to 10 mg/day for 4 weeks . RESULTS The subjects had failed a mean of 3.3 SRI trials ( range , 1 - 5 ) and had a mean + /- SD baseline Y-BOCS score of 29.0 + /- 4.9 . Nine patients completed the trial . The subjects ' mean + /- SD endpoint Y-BOCS score was 24.4 + /- 8.0 ( a 16 % decrease ) . The 3 responders ' Y-BOCS scores dropped 68 % , 30 % , and 29 % , but only 1 patient was rated \" much improved . \" He maintained this improvement during a 6-month follow-up period taking olanzapine , 5 mg/day . Improvement in OCD was independent of improvement in mood symptoms . Six patients ( 60 % ) experienced significant weight gain . CONCLUSION Olanzapine augmentation may benefit treatment-unresponsive OCD . Double-blind , placebo-controlled trials are warranted along with trials comparing risperidone and olanzapine augmentation",
"OBJECTIVE To assess the efficacy of quetiapine addition to citalopram in treatment-naive or medication-free obsessive-compulsive disorder ( OCD ) patients . METHOD Seventy-six patients who met DSM-IV criteria for OCD and who were drug-free or drug-naive at entry were r and omly assigned in a 10-week , double-blind trial with citalopram ( 60 mg/day ) plus quetiapine ( 300 - 450 mg/day ) or placebo ; treatment-refractory OCD patients were excluded . Of the 76 eligible patients , 66 patients completed the trial-31 in the quetiapine and 35 in the placebo group . The change from baseline to endpoint on the total Yale-Brown Obsessive Compulsive Scale ( YBOCS ) and the response to treatment in the quetiapine addition compared with the placebo addition group were the primary outcome measures . Response was defined as a 35 % or greater reduction on the YBOCS and a Clinical Global Impressions-Improvement ( CGI-I ) score at endpoint of 1 or 2 . The study was conducted from November 2003 to June 2005 at the University Medical Centre Utrecht , The Netherl and s. RESULTS As measured by the mean reduction in YBOCS scores following an intent-to-treat , last-observation-carried-forward analysis , quetiapine addition ( 11.9 ) was significantly superior to placebo ( 7.8 ; p = .009 ) . Quetiapine addition was also significantly superior to placebo on the CGI-I scale , with a mean + /- SD CGI-I score of 2.1 + /- 1.3 versus 1.4 + /- 1.2 , respectively ( p = .023 ) . Quetiapine addition ( N = 22 , 69 % ) was also associated with a significantly greater number of patients responding to treatment compared with placebo addition ( N = 15 , 41 % ; p = .019 ) . More patients receiving quetiapine ( N = 8) than placebo ( N = 2 ; NS ) discontinued treatment due to adverse events . CONCLUSIONS The combination of quetiapine and citalopram was more effective than citalopram alone in reducing OCD symptoms in treatment-naive or medication-free OCD patients . TRIAL REGISTRATION www.trialregister.nl Identifier NTR116",
"This study aim ed to determine the efficacy and tolerability of adding quetiapine to a serotonin reuptake inhibitor in treatment-resistant obsessive – compulsive disorder ( OCD ) . Twenty-one adult treatment-resistant OCD patients were r and omized to 16 weeks of augmentation with either quetiapine ( n=11 ) or placebo ( n=10 ) . Patients with significant comorbidities , including tic-spectrum disorders , were not included . The treatment was well tolerated , with only one premature dropout in each treatment-group . The primary analysis showed that individuals in the quetiapine-treated group showed a 14 % mean improvement in baseline Yale – Brown Obsessive – Compulsive Scale scores at study endpoint compared with a 6 % improvement in those treated with placebo , but this difference did not reach statistical significance ( F quetiapine met criteria for clinical response , compared to one patient who was treated with placebo . Larger studies are needed to explore the efficacy of second generation antipsychotics , such as quetiapine , when used as adjunct treatment in resistant OCD",
"The augmentation of serotonin reuptake inhibitors ( SRIs ) with atypical antipsychotics for the management of treatment-resistant obsessive-compulsive disorder ( OCD ) is gaining increasing acceptance . Quetiapine is a novel antipsychotic which is well tolerated , and which may therefore be particularly useful in this context . Charts of all patients treated in our OCD clinic with the combination of an SRI and quetiapine were review ed . Demographic details and clinical symptoms on the Yale-Brown Obsessive-Compulsive Scale and the Clinical Global Impressions Scale ( CGI ) were tabulated before and after augmentation . Eight OCD patients who had proven resistance to treatment with SRIs had received quetiapine augmentation . Four of these eight patients were responders ( CGI of 1 or 2 ) within 4 weeks . In the treatment-responders , the medication was well tolerated . Although limited by the retrospective design and lack of controls , these data are consistent with the growing literature suggesting that approximately one-half of OCD patients resistant to treatment with SRIs may respond to augmentation with an atypical antipsychotic . Quetiapine , a relatively well tolerated agent , deserves further controlled study in this context",
"Recently , atypical antipsychotics have been used for the management of the patients with refractory obsessive – compulsive disorder ( OCD ) . The aim of the present study was to evaluate the results of quetiapine augmentation to a serotonin reuptake inhibitor ( SRI ) in the patients with refractory OCD . Fifty-two patients with OCD according to DSM-IV entered 3 months of an open-label phase treatment with a SRI with or without concomitant adjunctive treatment regimen . Of them , 27 patients were refractory OCD . These patients were r and omly divided into two groups , SRI plus quetiapine and SRI plus placebo , for an 8-week single-blind phase . The course of OCD was evaluated by Yale – Brown Obsession – Compulsion ( Y-BOCS ) and Clinical Global Impression – Severity of Illness and Improvement ( CGI-SI and I ) Scales every other week for 8 weeks . Of the 14 patients in group I , nine ( 64.4 % ) showed significant improvement with 60 % or greater improvement on the Y-BOCS and one ( 7.1 % ) partial improvement with 30 % or greater improvement on the Y-BOCS , whereas no improvement was observed in group II . The addition of quetiapine to ongoing SRI therapy has been found to be effective and well-tolerated approach in patients with refractory OCD",
"The aim of the present study was to investigate the effect of adjunctive olanzapine in patients with obsessive-compulsive disorder ( OCD ) refractory to paroxetine . Twenty-one patients unresponsive to treatment with paroxetine , administered for at least 12 weeks at the dose of 60 mg/day , participated to a 12-week open-label , add-on trial with olanzapine ( 10 mg/day ) . The psychopathological state was evaluated by the Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) and by Clinical Global Impression ( CGI ) . Three patients did not complete the 12-week adjunctive treatment with olanzapine . In the 18 completers , the mean Y-BOCS score decreased significantly from 27.1+/-4.0 at baseline to 20.1+/-3.9 at final evaluation ( P Steady-state plasma concentrations of paroxetine were not modified during olanzapine coadministration . The drug combination was generally well tolerated and initial sedation and weight gain were the most frequent unwanted effects . Our findings confirm the results of previous studies and indicate that the addition of olanzapine to ongoing treatment with serotonin reuptake inhibitors ( SRI ) may be beneficial in some patients unresponsive to SRI monotherapy",
"To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrollment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results"
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Atrial fibrillation ( AF ) is highly prevalent in older adults and has been associated with increased morbidity and mortality . To reduce this AF-related morbidity in older adults , antiarrhythmic drugs ( AADs ) are regularly used for rhythm control , assuming that increasing time in sinus rhythm reduces AF-related morbidity . However , whether AADs can improve clinical outcomes in older adults remains unclear because of the increased risk for adverse drug events compared with rate control . The aim of this study was to determine the impact of rhythm control versus rate control on clinical outcomes in older adults with AF . We conducted a systematic review and meta- analysis targeting patients aged ≥65 years with AF and using drugs to control rate or rhythm . Articles that met the following criteria were included : enrolled older patients ( sample mean ≥75 years ) with AF , compared pharmacological rate versus rhythm control , and reported all-cause mortality , cardiovascular mortality , or ischemic stroke . Five observational studies were included . In total , 86,926 patients with AF with a mean age ranging from 75 to 92 years were studied . No differences were found between rhythm and rate control for all-cause mortality ( odds ratio [ OR ] 1.11 ; 95 % confidence interval [ CI ] 0.78–1.59 ; I2 = 79.6 % ; n = 28,526 ; four studies ) and cardiovascular mortality ( OR 1.09 ; 95 % CI 0.81–1.47 ; I2 = 0 % ; n = 2292 ; two studies ) . Rhythm control result ed in fewer strokes ( OR 0.86 ; 95 % CI 0.80–0.93 ; I2 = 0 % ; n = 59,496 ) , although this was mainly determined by one study . All collected data were observational , which precluded making strong recommendations . Furthermore , all CIs were wide , increasing the uncertainty of the observed effects . As such , evidence was insufficient to recommend rhythm or rate control as the first-line therapy for AF in older adults . As AF is particularly prevalent in older people , more r and omized controlled trials are needed in this population
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"Background and Purpose — Atrial fibrillation is associated with decline of cognitive function . Observational evidence suggests that anticoagulation might protect against this decline . We report the first r and omized controlled trial evidence on the effect of anticoagulation on cognitive function in elderly patients with atrial fibrillation . Methods — A total of 973 patients aged ≥75 years with atrial fibrillation were recruited from primary care and r and omly assigned to warfarin ( n=488 ; target international normalized ratio , 2–3 ) or aspirin ( n=485 ; 75 mg/d ) . Neither participants nor investigators were masked to group assignment . Follow-up was for a mean of 2.7 years ( SD , 1.2 ) . Cognitive outcome was assessed using the Mini-Mental State Examination at 9- , 21- , and 33-month follow-up . Participants who had a stroke were censored from the analysis , which was by intention to treat with imputation for missing data . Results — There was no difference between mean Mini-Mental State Examination scores in people assigned to warfarin or aspirin at 9 or 21 months . At 33-month follow-up , there was a nonsignificant difference of 0.56 in favor of warfarin that decreased to 0.49 ( 95 % confidence interval , –0.01 to 0.98 ) after imputation . Conclusions — We found no evidence that anticoagulation confers clinical ly important protection over aspirin against cognitive decline as measured by the Mini-Mental State Examination in atrial fibrillation in the first 33 months of treatment other than that provided by preventing clinical stroke . Clinical Trial Registration — URL : http://www.controlled-trials.com . Unique identifier : IS RCT N89345269",
"BACKGROUND Atrial fibrillation is an important cause of morbidity and mortality worldwide , but scant data are available for long-term outcomes in individuals outside North America or Europe , especially in primary care setting s. METHODS We did a cohort study using a prospect i ve registry of patients in 47 countries who presented to a hospital emergency department with atrial fibrillation or atrial flutter as a primary or secondary diagnosis . 15 400 individuals were enrolled to determine the occurrence of death and strokes ( the primary outcomes ) in this cohort over eight geographical regions ( North America , western Europe , and Australia ; South America ; eastern Europe ; the Middle East and Mediterranean crescent ; sub-Saharan Africa ; India ; China ; and southeast Asia ) 1 year after attending the emergency department . Patients from North America , western Europe , and Australia were used as the reference population , and compared with patients from the other seven regions FINDINGS Between Dec 24 , 2007 , and Oct 21 , 2011 , we enrolled 15 400 individuals to the registry . Follow-up was complete for 15 361 ( 99·7 % ) , of whom 1758 ( 11 % ) died within 1 year . Fewer deaths occurred among patients presenting to the emergency department with a primary diagnosis of atrial fibrillation compared with patients who had atrial fibrillation as a secondary diagnosis ( 377 [ 6 % ] of 6825 patients vs 1381 [ 16 % ] of 8536 , p had died by 1 year in South America ( 192 [ 17 % ] of 1132 ) and Africa ( 225 [ 20 % ] of 1137 ) compared with North America , western Europe , and Australia ( 366 [ 10 % ] of 3800 , p was the most common cause of death ( 519 [ 30 % ] of 1758 ) ; stroke caused 148 ( 8 % ) deaths . 604 ( 4 % ) of 15361 patients had had a stroke by 1 year ; 170 ( 3 % ) of 6825 for whom atrial fibrillation was a primary diagnosis and 434 ( 5 % ) of 8536 for whom it was a secondary diagnosis ( p ) . The highest number of strokes occurred in patients in Africa ( 89 [ 8 % ] of 1137 ) , China ( 143 [ 7 % ] of 2023 ) , and southeast Asia ( 88 [ 7 % ] of 1331 ) and the lowest occurred in India ( 20 [ stroke and mortality suggest that factors other than clinical variables might be important . Prevention of death from heart failure should be a major priority in the treatment of atrial fibrillation . FUNDING Boehringer Ingelheim",
"OBJECTIVES The study sought to evaluate clinical outcomes in clinical practice with rhythm control versus rate control strategy for management of atrial fibrillation ( AF ) . BACKGROUND R and omized trials have not demonstrated significant differences in stroke , heart failure , or mortality between rhythm and rate control strategies . The comparative outcomes in contemporary clinical practice are not well described . METHODS Patients managed with a rhythm control strategy targeting maintenance of sinus rhythm were retrospectively compared with a strategy of rate control alone in a AF registry across various U.S. practice setting s. Unadjusted and adjusted ( inverse-propensity weighted ) outcomes were estimated . RESULTS The overall study population ( N = 6,988 ) had a median of 74 ( 65 to 81 ) years of age , 56 % were males , 77 % had first detected or paroxysmal AF , and 68 % had CHADS2 score ≥2 . In unadjusted analyses , rhythm control was associated with lower all-cause death , cardiovascular death , first stroke/non- central nervous system systemic embolization/transient ischemic attack , or first major bleeding event ( all p in new onset heart failure ( p = 0.28 ) ; and more frequent cardiovascular hospitalizations ( p = 0.0006 ) . There was no difference in the incidence of pacemaker , defibrillator , or cardiac resynchronization device implantations ( p = 0.99 ) . In adjusted analyses , there were no statistical differences in clinical outcomes between rhythm control and rate control treated patients ( all p > 0.05 ) ; however , rhythm control was associated with more cardiovascular hospitalizations ( hazard ratio : 1.24 ; 95 % confidence interval : 1.10 to 1.39 ; p = 0.0003 ) . CONCLUSIONS Among patients with AF , rhythm control was not superior to rate control strategy for outcomes of stroke , heart failure , or mortality , but was associated with more cardiovascular hospitalizations ",
"Background : Atrial fibrillation ( AF ) and heart failure ( HF ) often coexist . The aim was to investigate whether restoring sinus rhythm ( SR ) could improve cardiac function , symptoms , exercise capacity and quality of life ( QoL ) in patients with chronic heart failure . Methods : Patients with HF and persistent AF receiving guideline -recommended treatments , including anticoagulants , were eligible for the study . Patients were r and omised to either rhythm ( treated with amiodarone for at least 3 months prior to attempting biphasic external cardioversion and continued amiodarone long-term if SR was restored ) or rate control . Anticoagulants were continued throughout the study regardless of rhythm , unless contraindications developed . Both groups were treated with beta blockers and /or digoxin to reduce the heart rate to 80 bpm at rest and walking . Symptoms , walk distance ( 6-minute corridor walk test , 6MWT ) , QoL and cardiac function were assessed at baseline and 1 year . Results : 61 patients with HF and persistent AF ( median duration 14 months ( IQR 5 to 32 ) ) were r and omly assigned to a rate or rhythm control strategy . Of patients assigned to rhythm control ( n = 30 ) , 66 % were in SR at 1 year , and 90 % of those assigned to rate control ( n = 31 ) achieved the heart rate target . At 1 year , NYHA class ( p = 0.424 ) and 6MWT distance ( p = 0.342 ) were similar between groups but patients assigned to rhythm control had improved LV function ( p = 0.014 ) , NT-proBNP concentration ( p = 0.046 ) and QoL ( p = 0.019 ) compared with those assigned to rate control . Greatest improvement was seen in patients in whom SR was maintained . Conclusion : Restoring SR in patients with AF and heart failure may improve QoL and LV function when compared with a strategy of rate control",
"BACKGROUND Atrial fibrillation ( AF ) is the most common sustained arrhythmia with serious clinical consequences in the absence of treatment . However , there are limited data on the treatment of these patients in Argentina . The objective was to describe the therapeutic management of patients with nonacute AF by Argentinean cardiologists and to determine the incidence of clinical events after 12 months follow-up . METHODS The Atrial Fibrillation study in Argentina ( FARAON ) was an observational , descriptive , prospect i ve , national , and multicentric study that included out patients with AF , followed for 12 months . The study included 38 sites in Argentina . Each research er included the first 10 patients who met the inclusion criteria of being over 21 and also being an AF carrier documented by electrocardiogram or Holter within 12 months prior to or at the time of enrollment . RESULTS A total of 373 patients were included , mean age 70 ± 11.5 years , 40 % women ; 65 % had AF rhythm at the time of inclusion , 57 % had permanent AF , and 56 % were asymptomatic . At the time of enrollment , 40 % of physicians opted for rhythm control strategy . β-blockers and amiodarone were the most used drugs . Patients with rhythm control drugs had higher success rate than those with frequency control drug therapy ( 80 % vs 57 % ) . CONCLUSION Cardiologists in Argentina receive patients with AF that are mostly permanent AF . More than half of the patients are asymptomatic . They opt primarily by controlling the pace . When choosing antiarrhythmic drugs , nearly half of them indicated amiodarone ",
"BACKGROUND The restoration and maintenance of sinus rhythm is a desirable goal in patients with atrial fibrillation , because the prevention of recurrences can improve cardiac function and relieve symptoms . Uncontrolled studies have suggested that amiodarone in low doses may be more effective and safer than other agents in preventing recurrence , but this agent has not been tested in a large , r and omized trial . METHODS We undertook a prospect i ve , multicenter trial to test the hypothesis that low doses of amiodarone would be more efficacious in preventing recurrent atrial fibrillation than therapy with sotalol or propafenone . We r and omly assigned patients who had had at least one episode of atrial fibrillation within the previous six months to amiodarone or to sotalol or propafenone , given in an open-label fashion . The patients in the group assigned to sotalol or propafenone underwent a second r and omization to determine whether they would receive sotalol or propafenone first ; if the first drug was unsuccessful the second agent was prescribed . Loading doses of the drugs were administered and electrical cardioversion was performed ( if necessary ) within 21 days after r and omization for all patients in both groups . The follow-up period began 21 days after r and omization . The primary end point was the length of time to a first recurrence of atrial fibrillation . RESULTS Of the 403 patients in the study , 201 were assigned to amiodarone and 202 to either sotalol ( 101 patients ) or propafenone ( 101 patients ) . After a mean of 16 months of follow-up , 71 of the patients who were assigned to amiodarone ( 35 percent ) and 127 of those who were assigned to sotalol or propafenone ( 63 percent ) had a recurrence of atrial fibrillation ( P Adverse events requiring the discontinuation of drug therapy occurred in 18 percent of the patients receiving amiodarone , as compared with 11 percent of those treated with sotalol or propafenone ( P=0.06 ) . CONCLUSIONS Amiodarone is more effective than sotalol or propafenone for the prevention of recurrences of atrial fibrillation",
"OBJECTIVES This study was design ed to compare two treatment strategies in patients with atrial fibrillation(AF ) : rhythm-control ( restoration and maintenance of sinus rhythm ) and rate-control ( pharmacologic or invasive rate-control and anticoagulation ) . BACKGROUND Atrial fibrillation is the most common arrhythmia . It is unclear whether a strategy of rhythm- or rate-control is better in terms of mortality , morbidity , and quality of life . METHODS The Strategies of Treatment of Atrial Fibrillation ( STAF ) multicenter pilot trial r and omized 200 patients ( 100 per group ) with persistent AF to rhythm- or rate-control . The combined primary end point was a combination of death , cardiopulmonary resuscitation , cerebrovascular event , and systemic embolism . RESULTS After 19.6 + /- 8.9 months ( range 0 to 36 months ) there was no difference in the primary end point between rhythm-control ( 9/100 ; 5.54%/year ) and rate-control ( 10/100 ; 6.09%/year ; p = 0.99 ) . The percentage of patients in sinus rhythm in the rhythm-control group after up to four cardioversions during the follow-up period ( rate-control group ) was 23 % ( 0 % ) at 36 months . Eighteen primary end points occurred in atrial fibrillation ; only one occurred in sinus rhythm ( p = 0.049 ) . CONCLUSIONS The STAF pilot study showed no differences between the two treatment strategies in all end points except hospitalizations . These data suggest that there was no benefit in attempting rhythm-control in these patients with a high risk of arrhythmia recurrence . It remains unclear whether the results in the rhythm-control group would have been better if sinus rhythm had been maintained in a higher proportion of patients , as all but one end point occurred during AF",
"BACKGROUND Maintenance of sinus rhythm is the main therapeutic goal in patients with atrial fibrillation . However , recurrences of atrial fibrillation and side effects of antiarrhythmic drugs offset the benefits of sinus rhythm . We hypothesized that ventricular rate control is not inferior to the maintenance of sinus rhythm for the treatment of atrial fibrillation . METHODS We r and omly assigned 522 patients who had persistent atrial fibrillation after a previous electrical cardioversion to receive treatment aim ed at rate control or rhythm control . Patients in the rate-control group received oral anticoagulant drugs and rate-slowing medication . Patients in the rhythm-control group underwent serial cardioversions and received antiarrhythmic drugs and oral anticoagulant drugs . The end point was a composite of death from cardiovascular causes , heart failure , thromboembolic complications , bleeding , implantation of a pacemaker , and severe adverse effects of drugs . RESULTS After a mean ( + /-SD ) of 2.3+/-0.6 years , 39 percent of the 266 patients in the rhythm-control group had sinus rhythm , as compared with 10 percent of the 256 patients in the rate-control group . The primary end point occurred in 44 patients ( 17.2 percent ) in the rate-control group and in 60 ( 22.6 percent ) in the rhythm-control group . The 90 percent ( two-sided ) upper boundary of the absolute difference in the primary end point was 0.4 percent ( the prespecified criterion for noninferiority was 10 percent or less ) . The distribution of the various components of the primary end point was similar in the rate-control and rhythm-control groups . CONCLUSIONS Rate control is not inferior to rhythm control for the prevention of death and morbidity from cardiovascular causes and may be appropriate therapy in patients with a recurrence of persistent atrial fibrillation after electrical cardioversion",
"BACKGROUND It is common practice to restore and maintain sinus rhythm in patients with atrial fibrillation and heart failure . This approach is based in part on data indicating that atrial fibrillation is a predictor of death in patients with heart failure and suggesting that the suppression of atrial fibrillation may favorably affect the outcome . However , the benefits and risks of this approach have not been adequately studied . METHODS We conducted a multicenter , r and omized trial comparing the maintenance of sinus rhythm ( rhythm control ) with control of the ventricular rate ( rate control ) in patients with a left ventricular ejection fraction of 35 % or less , symptoms of congestive heart failure , and a history of atrial fibrillation . The primary outcome was the time to death from cardiovascular causes . RESULTS A total of 1376 patients were enrolled ( 682 in the rhythm-control group and 694 in the rate-control group ) and were followed for a mean of 37 months . Of these patients , 182 ( 27 % ) in the rhythm-control group died from cardiovascular causes , as compared with 175 ( 25 % ) in the rate-control group ( hazard ratio in the rhythm-control group , 1.06 ; 95 % confidence interval , 0.86 to 1.30 ; P=0.59 by the log-rank test ) . Secondary outcomes were similar in the two groups , including death from any cause ( 32 % in the rhythm-control group and 33 % in the rate-control group ) , stroke ( 3 % and 4 % , respectively ) , worsening heart failure ( 28 % and 31 % ) , and the composite of death from cardiovascular causes , stroke , or worsening heart failure ( 43 % and 46 % ) . There were also no significant differences favoring either strategy in any predefined subgroup . CONCLUSIONS In patients with atrial fibrillation and congestive heart failure , a routine strategy of rhythm control does not reduce the rate of death from cardiovascular causes , as compared with a rate-control strategy . ( Clinical Trials.gov number , NCT00597077 .",
"OBJECTIVE The objective of this prespecified sub study of the AFFIRM study , in which no differences in survival or event rates were found in patients with atrial fibrillation ( AF ) r and omized to either rate control or rhythm control , was to test the None hypothesis that quality of life ( QoL ) is equal with rate- versus rhythm-control treatment strategies in AF . METHODS Fifty-six ( 25 % ) of AFFIRM sites were r and omly selected to recruit AFFIRM patients for the QoL sub study . Instruments used in the QoL assessment were ( 1 ) Perceived Health ; ( 2 ) the Cantril Ladder of Life ; ( 3 ) the Short Form 36 survey ; ( 4 ) the QoL Index ; and ( 5 ) the Symptom Checklist : Frequency and Severity . Data were collected at baseline , 2 months , 12 months , and annually ; data are reported through 4 years of follow-up . RESULTS Baseline characteristics of the AFFIRM QoL patients ( n = 716 ) were generally similar to those of the rest of AFFIRM patients . Quality -of-life scores were similar in rate- and rhythm-control assignment groups at all time points . Quality -of-life scores were similar whether the actual rhythm was sinus or AF . Scores increased from baseline to subsequent time points similarly for both groups ; these improvements were not additive over time . CONCLUSIONS Quality of life was comparable between rate- and rhythm-control treatment strategies . In addition , QoL was similar with sinus rhythm versus AF . Attempts to improve QoL by restoring sinus rhythm will usually be unsuccessful",
"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",
"OBJECTIVES RECORDAF is the first worldwide , prospect i ve , observational survey of management of atrial fibrillation ( AF ) in unselected , community-based patients . BACKGROUND Primary outcomes were therapeutic success and clinical outcomes associated with rhythm-control and rate-control strategies . METHODS Patients with recent-onset AF were included ( n = 5,604 ) . Treatment strategy ( rhythm control or rate control ) was noted at baseline . Follow-up was 12 months . Therapeutic success required that strategy was unchanged without clinical events . Further maintenance of sinus rhythm was required in the rhythm-control group , and heart rate ≤80 beats/min in the rate-control group . RESULTS Data from 5,171 patients were assessable . Therapeutic success was 54 % overall ( rhythm control 60 % vs. rate control 47 % ) , a result driven by control of AF : rhythm control , 81 % vs. rate control , 74 % . After adjustment for propensity score quintiles , the rhythm-control strategy was significantly related to superior therapeutic success ( odds ratio : 1.34 , 95 % confidence interval : 1.15 to 1.55 ; p = 0.0002 ) . Clinical events occurred in 18 % of patients . The arrhythmia management strategy was not predictive of clinical events . The type ( persistent ) , presence at baseline visit , and duration ( > 3 months ) of AF , together with age older than 75 years and the presence of heart failure , predicted progression to permanent AF . The choice of rhythm control reduced the likelihood of AF progression ( odds ratio : 0.20 , 95 % confidence interval : 0.17 to 0.25 ; p CONCLUSIONS Clinical outcomes in AF patients were driven mainly by hospitalizations for arrhythmia/proarrhythmia and other cardiovascular causes , but not by the choice of rate or rhythm strategy . Rhythm-control patients progressed less rapidly to permanent AF "
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4117dc0a-06ff-11f0-808a-c43d1ab1c353
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In developing countries , deficiencies of micronutrients are thought to have a major impact on child development ; however , a consensus on the specific relationship between dietary zinc intake and cognitive function remains elusive . The aim of this systematic review was to examine the relationship between zinc intake , status and indices of cognitive function in children and adults . A systematic literature search was conducted using EMBASE , MEDLINE and Cochrane Library data bases from inception to March 2014 . Included studies were those that supplied zinc as supplements or measured dietary zinc intake . A meta- analysis of the extracted data was performed where sufficient data were available . Of all of the potentially relevant papers , 18 studies met the inclusion criteria , 12 of which were r and omised controlled trials ( RCTs ; 11 in children and 1 in adults ) and 6 were observational studies ( 2 in children and 4 in adults ) . Nine of the 18 studies reported a positive association between zinc intake or status with one or more measure of cognitive function . Meta- analysis of data from the adult ’s studies was not possible because of limited number of studies . A meta- analysis of data from the six RCTs conducted in children revealed that there was no significant overall effect of zinc intake on any indices of cognitive function : intelligence , st and ard mean difference of ; executive function , st and ard mean difference of 0.08 ( 95 % CI , –0.06 , 022 ) P=0.26 ; and motor skills st and ard mean difference of 0.11 ( 95 % CI –0.17 , 0.39 ) P=0.43 . Heterogeneity in the study design s was a major limitation , hence only a small number ( n=6 ) of studies could be included in the meta-analyses . Meta- analysis failed to show a significant effect of zinc supplementation on cognitive functioning in children though , taken as a whole , there were some small indicators of improvement on aspects of executive function and motor development following supplementation but high- quality RCTs are necessary to investigate this further
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"BACKGROUND The Third National Health and Nutrition Examination Survey suggested some Mexican American children are at risk of zinc deficiency . OBJECTIVE We measured the effects of zinc and micronutrients or of micronutrients alone on indexes of cell-mediated immunity and antiinflammatory plasma proteins . DESIGN Subjects ( n = 54 ) aged 6 - 7 y were r and omly assigned and treated in double-blind fashion in equal numbers with 20 mg Zn ( as sulfate ) and micronutrients or with micronutrients alone 5 d/wk for 10 wk . RESULTS Before treatment the mean + /- SD plasma zinc was 14.9 + /- 1.7 micromol/dL and the range was within the reference ; hair zinc was 1.78 + /- 0.52 micromol/g and 41.6 % were serum ferritin was 25.7 + /- 18.6 microg/L and 50.0 % were zinc and micronutrients treatment increased the lymphocyte ratios of CD4(+ ) to CD8(+ ) and of CD4(+)CD45RA(+ ) to CD4(+)CD45RO(+ ) , increased the ex vivo generation of interleukin-2 ( IL-2 ) and interferon-gamma ( IFN-gamma ) , decreased the generation of interleukin-10 ( IL-10 ) , and increased plasma interleukin-1 receptor antagonist ( sIL-1ra ) and soluble tumor necrosis factor receptor 1 ( sTNF-R1 ) . Micronutrients alone increased the ratio of CD4(+ ) to CD8(+ ) but not of CD4(+)CD45RA(+ ) to CD4(+)CD45RO(+ ) , increased IFN-gamma but had no effect on IL-2 or IL-10 , and increased sIL-1ra but not sTNF-R1 . Efficacy of zinc and micronutrients was greater than micronutrients alone for all indexes except the ratio of CD4(+ ) to CD8(+ ) , which was affected similarly . CONCLUSIONS Before treatment , concentrations of hair zinc in 41.6 % of subjects and serum ferritin in 50 % were consistent with the presence of zinc deficiency . The greater efficacy of the zinc and micronutrients treatment compared with micronutrients alone supports this interpretation",
"Changes in growth , body composition , and zinc indexes were evaluated after 25 wk in a double-blind zinc-supplementation study of 162 periurban Guatemalan children aged 81.5 + /- 7.0 mo ( mean + /- SD ) . Children receiving the zinc supplement ( 10 mg Zn/d as amino acid chelate ) for 90.1 + /- 9.2 d had higher mean fasting plasma zinc ( 16.2 + /- 2.9 vs 14.9 + /- 2.1 mumol/L , P median triceps skinfold Z score ( 0.50 vs 0.38 , P median midarm circumference ( MAC ) Z score ( -0.03 vs -0.20 , P hair zinc classified as 1.68 mumol/g was the only laboratory variable that explained some of the variance in final Z scores of midarm-muscle area ( P MAC ( P zinc supplement with changes in indexes of body composition rather than growth",
"BACKGROUND A negative effect of prenatal zinc deficiency on brain function has been well established in experimental animals , but this association in humans is controversial . OBJECTIVE We evaluated the effect of prenatal zinc supplementation on the mental and psychomotor development of 355 children whose mothers participated in a double-blind trial of zinc supplementation that result ed in increased head circumference and birth weight . DESIGN The children took 6 tests-the Differential Ability Scales , Visual Sequential Memory , Auditory Sequential Memory , Knox Cube , Gross Motor Scale , and Grooved Pegboard tests-at a mean age of 5.3 y. The scores were compared between the children of women who received a daily oral dose of 25 mg Zn during the second half of pregnancy and the children of women who received placebo . RESULTS There were no differences in the test scores of neurologic development between the 2 groups . We analyzed the scores in 4 subgroups on the basis of maternal body mass index , because the increases in birth weight and head circumference due to the supplementation occurred only in the children of women with a body mass index ( in kg/m(2 ) ) Zinc supplementation of women in the latter half of pregnancy had no effect on the neurologic development of their children at age 5 y. It is not known whether our findings of no positive effect in the population with apparently inadequate zinc nutriture can be readily extrapolated to other population",
"OBJECTIVE To examine intellectual and motor functioning of children who received micronutrient supplementation from 12 to 35 months of age . DESIGN Cohort follow-up of children 7 to 9 years of age who participated in a 2 × 2 factorial , placebo-controlled , r and omized trial from October 2001 through January 2006 . SETTING Rural Nepal . PARTICIPANTS A total of 734 children 12 to 35 months of age at supplementation and 7 to 9 years of age at testing . INTERVENTIONS Children received iron plus folic acid ( 12.5 mg of iron and 50 μg of folic acid ) ; zinc ( 10 mg ) ; iron plus folic acid and zinc ; or placebo . MAIN OUTCOME MEASURES Intellectual , motor , and executive function . RESULTS In both the unadjusted and adjusted analyses , iron plus folic acid supplementation had no effect overall or on any individual outcome measures being tested . In the unadjusted analysis , zinc supplementation had an overall effect , although none of the individual test score differences were significant . In the adjusted analysis , the overall difference was not significant . CONCLUSION In rural Nepal , we found that iron plus folic acid or zinc supplementation during the preschool years had no effect on aspects of intellectual , executive , and motor function at 7 to 9 years of age , suggesting no long-term developmental benefit of iron or zinc supplementation during 12 to 35 months of age",
"Objective : To test the efficacy of zinc supplementation through diet or ayurvedic zinc tablet on cognitive function and taste acuity in adolescent girls . Methods : Using zinc-rich food items , snacks were prepared by adopting food-processing methods that enhance zinc bioavailability . Ayurvedic zinc tablet ( jasad bhasma ) was chosen as a natural elemental zinc supplement . Efficacy of snacks and the tablet was assessed in 180 schoolgirls ( 12.5 ± 0.85 years ) from Pune City , India , who were r and omly allocated to any of the 3 groups : ( 1 ) ayurvedic zinc tablet — J , ( 2 ) zinc-rich snacks — D , or ( 3 ) Control — C. Supplementation was given on every school day ( 6 days/wk ) for 10 weeks . All measurements were recorded at baseline and at the end of the study period . Food intake was recorded by 24-hour diet recall on 3 r and om days . Hemoglobin , serum ferritin , and plasma zinc were estimated on a fasting blood sample . Cognitive assessment was done on each participant using tests for simple reaction time ( SRT ) , recognition reaction time ( RRT ) , visual memory , and Raven 's Progressive Matrices ( RPM ) . Taste acuity was determined by recognition thresholds for salt ( RTS ) over a range of 10 different salt concentrations . Results : A higher increase in plasma zinc ( 61.3 % ) was observed in the J group than in the D group ( 9.9 % ) ( p ) , whereas plasma zinc declined in the control group ( −2.2 % ) over baseline ( p > 0.1 ) . Hemoglobin showed no change in all 3 groups ( p > 0.1 ) . Percent increment in scores for memory and RPM was significantly more in the D and J groups ( 24.5%–29.6 % ) than in the C group ( 6.5 % ) ( p 0.05 ) . Mean SRT and RRT were reduced more in the D and J groups ( 5%–16 % ) than in the C group ( 1.6 % ) ( p significant fall in median RTS from 5 to 2.5 mmol/L was noted after both diet and zinc supplementation ( p performance and the recognition threshold for salt of adolescent girls",
"The knowledge that zinc is essential for growth and neuropsychologic performance and a report of zinc-responsive stunting in Chinese children prompted this project . This article summarizes findings from a 10-wk , double-blind , controlled trial of zinc repletion in 740 urban , 6 - 9-y-old first grade rs from low-income families in Chongqing , Qingdao , and Shanghai , People 's Republic of China . Treatments were 20 mg Zn alone ( Z ) , 20 mg Zn with micronutrients ( ZM ) , and micronutrients alone ( M ) . The M mixture was based on National Research Council guidelines . Nutrients that might interfere with zinc retention were excluded or given in lower amounts . Main outcomes were changes in neuropsychologic performance and knee height . Hemoglobin , serum ferritin , plasma and hair zinc , and whole blood and hair lead were also measured . Anemia was not common , and serum ferritin concentrations were usually within the range of normal . Mean baseline plasma zinc concentrations were marginal in children from Chongqing and Qingdao and normal in children from Shanghai . After treatment with ZM or M plasma zinc increased . Hair zinc tended to decrease after all treatments . Mean baseline whole blood lead concentrations were slightly below the limit considered excessive for children by the US Centers for Disease Control and Prevention . Neuropsychologic performance and growth were most improved after treatment with ZM . These findings were consistent with the presence of zinc and other micronutrient deficiencies",
"CONTEXT Iron and zinc are important for the development of both intellectual and motor skills . Few studies have examined whether iron and zinc supplementation during gestation , a critical period of central nervous system development , affects children 's later functioning . OBJECTIVE To examine intellectual and motor functioning of children whose mothers received micronutrient supplementation during pregnancy . DESIGN , SETTING , AND PARTICIPANTS Cohort follow-up of 676 children aged 7 to 9 years in June 2007-April 2009 who had been born to women in 4 of 5 groups of a community-based , double-blind , r and omized controlled trial of prenatal micronutrient supplementation between 1999 and 2001 in rural Nepal . Study children were also in the placebo group of a subsequent preschool iron and zinc supplementation trial . INTERVENTIONS Women whose children were followed up had been r and omly assigned to receive daily iron/folic acid , iron/folic acid/zinc , or multiple micronutrients containing these plus 11 other micronutrients , all with vitamin A , vs a control group of vitamin A alone from early pregnancy through 3 months postpartum . These children did not receive additional micronutrient supplementation other than biannual vitamin A supplementation . MAIN OUTCOME MEASURES Children 's intellectual functioning , assessed using the Universal Nonverbal Intelligence Test ( UNIT ) ; tests of executive function , including go/no-go , the Stroop test , and backward digit span ; and motor function , assessed using the Movement Assessment Battery for Children ( MABC ) and finger-tapping test . RESULTS The difference across outcomes was significant ( Bonferroni-adjusted P mean UNIT T score in the iron/folic acid group was 51.7 ( SD , 8.5 ) and in the control group was 48.2 ( SD , 10.2 ) , with an adjusted mean difference of 2.38 ( 95 % confidence interval [ CI ] , 0.06 - 4.70 ; P = .04 ) . Differences were not significant between the control group and either the iron/folic acid/zinc ( 0.73 ; 95 % CI , -0.95 to 2.42 ) or multiple micronutrient ( 1.00 ; 95 % CI , -0.55 to 2.56 ) groups . In tests of executive function , scores were better in the iron/folic acid group relative to the control group for the Stroop test ( adjusted mean difference in proportion who failed , -0.14 ; 95 % CI , -0.23 to -0.04 ) and backward digit span ( adjusted mean difference , 0.36 ; 95 % CI , 0.01 - 0.71 ) but not for the go/no-go test . The MABC score was lower ( better ) in the iron/folic acid group compared with the control group but not after adjustment for confounders ( mean difference , -1.47 ; 95 % CI , -3.06 to 0.12 ; P = .07 ) . Finger-tapping test scores were higher ( mean difference , 2.05 ; 95 % CI , 0.87 - 3.24 ; P = .001 ) in the iron/folic acid group . CONCLUSION Aspects of intellectual functioning including working memory , inhibitory control , and fine motor functioning among offspring were positively associated with prenatal iron/folic acid supplementation in an area where iron deficiency is prevalent . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00115271",
"A r and omised double-blind placebo-controlled design was employed to investigate the effects of Zn supplementation on cognitive function in 387 healthy adults aged 55 - 87 years . Several measures of visual memory , working memory , attention and reaction time were obtained using the Cambridge Automated Neuropsychological Test Battery at baseline and then after 3 and 6 months of 0 ( placebo ) , 15 or 30 mg Zn/d . Younger adults ( performed significantly better on all tests than older adults ( > 70 years ) , and performance improved with practice on some measures . For two out of eight dependent variables , there were significant interactions indicating a beneficial effect ( at 3 months only ) of both 15 and 30 mg/d on one measure of spatial working memory and a detrimental effect of 15 mg/d on one measure of attention . Further work is required to establish whether these findings generalise to older adults in poorer mental and physical health and with less adequate Zn intake and status than the present sample",
"BACKGROUND Trace elements are involved in metabolic processes and oxidation-reduction reactions in the central nervous system and could have a possible effect on cognitive function . The relationship between trace elements measured in individual biological sample s and cognitive function in an elderly population had not been investigated extensively . METHODS The participant population is part of a large cohort study of 2000 rural elderly Chinese persons . Six cognitive assessment tests were used to evaluate cognitive function in this population , and a composite score was created to represent global cognitive function . Trace element levels of aluminum , calcium , cadmium , copper , iron , lead , and zinc were analyzed in plasma sample s of 188 individuals who were r and omly selected and consented to donating fasting blood . Analysis of covariance models were used to assess the association between each trace element and the composite cognitive score adjusting for demographics , medical history of chronic diseases , and the apolipoprotein E ( APOE ) genotype . RESULTS Three trace elements-calcium , cadmium , and copper-were found to be significantly related to the composite cognitive score . Increasing plasma calcium level was associated with higher cognitive score ( p cadmium and copper , in contrast , were significantly associated with lower composite score ( p = .0044 and p = .0121 , respectively ) . Other trace elements did not show significant association with the composite cognitive score . CONCLUSIONS Our results suggest that calcium , cadmium , and copper may be associated with cognitive function in the elderly population",
"OBJECTIVE Zinc is essential for growth and cognition of experimental animals . Past research found zinc repletion improved growth of stunted Chinese children . Therefore we measured effects of zinc repletion on growth and neuropsychological functions of children . DESIGN Double-blind r and omized controlled treatment trial . SETTING Elementary schools in low income districts of Chongqing , Qingdao and Shanghai . SUBJECTS Three hundred-seventy-two 6 to 9 year old first grade rs . INTERVENTIONS Treatments were 20 mg zinc , 20 mg zinc with micronutrients , or micronutrients alone . The micronutrient mixture was based on guidelines of the US NAS/NRC . Treatments were assigned to classrooms of 40 or more children each , and administered by teachers 6 days per week for 10 weeks . MEASURES OF OUTCOME Changes in knee height and neuropsychological functions . RESULTS Zinc alone had the least effect on growth while zinc with micronutrients had the largest effect ; micronutrients alone had an intermediate effect . Zinc-containing treatments improved neuropsychological functions , but micronutrients alone had little effect . CONCLUSIONS The findings confirm the essentiality of zinc for growth of children , and show , for the first time , the essentiality of zinc for neuropsychological functions of children . In addition , the need for repletion of other potentially limiting nutrients in studies examining the effects of specific nutrients on growth and neuropsychological functions was confirmed",
"With the exception of iodine and Fe , there is still very limited information on the effect of micronutrients on cognitive function , especially among school-age children . The present analysis evaluates the relationship between dietary Fe , Zn and B vitamins ( B12 , B6 , folate and riboflavin ) and gains in cognitive test scores among school children in rural Kenya . Data for the present study were obtained from The Child Nutrition Kenya Project , a 2-year longitudinal , r and omised controlled feeding intervention study using animal source foods . Dietary nutrient values were based on monthly and bimonthly 24 h recall data collected during the study period . In longitudinal regression analyses , available Fe , available Zn , vitamin B12 and riboflavin showed significant relationships with improved cognitive test scores , after controlling for confounders such as energy intake , school , socio-economic status and morbidity . Available Fe intake was associated with significantly higher gains in Raven 's Coloured Progressive Matrices test scores over time . Available Zn intake was associated with significantly higher gains in digit span-total test scores over time , while vitamin B12 and riboflavin intakes were each associated with significantly higher gains in digit span-forward test scores over time . This analysis demonstrates the influence of improved dietary micronutrient status on school children 's cognitive function ",
"A double-blind , pair-matched 12-mo study examined the effects of a zinc supplement ( 10 mg Zn/d as ZnSO4 ) on linear growth , taste acuity , attention span , biochemical indices , and energy intakes of 60 boys ( aged 5 - 7 y ) with height less than or equal to 15th and midparent height greater than 25th percentiles . Boys with initial hair Zn less than 1.68 mumol/g ( n = 16 ) had a lower mean ( + /- SD ) weight-for-age Z score ( -0.44 + /- 0.59 vs -0.08 + /- 0.84 ) , and a higher median recognition threshold for salt ( 15 vs 7.5 mmol ; p = 0.02 ) than those with hair Zn greater than 1.68 mumol/g . Only boys with hair Zn less than 1.68 mumol/g responded to the Zn supplement with a higher mean change in height-for-age Z score ( p less than 0.05 ) ; taste acuity , energy intakes , and attention span were unaffected . A growth-limiting Zn deficiency syndrome exists in boys with low height percentiles , hair Zn levels less than 1.68 mumol/g , and impaired taste acuity"
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Despite intensified efforts by the European Council since 2003 , the implementation of organized , population -based mammography screening is not uniform across Europe and depends greatly on the policies in place in different countries , the organization of health care , and available re sources ( 1 ) . Since the last edition of the European Guidelines on Breast Cancer Screening and Diagnosis was published in 2006 ( 2 ) , new evidence regarding breast cancer and innovation in guideline methodology prompted the European Commission Initiative on Breast Cancer ( ECIBC ) to develop new evidence -based recommendations ( in short , the European Breast Guidelines ) . This article provides a synopsis of 15 key recommendations selected from the European Breast Guidelines , coordinated by the European Commission 's Joint Research Centre and developed by an international guideline development group ( GDG ) . These guidelines inform women , health professionals , and policymakers about important questions related to organized mammography screening and breast cancer diagnosis , but recommendations may apply in context s in which organized screening programs are not in place . The recommendations primarily address women at average risk for breast cancer without increased risk due to genetic predisposition ( mutations in BRCA1 and BRCA2 ) , reproductive history , or race/ethnicity . However , women with a family history , who may have a higher-than-average risk , are included in the ECIBC recommendations . Some recommendations also focus on women with high breast density and suspicious lesions on screening . The corresponding evidence review s and recommendations are kept up to date and are available for adoption and adaptation at https://ecibc.jrc.ec.europa.eu/ recommendations . Guideline Development and Review Process The European Commission adheres to methods for producing trustworthy guidelines ( 36 ) , which we described in detail previously ( 7 ) . In brief , the European Commission authorized new systematic review s , or syntheses of existing ones , up to March 2016 for earlier recommendations and to December 2018 for later , more recent recommendations . This evidence informed the criteria in the GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) Evidence to Decision ( EtD ) frameworks that the GDG , guided by 4 cochairs and vice chairs , used to develop the recommendations ( 710 ) . Each recommendation is linked to the full online EtD containing references , explanations ( including considerations for implementation , monitoring , and research priorities ) , and judgments that were developed with GRADE 's official app GRADE pro ( www . grade pro.org ) ( 7 ) . Recommendations The Supplement Table lists all 40 questions and recommendations addressed by the group as of May 2019 ; the first 15 recommendations listed in the table are those addressed in this synopsis . The table includes the strength ( strong or conditional ) and certainty-of- evidence ratings and the date s of the last pertinent literature search es . The GDG took a programmatic population perspective , suggesting that strong recommendations in this context may be adopted as policies in most situations ( 11 ) . Conditional recommendations suggest that policymaking will require substantial debate and involvement of various stakeholders . The implication s of the recommendations for women and clinicians are supported by more specific , linked recommendations focusing on communication and shared decision making . Should Organized Mammography Screening in Women Be Used ? The GDG considered women in the following age groups : 40 to 44 , 45 to 49 , 50 to 69 , and 70 to 74 years . Evidence from some systematic review s applied to all age groups for 1 or more EtD criteria . For example , mammography screening does not seem to create anxiety in women who are given a clear result after a mammogram . However , women recalled for further testing reported transient or long-term anxiety ( from 6 months to 3 years after recall ) , but this was not consistent across studies ( 1214 ) . Women generally consider these undesirable effects acceptable ( low certainty of evidence ) , and a systematic review suggested that women place a relatively low value on the psychosocial and physical effects of false-positive results and overdiagnosis ; however , some studies raised concerns about whether women fully underst and the result ing implication s ( 15 ) . Organized Mammography Screening in Women Aged 40 to 44 Years or 45 to 49 Years Recommendation 1 . For asymptomatic women aged 40 to 44 years with an average risk for breast cancer , the ECIBC 's GDG suggests not implementing organized mammography screening ( conditional recommendation , moderate certainty of evidence ; EtD available at http://bit.ly/2pf8l9 M ) . Recommendation 2 . For asymptomatic women aged 45 to 49 years with an average risk for breast cancer , the ECIBC 's GDG suggests mammography screening over no mammography screening , in the context of an organized screening program ( conditional recommendation , moderate certainty of evidence ; EtD available at http://bit.ly/2Pn1HZx ) . Eight r and omized controlled trials ( RCTs ) of invitation to mammography screening provided breast cancer mortality data from 348478 women younger than 50 years ( 1622 ) , and 4 review s of observational studies evaluated relevant outcomes ( 1214 , 23 ) . Organized mammography screening probably reduces breast cancer mortality ( 1622 ) and may reduce the risk for breast cancer stage IIA or higher ( 17 , 18 , 22 , 2428 ) . The incidence of breast cancer and mortality increases with age , and the GDG extrapolated that the absolute health benefits are greater in women aged 45 to 49 than those aged 40 to 44 years . Data from 5 available trials in women aged 40 to 74 years suggest an increase in the rate of mastectomy ( 19 , 2932 ) , although the GDG was concerned that these results might be misleading because of lead time . One RCT suggests a rate of 12.4 % ( 95 % CI , 9.9 % to 14.9 % ) to 22.7 % ( CI , 18.4 % to 27.0 % ) for overdiagnosis , depending on whether a population or an individual woman perspective is taken ( 27 ) . The number of false-positives depends on the age of first screening , and women aged 40 to 44 years also have a greater radiation risk than older women . The balance of desirable versus undesirable health effects for starting screening at age 40 probably favors no screening ( the GDG judged that the undesirable health effects are large and the desirable ones small ) . However , for the 45- to 49-year age group , the higher breast cancer incidence and mortality compared with women between the ages of 40 and 44 , as well as observational evidence showing a greater benefit in this age group ( 33 ) , led the GDG to judge that the balance of health effects probably favors screening , although the required re sources for screening likely differ across setting s ( 34 , 35 ) . Organized Mammography Screening in Women Aged 50 to 69 Years Recommendation 3 . For asymptomatic women aged 50 to 69 years with an average risk for breast cancer , the ECIBC 's GDG recommends mammography screening over no mammography screening , in the context of an organized screening program ( strong recommendation , moderate certainty of evidence ; EtD available at http://bit.ly/2qNKE91 ) . On the basis of data from 249930 women aged 50 to 69 years from 6 RCTs , invitation to organized mammography screening reduces breast cancer mortality ( 17 , 1922 , 36 ) and may reduce the risk for breast cancer stage IIA or higher ( 17 , 22 , 2426 , 37 ) . Five trials describe increased rates of mastectomy in women between ages 40 and 74 ( 19 , 2932 ) , with concerns about lead-time bias similar to those for the younger age group . Pooled estimates from 2 RCTs suggest overdiagnosis rates of 10.1 % ( CI , 8.6 % to 11.6 % ) and 17.3 % ( CI , 14.7 % to 20.0 % ) ( 37 , 38 ) . The cost-effectiveness studies probably favored screening , but this would vary across countries ( 34 , 3941 ) . The GDG determined that screening in this age group has a net health benefit , and other EtD criteria were generally in favor of implementing organized mammography screening . Thus , despite uncertainty about the relative importance of outcomes or values , the GDG made a strong recommendation for organized screening but emphasizes that all invited women should receive clear information about the desirable and undesirable effects to make informed decisions . Organized Mammography Screening in Women Aged 70 to 74 Years Recommendation 4 . For asymptomatic women aged 70 to 74 years with an average risk for breast cancer , the ECIBC 's GDG suggests mammography screening over no mammography screening , in the context of an organized screening program ( conditional recommendation , moderate certainty of evidence ; EtD available at http://bit.ly/31KjCMA ) . According to 2 RCTs of invitation to mammography screening in 18233 women aged 70 years and older ( 19 , 21 ) , organized mammography screening reduces breast cancer mortality , the risk for breast cancer stage IIA or higher , and detection of tumors larger than 50 mm ( 25 ) . Five trials in women aged 40 to 74 years described increased mastectomy rates ( 19 , 2932 ) . Concerns have been raised about lead-time bias , the small number of women aged 70 to 74 years included for the outcome of mastectomy , and the available data for overdiagnosis being derived exclusively from women aged 50 to 69 years for an overall judgment of probable net health benefit . Other EtD criteria also were generally in favor of implementing organized mammography screening in this age group . How Often Should Women Attend an Organized Mammography Screening Program ? Women Aged 45 to 49 Years Recommendation 5 . For asymptomatic women aged 45 to 49 years with an average risk for breast cancer , the ECIBC 's GDG suggests either biennial or triennial mammography over annual screening in the context of an organized screening program ( conditional recommendation , very low certainty of evidence ; EtD available at http://bit.ly/32O1faP ) . Women Aged 50 to 69 Years Recommendations 6 and 7 . For asymptomatic women aged 50 to
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"Abstract Objectives To compare double readings when interpreting full field digital mammography ( 2D ) and tomo synthesis ( 3D ) during mammographic screening . Methods A prospect i ve , Ethical Committee approved screening study is underway . During the first year 12,621 consenting women underwent both 2D and 3D imaging . Each examination was independently interpreted by four radiologists under four reading modes : Arm A—2D ; Arm B—2D + CAD ; Arm C—2D + 3D ; Arm D— synthesis ed 2D + 3D . Examinations with a positive score by at least one reader were discussed at an arbitration meeting before a final management decision . Paired double reading of 2D ( Arm A + B ) and 2D + 3D ( Arm C + D ) were analysed . Performance measures were compared using generalised linear mixed models , accounting for inter-reader performance heterogeneity ( P Pre-arbitration false-positive scores were 10.3 % ( 1,286/12,501 ) and 8.5 % ( 1,057/12,501 ) for 2D and 2D + 3D , respectively ( P Recall rates were 2.9 % ( 365/12,621 ) and 3.7 % ( 463/12,621 ) , respectively ( P = 0.005 ) . Cancer detection was 7.1 ( 90/12,621 ) and 9.4 ( 119/12,621 ) per 1,000 examinations , respectively ( 30 % increase , P positive predictive values ( detected cancer patients per 100 recalls ) were 24.7 % and 25.5 % , respectively ( P = 0.97 ) . Using 2D + 3D , double-reading radiologists detected 27 additional invasive cancers ( P Double reading of 2D + 3D significantly improves the cancer detection rate in mammography screening . Key Points• Tomo synthesis -based screening was successfully implemented in a large prospect i ve screening trial . • Double reading of tomo synthesis -based examinations significantly reduced false-positive interpretations . • Double reading of tomo synthesis significantly increased the detection of invasive cancers",
" A trial in the UK to study the effect on mortality from breast cancer of invitation for annual mammography from the age of 40–41 , has r and omised a total of 160 921 women in the ratio 1 : 2 to the intervention and control arms . All breast cancers diagnosed in the two arms have been identified , and the histology review ed . This paper presents the results of an interim analysis using surrogate outcome measures to compare predicted breast cancer mortality in the two arms based on 1287 cases diagnosed to 31.12.1999 . Due to earlier diagnosis , there is currently an 8 % excess of invasive breast cancers in the intervention arm . The ratio of predicted deaths at 10 years in the intervention arm relative to the control arm , adjusted for this excess diagnosis , ranges from 0.89 ( 95 % confidence interval ( CI ) 0.78–1.01 ) to 0.90 ( 95 % CI 0.80–1.01 ) . Screening from age 40 may result in a lower reduction in breast cancer mortality than that observed in other trials including women below age 50 . This analysis based on surrogate outcome measures suggests that a reduction in breast cancer mortality may be observed in this trial . However , a number of assumptions have been necessary and firm conclusions must await the analysis of observed mortality from breast cancer",
"Purpose Digital breast tomo synthesis ( DBT ) has the potential to overcome limitations of conventional mammography . This study investigated the effects of addition of DBT on interval and detected cancers in population -based screening . Methods Oslo Tomo synthesis Screening Trial ( OTST ) was a prospect i ve , independent double-reading trial inviting women 50–69 years biennially , comparing full-field digital mammography ( FFDM ) plus DBT with FFDM alone . Performance indicators and characteristics of screen-detected and interval cancers were compared with two previous FFDM rounds . Results 24,301 consenting women underwent FFDM + DBT screening over a 2-year period . Results were compared with 59,877 FFDM examinations during prior rounds . Addition of DBT result ed in a non-significant increase in sensitivity ( 76.2 % , 378/496 , vs. 80.8 % , 227/281 , p = 0.151 ) and a significant increase in specificity ( 96.4 % , 57229/59381 vs. 97.5 % , 23427/24020 , p . Number of recalls per screen-detected cancer decreased from 6.7 ( 2530/378 ) to 3.6 ( 820/227 ) with DBT ( p . Cancer detection per 1000 women screened increased ( 6.3 , 378/59877 , vs. 9.3 , 227/24301 , p ) . Interval cancer rate per 1000 screens for FFDM + DBT remained similar to previous FFDM rounds ( 2.1 , 51/24301 vs. 2.0 , 118/59877 , p = 0.734 ) . Interval cancers post-DBT were comparable to prior rounds but significantly different in size , grade , and node status from cancers detected only using DBT . 39.6 % ( 19/48 ) of interval cancers had positive nodes compared with only 3.9 % ( 2/51 ) of additional DBT-only-detected cancers . Conclusions DBT-supplemented screening result ed in significant increases in screen-detected cancers and specificity . However , no significant change was observed in the rate , size , node status , or grade of interval cancers . Clinical Trials.gov : NCT01248546",
"Purpose To compare the performance of digital breast tomo synthesis ( DBT ) and two-dimensional synthetic mammography ( SM ) with that of digital mammography ( DM ) in a population -based mammographic screening program . Material s and Methods In this prospect i ve cohort study , data from 37 185 women screened with DBT and SM and from 61 742 women screened with DM as part of a population -based screening program in 2014 and 2015 were included . Early performance measures , including recall rate due to abnormal mammographic findings , rate of screen-detected breast cancer , positive predictive value of recall , positive predictive value of needle biopsy , histopathologic type , tumor size , tumor grade , lymph node involvement , hormonal status , Ki-67 level , and human epidermal growth factor receptor 2 status were compared in women who underwent DBT and SM screening and in those who underwent DM screening by using χ2 tests , two- sample unpaired t tests , and tests of proportions . Results Recall rates were 3.4 % for DBT and SM screening and 3.3 % for DM screening ( P = .563 ) . DBT and SM screening showed a significantly higher rate of screen-detected cancer compared with DM screening ( 9.4 vs 6.1 cancers per 1000 patients screened , respectively ; P The rate of detection of tumors 10 mm or smaller was 3.2 per 1000 patients screened with DBT and SM and 1.8 per 1000 patients screened with DM ( P of grade 1 tumors was 3.3 per 1000 patients screened with DBT and SM versus 1.4 per 1000 patients screened with DM ( P , rates of lymph node involvement and tumor subtypes did not differ between women who underwent DBT and SM screening and those who underwent DM screening . Conclusion DBT and SM screening increased the detection rate of histologically favorable tumors compared with that attained with DM screening . © RSNA , 2018 Online supplemental material is available for this article",
"BACKGROUND Breast tomo synthesis ( pseudo-3D mammography ) improves breast cancer detection when added to 2D mammography . In this study , we examined whether integrating 3D mammography with either st and ard 2D mammography acquisitions or with synthetic 2D images ( reconstructed from 3D mammography ) would detect more cases of breast cancer than 2D mammography alone , to potentially reduce the radiation burden from the combination of 2D plus 3D acquisitions . METHODS The Screening with Tomo synthesis Or st and ard Mammography-2 ( STORM-2 ) study was a prospect i ve population -based screening study comparing integrated 3D mammography ( dual-acquisition 2D-3D mammography or 2D synthetic-3D mammography ) with 2D mammography alone . Asymptomatic women aged 49 years or older who attended population -based screening in Trento , Italy were recruited for the study . All participants underwent digital mammography with 2D and 3D mammography acquisitions , with the use of software that allowed synthetic 2D mammographic images to be reconstructed from 3D acquisitions . Mammography screen-reading was done in two parallel double-readings conducted sequentially for 2D acquisitions followed by integrated acquisitions . Recall based on a positive mammography result was defined as recall at any screen read . Primary outcome measures were a comparison between integrated ( 2D-3D or 2D synthetic-3D ) mammography and 2D mammography alone of the number of cases of screen-detected breast cancer , the cancer detection rate per 1000 screens , the incremental cancer detection rate , and the number and percentage of false-positive recalls . FINDINGS Between May 31 , 2013 , and May 29 , 2015 , 10 255 women were invited to participate , of whom 9672 agreed to participate and were screened . In these 9672 participants ( median age 58 years [ IQR 53 - 63 ] ) , screening detected 90 cases of breast cancer , including 74 invasive breast cancers , in 85 women ( five women had bilateral breast cancer ) . To account for these bilateral cancers in cancer detection rate estimates , the number of screens used for analysis was 9677 . Both 2D-3D mammography ( cancer detection rate 8·5 per 1000 screens [ 82 cancers detected in 9677 screens ] ; 95 % CI 6·7 - 10·5 ) and 2D synthetic-3D mammography ( 8·8 per 1000 [ 85 in 9677 ] ; 7·0 - 10·8 ) had significantly higher rates of breast cancer detection than 2D mammography alone ( 6·3 per 1000 [ 61 in 9677 ] , 4·8 - 8·1 ; p both comparisons ) . The cancer detection rate did not differ significantly between 2D-3D mammography and 2D synthetic-3D mammography ( p=0·58 ) . Compared with 2D mammography alone , the incremental cancer detection rate from 2D-3D mammography was 2·2 per 1000 screens ( 95 % CI 1·2 - 3·3 ) and that from 2D synthetic-3D mammography was 2·5 per 1000 ( 1·4 - 3·8 ) . Compared with the proportion of false-positive recalls from 2D mammography alone ( 328 of 9587 participants not found to have cancer at assessment ) [ 3·42 % ; 95 % CI 3·07 - 3·80 ] ) , false-positive recall was significantly higher for 2D-3D mammography ( 381 of 9587 [ 3·97 % ; 3·59 - 4·38 ] , p=0·00063 ) and for 2D synthetic-3D mammography ( 427 of 9587 [ 4·45 % ; 4·05 - 4·89 ] , p INTERPRETATION Integration of 3D mammography ( 2D-3D or 2D synthetic-3D ) detected more cases of breast cancer than 2D mammography alone , but increased the percentage of false-positive recalls in sequential screen-reading . These results should be considered in the context of the trade-off between benefits and harms inherent in population breast cancer screening , including that significantly increased breast cancer detection from integrating 3D mammography into screening has the potential to augment screening benefit and also possibly contribute to overdiagnosis . FUNDING None",
"BACKGROUND & METHODS The prospect i ve ' screening with tomo synthesis or st and ard mammography ' ( STORM ) trial recruited women participating in biennial breast screening in Italy ( 2011 - 2012 ) , and compared sequential screen-readings based on 2D-mammography alone or based on tomo synthesis ( integrated 2D/3D-mammography ) . The STORM trial showed that tomo synthesis screen-reading significantly increased breast cancer detection compared to 2D-mammography alone . The present study completes reporting of the trial by examining interval breast cancers ascertained at two year follow-up . RESULTS 9 interval breast cancers were identified ; the estimated interval cancer rate was 1.23/1000 screens [ 9/7292 ] ( 95%CI 0.56 to 2.34 ) or 1.24/1000 negative screens [ 9/7235 ] ( 95%CI 0.57 to 2.36 ) . In concurrently screened women who attended the same screening services and received 2D-mammography , interval cancer rate was 1.60/1000 screens [ 40/25,058 ] ( 95 % CI 1.14 to 2.17 ) or 1.61/1000 negative screens [ 40/24,922 ] ( 95 % CI 1.15 to 2.18 ) . Estimated screening sensitivity for the STORM trial was 85.5 % [ 59/69 ] ( 95%CI 75.0%-92.8 % ) , and that for 2D-mammography screening was 77.3 % [ 136/176 ] ( 95%CI 70.4%-83.2 % ) . CONCLUSION Interval breast cancer rate amongst screening participants in the STORM trial was marginally lower ( and screening sensitivity higher ) than estimates amongst 2D-screened women ; these findings should be interpreted with caution given the small number of interval cases and the sample size of the trial . Much larger screening studies , or pooled analyses , are required to examine interval cancer rates arising after breast tomo synthesis screening versus digital mammography screening",
"OBJECTIVE The aim of this study was to supplement the paucity of information available on logistical aspects of the application of three-dimensional ( 3D ) mammography in breast screening . METHODS We prospect ively examined the effect on radiographers ' and radiologists ' workload of implementing 3D mammography in screening by comparing image acquisition time and screen-reading time for two-dimensional ( 2D ) mammography with that of combined 2D+3D mammography . Radiologists ' accuracy was also calculated . RESULTS Average acquisition time ( measured from start of first-view breast positioning to compression release at completion of last view ) for seven radiographers , based on 20 screening examinations , was longer for 2D+3D ( 4 min 3 s ; range 3 min 53 s-4 min 18 s ) than 2D mammography ( 3 min 13 s ; range 3 min 0 s-3 min 26 s ; p Average radiologists ' reading time per screening examination ( three radiologists reading case-mix of 100 screens : 10 cancers , 90 controls ) was longer for 2D+3D ( 77 s ; range 60 - 90 s ) than for 2D mammography ( 33 s ; range 25 - 46 s ; p 2D+3D screen-reading was associated with detection of more cancers and with substantially fewer recalls than 2D mammography alone . CONCLUSION Relative to st and ard 2D mammography , combined 2D+3D mammography prolongs image acquisition time and screen-reading time ( at initial implementation ) , and appears to be associated with improved screening accuracy . ADVANCES IN KNOWLEDGE These findings provide relevant information to guide larger trials of integrated 3D mammography ( 2D+3D ) and its potential implementation into screening practice",
"PURPOSE We compared detection measures for breast screening strategies comprising single-reading or double-reading using st and ard 2D-mammography or 2D/3D-mammography , based on the ' screening with tomo synthesis or st and ard mammography ' ( STORM ) trial . METHODS STORM prospect ively examined screen-reading in two sequential phases , 2D-mammography alone and integrated 2D/3D-mammography , in asymptomatic women participating in Trento and Verona ( Northern Italy ) population -based screening services . Outcomes were ascertained from assessment and /or excision histology or follow-up . For each screen-reading strategy we calculated the number of detected and non-detected ( including interval ) cancers , cancer detection rates ( CDRs ) , false positive recall ( FPR ) measures and incremental CDR relative to a comparator strategy . We estimated the false : true positive ( FP : TP ) ratio and sensitivity of each mammography screening strategy . Paired binary data were compared using McNemar 's test . RESULTS Amongst 7292 screening participants , there were 65 ( including six interval ) breast cancers ; estimated first-year interval cancer rate was 0.82/1000 screens ( 95 % confidence interval ( CI ) : 0.30 - 1.79/1000 ) . For single-reading , 35 cancers were detected at both 2D and 2D/3D-mammography , 20 cancers were detected only with 2D/3D-mammography compared with none at 2D-mammography alone ( p 2D-mammography and 2D/3D-mammography , 20 were detected only with 2D/3D-mammography compared with none detected at 2D-mammography alone ( p incremental CDR attributable to 2D/3D-mammography ( versus 2D-mammography ) of 2.7/1000 screens ( 95 % CI : 1.6 - 4.2 ) was evident for single and for double-reading . Incremental CDR attributable to double-reading ( versus single-reading ) of 0.55/1000 screens ( 95 % CI : -0.02 - 1.4 ) was evident for 2D-mammography and for 2D/3D-mammography . Estimated FP : TP ratios showed that 2D/3D-mammography screening strategies had more favourable FP to TP trade-off and higher sensitivity , applying single-reading or double-reading , relative to 2D-mammography screening . CONCLUSION The evidence we report warrants rethinking of breast screening strategies and should be used to inform future evaluations of 2D/3D-mammography that assess whether or not the estimated incremental detection translates into improved screening outcomes such as a reduction in interval cancer rates",
"Abstract Objective To assess the performance of one-view digital breast tomo synthesis ( DBT ) in breast cancer screening . Methods The Malmö Breast Tomo synthesis Screening Trial is a prospect i ve population -based one-arm study with a planned inclusion of 15000 participants ; a r and om sample of women aged 40–74 years eligible for the screening programme . This is an explorative analysis of the first half of the study population ( n = 7500 ) . Participants underwent one-view DBT and two-view digital mammography ( DM ) , with independent double reading and scoring . Primary outcome measures were detection rate , recall rate and positive predictive value ( PPV ) . McNemar 's test with 95 % confidence intervals was used . Results Breast cancer was found in sixty-eight women . Of these , 46 cases were detected by both modalities , 21 by DBT alone and one by DM alone . The detection rate for one-view DBT was 8.9/1000 screens ( 95 % CI 6.9 to 11.3 ) and 6.3/1000 screens ( 4.6 to 8.3 ) for two-view DM ( p The recall rate after arbitration was 3.8 % ( 3.3 to 4.2 ) for DBT and 2.6 % ( 2.3 to 3.0 ) for DM ( p The PPV was 24 % for both DBT and DM . Conclusion Our results suggest that one-view DBT might be feasible as a st and -alone screening modality . Key Points• One-view DBT as a st and -alone breast cancer screening modality has not been investigated . • One-view DBT increased the cancer detection rate significantly . • The recall rate increased significantly but was still low . • Breast cancer screening with one-view DBT as a st and -alone modality seems feasible",
"BACKGROUND : It has recently been suggested that all-cause mortality is a more appropriate end point than disease specific mortality in cancer screening trials , and that disease specific mortality is biased in favour of screening . This suggestion is based partly on supposed inconsistencies between all-cause mortality results and disease specific results in cancer screening trials , and alleged increases in deaths from causes other than breast cancer among breast cancer cases diagnosed among women invited to screening . METHODS : We used data from the Swedish Two-County Trial of mammographic screening for breast cancer , in which 77 080 women were r and omised to an invitation to screening and 55 985 to no invitation . We estimated relative risks ( RRs ) ( invited v control ) of death from breast cancer , death from other causes within the breast cancer cases , and death from all causes within the breast cancer cases . RRs were adjusted for age and took account of the longer follow up of breast cancer cases in the invited group due to lead time . RESULTS : There was a significant 31 % reduction in breast cancer mortality in the invited group ( RR 0.69 , 95 % confidence interval ( CI ) 0.58–0.80 ; p deaths from other causes among breast cancer cases in the invited group ( RR 1.12 , 95 % CI 0.96–1.31 ; p=0.14 ) . A significant 19 % reduction in deaths from all causes was observed among breast cancer cases in the group invited to screening ( RR 0.81 , 95 % CI 0.72–0.90 ; p reduction in breast cancer mortality . CONCLUSIONS : Invitation to screening was associated with a reduction in deaths from all causes among breast cancer cases , consistent with high participation rates in screening . There is no significant evidence of bias in cause of death classification in the Two-County Trial , and as breast cancer mortality is the targeted clinical outcome in breast cancer screening , it is the appropriate end point in a breast cancer screening trial . All-cause mortality is a poor and inefficient surrogate for breast cancer mortality",
"OBJECTIVES To evaluate the efficacy of the combination of annual screening with mammography , physical examination of the breasts and the teaching of breast self-examination in reducing the rate of death from breast cancer among women aged 40 to 49 years on entry . DESIGN Individually r and omized controlled trial . SETTING Fifteen urban centres in Canada with expertise in the diagnosis and treatment of breast cancer . PARTICIPANTS Women with no history of breast cancer and no mammography in the previous 12 months were r and omly assigned to undergo either annual mammography and physical examination ( MP group ) or usual care after an initial physical examination ( UC group ) . The 50,430 women enrolled from January 1980 through March 1985 were followed for a mean of 8.5 years . DATA COLLECTION Derived from the participants by initial and annual self-administered question naires , from the screening examinations , from the patients ' physicians , from the provincial cancer registries and by record linkage to the Canadian National Mortality Data Base . Expert panels evaluated histologic and death data . MAIN OUTCOME MEASURES Rates of referral from screening , rates of detection of breast cancer from screening and from community care , nodal status , tumour size , and rates of death from all causes and from breast cancer . RESULTS Over 90 % of the women in each group attended the screening sessions or returned the annual question naires , or both , over years 2 to 5 . The characteristics of the women in the two groups were similar . Compared with the Canadian population , the participants were more likely to be married , have fewer children , have more education , be in a professional occupation , smoke less and have been born in North America . The rate of screen-detected breast cancer on first examination was 3.89 per 1000 in the MP group and 2.46 per 1000 in the UC group ; more node-positive tumours were found in the MP group than in the UC group . During years 2 through 5 the ratios of observed to expected cases of invasive breast cancer were 1.26 in the MP group and 1.02 in the UC group . Of the women with invasive breast cancer through to 7 years , 191 and 157 women in the MP and UC groups respectively had no node involvement , 55 and 43 had one to three nodes involved , 47 and 23 had four or more nodes involved , and 38 and 49 had an unknown nodal status . There were 38 deaths from breast cancer in the MP group and 28 in the UC group . The ratio of the proportions of death from breast cancer in the MP group compared with those in the UC group was 1.36 ( 95 % confidence interval 0.84 to 2.21 ) . The survival rates were similar in the two groups . The highest survival rate occurred among women whose cancer had been detected by mammography alone . CONCLUSION The study was internally valid , and there was no evidence of r and omization bias . Screening with yearly mammography and physical examination of the breasts detected considerably more node-negative , small tumours than usual care , but it had no impact on the rate of death from breast cancer up to 7 years ' follow-up from entry",
"Abstract Objectives To analyse false positives ( FPs ) in breast cancer screening with tomo synthesis ( BT ) vs. mammography ( DM ) . Methods The Malmö Breast Tomo synthesis Screening Trial ( MBTST ) is a prospect i ve population -based study comparing one-view BT to DM in screening . This study is based on the first half of the MBTST population ( n = 7,500 ) . Differences in FP recall rate , findings leading to recall , work-up and biopsy rate between cases recalled on BT alone , DM alone and BT+DM were analysed . Results The FP recall rate was 1.7 % for BT alone ( n = 131 ) , 0.9 % for DM alone ( n = 69 ) and 1.1 % for BT + DM ( n = 81 ) . The FP recall rate for BT alone was halved after the initial phase of the trial , stabilising at 1.5 % . BT doubled the recall of stellate distortions compared to DM ( n = 64 vs. n = 33 ) . There were fewer fibroadenomas and cysts , and the biopsy rate was slightly lower for FP recalled on BT alone compared to DM alone ( 15.3 % vs. 27.6 % : p = 0.037 and 33.8 % vs. 36.2 % ; p = 0.641 , respectively ) . Conclusions FPs increased with BT screening mainly due to the recall of stellate distortions . The FP recall rate was still well within the European guidelines and showed evidence of a learning curve . Characterisation of rounded lesions was improved with BT.Key Points• Tomo synthesis screening gave a higher false-positive recall rate than mammography • There was a decline in the false-positive recall rate for tomo synthesis • The recall due to stellate distortions simulating malignancy was doubled with tomo synthesis • Tomo synthesis found more radial and postoperative scar tissue than mammography • Tomo synthesis is better at characterising rounded",
"Purpose Mammography , the st and ard method of breast cancer screening , misses many cancers , especially in dense-breasted women . We compared the performance and diagnostic yield of mammography alone versus an automated whole breast ultrasound ( AWBU ) plus mammography in women with dense breasts and /or at elevated risk of breast cancer . Methods AWBU screening was tested in 4,419 women having routine mammography ( Trial Registration : Clinical Trials.gov Identifier : NCT00649337 ) . Cancers occurring during the study and subsequent 1-year follow-up were evaluated . Sensitivity , specificity and positive predictive value ( PPV ) of biopsy recommendation for mammography alone , AWBU and mammography with AWBU were calculated . Results Breast cancer detection doubled from 23 to 46 in 6,425 studies using AWBU with mammography , result ing in an increase in diagnostic yield from 3.6 per 1,000 with mammography alone to 7.2 per 1,000 by adding AWBU . PPV for biopsy based on mammography findings was 39.0 % and for AWBU 38.4 % . The number of detected invasive cancers 10 mm or less in size tripled from 7 to 21 when AWBU findings were added to mammography . Conclusion AWBU result ed in significant cancer detection improvement compared with mammography alone . Additional detection and the smaller size of invasive cancers may justify this technology ’s expense for women with dense breasts and /or at high risk for breast cancer",
"BACKGROUND As mammographic screening becomes more widespread , larger numbers of tumours are diagnosed while small and node negative . METHODS We examined detection mode , tumour size , node status , histological type , therapy and outcome in 1053 breast cancers diagnosed in one county of the Swedish Two-County Trial of mammographic screening for breast cancer . RESULTS Of patients undergoing total mastectomy with axillary dissection , 65 % were found to be node negative . For tumours of size 1 - 9 mm , 95 % were node negative . The major effects on survival were tumour size , node status and histological type . Primary adjuvant therapy had no significant association with survival . CONCLUSIONS The advent of mammography has substantially enhanced the possibilities for less radical treatment . There is an urgent need for therapeutic trials utilizing mammographic-pathological correlations to ascertain in advance which tumours can and which can not benefit from more radical therapy",
"BACKGROUND Age-specific effects of mammographic screening , and the timing of such effects , are a matter of debate . The results of the UK Age trial , which compared the effect of invitation to annual mammographic screening from age 40 years with commencement of screening at age 50 years on breast cancer mortality , have been reported at 10 years of follow-up and showed no significant difference in mortality between the trial groups . Here , we report the results of the UK Age trial after 17 years of follow-up . METHODS Women aged 39 - 41 from 23 UK NHS Breast Screening Programme units years were r and omly assigned by individual r and omisation ( 1:2 ) to either an intervention group offered annual screening by mammography up to and including the calendar year of their 48th birthday or to a control group receiving usual medical care ( invited for screening at age 50 years and every 3 years thereafter ) . Both groups were stratified by general practice . We compared breast cancer incidence and mortality by time since r and omisation . Analyses included all women r and omly assigned who could be traced with the National Health Service Central Register and who had not died or emigrated before entry . The primary outcome measures were mortality from breast cancer ( defined as deaths with breast cancer coded as the underlying cause of death ) and breast cancer incidence , including in-situ , invasive , and total incidence . Because there is an interest in the timing of the mortality effect , we analysed the results in different follow-up periods . This trial is registered , number IS RCT N24647151 . FINDINGS Between Oct 14 , 1990 , and Sept 25 , 1997 , 160 921 participants were r and omly assigned ; 53 883 women in the intervention group and 106 953 assigned to usual medical care were included in this analysis . After a median follow-up of 17 years ( IQR 16·8 - 18·8 ) , the rate ratio ( RR ) for breast cancer mortality was 0·88 ( 95 % CI 0·74 - 1·04 ) from tumours diagnosed during the intervention phase . A significant reduction in breast cancer mortality was noted in the intervention group compared with the control group in the first 10 years after diagnosis ( RR 0·75 , 0·58 - 0·97 ) but not thereafter ( RR 1·02 , 0·80 - 1·30 ) from tumours diagnosed during the intervention phase . The overall breast cancer incidence during 17 year follow-up was similar between the intervention group and the control group ( RR 0·98 , 0·93 - 1·04 ) . INTERPRETATION Our results support an early reduction in mortality from breast cancer with annual mammography screening in women aged 40 - 49 years . Further data are needed to fully underst and long-term effects . Cumulative incidence figures suggest at worst a small amount of overdiagnosis . FUNDING National Institute for Health Research Health Technology Assessment programme and the American Cancer Society . Past funding was received from the Medical Research Council , Cancer Research UK , the UK Department of Health , and the US National Cancer Institute",
"Objective To compare breast cancer incidence and mortality up to 25 years in women aged 40 - 59 who did or did not undergo mammography screening . Design Follow-up of r and omised screening trial by centre coordinators , the study ’s central office , and linkage to cancer registries and vital statistics data bases . Setting 15 screening centres in six Canadian provinces,1980 - 85 ( Nova Scotia , Quebec , Ontario , Manitoba , Alberta , and British Columbia ) . Participants 89 835 women , aged 40 - 59 , r and omly assigned to mammography ( five annual mammography screens ) or control ( no mammography ) . Interventions Women aged 40 - 49 in the mammography arm and all women aged 50 - 59 in both arms received annual physical breast examinations . Women aged 40 - 49 in the control arm received a single examination followed by usual care in the community . Main outcome measure Deaths from breast cancer . Results During the five year screening period , 666 invasive breast cancers were diagnosed in the mammography arm ( n=44 925 participants ) and 524 in the controls ( n=44 910 ) , and of these , 180 women in the mammography arm and 171 women in the control arm died of breast cancer during the 25 year follow-up period . The overall hazard ratio for death from breast cancer diagnosed during the screening period associated with mammography was 1.05 ( 95 % confidence interval 0.85 to 1.30 ) . The findings for women aged 40 - 49 and 50 - 59 were almost identical . During the entire study period , 3250 women in the mammography arm and 3133 in the control arm had a diagnosis of breast cancer , and 500 and 505 , respectively , died of breast cancer . Thus the cumulative mortality from breast cancer was similar between women in the mammography arm and in the control arm ( hazard ratio 0.99 , 95 % confidence interval 0.88 to 1.12 ) . After 15 years of follow-up a residual excess of 106 cancers was observed in the mammography arm , attributable to over-diagnosis . Conclusion Annual mammography in women aged 40 - 59 does not reduce mortality from breast cancer beyond that of physical examination or usual care when adjuvant therapy for breast cancer is freely available . Overall , 22 % ( 106/484 ) of screen detected invasive breast cancers were over-diagnosed , representing one over-diagnosed breast cancer for every 424 women who received mammography screening in the trial",
"PURPOSE To assess cancer detection rates , false-positive rates before arbitration , positive predictive values for women recalled after arbitration , and the type of cancers detected with use of digital mammography alone and combined with tomo synthesis in a large prospect i ve screening trial . MATERIAL S AND METHODS A prospect i ve , reader- and modality-balanced screening study of participants undergoing combined mammography plus tomo synthesis , the results of which were read independently by four different radiologists , is under way . The study was approved by a regional ethics committee , and all participants provided written informed consent . The authors performed a preplanned interim analysis of results from 12,631 examinations interpreted by using mammography alone and mammography plus tomo synthesis from November 22 , 2010 , to December 31 , 2011 . Analyses were based on marginal log-linear models for binary data , accounting for correlated interpretations and adjusting for reader-specific performance levels by using a two-sided significance level of .0294 . RESULTS Detection rates , including those for invasive and in situ cancers , were 6.1 per 1000 examinations for mammography alone and 8.0 per 1000 examinations for mammography plus tomo synthesis ( 27 % increase , adjusted for reader ; P = .001 ) . False-positive rates before arbitration were 61.1 per 1000 examinations with mammography alone and 53.1 per 1000 examinations with mammography plus tomo synthesis ( 15 % decrease , adjusted for reader ; P positive predictive values for recalled patients with cancers verified later were comparable ( 29.1 % and 28.5 % , respectively , with mammography alone and mammography plus tomo synthesis ; P = .72 ) . Twenty-five additional invasive cancers were detected with mammography plus tomo synthesis ( 40 % increase , adjusted for reader ; P mean interpretation time was 45 seconds for mammography alone and 91 seconds for mammography plus tomo synthesis ( P mammography plus tomo synthesis in a screening environment result ed in a significantly higher cancer detection rate and enabled the detection of more invasive cancers . Clinical trial registration no. NCT01248546",
"Background Uncertainty exists about the appropriate use of screening mammography among older women because comorbid illnesses may diminish the benefit of screening . We examined the risk of adverse tumor characteristics and false positive rates according to screening interval , age , and comorbidity . Methods From January 1999 to December 2006 , data were collected prospect ively on 2993 older women with breast cancer and 137 949 older women without breast cancer who underwent mammography at facilities that participated in a data linkage between the Breast Cancer Surveillance Consortium and Medicare cl aims . Women were aged 66 to 89 years at study entry to allow for measurement of 1 year of preexisting illnesses . We used logistic regression analyses to calculate the odds of advanced ( IIb , III , IV ) stage , large ( > 20 millimeters ) tumors , and 10-year cumulative probability of false-positive mammography by screening frequency ( 1 vs 2 years ) , age , and comorbidity score . The comorbidity score was derived using the Klabunde approximation of the Charlson score . All statistical tests were two-sided . Results Adverse tumor characteristics did not differ statistically significantly by comorbidity , age , or interval . Cumulative probability of a false-positive mammography result was higher among annual screeners than biennial screeners irrespective of comorbidity : 48.0 % ( 95 % confidence interval [ CI ] = 46.1 % to 49.9 % ) of annual screeners aged 66 to 74 years had a false-positive result compared with 29.0 % ( 95 % CI = 28.1 % to 29.9 % ) of biennial screeners . Conclusion Women aged 66 to 89 years who undergo biennial screening mammography have similar risk of advanced-stage disease and lower cumulative risk of a false-positive recommendation than annual screeners , regardless of comorbidity",
"Context Seven- and 10-year results of the Canadian National Breast Screening Study ( CNBSS ) showed no reduction in breast cancer mortality from five annual mammographies and breast examinations for 40- to 49-year-old women . Some authors have argued that longer follow-up would reveal important benefits . Contribution After 11 to 16 years , the cumulative rate ratios for mammography versus usual care were 0.97 ( 95 % CI , 0.74 to 1.27 ) for breast cancer mortality without adjustment for non study mammography and 1.06 ( CI , 0.80 to 1.40 ) with adjustment . Clinical Implication s The CNBSS suggests that screening 40- to 49-year-old women is unlikely to reduce breast cancer by 20 % or more . Controversy will persist because other studies suggest that screening causes small reductions in breast cancer mortality . The Editors The Canadian National Breast Screening Study -1 ( CNBSS-1 ) , an individually r and omized trial in women 40 to 49 years of age at study entry , evaluated the efficacy of annual mammography , breast physical examination , and instruction on breast self-examination in reducing breast cancer mortality ( 1 ) . The 7-year ( 2 ) and preliminary 10-year ( 3 ) mortality results were previously reported . At 7 years , 38 women in the mammography group and 28 women in the usual care group had died of breast cancer , for a rate ratio of 1.36 ( 95 % CI , 0.84 to 2.21 ) ( 2 ) . At 10 years , there were 82 breast cancer deaths in the mammography group and 72 in the usual care group ( rate ratio , 1.14 [ CI , 0.83 to 1.56 ] ) ( 3 ) . This article reports CNBSS-1 results after an average 13-year follow-up from study entry . Methods Patient Selection and Recruitment Participants were recruited through media publicity , personal invitation letters using population lists ( municipal registers and provincial health insurance registers ) , group mailings , and physicians ( 4 ) . Eligibility criteria were age 40 to 49 years , no previous diagnosis of breast cancer , not being pregnant , no mammography in the previous 12 months , and signed informed consent . The Human Experimentation Committee of the University of Toronto ( Toronto , Ontario , Canada ) and Human Experimentation Committees at 15 CNBSS collaborating centers approved the study . A total of 50 430 women age 40 to 49 years were enrolled from January 1980 through March 1985 . R and omization Before r and omization , all participants received an initial breast physical examination and instruction on breast self-examination . They were then immediately r and omly assigned to receive mammography and , thereafter , either annual screening with mammography and breast physical examination ( 25 214 women in the mammography group were available for analysis ) or usual care in the context of the Canadian health care system ( 25 216 women in the usual care group were available for analysis ) . Center coordinators r and omly assigned participants using prepared allocation lists , independent of breast physical examination findings . This sequence ensured that the conduct and interpretation of the breast physical examination would be unbiased by knowledge of whether mammography would follow . Intervention Screening Schedule In the mammography group , 62 % of women received five annual screenings . The remainder , recruited later , received four . Each screening examination comprised mammography , breast physical examination , and instruction and evaluation on breast self-examination . Women in the mammography group completed question naires at each rescreening visit . Women in the usual care group were not recalled for rescreening but were mailed annual question naires . We expected that these participants would continue their normal pattern of medical care as delivered through Canada 's universal health care coverage , including access to mammography for diagnosis . Study Procedures Two-view mammography was done on dedicated mammography units ( 5 ) , and second readers review ed mammograms deemed abnormal . Systematic audit procedures were used ( 6 ) . Nurses provided breast physical examination in 12 centers and physicians in 3 centers in Qubec ( 7 ) . These providers taught and evaluated breast self-examination while conducting their own examination ( 8) . If findings on breast physical examination or mammography were abnormal , participants were referred to a CNBSS review clinic . The study surgeon discussed mammography findings with the study radiologist , examined the participant , and decided whether further diagnostic procedures should be recommended to the woman 's physician . The woman 's physician determined whether and how to implement the study surgeon 's recommendations . Data Collection Protocol During the screening period , the center coordinators collected surgery and pathology reports for breast-related diagnostic and therapeutic procedures . The CNBSS pathologists review ed all slides . If the community and CNBSS pathologist disagreed , a panel of three to five CNBSS pathologists blindedly and independently review ed the slides . Extensive quality control procedures were used during data collection . After the screening centers closed in 1988 , the central CNBSS central office annually followed all women known to have breast cancer until 30 June 1996 , the cut-off for this analysis . Passive follow-up of all participants through linkage with the National Cancer Registry identified new diagnoses of breast cancer in study participants through 31 December 1993 . The central office collected pathology reports for postscreening cases of breast cancer . The community diagnosis was accepted for study purpose s. Family members responding to the annual mailed question naire identified deaths that occurred before completion of a participant 's screening schedule . Thereafter , women not known to have cancer were followed only through registry linkage ; their mammography experience was not traced . However , for women known to have breast cancer , attending physicians received annual requests for up date d clinical information , including death . Attending physicians , who received annual requests for information on women with breast cancer , reported deaths until 30 June 1996 . Linkage with the Canadian Mortality Data base at Statistics Canada ( including deaths in Canadians who resided in the United States at the time of death ) identified causes of death in the entire cohort until 31 December 1993 . The procedures used to verify deaths from breast cancer were described previously ( 2 ) . Investigative procedures were initiated for women dying with breast cancer ; those whose death certificates mentioned breast cancer ; and those whose cause of death was described as unknown , unknown primary , lung cancer , colon cancer , or liver cancer . The review ers were blinded to study group allocation . All other causes of death were accepted as certified . For the most recent record linkage , more stringent confidentiality requirements exercised by many hospitals hindered verification . Thus , of the breast cancer deaths reported in this paper , a panel review ed 67 % in the mammography group and 77 % in the usual care group . The remaining deaths are as reported on death certificates . Study Outcomes Death due to or probably due to breast cancer was the major study outcome . A previous report of the CNBBS-1 noted axillary node status , as assessed by community pathologists , through 7 years of follow-up ( 2 ) . Subsequently ( 1993 to 1997 ) , to achieve consistent reporting of tumor size , all available material for screening-detected cancer and cancer detected between screenings was re-collected from originating institutions and review ed by one of the CNBSS pathologists or a colleague . Slides were obtained for review for nearly 80 % of requested cases . For the current analysis , pathologists measured the size of small tumors as observed on the slide or the size of the invasive component for mixed invasive and in situ tumors . Statistical Analysis Sample Size The CNBSS-1 was planned to evaluate whether breast cancer mortality would decrease by 40 % in the mammography group compared with the usual care group after 5 years of follow-up , with a required sample size of 50 000 women ( = 0.05 ; power , 80 % ) ( 1 ) . At 5 years , however , too few women had died of breast cancer for the study to achieve the planned power . Thus , for the first report on breast cancer mortality , we extended follow-up to 7 years ( 2 ) . CNBSS Data base The data base includes records for 50 430 women , including demographic and risk factor variables and results of screening examinations , diagnostic and therapeutic procedures , pathology results , and causes of death . CNBSS Terminology The terms screen 1 , screen 2 , through screen 5 denote events associated with screening examinations in the mammography group . The initial breast physical examination received by the usual care group is called screen 1 . Screening-detected cancers are those diagnosed after a recommendation made by the study surgeon at the CNBSS review clinic . Interval cancers are cases of cancer that occurred less than 12 months after a screening examination at which no recommendation for diagnostic procedures was made . Incident cancers are cases of cancer that occurred more than 12 months after the previous CNBSS screening examination . Statistical Tests The statistical significance of differences in proportions was determined by using the chi-square test ( two-sided = 0.05 ) . For all observed-to-expected ratios , 95 % CIs were computed . Death rates were computed by using person-years based on stratification by quinquennium of age ; we assumed that all women not known to be dead are alive . Age was defined as age at entry . Because all eligible participants were included in the analysis and follow-up , this is an intention-to-treat analysis . Cox proportional-hazards regression was done to examine variables with the most significant independent influence on survival ( 9 ) , using the PHREG program in SAS software , version 6.12 ( SAS Institute , Inc. , Cary , North Carolina ) . Because the variable allocation to screening was our primary interest , it was",
"PURPOSE To compare the performance of two versions of reconstructed two-dimensional ( 2D ) images in combination with digital breast tomo synthesis ( DBT ) versus the performance of st and ard full-field digital mammography ( FFDM ) plus DBT . MATERIAL S AND METHODS This trial had ethical committee approval , and all participants gave written informed consent . Examinations ( n = 24 901 ) in women between the ages of 50 and 69 years ( mean age , 59.2 years ) were interpreted prospect ively as part of a screening trial that included independent interpretations of FFDM plus DBT and reconstructed 2D images plus DBT . Reconstructed 2D images do not require radiation exposure . Using analyses for binary data that accounted for correlated interpretations and were adjusted for reader-specific volume , two versions ( initial and current ) of reconstructed 2D images used during trial periods 1 ( from November 22 , 2010 , to December 21 , 2011 ; 12 631 women ) and 2 ( from January 20 , 2012 , to December 19 , 2012 ; 12 270 women ) were compared in terms of cancer detection and false-positive rates with the corresponding FFDM plus DBT interpretations . RESULTS Cancer detection rates were 8.0 , 7.4 , 7.8 , and 7.7 per 1000 screening examinations for FFDM plus DBT in period 1 , initial reconstructed 2D images plus DBT in period 1 , FFDM plus DBT in period 2 , and current reconstructed 2D images plus DBT in period 2 , respectively . False-positive scores were 5.3 % , 4.6 % , 4.6 % , and 4.5 % , respectively . Corresponding reader-adjusted paired comparisons of false-positive scores revealed significant differences for period 1 ( P = .012 ) but not for period 2 ( ratio = 0.99 ; 95 % confidence interval : 0.88 , 1.11 ; P = .85 ) . CONCLUSION The combination of current reconstructed 2D images and DBT performed comparably to FFDM plus DBT and is adequate for routine clinical use when interpreting screening mammograms",
"OBJECTIVE Our goal was to determine differences in outcome measures between women undergoing annual versus biennial screening mammography . MATERIAL S AND METHODS A retrospective review of prospect ively collected data on 24,211 consecutive screening mammography examinations was performed in women aged 40 - 79 years , all of whom had undergone previous normal screening mammography . Annual screening and biennial screening were defined as examinations performed 10 - 14 months and 22 - 26 months , respectively , after previous normal screening mammography . The rates of recall , biopsy , cancer detection , and interval cancer for annual and biennial screening cohorts were calculated , as were tumor size , lymph node status , and stage of invasive cancer . Interval cancer cases were identified by linkage with a regional tumor registry . RESULTS Of the 4306 biennially screened women , 160 were recalled ( 3.7 % ) , 45 were biopsied ( 1.0 % ) , and cancer was detected in 19 ( 0.44 % ) . Of the 19,905 annually screened women , 518 were recalled ( 2.6 % ) , 150 were biopsied ( 0.75 % ) , and cancer was detected in 71 ( 0.36 % ) . Of the 3278 registry-linked biennially screened women , five had interval cancer ( 0.15 % ) ; of the 15,031 registry-linked annually screened women , 10 had interval cancer ( 0.07 % ) . For biennial screening-detected cancer and interval invasive cancer combined , the median tumor size was 15 mm , 24 % had lymph node metastasis , and 29 % were stage 2 or higher . For annual screening-detected cancer , these measures were 11 mm , 14 % positive nodes , and 17 % stage 2 + cancer , respectively . CONCLUSION Annual screening mammography results in lower recall rates than does biennial screening ( p screening results in the detection of smaller tumors that have a more favorable prognosis ( p = .04 )",
"Although there is evidence for a reduction in breast carcinoma mortality with mammographic screening , some doubts have been expressed , and there is still uncertainty regarding the age specific effects",
"OBJECTIVE To compare the accuracy of st and ard supplementary views and GE digital breast tomo synthesis ( DBT ) for assessment of soft-tissue mammographic abnormalities . METHODS Women recalled for further assessment of soft-tissue abnormalities were recruited and received st and ard supplementary views ( typically spot compression views ) and two-view GE DBT . The added value of DBT in the assessment process was determined by analysing data collected prospect ively by radiologists working up the cases . Following anonymization of cases , there was also a retrospective multireader review . The readers first read bilateral st and ard two-view digital mammography ( DM ) together with the supplementary mammographic views and gave a combined score for suspicion of malignancy on a five-point scale . The same readers then read bilateral st and ard two-view DM together with two-view DBT . Pathology data were obtained . Differences were assessed using receiver operating characteristic analysis . RESULTS The study population was 342 lesions in 322 patients . The final diagnosis was malignant in 113 cases ( 33 % ) and benign/normal in 229 cases ( 67 % ) . In the prospect i ve analysis , the performance of two-view DM plus DBT was at least equivalent to the performance of two-view DM and st and ard mammographic supplementary views-the area under the curve ( AUC ) was 0.946 and 0.922 , respectively , which did not reach statistical significance . Similar results were obtained for the retrospective review -AUC was 0.900 ( DBT ) and 0.873 ( supplementary views ) , which did not reach statistical significance . CONCLUSION The accuracy of GE DBT in the assessment of screen detected soft-tissue abnormalities is equivalent to the use of st and ard supplementary mammographic views . ADVANCES IN KNOWLEDGE The vast majority of evidence relating to the use of DBT has been gathered from research using Hologic equipment . This study provides evidence for the use of the commercially available GE DBT system demonstrating that it is at least equivalent to supplementary mammographic views in the assessment of soft-tissue screen-detected abnormalities",
"IMPORTANCE Screening mammography intervals remain under debate in the United States . OBJECTIVE To compare the proportion of breast cancers with less vs more favorable prognostic characteristics in women screening annually vs biennially by age , menopausal status , and postmenopausal hormone therapy ( HT ) use . DESIGN , SETTING , AND PARTICIPANTS This was a study of a prospect i ve cohort from 1996 to 2012 at Breast Cancer Surveillance Consortium facilities . A total of 15,440 women ages 40 to 85 years with breast cancer diagnosed within 1 year of an annual or within 2 years of a biennial screening mammogram . EXPOSURES We up date d previous analyses by using narrower intervals for defining annual ( 11 - 14 months ) and biennial ( 23 - 26 months ) screening . MAIN OUTCOMES AND MEASURES We defined less favorable prognostic characteristics as tumors that were stage IIB or higher , size greater than 15 mm , positive nodes , and any 1 or more of these characteristics . We used log-binomial regression to model the proportion of breast cancers with less favorable characteristics following a biennial vs annual screen by 10-year age groups and by menopausal status and current postmenopausal HT use . RESULTS Among 15,440 women with breast cancer , most were 50 years or older ( 13,182 [ 85.4 % ] ) , white ( 12,063 [ 78.1 % ] ) , and postmenopausal ( 9823 [ 63.6 % ] ) . Among 2027 premenopausal women ( 13.1 % ) , biennial screeners had higher proportions of tumors that were stage IIB or higher ( relative risk [ RR ] , 1.28 [ 95 % CI , 1.01 - 1.63 ] ; P=.04 ) , size greater than 15 mm ( RR , 1.21 [ 95 % CI , 1.07 - 1.37 ] ; P=.002 ) , and with any less favorable prognostic characteristic ( RR , 1.11 [ 95 % CI , 1.00 - 1.22 ] ; P=.047 ) compared with annual screeners . Among women currently taking postmenopausal HT , biennial screeners tended to have tumors with less favorable prognostic characteristics compared with annual screeners ; however , 95 % CIs were wide , and differences were not statistically significant ( for stage 2B+ , RR , 1.14 [ 95 % CI , 0.89 - 1.47 ] , P=.29 ; size>15 mm , RR , 1.13 [ 95 % CI , 0.98 - 1.31 ] , P=.09 ; node positive , RR , 1.18 [ 95 % CI , 0.98 - 1.42 ] , P=.09 ; any less favorable characteristic , RR , 1.12 [ 95 % CI , 1.00 - 1.25 ] , P=.053 ) . The proportions of tumors with less favorable prognostic characteristics were not significantly larger for biennial vs annual screeners among postmenopausal women not taking HT ( eg , any characteristic : RR , 1.03 [ 95 % CI , 0.95 - 1.12 ] ; P=.45 ) , postmenopausal HT users after subdividing by type of hormone use ( eg , any characteristic : estrogen+progestogen users , RR , 1.16 [ 95 % CI , 0.91 - 1.47 ] ; P=.22 ; estrogen-only users , RR , 1.14 [ 95 % CI , 0.94 - 1.37 ] ; P=.18 ) , or any 10-year age group ( eg , any characteristic : ages 40 - 49 years , RR , .1.04 [ 95 % CI , 0.94 - 1.14 ] ; P=.48 ; ages 50 - 59 years , RR , 1.03 [ 95 % CI , 0.94 - 1.12 ] ; P=.58 ; ages 60 - 69 years , RR , 1.07 [ 95 % CI , 0.97 - 1.19 ] ; P=.18 ; ages 70 - 85 years , RR , 1.05 [ 95 % CI , 0.94 - 1.18 ] ; P=.35 ) . CONCLUSIONS AND RELEVANCE Premenopausal women diagnosed as having breast cancer following biennial vs annual screening mammography are more likely to have tumors with less favorable prognostic characteristics . Postmenopausal women not using HT who are diagnosed as having breast cancer following a biennial or annual screen have similar proportions of tumors with less favorable prognostic characteristics",
"PURPOSE We investigated whether an abbreviated protocol ( AP ) , consisting of only one pre- and one postcontrast acquisition and their derived images ( first postcontrast subtracted [ FAST ] and maximum-intensity projection [ MIP ] images ) , was suitable for breast magnetic resonance imaging ( MRI ) screening . METHODS We conducted a prospect i ve observational reader study in 443 women at mildly to moderately increased risk who underwent 606 screening MRIs . Eligible women had normal or benign digital mammograms and , for those with heterogeneously dense or extremely dense breasts ( n = 427 ) , normal or benign ultrasounds . Expert radiologists review ed the MIP image first to search for significant enhancement and then review ed the complete AP ( consisting of MIP and FAST images and optionally their nonsubtracted source images ) to characterize enhancement and establish a diagnosis . Only thereafter was the regular full diagnostic protocol ( FDP ) analyzed . RESULTS MRI acquisition time for FDP was 17 minutes , versus 3 minutes for the AP . Average time to read the single MIP and complete AP was 2.8 and 28 seconds , respectively . Eleven breast cancers ( four ductal carcinomas in situ and seven invasive cancers ; all T1N0 intermediate or high grade ) were diagnosed , for an additional cancer yield of 18.2 per 1,000 . MIP readings were positive in 10 ( 90.9 % ) of 11 cancers and allowed establishment of the absence of breast cancer , with a negative predictive value ( NPV ) of 99.8 % ( 418 of 419 ) . Interpretation of the complete AP , as with the FDP , allowed diagnosis of all cancers ( 11 [ 100 % ] of 11 ) . Specificity and positive predictive value ( PPV ) of AP versus FDP were equivalent ( 94.3 % v 93.9 % and 24.4 % v 23.4 % , respectively ) . CONCLUSION An MRI acquisition time of 3 minutes and an expert radiologist MIP image reading time of 3 seconds are sufficient to establish the absence of breast cancer , with an NPV of 99.8 % . With a reading time diagnostic accuracy was equivalent to that of the FDP and result ed in an additional cancer yield of 18.2 per 1,000",
"BACKGROUND Digital breast tomo synthesis with 3D images might overcome some of the limitations of conventional 2D mammography for detection of breast cancer . We investigated the effect of integrated 2D and 3D mammography in population breast-cancer screening . METHODS Screening with Tomo synthesis OR st and ard Mammography ( STORM ) was a prospect i ve comparative study . We recruited asymptomatic women aged 48 years or older who attended population -based breast-cancer screening through the Trento and Verona screening services ( Italy ) from August , 2011 , to June , 2012 . We did screen-reading in two sequential phases-2D only and integrated 2D and 3D mammography-yielding paired data for each screen . St and ard double-reading by breast radiologists determined whether to recall the participant based on positive mammography at either screen read . Outcomes were measured from final assessment or excision histology . Primary outcome measures were the number of detected cancers , the number of detected cancers per 1000 screens , the number and proportion of false positive recalls , and incremental cancer detection attributable to integrated 2D and 3D mammography . We compared paired binary data with McNemar 's test . FINDINGS 7292 women were screened ( median age 58 years [ IQR 54 - 63 ] ) . We detected 59 breast cancers ( including 52 invasive cancers ) in 57 women . Both 2D and integrated 2D and 3D screening detected 39 cancers . We detected 20 cancers with integrated 2D and 3D only versus none with 2D screening only ( p Cancer detection rates were 5.3 cancers per 1000 screens ( 95 % CI 3.8 - 7.3 ) for 2D only , and 8.1 cancers per 1000 screens ( 6.2 - 10.4 ) for integrated 2D and 3D screening . The incremental cancer detection rate attributable to integrated 2D and 3D mammography was 2.7 cancers per 1000 screens ( 1.7 - 4.2 ) . 395 screens ( 5.5 % ; 95 % CI 5.0 - 6.0 ) result ed in false positive recalls : 181 at both screen reads , and 141 with 2D only versus 73 with integrated 2D and 3D screening ( p integrated 2D and 3D mammography as a condition to recall ) could have reduced false positive recalls by 17.2 % ( 95 % CI 13.6 - 21.3 ) without missing any of the cancers detected in the study population . INTERPRETATION Integrated 2D and 3D mammography improves breast-cancer detection and has the potential to reduce false positive recalls . R and omised controlled trials are needed to compare integrated 2D and 3D mammography with 2D mammography for breast cancer screening . FUNDING National Breast Cancer Foundation , Australia ; National Health and Medical Research Council , Australia ; Hologic , USA ; Technologic , Italy",
" The Health Insurance Plan ( HIP ) of Greater New York conducted a clinical trial to determine if screening for breast cancer with mammography and clinical examination would decrease breast cancer mortality . The extent of disease at diagnosis among breast cancers detected by screening and the effect of screening on breast cancer mortality have been evaluated in the cohort of all HIP women diagnosed with breast cancer within 6 years of entry into the trial and followed at least 18 years after trial entry . Six years was the earliest time at which the number of cases diagnosed in the control group was equal to the number of cases diagnosed in the study group . In the cohorts of women 40 - 49 and 50 - 64 years of age at entry , shifts were significant to lower stages for screen-detected cases . As a result , the study group women in each age cohort had significantly lower breast cancer mortality than control group women when statistical analyses were restricted to data from cases only . In the 40 - 49 age-at-entry cohort , the reduced breast cancer mortality in the study group appears to result from lower mortality in stage I cases as well as from earlier case detection , and this may explain differences between the two age-at-entry cohorts in the length of follow-up time required to demonstrate a mortality reduction due to screening",
"CONTEXT Annual ultrasound screening may detect small , node-negative breast cancers that are not seen on mammography . Magnetic resonance imaging ( MRI ) may reveal additional breast cancers missed by both mammography and ultrasound screening . OBJECTIVE To determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer . DESIGN , SETTING , AND PARTICIPANTS From April 2004-February 2006 , 2809 women at 21 sites with elevated cancer risk and dense breasts consented to 3 annual independent screens with mammography and ultrasound in r and omized order . After 3 rounds of both screenings , 612 of 703 women who chose to undergo an MRI had complete data . The reference st and ard was defined as a combination of pathology ( biopsy results that showed in situ or infiltrating ductal carcinoma or infiltrating lobular carcinoma in the breast or axillary lymph nodes ) and 12-month follow-up . MAIN OUTCOME MEASURES Cancer detection rate ( yield ) , sensitivity , specificity , positive predictive value ( PPV3 ) of biopsies performed and interval cancer rate . RESULTS A total of 2662 women underwent 7473 mammogram and ultrasound screenings , 110 of whom had 111 breast cancer events : 33 detected by mammography only , 32 by ultrasound only , 26 by both , and 9 by MRI after mammography plus ultrasound ; 11 were not detected by any imaging screen . Among 4814 incidence screens in the second and third years combined , 75 women were diagnosed with cancer . Supplemental incidence-screening ultrasound identified 3.7 cancers per 1000 screens ( 95 % CI , 2.1 - 5.8 ; P Sensitivity for mammography plus ultrasound was 0.76 ( 95 % CI , 0.65 - 0.85 ) ; specificity , 0.84 ( 95 % CI , 0.83 - 0.85 ) ; and PPV3 , 0.16 ( 95 % CI , 0.12 - 0.21 ) . For mammography alone , sensitivity was 0.52 ( 95 % CI , 0.40 - 0.64 ) ; specificity , 0.91 ( 95 % CI , 0.90 - 0.92 ) ; and PPV3 , 0.38 ( 95 % CI , 0.28 - 0.49 ; P MRI participants , 16 women ( 2.6 % ) had breast cancer diagnosed . The supplemental yield of MRI was 14.7 per 1000 ( 95 % CI , 3.5 - 25.9 ; P = .004 ) . Sensitivity for MRI and mammography plus ultrasound was 1.00 ( 95 % CI , 0.79 - 1.00 ) ; specificity , 0.65 ( 95 % CI , 0.61 - 0.69 ) ; and PPV3 , 0.19 ( 95 % CI , 0.11 - 0.29 ) . For mammography and ultrasound , sensitivity was 0.44 ( 95 % CI , 0.20 - 0.70 , P = .004 ) ; specificity 0.84 ( 95 % CI , 0.81 - 0.87 ; P PPV3 , 0.18 ( 95 % CI , 0.08 to 0.34 ; P = .98 ) . The number of screens needed to detect 1 cancer was 127 ( 95 % CI , 99 - 167 ) for mammography ; 234 ( 95 % CI , 173 - 345 ) for supplemental ultrasound ; and 68 ( 95 % CI , 39 - 286 ) for MRI after negative mammography and ultrasound results . CONCLUSION The addition of screening ultrasound or MRI to mammography in women at increased risk of breast cancer result ed in not only a higher cancer detection yield but also an increase in false-positive findings . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00072501",
"Purpose To investigate the utility and accuracy of breast magnetic resonance ( MR ) imaging as a supplemental screening tool in women at average risk for breast cancer and to investigate the types of cancer detected with MR imaging screening . Material s and Methods This prospect i ve observational study was conducted at two academic breast centers in women aged 40 - 70 years without breast cancer-associated risk factors ( lifetime risk Between January 2005 and December 2013 , women with at least minimal residual breast tissue ( American College of Radiology categories A-D ) and normal conventional imaging findings ( screening mammography with or without screening ultrasonography [ US ] ) were invited to undergo supplemental MR imaging screening . Outcome measures were supplemental cancer detection rates , interval cancer rates , and biologic profiles of MR imaging-detected additional cancers , as well as specificity and positive predictive value ( PPV ) of MR imaging screening . Tissue diagnoses or 2 years of follow-up were used to establish the reference st and ard . Results A total of 2120 women were recruited and underwent 3861 screening MR imaging studies , covering an observation period of 7007 women-years . Breast MR imaging depicted 60 additional breast cancers ( ductal carcinoma in situ , n = 20 ; invasive carcinoma , n = 40 ) for an overall supplemental cancer detection rate of 15.5 per 1000 cases ( 95 % confidence interval [ CI ] : 11.9 , 20.0 ) . Forty-eight additional cancers were detected with MR imaging at initial screening ( supplemental cancer detection rate , 22.6 per 1000 cases ) . During the 1741 subsequent screening rounds , 12 of 13 incident cancers were found with MR imaging alone ( supplemental cancer detection rate , 6.9 per 1000 cases ) . One cancer was diagnosed with all three methods ( mammography , US , and MR imaging ) , and none were diagnosed with mammography only or US only . Cancers diagnosed with MR imaging were small ( median , 8 mm ) , node negative in 93.4 % of cases , and dedifferentiated ( high- grade cancer ) in 41.7 % of cases at prevalence screening and 46.0 % of cases at incidence screening . No interval cancers were observed . MR imaging screening offered high specificity ( 97.1 % ; 95 % CI : 96.5 , 97.6 ) and high PPV ( 35.7 % ; 95 % CI : 28.9 , 43.1 ) . Conclusion In women at average risk for breast cancer , MR imaging screening improves early diagnosis of prognostically relevant breast cancer . © RSNA , 2017 Online supplemental material is available for this article",
"OBJECTIVE To evaluate the efficacy of annual mammography over and above annual physical examination of the breasts and the teaching of breast self-examination among women aged 50 to 59 on entry . DESIGN Individually r and omized controlled trial . SETTING Fifteen urban centres in Canada with expertise in the diagnosis and treatment of breast cancer . PARTICIPANTS Women with no history of breast cancer and no mammography in the previous 12 months were r and omly assigned to undergo either annual mammography and physical examination ( MP group ) or annual physical examination only ( PO group ) . The 39,405 women enrolled from January 1980 through March 1985 were followed for a mean of 8.3 years . DATA COLLECTION Derived from the participants by initial and annual self-administered question naires , from the screening examinations , from the patients ' physicians , from the provincial cancer registries and by record linkage to the Canadian National Mortality Data Base . Expert panels evaluated histologic and death data . MAIN OUTCOME MEASURES Rates of referral from screening , rates of detection of breast cancer from screening and from community care , nodal status , tumour size and rates of death from all causes and from breast cancer . RESULTS Over 85 % of the women in each group attended the screening sessions after screen 1 . The characteristics of the women in the two groups were similar . Compared with the Canadian population the participants were more likely to be married , have fewer children , have more education , be in a professional occupation , smoke less and have been born in North America . The rate of screen-detected breast cancer on first examination was 7.20 per 1000 in the MP group and 3.45 per 1000 in the PO group , more node-positive tumours were found in the MP group than in the PO group . At subsequent screens the detection rates were a little less than half the rates at screen 1 . During years 2 through 5 the ratios of observed to expected cases of invasive breast cancer were 1.28 in the MP group and 1.18 in the PO group . Of the women with invasive breast cancer through to 7 years , 217 in the MP group and 184 in the PO group had no node involvement , 66 and 56 had one to three nodes involved , 32 and 34 had four or more nodes involved , and 55 and 46 had an unknown nodal status . There were 38 deaths from breast cancer in the MP group and 39 in the PO group . The ratio of the proportions of death from breast cancer in the MP group compared with those in the UC group was 0.97 ( 95 % confidence interval 0.62 to 1.52 ) . The survival rates were similar in the two groups . Women whose cancer had been detected by mammography alone had the highest survival rate . CONCLUSION The study was internally valid , and there was no evidence of r and omization bias . Screening with yearly mammography in addition to physical examination of the breasts detected considerably more node-negative , small tumours than screening with physical examination alone , but it had no impact on the rate of death from breast cancer up to 7 years ' follow-up from entry",
"Background . Several studies have found a smaller effect of breast cancer screening on breast cancer mortality in women aged younger than 50 years compared with older women . Various possible reasons have been suggested for this , but none firmly is established",
"This paper summarizes the findings of the first breast cancer screening trial , which was initiated in December 1963 to explore the efficacy of screening . Women aged 40 - 64 years were selected from enrollees in the Health Insurance Plan ( HIP ) of Greater New York and were r and omly assigned to study and control groups . Study group women were invited for screening , an initial examination , and three annual reexaminations . Screening consisted of film mammography ( cephalocaudal and lateral views of each breast ) and clinical examination of breasts . Breast cancer and mortality from breast cancer were examined by treatment group ( study vs. control ) and by entry-age subgroup . By the end of 18 years from entry , the study group had about a 25 % lower breast cancer mortality among women aged 40 - 49 and 50 - 59 at time of entry than did the control group . However , to a large extent the difference among the 40 - 49-year-olds occurred in the subgroup with breast cancer diagnosed after these women had passed their 50th birthday , and utility of screening women in their forties is question able",
"The 14-year follow-up mortality results from the r and omized breast cancer screening trial of the Health Insurance Plan of Greater New York ( HIP ) were analyzed with respect to the problem of age-specific screening effects . Mortality reduction was measured in three different ways and appears to be homogeneous across age groups . This finding challenges the widespread opinion that the results of the HIP study support the conclusion that breast cancer screening is not effective below age 50",
"Background Data on the value of digital breast tomo synthesis ( DBT ) for further assessment of screen-detected lesions are still limited . Purpose To compare screening mammography , single-view DBT and ultrasound-information ( TS ) vs. screening mammography , additional views and ultrasound-information ( AV ) for assessment of screen-detected abnormalities . Material and Methods The use of wide-angle DBT for screen-detected , soft-tissue abnormalities requiring additional views was investigated : 241 cases ( 206 benign and 35 malignant lesions ) , verified by histology or two-year follow-up , were read by ten readers as TS and as AV sets , yielding 2410 diagnoses for each set . Readings were r and omly sequenced . Results The mean interval between readings was nine weeks ( r and om sequence ) . Evaluation was breast-based . Overall , in terms of area under receiver operating characteristic ( AUC ; varying degree of suspicion cutoff ) , TS and AV readings showed similar performance : for TS , AUC was 0.889 ( 95 % confidence interval [ CI ] = 0.871–0.907 ) and for AV , AUC was 0.903 ( 95 % CI = 0.886–0.921 ) . TS readings had slightly higher sensitivity than AV readings ( 96.9 % vs. 95.4 % ) but lower specificity ( 50 % vs. 58.1 % ) and more variations between reader performance ; absolute false negatives ( FN ) were reduced in 8/16 readers , equal in 5/16 , and increased in only 3/16 . Conclusion This study broadly confirms previous data showing equivalence of DBT to AV . However , bias against TS may have occurred since the region of interest was not indicated in the TS set as compared to its obvious identification on the AV set by the selected spot views . A key finding is that reader experience with DBT may be more important than so far reported",
"PURPOSE To compare the diagnostic performance of two-dimensional ( 2D ) mammography , 2D mammography plus digital breast tomo synthesis ( DBT ) , and synthetic 2D mammography plus DBT in depicting malignant radiographic features . MATERIAL S AND METHODS In this multicenter , multireader , retrospective reading study ( the TOMMY trial ) , after written informed consent was obtained , 8869 women ( age range , 29 - 85 years ; mean , 56 years ) were recruited from July 2011 to March 2013 in an ethically approved study . From these women , a reading data set of 7060 cases was r and omly allocated for independent blinded review of ( a ) 2D mammography images , ( b ) 2D mammography plus DBT images , and ( c ) synthetic 2D mammography plus DBT images . Review ers had no access to results of previous examinations . Overall sensitivities and specificities were calculated for younger women and those with dense breasts . RESULTS Overall sensitivity was 87 % for 2D mammography , 89 % for 2D mammography plus DBT , and 88 % for synthetic 2D mammography plus DBT . The addition of DBT was associated with a 34 % increase in the odds of depicting cancer ( odds ratio [ OR ] = 1.34 , P = .06 ) ; however , this level did not achieve significance . For patients aged 50 - 59 years old , sensitivity was significantly higher ( P = .01 ) for 2D mammography plus DBT than it was for 2D mammography . For those with breast density of 50 % or more , sensitivity was 86 % for 2D mammography compared with 93 % for 2D mammography plus DBT ( P = .03 ) . Specificity was 57 % for 2D mammography , 70 % for 2D mammography plus DBT , and 72 % for synthetic 2D mammography plusmDBT . Specificity was significantly higher than 2D mammography ( P DBT increased the sensitivity of 2D mammography in patients with dense breasts and the specificity of 2D mammography for all subgroups . The use of synthetic 2D DBT demonstrated performance similar to that of st and ard 2D mammography with DBT . DBT is of potential benefit to screening programs , particularly in younger women with dense breasts . ( © ) RSNA , 2015",
"BACKGROUND Screening for breast cancer with mammography in women aged 50 years or more has been shown to reduce mortality from breast cancer . However , the extent to which mammography contributes to the reduction of mortality in women who also undergo physical examination of the breasts is not known . This study was design ed to compare breast cancer mortality following annual screening consisting of two-view mammography and physical examination of the breasts with mortality following annual screening by physical examination only . Breast self-examination was taught to all participants . METHODS This trial r and omly and individually assigned 39 405 women aged 50 - 59 years , recruited from January 1980 through March 1985 , to one of the study arms . The women were followed by record linkage with the Canadian National Cancer Registry and National Mortality Data base to December 31 , 1993 , and by active follow-up of breast cancer patients to June 30 , 1996 . RESULTS R and omization achieved virtually equal distribution of demographic and breast cancer risk variables . At the first annual screen , 21 % of the cancers found by mammography alone ( in the mammography plus physical examination group ) were 20 mm or more in size compared with 46 % of those found by physical examination in the mammography plus physical examination group and 56 % in the physical examination-only group . The corresponding percentages for screens 2 - 5 were 10 % , 42 % , and 50 % , respectively . Screening detected 267 invasive breast cancers in the mammography plus physical examination group compared with 148 in the physical examination-only group . By December 31 , 1993 , 622 invasive and 71 in situ breast carcinomas were ascertained in the mammography plus physical examination group , and 610 and 16 were ascertained in the physical examination-only group . At 13-year follow-up , with 107 and 105 deaths from breast cancer in the respective groups , the cumulative rate ratio was 1.02 ( 95 % confidence interval = 0.78 - 1.33 ) . CONCLUSION In women aged 50 - 59 years , the addition of annual mammography screening to physical examination has no impact on breast cancer mortality",
"BACKGROUND Mammography is the only proven method for breast cancer screening that reduces mortality , although it is inaccurate in young women or women with dense breasts . We investigated the efficacy of adjunctive ultrasonography . METHODS Between July , 2007 , and March , 2011 , we enrolled asymptomatic women aged 40 - 49 years at 42 study sites in 23 prefectures into the Japan Strategic Anti-cancer R and omized Trial ( J-START ) . Eligible women had no history of any cancer in the previous 5 years and were expected to live for more than 5 years . R and omisation was done central ly by the Japan Clinical Research Support Unit . Participants were r and omly assigned in 1:1 ratio to undergo mammography and ultrasonography ( intervention group ) or mammography alone ( control group ) twice in 2 years . The primary outcome was sensitivity , specificity , cancer detection rate , and stage distribution at the first round of screening . Analysis was by intention to treat . This study is registered , number UMIN000000757 . FINDINGS Of 72,998 women enrolled , 36,859 were assigned to the intervention group and 36,139 to the control group . Sensitivity was significantly higher in the intervention group than in the control group ( 91·1 % , 95 % CI 87·2 - 95·0 vs 77·0 % , 70·3 - 83·7 ; p=0·0004 ) , whereas specificity was significantly lower ( 87·7 % , 87·3 - 88·0 vs 91·4 % , 91·1 - 91·7 ; p ) . More cancers were detected in the intervention group than in the control group ( 184 [ 0·50 % ] vs 117 [ 0·32 % ] , p=0·0003 ) and were more frequently stage 0 and I ( 144 [ 71·3 % ] vs 79 [ 52·0 % ] , p=0·0194 ) . 18 ( 0·05 % ) interval cancers were detected in the intervention group compared with 35 ( 0·10 % ) in the control group ( p=0·034 ) . INTERPRETATION Adjunctive ultrasonography increases sensitivity and detection rate of early cancers . FUNDING Ministry of Health , Labour and Welfare of Japan",
"Purpose To compare digital mammography ( DM ) plus digital breast tomo synthesis ( DBT ) versus DM alone for breast cancer screening in the Reggio Emilia Tomo synthesis trial , a two-arm test- and -treat r and omized controlled trial . Material s and Methods For this trial , eligible women ( 45 - 70 years old ) who previously participated in the Reggio Emilia screening program were invited for mammography . Consenting women were r and omly assigned 1:1 to undergo DBT+DM or DM ( both of which involved two projections and double reading ) . Women were treated according to the decision at DBT+DM . Sensitivity , recall rate , and positive predictive value ( PPV ) at baseline were determined ; the ratios of these rates for DBT+DM relative to DM alone were determined . Results From March 2014 to March 2016 , 9777 women were recruited to the DM+DBT arm of the study , and 9783 women were recruited to the DM arm ( mean age , 56.2 vs 56.3 years ) . Recall was 3.5 % in both arms ; detection was 4.5 per 1000 ( 44 of 9783 ) and 8.6 per 1000 ( 83 of 9777 ) , respectively ( + 89 % ; 95 % confidence interval [ CI ] : 31 , 72 ) . PPV of the recall was 13.0 % and 24.1 % , respectively ( P = .0002 ) ; 72 of 80 cancers found in the DBT+DM arm and with complete DBT imaging were positive at least at one DBT-alone reading . The greater detection rate for DM+DBT was stronger for ductal carcinoma in situ ( + 180 % , 95 % CI : 1 , 665 ) ; it was notable for small and medium invasive cancers , but not for large ones ( + 94 [ 95 % CI : 6 , 254 ] ; + 122 [ 95 % CI : 18 , 316 ] ; -12 [ 95 % CI : -68 , 141 ] ; for invasive cancers Conclusion DBT+DM depicts 90 % more cancers in a population previously screened with DM , with similar recall rates",
"BACKGROUND Digital breast tomo synthesis is an advancement of the mammographic technique , with the potential to increase detection of lesions during breast cancer screening . The main aim of the Malmö Breast Tomo synthesis Screening Trial ( MBTST ) was to investigate the accuracy of one-view digital breast tomo synthesis in population screening compared with st and ard two-view digital mammography . METHODS In this prospect i ve , population -based screening study , of women aged 40 - 74 years invited to attend national breast cancer screening at Skåne University Hospital , Malmö , Sweden , a r and om sample was asked to participate in the trial ( every third woman who was invited to attend regular screening was invited to participate ) . Participants had to be able to speak English or Swedish and were excluded from the study if they were pregnant . Participants underwent screening with two-view digital mammography ( ie , craniocaudal and mediolateral oblique views ) followed by one-view digital breast tomo synthesis with reduced compression in the mediolateral oblique view ( with a wide tomo synthesis angle of 50 ° ) at one screening visit . Images were read with masked double reading and scoring by two separate reading groups , one for each method , made up of seven radiologists . Any cancer detected with a malignancy probability score of three or higher by any reader in either group was discussed in a consensus meeting of at least two readers , from which the decision of whether or not to recall the woman for further investigation was made . The primary outcome measures were sensitivity and specificity of breast cancer detection . Secondary outcome measures were screening performance measures of cancer detection , recall , and interval cancers ( cancers clinical ly detected between screenings ) , and positive predictive value for screen recalls and negative predictive value of each method . Outcomes were analysed in the per- protocol population . Follow-up of the participants for at least 2 years allowed for identification of interval cancers . This trial is registered with Clinical Trials.gov , number NCT01091545 . FINDINGS Between Jan 27 , 2010 , and Feb 13 , 2015 , of 21 691 women invited , 14 851 ( 68 % ) agreed to participate . Three women withdrew consent during follow-up and were excluded from the analyses . 139 breast cancers were detected in 137 ( 1 % ) of 14 848 women . Sensitivity was higher for digital breast tomo synthesis than for digital mammography ( 81·1 % , 95 % CI 74·2 - 86·9 , vs 60·4 % , 52·3 - 68·0 ) and specificity was slightly lower for digital breast tomo synthesis than was for digital mammography ( 97·2 % , 95 % CI 97·0 - 97·5 , vs 98·1 % , 97·9 - 98·3 ) . The proportion of cancers detected was significantly higher with digital breast tomo synthesis than with digital mammography ( 8·7 cancers per 1000 women screened , 95 % CI 7·3 - 10·3 vs 6·5 cancers per 1000 screened , 5·2 - 7·9 ; p was higher among cancers detected by digital breast tomo synthesis than for those detected by digital mammography after consensus ( 3·6 % , 95 % CI 3·3 - 3·9 vs 2·5 % , 2·2 - 2·8 ; p was 24·1 % ( 95 % CI 20·5 - 28·0 ) for digital breast tomo synthesis and 25·9 % ( 21·6 - 30·7 ) for digital mammography , and the negative predictive value was 99·8 % ( 99·7 - 99·9 ) and 99·6 % ( 99·4 - 99·7 ) , respectively . The proportion of women who developed interval cancers after trial screening was 1·48 cancers per 1000 women screened ( 95 % CI 0·93 - 2·24 ) . INTERPRETATION Breast cancer screening by use of one-view digital breast tomo synthesis with a reduced compression force has higher sensitivity at a slightly lower specificity for breast cancer detection compared with two-view digital mammography and has the potential to reduce the radiation dose and screen-reading burden required by two-view digital breast tomo synthesis with two-view digital mammography . FUNDING The Swedish Cancer Society , The Swedish Research Council , The Breast Cancer Foundation , The Swedish Medical Society , The Crafoord Foundation , The Gunnar Nilsson Cancer Foundation , The Skåne University Hospital Foundation , Governmental funding for clinical research , The South Swedish Health Care Region , The Malmö Hospital Cancer Foundation and The Cancer Foundation at the Department of Oncology , Skåne University Hospital",
"Breast cancer is the most common cancer type in women and the fourth leading cause of cancer death in the United States ( 1 ) . The goal of screening is to reduce morbidity and mortality , both specific to breast cancer and overall , with acceptable tradeoffs ( 2 , 3 ) . The most commonly used screening test is mammography . Recommended strategies vary for breast cancer screening in average-risk women . Ages to start and discontinue mammography , screening intervals , the role of imaging methods other than mammography , and the role of clinical breast examination ( CBE ) have been points of disagreement among guideline developers . Purpose and Target Population The goal of this American College of Physicians ( ACP ) guidance statement is to critically review selected guidelines from around the world and their included evidence to assist clinicians in making decisions about breast cancer screening in asymptomatic women with average risk for breast cancer . Included screening methods are CBE and breast imaging ( that is , mammography , ultrasonography , magnetic resonance imaging [ MRI ] , and digital breast tomo synthesis [ DBT ] ) . This guidance statement does not address breast self-examination because no evaluated guideline recommends it for screening . The target population for this guidance statement is women with average risk for breast cancer . The target audience is all clinicians . Age is the single most important risk factor for breast cancer . Included guidelines generally define average-risk women as those who do not have a personal history of breast cancer or a previous diagnosis of a high-risk breast lesion , are not at high risk for breast cancer due to genetic mutations known to increase that risk ( such as BRCA1/2 gene mutation or another familial breast cancer syndrome ) , and were not exposed to radiation therapy to the chest in childhood ( 4 , 5 ) . However , definitions of average risk vary among guidelines . In addition , although risk factors ( including early menarche , late menopausal onset , oral contraceptive or menopausal hormone therapy , increased breast density on mammography , and a family member with a history of postmenopausal breast cancer ) may put a woman at greater risk for breast cancer than women without these factors , the evaluated guidelines generally include women with these factors under the umbrella of average risk . Therefore , our guidance statement applies to these women . Guidelines vary somewhat in target population s and screening methods addressed ( Table [ 411 ] and Appendix ) . Both the U.S. Preventive Services Task Force ( USPSTF ) and the World Health Organization ( WHO ) include women with dense breasts and those with a single family member with breast cancer in their guideline 's target population ( 5 , 6 ) . The Canadian Task Force on Preventive Health Care ( CTFPHC ) guideline also includes women with dense breasts ; however , it explicitly mentions that women with a first-degree relative with breast cancer are considered to be at increased risk and are thus excluded from the guideline ( 7 ) . Table . Summary of Included Recommendations in Assessed Guidelines for Breast Cancer Screening of Average-Risk Women Methods The ACP Clinical Guidelines Committee develops guidance statements on topics where several conflicting guidelines are available . Guidance statements rely on evidence presented or referenced in selected guidelines and accompanying evidence reports ; they do not include de novo review s or search es of the literature outside the body of evidence referenced by the guidelines . The goal of ACP guidance statements is to provide clinicians with a rigorous review of the available guidelines and their included evidence and to develop subsequent guidance based on an assessment of the benefits and harms reported by each guideline and its evidence . Unlike ACP guidelines , guidance statements are not derived from a systematic evidence review and hence do not use GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) ( 12 ) to assess the quality of evidence or strength of recommendations . Data Sources and Guideline Selection We search ed the National Guideline Clearinghouse and the Guidelines International Network library for breast cancer screening guidelines from national organizations that addressed breast imaging ( that is , mammography , ultrasonography , MRI , or DBT ) and CBE in women and were published in English between 1 January 2013 and 15 November 2017 . We search ed Web sites housing the selected guidelines for up date s on 10 December 2018 . We excluded guidelines that addressed specific population s ( such as pregnant women and women at increased risk for breast cancer ) or were more than 5 years old ( thus considered inactive ) . We also excluded guidelines that directly endorsed another guideline , such as that of the American Academy of Family Physicians , which endorsed the USPSTF guideline . Our search yielded 3 guidelines , from the American College of Radiology ( published in 2017 ; literature search end date , February 2016 ) ( 9 ) , American Cancer Society ( ACS ) ( published in 2015 ; literature search end date , March 2014 ) ( 4 ) , and USPSTF ( published in 2016 ; literature search end date , June 2015 ) ( 5 ) . We also selected 3 guidelines not identified in either data base but commonly used in clinical practice , from the National Comprehensive Cancer Network ( NCCN ) ( published in 2018 ; literature search end date not reported ) ( 10 ) , WHO ( published in 2014 ; literature search end date , December 2012 ) ( 6 ) , and American College of Obstetricians and Gynecologists ( published in 2017 ; literature search end date not applicable ) ( 8) . In addition , we selected the CTFPHC guideline , which was up date d after our initial search ( published in 2018 ; literature search end date , January 2017 ) ( 7 ) . The American College of Obstetricians and Gynecologists guideline was based on guidelines from the ACS , NCCN , and USPSTF and supporting evidence review s. Critical Appraisal Five co authors independently review ed , assessed , and scored each guideline using the AGREE II ( Appraisal of Guidelines for Research and Evaluation II ) instrument ( 13 , 14 ) ( Appendix Table 1 ) . Appendix Table 1 . Scaled AGREE II Domain Scores for Each Guideline and Overall Assessment Clinician Peer Review The guidance statement was peer- review ed through Annals of Internal Medicine and by ACP Regents and Governors , who represent ACP members at the regional and international level . Public Member Review The development process for the guidance statement included participation by public members ( 2 of the Clinical Guidelines Committee and 7 of ACP 's Public Panel ) to share their perspectives , values , and preferences . Critical Appraisal of Evaluated Guidelines The major difference between high- and low-scoring guidelines ( Appendix Table 1 ) was methodology . Guidelines from ACS ( 4 ) , CTFPHC ( 7 ) , USPSTF ( 5 ) , and WHO ( 6 ) scored highest on the AGREE II instrument , whereas those from the American College of Obstetricians and Gynecologists ( 8) , American College of Radiology ( 9 ) , and NCCN ( 10 ) scored lowest . In addition to our review of each guideline , we examined the evidence supporting the 4 that scored highest ( ACS , CTFPHC , USPSTF , and WHO ) . We also considered recommendations for adoption or adaptation from these 4 guidelines when developing our own guidance . Several factors were important in considering guideline quality . The ACS , CTFPHC , USPSTF , and WHO guidelines best articulated benefits , harms , and strength of the evidence and how these link to recommendations . The lower-scoring guidelines often inadequately described how they considered these factors in developing the recommendations , or they relied on lower- quality evidence . The guidelines varied in the studies they reported , weighting of observational or modeling studies relative to r and omized controlled trials ( RCTs ) , and emphasis on relative versus absolute effects . The guidelines rarely addressed the small absolute effect on breast cancer mortality ; the long lead time to any reduction in this mortality , especially in women with estimated life expectancy less than 15 to 20 years ; and the low incidence of breast cancer for women younger than 60 years . Mammography Depending on the guideline , the recommended age to discuss initiating screening is 40 years ( 4 , 5 , 8) and the recommended age to start screening ranges from 40 ( 9 , 10 ) to 45 ( 4 ) to 50 ( 58 ) years . Most guidelines agree to screen average-risk women with mammography between ages 50 and 74 years . However , WHO and CTFPHC recommend that screening in women aged 50 to 69 years should include shared decision making because screening is conditional on a woman 's values and preferences . For women aged 70 to 75 years , WHO recommends screening only in the context of both rigorous research and shared decision making . Other areas of disagreement include screening in women aged 40 to 49 years , screening in women aged 75 years or older , and recommended screening intervals ( Table ) . Intervals range from annual ( particularly in women aged 40 to 49 years ) to biennial or triennial . Guidelines from ACS , USPSTF , and WHO conclude that a close balance exists between screening benefits and harms for women in their 40s ( for ACS , 40 to 44 years ) and that decisions are influenced by patient preferences . The WHO guideline suggests population -based screening programs in women aged 40 to 49 years only in the context of rigorous research , monitoring , and evaluation and if shared decision-making strategies are implemented . The CTFPHC conditionally recommends against screening in women aged 40 to 49 years ( without a first-degree family history of breast cancer ) ; however , it states that some women in this age group may wish to be screened and that clinicians should engage in shared decision making with women who express interest ( Appendix ) . Appendix Table 2 summarizes the available data from the 4 guidelines with the highest AGREE II scores ( ACS , CTFPHC , USPSTF , and WHO ) . Appendix Table 2 . Summary of Evidence on Screening",
"In December 2003 , the European Council identified best practice as key for ensuring development of high- quality cancer-screening programs . To support national policies on cancer control , the European Union institutions progressed several initiatives on cancer . The European Commission ( EC ) Initiative on Breast Cancer ( ECIBC ) is the most recent of these projects and the most implementation driven . Within this initiative , the European Guidelines for Breast Cancer Screening and Diagnosis ( in short , European Breast Guidelines ) are being developed ( http://ecibc.jrc.ec.europa.eu/ ) . Guidelines are approaches to generally improve prevention , diagnosis , treatment , and follow-up of diseases , overcoming inappropriate variations by providing recommendations for best care . The new era of guidelines promises recommendations that are based on the best available evidence summarized in systematic review s while providing the necessary flexibility needed to individualize decisions . The best methods for development of practice guidelines have experienced intense elaboration and attention during the past decades ( 17 ) . The impetus for this attention has been the change from expert- or consensus-based to evidence -based health care recommendations . Although this change in terminology should express the shift from un systematic development of guidelines to systematic and trustworthy recommendations , it is often misunderstood and misconstrued as meaning that experts are now meaningless in the process or as if consensus through discussion is a matter of the past . Neither is correct . Experts from various disciplines and consensus as a result of deliberation remain a mainstay of health care guideline development ( 810 ) . These experts are responsible for prioritization of questions that should be addressed in guidelines ; judgments that result from interpretation of evidence , including the rating of the certainty of the available evidence ; and decisions about how the judgments on the different criteria bear on recommendations . What has changed over time in guideline development are the rules , the structure and explicitness of the process , and the guideline product . Indeed , review s of guideline development methodology and how guidelines can be improved have led to more structured and documented processes that allow a reduction of bias and provide balanced views of appropriately composed guideline panels ( 2 , 5 , 6 ) . Core components for trustworthy guideline development ( 13 , 5 , 7 , 11 ) include that guidelines be developed by a knowledgeable , multidisciplinary panel of experts and representatives from key affected groups ; be based on a systematic review of the existing evidence ; consider important patient subgroups and patient preferences as appropriate ; be based on an explicit and transparent process that minimizes distortions , biases , and conflicts of interest ( 12 ) ; provide a clear explanation of the logical relationships between alternative care options and health outcomes and provide ratings of both the quality of evidence and the strength of the recommendations ( 1316 ) ; and be reconsidered and revised as appropriate when important new evidence warrants modifications . In addition , greater transparency in linking the considered research evidence and the recommendations , as well as the requirement of making structured expert judgments , represents a shift in the guideline development paradigm ( 5 , 11 , 1719 ) . At the same time , developing guidelines for a large number of member states and those that aim to adapt the guidelines poses challenges , such as the feasibility of implementing strategies that may exist in some member countries but not others ( for example , organized population -based screening in Italy but not Greece ) . Addressing these challenges requires considerations that extend beyond strictly clinical efforts in guideline development and mastering the many factors that influence recommendations and their implementation . This article describes the rationale , methods , and processes the ECIBC has adopted to develop the European Breast Guidelines in the context of evolving international st and ards . It also describes an innovative approach to presenting , disseminating , and accelerating implementation of recommendations . Guideline Methodology and Development To adhere to the core requirements for guideline development , the EC has taken several steps . First , it selected , via an open call ( https://ecibc.jrc.ec.europa.eu/ guidelines -team ) , a panel with broad representation of expertise , knowledge , and background , which includes patients , health care professionals , epidemiologists , guideline method ologists , and others ( Appendix ) . These individuals voluntarily participate in the ECIBC and compose the guidelines development group ( GDG ) . Second , it ensured that all recommendations were supported by systematic review s of the evidence conducted by independent scientists from Cochrane Iberoamricathe systematic review team (SRT)following st and ard Cochrane Collaboration methods ( 20 , 21 ) . Third , because this is a women-centered initiative , we included women advocates in the GDG as full voting guideline group members . We separately considered important subgroups of women during recommendation development ( for example , different age groups ) , and we specifically focused on evidence that supports best ways of communicating this information to women to inform their decisions . Fourth , we applied EC conflict of interest rules ( http://ecibc.jrc.ec.europa.eu/rules ) , which are consistent with international recommendations , and used GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) Evidence to Decision ( EtD ) frameworks to minimize the influence of competing interests on the recommendations ( 12 , 17 , 18 ) . These EtD frameworks help guideline panels use evidence in a structured , transparent way to inform decisions with a series of criteria , such as anticipated harms and benefits of the options considered , the certainty of the evidence for those effects , and the costs and feasibility of the options , to help them reach their decision . Fifth , using the GRADE approach to guideline development and its EtD frameworks , we focused our questions and recommendations on outcomes that matter to women and provided a rating of the certainty or quality of evidence and the strength of recommendations that is widely accepted as the reference st and ard ( Figures 1 and 2 ) . Sixth , our evidence review s are up to date when the recommendations are formulated , and we engage in international stakeholder feedback to ensure that recommendations remain timely and relevant to public health and clinical practice . The ECIBC is committed to review ing and updating the recommendations as required when new evidence becomes available . The general process is explained in Figure 3 and is based on the Guidelines International NetworkMcMaster Guideline Development Checklist ( https://hei grade .mcmaster.ca/ guideline -development/using-checklist ) ( 5 ) . Figure 1 . According to GRADE , certainty , quality , strength of evidence , or confidence in the estimate of effect is determined on the basis of a systematic review of the evidence for each outcome ( based on the domains risk of bias , indirectness , imprecision , inconsistency , and publication bias that lower certainty and , usually only for nonr and omized studies , large effects , doseresponse relations and opposing plausible residual confounding that may increase the certainty ) . For recommendations , the overall certainty is determined across outcomes based on the lowest certainty outcome among those critical for decision making for the specific context . The guidelines development group applies the GRADE Evidence -to-Decision frameworks to make recommendations that are made available on the European Commission Web site . ( Reproduced from reference 15 , with permission from Schnemann HJ . ) . GRADE = Grading of Recommendations Assessment , Development and Evaluation . Figure 2 . GRADE EtD frameworks . The GRADE EtD frameworks as available in the GRADE pro software ( www . grade pro.org ) . They help with structuring the entire guideline process into 4 sections and support the conduct of guideline group meetings , presentation , and implementation . They clarify the perspective that is taken by the guideline panel or decision maker and the type of question that is asked in the question section . The section on assessment includes the criteria if the problem is a priority , the balance of health benefits and harms , values and preferences related to the outcomes , cost , re sources and cost-effectiveness , equity , acceptability , and feasibility . Conclusions provide the decision or recommendation with a justification and implementation , as well as research considerations . The presentation function supports the conduct of guideline group meetings and facilitates the output of EtD frameworks to other implementation tools , such as Web sites , h and -held apps , and interactive decision aids . EtD = Evidence to Decision ; GRADE = Grading of Recommendations Assessment , Development and Evaluation ; HTA = health technology assessment ; PICO = population , intervention , comparators , and outcomes . Figure 3 . Approach to guideline development used by the European Commission Initiative on Breast Cancer . The European Commission JRC has oversight of the organization , budgeting , planning , and training . The JRC also manages conflicts of interest , documents all aspects of the work , and manages the membership and group processes . The guideline development group and JRC formulate the questions and work with the systematic review team on identifying and assessing the evidence . The guidelines development group is responsible for developing the recommendations . The JRC is responsible for most other aspects as described in the figure under dissemination , implementation , and updating . JRC = Joint Research Centre ; PICO = population , intervention , comparator , and outcomes . ( Reproduced with adaptation to the JRC process from",
"IMPORTANCE Controversy exists about the frequency women should undergo screening mammography and whether screening interval should vary according to risk factors beyond age . OBJECTIVE To compare the benefits and harms of screening mammography frequencies according to age , breast density , and postmenopausal hormone therapy ( HT ) use . DESIGN Prospect i ve cohort . SETTING Data collected January 1994 to December 2008 from mammography facilities in community practice that participate in the Breast Cancer Surveillance Consortium ( BCSC ) mammography registries . PARTICIPANTS Data were collected prospect ively on 11,474 women with breast cancer and 922,624 without breast cancer who underwent mammography at facilities that participate in the BCSC . MAIN OUTCOMES AND MEASURES We used logistic regression to calculate the odds of advanced stage ( IIb , III , or IV ) and large tumors ( > 20 mm in diameter ) and 10-year cumulative probability of a false-positive mammography result by screening frequency , age , breast density , and HT use . The main predictor was screening mammography interval . RESULTS Mammography biennially vs annually for women aged 50 to 74 years does not increase risk of tumors with advanced stage or large size regardless of women 's breast density or HT use . Among women aged 40 to 49 years with extremely dense breasts , biennial mammography vs annual is associated with increased risk of advanced-stage cancer ( odds ratio [ OR ] , 1.89 ; 95 % CI , 1.06 - 3.39 ) and large tumors ( OR , 2.39 ; 95 % CI , 1.37 - 4.18 ) . Cumulative probability of a false-positive mammography result was high among women undergoing annual mammography with extremely dense breasts who were either aged 40 to 49 years ( 65.5 % ) or used estrogen plus progestogen ( 65.8 % ) and was lower among women aged 50 to 74 years who underwent biennial or triennial mammography with scattered fibrogl and ular densities ( 30.7 % and 21.9 % , respectively ) or fatty breasts ( 17.4 % and 12.1 % , respectively ) . CONCLUSIONS AND RELEVANCE Women aged 50 to 74 years , even those with high breast density or HT use , who undergo biennial screening mammography have similar risk of advanced-stage disease and lower cumulative risk of false-positive results than those who undergo annual mammography . When deciding whether to undergo mammography , women aged 40 to 49 years who have extremely dense breasts should be informed that annual mammography may minimize their risk of advanced-stage disease but the cumulative risk of false-positive results is high",
"Editors ' Notes Context Many states have enacted laws that require mammography facilities to advise women with dense breasts and a negative mammography to consider supplemental testing with their providers . Contribution Three vali date d microsimulation models compared breast cancer outcomes , quality -adjusted life-years gained , and costs for mammography alone versus supplemental ultrasonography after a negative mammography result for women with dense breasts aged 50 to 74 years . Caution Other imaging methods , such as digital breast tomo synthesis , were not assessed . Implication Supplemental ultrasonography screening for women with dense breasts would result in limited health gains and substantially increase costs . Mammographic breast density is a risk factor for breast cancer ( 1 , 2 ) . It also affects mammography performance ( 36 ) . The false-negative rate of screening mammography varies as much as 10-fold from the lowest to the highest categories of breast density ( 5 ) . Because breast density affects cancer risk and the false-negative rate of screening , at least 19 states have enacted legislation requiring that women with dense breasts be told about their breast density after screening mammography and that they should discuss supplemental screening tests , such as ultrasonography , with their providers ( 7 , 8) . Similar legislation is under consideration at the national level ( 9 ) . Breast density notification laws have an uncertain effect on health but could affect millions of women . More than 40 % of women aged 40 to 74 years have dense breasts ( 10 ) , defined in the laws as heterogeneously or extremely dense breast tissue by the American College of Radiology 's Breast Imaging Reporting and Data System ( BI-RADS ) ( 9 , 11 ) . However , the American College of Radiology and other organizations have caution ed legislators , health policymakers , and health care providers to carefully consider the unintended consequences of legislation about breast density notification , including the uncertain harms and benefits of supplemental screening ( 8 , 1215 ) . These concerns are amplified because of the subjective nature of the BI-RADS breast density assessment and the challenges that providers face in accurately assessing and communicating breast cancer risk to their patients . Ultrasonography is often suggested for supplemental screening of women with dense breasts because it is widely available and has relatively low direct medical costs ( 1618 ) . Shortly after Connecticut became the first state to enact a law about breast density notification , as many as 30 % of women with dense breasts at some practice s within the state were having supplemental ultrasonography screening ( 1921 ) . Limited data from clinical trials and observational studies suggest that the addition of h and held ultrasonography screening to mammography for women with dense breasts increases cancer detection rates at the expense of increased biopsies for women without cancer ( 16 , 1922 ) . Moreover , the effect of supplemental ultrasonography screening on long-term outcomes , such as breast cancer mortality and its cost-effectiveness at a population level , are unknown ( 8) . We assessed the potential benefits , harms , and cost-effectiveness of supplemental screening ultrasonography for women with dense breasts using 3 established Cancer Intervention and Surveillance Modeling Network breast cancer models ( 23 ) . The models incorporate evidence from clinical trials and observational studies to estimate the effect of various screening scenarios on breast cancer outcomes , including breast cancer mortality , quality -adjusted life-years ( QALYs ) , and costs ( 24 , 25 ) . The results provide evidence for policymakers considering legislation about breast density notification and for women and providers evaluating screening options for women with dense breasts . Methods We used 3 microsimulation models developed independently within the National Cancer Institutefunded Cancer Intervention and Surveillance Modeling Network consortium ( www.cisnet.cancer.gov ) : Model E ( Erasmus University Medical Center , Rotterdam , the Netherl and s ) , model G-E ( Georgetown University Medical Center , Washington , DC , and Albert Einstein College of Medicine , Bronx , New York ) , and model W ( University of Wisconsin , Madison , Wisconsin , and Harvard Medical School , Boston , Massachusetts ) . These modeling groups collaborate in the program project grant that supported this study and are described at http://cisnet.cancer.gov/breast/profiles.html and elsewhere ( 2628 ) . Appendix Table 1 outlines the main model differences and assumptions . Our analyses used a lifetime horizon and federal payer perspective . In brief , the models simulated life histories of women who were at risk for breast cancer , had screening , were treated for breast cancer diagnosed by screening or clinical detection , and were at risk for dying of breast cancer and other causes . The models had independent approaches and modeling structures ( 23 ) but used common inputs , including incidence in the absence of screening , mammography performance , treatment effectiveness , and competing causes of death ( 29 ) . The models approximately replicated U.S. breast cancer incidence and mortality trends ( 2628 , 30 ) ( Appendix Figure ) . For this analysis , we used simulated cohorts of women born in 1960 , as described elsewhere ( 24 , 25 ) . Appendix Table 1 . Key Assumptions and Features in the 3 Simulation Models Appendix Figure . Model replication of U.S. incidence and mortality patterns for women aged 30 to 79 y during 19752000 . Model E = Erasmus University Medical Center , Rotterdam , the Netherl and s ; model G-E = Georgetown University Medical Center , Washington , DC , and Albert Einstein College of Medicine , Bronx , New York ; model W = University of Wisconsin , Madison , Wisconsin , and Harvard Medical School , Boston , Massachusetts ; SEER = Surveillance , Epidemiology , and End Results Program . Model Variables At age 40 years , women in the simulated model cohorts were assigned an initial breast density on the basis of the distribution of BI-RADS density categories for premenopausal women in the Breast Cancer Surveillance Consortium ( BCSC ) ( Table 1 ) ( 31 ) . At age 50 years , women were assigned to the same breast density category or the next lower category so the prevalence of breast density categories matched the BCSC observed prevalence for postmenopausal women ( 31 ) . Sensitivity analyses were conducted with model W to examine the effect of reassigning density at both ages 50 and 65 years , on the basis of the BCSC data on the prevalence of breast density for women aged 50 to 64 years ( 44 % with dense breasts ) and 65 years or older ( 33 % with dense breasts ) . In all scenarios , a woman 's modeled risk for breast cancer depended on her age and breast density , on the basis of BCSC data ( Table 1 ) . Table 1 . Key Common Input Used by the 3 Simulation Models : BI-RADS Breast Density Sensitivity and specificity of digital mammography were determined as a function of age , breast density , and screening interval using BCSC data ( Appendix Table 2 ) ( 32 ) . To our knowledge , the American College of Radiology Imaging Network Protocol 6666 study , a r and omized trial of using h and held ultrasonography to screen women with at least 1 risk factor for breast cancer , was the only controlled study of ultrasonography test performance ( 33 ) . On the basis of this study , experts estimated screening ultrasonography performance after a negative mammography result for average-risk women . We used a screening ultrasonography sensitivity of 55 % for women with dense breasts after a negative mammography result . We used a specificity of 94 % , with positive examination results defined as those recommended for biopsy . Models were calibrated so 94 % of ultrasonography screendetected cancer cases were invasive and 6 % were in situ , as seen in published studies ( 16 , 22 ) . Sensitivity analyses evaluated a range of performance characteristics ( Table 2 ) . Appendix Table 2 . Digital Mammography Sensitivity and Specificity , by Screening Interval , Age Group , and Breast Density Table 2 . Key Common Input Used by the 3 Simulation Models : Screening Ultrasonography Performance Health-related quality -of-life utilities were a function of age ( 34 ) and decremented for breast cancer diagnosis and stage-specific treatment ( 35 ) . Sensitivity analyses included short-term reductions in quality of life for a screening examination ( 0.6 % for 1 week per screening examination ) or a positive screening result ( 10.5 % for 5 weeks ) ( 36 ) . The cost of a digital mammography screen was $ 138 based on the 2013 Medicare reimbursement rate . Screening ultrasonography does not currently have a specific reimbursement rate , so we used the reimbursement rate for diagnostic breast ultrasonography , which is $ 100 . Sensitivity analyses were also conducted using higher potential reimbursement rates for screening ultrasonography because of its increased work intensity compared with diagnostic ultrasonography . Diagnostic costs for additional imaging and biopsy after a positive screening mammography result and costs for cancer treatment were based on Medicare reimbursement rates , utilization patterns seen in the BCSC , and estimates from the literature ( 32 , 37 ) . Diagnostic costs after a positive ultrasonography result were assumed to be equal to the biopsy-related costs of diagnostic work-up after a positive mammography result . All costs were in 2013 U.S. dollars . Screening Strategies Primary analysis compared 3 strategies for women aged 50 to 74 years receiving biennial mammography screening : mammography alone , mammography plus screening ultrasonography after a negative mammography result for women with extremely dense breasts , and mammography plus h and held screening ultrasonography after a negative mammography result for women with heterogeneously or extremely dense breasts ( base case ) . Secondary analyses evaluated the 3 strategies as an annual screening regimen for women aged 40 to 74 years . All strategies were compared with no"
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UNLABELLED The worldwide epidemic of type 2 diabetes ( T2D ) emphasizes the need for guidelines regarding community implementation of lifestyle modification prevention programs . An underst and ing of effective behavioral strategies is needed if evidence translation is to be realized . The aim of this paper is to systematic ally review the behavioral change strategies for lifestyle T2D prevention programs . METHODS r and omized controlled trials ( RCTs ) of lifestyle interventions for the prevention of T2D were review ed with a systematic literature search . Data relating to the behavioral strategies and trial outcomes were extracted . RESULTS overall , lifestyle interventions were successful in reducing the incidence of T2D . The behavioral strategies utilized in these interventions were drawn from a variety of theoretical background s. All RCTs utilized intensive modes of delivery and were associated with low dropout rates of 5.5 - 13.4 % . CONCLUSIONS the available evidence shows that a robust behavioral change strategy is an essential part of an effective lifestyle modification program , as the absence of intensive individualized advice or " information only " more closely resembles the control group interventions used in these RCTs
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"BACKGROUND The Diabetes Prevention Program ( DPP ) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes , but there is little information about the feasibility of offering such an intervention in community setting s. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA . METHODS This pilot cluster-r and omized trial was design ed to compare group-based DPP lifestyle intervention delivery by the YMCA to brief counseling alone ( control ) in adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities and who had a BMI > or=24 kg/m2 , > or=2 diabetes risk factors , and a r and om capillary blood glucose of 110 - 199 mg/dL. Multivariate regression was used to compare between-group differences in changes in body weight , blood pressures , HbA1c , total cholesterol , and HDL-cholesterol after 6 and 12 months . RESULTS Among 92 participants , controls were more often women ( 61 % vs 50 % ) and of nonwhite race ( 29 % vs 7 % ) . After 6 months , body weight decreased by 6.0 % ( 95 % CI=4.7 , 7.3 ) in intervention participants and 2.0 % ( 95 % CI=0.6 , 3.3 ) in controls ( p total cholesterol ( -22 mg/dL vs + 6 mg/dL controls ; p YMCA sites , it was not possible to adjust for potential clustering by site . CONCLUSIONS The YMCA may be a promising channel for wide-scale dissemination of a low-cost approach to lifestyle diabetes prevention",
"PURPOSE The purpose of this pilot study was to determine the effectiveness of an edited Diabetes Prevention Program ( DPP ) Lifestyle Re sources Core Teaching Plan for managing patients with type 2 diabetes in an urban underserved setting . Modifications were made to attempt to cut to the bare essentials to work within the constrained budgets of safety net providers . The primary aim was to achieve a mean absolute reduction in HbA1c level of 1 percentage point . METHODS The authors conducted a r and omized controlled trial of 9 months ' duration for patients with type 2 diabetes with an HbA1c > or=8.0 % . A total of 67 patients r and omized into usual-care and case management groups were evaluated with an intention-to-treat analysis . A modified DPP workbook was used during 7 monthly visits with a nurse case manager . RESULTS As compared with the usual-care group , those in the case management group experienced a greater reduction in HbA1c level ( -1.87 vs -0.54 ; P=.011 ) and weight ( -2.47 kg vs + 0.88 kg ; P=.011 ) . CONCLUSION Use of an edited version of the DPP workbook in an urban , low-income , minority population with type 2 diabetesproduced a significant absolute reduction in HbA1c percentage and weight",
"Prevention of type 2 diabetes by intensive lifestyle intervention design ed to achieve and maintain ideal body weight was assessed in subjects with impaired glucose tolerance ( IGT ) . Male subjects with IGT recruited from health-screening examinees were r and omly assigned in a 4:1 ratio to a st and ard intervention group ( control group ) and intensive intervention group ( intervention group ) . The final numbers of subjects were 356 and 102 , respectively . The subjects in the control group and in the intervention group were advised to maintain body mass index ( BMI ) of 24.0 kg/m2 and of , respectively , by diet and exercise . In the intervention group , detailed instructions on lifestyle were repeated every 3 - 4 months during hospital visits . Diabetes was judged to have developed when two or more consecutive fasting plasma glucose ( FPG ) values exceeded 140 mg/dl . A 100 g oral glucose tolerance test was performed every 6 months to detect improvement of glucose tolerance . The subjects were seen in an ordinary outpatient clinic . The cumulative 4-year incidence of diabetes was 9.3 % in the control group , versus 3.0 % in the intervention group , and the reduction in risk of diabetes was 67.4 % ( P Body weight decreased by 0.39 kg in the control group and by 2.18 kg in the intervention group ( P decrease in body weight . The incidence of diabetes was positively correlated with the changes in body weight , and the improvement in glucose tolerance was negatively correlated . Subjects with higher FPG at baseline developed diabetes at a higher rate than those with lower FPG . Higher 2h plasma glucose values and higher BMI values at baseline were also associated with a higher incidence of diabetes , but the differences were not significant . Subjects with a low insulinogenic index ( DeltaIRI/DeltaPG 30 min after an oral glucose load ) developed diabetes at a significantly higher rate than those with a normal insulinogenic index . Comparison of the BMI data and incidence of diabetes in five diabetes prevention studies by lifestyle intervention revealed a linear correlation between the incidence of diabetes and the BMI values , with the exception of the DaQing Study . However , the slope of the reduction in incidence of diabetes in the intensive intervention groups was steeper than expected simply on the basis of the reduction of BMI , suggesting that the effect of lifestyle intervention can not be solely ascribed to the body weight reduction . We conclude that lifestyle intervention aim ed at achieving ideal body weight in men with IGT is effective and can be conducted in an outpatient clinic setting",
"Aims /hypothesis . The aim of the Diabetes Prevention Study is to assess the efficacy of an intensive diet-exercise programme in preventing or delaying Type II ( non-insulin-dependent ) diabetes mellitus in subjects with impaired glucose tolerance , to evaluate the effects of the intervention programme on cardiovascular risk factors and to assess the determinants for the progression to diabetes in persons with impaired glucose tolerance . Methods . A total of 523 overweight subjects with impaired glucose tolerance ascertained by two oral glucose tolerance tests were r and omised to either a control or intervention group . The control subjects received general information at the start of the trial about the lifestyle changes necessary to prevent diabetes and about annual follow-up visits . The intervention subjects had seven sessions with a nutritionist during the first year and a visit every 3 months thereafter aim ed at reducing weight , the intake of saturated fat and increasing the intake of dietary fibre . Intervention subjects were also guided individually to increase their physical activity . Results . During the first year , weight loss in the first 212 study subjects was 4.7 ± 5.5 vs 0.9 ± 4.1 kg in the intervention and control group , respectively ( p The plasma glucose concentrations ( fasting : 5.9 ± 0.7 vs 6.4 ± 0.8 mmol/l , p in blood pressure , serum lipids and anthropometric indices in the intervention group . Conclusion /interpretation . The interim results show the efficacy and feasibility of the lifestyle intervention programme . [ Diabetologia ( 1999 ) 42 : 793–801",
"OBJECTIVE To describe the 1 ) lifestyle intervention used in the Finnish Diabetes Prevention Study , 2 ) short- and long-term changes in diet and exercise behavior , and 3 ) effect of the intervention on glucose and lipid metabolism . RESEARCH DESIGN AND METHODS There were 522 middle-aged , overweight subjects with impaired glucose tolerance who were r and omized to either a usual care control group or an intensive lifestyle intervention group . The control group received general dietary and exercise advice at baseline and had an annual physician 's examination . The subjects in the intervention group received additional individualized dietary counseling from a nutritionist . They were also offered circuit-type resistance training sessions and advised to increase overall physical activity . The intervention was the most intensive during the first year , followed by a maintenance period . The intervention goals were to reduce body weight , reduce dietary and saturated fat , and increase physical activity and dietary fiber . RESULTS The intervention group showed significantly greater improvement in each intervention goal . After 1 and 3 years , weight reductions were 4.5 and 3.5 kg in the intervention group and 1.0 and 0.9 kg in the control group , respectively . Measures of glycemia and lipemia improved more in the intervention group . CONCLUSIONS The intensive lifestyle intervention produced long-term beneficial changes in diet , physical activity , and clinical and biochemical parameters and reduced diabetes risk . This type of intervention is a feasible option to prevent type 2 diabetes and should be implemented in the primary health care system",
"Clinical trials have demonstrated that lifestyle changes can prevent type 2 diabetes , but the importance of leisure-time physical activity ( LTPA ) is still unclear . We carried out post hoc analyses on the role of LTPA in preventing type 2 diabetes in 487 men and women with impaired glucose tolerance who had completed 12-month LTPA question naires . The subjects were participants in the Finnish Diabetes Prevention Study , a r and omized controlled trial of lifestyle changes including diet , weight loss , and LTPA . There were 107 new cases of diabetes during the 4.1-year follow-up period . Individuals who increased moderate-to-vigorous LTPA or strenuous , structured LTPA the most were 63 - 65 % less likely to develop diabetes . Adjustment for changes in diet and body weight during the study attenuated the association somewhat ( upper versus lower third : moderate-to-vigorous LTPA , relative risk 0.51 , 95 % CI 0.26 - 0.97 ; strenuous , structured LTPA , 0.63 , 0.35 - 1.13 ) . Low-intensity and lifestyle LTPA and walking also conferred benefits , consistent with the finding that the change in total LTPA ( upper versus lower third : 0.34 , 0.19 - 0.62 ) was the most strongly associated with incident diabetes . Thus increasing physical activity may substantially reduce the incidence of type 2 diabetes in high-risk individuals",
"OBJECTIVE The Diabetes Prevention Program ( DPP ) showed that intensive lifestyle intervention reduced the risk of diabetes by 58 % . This paper examines demographic , psychosocial , and behavioral factors related to achieving weight loss and physical activity goals in the DPP lifestyle participants . RESEARCH METHODS AND PROCEDURES Lifestyle participants ( n = 1079 ; mean age = 50.6 , BMI = 33.9 , 68 % female , and 46 % from minority groups ) had goals of 7 % weight loss and 150 min/wk of physical activity . Goal achievement was assessed at the end of the 16-session core curriculum ( approximately week 24 ) and the final intervention visit ( mean = 3.2 years ) as a function of demographic , psychosocial , and behavioral variables . RESULTS Forty-nine percent met the weight loss goal and 74 % met the activity goal initially , while 37 % and 67 % , respectively , met these goals long-term . Men and those with lower initial BMI were more likely to meet activity but not weight loss goals . Hispanic , Asian , and Native Americans were more likely to meet the long-term activity goals , and whites were more likely to meet the initial weight loss goal . In multivariate analyses , meeting the long-term weight loss goal and both activity goals increased with age , while psychosocial and depression measures were unrelated to goal achievement . Dietary self-monitoring was positively related to meeting both weight loss and activity goals , and meeting the activity goal was positively related to meeting the weight loss goal . Participants who met initial goals were 1.5 to 3.0 times more likely to meet these goals long-term . DISCUSSION Success at meeting the weight loss and activity goals increased with age . Initial success predicted long-term success . Self-monitoring and meeting activity goals were related to achieving and sustaining weight loss",
"BACKGROUND Type 2 diabetes mellitus is increasingly common , primarily because of increases in the prevalence of a sedentary lifestyle and obesity . Whether type 2 diabetes can be prevented by interventions that affect the lifestyles of subjects at high risk for the disease is not known . METHODS We r and omly assigned 522 middle-aged , overweight subjects ( 172 men and 350 women ; mean age , 55 years ; mean body-mass index [ weight in kilograms divided by the square of the height in meters ] , 31 ) with impaired glucose tolerance to either the intervention group or the control group . Each subject in the intervention group received individualized counseling aim ed at reducing weight , total intake of fat , and intake of saturated fat and increasing intake of fiber and physical activity . An oral glucose-tolerance test was performed annually ; the diagnosis of diabetes was confirmed by a second test . The mean duration of follow-up was 3.2 years . RESULTS The mean ( + /-SD ) amount of weight lost between base line and the end of year 1 was 4.2+/-5.1 kg in the intervention group and 0.8+/-3.7 kg in the control group ; the net loss by the end of year 2 was 3.5+/-5.5 kg in the intervention group and 0.8+/-4.4 kg in the control group ( P cumulative incidence of diabetes after four years was 11 percent ( 95 percent confidence interval , 6 to 15 percent ) in the intervention group and 23 percent ( 95 percent confidence interval , 17 to 29 percent ) in the control group . During the trial , the risk of diabetes was reduced by 58 percent ( P the incidence of diabetes was directly associated with changes in lifestyle . CONCLUSIONS Type 2 diabetes can be prevented by changes in the lifestyles of high-risk subjects",
"Aims /hypothesisLifestyle modification helps in the primary prevention of diabetes in multiethnic American , Finnish and Chinese population s. In a prospect i ve community-based study , we tested whether the progression to diabetes could be influenced by interventions in native Asian Indians with IGT who were younger , leaner and more insulin resistant than the above population s. Methods We r and omised 531 ( 421 men 110 women ) subjects with IGT ( mean age 45.9±5.7 years , BMI 25.8±3.5 kg/m2 ) into four groups . Group 1 was the control , Group 2 was given advice on lifestyle modification ( LSM ) , Group 3 was treated with metformin ( MET ) and Group 4 was given LSM plus MET . The primary outcome measure was type 2 diabetes as diagnosed using World Health Organization criteria . Results The median follow-up period was 30 months , and the 3-year cumulative incidences of diabetes were 55.0 % , 39.3 % , 40.5 % and 39.5 % in Groups 1–4 , respectively . The relative risk reduction was 28.5 % with LSM ( 95 % CI 20.5–37.3 , p=0.018 ) , 26.4 % with MET ( 95 % CI 19.1–35.1 , p=0.029 ) and 28.2 % with LSM + MET ( 95 % CI 20.3–37.0 , p=0.022 ) , as compared with the control group . The number needed to treat to prevent one incident case of diabetes was 6.4 for LSM , 6.9 for MET and 6.5 for LSM + MET . Conclusions /interpretationProgression of IGT to diabetes is high in native Asian Indians . Both LSM and MET significantly reduced the incidence of diabetes in Asian Indians with IGT ; there was no added benefit from combining them",
"BACKGROUND The worldwide increase in type 2 diabetes mellitus is becoming a major health concern . We aim ed to assess the effect of acarbose in preventing or delaying conversion of impaired glucose tolerance to type 2 diabetes . METHODS In a multicentre , placebo-controlled r and omised trial , we r and omly allocated patients with impaired glucose tolerance to 100 mg acarbose or placebo three times daily . The primary endpoint was development of diabetes on the basis of a yearly oral glucose tolerance test ( OGTT ) . Analyses were by intention to treat . FINDINGS We r and omly allocated 714 patients with impaired glucose tolerance to acarbose and 715 to placebo . We excluded 61 ( 4 % ) patients because they did not have impaired glucose tolerance or had no postr and omisation data . 211 ( 31 % ) of 682 patients in the acarbose group and 130 ( 19 % ) of 686 on placebo discontinued treatment early . 221 ( 32 % ) patients r and omised to acarbose and 285 ( 42 % ) r and omised to placebo developed diabetes ( relative hazard 0.75 [ 95 % CI 0.63 - 0.90 ] ; p=0.0015 ) . Furthermore , acarbose significantly increased reversion of impaired glucose tolerance to normal glucose tolerance ( p placebo for 3 months was associated with an increase in conversion of impaired glucose tolerance to diabetes . The most frequent side-effects to acarbose treatment were flatulence and diarrhoea . INTERPRETATION Acarbose could be used , either as an alternative or in addition to changes in lifestyle , to delay development of type 2 diabetes in patients with impaired glucose tolerance",
"Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists",
"Aims : To compare data on cardiovascular risk factor changes in lipids , insulin , proinsulin , fibrinolysis , leptin and C-reactive protein , and on diabetes incidence , in relation to changes in lifestyle . Methods : The study was a r and omized lifestyle intervention trial conducted in northern Sweden between 1995 and 2000 , in 168 individuals with impaired glucose tolerance ( IGT ) and body mass index above 27 at start . The intensive intervention group ( n = 83 ) was subjected to a 1-month residential lifestyle programme . The usual care group ( n = 85 ) participated in a health examination ending with a single counselling session . Follow-up was conducted at 1 , 3 and 5 years . Results : At 1-year follow-up , an extensive cardio-metabolic risk factor reduction was demonstrated in the intensive intervention group , along with a 70 % decrease of progress to type 2 diabetes . At 5-year follow-up , most of these beneficial effects had disappeared . Reported physical activity and fibre intake as well as high-density lipoprotein cholesterol were still increased , and fasting insulin and proinsulin were lower . Conclusions : The intervention affected several important cardio-metabolic risk variables beneficially , and reduced the risk for type 2 diabetes , but the effects persisted only as long as the new lifestyle was maintained . Increased physical activity seemed to be the behaviour that was most easy to preserve",
"OBJECTIVE To assess the effects of lifestyle intervention on cardiovascular risk factors in general and especially on fibrinolysis . DESIGN R and omized clinical study . SUBJECTS A total of 186 subjects with impaired glucose tolerance and obesity . INTERVENTIONS The intervention programme included a low-fat , high-fibre diet and regular physical exercise . Half of the participants ( n = 93 ) took part in a one-month learning and training session using different behavioural modification techniques and conducted in a full-board wellness centre ( intense intervention group ) . The other half ( n = 93 ) was r and omized a one-hour counselling session with a specially trained nurse ( usual care group ) . Follow-up was carried out after 12 months . MAIN OUTCOME MEASURES Body weight , oxygen consumption , plasminogen activator inhibitor type 1 ( PAI-1 ) activity , tissue plasminogen activator ( tPA ) antigen , fibrinogen and fasting plasma insulin measured at the start of the programme and at follow-up after 1 year . RESULTS The intense intervention group had a mean weight decline by 1 year of 5.4 kg compared to 0.5 kg in the usual care group . Oxygen consumption in the intense group increased 10 % vs. a 1 % decline in the usual care group . In the intense group , PAI-1 activity decreased 31 % ( -10.1 U mL(-1 ) ) , which was significantly more than in the usual care group ( 12 % ; -3.0 U mL(-1 ) ) . The corresponding reductions in tPA antigen were 14 % ( -1.65 microg L(-1 ) ) and 6 % ( -0.69 microg L(-1 ) ) . CONCLUSIONS The present r and omized study shows that an intense lifestyle programme has sustained beneficial effects on fibrinolysis",
"BACKGROUND Lifestyle interventions can prevent the deterioration of impaired glucose tolerance to manifest type 2 diabetes , at least as long as the intervention continues . In the extended follow-up of the Finnish Diabetes Prevention Study , we assessed the extent to which the originally-achieved lifestyle changes and risk reduction remain after discontinuation of active counselling . METHODS Overweight , middle-aged men ( n=172 ) and women ( n=350 ) with impaired glucose tolerance were r and omly assigned to intensive lifestyle intervention or control group . After a median of 4 years of active intervention period , participants who were still free of diabetes were further followed up for a median of 3 years , with median total follow-up of 7 years . Diabetes incidence , bodyweight , physical activity , and dietary intakes of fat , saturated fat , and fibre were measured . FINDINGS During the total follow-up , the incidence of type 2 diabetes was 4.3 and 7.4 per 100 person-years in the intervention and control group , respectively ( log-rank test p=0.0001 ) , indicating 43 % reduction in relative risk . The risk reduction was related to the success in achieving the intervention goals of weight loss , reduced intake of total and saturated fat and increased intake of dietary fibre , and increased physical activity . Beneficial lifestyle changes achieved by participants in the intervention group were maintained after the discontinuation of the intervention , and the corresponding incidence rates during the post-intervention follow-up were 4.6 and 7.2 ( p=0.0401 ) , indicating 36 % reduction in relative risk . INTERPRETATION Lifestyle intervention in people at high risk for type 2 diabetes result ed in sustained lifestyle changes and a reduction in diabetes incidence , which remained after the individual lifestyle counselling was stopped",
"OBJECTIVE Individuals with impaired glucose tolerance ( IGT ) have a high risk of developing NIDDM . The purpose of this study was to determine whether diet and exercise interventions in those with IGT may delay the development of NIDDM , i.e. , reduce the incidence of NIDDM , and thereby reduce the overall incidence of diabetic complications , such as cardiovascular , renal , and retinal disease , and the excess mortality attributable to these complications . RESEARCH DESIGN AND METHODS In 1986 , 110,660 men and women from 33 health care clinics in the city of Da Qing , China , were screened for IGT and NIDDM . Of these individuals , 577 were classified ( using World Health Organization criteria ) as having IGT . Subjects were r and omized by clinic into a clinical trial , either to a control group or to one of three active treatment groups : diet only , exercise only , or diet plus exercise . Follow-up evaluation examinations were conducted at 2-year intervals over a 6-year period to identify subjects who developed NIDDM . Cox 's proportional hazard analysis was used to determine if the incidence of NIDDM varied by treatment assignment . RESULTS The cumulative incidence of diabetes at 6 years was 67.7 % ( 95 % CI , 59.8–75.2 ) in the control group compared with 43.8 % ( 95 % CI , 35.5–52.3 ) in the diet group , 41.1 % ( 95 % CI , 33.4–49.4 ) in the exercise group , and 46.0 % ( 95 % CI , 37.3–54.7 ) in the diet-plus-exercise group ( P relative decrease in rate of development of diabetes in the active treatment groups was similar when subjects were stratified as lean or overweight ( BMI baseline BMI and fasting glucose , the diet , exercise , and diet-plus-exercise interventions were associated with 31 % ( P risk of developing diabetes , respectively . CONCLUSIONS Diet and /or exercise interventions led to a significant decrease in the incidence of diabetes over a 6-year period among those with IGT",
"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",
"OBJECTIVES The purpose of this study was to determine the feasibility of implementing a diabetes prevention program ( DPP ) in a rural African-American church . METHODS A six-session DPP , modeled after the successful National Institutes of Health ( NIH ) DPP , was implemented in a rural African-American church . Adult members of the church identified as high risk for diabetes , based on results of a risk question naire , were screened with a fasting glucose . Persons with prediabetes , a fasting glucose of 100 - 125 mg/dL , participated in the six-session , Lifestyle Balance Church DPP . The primary outcomes were attendance rates and changes in fasting glucose , weight and body mass index measured at baseline , six- and 12-month follow-up . RESULTS Ninety-nine adult church members were screened for diabetes risk . Eleven had impaired fasting glucose . Ten of 11 participated in the six-session intervention , for an attendance rate of 78 % . After the intervention and 12-month follow-up , there was a mean weight loss of 7.9 lbs and 10.6 lbs , respectively . CONCLUSIONS This pilot project suggests that a modified six-session DPP can be translated to a group format and successfully implemented in a church setting . Further r and omized studies are needed to determine the effectiveness of such an intervention",
"OBJECTIVE To examine whether improvements in glycemic control and body composition result ing from 6 months of supervised high-intensity progressive resistance training could be maintained after an additional 6 months of home-based resistance training . RESEARCH DESIGN AND METHODS We performed a 12-month r and omized controlled trial in 36 sedentary , overweight men and women with type 2 diabetes ( aged 60 - 80 years ) who were r and omly assigned to moderate weight loss plus high-intensity progressive resistance training ( RT&WL group ) or moderate weight loss plus a control program ( WL group ) . Supervised gymnasium-based training for 6 months was followed by an additional 6 months of home-based training . Glycemic control ( HbA1c ) , body composition , muscle strength , and metabolic syndrome abnormalities were assessed at 0 , 3 , 6 , 9 , and 12 months . RESULTS Compared with the WL group , HbA1c decreased significantly more in the RT&WL group ( -0.8 % ) during 6 months of supervised gymnasium-based training ; however , this effect was not maintained after an additional 6 months of home-based training . In contrast , the greater increase in lean body mass ( LBM ) observed in the RT&WL group compared with the WL group ( 0.9 kg , P upper body and lower body muscle strength in the RT&WL group were maintained over the 12 months ( P body weight , fat mass , fasting glucose , or insulin at 6 or 12 months . CONCLUSIONS In older adults with type 2 diabetes , home-based progressive resistance training was effective for maintaining the gymnasium-based improvements in muscle strength and LBM but not glycemic control . Reductions in adherence and exercise training volume and intensity seem to impede the effectiveness of home-based training for maintaining improved glycemic control",
"Aims /hypothesisThe aim of this study was to investigate the association of dietary macronutrient composition and energy density with the change in body weight and waist circumference and diabetes incidence in the Finnish Diabetes Prevention Study .Subjects and methods Overweight , middle-aged men ( n=172 ) and women ( n=350 ) with impaired glucose tolerance were r and omised to receive either ‘ st and ard care ’ ( control ) or intensive dietary and exercise counselling . Baseline and annual examinations included assessment of dietary intake with 3-day food records and diabetes status by repeated 75-g OGTTs . For these analyses the treatment groups were combined and only subjects with follow-up data ( n=500 ) were included . Results Individuals with low fat ( median ) and high fibre ( > median ) intakes lost more weight compared with those consuming a high-fat ( > median ) , low-fibre ( , hazard ratios for diabetes incidence during a mean follow-up of 4.1 years were ( highest compared with lowest quartile ) 0.38 ( 95 % CI 0.19–0.77 ) for fibre intake , 2.14 ( 95 % CI 1.16–3.92 ) for fat intake , and 1.73 ( 95 % CI 0.89–3.38 ) for saturated-fat intake , after adjustment for sex , intervention assignment , weight and weight change , physical activity , baseline 2-h plasma glucose and intake of the nutrient being investigated . Compared with the low-fat/high-fibre category , hazard ratios were 1.98 ( 95 % CI 0.98–4.02 ) , 2.68 ( 95 % CI 1.40–5.10 ) , and 1.89 ( 95 % CI 1.09–3.30 ) for low-fat/low-fibre , high-fat/high-fibre , and high-fat/low-fibre , respectively . Conclusions /interpretationDietary fat and fibre intake are significant predictors of sustained weight reduction and progression to type 2 diabetes in high-risk subjects , even after adjustment for other risk factors"
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Background The evidence on selective serotonin reuptake inhibitors ( SSRIs ) for major depressive disorder is unclear . Methods Our objective was to conduct a systematic review assessing the effects of SSRIs versus placebo , ‘ active ’ placebo , or no intervention in adult participants with major depressive disorder . We search ed for eligible r and omised clinical trials in The Cochrane Library ’s CENTRAL , PubMed , EMBASE , PsycLIT , PsycINFO , Science Citation Index Exp and ed , clinical trial registers of Europe and USA , websites of pharmaceutical companies , the U.S. Food and Drug Administration ( FDA ) , and the European Medicines Agency until January 2016 . All data were extracted by at least two independent investigators . We used Cochrane systematic review methodology , Trial Sequential Analysis , and calculation of Bayes factor . An eight-step procedure was followed to assess if thresholds for statistical and clinical significance were crossed . Primary outcomes were reduction of depressive symptoms , remission , and adverse events . Secondary outcomes were suicides , suicide attempts , suicide ideation , and quality of life . Results A total of 131 r and omised placebo-controlled trials enrolling a total of 27,422 participants were included . None of the trials used ‘ active ’ placebo or no intervention as control intervention . All trials had high risk of bias . SSRIs significantly reduced the Hamilton Depression Rating Scale ( HDRS ) at end of treatment ( mean difference −1.94 HDRS points ; 95 % CI −2.50 to −1.37 ; P the risk of no remission ( RR 0.88 ; 95 % CI 0.84 to 0.91 ; P increased the risks of serious adverse events ( OR 1.37 ; 95 % CI 1.08 to 1.75 ; P = 0.009 ; 44 trials ; Trial Sequential Analysis -adjusted CI 1.03 to 1.89 ) . This corresponds to 31/1000 SSRI participants will experience a serious adverse event compared with 22/1000 control participants . SSRIs also significantly increased the number of non-serious adverse events . There were almost no data on suicidal behaviour , quality of life , and long-term effects . Conclusions SSRIs might have statistically significant effects on depressive symptoms , but all trials were at high risk of bias and the clinical significance seems question able . SSRIs significantly increase the risk of both serious and non-serious adverse events . The potential small beneficial effects seem to be outweighed by harmful effects . Systematic review registration PROSPERO CRD42013004420
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"The current study sought to test the efficacy and safety of the novel selective norepinephrine reuptake inhibitor LY2216684 compared to placebo in patients with major depressive disorder ( MDD ) . Escitalopram was used as a control for assay sensitivity . Adult out patients with MDD , confirmed at screening by the Mini International Neuropsychiatric Interview , a Self-Rated Quick Inventory of Depressive Symptomatology ( QIDS-SR ) score of at least 12 and a Clinical Global Impression-Severity Score of at least 4 , were r and omly assigned to LY2216684 ( N=269 ) , placebo ( N=138 ) , or escitalopram ( N=62 ) . Efficacy , safety , and tolerability outcomes were compared during 8 weeks of double-blind treatment . LY2216684 plasma concentrations were measured . LY2216684 did not show statistically significant improvement from baseline compared to placebo in the primary analysis of the Hamilton depression rating scale ( HAM-D(17 ) ) total score . Escitalopram demonstrated significant improvement compared to placebo on the HAM-D(17 ) total score , suggesting adequate assay sensitivity . Both LY2216684 and escitalopram showed statistically significant improvement from baseline on the patient-rated QIDS-SR total score compared to placebo . Headache , nausea , constipation , dry mouth , and insomnia were the most frequently reported adverse events in the LY2216684 group . A 3 - 6 beats per minute mean increase from baseline in pulse rate was observed in the LY2216684 group . LY2216684 plasma concentrations increased as the dose increased from 3 mg to 12 mg . The results of this initial investigation of LY2216684 's efficacy suggest that it may have antidepressant potential . More definitive data to confirm this is necessary . Its safety profile does not preclude further clinical development",
"Objectives To evaluate the efficacy and tolerability of once-daily extended release quetiapine fumarate ( quetiapine XR ) monotherapy in patients with major depressive disorder ( MDD ) . Patients and methods This was a 10-week ( 8-week active treatment/2-week post-treatment ) r and omized , double-blind , placebo- and active-controlled study ( D1448C00004 ) . Patients received quetiapine XR 150 mg/day , escitalopram 10 mg/day , or placebo ; patients with an inadequate response ( The primary end point was week eight change from r and omization in MADRS total score . Secondary end points included MADRS response ( ≥50 % improvement ) and remission ( score ≤8 ) ; Hamilton Rating Scale for Depression total and item 1 ; Hamilton Rating Scale for Anxiety total , psychic , and somatic ; Clinical Global Impressions – Severity of Illness total ; Pittsburgh Sleep Quality Index ( PSQI ) global ; and Quality of Life Enjoyment and Satisfaction Question naire – Short Form percentage maximum total scores . Tolerability was assessed throughout . Results A total of 471 patients was r and omized . No significant improvements in MADRS total score were observed at week eight ( last observation carried forward ) with either active treatment ( quetiapine XR , −17.21 [ P=0.174 ] ; escitalopram , −16.73 [ P=0.346 ] ) versus placebo ( −15.61 ) . There were no significant differences in secondary end points versus placebo , with the exception of week-eight change in PSQI global score ( quetiapine XR , −4.96 [ P included dry mouth , somnolence , and dizziness for quetiapine XR , and headache and nausea for escitalopram . Conclusion In this study , neither quetiapine XR ( 150/300 mg/day ) nor escitalopram ( 10/20 mg/day ) showed significant separation from placebo . Both compounds have been shown previously to be effective in the treatment of MDD ; possible reasons for this failed study are discussed . Quetiapine XR was generally well tolerated , with a profile similar to that reported previously",
"This study was aim ed at resolving the time course of clinical action of antidepressants ( ADs ) and the type of early behavioral changes that precede recovery in treatment-responsive depressed patients . The first goal was to identify , during the first 2 weeks of treatment , the onset of clinical actions of the selective serotonin reuptake inhibitor ( SSRI ) , paroxetine , and the selective noradrenergic reuptake inhibitor , desipramine ( DMI ) . The second aim was to test the hypothesis that the two pharmacologic subtypes would induce different early behavioral changes in treatment-responsive patients . The design was a r and omized , parallel group , placebo-controlled , double-blind study for 6 weeks of treatment following a 1-week washout period . The study utilized measures of the major behavioral components of the depressive disorder as well as overall severity . The results indicated that the onset of clinical actions of DMI ranged from 3 to 13 days , averaged 13 days for paroxetine , and was 16–42 days for placebo . Furthermore , as hypothesized , the different types of ADs initially impacted different behavioral aspects of the disorder . After 1 week of treatment , DMI produced greater reductions in motor retardation and depressed mood than did paroxetine and placebo , and this difference persisted at the second week of treatment . Early improvement in depressed mood – motor retardation differentiated patients who responded to DMI after 6 weeks of treatment from those that did not . Paroxetine initially reduced anxiety more in responders than in nonresponders , and by the second week , significantly improved depressed mood and distressed expression in responders to a greater extent . Depressed patients who responded to placebo showed no consistent early pattern of behavior improvement . Early drug-specific behavioral changes were highly predictive of ultimate clinical response to the different ADs , results that could eventually be applied directly to clinical practice",
"OBJECTIVE Duloxetine doses of 80 and 120 mg/day were assessed for efficacy and safety in the treatment of major depressive disorder ( MDD ) . METHODS In this r and omized , double-blind trial , patients age > or = 18 meeting DSM-IV criteria for MDD were r and omized to placebo ( N=99 ) , duloxetine 80 mg/day ( N=93 ) , duloxetine 120 mg/day ( N=103 ) , or paroxetine 20 mg/day ( N=97 ) . The primary outcome measure was mean change from baseline in the 17-item Hamilton rating scale for depression ( HAMD(17 ) ) total score after 8 weeks of treatment ; a number of secondary efficacy measures also were assessed . Safety and tolerability were assessed via collection and analysis of treatment-emergent adverse events ( TEAEs ) , vital signs , and weight . The Arizona sexual experiences scale was used to assess sexual functioning . Patients who had a > or = 30 % reduction from baseline in the HAMD(17 ) total score at the end of the acute phase entered a 6-month continuation phase where they remained on the same treatment as they had taken during the acute phase ; efficacy and safety/tolerability outcomes were assessed during continuation treatment . RESULTS More than 87 % of patients completed the acute phase in each treatment group . Duloxetine-treated patients ( both doses ) showed significantly greater improvement ( P HAMD(17 ) total score at week 8 compared with placebo . Paroxetine was not significantly different from placebo ( P=0.089 ) on mean change on the HAMD(17 ) . Duloxetine 120 mg/day also showed significant improvement on most secondary efficacy measures ( six of nine ) compared with placebo while duloxetine 80 mg/day ( three of nine ) and paroxetine ( three of nine ) were significantly superior to placebo on fewer secondary measures . HAMD(17 ) mean change data from this study and an identical sister study were pooled as defined a priori for the purpose s of performing a non-inferiority test versus paroxetine . Both duloxetine doses met statistical criteria for non-inferiority to paroxetine . TEAE reporting rates were low in all treatment groups and no deaths occurred in the acute or continuation phases . CONCLUSIONS The efficacy of duloxetine at doses of 80 and 120 mg/day in the treatment of MDD was demonstrated . Tolerability , as measured by TEAEs , and safety were similar to paroxetine 20 mg/day and consistent with previous published data on duloxetine in the treatment of MDD",
"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",
"Previous studies indicate that selective serotonin reuptake inhibitors ( SSRIs ) , including fluoxetine , fluvoxamine , citalopram and paroxetine , suppress rapid eye movement sleep , and increased nocturnal arousals . There has been no published report of the impact of sertraline on the sleep of depressed patients . This study examines such effects . Forty-seven patients with major depressive disorder , r and omized to double-blind treatment with sertraline or placebo , completed sleep studies before and after 12 weeks of pharmacotherapy . Groups were compared using multivariate analyses of covariance and /or analyses of covariance to examine 4 empirically defined sets of sleep measures . Compared to the placebo-treated group , patients who received sertraline experienced an increase in delta wave sleep in the first sleep cycle and prolonged rapid eye movement ( REM ) sleep latency . Although , sertraline therapy decreased the average number of REM periods ( from 3.86 to 2.40 ) , the activity of both REM period 1 and REM period 2 was significantly increased . Aside from an increase in sleep latency , sertraline therapy was not associated with a worsening of measures of sleep continuity . There was also no significant difference between the groups on a measure of subjective sleepiness . These findings are both similar and different from those observed in previous studies of other SSRIs . The increase in delta sleep ratio and consolidation of REM sleep may have some other clinical implication s. However , the generalizability of these findings is limited because of a number of reasons . Further studies are needed to examine the effects of SSRIs in acute treatment of depressed patients with severe insomnia , and the relationship of acute changes and relapse prevention of recurrent depression",
"BACKGROUND Previous comparative studies of the selective serotonin reuptake inhibitors ( SSRIs ) have rarely included a placebo control group and have rarely demonstrated significant between-group differences . The study reported on here was a placebo-controlled comparison of the antidepressant effects of two SSRIs , citalopram and sertraline . METHODS Three hundred twenty-three patients with DSM-IV-defined major depressive disorder were r and omized to 24 weeks of double-blind treatment with citalopram ( 20 - 60 mg/day ) , sertraline ( 50 - 150 mg/day ) , or a placebo . The primary efficacy measure was the Hamilton Depression Rating Scale ( HAMD ) and the primary statistical analysis was an analysis of variance comparing the change from baseline to the last observation carried forward in each treatment group . RESULTS Both citalopram and sertraline produced significantly greater improvement than placebo on the HAMD , the Montgomery-Asberg Depression Rating Scale , and the Clinical Global Impression Scale . Significant improvement was observed at earlier timepoints in the citalopram group than the sertraline group ; however , sertraline treatment was associated with increased gastrointestinal side effects and a tendency toward early discontinuation , and analyses that excluded early dropouts revealed similar acute efficacy for the two active treatments . The Hamilton Anxiety Scale demonstrated a significant anxiolytic effect of citalopram , but not sertraline , relative to placebo . CONCLUSIONS This study confirms the antidepressant efficacy of two SSRIs , citalopram and sertraline . It is hypothesized that the more consistent evidence of antidepressant activity that was observed early in treatment in the citalopram group was related to more pronounced antianxiety effects and better tolerability upon initiation of therapy",
"In a placebo-controlled , double-blind study of 91 out-patient depressives , the anti-depressant effect of fluvoxamine , a selective serotonin uptake inhibitor was compared to that of imipramine . Overall drug effects were relatively weak but analyses in selected sub-groups showed both active drugs superior to placebo . Effects of fluvoxamine were more marked in non-situational depressives and it did not improve sleep while effects of imipramine were more marked in retarded depressives and on retardation ratings , suggesting that fluvoxamine may have a different pattern of clinical effects . Side effects of Fluvoxamine were predominantly gastrointestinal and it did not produce postural hypotension or anticholinergic side-effects",
"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",
"To compare the safety and antidepressant efficacy of paroxetine , imipramine , and placebo , data from six centres using the same protocol were pooled . A double-blind parallel-group design was used , with therapy lasting six weeks . From week 2 onwards , both the 240 paroxetine-treated and the 237 imipramine-treated patients were significantly different from the 240 placebo-treated patients , but no different from each other . Side-effects with paroxetine were less likely to lead to drop-out than with imipramine . Paroxetine had a possible earlier antidepressant effect than imipramine , and a possible earlier beneficial effect on anxiety symptoms associated with depression ",
"Objective : To assess whether patients receiving aerobic exercise training performed either at home or in a supervised group setting achieve reductions in depression comparable to st and ard antidepressant medication ( sertraline ) and greater reductions in depression compared to placebo controls . Methods : Between October 2000 and November 2005 , we performed a prospect i ve , r and omized controlled trial ( SMILE study ) with allocation concealment and blinded outcome assessment in a tertiary care teaching hospital . A total of 202 adults ( 153 women ; 49 men ) diagnosed with major depression were assigned r and omly to one of four conditions : supervised exercise in a group setting ; home-based exercise ; antidepressant medication ( sertraline , 50–200 mg daily ) ; or placebo pill for 16 weeks . Patients underwent the structured clinical interview for depression and completed the Hamilton Depression Rating Scale ( HAM-D ) . Results : After 4 months of treatment , 41 % of the participants achieved remission , defined as no longer meeting the criteria for major depressive disorder ( MDD ) and a HAM-D score of higher remission rates than the placebo controls : supervised exercise = 45 % ; home-based exercise = 40 % ; medication = 47 % ; placebo = 31 % ( p = .057 ) . All treatment groups had lower HAM-D scores after treatment ; scores for the active treatment groups were not significantly different from the placebo group ( p = .23 ) . Conclusions : The efficacy of exercise in patients seems generally comparable with patients receiving antidepressant medication and both tend to be better than the placebo in patients with MDD . Placebo response rates were high , suggesting that a considerable portion of the therapeutic response is determined by patient expectations , ongoing symptom monitoring , attention , and other nonspecific factors . BDI = Beck Depression Inventory ; CI = confidence interval ; HAM-D = Hamilton Depression Rating Scale ; ITT = intention-to-treat ; MDD = major depressive disorder ; SD = st and ard deviation ; SSRIs = selective serotonin reuptake inhibitors ; TSH = thyroid stimulating hormone",
"Methods After initial screening and a seven-day washout period , in the case of patients who had received previous antidepressant medication , 47 adult patients who fulfiIled Feighner ’s criteria for the diagnosis of depression ( 1 ) and had a Hamilton Depression Rating Scale ( HAMD ) total score ( 21-item ) of 18 or more were r and omized to treatment with either paroxetine or placebo . The intended duration of double-blind treatment was four weeks . Paroxetine at a single daily dose of 30 mg or matched placebo was administered at night . No concomitant psychotropic medication other than triazolam or flunitrazepam as a hypnotic was permitted . Patients attended for review on days 7,14 , and 28 . The measures of severity of depression were the HAMD scale total score ( 21-item ) , the Beck Depression Inventory ( BDI ) , the Visual Analogue Scale ( VAS ) , and the Clinical Global Impression ( CGI ) of severity of illness . Assessment of tolerability was based on reports of adverse experiences , both spontaneously reported and elicited in response to asideeffect symptom checklist , physical examination , vital signs , and laboratory investigations",
"CONTEXT Extracts of Hypericum perforatum ( St John 's wort ) are widely used for the treatment of depression of varying severity . Their efficacy in major depressive disorder , however , has not been conclusively demonstrated . OBJECTIVE To test the efficacy and safety of a well-characterized H perforatum extract ( LI-160 ) in major depressive disorder . DESIGN AND SETTING Double-blind , r and omized , placebo-controlled trial conducted in 12 academic and community psychiatric research clinics in the United States . PARTICIPANTS Adult out patients ( n = 340 ) recruited between December 1998 and June 2000 with major depression and a baseline total score on the Hamilton Depression Scale ( HAM-D ) of at least 20 . INTERVENTIONS Patients were r and omly assigned to receive H perforatum , placebo , or sertraline ( as an active comparator ) for 8 weeks . Based on clinical response , the daily dose of H perforatum could range from 900 to 1500 mg and that of sertraline from 50 to 100 mg . Responders at week 8 could continue blinded treatment for another 18 weeks . MAIN OUTCOME MEASURES Change in the HAM-D total score from baseline to 8 weeks ; rates of full response , determined by the HAM-D and Clinical Global Impressions ( CGI ) scores . RESULTS On the 2 primary outcome measures , neither sertraline nor H perforatum was significantly different from placebo . The r and om regression parameter estimate for mean ( SE ) change in HAM-D total score from baseline to week 8 ( with a greater decline indicating more improvement ) was -9.20 ( 0.67 ) ( 95 % confidence interval [ CI ] , -10.51 to -7.89 ) for placebo vs -8.68 ( 0.68 ) ( 95 % CI , -10.01 to -7.35 ) for H perforatum ( P = .59 ) and -10.53 ( 0.72 ) ( 95 % CI , -11.94 to -9.12 ) for sertraline ( P = .18 ) . Full response occurred in 31.9 % of the placebo-treated patients vs 23.9 % of the H perforatum-treated patients ( P = .21 ) and 24.8 % of sertraline-treated patients ( P = .26 ) . Sertraline was better than placebo on the CGI improvement scale ( P = .02 ) , which was a secondary measure in this study . Adverse-effect profiles for H perforatum and sertraline differed relative to placebo . CONCLUSION This study fails to support the efficacy of H perforatum in moderately severe major depression . The result may be due to low assay sensitivity of the trial , but the complete absence of trends suggestive of efficacy for H perforatum is noteworthy",
"OBJECTIVE The present study examined the efficacy and tolerability of acute escitalopram treatment in depressed patients aged 60 years or older . METHODS Patients aged > or = 60 years with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition major depressive disorder were r and omized to 12 weeks of double-blind , flexible-dose treatment with escitalopram ( 10 - 20 mg/day ; N = 130 ) or placebo ( N = 134 ) . The prospect ively defined primary efficacy end point was change from baseline to week 12 in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score using the last observation carried forward approach . RESULTS A total of 109 ( 81 % ) patients in the placebo group and 96 ( 74 % ) patients in the escitalopram group completed treatment . Mean age in both groups was approximately 68 years . Mean baseline MADRS scores were 28.4 and 29.4 for the placebo and escitalopram treatment groups , respectively . Escitalopram did not achieve statistical significance compared with placebo in change from baseline on the MADRS ( least square mean difference : -1.34 ; last observation carried forward ) . Discontinuation rates result ing from adverse events were 6 % for placebo and 11 % for escitalopram . Treatment-emergent adverse events reported by > 10 % of patients in the escitalopram group were headache , nausea , diarrhea , and dry mouth . CONCLUSIONS Escitalopram treatment was not significantly different from placebo treatment on the primary efficacy measure , change from baseline to week 12 in MADRS . In patients aged 60 years or older with major depression , acute escitalopram treatment appeared to be well tolerated",
" Sixty-eight male and female individuals with both DSM-IV diagnoses of cocaine dependence and major depressive disorder were r and omly assigned to one of two medication conditions ( placebo vs. 40 mg per day ) as part of a double-blind , placebo-controlled clinical efficacy trial of fluoxetine for the treatment of this dual diagnosis . During the 12-week outpatient treatment phase all participants also received individual cognitive-behavioral psychotherapy targeting both cocaine use and depression . Depressive symptoms remitted as a function of time in treatment , with no significant medication effects found . Fewer cocaine positive urines were found during the first 6 weeks of treatment in the placebo group compared with the 40-mg group . Cocaine use and depressive symptoms during treatment were significantly correlated . The findings fail to support the role of fluoxetine for treatment of cocaine use and depression in dually-diagnosed patients",
"OBJECTIVE Administration of placebo can result in a clinical response indistinguishable from that seen with active antidepressant treatment . Functional brain correlates of this phenomenon have not been fully characterized . METHOD Changes in brain glucose metabolism were measured by using positron emission tomography in hospitalized men with unipolar depression who were administered placebo as part of an inpatient imaging study of fluoxetine . Common and unique response effects to administration of placebo or fluoxetine were assessed after a 6-week , double-blind trial . RESULTS Placebo response was associated with regional metabolic increases involving the prefrontal , anterior cingulate , premotor , parietal , posterior insula , and posterior cingulate and metabolic decreases involving the subgenual cingulate , parahippocampus , and thalamus . Regions of change overlapped those seen in responders administered active fluoxetine . Fluoxetine response , however , was associated with additional subcortical and limbic changes in the brainstem , striatum , anterior insula , and hippocampus , sources of efferent input to the response-specific regions identified with both agents . CONCLUSIONS The common pattern of cortical glucose metabolism increases and limbic-paralimbic metabolism decreases in placebo and fluoxetine responders suggests that facilitation of these changes may be necessary for depression remission , regardless of treatment modality . Clinical improvement in the group receiving placebo as part of an inpatient study is consistent with the well-recognized effect that altering the therapeutic environment may significantly contribute to reducing clinical symptoms . The additional subcortical and limbic metabolism decreases seen uniquely in fluoxetine responders may convey additional advantage in maintaining long-term clinical response and in relapse prevention",
"Background Antidepressant drugs such as selective serotonin re-uptake inhibitors ( SSRIs ) remediate negative biases in emotional processing in depressed patients in both behavioural and neural outcome measures . However , it is not clear if these effects occur before , or as a consequence of , changes in clinical state . Method In the present study , we investigated the effects of short-term SSRI treatment in depressed patients on the neural response to fearful faces prior to clinical improvement in mood . Altogether , 42 unmedicated depressed patients received SSRI treatment ( 10 mg escitalopram daily ) or placebo in a r and omised , parallel-group design . The neural response to fearful and happy faces was measured on day 7 of treatment using functional magnetic resonance imaging . A group of healthy controls was imaged in the same way . Results Amygdala responses to fearful facial expressions were significantly greater in depressed patients compared to healthy controls . However , this response was normalised in patients receiving 7 days treatment with escitalopram . There was no significant difference in clinical depression ratings at 7 days between the escitalopram and placebo-treated patients . Conclusions Our results suggest that short-term SSRI treatment in depressed patients remediates amygdala hyperactivity in response to negative emotional stimuli prior to clinical improvement in depressed mood . This supports the hypothesis that the clinical effects of antidepressant treatment may be mediated in part through early changes in emotional processing . Further studies will be needed to show if these early effects of antidepressant medication predict eventual clinical outcome",
"Rationale High placebo response rates are a confound in treatment trials for major depressive disorder ( MDD ) . A method for prospect i ve identification of placebo responders could enhance the efficiency of clinical trials . Objective The objective was to identify the neurophysiological , symptomatic , and cognitive characteristics of subjects who were likely to respond to placebo in clinical trials for MDD . Methods Fifty-one subjects with MDD were treated in clinical trials with either fluoxetine ( n=24 ) or venlafaxine ( n=27 ) versus placebo . All subjects underwent pretreatment assessment with quantitative electroencephalographic ( QEEG ) power and cordance , as well as symptom ratings and neuropsychological testing . After a 1-week single-blind placebo lead-in , subjects were r and omized to double-blind placebo controlled treatment with a medication or placebo . At the end of 8 weeks , the blind was broken and treatment response assessed . Response was defined by a final Hamilton Depression Rating Scale score of ≤10 . Results Of the medication-treated and placebo-treated subjects , 52 % ( 13/25 ) and 38 % ( 10/26 ) responded . Placebo responders had lower pretreatment fronto central cordance in the theta frequency b and than all other subjects ( P faster cognitive processing time , as assessed by neuropsychological testing , and lower reporting of late insomnia ( P identifying MDD subjects who are likely to show robust response to placebo . Prospect i ve validation of these results in a larger , independent sample of subjects is necessary to establish the reliability and usefulness of this method for prospect i ve identification of placebo responders",
"Escitalopram , a selective serotonin reuptake inhibitor ( SSRI ) , was compared to placebo in a study of patients with major depressive disorder ( DSM-IV ) who had baseline Montgomery – Åsberg Depression Rating Scale ( MADRS ) total scores ≥22 and ≤40 . After a 1-week , single-blind placebo period , patients were r and omized to receive escitalopram 10 mg/day ( n = 191 ) or placebo ( n = 189 ) in an 8-week , double-blind period . The primary efficacy analysis of adjusted mean change in MADRS total score from baseline showed a statistically significantly larger effect for escitalopram than for placebo with a treatment difference at week 8 ( last observation carried forward , LOCF ) of 2.7 points ( SE 0.85;P = 0.002 ) . In further by-week efficacy analyses , the effect of escitalopram was consistently larger than that of placebo ( P ( Clinical Global Impression – Improvement score ) , week 2 ( MADRS score ) or week 3 ( Clinical Global Impression – Severity score ) . Escitalopram was very well tolerated with a low overall withdrawal rate similar to that for placebo . Nausea was the only adverse event reported significantly more in escitalopram-treated patients than in placebo-treated patients , although it was infrequent and transient . Escitalopram 10 mg/day had a statistically significantly better antidepressant effect than placebo as early as week 1 , and was safe and very well tolerated",
"GSK372475 is a triple reuptake inhibitor with approximately equipotent inhibition of serotonin , norepinephrine , and dopamine transporters . Two r and omized , placebo- and active-controlled , double-blind studies examined the efficacy and safety of GSK372475 in out patients ( aged 18–64 years ) with a diagnosis of major depressive episode associated with major depressive disorder ( MDD ) . Patients were r and omized 1:1:1 to placebo , GSK372475 ( 1–2 mg/d ) , or active control ( Study 1 : venlafaxine XR 150–225 mg/d ; Study 2 : paroxetine 20–30 mg/d ) . GSK372475 did not significantly differ from placebo on any of the key efficacy endpoints ( six-item Bech scale , IDS-Clinician Rated , MADRS ) in either study . Both active controls demonstrated significant antidepressant activity compared with placebo on both primary and secondary endpoints . The most common adverse effects ( AEs ) with GSK372475 were dry mouth , headache , insomnia , and nausea . AEs were more frequent for GSK372475 versus placebo for sleep , anxiety-related , gastrointestinal , and tachycardia events . Increases in mean change from baseline in heart rate and sitting blood pressure were greater for GSK372475 than observed for either placebo or active control groups . Completion rates were lower for GSK372475 ( 49 % , 58 % ) compared with placebo ( 67 % , 74 % ) , venlafaxine XR ( 63 % ) , or paroxetine ( 77 % ) . GSK372475 was neither efficacious nor well tolerated in patients with MDD in two 10-week studies",
"BACKGROUND There is substantial evidence that antidepressant medications treat moderate to severe depression effectively , but there is less data on cognitive therapy 's effects in this population . OBJECTIVE To compare the efficacy in moderate to severe depression of antidepressant medications with cognitive therapy in a placebo-controlled trial . DESIGN R and om assignment to one of the following : 16 weeks of medications ( n = 120 ) , 16 weeks of cognitive therapy ( n = 60 ) , or 8 weeks of pill placebo ( n = 60 ) . SETTING Research clinics at the University of Pennsylvania , Philadelphia , and V and erbilt University , Nashville , Tenn. PATIENTS Two hundred forty out patients , aged 18 to 70 years , with moderate to severe major depressive disorder . INTERVENTIONS Some study subjects received paroxetine , up to 50 mg daily , augmented by lithium carbonate or desipramine hydrochloride if necessary ; others received individual cognitive therapy . MAIN OUTCOME MEASURE The Hamilton Depression Rating Scale provided continuous severity scores and allowed for design ations of response and remission . RESULTS At 8 weeks , response rates in medications ( 50 % ) and cognitive therapy ( 43 % ) groups were both superior to the placebo ( 25 % ) group . Analyses based on continuous scores at 8 weeks indicated an advantage for each of the active treatments over placebo , each with a medium effect size . The advantage was significant for medication relative to placebo , and at the level of a nonsignificant trend for cognitive therapy relative to placebo . At 16 weeks , response rates were 58 % in each of the active conditions ; remission rates were 46 % for medication , 40 % for cognitive therapy . Follow-up tests of a site x treatment interaction indicated a significant difference only at V and erbilt University , where medications were superior to cognitive therapy . Site differences in patient characteristics and in the relative experience levels of the cognitive therapists each appear to have contributed to this interaction . CONCLUSION Cognitive therapy can be as effective as medications for the initial treatment of moderate to severe major depression , but this degree of effectiveness may depend on a high level of therapist experience or expertise",
"Background : Major depressive disorder occurs commonly in association with alcohol dependence , both in clinical sample s and in the community . Efforts to treat major depressive disorder in alcoholics with antidepressants have yielded mixed results . This multicenter , double-blind , placebo-controlled trial of sertraline was design ed to address many of the potential method ological shortcomings of studies of co-occurring disorders . Method : Following a 1-week , single-blind , placebo lead-in period , 328 patients with co-occurring major depressive disorder and alcohol dependence were r and omly assigned to receive 10 weeks of treatment with sertraline ( at a maximum dose of 200 mg/d ) or matching placebo . R and omization was stratified , based on whether initially elevated scores on the 17-item Hamilton Depression Rating Scale declined with cessation of heavy drinking , result ing in a sample of 189 patients with Hamilton Depression Rating Scale scores ≥17 ( group A ) and 139 patients with Hamilton Depression Rating Scale scores ≤16 ( group B ) . Results : Both depressive symptoms and alcohol consumption decreased substantially over time in both groups . There were no reliable medication group differences on depressive symptoms or drinking behavior in either group A or B patients . Conclusion : Despite careful attention to method ological considerations , this study does not provide consistent support for the use of sertraline to treat co-occurring major depressive disorder and alcohol dependence . The high rate of response among placebo-treated patients may help to explain these findings . Further research is needed to identify efficacious treatments for patients with these commonly co-occurring disorders",
"The outcome of antidepressant therapy in terms of social functioning was evaluated in a r and omized , placebo-controlled , double-blind study comparing the selective noradrenaline reuptake inhibitor ( NARI ) , reboxetine , with the selective serotonin reuptake inhibitor ( SSRI ) fluoxetine . Of the 381 patients with major depression participating in the study , 302 patients were assessed using the new self-rating Social Adaptation Self-evaluation Scale ( SASS ) . Mean SASS total score at last assessment was superior ( p placebo for both reboxetine and fluoxetine . Moreover , reboxetine was superior ( p . Evaluation of the sensitivity to change in individual items by point-biserial correlation analysis showed a significant correlation between improvement in item score and reboxetine treatment in all but one item for the reboxetine-placebo comparison . In the fluoxetine-placebo comparison , a significant correlation was evident for only 12 of the 21 items . Direct comparison of reboxetine with fluoxetine revealed a significant correlation between change in item score and treatment for nine items , in favour of reboxetine . The association was maximal for six items , mainly related to negative self-perception and to active social behaviour . In the subset of patients in remission at last assessment ( n = 91 ) , the mean SASS total score for reboxetine was superior to that of both fluoxetine and placebo ( p reboxetine ( 17 items ) or fluoxetine ( nine items ) in patients in remission . In the reboxetine-fluoxetine comparison , 14 items showed a significant association with reboxetine treatment . In conclusion , while social motivation and behaviour in depression are significantly affected by both noradrenergic and serotonergic antidepressant treatment , noradrenergic therapy seems particularly effective in improving negative self-perception and motivation towards action , result ing in a better quality of remission in terms of social functioning",
"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",
"OBJECTIVE These studies were design ed to evaluate the efficacy and tolerability of the first nonpeptide vasopressin V(1b ) receptor antagonist , SSR149415 , in the treatment of major depressive disorder ( MDD ) and generalized anxiety disorder ( GAD ) . METHOD Studies were r and omized 8-week , double-blind , placebo-controlled trials evaluating 100- and 250-mg twice daily doses of SSR149415 , placebo , and escitalopram 10 mg/day or paroxetine 20 mg/day , conducted from August 2006 through February 2008 . Participants met the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision criteria for MDD or GAD . Baseline Montgomery-Asberg Depression Rating Scale ( MADRS ) and Hamilton Depression Rating Scale ( HDRS ) total scores were ≥ 24 and 18 , respectively , and in the GAD trial baseline Hamilton Anxiety Rating Scale ( HARS ) score was ≥ 22 . Primary efficacy variables included changes from baseline in total score on HDRS or HARS and MADRS , and the secondary variable included changes in the Clinical Global Impressions-Severity of Illness score ( CGI-S ) . A 4-week , double-blind , placebo-controlled study evaluating the effect of 100- and 250-mg twice daily doses of SSR149415 on the hypothalamic-pituitary-adrenal ( HPA ) axis in MDD patients was also conducted . RESULTS In the GAD trial , SSR149415 did not separate from placebo on the primary ( HARS-100 mg : P = .29 ; 250 mg : P = .21 ) and secondary ( CGI-S-100 mg : P = .18 ; 250 mg : P = .24 ) outcome measures , while paroxetine demonstrated efficacy ( HARS : P = .003 ; CGI-S : P = .01 ) . In 2 MDD trials , SSR149415-treated patients did not show significant improvement from baseline on any outcome measure compared with placebo-treated patients ( HDRS-100 mg : P = .21 and .48 , respectively ; 250 mg : P = .22 and P = .46 , respectively ; CGI-S-100 mg : P = .64 and P = .82 , respectively ; 250 mg : P = .33 and P = .08 , respectively ) . In the third MDD study , SSR149415 250 mg ( P = .04 ) , but not escitalopram ( P = .15 ) , demonstrated significant improvement compared to placebo on the HDRS total score at week 8 . SSR149415 had no deleterious effects on the HPA axis . CONCLUSIONS These studies demonstrate that SSR149415 may not be useful for the treatment of GAD and that its antidepressant potential needs to be further evaluated . TRIAL REGISTRATION Clinical Trials.gov identifiers : NCT00374166 ( Sanofi ID number : DFI5880 ) , NCT00361491 ( Sanofi ID number : DFI5879 ) , NCT00358631 ( Sanofi ID number : DFI5878 ) , NCT01606384 ( Sanofi ID number : PDY5467 )",
"BACKGROUND Many patients with depression take benzodiazepine drugs long term despite the absence of continuing therapeutic value . AIMS To evaluate a treatment programme involving gradual discontinuation with or without simultaneous selective serotonin reuptake inhibitor ( SSRI ) prescribing and to determine the long-term outcome after benzodiazepine withdrawal . METHOD Patients went through three phases - change to an equivalent dose of diazepam ; subsequent r and omisation to either 20 mg of paroxetine or placebo ; and gradual reduction of diazepam in depression-free patients - with a follow-up after 2 or 3 years . RESULTS A total of 230 patients were recruited and 75 % in the paroxetine group and 61 % in the placebo group were successfully treated after 6 weeks ( P:=0.067 ) . After 2 or 3 years 13 % of patients were still benzodiazepine free : 26 % of those who had successfully tapered off benzodiazepine and 6 % of the total group . CONCLUSIONS Transfer to diazepam followed by gradual withdrawal is an effective way of discontinuing chronic benzodiazepine use . The addition of SSRI treatment is of limited value",
"Objective : This study looks to compare the antidepressant efficacy and safety of a st and ardized extract of St John 's wort with both placebo and fluoxetine . Method : After a 1-week single-blind washout , patients with major depressive disorder diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition were r and omized to 12 weeks of double-blind treatment with LI-160 St John 's wort extract ( 900 mg/d ) , fluoxetine ( 20 mg/d ) , or placebo . The 17-item Hamilton Rating Scale for Depression ( HAMD-17 ) was the primary efficacy measure , and analysis of covariance was used to compare differences in end point HAMD-17 scores across the 3 treatment groups , treating the baseline HAMD-17 as the covariate . Results : One hundred thirty-five patients ( 57 % women ; mean age , 37.3 ± 11.0 ; mean HAMD-17 , 19.7 ± 3.2 ) were r and omized to double-blind treatment and were included in the intent-to-treat analyses . Analysis of covariance analyses showed lower mean HAMD-17 scores at end point in the St John 's wort group ( n = 45 ; mean ± SD , 10.2 ± 6.6 ) compared with the fluoxetine group ( n = 47 ; 13.3 ± 7.3 ; P higher rates of remission ( HAMD-17 appeared to be safe and well tolerated . Conclusion : St John 's wort was significantly more effective than fluoxetine and showed a trend toward superiority over placebo . A ( 25 % ) smaller than planned sample size is likely to account for the lack of statistical significance for the advantage ( indicating a moderate effect size , d = 0.45 ) of St John 's wort over placebo",
"Background Thresholds for statistical significance are insufficiently demonstrated by 95 % confidence intervals or P-values when assessing results from r and omised clinical trials . First , a P-value only shows the probability of getting a result assuming that the None hypothesis is true and does not reflect the probability of getting a result assuming an alternative hypothesis to the None hypothesis is true . Second , a confidence interval or a P-value showing significance may be caused by multiplicity . Third , statistical significance does not necessarily result in clinical significance . Therefore , assessment of intervention effects in r and omised clinical trials deserves more rigour in order to become more valid . Methods Several method ologies for assessing the statistical and clinical significance of intervention effects in r and omised clinical trials were considered . Balancing simplicity and comprehensiveness , a simple five-step procedure was developed . Results For a more valid assessment of results from a r and omised clinical trial we propose the following five-steps : ( 1 ) report the confidence intervals and the exact P-values ; ( 2 ) report Bayes factor for the primary outcome , being the ratio of the probability that a given trial result is compatible with a ‘ None ’ effect ( corresponding to the P-value ) divided by the probability that the trial result is compatible with the intervention effect hypothesised in the sample size calculation ; ( 3 ) adjust the confidence intervals and the statistical significance threshold if the trial is stopped early or if interim analyses have been conducted ; ( 4 ) adjust the confidence intervals and the P-values for multiplicity due to number of outcome comparisons ; and ( 5 ) assess clinical significance of the trial results . Conclusions If the proposed five-step procedure is followed , this may increase the validity of assessment s of intervention effects in r and omised clinical trials ",
"CONTEXT Paroxetine controlled release ( CR ) is approved for the treatment of major depressive disorder ( MDD ) in the dosage range of 25 to 62.5 mg daily . However , lower daily doses ( 12.5 mg and 25 mg ) of this formulation have not been investigated in the treatment of MDD . If the 12.5-mg and 25-mg doses are found to be efficacious , these lower doses may well convey a superior tolerability profile for paroxetine CR in the treatment of MDD . OBJECTIVE To evaluate the antidepressant efficacy and tolerability profile of daily doses of paroxetine CR 12.5 mg and 25 mg versus placebo in the treatment of MDD . DESIGN AND SETTING R and omized , double-blind , placebo-controlled clinical trial conducted in 40 clinical investigation centers in the United States . PARTICIPANTS 447 adult ( > or = 18 years of age ) out patients who met DSM-IV criteria for MDD and with a baseline 17-item Hamilton Rating Scale for Depression ( HAM-D ) score of at least 20 comprised the intent-to-treat study population ( mean age = 38.8 years ; 58.4 % female ; 75.6 % white ) . INTERVENTION Eligible patients completing a 1-week single-blind placebo run-in period were r and omly assigned to receive once-a-day study medication ( paroxetine CR 12.5 mg [ N = 156 ] , paroxetine CR 25 mg [ N = 154 ] , or placebo [ N = 149 ] ) in an 8-week , double-blind , parallel cell comparison . MAIN OUTCOME MEASURES The primary efficacy measure was the change from baseline to study endpoint ( week 8) as measured by the HAM-D. Secondary efficacy measures included change from baseline to study endpoint as assessed by both the depressed mood item on the HAM-D and the Clinical Global Impressions ( CGI ) Severity of Illness scale ( CGI-S ) . The proportion of patients considered at study endpoint to be in response ( CGI-Improvement score of 1 or 2 ) or in remission ( HAM-D Quality of life was assessed by the change from baseline in total score of the short form of the Quality of Life Enjoyment and Satisfaction Question naire ( Q-LES-Q ) . Safety observations were made by assessing the proportion of patients who had adverse experiences , including laboratory and electrocardiographic abnormalities , during the treatment period . RESULTS The primary efficacy analysis revealed that both the 12.5-mg and the 25-mg paroxetine CR treatment groups were associated with significant therapeutic effects ( change in HAM-D score ) from baseline to study endpoint ( LOCF : p = .038 , 95 % CI = -3.38 to -0.09 and p = .005 , 95 % CI = -4.06 to -0.74 , respectively ) . Results from the Wilcoxon rank sum test of the depressed mood item of the HAM-D ( p = .011 , 95 % CI = -0.57 to -0.07 ) demonstrated significant efficacy in the 25-mg treatment group but not in the 12.5-mg group . However , LOCF analysis of the CGI-S revealed significant therapeutic effects for both the 12.5-mg ( p = .018 , 95 % CI = -0.61 to -0.06 ) and 25-mg ( p 25-mg paroxetine CR-treated group than in the placebo-treated group met criteria for response ( CGI-Improvement score of 1 or 2 , p = .035 , OR = 1.68 , 95 % CI = 1.04 to 2.73 ) as well as for remission ( HAM-D score HAM-D remission analysis nor CGI responder analysis showed statistical separation from placebo for paroxetine CR 12.5-mg treatment . Quality of life improvements were statistically significant for the 25-mg treatment ( p = .041 , 95 % CI = 0.17 to 8.03 ) on the Q-LES-Q total score . Post hoc LOCF analyses of HAM-D sleep disturbance , psychic anxiety , and anxiety/somatization factors revealed significant improvements from baseline in the paroxetine CR 25-mg and 12.5-mg treatment groups . The types of adverse events reported in the 12.5-mg and 25-mg groups were similar to those reported with paroxetine CR at the customary 25-mg to 62.5-mg range ; however , the lower doses of paroxetine CR were associated with a relatively reduced incident rate of these adverse events and an overall improved tolerability compared with the incident rate and tolerability profile associated with the customary dose range of paroxetine CR ( 25 to 62.5 mg ) . CONCLUSION Paroxetine CR , at 12.5 mg/day and 25 mg/day , demonstrated significant antidepressant effects",
"OBJECTIVE Authors tested the hypothesis that one night of total sleep deprivation ( TSD ) would accelerate antidepressant response to paroxetine , as compared with TSD+placebo ( PBO ) and paroxetine-alone , in late-life major depression . METHODS Eighty elderly out patients with current episodes of non-psychotic , non-bipolar major depression were r and omly assigned to one of three treatment conditions : TSD+paroxetine ( N = 27 ) , TSD + PBO ( N = 27 ) , and paroxetine-only ( N = 26 ) . Primary outcome was percentage of subjects in each condition who demonstrated early response ( Hamilton Rating Scale for Depression scores [ Ham-D : 17-item ] of remission ( score of Response rates after 14 days were 22 % in subjects r and omly assigned to the TSD + paroxetine condition , 41 % in TSD + PBO , and 46 % in paroxetine alone . Remission rates after 14 days were 11 % in TSD+paroxetine , 22 % in TSD + PBO , and 38 % in paroxetine . After adjusting for baseline depression severity , there were no statistically significant differences in response or remission rates . CONCLUSION Contrary to the study hypothesis , one night of total sleep deprivation did not accelerate onset of antidepressant response to paroxetine pharmacotherapy of late-life depression . The data suggest , rather , that the two interventions might have counteracted each other",
"& NA ; Approximately 20 million patients suffer from major depressive disorder each year , indicating a need for antidepressant agents that are synonymous with effectiveness , tolerability and patient compliance . The authors examined the effects of fluvoxamine , a selective serotonin reuptake inhibitor , in the treatment of out patients meeting DSM‐III‐R criteria for major depressive disorder . A r and omized , double‐blind , parallel group , placebo‐ and imipramine‐controlled single center study was conducted in 150 out patients . Patients were r and omized to receive up to 150 mg/day of fluvoxamine as a single bedtime dose , 240 mg/day of imipramine on a twice‐daily ( BID ) schedule , or placebo for six weeks . Efficacy measurements included HAM‐D , MADRS , CGI , Raskin‐Covi and SCL‐56 scales . The HAM‐D total score indicated that both active treatment groups showed significantly ( p ≤ 0.05 ) greater therapeutic benefit than did placebo . Severely depressed patients ( HAM‐D ≥ 30 ) responded better to fluvoxamine in five of six measures . Side‐effects from fluvoxamine were similar to those reported for other selective serotonin reuptake inhibitors ( nausea , somnolence ) and were well tolerated . Imipramine was associated with anticholinergic effects such as dry mouth and dizziness . The pharmacokinetic properties of fluvoxamine which allow the drug to be administered as a single daily dose should aid in the maintenance of patient compliance , while offering significant clinical benefit in the improvement of depressive symptoms",
"Summary Recent research aims at developing a biomarker to predict antidepressant treatment outcomes in major depressive disorder . The Antidepressant Treatment Response ( ATR ) index has been correlated with response to antidepressant medication ( Leuchter et al. , 2009a , 2009b ) but has not been assessed in a placebo-controlled trial . EEGs recorded at pretreatment baseline and after 1 week of r and omized treatment were used to calculate ATR index for 23 subjects with major depressive disorder who were treated for 8 weeks with fluoxetine ( FLX ) 20 mg ( n = 12 ) or placebo ( n = 11 ) . The 17-item Hamilton Depression Rating Scale ( HamD17 ) assessed symptom severity ; ATR index was assessed as a predictor of percent change in HamD17 score , endpoint response ( ≥ 50 % improvement ) and remission ( HamD17 score ⩽ 7 ) . The ATR index was significantly associated with improvement on FLX ( r = 0.64 , P = 0.01 ) , with a higher mean ATR index for FLX responders than for nonresponders ( t(10 ) = −2.07 , P = 0.03 ) . Receiver operating characteristic analysis found a 0.83 area under the curve ( P = 0.03 ) , for ATR index as a predictor for FLX , while an optimized ATR index cutoff of 47.3 yielded 100 % sensitivity , 66.7 % specificity , 75 % positive predictive value , and 100 % negative predictive value . Importantly , ATR index did not correlate significantly with placebo outcomes . Results extend ATR index findings to include predictive validity with fluoxetine , suggesting that this biomarker has specificity for drug effects",
"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",
"Considerable research shows that serotonin dysfunction is implicated in major depression . Paroxetine is an investigational antidepressant that appears to act by selectively blocking neuronal serotonin uptake . Seventy-two out patients with moderate-to-severe major depression entered this 6-week , double-blind comparison of paroxetine and placebo . The results showed clear and significant superiority of paroxetine on all of the major outcome variables . These included physician-rated measures such as the Hamilton Rating Scale for Depression and its four factor scores , the Clinical Global Impressions scale , the Montgomery and Asberg Depression Rating Scale , and the Raskin Depression Scale . Results on these agreed well with patient-rated measures like the Hopkins Symptom Checklist and Patient Global Evaluation Scale . Paroxetine was also very well tolerated . Nausea and constipation occurred significantly more often with paroxetine , but only 9 % of paroxetine patients dropped out of the study due either in whole or in part to an adverse effect . This compares to 8 % of the placebo patients who were discontinued for the same reason . This study suggests that paroxetine is a safe and effective medication for the treatment of major depression",
"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",
"Vilazodone is a selective serotonin reuptake inhibitor and 5-HT1A partial agonist approved for major depressive disorder ( MDD ) treatment in adults . This was a 10-week , multicenter , double-blind , placebo-controlled and active-controlled , fixed-dose trial ( NCT01473381 ) . Adult patients with MDD ( Diagnostic and Statistical Manual of Mental Disorders , 4th ed . , text revision criteria ) were r and omized 1 : 1 : 1 : 1 to vilazodone 20 or 40 mg/day , citalopram 40 mg/day , or placebo . Primary efficacy : Montgomery – Åsberg Depression Rating Scale ( MADRS ) ; secondary efficacy : Clinical Global Impressions-Severity and sustained response ( MADRS total score⩽12 for at least the last two consecutive double-blind visits ) . The intent-to-treat population comprised 1133 patients , ( placebo=281 ; vilazodone 20 mg/day=288 ; vilazodone 40 mg/day=284 ; citalopram=280 ) . MADRS and Clinical Global Impressions-Severity score change from baseline to week 10 was significantly greater for vilazodone 20 mg/day , vilazodone 40 mg/day , and citalopram versus placebo . Sustained response rates were numerically higher , but not significantly different , in all active treatment groups versus placebo . The most common adverse events ( ≥5 % of vilazodone patients , twice the rate of placebo ) were diarrhea , nausea , vomiting ( vilazodone 40 mg/day only ) , and insomnia . Improved sexual function ( Changes in Sexual Functioning Question naire scores ) was seen in all groups ; between-group differences were not significant . Vilazodone 20 and 40 mg/day demonstrated efficacy and tolerability in the treatment of MDD",
"AIM The main purpose of this study was to evaluate the efficacy of paroxetine controlled-release ( CR ) formulation compared to placebo . A secondary objective was to test the hypothesis that the CR decreases selective-serotonin-reuptake-inhibitors-induced nausea as its formulation allows more distal gastrointestinal absorption than the paroxetine immediate-release ( IR ) formulation . METHODS We conducted this study in Japanese and Korean patients with major depressive disorder ( MDD ) in order to demonstrate the efficacy and safety of paroxetine CR compared with placebo . The primary efficacy end-point was the adjusted mean change from baseline in the 17-item Hamilton Rating Scale for Depression total score at Week 8 . RESULTS A total of 416 patients with MDD were r and omly assigned to the CR , IR and placebo groups . The mean change from baseline in the 17-item Hamilton Rating Scale for Depression was -12.8 in the CR group , -12.5 in the IR group , and -10.4 in the placebo group , which showed a statistically significant difference compared to placebo in CR ( P incidence of adverse events was 65 % in CR , 69 % in IR and 55 % in placebo . The adverse events were mostly mild or moderate in severity . In the early treatment period , when initiated from 12.5 mg , the incidence of nausea in the CR group was 6 % , which was comparable with that of placebo ( 5 % ) . CONCLUSION Paroxetine CR is efficacious in the acute treatment of MDD and may have the potential benefit of decreasing the incidence of nausea in the early treatment period",
"This multicenter study compared the efficacy and safety of citalopram and placebo in a population of moderately to severely depressed patients with melancholia . This r and omized , double-blind , parallel-group study compared citalopram ( flexible dose ; 20 - 80 mg/day ) with placebo in 180 psychiatric out patients with a DSM-III diagnosis of major depression or bipolar disorder , depressed , who also met DSM-III criteria for melancholia . Following a 1-week placebo washout period , patients meeting study entry criteria were r and omized to 4 weeks of double-blind treatment with either citalopram or placebo . Efficacy measures included the Hamilton Rating Scale for Depression ( HAM-D ) , the Clinical Global Impressions ( CGI ) Scale , and the Zung Self-Rating Depression Scale . Patients treated with citalopram showed significantly greater improvement at endpoint than placebo patients on the HAM-D , CGI , and Zung scales . On the HAM-D , citalopram patients exhibited significantly greater improvement than placebo patients after 1 week of double-blind treatment and at all subsequent study visits . Endpoint analyses of the HAM-D subscales demonstrated that citalopram produced significant improvement of the psychomotor retardation , cognitive disturbance , sleep disturbance , and melancholia symptom clusters . Nausea , dry mouth , somnolence , dizziness , and increased sweating were reported at higher rates by citalopram-treated patients than by placebo-treated patients , but there were no significant citalopram-placebo differences in the incidence of activation ( e.g. , anxiety , nervousness , insomnia ) or sexual dysfunction . Analysis of electrocardiograms , vital signs , and laboratory tests did not reveal any clinical ly significant effects of citalopram treatment . The results of this study indicate that citalopram is safe and effective in the treatment of depressed patients with melancholia , and is associated with a favorable side effect profile and a potentially rapid onset of action",
"Major depression during later life represents a clinical challenge . Conventional antidepressant pharmacotherapy is relatively less well tolerated in geriatric patients compared with younger patients . Despite the striking impairments associated with this disorder , clinical investigations into the relative risk-benefit ratio of various depression treatment strategies have been limited . In this multicentre , placebo-controlled , double-blind trial with fluoxetine , 671 major depressed ( DSM-III-R-compatible ) out patients aged 60 years or older were evaluated . The 21-item Hamilton Depression Rating le ( HAMD21 ) response ( p = 0.014 ) and remission ( p = 0.008 ) criteria favoured fluoxetine over placebo . Analysis of the treatment effect on change in the HAMD21 factors ( anxiety/somatization , cognitive disturbance , psychomotor retardation , and sleep disturbance ) revealed advantages for fluoxetine within the cognitive disturbance and psychomotor retardation factors . Overall , the rate of discontinuation for an adverse event between fluoxetine ( 11.6 % ) and placebo ( 8.6 % ) was not statistically significant . Baseline HAMD21 factor scores were not predictive of adverse events leading to premature treatment discontinuation . Fluoxetine , 20 mg/day , is a well-tolerated and effective treatment option in the management of geriatric major depression",
"This study compared the sexual functioning effects as well as the safety and efficacy of bupropion sustained release ( bupropion SR ) and sertraline . Three hundred sixty-four patients with normal sexual functioning and recurrent major depression were treated with bupropion SR ( 150 - 400 mg/day ) , sertraline ( 50 - 200 mg/day ) , or placebo for 8 weeks in this r and omized , double-blind , multicenter study . Patients ' depression , sexual functioning , and overall safety were assessed at regular clinic visits . Significantly ( P sertraline experienced orgasm dysfunction compared with patients treated with bupropion SR or placebo . Bupropion SR , but not sertraline , was statistically significantly superior to placebo in improving scores on all depression scales by the end of the study . Headache occurred with similar frequency in all groups . Gastrointestinal disturbances occurred more frequently with sertraline ; insomnia and agitation occurred more frequently with bupropion SR . Small decreases in mean weight were seen with both active treatments ; the placebo group experienced a minor increase in mean weight . Both bupropion SR and sertraline were generally well tolerated , although sertraline was more often associated with sexual dysfunction . Bupropion SR , but not sertraline , was statistically superior to placebo in relieving depression by the end of the study . Bupropion SR may offer advantages over sertraline in treating depressed patients concerned with sexual functioning",
"This study investigated the psychological characteristics and clinical features of 55 patients with geriatric depression , and evaluated the efficacy and safety of escitalopram in the treatment of geriatric depression , in a r and omized controlled trial . Fifty-five patients with geriatric depression were r and omly assigned to receive 8 weeks of escitalopram 10 mg , daily , orally ( n = 29 ) or placebo ( n = 26 ) . At baseline , these patients had significantly higher neuroticism and psychoticism scores on the Eysenck Personality Question naire - Adult scale than Chinese population norms . General Severity Index scores and the mean values of the nine subscales of the Symptom Checklist-90- Revised scale were also significantly higher in these patients than in Chinese population norms . The response rate to escitalopram after 8 weeks ' treatment was 74.1 % ( 20/27 patients ) . Adverse reactions included nausea , dry mouth and dizziness . In conclusion , depressed geriatric patients were found to have abnormal personality traits , and escitalopram was efficacious and had a good safety profile in the treatment of geriatric depression",
"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",
"This study tested the effectiveness of fluoxetine as a treatment for depression in a population of methadone-maintained opioid addicts . Methadone-maintained opioid addicts ( 44 ) with depression received fluoxetine or placebo in addition to their methadone , in a double-blind r and omized trial , for 12 weeks . Depressive symptoms decreased significantly overall with no significant differences between the groups treated with fluoxetine versus placebo . In addition , drug use outcomes , including cocaine and heroin self-reported use and urine toxicology were measured . There was a significant decrease in heroin use in treatment , but no medication effect . Cocaine use , was unchanged from pre-treatment to endpoint . In separately analyzing data for the sub sample of subjects with the most severe depression , there was a significant decrease in depression during treatment and a significant decrease in self-reported cocaine use , but no medication effect on either depressive symptoms or on cocaine use . This study suggests that fluoxetine is not an effective agent in treating depression or cocaine use in this population",
"Fluvoxamine was given in placebo-controlled trials to 33 severely depressed patients of between 60 and 71 years , 29 received imipramine and 14 placebo . At week 4 of treatment fluvoxamine and imipramine were superior to placebo on the HAMD and CGI scales ( P less than 0.05 ) . There was indication of an earlier onset of antidepressant activity in the fluvoxamine group . There was no evidence of systematic changes in laboratory variables in any treatment group . Fluvoxamine and placebo had similar effects on heart rate and blood pressure . Imipramine was associated with significant postural falls in mean systolic pressure . The most frequent unwanted symptom with fluvoxamine was mild nausea , with imipramine , dry mouth . Toxic confusion was the major reason for dropout in the imipramine ( n = 4 ) and nausea ( n = 3 ) in the fluvoxamine-treated group",
"The efficacy and safety of fluvoxamine maleate , a selective serotonin reuptake inhibitor , was compared with placebo and imipramine in patients with major depressive disorder . Previous literature has cited a dose range of 100 to 300 mg/day of fluvoxamine maleate for the treatment of major depression ; however , this study demonstrates that a dose range of 50 to 150 mg/day is as effective as imipramine ( 80 - 240 mg/day ) . After a 1- to 2-week , single-blind , placebo washout phase , 150 depressed out patients were r and omized to double-blind treatment with fluvoxamine maleate ( 50 - 150 mg/day ) , imipramine ( 80 - 240 mg/day ) , or placebo for 6 weeks . Fluvoxamine produced a significant therapeutic benefit over placebo ( p Hamilton Rating Scale for Depression ; imipramine ( 80 - 240 mg/day ) produced similar results . The secondary outcome variables ( i.e. , Clinical Global Impression severity of illness item and 56-Item Hopkins Symptom Checklist depression factor ) also showed significant differences between fluvoxamine maleate and placebo during three of the four final weeks of the study . Both fluvoxamine maleate and imipramine appeared to be safe and well tolerated by the majority of patients . As expected from the pharmacology of these agents , the imipramine groups reported more anticholinergic effects ( dry mouth , dizziness , and urinary retention ) and electrocardiographic effects , whereas the fluvoxamine group reported more nausea , somnolence , and abnormal ejaculation . The majority of these adverse events were mild to moderate and , with the exception of dry mouth ( imipramine ) and abnormal ejaculation ( fluvoxamine ) , were transient . The data clearly demonstrate the antidepressant activity and tolerability of fluvoxamine maleate ( 50 - 150 mg/day ) as compared with placebo ; it is also as effective as the tricyclic antidepressant imipramine ( 80 - 240 mg/day ) in patients with major depressive disorder",
"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",
"The aim of this proof-of-concept study was to compare the efficacy of escitalopram ( 20 mg/d ) in combination with fixed doses of gaboxadol to escitalopram ( 20 mg ) in the treatment of patients with severe major depressive disorder ( MDD ) . Adult patients were r and omized to 8 wk of double-blind treatment with fixed doses of placebo ( n=71 ) , escitalopram ( 20 mg , n=140 ) , escitalopram ( 20 mg)+gaboxadol ( 5 mg ) ( n=139 ) , or escitalopram ( 20 mg)+gaboxadol ( 10 mg ) ( n=140 ) . The pre-defined primary analysis of efficacy was an analysis of covariance ( ANCOVA ) of change from baseline to endpoint ( week 8) in Montgomery-Åsberg Depression Rating Scale ( MADRS ) total score using last observation carried forward ( LOCF ) . There was no statistically significant difference in the mean change from baseline in MADRS total score between the 20 mg escitalopram+10 mg gaboxadol group and the 20 mg escitalopram group [ difference=-0.45 MADRS points ( 95 % CI -2.5 to 1.6 , p=0.6619 , full analysis set ( FAS ) , LOCF , ANCOVA ) ] at week 8 . The mean treatment differences to placebo at week 8 were -5.6 ( 95 % CI -8.0 to -3.1 , p ) , -5.1 ( 95 % CI -7.5 to -2.7 , p escitalopram+5 mg gaboxadol ) , and -6.0 ( 95 % CI -8.4 to -3.6 , p gaboxadol ) . The most common adverse events reported in the active treatment groups for which the incidence was higher than that in the placebo group , comprised nausea , anxiety and insomnia . There were no clinical ly relevant efficacy differences between a combination of escitalopram and gaboxadol compared to escitalopram alone in the treatment of severe MDD . All active treatment groups were superior in efficacy to placebo and were well tolerated",
"BACKGROUND Citalopram , the most selective serotonin reuptake inhibitor ( SSRI ) , is a bicyclic phthalane derivative with a chemical structure that is unrelated to that of other SSRIs and available antidepressants . The drug is approved for use in 69 countries . This 6-week , fixed-dose , placebo-controlled , parallel-arm , multicenter trial was performed to confirm its efficacy and safety in treatment of out patients with major depression in the United States . METHOD Six hundred and fifty adult out patients with moderate-to-severe major depression ( DSM-III-R ) were r and omly assigned to receive citalopram at doses of 10 mg ( N = 131 ) , 20 mg ( N = 130 ) , 40 mg ( N = 131 ) , or 60 mg ( N = 129 ) or placebo ( N = 129 ) once daily . Outcome assessment s were the 21-item Hamilton Rating Scale for Depression ( HAM-D ) , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the Clinical Global Impressions scale . RESULTS Between-group comparisons of the change from baseline to endpoint revealed significantly greater improvement in the citalopram patients relative to the placebo patients on all 3 efficacy measures . Patients r and omly assigned to 40 mg/day and 60 mg/day of citalopram showed significantly greater improvement than placebo on all efficacy measures , as well as on the HAM-D symptom clusters measuring depressed mood , melancholia , cognitive disturbance , and psychomotor retardation . Patients who received 10 mg/day and 20 mg/day of citalopram also showed consistent improvement relative to placebo on all efficacy ratings , with statistical significance demonstrated in the MADRS response rate , the HAM-D depressed mood item , and the HAM-D melancholia subscale . Citalopram was well tolerated , with only 15 % of patients discontinuing for adverse events . The side effects most commonly associated with citalopram treatment were nausea , dry mouth , somnolence , insomnia , and increased sweating . CONCLUSION Citalopram was significantly more effective than placebo in the treatment of moderate-to-severe major depression , especially symptoms of depressed mood and melancholia , with particularly robust effects shown at doses of 40 and 60 mg/day . Citalopram was well tolerated in spite of forced upward titration to fixed-dose levels , with a low incidence of anxiety , agitation , and nervousness",
"Little is known about the clinical relevance of the Hamilton Rating Scale for Depression ( HAMD-17 ) total scores . It is unclear how total scores translate into clinical severity , or what commonly used measures for response ( reduction from baseline of ≥ 50 % in the total score ) and remission ( total HAMD-17 score ≤ 7 ) mean from a clinical perspective . We therefore compared : ( a ) the percentage and absolute change in the HAMD-17 total scores with Clinical Global Impression-Improvement ( CGI-I ) ; ( b ) the absolute and percentage change in the HAMD-17 total scores with Clinical Global Impression-Severity ( CGI-S ) absolute change ; and ( c ) the percentage and absolute change in the HAMD-17 total scores with CGI-I in the subgroups of patients with ≤ median and > median HAMD-17 total scores at baseline . The method used was equipercentile linking of HAMD-17 and CGI ratings from 43 drug trials in patients with Major Depressive Disorder ( MDD ) ( n = 7131 ) . Our results confirm the validity of the commonly used measures for remission and response in MDD trials : a CGI-I score of 2 ( ' much improved ' ) corresponded to a reduction from baseline of > 50 % and and a CGI-I score of 1 ( ' very much improved ' ) to a reduction of > 75 % and The CGI-S score of 1 ( ' normal . , not at all ill ' ) corresponded to the HAMD-17 total score of the CGI-S score of 2 ( ' borderline mentally ill ' ) to the score between 6 and 8 . An effect of baseline illness severity was observed",
"Twelve patients with DSM-III-R major depressive illness were tested for growth hormone ( GH ) response to desipramine ( DMI ) , a noradrenergic ( NA ) reuptake inhibitor . The response is mediated by NA alpha 2 receptors . They were then r and omly assigned to treatment under double-blind conditions with either fluoxetine , the highly selective serotonin reuptake inhibitor or placebo . After 4 weeks they were retested . Fluoxetine but not placebo was effective in promoting recovery in four of the six patients treated . Patients treated with fluoxetine showed a significant decrease in DMI-mediated GH release irrespective of therapeutic outcome . This is consistent with marked alteration of NA function and raises questions as to the selectivity of fluoxetine",
"BACKGROUND We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola rosea ( R. rosea ) versus sertraline for mild to moderate major depressive disorder . HYPOTHESIS We hypothesize that R. rosea would have similar therapeutic effects as sertraline but with less adverse events . STUDY DESIGN Phase II r and omized placebo controlled clinical trial . METHODS 57 subjects were r and omized to 12 weeks of st and ardized R. rosea extract , sertraline , or placebo . Changes over time in Hamilton Depression Rating ( HAM-D ) , Beck Depression Inventory ( BDI ) , and Clinical Global Impression Change ( CGI/C ) scores among groups were examined using mixed-effects models . RESULTS Modest , albeit statistically non-significant , reductions were observed for HAM-D , BDI , and CGI/C scores for all treatment conditions with no significant difference between groups ( p = 0.79 , p = 0.28 , and p = 0.17 , respectively ) . The decline in HAM-D scores was greater for sertraline ( -8.2 , 95 % confidence interval [ CI ] , -12.7 to -3.6 ) versus R. rosea ( -5.1 , 95 % CI : -8.8 to -1.3 ) and placebo ( -4.6 , 95 % CI : -8.6 to -0.6 ) . While the odds of improving ( versus placebo ) were greater for sertraline ( 1.90 [ 0.44 - 8.20 ] ; odds ratio [ 95 % CI ] ) than R. rosea ( 1.39 [ 0.38 - 5.04 ] ) , more subjects on sertraline reported adverse events ( 63.2 % ) than R. rosea ( 30.0 % ) or placebo ( 16.7 % ) ( p = 0.012 ) . CONCLUSIONS Although R. rosea produced less antidepressant effect versus sertraline , it also result ed in significantly fewer adverse events and was better tolerated . These findings suggest that R. rosea , although less effective than sertraline , may possess a more favorable risk to benefit ratio for individuals with mild to moderate depression ",
"BACKGROUND Escitalopram is the single isomer responsible for the serotonin reuptake inhibition produced by the racemic antidepressant citalopram . The present r and omized , double-blind , placebo-controlled , fixed-dose multicenter trial was design ed to evaluate the efficacy and tolerability of escitalopram in the treatment of major depressive disorder . METHOD Out patients with an ongoing DSM-IV major depressive episode ( N = 491 ) were r and omly assigned to placebo , escitalopram , 10 mg/day , escitalopram , 20 mg/day , or citalopram , 40 mg/day , and entered an 8-week double-blind treatment period following a 1-week single-blind placebo lead-in . Clinical response was evaluated by the Montgomery-Asberg Depression Rating Scale ( MADRS ) , the 24-item Hamilton Rating Scale for Depression ( HAM-D ) , the Clinical Global Impressions ( CGI ) scales , the Hamilton Rating Scale for Anxiety ( HAM-A ) , and patient-rated quality -of-life scales . RESULTS Escitalopram , at both doses , produced significant improvement at study endpoint relative to placebo on all measures of depression ; significant separation of escitalopram from placebo was observed within I week of double-blind treatment . Citalopram treatment also significantly improved depressive symptomatology compared with placebo ; however , escitalopram , 10 mg/day , was at least as effective as citalopram , 40 mg/day , at endpoint . Anxiety symptoms and quality of life were also significantly improved by escitalopram compared with placebo . The incidence of discontinuations due to adverse events for the escitalopram 10 mg/day group was not different from the placebo group ( 4.2 % vs. 2.5 % ; p = .50 ) , and not different for the escitalopram 20 mg/day group and the citalopram 40 mg/day group ( 10.4 % vs. 8.8 % ; p = .83 ) . CONCLUSION Escitalopram , a single isomer SSRI , is well-tolerated and has demonstrated antidepressant efficacy at a dose of 10 mg/day",
"BACKGROUND Despite the high prevalence of depression in elderly patients , few well- design ed , placebo-controlled studies of antidepressants have been conducted in this population . This masked , placebo-controlled trial assessed the efficacy and safety of venlafaxine and fluoxetine in depressed patients older than 65 years . METHOD Three hundred patients were r and omly assigned to treatment with venlafaxine immediate release ( [ IR ] ; N = 104 ) , fluoxetine ( N = 100 ) , or placebo ( N = 96 ) in an eight-week trial . Venlafaxine doses were titrated from 37.5 to 225 mg per day and fluoxetine doses were titrated from 20 to 60 mg per day , as necessary , over 29 days . Efficacy variables included the 21-item Hamilton Depression Rating Scale ( HAM-D21 ) total score , HAM-D21 depressed mood item score , scores on the Montgomery Asberg Depression Rating Scale ( MADRS ) , Clinical Global Impression-Severity of Illness ( CGI-S ) and Improvement ( CGI-I ) scales , and rates of response ( based on change from baseline HAM-D or MADRS score or CGI-I score ) and remission ( HAM-D17 monitoring of adverse events ( AEs ) , physical examinations , vital signs assessment s , laboratory determinations , and electrocardiograms . RESULTS In all three of the treatment groups , there was a significant reduction at week 8 compared with the baseline HAM-D21 total score . However , there were no significant differences among the three treatment groups on the change in HAM-D21 , MADRS , or CGI scores from baseline to week 8 . There was no statistically significant difference in the proportion of remitters at the last on-therapy visit . The incidence of individual AEs was higher in the venlafaxine group ( 27 % ) compared with patients taking fluoxetine ( 19 % ) or placebo ( 9 % ) . CONCLUSION In this study , there was no significant difference in efficacy among placebo , venlafaxine , and fluoxetine for the treatment of depression",
"OBJECTIVE Empirical evidence has only weakly supported antidepressant treatment for patients with co-occurring depression and alcohol dependence . While some studies have demonstrated that antidepressants reduce depressive symptoms in individuals with depression and alcohol dependence , most studies have not found antidepressant treatment helpful in reducing excessive drinking in these patients . The authors provide results from a double-blind , placebo-controlled trial that evaluated the efficacy of combining approved medications for depression ( sertraline ) and alcohol dependence ( naltrexone ) in treating patients with both disorders . METHOD A total of 170 depressed alcohol-dependent patients were r and omly assigned to receive 14 weeks of treatment with sertraline ( 200 mg/day [ N=40 ] ) , naltrexone ( 100 mg/day [ N=49 ] ) , the combination of sertraline plus naltrexone ( N=42 ) , or double placebo ( N=39 ) while receiving weekly cognitive-behavioral therapy . RESULTS The sertraline plus naltrexone combination produced a higher alcohol abstinence rate ( 53.7 % ) and demonstrated a longer delay before relapse to heavy drinking ( median delay=98 days ) than the naltrexone ( abstinence rate : 21.3 % ; delay=29 days ) , sertraline ( abstinence rate : 27.5 % ; delay=23 days ) , and placebo ( abstinence rate : 23.1 % ; delay=26 days ) groups . The number of patients in the medication combination group not depressed by the end of treatment ( 83.3 % ) approached significance when compared with patients in the other treatment groups . The serious adverse event rate was 25.9 % , with fewer reported with the medication combination ( 11.9 % ) than the other treatments . CONCLUSIONS More depressed alcohol-dependent patients receiving the sertraline plus naltrexone combination achieved abstinence from alcohol , had delayed relapse to heavy drinking , reported fewer serious adverse events , and tended to not be depressed by the end of treatment",
"OBJECTIVE The corticotropin-releasing hormone ( CRH ) system is implicated in the pathogenesis of several psychiatric disorders , including major depressive disorder . This study was design ed to evaluate the safety and efficacy of CP-316,311 , a selective nonpeptide antagonist of corticotropin-releasing hormone type 1 ( CRH(1 ) ) receptors , in the treatment of recurrent major depressive disorder . METHOD Of a total of 167 patients with recurrent major depression who were screened , 123 were r and omly assigned to receive 400 mg of CP-316,311 twice daily , or 100 mg of sertraline daily , or placebo in a 6-week fixed-dose , double-blind , double-dummy , parallel-group , placebo- and sertraline-controlled trial . The primary efficacy analysis compared the change in score from baseline to endpoint on the 17-item Hamilton Depression Rating Scale ( HAM-D ) between the CP-316,311 and placebo groups . A group sequential design was used to support early trial termination based on efficacy or futility at a planned interim analysis . RESULTS The evaluable data set for the interim analysis included 28 patients in the CP-316,311 group , 31 patients in the placebo group , and 30 patients in the sertraline group . In the interim analysis , the change from baseline in the HAM-D score at the final visit was not significantly different between the CP-316,311 and placebo groups , while change from baseline between the sertraline and placebo groups was significantly different . Given these results , futility was declared for CP-316,311 and the trial was terminated . CONCLUSIONS Although CP-316,311 was safe and well tolerated in this study population , it failed to demonstrate efficacy in the treatment of major depression",
"BACKGROUND Depression is the second most common neuropsychiatric disorder in older Americans , with significant clinical and public health costs . Despite advances in treatment , late-life depression remains a clinical challenge . Although the selective serotonin reuptake inhibitors ( SSRIs ) are the most common pharmacologic intervention for late-life depression , few placebo-controlled trials have assessed the efficacy of SSRIs for this condition . METHOD In this 12-week , multicenter , placebo-controlled , flexible-dose , double-blind , r and omized trial , 319 elderly patients ( mean age = 70 years ) were treated with controlled-release paroxetine ( paroxetine CR ) up to 50 mg/day ( N = 104 ) , immediate-release paroxetine ( paroxetine IR ) up to 40 mg/day ( N = 106 ) , or placebo ( N = 109 ) . Patients met DSM-IV criteria for major depressive disorder and had a total score of 18 or more on the 17-item Hamilton Rating Scale for Depression ( HAM-D ) . The primary efficacy measure was change from baseline to endpoint in HAM-D total score . RESULTS The primary efficacy analysis showed an adjusted difference between change from baseline in HAM-D score for paroxetine CR and placebo of -2.6 ( 95 % confidence interval [ CI ] = -4.47 to -0.73 , p = .007 ) at the week 12 last-observation-carried-forward ( LOCF ) endpoint . The adjusted difference between paroxetine IR and placebo was -2.8 ( 95 % CI = -4.65 to -0.99 , p = .003 ) at week 12 . Paroxetine CR and IR were more effective than placebo , with mean + /- SD endpoint HAM-D total scores of 10.0 + /- 7.41 and 10.0 + /- 7.10 , respectively , for the active treatments compared with 12.6 + /- 7.34 for placebo . Response , defined as a score of 1 or 2 on the Clinical Global Impressions-global improvement scale , was achieved by 72 % of paroxetine CR patients ( LOCF ; p Remission , defined as a HAM-D total score paroxetine CR patients ( LOCF ; p = .009 vs. placebo ) , 44 % of paroxetine IR patients ( p = .01 vs. placebo ) , and 26 % of placebo patients . In a post hoc analysis , mean HAM-D improvement for paroxetine CR and paroxetine IR was greater than for placebo in both chronically depressed patients ( duration > 2 years ) and those with short-term ( or = 2 years ) depression . Dropout rates due to adverse events were 12.5 % for paroxetine CR , 16.0 % for paroxetine IR , and 8.3 % for placebo . CONCLUSION Paroxetine CR and paroxetine IR are effective and well tolerated treatments for major depressive disorder in elderly patients , including those with chronic depression",
"OBJECTIVE To evaluate the efficacy and tolerability of low daily doses of controlled-release ( CR ) paroxetine in patients with late-life depression . METHOD This was a 10-week , multicenter , placebo-controlled , double-blind , fixed-dose trial r and omly assigning patients > or= 60 years old to daily doses of paroxetine CR 12.5 mg ( N = 168 ) , paroxetine CR 25 mg ( N = 177 ) , or placebo ( N = 180 ) . Patients had major depressive disorder ( DSM-IV criteria ) and 17-item Hamilton Rating Scale for Depression ( HAM-D ) total scores of > or= 18 . The primary efficacy variable was the change from baseline to study endpoint in total HAM-D scores . The study was conducted from June 2003 to October 2004 . RESULTS The drug/placebo difference in HAM-D change from baseline at study endpoint was -1.8 ( 95 % CI = -3.41 to -0.19 , p = .029 ) for paroxetine CR 12.5 mg , and -3.3 ( 95 % CI = -4.84 to -1.68 , p paroxetine CR 25 mg . A significantly larger percentage of patients achieved remission ( HAM-D total score paroxetine CR 25 mg ( 41 % ) , but not with 12.5 mg ( 31 % ) , as compared with placebo ( 28 % ) ( p = .008 ) . Both doses of paroxetine CR also achieved statistical significance compared to placebo for the Clinical Global Impressions-Severity of Illness scale ( p patient-rated measures of depression severity ( p quality of life ( p tolerated , with adverse event withdrawal rates of 6 % , 8 % , and 7 % for paroxetine CR 12.5 mg , paroxetine CR 25 mg , and placebo , respectively . CONCLUSION These data demonstrate that paroxetine CR 12.5 mg and 25 mg daily are efficacious and well tolerated in the treatment of major depressive disorder in patients > or= 60 years of age , although effect sizes are relatively smaller with the 12.5 mg/day dose",
"Clinical study results for neurokinin ( NK ) receptor antagonists in the treatment of depression have been mixed , with Phase III studies failing to fulfill the early promise demonstrated in Phase II studies . Casopitant , a selective NK1 antagonist that achieves nearly complete receptor occupancy was studied in 2 r and omized , placebo-controlled , double-blind , Phase II trials in depressed out patients to test the hypothesis that nearly complete NK1 receptor occupancy is required to achieve antidepressant efficacy . Study 092 used an interactive voice response system to recruit depressed patients with baseline Hamilton Depression ( 17-item , HAMD17 ) total scores higher than 24 who were r and omized to fixed-dose casopitant 30 mg/d , 80 mg/d , or placebo for 8 weeks ( n = 356 ) . Study 096 required Carroll Depression Scale-Revised self- assessment scores of higher than 24 for r and omization to casopitant 120 mg/d , paroxetine 30 mg/d ( both reached via forced titration ) , or placebo for 8 weeks ( n = 362 ) . In study 092 , casopitant 80 mg but not 30 mg achieved statistically significant improvement versus placebo on the primary outcome measure , week 8 last observation carried forward change from baseline HAMD17 ( difference = −2.7 ; 95 % confidence interval , −5.1 to −0.4 , P = 0.023 ) . In study 096 , neither casopitant nor paroxetine achieved statistical separation from placebo at end point on HAMD17 ( casopitant difference = −1.7 ; 95 % CI , −3.8 to 0.4 , P = 0.282 ) . Casopitant and paroxetine were generally well tolerated in most patients . These studies suggest that NK1 antagonists that have nearly complete receptor occupancy may be effective in the treatment of depression ",
"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",
"OBJECTIVE To determine whether supportive-expressive psychotherapy ( SET ) , a form of dynamic psychotherapy , and pharmacotherapy + clinical management ( MED ) for major depressive disorder ( MDD ) are more effective than pill-placebo + clinical management ( PBO ) . METHOD This National Institute of Mental Health (NIMH)-sponsored r and omized controlled trial was conducted ( from November 2001 through June 2007 ) at the University of Pennsylvania Medical School . The sample included 156 patients diagnosed with MDD ( DSM-IV ) and having a 17-item Hamilton Rating Scale for Depression ( HRSD(17 ) ) score ≥ 14 for at least 2 consecutive weeks . This was an underserved sample in which 41 % were male , 52 % were self- design ated minorities , and 76 % had an annual income under $ 30,000 . Treatment lasted 16 weeks . Medication patients not responsive by week 8 ( maximum dose 200 mg/d of sertraline ) were switched to venlafaxine ( maximum dose 375 mg/d ) . Nonresponsive placebo patients at week 8 were switched to a different placebo . RESULTS Patients ' depression improved over the 16 weeks ( P . Response rates did not differ between groups ( P = .73 ) . Gender and minority status moderated outcome ( P = .014 ) , with psychotherapy more efficacious for minority men than MED ( P = .027 , Cohen d = 1.02 ) and PBO ( P = .019 , d = 1.09 ) . PBO was more efficacious for white men than MED ( P = .03 , d = 0.62 ) and SET ( P = .003 , d = 1.07 ) . For white women , MED ( P = .005 , d = 0.77 ) and SET ( P = .033 , d = 0.71 ) were more efficacious than placebo . No differences among treatments were found for minority women . CONCLUSIONS This trial of urban MDD patients failed to confirm that either active treatment was better than placebo . Minority status and gender had significant and differential effects on outcome that warrant replication in future studies . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00043550",
"OBJECTIVE This study determined the efficacy of antidepressant medication for the treatment of depression in the \" old-old . \" METHOD This r and omized 8-week medication trial compared citalopram , 10 - 40 mg/day , to placebo in the treatment of patients 75 and older with unipolar depression . RESULTS A total of 174 patients who were 58 % women with a mean age of 79.6 years ( SD=4.4 ) and a mean baseline Hamilton Depression Rating Scale score of 24.3 ( SD=4.1 ) were r and omly assigned to treatment at 15 sites . There was a main effect for site but not for treatment condition . The remission rate , defined as a final Hamilton depression scale score citalopram and 33 % for the placebo groups . However , patients with severe depression ( baseline Hamilton depression scale score > 24 ) tended to have a higher remission rate with medication than with placebo ( 35 % versus 19 % ) . CONCLUSIONS In the oldest group of community-dwelling patients to be studied to date , medication was not more effective than placebo for the treatment of depression . However , given the considerable psychosocial support received by all patients , the placebo condition represents more than the ingestion of an inactive pill . Across sites , there was considerable range in response to medication , 18 % to 82 % , and to placebo , 16 % to 80 %",
"PURPOSE Although cross-sectional studies have demonstrated an association between higher levels of aerobic fitness and improved neurocognitive function , there have been relatively few interventional studies investigating this relationship , and results have been inconsistent . We assessed the effects of aerobic exercise on neurocognitive function in a r and omized controlled trial of patients with major depressive disorder ( MDD ) . METHODS Two-hundred and two sedentary men ( n = 49 ) and women ( n = 153 ) , aged 40 yr and over and who met diagnostic criteria for MDD , were r and omly assigned to the following : a ) supervised exercise , b ) home-based exercise , c ) sertraline , or d ) placebo pill . Before and after 4 months of treatment , participants completed measures of : Executive Function ( Trail Making Test B-A difference score , Stroop Color-Word , Ruff 2 & 7 Test , Digit Symbol ) , Verbal Memory ( Logical Memory , Verbal Paired Associates ) , and Verbal Fluency/Working Memory ( Animal Naming , Controlled Oral Word Association Test , Digit Span ) . Multivariate analyses of covariance were performed to test the effects of treatment on posttreatment neuropsychological test scores , with baseline neuropsychological test scores , age , education , and change in depression scores entered as covariates . RESULTS The performance of exercise participants was no better than participants receiving placebo across all neuropsychological tests . Exercise participants performed better than participants receiving sertraline on tests of executive function but not on tests of verbal memory or verbal fluency/working memory . CONCLUSIONS We found little evidence to support the benefits of an aerobic exercise intervention on neurocognitive performance in patients with MDD",
"OBJECTIVE There have been few placebo-controlled trials of selective serotonin reuptake inhibitors for depressed elderly patients . This placebo-controlled study of sertraline was design ed to confirm the results of non-placebo-controlled trials . METHOD The subjects were out patients age 60 years or older who had a DSM-IV diagnosis of major depressive disorder and a total score on the 17-item Hamilton Depression Rating Scale of 18 or higher . The patients were r and omly assigned to 8 weeks of double-blind treatment with placebo or a flexible daily dose of 50 or 100 mg of sertraline . The primary outcome variables were the Hamilton scale and Clinical Global Impression ( CGI ) scales for severity and improvement . RESULTS A total of 371 patients assigned to sertraline and 376 assigned to placebo took at least one dose . At endpoint , the patients receiving sertraline evidence d significantly greater improvements than those receiving placebo on the Hamilton depression scale and CGI severity and improvement scales . The mean changes from baseline to endpoint in Hamilton score were -7.4 points ( SD=6.3 ) for sertraline and -6.6 points ( SD=6.4 ) for placebo . The rate of CGI-defined response at endpoint was significantly higher for sertraline ( 45 % ) than for placebo ( 35 % ) , and the time to sustained response was significantly shorter for sertraline ( median , 57 versus 61 days ) . There were few discontinuations due to treatment-related adverse events , 8 % for sertraline and 2 % for placebo . CONCLUSIONS Sertraline was effective and well tolerated by older adults with major depression , although the drug-placebo difference was not large in this 8-week trial",
"1 A double-blind placebo-controlled study of fluvoxamine and imipramine was performed in a group of depressed patients . Twenty-two patients received fluvoxamine ( mean dose 101 mg/day ) , 25 received imipramine ( mean dose 127 mg/day ) and 22 received placebo . 2 Apart from an increase in the SGOT and SGPT values of four imipramine patients , no statistically significant changes in haematology or urinalysis were judged to be medically relevant . Fluvoxamine exhibited fewer anticholinergic side effects than imipramine . 3 Both fluvoxamine treated patients and imipramine-treated patients exhibited a statistically significant improvement at the end of the 28-day treatment period with respect to the placebo patients , as measured using the Hamilton Rating Scale for Depression , and the Clinical Global Impression Scale . Evaluations of the results of the Beck Depression Inventory and the Profile of Mood States revealed a statistically significant improvement for imipramine patients with respect to placebo at week 4 , but not for fluvoxamine patients . It is postulated on the basis of quantitative pharmaco-EEG findings , that the slight superiority of imipramine over fluvoxamine was due to underdosing of the latter",
"BACKGROUND This study was design ed to compare the efficacy , safety , tolerability profiles , and effects on quality of life of the serotonin selective reuptake inhibitor antidepressant sertraline versus the nonselective tricyclic antidepressant amitriptyline and placebo in patients with major depression . METHOD Out patients with DSM-III-R major depression were r and omly assigned to double-blind treatment for 8 weeks with sertraline ( 50 - 200 mg daily ) , amitriptyline ( 50 - 150 mg daily ) , or matching placebo . Assessment s included the Hamilton Rating Scale for Depression , Montgomery-Asberg Depression Rating Scale , Clinical Global Impressions-Severity of Illness scale , Clinical Global Impressions-Improvement scale , Global Assessment Scale , Profile of Mood States , Beck Depression Inventory , Quality of Life Enjoyment and Satisfaction Question naire , and Health-Related Quality of Life battery . RESULTS All treatment groups demonstrated statistically significant improvement from baseline in depression ratings by Week 1 and thereafter . The antidepressant effects of amitriptyline and sertraline were significantly ( p placebo and did not differ significantly from each other . Sertraline was associated with significantly ( p subjective ( i.e. , patient-rated ) improvement in mood than amitriptyline or placebo . Both active drugs were associated with greater improvements than placebo on most quality of life measurements . On several items , sertraline , but not amitriptyline , was superior to placebo . There was a discernible effect of sertraline earlier than amitriptyline on most quality of life scales . Amitriptyline therapy was associated with significantly more treatment-related adverse events , and discontinuations due to treatment-related adverse events , in comparison to both sertraline and placebo therapy . CONCLUSION Sertraline and amitriptyline each were effective treatments for major depression as assessed by both physician- and patient-rated scales . These results show that sertraline therapy is better tolerated than amitriptyline therapy . Quality of life was also improved by effective antidepressant treatment , with sertraline showing a tendency to produce greater improvements on quality of life measures",
"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",
"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",
"In a 6-week , r and omized , double-blind , multicenter trial , sertraline 50 mg , 100 mg , or 200 mg , or placebo , was administered once daily to 369 patients with DSM-III-defined major depression . Efficacy variables included changes from baseline scores for total Hamilton Rating Scale for Depression ( HAMD ) , HAMD Bech Depression Cluster , Clinical Global Impressions ( CGI ) Severity , CGI Improvement , and Profile of Mood States Depression/Dejection Factor . For the evaluable- patients analysis , all sertraline groups showed significantly ( p efficacy variables except one when compared with the placebo group . For the all- patients analysis , all efficacy variables in the 50 mg group were statistically significantly ( p placebo . Side effects increased with increasing dosage but were usually mild and well tolerated . The results of this study show that sertraline 50 mg once daily is as effective as higher dosages for the treatment of major depression with fewer side effects and therapy discontinuations",
"This 7- to 8-week , multicenter , r and omized , double-blind , placebo-controlled study was performed to determine the dose-effect relationship and minimum effective dose for fluvoxamine maleate in a titrated fixed-dose study of major depressive disorder . Gradual titration over 2 weeks to fixed maintenance doses was employed to minimize dropout due to initial side effects . The study enrolled 600 out patients , male and female , age 18 - 65 , meeting DSM-III-R criteria for major depressive disorder . A 13-item subscore of the st and ard 21-Item Hamilton Depression Scale was used to minimize the possible contribution of known side effects from serotonin reuptake inhibitors to the overall HAM-D score . Secondary efficacy assessment s included the HAM-D retardation factor , HAM-D depressed mood item , CGI-severity of illness item , and SCL depression factor . Fluvoxamine ( 50 - 150 mg/day ) was therapeutically effective and well tolerated during 6 weeks of therapy . Based on the HAM-D depressed mood item , efficacy was dose dependent . The minimum effective dose was 50 mg/day . Fluvoxamine maleate shows dose-related effectiveness in the acute treatment of major depressive disorder",
"IMPORTANCE Transcranial direct current stimulation ( tDCS ) trials for major depressive disorder ( MDD ) have shown positive but mixed results . OBJECTIVE To assess the combined safety and efficacy of tDCS vs a common pharmacological treatment ( sertraline hydrochloride , 50 mg/d ) . DESIGN Double-blind , controlled trial . Participants were r and omized using a 2 × 2 factorial design to sertraline/placebo and active/sham tDCS . SETTING Outpatient , single-center academic setting in São Paulo , Brazil . PARTICIPANTS One hundred twenty antidepressant-free patients with moderate to severe , nonpsychotic , unipolar MDD . INTERVENTIONS Six-week treatment of 2-mA anodal left/cathodal right prefrontal tDCS ( twelve 30-minute sessions : 10 consecutive sessions once daily from Monday to Friday plus 2 extra sessions every other week ) and sertraline hydrochloride ( 50 mg/d ) . MAIN OUTCOME MEASURES In this intention-to-treat analysis , the primary outcome measure was the change in Montgomery-Asberg depression rating scale score at 6 weeks ( end point ) . We considered a difference of at least 3 points to be clinical ly relevant . The analysis plan was previously published . Safety was measured with an adverse effects question naire , the young mania rating scale , and cognitive assessment . Secondary measures were rates of clinical response and remission and scores on other scales . RESULTS At the main end point , there was a significant difference in Montgomery-Asberg depression rating scale scores when comparing the combined treatment group ( sertraline/active tDCS ) vs sertraline only ( mean difference , 8.5 points ; 95 % CI , 2.96 to 14.03 ; P = .002 ) , tDCS only ( mean difference , 5.9 points ; 95 % CI , 0.36 to 11.43 ; P = .03 ) , and placebo/sham tDCS ( mean difference , 11.5 points ; 95 % CI , 6.03 to 17.10 ; P comparable efficacies ( mean difference , 2.6 points ; 95 % CI , -2.90 to 8.13 ; P = .35 ) . Use of tDCS only ( but not sertraline only ) was superior to placebo/sham tDCS . Common adverse effects did not differ between interventions , except for skin redness on the scalp in active tDCS ( P = .03 ) . There were 7 episodes of treatment-emergent mania or hypomania , 5 occurring in the combined treatment group . CONCLUSIONS AND RELEVANCE In MDD , the combination of tDCS and sertraline increases the efficacy of each treatment . The efficacy and safety of tDCS and sertraline did not differ . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01033084",
"BACKGROUND Recent publications have raised questions over the efficacy and clinical ly relevant effects of antidepressants that have been approved for the treatment of major depression . In this context , the European Commission requested that the European Medicines Agency ( EMEA ) and its scientific committee ( CHMP ) issue an opinion on these data under Article 5(3 ) of Regulation ( EC ) No 726/2004 . FINDINGS Results from a recent meta- analysis [ Kirsch , I. , Deacon , B.J. et al. , ( 2008 ) Initial severity and antidepressant benefits : a meta- analysis of data su bmi tted to the Food and Drug Administration . PLoS Med . 5(2 ) , e45 . ] have question ed the clinical relevance of the use of some antidepressants in treating major depression . This analysis focused only on statistically significant mean differences versus placebo in changes in a rating scale ( such as the Hamilton Depression Rating Scale ) . This , however , would not be an adequate basis for the evaluation of clinical relevance and , from a regulatory perspective , would not be sufficient to grant an antidepressant the approval needed to allow it onto the market . Improvements that are both statistically significant ( based on improvements in vali date d rating scales between baseline and study end ) and clinical ly relevant ( based on responder rates ) need to be shown in short-term studies . In addition , these short-term results need to be confirmed in a r and omised withdrawal study to demonstrate the maintenance of an antidepressant 's effects . CONCLUSIONS The CHMP concluded that the approval of antidepressants for the treatment of patients with major depression is based on data that provide robust and sufficient evidence of clinical ly meaningful benefits for patients with major depression . Therefore , the CHMP is of the opinion that , as no public health concerns have been identified , no regulatory action is necessary on the basis of Kirsch et al. 's findings",
"This double-blind , placebo-controlled study compared venlafaxine ( immediate release ) , the first modern serotonin-norepinephrine reuptake inhibitor , with the selective serotonin reuptake inhibitor fluoxetine . Out patients were r and omly assigned to 6 weeks of treatment with venlafaxine ( 75 - 225mg/day ; n=102 ) , fluoxetine ( 20 - 60mg/day ; n=104 ) , or placebo ( n=102 ) . Efficacy was assessed using the 21-item Hamilton Depression Rating Scale ( HAM-D(21 ) ) , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , the Clinical Global Impression-Severity of Illness ( CGI-S ) scale , response and remission rates , and several other measures . Intent-to-treat analyses utilized both the last observation carried forward and ETRANK methods to account for missing data . At week 6 or study endpoint , venlafaxine ( mean dose : 142mg/day ) was superior to placebo on most outcomes measures , whereas the differences between fluoxetine ( mean dose : 41mg/day ) and placebo were less consistent . Final remission ( defined as HAM-D venlafaxine , fluoxetine , and placebo , respectively . Few differences between the active treatments attained statistical significance . Both active therapies were generally well tolerated ; however , attrition due to adverse events , incidence of selected side effects , and increases in pulse and blood pressure favored fluoxetine over venlafaxine . This study provides further evidence that venlafaxine is effective after 6 weeks of treatment compared with placebo . The efficacy profile of fluoxetine was somewhat less consistent . It is strongly recommended that future studies of comparative antidepressant efficacy be adequately powered to detect modest between-drug differences in efficacy",
"1 . The efficacy of fluvoxamine is compared to that of desipramine in a multicenter double blind placebo controlled six-week flexible dose trial of 90 out patients with major depressive disorder . 2 . Although overall drug effects were relatively weak , there were trends suggesting separation of both active drugs from placebo at week six . Both drugs were well tolerated . 3 . Studies of major depression ought to be design ed to last 8 - 10 weeks in order to demonstrate placebo active drug differences and the stability of such a difference should it occur in the first six weeks",
"Paroxetine is a selective serotonin uptake inhibitor , which is being investigated as an antidepressant . In this double‐blind , six‐week study 120 out patients with DSM‐I11 major depression were r and omly assigned to treatment with paroxetine , imipramine , or placebo . Results showed a statistically significant superiority of paroxetineover placebo on almost all outcome measures . Paroxetine was significantly superior to imipramine on the HAMD total score and was generally better tolerated than imipramine . The results support paroxetine 's effectiveness in the treatment of major depression and suggest that further studies with this compound are warranted",
"The predictive value of the dexamethasone suppression test ( DST ) was evaluated in two consecutive double-blind , placebo-controlled trials evaluating 61 depressed in patients r and omized to either one of two drugs , sertraline or oxaprotiline , or placebo over a 4-week clinical trial . For 30 patients who completed at least 3 weeks of double-blind treatment on either drug , the initial DST was not predictive of response to drug treatment . For the 17 patients who completed at least 3 weeks of double-blind treatment on placebo , the presence of a positive DST predicted a statistically significantly poorer response to placebo as opposed to a negative DST . These preliminary findings suggest that for depressed individuals who present with a positive DST , remission without active medication is less likely and somatic treatment should be considered",
"& NA ; Escitalopram was compared to placebo in moderately to severely depressed patients in primary care with citalopram as the active reference . Patients were r and omized to receive flexible doses of 10–20 mg/day escitalopram ( n=155 ) , 20–40 mg/day citalopram ( n=160 ) , or placebo ( n=154 ) over an 8‐week double‐blind period . The primary efficacy parameter was the change from baseline to last assessment in the Montgomery – Asberg Depression Rating Scale total score . Escitalopram produced a statistically significant therapeutic difference of 2.9 points ( P=0.002 ) compared to placebo , and escitalopram was consistently and statistically significantly more efficacious than placebo from week 1 onwards . Analysis of Clinical Global Impression – Severity and Clinical Global Impression – Improvement confirmed the primary efficacy results . By week 8 , significantly more patients had responded to treatment with escitalopram than with citalopram ( P=0.021 ) or placebo ( P=0.009 ) . Escitalopram was as well tolerated as citalopram and had a similar adverse event profile . Both escitalopram‐ and citalopram‐treated patients had placebo‐level adverse event withdrawal rates ( 3 % and 4 % , respectively ) . This study demonstrates the consistent antidepressant efficacy and excellent tolerability of escitalopram 10–20 mg/day in primary care patients with major depressive disorder",
"OBJECTIVE Management of depression in elderly patients presents a significant medical challenge , and there is a need for further clinical trials . The authors examined the efficacy and tolerability of escitalopram and fluoxetine versus placebo in the treatment of elderly patients with major depressive disorder ( MDD ) . METHODS This was an 8-week , r and omized , double-blind comparison of the efficacy and tolerability of escitalopram ( 10 mg/day ) and fluoxetine ( 20 mg/day ) , to placebo in elderly patients with MDD . The prospect ively defined primary efficacy parameter was the change from baseline in mean Montgomery-Asberg Depression Rating Scale ( MADRS ) total score at endpoint , using last observation carried forward . RESULTS The intent-to-treat set comprised 517 patients ; the escitalopram group included 173 patients ; fluoxetine , 164 patients ; and placebo , 180 patients . Mean age was 75 years , with a range of 65 to 93 . Formally , this was a \" failed study \" ( i.e. , neither active treatment was superior to placebo ) , and the efficacy results should , therefore , be interpreted with caution . On the basis of the primary efficacy parameter , fluoxetine showed significantly lower efficacy than both escitalopram and placebo , which were not significantly different from each other . Rates of withdrawal because of adverse events/lack of efficacy were : placebo ( 2.8%/4.4 % , respectively ) , escitalopram ( 9.8%/1.7 % , respectively ) , and fluoxetine ( 12.2%/1.8 % , respectively ) . No single adverse event occurred at an incidence > or = 10 % in escitalopram-treated patients . CONCLUSIONS Both escitalopram and fluoxetine were well tolerated by elderly patients with MDD . Neither demonstrated superior efficacy on primary endpoint versus placebo",
"ABSTRACT Objective : The goal of a non-inferiority study is to test whether a new treatment has at least as much efficacy as an established treatment1 . The purpose of this non-inferiority study was to compare the speed of onset of antidepressant efficacy for duloxetine ( a dual serotonin and norepinephrine reuptake inhibitor ) and escitalopram ( a selective serotonin reuptake inhibitor ) . Research design and methods : This was a r and omized , double-blind , placebo- and active comparator-controlled study , in which patients ( ≥ 18 years ) meeting DSM‑IV criteria for Major Depressive Disorder ( MDD ) received duloxetine 60 mg once daily ( QD ; N = 273 ) , escitalopram 10 mg QD ( N = 274 ) , or placebo ( N = 137 ) for 8 weeks . The primary objective was to compare the onset of antidepressant efficacy , by testing the hypothesis that the percentage of duloxetine-treated patients achieving onset criteria at Week 2 was not inferior to that in the escitalopram group . Main outcome measures : Onset of efficacy was defined as a 20 % decrease from baseline on the 17‑item Hamilton Rating Scale for Depression ( HAMD17 ) Maier subscale that was maintained or exceeded at all subsequent visits . Results : Probabilities of meeting onset criteria at Week 2 for duloxetine- and escitalopram-treated patients were 42.6 % versus 35.2 % , respectively ( treatment difference = 7.4 % ; 95 % confidence interval , –1.3 % to 16.2 % ; p = 0.097 ) . Both drugs showed significant improvement compared with placebo ( p ≤ 0.05 ) on the primary efficacy measure ( Maier subscale ) at Week 1 and endpoint ( Week 8) . No differences were found between duloxetine , escitalopram , and placebo rates of remission or response at 8 weeks . Adverse events that occurred significantly more frequently among duloxetine-treated patients when compared with those receiving escitalopram were nausea , dry mouth , vomiting , yawning , and irritability . The rate of discontinuation due to adverse events did not differ significantly between treatment groups . Limitations : Given the difficulties in constructing appropriate dose comparisons , the results of this study should be interpreted specific to the doses tested and not extrapolated to the drug as a whole . This study employed a fixed-dose design ; flexible-dose design s are more likely to find a difference between antidepressants and placebo . Conclusion : In this study , both duloxetine and escitalopram showed significantly greater improvement on the primary efficacy measure than placebo over the 8‑week acute treatment period , while no differences were observed between drugs or between drugs and placebo on response and remission rates at 8 weeks . Escitalopram at a starting dose of 10 mg QD was better tolerated than duloxetine at a starting dose of 60 mg QD . This study met its pre-defined primary objective of assessing if duloxetine was non-inferior to escitalopram in antidepressant onset efficacy , and the results show that duloxetine is at least as fast as ( non-inferior to ) escitalopram . Trial registration : Clinical Trials.gov identifier : NCT00073411",
"OBJECTIVE To examine the comparative antidepressant efficacy of S-adenosyl-L-methionine ( SAMe ) and escitalopram in a placebo-controlled , r and omized , double-blind clinical trial . METHOD One hundred eighty-nine out patients ( 49.7 % female , mean [ SD ] age = 45 [ 15 ] years ) with DSM-IV-diagnosed major depressive disorder ( MDD ) were recruited from April 13 , 2005 , to December 22 , 2009 , at the Massachusetts General Hospital and at Butler Hospital . Patients were r and omized for 12 weeks to SAMe 1,600 - 3,200 mg/d , escitalopram 10 - 20 mg/d , or placebo . Doses were escalated at 6 weeks in the event of nonresponse . The main outcome measure was the 17-item Hamilton Depression Rating Scale ( HDRS-17 ) . Tolerability was assessed by the Systematic Assessment for Treatment of Emergent Events-Specific Inquiry ( SAFTEE-SI ) . RESULTS All 3 treatment arms demonstrated a significant improvement of about 5 - 6 points in HDRS-17 scores ( P .05 for all ) . Response rates in the intent-to-treat sample were 36 % for SAMe , 34 % for escitalopram , and 30 % for placebo . Remission rates were 28 % for SAMe , 28 % for escitalopram , and 17 % for placebo . No comparisons between treatment groups attained significance ( P > .05 for all ) . Tolerability was good , with gastrointestinal side effects ( 19 % for stomach discomfort and 20 % for diarrhea ) as the most common in the SAMe arm . Significant differences were observed between treatment groups for dizziness , anorgasmia , diminished mental acuity , and hot flashes ( P SAMe or the st and ard treatment escitalopram for MDD . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00101452",
"Fluvoxamine , a selective serotonin reuptake inhibitor , was investigated in a 6-week double-blind study among severely ill in patients with DSM-III major depression . All but 1 patient also fulfilled criteria for melancholia . Following a 3-day placebo wash-out patients were r and omly assigned to fluvoxamine , imipramine or placebo . Sixty of 81 patients completed at least 2 weeks following wash-out and were evaluated for efficacy . Analysis of covariance ( controlling for baseline scores ) showed significant ( p less than 0.05 ) differences on CGI severity and BPRS total and a similar trend ( p = 0.08 ) on the Hamilton Depression Scale . Fluvoxamine was superior ( p less than or equal to 0.02 ) to both placebo and imipramine on these measures . Fluvoxamine 's most common adverse effects were nausea and agitation . The number of fluvoxamine patients withdrawn for side-effects was less than imipramine and not significantly different than placebo . Fluvoxamine was not associated with significant changes in vital signs , ECG or laboratory tests . The results therefore indicate that fluvoxamine is a safe and highly effective treatment for hospitalized patients with major depression",
"BACKGROUND The selective serotonergic medication fluoxetine has demonstrated efficacy in the treatment of major depression and has suggested efficacy in the treatment of alcoholism . However , no completed trials with any selective serotonergic medication have been reported in patients who display both major depression and alcoholism , despite previous observations that both depression and alcoholism are associated with low serotonergic functioning . METHODS Fifty-one patients diagnosed as having comorbid major depressive disorder and alcohol dependence were r and omized to receive fluoxetine ( n = 25 ) or placebo ( n = 26 ) in a 12-week , double-blind , parallel-group trial . Weekly ratings of depression and alcohol consumption were obtained throughout the 12-week course of the study . RESULTS The improvement in depressive symptoms during the medication trial was significantly greater in the fluoxetine group than in the placebo group . Total alcohol consumption during the trial was significantly lower in the fluoxetine group than in the placebo group . CONCLUSIONS Fluoxetine is effective in reducing the depressive symptoms and the alcohol consumption of patients with comorbid major depressive disorder and alcohol dependence . It is unknown whether these results generalize to the treatment of less depressed and less suicidal alcoholics",
"Abstract Despite the high rate of co-occurrence of major depression and alcohol dependence , the role of pharmacotherapy in their treatment remains unclear . In the new era of naltrexone for alcohol dependence , it is notable that only 1 study to date has examined the efficacy of antidepressant medication prescribed concurrently with naltrexone . We aim ed to determine whether combining naltrexone with citalopram produced better treatment outcomes than naltrexone alone in patients with co-occurring alcohol dependence and depression , and to investigate whether either sex or depression type ( independent or substance-induced depression ) moderated treatment response . Participants were 138 depressed alcohol-dependent adults who were not required to be abstinent at the commencement of the trial . They were r and omized to 12 weeks of citalopram or placebo , plus naltrexone and clinical case management . Treatment was well attended , and medications were reasonably well tolerated with high adherence rates . Substantial improvements in both mood and drinking occurred in both groups , with no significant differences between groups on any of the mood or drinking outcome measures , whether or not other variables were controlled for . No interaction effect was found for independent/substance-induced depression status , whereas there was a marginal effect found by sex , with greater improvement in 1 drinking outcome measure ( percent days abstinent ) in women taking citalopram . These findings suggest that citalopram is not a clinical ly useful addition to naltrexone and clinical case management in this treatment population . Independent/substance-induced depression status did not predict treatment response . Findings for sex were equivocal",
"Paroxetine is a phenylpiperidine compound that selectively inhibits neuronal serotonin uptake in man . In this study , the efficacy of paroxetine was compared with that of placebo in the treatment of 66 out patients with the diagnosis of moderate-to-severe major depression . The research was a 6-week , prospect i ve , double-blind design after a 1-week placebo baseline phase . Paroxetine was associated with a consistent pattern of greater improvement on the primary efficacy scales , but the differences were not statistically significant . Paroxetine did produce significantly greater improvement than placebo for patients whose illness had lasted more than 1 year , and there was a significant reduction in suicidal ideation . Significantly fewer dropouts were due to lack of efficacy in those patients treated with paroxetine compared with those in the placebo group . Paroxetine was well tolerated . There was no difference between paroxetine and placebo in the rate of adverse effects or in the number of patients who dropped out because of adverse effects",
"A double-blind , placebo- and amitriptyline-controlled comparison study was performed to evaluate the antidepressant efficacy of sertraline , a specific serotonin uptake inhibitor . Patients with DSM-III-defined major depression r and omly received either sertraline ( N = 149 ) , amitriptyline ( N = 149 ) , or placebo ( N = 150 ) once daily for the 8-week study period . The mean final daily medication dose for the all- patients group was 145 mg and 104 mg for the sertraline- and amitriptyline-treatment groups , respectively . As measured by the Hamilton Rating Scale for Depression and the Clinical Global Impressions Scale , both the sertraline and amitriptyline treatment groups showed a significantly greater improvement from baseline ( p less than or equal to .001 ) than the placebo group . The sertraline group had a higher proportion of gastrointestinal complaints and male sexual dysfunction than either the amitriptyline or the placebo group . The amitriptyline group showed a higher proportion of anticholinergic and sedative side effects and dizziness compared with patients who received either sertraline or placebo",
"Paroxetine is a selective serotonin reuptake inhibitor which is being developed as an antidepressant . Previous studies suggest it is effective in the treatment of depression and has a low incidence of side effects . The authors report on a 6-week , r and omized , prospect i ve trial of paroxetine , imipramine , and placebo in 120 out patients with major depression . The results showed that paroxetine was significantly superior to placebo in relieving depression . There were no significant differences in antidepressant efficacy between paroxetine and imipramine . However , paroxetine was also significantly superior to placebo on several measures of anxiety . Imipramine either was not superior on these measures or took longer to show a significant difference . Paroxetine lacked the typical anticholinergic side effects that accompanied imipramine therapy . The results show that paroxetine is an effective antidepressant that may have value especially when depression is accompanied by significant anxiety",
"Paroxetine is an investigational antidepressant that acts through selective inhibition of serotonin reuptake at the synapse . In this study , 81 out patients with major depression according to DSM-III criteria were treated with either paroxetine or placebo in a 6-week , r and omized , double-blind study . Paroxetine was significantly superior to placebo on all major efficacy variables , including depression as well as anxiety , cognitive disturbance , insomnia , psychomotor retardation , and sleep disturbance . Significant differences in favor of paroxetine were apparent by Week 2 . Paroxetine was also well tolerated . The results support the efficacy and safety of paroxetine as a treatment for patients with major depression",
"We evaluated the dexamethasone suppression test ( DST ) as a predictor of response to drugs and placebo in 105 patients , in a large double-blind placebo-controlled out-patient trial to determine the efficacy of paroxetine HCl , a selective serotonin reuptake inhibitor , compared with that of imipramine HCl and placebo . The presence of a positive or negative DST did not predict response to either paroxetine or imipramine . However , a positive DST predicted a poorer response to placebo : only 3 out of 18 patients who showed DST non-suppression responded to placebo , as opposed to 11 out of 21 who exhibited DST suppression ( P less than 0.05 ) . A positive DST was associated with a 61 % response to drugs and a 16 % response to placebo . This finding suggests that the presence of a positive DST implies the need for active somatic treatment ",
"In a double-blind multi-centre study of general practice patients with DSM-III-R major depressive disorder , sertraline ( 50 or 100 mg/day ) was compared with dothiepin ( 75 or 150 mg/day ) and with placebo . There were 83 , 96 and 90 patients evaluated in the respective treatment groups ; treatment lasted 6 weeks . Patients were assessed on the MADRS , CGI , and Leeds Self-rating Scales . Statistically significant differences ( p sertraline and placebo were found on MADRS and CGI but not the Leeds Scales . In the mild subgroup analyses , there were no significant differences between sertraline and placebo . However , clear significant differences ( p sertraline and placebo were present in the severe subgroup . Dothiepin failed to achieve a statistically significant difference from placebo on any analyses . Seventy-six per cent of patients were treated with 50 mg sertraline and 81 % of patients received 150 mg dothiepin . Both sertraline and dothiepin were generally well tolerated ; the most frequent side effects with sertraline were nausea , dizziness and headache ; with dothiepin the most frequent side effects were dry mouth , somnolence and headache",
"Sexual dysfunction , a frequently reported side effect of many antidepressants , may result in patient dissatisfaction and noncompliance with treatment regimens . This paper describes the results of the first placebo-controlled comparison of the efficacy , safety , and effects on sexual functioning of sustained-release bupropion ( bupropion SR ) and the selective serotonin reuptake inhibitor sertraline . This r and omized , double-masked , double-dummy , parallel-group , multicenter trial enrolled 360 patients with moderate-to-severe recurrent major depression . Patients were treated with bupropion SR 150 to 400 mg/d , sertraline 50 to 200 mg/d , or placebo for up to 8 weeks . Patients ' depression and sexual functioning were assessed at weekly or biweekly clinic visits ; safety was assessed by regular monitoring of adverse events , vital signs , and body weight . Treatment groups were similar at baseline in terms of age , sex , and race , and most patients had a diagnosis of moderate uncomplicated depression . Patients treated with bupropion SR or sertraline showed similar improvements on all efficacy measures ; both active treatments were superior to placebo in improving scores on all rating scales for depression at various time points . Significantly more patients treated with sertraline experienced orgasmic dysfunction throughout the study than did patients treated with bupropion SR or placebo ( P Headache was the most frequently reported adverse event in all 3 treatment groups and occurred with similar frequency in each group ( 30 % to 40 % ) . Nausea ( 31 % ) , diarrhea ( 26 % ) , insomnia ( 18 % ) , and somnolence ( 17 % ) occurred in significantly more patients in the sertraline group than in the bupropion SR group ( 18 % , 7 % , 13 % , and 3 % , respectively ) and the placebo group ( 10 % , 11 % , 4 % , and 6 % , respectively ) . Dry mouth occurred more frequently with bupropion SR ( 19 % ) than with sertraline ( 14 % ) or placebo ( 12 % ) , although the differences were not significant . Changes in vital signs were similar in all groups . Similar ( small , but not statistically significant ) decreases in mean body weight were seen in both the bupropion SR ( -1.06 kg ) and sertraline ( -0.79 kg ) groups , whereas the placebo group experienced a minor increase ( 0.21 kg ) . Although bupropion SR and sertraline were similarly well tolerated and effective in the treatment of depression , sertraline treatment was more often associated with sexual dysfunction and certain other adverse events compared with bupropion SR and placebo . Therefore , bupropion SR may be an appropriate choice as an antidepressant for the treatment of sexually active patients",
"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",
"BACKGROUND Depression is common among recently abstinent alcoholics ; however , its treatment has been little studied . METHODS Thirty-six depressed recently abstinent alcoholics were r and omized in a 6-week double-blind placebo-controlled trial of sertraline 100 mg daily . RESULTS There was a significant group x time interaction for both the Hamilton Depression Rating Scale ( HDRS ) and the Beck Depression Inventory ( BDI ) . For the HDRS there were significant differences between the sertraline and placebo groups at weeks 3 and 6 and for the BDI at week 3 . Also , patients receiving sertraline had significantly lower mean posttreatment HDRS and BDI scores than patients receiving placebo . Furthermore , significantly more of the patients receiving sertraline obtained a Clinical Global Impression rating of \" very much improved . \" CONCLUSIONS Depressed recently abstinent alcoholics benefit from antidepressant medication",
"The authors employed a double-blind , placebo-controlled design to investigate the effectiveness of fluvoxamine versus imipramine in 54 out patients with moderate major depression . Fluvoxamine proved superior to placebo but not to imipramine on the Hamilton Rating Scale for Depression and the Montgomery and Asberg Depression Rating Scale . Nausea and hyperarousal were the most common side effects in the fluvoxamine-treated patients",
"Background Cocaine dependence is a major public health problem with no available robustly effective pharmacotherapy . This study ’s aim was to determine if treatment with sertraline ( SERT ) or SERT plus gabapentin ( GBP ) improved treatment retention , depressive symptoms , and /or cocaine use . Methods Depressed cocaine-dependent patients ( N = 99 ) were enrolled in a 12-week , double-blind , r and omized , placebo (PLA)-controlled , clinical trial and placed in research beds at a residential treatment facility ( Recovery Centers of Arkansas ) . They were r and omized by depressive symptom severity and inducted onto 1 of the following while residing at the Recovery Centers of Arkansas : SERT ( 200 mg/d ) , SERT ( 200 mg/d ) plus GBP ( 1200 mg/d ) , or PLA . Participants transferred to outpatient treatment at the start of their third week , continued receiving study medications or PLA ( weeks 3–12 ) , and participated in weekly individual cognitive behavioral therapy . Compliance was facilitated through the use of contingency management procedures . Supervised urine sample s were obtained thrice weekly and self-reported mood weekly . At the end of 12 weeks , participants were tapered off the study medication over 5 days and referred to a local treatment program . Results Sertraline , but not SERT plus GBP , showed a significantly lower overall percentage of cocaine-positive urine sample s compared with that of PLA . A significantly greater percentage of participants experienced relapse in the PLA group ( 88.9 % ) compared with that of the SERT group ( 65.2 % ) . Hamilton depression ratings decreased significantly over time regardless of the treatment group . Retention in treatment did not differ significantly between the treatment groups . Conclusions Sertraline plus GBP may not be superior to SERT alone in delaying relapse among abstinent cocaine-dependent individuals undergoing cognitive behavioral therapy",
"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",
"Paroxetine is a novel antidepressant that selectively inhibits neuronal reuptake of serotonin . Results are reported from a 6-week , double-blind trial of paroxetine , imipramine , and placebo in 120 out patients with DSM-III major depression . Paroxetine was significantly superior to placebo on almost all measures . This included the main outcome variable , the Hamilton Rating Scale for Depression ( HAM-D ) , and its factor scores , anxiety-somatization , cognitive disturbance , psychomotor retardation , and sleep disturbance . There were no significant differences between paroxetine and imipramine on the same scales . Imipramine-treated patients were significantly more likely than those taking placebo to report one or more adverse effects , which were predominantly anticholinergic in nature . There was no significant difference in the number of paroxetine and placebo patients who reported one or more adverse effects . The results of this and similar studies indicate that paroxetine is an effective treatment in major depression and has a favorable side effect profile",
"Results from a single-center , 6-week , double-blind , r and omized prospect i ve study of paroxetine , a selective serotonin reuptake inhibitor ; imipramine ; and placebo are reported . One hundred twenty out patients with a moderate-to-severe DSM-III diagnosis of major depression were r and omly assigned to one of the three treatments following a 4- to 10-day single-blind placebo washout period . Significant differences favoring paroxetine over placebo were present at endpoint on most major efficacy measures . Paroxetine was also well tolerated ; 5 ( 15 % ) paroxetine and 5 ( 14 % ) placebo patients dropped out of the study due to adverse effects . Imipramine , however , was comparatively poorly tolerated . Forty-five percent of imipramine-treated patients ( N = 17 ) dropped out of the study due to adverse effects . None of the efficacy measures showed a significant difference between imipramine and placebo . This finding was probably due to the high number of imipramine patients who discontinued before they could improve . These results support the efficacy of paroxetine in the treatment of major depression and underline its favorable side effect profile compared with tricyclic antidepressants",
"INTRODUCTION Flibanserin , a novel 5-HT(1A ) agonist and 5-HT(2A ) antagonist , has the potential to treat sexual dysfunction . AIM Provide historical perspective on the rationale for development of flibanserin to treat sexual dysfunction , based on post hoc analyses of data . MAIN OUTCOME MEASURES The Arizona Sexual Experiences ( ASEX ) scale and the Hamilton depression rating scale ( HAMD ) Genital Symptoms item . METHODS Sexual function outcomes are presented from four double-blind , r and omized controlled studies involving a total of 369 men and 523 women diagnosed with Major Depressive Disorder . Each study had an active treatment arm to confirm assay sensitivity on the primary antidepressive endpoint . Two studies placebo , flibanserin ( 50 mg bid ) , or fluoxetine ( 20 mg qd ) for 6 weeks and two involved placebo , flibanserin ( 50 - 100 mg bid ) , or paroxetine ( 20 - 40 mg qd ) for 8 weeks . RESULTS Individual study completion rates were 77 - 80 % . At baseline , 38 % of men and 67 % of women reported sexual dysfunction . Assay sensitivity was not demonstrated in the fluoxetine trials and sexual function outcomes were inconsistent . Flibanserin and placebo were associated with low rates of treatment-emergent sexual dysfunction in women during the paroxetine studies . In one study , 70 % of flibanserin-treated women with baseline sexual dysfunction reported improvement in sexual function , compared with 30 % of placebo-treated women . Mean change from baseline on the HAMD \" Genital Symptoms \" item in one paroxetine study was significantly better among flibanserin- than placebo-treated women at weeks 4 , 6 , and 8 ( P Sexual function adverse events across flibanserin groups were generally comparable to placebo . CONCLUSIONS Although these studies were not design ed or powered to compare sexual function outcomes , results suggested a potential benefit of flibanserin on sexual function , particularly on female sexual desire , and provided a rationale to evaluate the efficacy of flibanserin as a treatment for female hypoactive sexual desire disorder",
"Meta-analyses indicate that antidepressants are superior to placebos in statistical terms , but the clinical relevance of the differences has not been established . Previous suggestions of clinical ly relevant effect sizes have not been supported by empirical evidence . In the current paper we apply an empirical method that consists of comparing scores obtained on the Hamilton rating scale for depression ( HAM-D ) and scores from the Clinical Global Impressions-Improvement ( CGI-I ) scale . This method reveals that a HAM-D difference of 3 points is undetectable by clinicians using the CGI-I scale . A difference of 7 points on the HAM-D , or an effect size of 0.875 , is required to correspond to a rating of ' minimal improvement ' on the CGI-I. By these criteria differences between antidepressants and placebo in r and omised controlled trials , including trials conducted with people diagnosed with very severe depression , are not detectable by clinicians and fall far short of levels consistent with clinical ly observable minimal levels of improvement . Clinical significance should be considered alongside statistical significance when making decisions about the approval and use of medications like antidepressants",
"BACKGROUND Antidepressant efficacy may be compromised by early discontinuation of treatment secondary to common , treatment-emergent side effects , including nausea , agitation , and somnolence . Paroxetine controlled-release ( CR ) was developed to improve general tolerability and , in particular , gastrointestinal tolerability . OBJECTIVE To determine the antidepressant efficacy and tolerability of paroxetine CR in adult patients 18 to 65 years of age with DSM-IV major depressive disorder . METHOD Paroxetine CR ( 25 - 62.5 mg/day ; N = 212 ) and paroxetine immediate-release ( IR ; 20 - 50 mg/day ; N = 217 ) were compared with placebo ( N = 211 ) in the pooled data set from 2 identical , double-blind , 12-week clinical trials . RESULTS Both paroxetine CR and paroxetine IR exhibited efficacy in major depressive disorder as assessed by the reduction in 17-item Hamilton Rating Scale for Depression total score compared with placebo . Moreover , depressed mood and psychic anxiety symptoms improved as early as treatment week 1 in the paroxetine CR group compared with the placebo group . After 6 weeks of treatment , response and remission rates were 41.5 % and 20.5 % for placebo , 52.8 % and 29.6 % for paroxetine IR , and 58.9 % and 34.4 % for paroxetine CR , respectively . After 12 weeks of treatment , response and remission rates were 61.2 % and 44.0 % for placebo , 72.9 % and 52.5 % for paroxetine IR , and 73.7 % and 56.2 % for paroxetine CR , respectively . Rates of nausea were significantly lower for paroxetine CR ( 14 % ) than for paroxetine IR ( 23 % ; p Rates of dropout due to adverse events were comparable between paroxetine CR and placebo , while significantly ( p = .0008 ) more patients treated with paroxetine IR withdrew from the study prematurely compared with those treated with placebo . CONCLUSION Paroxetine CR is an effective and well-tolerated antidepressant exhibiting symptomatic improvement as early as week 1 . Paroxetine CR is associated with low rates of early-onset nausea and dropout rates due to adverse events comparable to those of placebo . The clinical improvement seen with paroxetine CR , coupled with its favorable adverse event profile , suggests a benefit for therapeutic outcome with paroxetine CR",
" A total of 149 patients in 7 centers in Denmark , Norway and Sweden entered a 6‐week double‐blind trial intended to assess the antidepressant effect and safety of citalopram vs placebo in depressed elderly patients ( 65 years of age or older ) who might also suffer from somatic disorders and /or senile dementia . Results of ratings on the Hamilton Rating Scale for Depression , the Montgomery‐Åsberg Depression Rating Scale and the Clinical Global Impression Scale provided consistent evidence that the citalopram‐treated patients improved more than the placebo‐treated patients . Results of ratings on the Gottfries‐Bråne‐Steen dementia rating scale indicated that both cognitive and emotional functioning improved significantly more in the citalopram‐treated subgroup of patients with dementia than in the placebo‐treated subgroup",
"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",
"Paroxetine , a phenylpiperidine derivative , is an antidepressant that selectively inhibits serotonin reuptake . In this study 111 out patients with major depression diagnosed by DSM-III criteria were treated with either paroxetine or placebo in a 6-week , r and omized , double-blind study . Paroxetine was significantly superior to placebo on six of the seven major efficacy variables . Significant differences in favor of paroxetine were apparent by Week 2 . Paroxetine was also well tolerated . These results support the efficacy and safety of paroxetine as a treatment for patients with major depression",
" Aprepitant is a neurokinin 1 receptor antagonist approved for prevention of chemotherapy‐induced and post‐operative nausea and vomiting . Early studies demonstrated promising antidepressant activity as monotherapy , although this was unsupported by subsequent phase 3 trials . This phase 2 study evaluated whether aprepitant potentiated the antidepressant effects of paroxetine",
"The objective of this study was to compare venlafaxine and fluoxetine with placebo in treating major depressive disorder with melancholic features . Adult in patients with Diagnostic and Statistical Manual of Mental Disorders , fourth edition major depressive disorder with melancholia and 21-item Hamilton Depression Rating Scale ( HAM-D21 ) scores ≥24 ( n=289 ) were r and omized to receive ( double-blind ) venlafaxine 225–375 mg/day , fluoxetine 60–80 mg/day , or placebo for 6 weeks . The primary outcome measures were HAM-D21 total score , HAM-D depressed mood item , Montgomery Åsberg Depression Rating Scale total score and the Clinical Global Impressions-Severity ( CGI-S ) and Improvement ( CGI-I ) scores . Last observation carried forward ( LOCF ) was the primary analysis method . In the LOCF analysis , venlafaxine was statistically superior to placebo on the CGI-S ( venlafaxine −1.7 , placebo −1.1 ; P=0.003 ) and the HAM-D depressed mood item ( venlafaxine −1.6 , placebo −1.1 ; P=0.010 ) ; and to fluoxetine on the CGI-S ( −1.2 ; P=0.012 ) . No significant differences were observed on the other 12 LOCF primary efficacy comparisons . Increases in pulse and blood pressure , dry mouth , constipation , and lightheadedness were significantly more common with venlafaxine than fluoxetine . Venlafaxine was statistically superior to placebo on two of five primary and two of five secondary outcome measures and to fluoxetine on one primary and one secondary outcome measure ( LOCF ) . Venlafaxine was not superior to fluoxetine or placebo in providing remission",
"Published evidence suggests that aspects of trial design lead to biased intervention effect estimates , but findings from different studies are inconsistent . This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials . Outcome measures were classified as \" mortality , \" \" other objective , \" \" or subjective , \" and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity . Intervention effect estimates seemed to be exaggerated in trials with inadequate or unclear ( vs. adequate ) r and om-sequence generation ( ratio of odds ratios , 0.89 [ 95 % credible interval { CrI } , 0.82 to 0.96 ] ) and with inadequate or unclear ( vs. adequate ) allocation concealment ( ratio of odds ratios , 0.93 [ CrI , 0.87 to 0.99 ] ) . Lack of or unclear double-blinding ( vs. double-blinding ) was associated with an average of 13 % exaggeration of intervention effects ( ratio of odds ratios , 0.87 [ CrI , 0.79 to 0.96 ] ) , and between-trial heterogeneity was increased for such studies ( SD increase in heterogeneity , 0.14 [ CrI , 0.02 to 0.30 ] ) . For each characteristic , average bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes , with little evidence of bias in trials with objective and mortality outcomes . This study is limited by incomplete trial reporting , and findings may be confounded by other study design characteristics . Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes"
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4117dcfa-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES Orthostatic hypotension is a common condition among older adults and is associated with a range of deleterious outcomes . Recently , interest has developed in hypovitaminosis D ( defined as low 25 hydroxiyvitamin D levels ) as a potential risk factor for orthostatic hypotension . We conducted a systematic review and meta- analysis examining the association of orthostatic hypotension between study participants with and without hypovitaminosis D , including the adjustment of potential confounders ( age , sex , BMI , renal function , comorbidities , seasonality , use of antihypertensive medications , and supplementation with cholecalciferol ) . METHODS A systematic literature search of major electronic data bases from inception until 09/2015 was made for articles providing data on orthostatic hypotension and hypovitaminosis D. A r and om effects meta- analysis of cross-sectional studies investigating orthostatic hypotension prevalence comparing participants with vs. those without hypovitaminosis D was undertaken , calculating the odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) . RESULTS Of 317 initial hits , five cross-sectional studies were meta-analysed including 3646 participants ( 1270 with hypovitaminosis D and 2376 without ) . The participants with hypovitaminosis D had a higher prevalence of orthostatic hypotension ( OR = 1.88 ; 95 % CI : 1.25 - 2.84 ; I = 68 % ) that was not affected by adjusting for a median of five potential confounders ( OR = 2.03 ; 95 % CI : 1.13 - 3.68 ; I = 73 % ) . People with orthostatic hypotension had significantly reduced serum vitamin D concentrations ( st and ardized mean difference = -0.42 ; 95 % CI : -0.72 to -0.12 ) . One longitudinal study confirmed the association between hypovitaminosis D and orthostatic hypotension . CONCLUSION Our meta- analysis highlights that hypovitaminosis D is associated with orthostatic hypotension , independent of potential confounders . Further longitudinal studies and clinical trials are required to confirm these findings
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[
"Previous prospect i ve cohort studies on the association between potassium intake and risk of hypertension have almost exclusively relied on self-reported dietary data , whereas repeated 24-hour urine excretions , as estimate of dietary uptake , may provide a more objective and quantitative estimate of this association . Risk of hypertension ( defined as blood pressure ≥140/90 mm Hg or initiation of blood pressure – lowering drugs ) was prospect ively studied in 5511 normotensive subjects aged 28 to 75 years not using blood pressure – lowering drugs at baseline of the Prevention of Renal and Vascular End-Stage Disease ( PREVEND ) study . Potassium excretion was measured in two 24-hour urine specimens at baseline ( 1997–1998 ) and midway during follow-up ( 2001–2003 ) . Baseline median potassium excretion was 70 mmol/24 h ( interquartile range , 57–85 mmol/24 h ) , which corresponds to a dietary potassium intake of ≈91 mmol/24 h. During a median follow-up of 7.6 years ( interquartile range , 5.0–9.3 years ) , 1172 subjects developed hypertension . The lowest sex-specific tertile of potassium excretion ( men : increased risk of hypertension after multivariable adjustment ( hazard ratio , 1.20 ; 95 % confidence interval , 1.05–1.37 ) , compared with the upper 2 tertiles ( Pnonlinearity=0.008 ) . The proportion of hypertension attributable to low potassium excretion was 6.2 % ( 95 % confidence interval , 1.7%–10.9 % ) . No association was found between the sodium to potassium excretion ratio and risk of hypertension after multivariable adjustment . Low urinary potassium excretion was associated with an increased risk of developing hypertension . Dietary strategies to increase potassium intake to the recommended level of 90 mmol/d may have the potential to reduce the incidence of hypertension",
"Summary Background Low circulating concentrations of 25-hydroxyvitamin D ( 25[OH]D ) , a marker of vitamin D status , are associated with an increased risk of type 2 diabetes , but whether this association is causal remains unclear . We aim ed to estimate the unconfounded , causal association between 25(OH)D concentration and risk of type 2 diabetes using a mendelian r and omisation approach . Methods Using several data sources from population s of European descent , including type 2 diabetes cases and non-cases , we did a mendelian r and omisation analysis using single nucleotide polymorphisms ( SNPs ) within or near four genes related to 25(OH)D synthesis and metabolism : DHCR7 ( related to vitamin D synthesis ) , CYP2R1 ( hepatic 25-hydroxylation ) , DBP ( also known as GC ; transport ) , and CYP24A1 ( catabolism ) . We assessed each SNP for an association with circulating 25(OH)D concentration ( 5449 non-cases ; two studies ) , risk of type 2 diabetes ( 28 144 cases , 76 344 non-cases ; five studies ) , and glycaemic traits ( concentrations of fasting glucose , 2-h glucose , fasting insulin , and HbA1c ; 46 368 non-cases ; study consortium ) . We combined these associations in a likelihood-based mendelian r and omisation analysis to estimate the causal association of 25(OH)D concentration with type 2 diabetes and the glycaemic traits , and compared them with that from a meta- analysis of data from observational studies ( 8492 cases , 89 698 non-cases ; 22 studies ) that assessed the association between 25(OH)D concentration and type 2 diabetes . Findings All four SNPs were associated with 25(OH)D concentrations ( p unconfounded odds ratio for type 2 diabetes was 1·01 ( 95 % CI 0·75–1·36 ; p=0·94 ) per 25·0 nmol/L ( 1 SD ) lower 25(OH)D concentration . The corresponding ( potentially confounded ) relative risk from the meta- analysis of data from observational studies was 1·21 ( 1·16–1·27 ; p=7·3 × 10−19 ) . The mendelian r and omisation-derived estimates for glycaemic traits were not significant ( p>0·25 ) . Interpretation The association between 25(OH)D concentration and type 2 diabetes is unlikely to be causal . Efforts to increase 25(OH)D concentrations might not reduce the risk of type 2 diabetes as would be expected on the basis of observational evidence . These findings warrant further investigations to identify causal factors that might increase 25(OH)D concentration and also reduce the risk of type 2 diabetes . Funding UK Medical Research Council Epidemiology Unit and European Union Sixth Framework Programme",
"Previous observational studies on the vascular effects of vitamin D have predominantly relied on measurement of its inactive precursor , 25-hydroxyvitamin D , whereas the active metabolite 1,25-dihydroxyvitamin D may be of more physiological relevance . We prospect ively studied the associations of 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D with hypertension risk ( blood pressure ≥140/90 mm Hg or initiation of blood pressure – lowering drugs ) in 5066 participants aged 28 to 75 years , free of hypertension at baseline from the Prevention of Renal and Vascular End-Stage Disease Study , a well-defined cohort with serial follow-up . We measured plasma 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D using liquid chromatography-t and em mass spectrometry . Mean±SD plasma concentration of 1,25-dihydroxyvitamin D was 145±47.0 pmol/L and 25-hydroxyvitamin D was 58.6±23.8 nmol/L. During a median follow-up of 6.4 years , 1036 participants ( 20.5 % ) developed hypertension . As expected , low 25-hydroxyvitamin D was associated with a higher hypertension risk ; each 1-SD decrement in 25-hydroxyvitamin D was associated with a 8 % higher hypertension risk ( hazard ratio , 1.08 ; 95 % confidence interval , 1.01–1.16 ) after adjustment for potential confounders . However , the association of 1,25-dihydroxyvitamin D was in the opposite direction ; each 1-SD decrement of 1,25-dihydroxyvitamin D was associated with a 10 % lower hypertension risk ( hazard ratio , 0.90 ; 95 % confidence interval , 0.84–0.96 ) , independent of potential confounders . In contrast to the inverse association between 25-hydroxyvitamin D and hypertension risk , 1,25-dihydroxyvitamin D was positively associated with risk of hypertension . Thus , higher circulating concentrations of 1,25-dihydroxyvitamin D are associated with a higher risk of hypertension "
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4117dd36-06ff-11f0-808a-c43d1ab1c353
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PURPOSE To systematic ally identify and review the currently available evidence on the long-term outcomes of recommended attention-deficit hyperactivity disorder ( ADHD ) interventions following r and omized controlled trials with children and young people . METHOD A systematic search was conducted to identify trials > 1 year in length using the following data bases : CINAHL ( January 1982- July 2012 ) , MEDLINE ( Ovid and Cambridge Scientific Abstract s [ CSA ] ) , Psych info , Science Direct ( Elsevier ) , and Cochrane Library . H and search es of key journals in the subject , book chapters , and conference proceedings were also carried out . Relevant papers were critically appraised using the Cochrane risk of bias tool . RESULTS Eight controlled trials were identified as being relevant , of duration ranging from 1 year to 8 years ( at follow up ) . The total number of participants in the studies was 1,057 , of whom 579 ( 54.7 % ) were from one cohort and included 26 different outcome measures . Results suggest there is moderate-to-high-level evidence that combined pharmacological and behavioral interventions , and pharmacological interventions alone can be effective in managing the core ADHD symptoms and academic performance at 14 months . However , the effect size may decrease beyond this period . CONCLUSION This review has highlighted the paucity and limitations of the evidence investigating the long-term outcomes of recommended interventions for managing ADHD symptoms . There is little evidence to suggest that the effects observed over the relatively short term are maintained throughout longer periods of impairment . Furthermore , much of the existing evidence examining effectiveness beyond 12 months does not include newer medications currently available or consider significant context ual and cultural differences , such as UK/European and Asian population s. Longitudinal studies are required to examine the long-term outcomes for children and young people with ADHD managed with currently recommended service interventions . They should also include the whole spectrum of ADHD , with its full range of coexisting conditions , and cultural and context ual diversity
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[
"Objective : To examine the rate of psychotic and mood-congruent psychotic side effects of stimulant medications in children treated for attention-deficit hyperactivity disorder ( ADHD ) . Method : A chart review was completed of all children diagnosed with ADHD in an outpatient clinic from January 1989 to March 1995 . Results : Over 5 years , 192 children were diagnosed with ADHD . Ninety-eight children received treatment at the clinic with stimulants . Six children developed psychotic or mood-congruent psychotic symptoms during treatment . Children on medication were followed for an average of 1 year and 9 months . Conclusions : Awareness of the potential for psychotic side effects from stimulant medications is important when prescribing for children . A large prospect i ve study would be useful to predict the frequency and classification of the side effects in children",
"BACKGROUND The effectiveness of a combined methylpheni date /behavioural treatment ( BT ) versus methylpheni date -only for Chinese children with Attention-Deficit/Hyperactivity Disorder ( ADHD ) was tested in routine clinical practice in Hong Kong . METHODS A r and omized group comparison design was adopted with two treatment conditions ( methylpheni date -only ; methylpheni date /BT ) , which lasted for 6 months . There were four assessment time points ( pre-treatment , post-treatment , and 6-month and 12-month follow-ups ) , using the Strengths and Weaknesses of ADHD Symptoms and Normal Behaviours ( SWAN ) Rating Scale . Parental attitude toward different treatment options of ADHD was also assessed at pre-treatment and post-treatment . Participants included 90 Chinese ADHD children ( mean age=8 years , SD=.95 ) . RESULTS The combination of BT and a low-dose methylpheni date was significantly more effective than methylpheni date -only in reducing ADHD and ODD symptoms at post-treatment . At follow-ups , the benefits of the combined treatment were maintained , while the methylpheni date -only group caught up in improvement in ADHD symptoms . Parents in both treatment conditions showed improved attitude toward medication after the 6-month treatment phase , while their attitude toward BT was positive all along . CONCLUSIONS This study supported the added benefits of BT , on top of medication , for Chinese ADHD children in routine practice with treatments conducted by regular medical and paramedical staffs",
"OBJECTIVE To test the hypotheses that in children with attention-deficit/hyperactivity disorder ( ADHD ) ( 1 ) symptoms of ADHD , oppositional defiant disorder , and overall functioning are significantly improved by methylpheni date combined with intensive multimodal psychosocial treatment compared with methylpheni date alone and with methylpheni date plus attention control and ( 2 ) more children receiving combined treatment can be taken off methylpheni date . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to ( 1 ) methylpheni date alone ; ( 2 ) methylpheni date plus psychosocial treatment that included parent training and counseling , social skills training , psychotherapy , and academic assistance , or ( 3 ) methylpheni date plus attention psychosocial control treatment . Assessment s included parent , teacher , and psychiatrist ratings , and observations in academic and gym classes . RESULTS Combination treatment did not lead to superior functioning and did not facilitate methylpheni date discontinuation . Significant improvement occurred across all treatments and continued over 2 years . CONCLUSIONS In stimulant-responsive children with ADHD , there is no support for adding ambitious long-term psychosocial intervention to improve ADHD and oppositional defiant disorder symptoms . Significant benefits from methylpheni date were stable over 2 years",
"OBJECTIVE In the intent-to-treat analysis of the Multimodal Treatment Study of Children With ADHD ( MTA ) , the effects of medication management ( MedMgt ) , behavior therapy ( Beh ) , their combination ( Comb ) , and usual community care ( CC ) differed at 14 and 24 months due to superiority of treatments that used the MTA medication algorithm ( Comb+MedMgt ) over those that did not ( Beh+CC ) . This report examines 36-month outcomes , 2 years after treatment by the study ended . METHOD For primary outcome measures ( attention-deficit/hyperactivity disorder [ ADHD ] and oppositional defiant disorder [ ODD ] symptoms , social skills , reading scores , impairment , and diagnostic status ) , mixed-effects regression models and orthogonal contrasts examined 36-month outcomes . RESULTS At 3 years , 485 of the original 579 subjects ( 83.8 % ) participated in the follow-up , now at ages 10 to 13 years , ( mean 11.9 years ) . In contrast to the significant advantage of MedMgt+Comb over Beh+CC for ADHD symptoms at 14 and 24 months , treatment groups did not differ significantly on any measure at 36 months . The percentage of children taking medication > 50 % of the time changed between 14 and 36 months across the initial treatment groups : Beh significantly increased ( 14 % to 45 % ) , MedMed+Comb significantly decreased ( 91 % to 71 % ) , and CC remained constant ( 60%-62 % ) . Regardless of their treatment use changes , all of the groups showed symptom improvement over baseline . Notably , initial symptom severity , sex ( male ) , comorbidity , public assistance , and parental psychopathology ( ADHD ) did not moderate children 's 36-month treatment responses , but these factors predicted worse outcomes over 36 months , regardless of original treatment assignment . CONCLUSIONS By 36 months , the earlier advantage of having had 14 months of the medication algorithm was no longer apparent , possibly due to age-related decline in ADHD symptoms , changes in medication management intensity , starting or stopping medications altogether , or other factors not yet evaluated",
"Fifty-two children ( ages 7 to 14 years ) with moderate mental retardation to borderline intellectual functioning were recontacted 12 to 65 months following participation in a double-blind , placebo-controlled trial of methylpheni date ( MPH ) . Sixty-nine percent of subjects continued to be prescribed medication for behavior control at follow-up . While 72 % of the sample evidence d improvement , over two-thirds continued to be rated at or above the 98th percentile on the Hyperactivity Index of the Parent Conners . In fact , 22 % of subjects had received inpatient psychiatric treatment between the time of the initial MPH trial and follow-up . Finally , subjects with high initial ratings on the Parent Conners Conduct Problems scale were more likely to be suspended from school or receive inpatient psychiatric treatment than subjects with low initial ratings . The results suggested that children with ADHD and mental retardation or borderline intellectual functioning continued to exhibit significant symptoms associated with attention deficit hyperactivity disorder ( ADHD ) at follow-up and that early conduct problems were predictive of continuing behavioral difficulties",
"We report a prospect i ve longitudinal study of 101 male adolescents ( ages 16 to 23 years ) who had been diagnosed hyperactive in childhood ( ages 6 to 12 years ) , compared with 100 normal controls . The DSM-III diagnoses were made blind to group membership . Information was obtained for 98 % of the original cohort . The full attention deficit disorder with hyperactivity ( ADDH ) syndrome persisted in 31 % of the prob and s vs in 3 % of the controls . The only other two conditions that distinguished the groups significantly were conduct and substance use disorders . These disorders aggregated significantly among the prob and s with continued ADDH . The results indicate that the greatest risk factor for the development of antisocial behavior and drug abuse is the maintenance of ADDH symptoms . Substance use disorders followed the onset of conduct disorder in the overwhelming majority of the cases",
"OBJECTIVE To test that methylpheni date combined with intensive multimodal psychosocial intervention , which includes social skills training , significantly enhances social functioning in children with attention-deficit/hyperactivity disorder ( ADHD ) compared with methylpheni date alone and methylpheni date plus nonspecific psychosocial treatment ( attention control ) . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to receive ( 1 ) methylpheni date alone , ( 2 ) methylpheni date plus multimodal psychosocial treatment that included social skills training , or ( 3 ) methylpheni date plus attention control treatment . Assessment s included parent , child , and teacher ratings of social function and direct school observations in gym . RESULTS No advantage was found on any measure of social functioning for the combination treatment over methylpheni date alone or methylpheni date plus attention control . Significant improvement occurred across all treatments and continued over 2 years . CONCLUSIONS In young children with ADHD , there is no support for clinic-based social skills training as part of a long-term psychosocial intervention to improve social behavior . Significant benefits from methylpheni date were stable over 2 years",
"CONTEXT Prospect i ve studies of childhood attention-deficit/hyperactivity disorder ( ADHD ) have not extended beyond early adulthood . OBJECTIVE To examine whether children diagnosed as having ADHD at a mean age of 8 years ( prob and s ) have worse educational , occupational , economic , social , and marital outcomes and higher rates of ongoing ADHD , antisocial personality disorder ( ASPD ) , substance use disorders ( SUDs ) , adult-onset psychiatric disorders , psychiatric hospitalizations , and incarcerations than non-ADHD comparison participants at a mean age of 41 years . DESIGN Prospect i ve , 33-year follow-up study , with masked clinical assessment s. SETTING Research clinic . PARTICIPANTS A total of 135 white men with ADHD in childhood , free of conduct disorder , and 136 men without childhood ADHD ( 65.2 % and 76.4 % of original cohort , respectively ) . MAIN OUTCOME MEASURES Occupational , economic , and educational attainment ; marital history ; occupational and social functioning ; ongoing and lifetime psychiatric disorders ; psychiatric hospitalizations ; and incarcerations . RESULTS Prob and s had significantly worse educational , occupational , economic , and social outcomes ; more divorces ; and higher rates of ongoing ADHD ( 22.2 % vs 5.1 % , P .001 ) , ASPD ( 16.3 % vs 0 % , P ( 14.1 % vs 5.1 % , P = .01 ) but not more mood or anxiety disorders ( P = .36 and .33 ) than did comparison participants . Ongoing ADHD was weakly related to ongoing SUDs ( ϕ = 0.19 , P = .04 ) , as well as ASPD with SUDs ( ϕ = 0.20 , P = .04 ) . During their lifetime , prob and s had significantly more ASPD and SUDs but not mood or anxiety disorders and more psychiatric hospitalizations and incarcerations than comparison participants . Relative to comparisons , psychiatric disorders with onsets at 21 years or older were not significantly elevated in prob and s. Prob and s without ongoing psychiatric disorders had worse social , but not occupational , functioning . CONCLUSIONS The multiple disadvantages predicted by childhood ADHD well into adulthood began in adolescence , without increased onsets of new disorders after 20 years of age . Findings highlight the importance of extended monitoring and treatment of children with ADHD",
"OBJECTIVE To test the hypothesis that multimodal psychosocial intervention , which includes parent training , combined with methylpheni date significantly enhances the behavior of parents of children with attention-deficit/hyperactivity disorder ( ADHD ) , compared with methylpheni date alone and compared with methylpheni date and nonspecific psychosocial treatment ( attention control ) . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date therapy were r and omized for 2 years to receive either ( 1 ) methylpheni date treatment alone ; ( 2 ) methylpheni date plus psychosocial treatment that included parent training and counseling , social skills training , academic assistance , and psychotherapy ; or ( 3 ) methylpheni date plus attention control treatment . Parents rated their knowledge of parenting principles and negative and positive parenting behavior . Children rated their parents ' behavior . RESULTS Psychosocial treatment led to significantly better knowledge of parenting principles but did not enhance parenting practice s , as rated by parents and children . Significant improvement in mothers ' negative parenting occurred across all treatments and was maintained . CONCLUSIONS In nonconduct-disordered , stimulant-treated children with ADHD , parent training does not improve self-rated parental behavior . The benefits of brief stimulant treatment for negative parental behavior are sustained with extended treatment",
"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",
"BACKGROUND Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder ( ADHD ) , but no longer-term ( i.e. , > 4 months ) investigations have compared these 2 treatments or their combination . METHODS A group of 579 children with ADHD Combined Type , aged 7 to 9.9 years , were assigned to 14 months of medication management ( titration followed by monthly visits ) ; intensive behavioral treatment ( parent , school , and child components , with therapist involvement gradually reduced over time ) ; the two combined ; or st and ard community care ( treatments by community providers ) . Outcomes were assessed in multiple domains before and during treatment and at treatment end point ( with the combined treatment and medication management groups continuing medication at all assessment points ) . Data were analyzed through intent-to-treat r and om-effects regression procedures . RESULTS All 4 groups showed sizable reductions in symptoms over time , with significant differences among them in degrees of change . For most ADHD symptoms , children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care . Combined and medication management treatments did not differ significantly on any direct comparisons , but in several instances ( oppositional/aggressive symptoms , internalizing symptoms , teacher-rated social skills , parent-child relations , and reading achievement ) combined treatment proved superior to intensive behavioral treatment and /or community care while medication management did not . Study medication strategies were superior to community care treatments , despite the fact that two thirds of community-treated subjects received medication during the study period . CONCLUSIONS For ADHD symptoms , our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication . Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms , but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes",
"The purpose of this investigation was to evaluate the relative efficacy of two consultation-based models for design ing academic interventions to enhance the educational functioning of children with attention-deficit/hyperactivity disorder ( ADHD ) . Children ( N=167 ) meeting DSM-IV criteria for ADHD were r and omly assigned to one of two consultation groups : Individualized Academic Intervention ( IAI ; interventions design ed using a data -based decision-making model that involved ongoing feedback to teachers ) and Generic Academic Intervention ( GAI ; interventions design ed based on consultant-teacher collaboration , representing “ consultation as usual ” ) . Teachers implemented academic interventions over 15 months . Academic outcomes ( e.g. , st and ardized achievement test , and teacher ratings of academic skills ) were assessed on four occasions ( baseline , 3 months , 12 months , 15 months ) . Hierarchical linear modeling analyses indicated significant positive growth for 8 of the 14 dependent variables ; however , trajectories did not differ significantly across consultation groups . Interventions in the IAI group were delivered with significantly greater integrity ; however , groups did not differ with respect to teacher ratings of treatment acceptability . The results of this study provide partial support for the effectiveness of consultation-based academic interventions in enhancing educational functioning in children with ADHD ; however , the relative advantages of an individualized model over “ consultation as usual ” have yet to be established",
"OBJECTIVE To compare delinquent behavior and early substance use between the children in the Multimodal Treatment Study of Children With ADHD ( MTA ; N = 487 ) and those in a local normative comparison group ( n = 272 ) at 24 and 36 months postr and omization and to test whether these outcomes were predicted by the r and omly assigned treatments and subsequent self-selected prescribed medications . METHOD Most MTA children were 11 to 13 years old by 36 months . Delinquency seriousness was coded ordinally from multiple measures /reporters ; child-reported substance use was binary . RESULTS Relative to local normative comparison group , MTA children had significantly higher rates of delinquency ( e.g. , 27.1 % vs. 7.4 % at 36 months ; p = .000 ) and substance use ( e.g. , 17.4 % vs. 7.8 % at 36 months ; p = .001 ) . Children r and omized to intensive behavior therapy reported less 24-month substance use than other MTA children ( p = .02 ) . R and om effects ordinal growth models revealed no other effects of initial treatment assignment on delinquency seriousness or substance use . By 24 and 36 months , more days of prescribed medication were associated with more serious delinquency but not substance use . CONCLUSIONS Cause- and -effect relationships between medication treatment and delinquency are unclear ; the absence of associations between medication treatment and substance use needs to be re-evaluated at older ages . Findings underscore the need for continuous monitoring of these outcomes as children with attention-deficit/hyperactivity disorder enter adolescence ",
"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",
"OBJECTIVE To evaluate the predictors of persistence and the timing of remission of attention-deficit hyperactivity disorder ( ADHD ) . METHOD Subjects were 6- to 17-year old Caucasian , non-Hispanic boys with and without ADHD . DSM-III-R structured diagnostic interviews and blind raters were used to examine psychiatric diagnoses , cognitive achievement , social , school , and family functioning at a 4-year follow-up assessment . RESULTS At the 4-year follow-up assessment , 85 % of children with ADHD continued to have the disorder and 15 % remitted . Of those who remitted , half did so in childhood and the other half in adolescence . Predictors of persistence were familiality of ADHD , psychosocial adversity , and comorbidity with conduct , mood , and anxiety disorders . CONCLUSIONS The findings prospect ively confirm that the majority of children with ADHD will continue to express the disorder 4 years later . For a minority of children , ADHD was a transient disorder that remits early in development . In addition , we have shown that persistence of ADHD is predictable . Familiality , adversity , and psychiatric comorbidity may be clinical ly useful predictors of which children with ADHD are at risk for a persistent disorder",
"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",
"The psychiatric outcome is reported for a large sample of hyperactive children ( N = 123 ) , meeting research diagnostic criteria , and normal control children ( N = 66 ) followed prospect ively over an 8-year period into adolescence . Over 80 % of the hyperactives were attention deficit hyperactivity disorder ( ADHD ) and 60 % had either oppositional defiant disorder and /or conduct disorder at outcome . Rates of antisocial acts were considerably higher among hyperactives than normals , as were cigarette and marijuana use and negative academic outcomes . The presence of conduct disorder accounted for much though not all of these outcomes . Family status of hyperactives was much less stable over time than in the normal subjects . The use of research criteria for diagnosing children as hyperactive identifies a pattern of behavioral symptoms that is highly stable over time and associated with considerably greater risk for family disturbance and negative academic and social outcomes in adolescence than has been previously reported",
"OBJECTIVE To test the hypothesis that intensive multimodal psychosocial intervention ( that includes academic assistance and psychotherapy ) combined with methylpheni date significantly enhances the academic performance and emotional status of children with attention-deficit/hyperactivity disorder ( ADHD ) compared with methylpheni date alone and with methylpheni date combined with nonspecific psychosocial treatment ( attention control ) . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to receive one of three treatments : ( 1 ) methylpheni date alone , ( 2 ) methylpheni date plus psychosocial treatment that included academic remediation , organizational skills training , and psychotherapy as well as parent training and counseling and social skills training , or ( 3 ) methylpheni date plus attention control treatment . Children 's function was assessed through academic testing , parent ratings of homework problems , and self-ratings of depression and self-esteem . RESULTS No advantage was found on any measure of academic performance or emotional status for the combination treatment over methylpheni date alone and over methylpheni date plus attention control . Significant improvement occurred across all treatments and was maintained over 2 years . CONCLUSIONS In stimulant-responsive young children with ADHD without learning and conduct disorders , there is no support for academic assistance and psychotherapy to enhance academic achievement or emotional adjustment . Significant short-term improvements were maintained over 2 years",
"OBJECTIVES To investigate the impact of early school-based screening and educational interventions on longer-term outcomes for children at risk for attention-deficit/hyperactivity disorder ( ADHD ) and the predictive utility of teacher ratings . DESIGN A population -based 5-year follow-up of a r and omized , school-based intervention . SETTING Schools in Engl and . PARTICIPANTS Children between 4 and 5 years of age with high teacher-rated hyperactivity/inattention scores . Follow-up data were collected on 487 children in 308 schools . INTERVENTIONS Following screening , using a 2 x 2 factorial design , schools r and omly received an educational intervention ( books about ADHD for teachers ) , the names of children with high hyperactivity/inattention scores between ages 4 and 5 years ( identification ) , both educational intervention and identification , or no intervention . OUTCOME MEASURES Parent-rated hyperactivity/inattention , impairment in classroom learning , and access to specialist health services for mental health or behavioral problems . RESULTS None of the interventions were associated with improved outcomes . However , children receiving the identification -only intervention were twice as likely as children in the no-intervention group to have high hyperactivity/inattention scores at follow-up ( adjusted odds ratio , 2.11 ; 95 % confidence interval , 1.12 - 4.00 ) . Regardless of intervention , high baseline hyperactivity/inattention scores were associated with high hyperactivity/inattention and specialist health service use at follow-up . CONCLUSIONS We did not find evidence of long-term , generalizable benefits following a school-based universal screening program for ADHD . There may be adverse effects associated with labeling children at a young age",
"OBJECTIVE To evaluate the impact of adherence and medication status on effectiveness and adverse effects of stimulant use in children with attention-deficit/hyperactivity disorder ( ADHD ) over 5 years . METHOD Seventy-nine of 91 participants in a 12-month r and omized controlled trial of methylpheni date and parent groups enrolled in a follow-up study . Adherence to stimulants , treatment response , and adverse effects were evaluated annually for 5 years . Changes in teacher-reported symptoms and parent-reported adverse effects were compared at 2 , 3 , 4 , and 5 years for 3 groups : adherents , nonadherents on medication , or nonadherents off medication . Controlling for age , gender , and baseline severity , adherence status and medication status were evaluated as correlates of teacher-reported ADHD symptom scores at each year using multiple regression analyses . RESULTS At 2 years , adherents ( n = 41 ) showed greater improvement in teacher-reported symptoms than those off medication ( n = 16 ) and equivalent response to nonadherents on stimulants ( n = 16 ) ( p = .02 ) . At 5 years , adherents ( n = 16 ) showed greater improvement in teacher-reported symptoms than nonadherents on stimulants ( n = 15 ) and those off medication ( n = 14 ) ( p = .04 ) . At year 2 medication status ( beta = 4.67 [ 0.40 - 8.95 , p = .033 ] ) and at year 5 adherence status ( beta = 7.23 [ 3.01 - 11.44 , p = .001 ] ) correlated with higher teacher-reported symptom scores . Clinical ly significant adverse effects were present for 5 years , most commonly loss of appetite . CONCLUSIONS Psychostimulants improve ADHD symptoms for up to 5 years , but adverse effects persist",
"The height of young adults who were treated with methylpheni date hydrochloride in childhood because of hyperactivity ( average daily dose , 45 mg ; duration of treatment , six months to five years ) was studied . There was no significant difference in height between the treated patients ( n = 61 ) and controls ( n = 99 ) ; both groups were at the national US norm in stature . The findings indicated that methylpheni date therapy does not compromise final height , even when it has an adverse impact on children 's growth rate during the active treatment phase . A compensatory growth rate , or growth rebound , appears to occur following discontinuation of stimulant therapy",
"OBJECTIVE Intent-to-treat analyses of the Multimodal Treatment Study of ADHD ( MTA ) revealed group differences on attention-deficit/hyperactivity disorder symptoms ratings , with better outcome in groups of participants who were assigned the medication algorithm-medication alone ( MedMgt ) and combined (Comb)--than in those who were not-behavior modification ( Beh ) alone and community comparison ( CC ) . However , the effect size was reduced by 50 % from the end of treatment to the first follow-up . The convergence of outcomes suggests differential changes by treatment group beween 14 and 24 months , which this report explores , both for benefits of treatment and for side effects on growth . METHODS We documented reported medication use at 14- and 24-month assessment s and formed 4 naturalistic subgroups ( Med/Med , Med/NoMed , NoMed/Med , and NoMed/NoMed ) . Then we performed exploratory mediator analyses to evaluate effects of changes in medication use on 14- to 24-month change scores of effectiveness ( symptom ratings ) and growth ( height and weight measures ) . RESULTS The r and omly assigned groups with the greatest improvement at the end of the treatment phase ( Comb and MedMgt ) deteriorated during the follow-up phase , but the other 2 groups ( Beh and CC ) did not . There were no significant differences in the 14- to 24-month growth rates among the r and omly assigned groups , in contrast to significant growth suppression in the Comb and MedMgt at the end of the treatment phase . Changes in medication use mediated the 14- to 24-month change in attention-deficit/hyperactivity disorder symptom ratings : the subgroup that reported stopping medication ( Med/NoMed ) showed the largest deterioration , the subgroup that consistently reported ( Med/Med ) or never reported ( NoMed/NoMed ) medication use showed modest deterioration , and the subgroup that reported starting medication ( NoMed/Med ) showed improvement . Changes in medication use also mediated growth effects : the subgroup that consistently reported medication use ( Med/Med ) showed reduced height gain compared with the subgroup that never reported medication use ( NoMed/NoMed ) , which actually grew faster than predicted by population norms . CONCLUSION In the MTA follow-up , exploratory naturalistic analyses suggest that consistent use of stimulant medication was associated with maintenance of effectiveness but continued mild growth suppression",
"OBJECTIVE In the Multimodal Treatment Study of ADHD ( MTA ) , the effects of medication management ( MedMgt ) and behavior modification therapy ( Beh ) and their combination ( Comb ) and usual community comparison ( CC ) in the treatment of attention-deficit/hyperactivity disorder ( ADHD ) differed at the 14-month assessment as a result of superiority of the MTA MedMgt strategy ( Comb or MedMgt ) over Beh and CC and modest additional benefits of Comb over MedMgt alone . Here we evaluate the persistence of these beneficial effects 10 months beyond the 14 months of intensive intervention . METHODS Of 579 children who entered the study , 540 ( 93 % ) participated in the first follow-up 10 months after the end of treatment . Mixed-effects regression models explored possible persisting effects of the MTA medication strategy , the incremental benefits of Comb over MedMgt alone , and the possible superiority of Beh over CC on 5 effectiveness and 4 service use domains . RESULTS The MTA medication strategy showed persisting significant superiority over Beh and CC for ADHD and oppositional-defiant symptoms at 24 months , although not as great as at 14 months . Significant additional benefits of Comb over MedMgt and of Beh over CC were not found . The groups differed significantly in mean dose ( methylpheni date equivalents 30.4 , 37.5 , 25.7 , and 24.0 mg/day , respectively ) . Continuing medication use partly mediated the persisting superiority of Comb and MedMgt . CONCLUSION The benefits of intensive MedMgt for ADHD extend 10 months beyond the intensive treatment phase only in symptom domains and diminish over time",
"BACKGROUND We wanted to study the effects of amphetamine on symptoms of attention-deficit hyperactivity disorder ( ADHD ) over a longer period than has been reported in previous studies of central stimulants in this condition . METHODS Sixty-two children , aged 6 to 11 years , meeting DSM-III-R symptom criteria for ADHD participated in a parallel-group design , r and omized , double-blind , placebo-controlled study of amphetamine treatment . Treatment was not restricted to children with \" pure \" ADHD , ie , some had comorbid diagnoses . In the amphetamine group , children received active treatment for 15 months . RESULTS Amphetamine was clearly superior to placebo in reducing inattention , hyperactivity , and other disruptive behavior problems and tended to lead to improved results on the Wechsler Intelligence Scale for Children -- Revised . Treatment failure rate was considerably lower and time to treatment failure was longer in the amphetamine group . Adverse effects were few and relatively mild . CONCLUSION The results of this long-term , placebo-controlled study of the central stimulant amphetamine in the treatment of ADHD indicate that there are remaining positive effects of the drug 15 months after starting treatment",
"OBJECTIVE To outline the key features of the developmental progression of ADHD and to consider the most prominent influences on its developmental course and outcomes . METHODS This is a selective review focusing primarily on prospect i ve follow-up studies . Relevant publications were selected by search ing the MEDLINE and PubMed data bases using keywords : ADHD , development , preschool , adolescent , adult , follow up , outcome , long-term , predictors , and treatment . Reference lists of the result ing articles were then review ed for additional publications . RESULTS Presentation of ADHD and associated impairments evolve across development , as do outcome predictors . In early development , in addition to genetics , some forms of prenatal adversity increase the risk for ADHD . In preschool years , symptom severity , cognitive function , and family factors become significant predictors of school age outcomes . These continue to predict long-term outcomes in school aged children , and comorbidity emerges as another significant long-term outcome predictor at this stage . CONCLUSIONS Presentation of ADHD and risk factors for later adversity evolve across development , which calls for developmentally-informed clinical practice",
"OBJECTIVE The paucity of data concerning the long-term natural history of attention-deficit hyperactivity disorder ( ADHD ) , a common childhood psychiatric disorder , prompted a longitudinal study to investigate the adult sequelae of the childhood disorder . DESIGN Prospect i ve study , follow-up intervals ranging from 13 to 19 years ( mean , 16 years ) , with blind systematic clinical assessment s. SUBJECTS Ninety-one white males ( mean age , 26 years ) , representing 88 % of a cohort systematic ally diagnosed as hyperactive in childhood , and 95 ( 95 % ) of comparison cases of similar race , gender , age , whose teachers had voiced no complaints about their school behavior in childhood . RESULTS Prob and s had significantly higher rates than comparisons of ADHD symptoms ( 11 % vs 1 % ) , antisocial personality disorders ( 18 % vs 2 % ) , and drug abuse disorders ( 16 % vs 4 % ) . Significant comorbidity occurred between antisocial and drug disorders . Educational and occupational achievements were significantly compromised in the prob and s. These disadvantages were independent of psychiatric status . We did not find increased rates of affective or anxiety disorders in the prob and s. CONCLUSIONS Childhood ADHD predicts specific adult psychiatric disorders , namely antisocial and drug abuse disorders . In the adolescent outcome of this cohort , we found that these disturbances were dependent on the continuation of ADHD symptoms . In contrast , in adulthood , antisocial and drug disorders appeared , in part , independent of sustained ADHD . In addition , regardless of psychiatric status , ADHD placed children at relative risk for educational and vocational disadvantage . The results do not support a relationship between childhood ADHD and adult mood or anxiety disorders"
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Aim The increasing rate of all-cause dementia worldwide and the lack of effective pharmaceutical treatments emphasise the value of lifestyle approaches as prevention strategies . Emerging evidence suggests sedentary behaviour is associated with impaired cognitive function . A better underst and ing of this association would significantly add to our knowledge of how to best promote healthy cognitive ageing . Thus , we conducted a systematic review ascertaining the contribution of sedentary behaviour towards associated changes in cognitive function over the adult lifespan . Study design Systematic review of peer- review ed literature examining the association of sedentary behaviour with cognition . Data sources We search ed PubMed , PsycINFO , EBSCO and Web of Science , and reference lists of relevant review s on sedentary behaviour . Two independent review ers extracted ( 1 ) study characteristics and ( 2 ) information regarding measurement of sedentary behaviour and cognitive function . We also assessed study quality using the Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) checklist . Eligibility criteria We limited search results to adults ≥40 years , observational studies published in English since 1990 and studies investigating associations between sedentary behaviour and cognitive function . Results 8 studies examined the association of sedentary behaviour with cognitive function . 6 studies reported significant negative associations between sedentary behaviour and cognitive function . 8 different measures of sedentary behaviour and 13 different measures of cognitive function were used across all eight studies . Summary Sedentary behaviour is associated with lower cognitive performance , although the attributable risk of sedentary time to all-cause dementia incidence is unclear . Our systematic review provides evidence that limiting sedentary time and concomitantly engaging in regular moderate-to-vigorous physical activity may best promote healthy cognitive ageing
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"Background Mild cognitive impairment ( MCI ) is a well-recognised risk factor for dementia and represents a vital opportunity for intervening . Exercise is a promising strategy for combating cognitive decline by improving brain structure and function . Specifically , aerobic training ( AT ) improved spatial memory and hippocampal volume in healthy community-dwelling older adults . In older women with probable MCI , we previously demonstrated that resistance training ( RT ) and AT improved memory . In this secondary analysis , we investigated : ( 1 ) the effect of RT and AT on hippocampal volume and ( 2 ) the association between change in hippocampal volume and change in memory . Methods 86 women aged 70–80 years with probable MCI were r and omly assigned to a 6-month , twice-weekly programme of : ( 1 ) AT , ( 2 ) RT or ( 3 ) balance and tone training ( BAT ; ie , control ) . At baseline and trial completion , participants performed a 3 T MRI scan to determine hippocampal volume . Verbal memory and learning were assessed by Rey 's Auditory Verbal Learning Test . Results Compared with the BAT group , AT significantly improved left , right and total hippocampal volumes ( p≤0.03 ) . After accounting for baseline cognitive function and experimental group , increased left hippocampal volume was independently associated with reduced verbal memory and learning performance as indexed by loss after interference ( r=0.42 , p=0.03 ) . Conclusions Aerobic training significantly increased hippocampal volume in older women with probable MCI . More research is needed to ascertain the relevance of exercise-induced changes in hippocampal volume on memory performance in older adults with MCI . Trail registration number NCT00958867",
"The risk of dementia and Alzheimer 's disease ( AD ) probably results from an interaction between genetic and environmental factors . The aim of this study was to investigate the effects and putative interactions between the apoE ε4 allele and lifestyle related risk factors for dementia and AD . Participants of the Cardiovascular Risk Factors , Aging , and Dementia ( CAIDE ) study were derived from r and om , population -based sample s previously studied in 1972 , 1977 , 1982 or 1987 . After an average follow-up of 21 years , 1449 individuals ( 72.5 % ) aged 65–79 years were re-examined in 1998 . The apoE ε4 allele was an independent risk factor for dementia/AD even after adjustments for sociodemographic , lifestyle and vascular factors ( odds ratio [OR]= 2.83 , 95 % confidence interval [CI]ε1.61–4.97 ) . Physical inactivity , alcohol drinking and smoking increased the risk of dementia/AD particularly among the apoE ε4 carriers . Furthermore , low – moderate intake of polyunsaturated , and moderate – high intake of saturated fats were associated with an increased risk of dementia/AD more pronouncedly among apoE ε4 carriers . Composite effect of the lifestyle factors was particularly seen among the ε4 carriers ( OR = 11.42 , 95 % CI = 1.94–67.07 in the 4th quartile ) . Physical inactivity , dietary fat intake , alcohol drinking and smoking at midlife are associated with the risk of dementia and AD , especially among the apoE ε4 carriers . The apoE ε4 carriers may be more vulnerable to environmental factors , and thus , lifestyle interventions may greatly modify dementia risk particularly among the genetically susceptible individuals",
"Even when adults meet physical activity guidelines , sitting for prolonged periods can compromise metabolic health . Television ( TV ) time and objective measurement studies show deleterious associations , and breaking up sedentary time is beneficial . Sitting time , TV time , and time sitting in automobiles increase premature mortality risk . Further evidence from prospect i ve studies , intervention trials , and population -based behavioral studies is required",
"CONTEXT Dementia is common , costly , and highly age related . Little attention has been paid to the identification of modifiable lifestyle habits for its prevention . OBJECTIVE To explore the association between physical activity and the risk of cognitive impairment and dementia . DESIGN , SETTING , AND SUBJECTS Data come from a community sample of 9008 r and omly selected men and women 65 years or older , who were evaluated in the 1991 - 1992 Canadian Study of Health and Aging , a prospect i ve cohort study of dementia . Of the 6434 eligible subjects who were cognitively normal at baseline , 4615 completed a 5-year follow-up . Screening and clinical evaluations were done at both waves of the study . In 1996 - 1997 , 3894 remained without cognitive impairment , 436 were diagnosed as having cognitive impairment-no dementia , and 285 were diagnosed as having dementia . MAIN OUTCOME MEASURE Incident cognitive impairment and dementia by levels of physical activity at baseline . RESULTS Compared with no exercise , physical activity was associated with lower risks of cognitive impairment , Alzheimer disease , and dementia of any type . Significant trends for increased protection with greater physical activity were observed . High levels of physical activity were associated with reduced risks of cognitive impairment ( age- , sex- , and education-adjusted odds ratio , 0.58 ; 95 % confidence interval , 0.41 - 0.83 ) , Alzheimer disease ( odds ratio , 0.50 ; 95 % confidence interval , 0.28 - 0.90 ) , and dementia of any type ( odds ratio , 0.63 ; 95 % confidence interval , 0.40 - 0.98 ) . CONCLUSION Regular physical activity could represent an important and potent protective factor for cognitive decline and dementia in elderly persons",
"Cognitive decline is one of the most pressing healthcare issues of the 21st century . Worldwide , one new case of major cognitive decline ( ie , dementia ) is detected every 4 s.1 Given that no effective pharmacological treatment to alter the progress of cognitive decline exists , there is much interest in lifestyle approaches for preventing or treating dementia . Ideally , such strategies should be cost-efficient and widely accessible at a societal level to have the largest benefit for older adults with varying income and functional status levels . One attractive solution that aligns with the above criteria is exercise . However , despite a large and consistent pool of evidence generated over the past five decades linking exercise to improved cognitive functions in older adults,2 there is a reluctance among academics , healthcare practitioners and the public alike to embrace exercise as a prevention and treatment strategy for cognitive decline . For example , the National Institutes of Health ( NIH ) consensus statement from 20103 concedes that there appears to be preliminary data to support the efficacy of exercise in improving cognitive function . However , they caution that there is currently no strong evidence to suggest that modifiable lifestyle factors can alter the trajectory of cognitive decline . Adding fuel to the fire are publications such as a 2013 systematic review of r and omised controlled trials ( RCTs ) ( prior to 31 October 2011 ) reporting ‘ weak ’ evidence for the effects of exercise on cognition.4 We must highlight that the search strategy used in that systematic review failed to capture many pertinent papers providing evidence from RCTs that exercise promotes cognitive and brain plasticity not only in healthy older adults but also in those with cognitive impairment . Furthermore , there are a number of animal studies that provide insight into the molecular and cellular mechanisms by which exercise promotes neuroplasticity.5 In a previous commentary ,",
"Objective : To investigate the risk of AD associated with a family history of dementia , female gender , low levels of education , smoking , and head trauma . Background : These putative factors have been identified in cross-sectional studies . However , those studies are prone to bias due to systematic differences between patients and control subjects regarding survival and how risk factors are recalled . Methods : The authors performed a pooled analysis of four European population -based prospect i ve studies of individuals 65 years and older , with 528 incident dementia patients and 28,768 person-years of follow-up . Patients were detected by screening the total cohort with brief cognitive tests , followed by a diagnostic assessment of those who failed the screening tests . Dementia was diagnosed with the Diagnostic and Statistical Manual of Mental Disrders , 3rd ed . ( revised ) , and AD was diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke – Alzheimer ’s Disease and Related Disorders Association criteria . Incident rates and relative risk ( 95 % CI ) express the association of a risk factor for dementia . Results : Incident rates for dementia and AD were similar across studies . The incidence of AD increased with age . At 90 years of age and older the incidence was 63.5 ( 95 % CI , 49.7 to 81.0 ) per 1,000 person-years . Female gender , current smoking ( more strongly in men ) , and low levels of education ( more strongly in women ) increased the risk of AD significantly . A history of head trauma with unconsciousness and family history of dementia did not increase risk significantly . Conclusion : Contrary to previous reports , head trauma was not a risk factor for AD , and smoking did not protect against AD . The association of family history with the risk of AD is weaker than previously estimated on the basis of cross-sectional studies . Female gender may modify the risk of AD , whether it be via biological or behavioral factors",
"Methods of sample size and power calculations are review ed for the most common study design s. The sample size and power equations for these design s are shown to be special cases of two generic formulae for sample size and power calculations . A computer program is available that can be used for studies with dichotomous , continuous , or survival response measures . The alternative hypotheses of interest may be specified either in terms of differing response rates , means , or survival times , or in terms of relative risks or odds ratios . Studies with dichotomous or continuous outcomes may involve either a matched or independent study design . The program can determine the sample size needed to detect a specified alternative hypothesis with the required power , the power with which a specific alternative hypothesis can be detected with a given sample size , or the specific alternative hypotheses that can be detected with a given power and sample size . The program can generate help messages on request that facilitate the use of this software . It writes a log file of all calculated estimates and can produce an output file for plotting power curves . It is written in FORTRAN-77 and is in the public domain",
"Free delayed recall is considered the memory measure with the greatest sensitivity for the early diagnosis of dementia . However , its specificity for dementia could be lower , as deficits other than those of pure memory might account for poor performance in this difficult and effortful task . Cued recall is supposed to allow a better distinction between poor memory due to concurrent factors and impairments related to the neurodegenerative process . The available cued recall tests suffer from a ceiling effect . This is a prospect i ve , longitudinal study aim ing to assess the utility of a new memory test based on cued recall that avoids the ceiling effect in the early diagnosis of Alzheimer ’s disease ( AD ) . Twenty-five patients with mild cognitive impairment ( MCI ) , 22 probable AD patients ( NINCDS-ADRDA ) at a mild stage , 22 elderly patients with subjective memory complaints ( SMC ) and 38 normal age-matched controls took part in the study . The patients underwent a thorough cognitive evaluation and the recommended screening procedure for the diagnosis of dementia . All patients were re-examined 12–18 months later . A newly devised delayed cued recall test using semantic cues ( The RI48 Test ) was compared with three established memory tests : the Ten Word-List Recall from CERAD , the “ Doors ” and the “ Shapes ” Tests from “ The Doors and People Test Battery ” . Forty-four % of the MCI patients fulfilled criteria for probable AD at follow-up . The RI48 Test classified correctly 88 % of the MCI and SMC participants and was the best predictor of the status of MCI and mild AD as well as the outcome of the MCI patients . Poor visual memory was the second best predictor of those MCI patients who evolved to AD . A cued recall test which avoids the ceiling effect is at least as good as the delayed free recall tests in the early detection of AD",
"PURPOSE The Modifiable Activity Question naire ( MAQ ) is a physical activity question naire shown to be both valid and reliable and was initially design ed to be interviewer-administered . After translation and adaptation into French , the objective of the study was to compare past-year physical activity data obtained by self-administration of this question naire and by interviewer-administration . METHODS 84 subjects ( 22 men , 62 women , age 36 - 63 yr ) enrolled in an ongoing prospect i ve study in France ( the SUpplementation en VItamines et Minéraux AntioXydants or SU.VI.MAX study ) completed both versions of the question naire in a r and omized order with a mean ( SD ) delay of 7.9 ( 5.8 ) d between the two modes . Past-year leisure and occupational physical activity were expressed as both h x wk(-1 ) and MET-h x wk(-1 ) of activity , and television watching was expressed as h x d(-1 ) . Analysis of variance on ranks was used to compare activity variables obtained by self-administration and interview . Agreement was assessed by nonparametric intraclass correlation coefficients . RESULTS A significant effect of the mode of administration was found only for past-year leisure physical activity with lower values reported in self-administered conditions compared with interview . However , a high level of concordance between the two modes of administration was observed for all variables as shown by the intraclass correlation coefficients : 0.90 for leisure physical activity ( h x wk(-1 ) ) , 0.82 for occupational activity ( h x wk(-1 ) ) , 0.83 for total ( leisure and occupational combined ) physical activity ( h x wk(-1 ) ) , and 0.97 for television viewing ( h x d(-1 ) ) . CONCLUSIONS The agreement between the two modes of administration of the question naire suggests that the self-administered version of the MAQ is a valuable tool to assess past-year physical activity and inactivity in self-administered conditions . This instrument could be used in large-scale population studies investigating the relationships between physical activity and health outcomes ",
"PURPOSE We established accelerometer count ranges for the Computer Science and Applications , Inc. ( CSA ) activity monitor corresponding to commonly employed MET categories . METHODS Data were obtained from 50 adults ( 25 males , 25 females ) during treadmill exercise at three different speeds ( 4.8 , 6.4 , and 9.7 km x h(-1 ) ) . RESULTS Activity counts and steady-state oxygen consumption were highly correlated ( r = 0.88 ) , and count ranges corresponding to light , moderate , hard , and very hard intensity levels were or = 9499 cnts x min(-1 ) , respectively . A model to predict energy expenditure from activity counts and body mass was developed using data from a r and om sample of 35 subjects ( r2 = 0.82 , SEE = 1.40 kcal x min(-1 ) ) . Cross validation with data from the remaining 15 subjects revealed no significant differences between actual and predicted energy expenditure at any treadmill speed ( SEE = 0.50 - 1.40 kcal x min(-1 ) ) . CONCLUSIONS These data provide a template on which patterns of activity can be classified into intensity levels using the CSA accelerometer"
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4117ddb8-06ff-11f0-808a-c43d1ab1c353
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Background A substantial number of adults suffer from obesity , that is caused by the risk factor , masticatory dysfunction . The association between mastication and obesity , however , is inconclusive . This systematic review aims to provide literature regarding the association between mastication and factors affecting masticatory function , and obesity in adults . Methods Four electronic data bases ( PubMed , EMBASE , Cochrane Library , and Web of Science ) were used to search for publications that met the following criteria : published between 2007 and 2016 , written in English , and assessed the associations between mastication and obesity among the population aged ≥18 years . The included publications were analyzed based on the study design , main conclusions , and strength of evidence identified by the two authors who screened all the abstract s and full-text articles and , abstract ed data , and performed quality assessment s by using a critical appraisal tool , the Critical Appraisal Skills Programme Cohort Studies Checklists . Results A total of 18 articles ( 16 cross-sectional , 1 cohort studies , and 1 r and omized controlled trial [ RCT ] ) met our inclusion criteria and were evaluated . Poorer mastication was associated with obesity in 12 out of 16 cross-sectional studies . One cohort study showed that the obesity group displayed higher tooth loss than the normal weight group . One RCT demonstrated that gum-chewing intervention for 8 weeks significantly decreased waist circumference . Conclusions Most studies revealed a positive association between mastication and obesity among adults . Nonetheless , most of them are cross-sectional studies , which are insufficient to demonstrate a causal relation . Further advancement requires RCT , especially an intervention of improvement of mastication and obesity needed to confirm this association
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"Aims To assess the relationship between oral health status and Body Mass Index . Material and methods This paper relates to the free-living sample ( participants who lived in their own home , rather than an institution ) of the National Diet and Nutrition Survey : people aged 65 years and older . Subjects 629 adults . Data collection A probability r and om national sample of adults who had a dental examination , an interview and an anthropometric examination . Data analysis Fisher 's exact test and multivariate logistic modeling . Findings Being underweight was relatively uncommon in this population . People without teeth were significantly ( P=0.05 ) more likely to be underweight than those with 11 or more teeth ; 12.3 % and 2.9 % . A highly statistically significant ( P=0.001 ) difference was observed in BMI between dentate people with 1 - 10 teeth and with more than 10 teeth ; 24 % and 2.9 % were underweight . Dentate people with less than 21 natural teeth were on average more than 3 times more likely to be obese than those with 21 - 32 teeth ( P=0.036 ) . There was no significant difference in both the proportion of overweight and obese adults between those who were edentulous and dentate with 21 or more teeth . A similar pattern was observed when the number of posterior occluding pairs was compared with BMI categories . Results of multiple logistic regression were adjusted for the confounding effects of age , social class , region of origin and partial denture wearing . Conclusions Older people in Britain with more than 20 teeth are more likely to have a normal Body Mass Index",
"OBJECTIVE Many cross-sectional studies have reported a relationship between overweight/obesity and eating quickly , but there have been few longitudinal studies to address this relationship in younger population s. The purpose of this prospect i ve longitudinal study was to investigate whether eating quickly was related to being overweight in Japanese university students . METHODS Of 1,396 students who underwent a general examination and completed question naires at the start of university and before graduation , 1,314 students ( 676 male and 638 female ) of normal body composition [ body mass index ( BMI ) were included in the analysis . The question naires included speed of eating and other lifestyle factors . After a 3-year follow-up , the students whose BMI s were ≥ 25 kg m(-2 ) were defined as overweight . RESULTS In this study , 38 participants ( 2.9 % ) became overweight . In the logistic regression analysis , the risk of being overweight was increased in males [ adjusted odds ratio ( OR ) : 2.77 ; 95 % confidence interval ( CI ) : 1.33 - 5.79 ; P Eating quickly may predict risk of being overweight in Japanese university students",
"Background In western Sweden , the aim was to study the associations between oral health variables and total and central adiposity , respectively , and to investigate the influence of socio-economic factors ( SES ) , lifestyle , dental anxiety and co-morbidity . Methods The subjects constituted a r and omised sample from the 1992 data collection in the Prospect i ve Population Study of Women in Gothenburg , Sweden ( n = 999 , 38- > = 78 yrs ) . The study comprised a clinical and radiographic examination , together with a self-administered question naire . Obesity was defined as body mass index ( BMI ) > = 30 kg/m2 , waist-hip ratio ( WHR ) > = 0.80 , and waist circumference > 0.88 m. Associations were estimated using logistic regression including adjustments for possible confounders . Results The mean BMI value was 25.96 kg/m2 , the mean WHR 0.83 , and the mean waist circumference 0.83 m. The number of teeth , the number of restored teeth , xerostomia , dental visiting habits and self-perceived health were associated with both total and central adiposity , independent of age and SES . For instance , there were statistically significant associations between a small number of teeth ( obesity : BMI ( OR 1.95 ; 95 % CI 1.40 - 2.73 ) , WHR ( 1.67 ; 1.28 - 2.19 ) and waist circumference ( 1.94 ; 1.47 - 2.55 ) , respectively . The number of carious lesions and masticatory function showed no associations with obesity . The obesity measure was of significance , particularly with regard to behaviour , such as irregular dental visits , with a greater risk associated with BMI ( 1.83 ; 1.23 - 2.71 ) and waist circumference ( 1.96 ; 1.39 - 2.75 ) , but not with WHR ( 1.29 ; 0.90 - 1.85 ) . Conclusions Associations were found between oral health and obesity . The choice of obesity measure in oral health studies should be carefully considered",
"BACKGROUND AND OBJECTIVE The loss of a functional dentition imposes eating difficulties and food avoidance , which may be detrimental in terms of nutritional status and health . The objective of this study was to investigate whether tooth loss and edentulism that were not rehabilitated with dental prostheses were associated with obesity among elderly in Southern Brazil . MATERIAL S AND METHODS A r and om sample of 872 independently living elderly was evaluated by means of a cross-sectional study . Socio-demographic , medical history and behaviour data were assessed using a st and ardised question naire . Two trained dentists assessed the number of teeth and use of prostheses in accordance with the WHO criteria . Height and weight were assessed and used to generate body mass index ( BMI = weight (kilos)/height (cm)(2 ) ) data . Participants were categorised into non-obese ( BMI 30 ) . Multivariate logistic regression was used to model the relationship between number of teeth and use of dental prostheses with obesity adjusting for confounders . RESULTS Multivariate logistic regression revealed that edentulous persons wearing only upper dentures ( OR = 2.34 , 95 % CI 1.18 - 4.27 ) and dentate participants with one to eight teeth wearing 0-to-1 prosthesis ( OR = 2.96 , 95 % CI 1.68 - 5.19 ) were more likely to be obese . CONCLUSION The results show that a poorer oral status , represented by having fewer teeth that were not replaced by dental prostheses , was associated with obesity in Southern Brazil older people , suggesting a close relationship between poor oral status and systemic conditions that may have important clinical implication",
"Chewing reportedly contributes to satiation and satiety signals . Attempts to document and quantify this have led to small and inconsistent effects . The present trial manipulated oral processing effort though required chewing of gums of different hardness and measured appetitive sensations , energy intake , gastric emptying , GI transit time , and concentrations of glucose , insulin , GLP-1 , ghrelin and pancreatic polypeptide . Sixty adults classified by sex and BMI ( 15 each of lean females , obese females , lean males and obese males ) were tested in a r and omized , controlled , cross-over trial with three arms . They chewed nothing , soft gum or hard gum for 15 min while sipping grape juice ( 10 % of individual energy needs ) containing acetaminophen and lactulose on one day each separated by 7 days . Electromyographic recordings and self-reports were obtained during and after chewing to quantify oral processing effort . Blood was sample d through an indwelling catheter and appetite ratings were obtained at baseline and at 0 , 15 , 30 , 45 , 60 , 90 , 120 , 180 and 240 min after chewing initiation . Breath sample s were collected at 10 min intervals for the first 2h and at 30 min intervals for the next 2h . No effects of chewing were observed for appetitive sensations or gut peptide concentrations . Energy intake tended to decline in lean and increase in obese participants so that daily energy intake differed significantly between the two groups when chewing either gum , while no difference was observed on the non-chewing day . Serum glucose and insulin were significantly lower at selected time points 90 - 240 min after chewing compared to baseline and the non-chewing day . These data indicate chewing effort does not affect appetitive sensations or gut peptide secretion , but may exert a small differential effect on acute energy intake in lean and obese individuals and lead to greater post-pr and ial declines of serum glucose and insulin . The efficacy of gum chewing as a substitute for eating for weight management remains uncertain",
"OBJECTIVE To evaluate if poor oral status was associated with percentage body fat in a representative sample of south Brazilian community-dwelling elderly . BACKGROUND Evidence suggests that elders with extensive tooth loss and edentulism present with compromised chewing function , which results in dietary changes . However , few studies have assessed whether poor oral status is associated with percentage body fat in community-dwelling elderly . MATERIAL S AND METHODS A r and om sample of 471 south Brazilians = > 60 years of age was evaluated . Measurements included a question naire to assess socio-demographic , behavioural , general , and oral health data . Percentage body fat was measured with a Tanita TBF 612 digital scale , which measures foot-to-foot bioelectrical impedance ; and oral status assessment , by means of oral examinations assessing the number of teeth and use of dental prostheses . Correlates of risk of inadequate percentage body fat were assessed by means of multinomial logistic regression . RESULTS Edentulous participants were more likely to be underfat [ OR : 3.11 ( 1.27 - 7.61 ) ] or overfat/obese [ OR : 1.82 ( 1.05 - 3.16 ) ] . CONCLUSION The present study shows that edentulous older people had higher odds for inadequate percentage body fat . The maintenance of teeth had a crucial role in increasing the chance of having an adequate body fat percentage in the study population",
"The possible effects on body weight of chewing gum on a regular schedule have not been tested in a r and omized controlled trial ( RCT ) . We conducted an 8-week RCT in 201 overweight and obese adults to test the hypothesis that receiving printed material on good nutrition and chewing gum for a minimum of 90 min/day ( n = 102 ) would lead to greater weight loss than receiving printed nutrition information only ( n = 99 ) . Changes in BMI , waist circumference , and blood pressure were secondary outcomes . Adherence to the gum-chewing protocol in the intervention group was > 95 % . In the intention-to-treat analysis , there were virtually no changes in weight or BMI in either group between baseline and the end of the intervention at 8 weeks . Waist circumference decreased significantly in the intervention group between baseline and 8 weeks ( mean ± SD change = -1.4 ± 5.3 cm ; P = 0.0128 ) ; however , there was no significant difference in change in waist circumference comparing the groups . Similarly , systolic and diastolic blood pressure decreased significantly in the intervention group between baseline and 8 weeks ( -3.0 ± 9.9 mm Hg ; P = 0.0032 and -3.2 ± 7.3 mm Hg ; P = 0.0001 , respectively ) ; however , there were no significant differences in the changes in systolic or diastolic blood pressure between the groups . Analyses including completers only produced essentially the same results . We conclude that chewing gum on a regular schedule for 8 weeks did not facilitate weight loss in these overweight and obese adults",
"OBJECTIVE To analyze if differences according to gender exists in the association between tooth loss and obesity among older adults . METHODS We analyzed data on 1,704 older adults ( 60 years and over ) from the baseline of a prospect i ve cohort study conducted in Florianopolis , SC , Southern Brazil . Multivariable logistic regression models were used to assess the association between tooth loss and general and central obesity after adjustment for confounders ( age , gender , skin color , educational attainment , income , smoking , physical activity , use of dentures , hypertension , and diabetes ) . Linear regressions were also assessed with body mass index and waist circumference as continuous outcomes . Interaction between gender and tooth loss was further assessed . RESULTS Overall mean body mass index was 28.0 kg/m2 . Mean waist circumference was 96.8 cm for males and 92.6 cm for females . Increasing tooth loss was positively associated with increased body mass index and waist circumference after adjustment for confounders . Edentates had 1.4 ( 95%CI 1.1;1.9 ) times higher odds of being central ly obese than individuals with a higher number of teeth ; however , the association lost significance after adjustment for confounders . In comparison with edentate males , edentate females presented a twofold higher adjusted prevalence of general and central obesity . In the joint effects model , edentate females had a 3.8 ( 95%CI 2.2;6.6 ) times higher odds to be central ly obese in comparison with males with more than 10 teeth present in both the arches . Similarly , females with less than 10 teeth in at least one arch had a 2.7 ( 95%CI 1.6;4.4 ) times higher odds ratio of having central obesity in comparison with males with more than 10 teeth present in both the arches . CONCLUSIONS Central obesity was more prevalent than general obesity among the older adults . We did not observe any association between general obesity and tooth loss . The association between central obesity and tooth loss depends on gender – females with tooth loss had greater probability of being obese"
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4117ddf4-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Despite the burden of schizophrenia and bipolar disorder in the Chinese population , country-specific data to guide practitioners regarding antipsychotic therapy are lacking . The primary aim of this systematic review was to examine evidence of the efficacy , effectiveness , and safety of olanzapine in Chinese population s. METHODS A systematic literature search was conducted using data bases covering international and Chinese core journals using search terms related to schizophrenia and bipolar disorder , specified countries ( People 's Republic of China , Hong Kong , Taiwan ) , and olanzapine treatment . Following initial screening , inclusion and exclusion criteria were applied to the search results to identify relevant studies from which data were extracted . RESULTS A total of 489 publications were retrieved and 61 studies were identified for inclusion . Most studies were related to schizophrenia ( n=54 ) , with six studies related to bipolar disorder and one study related to both conditions . The quality of study methods and reporting in international journals was noticeably better than in Chinese language journals . Most studies included relatively small patient population s and were of short duration . The efficacy of olanzapine in Chinese population s was confirmed by multiple comparative and noncomparative studies that found statistically significant reductions in symptom measures in studies conducted for ≥6 weeks ( schizophrenia ) or ≥3 weeks ( bipolar disorder ) . Findings related to effectiveness ( treatment discontinuation , quality of life , and neurocognitive improvements ) were generally consistent with those observed in non-Chinese population s. No new safety signals specific for Chinese population s were raised for olanzapine . CONCLUSION Chinese and non-Chinese population s with schizophrenia or bipolar disorder treated with olanzapine display broadly similar responses . Differences between these population s , especially in relation to the relative efficacy of olanzapine versus other antipsychotics , may warrant further investigation via studies incorporating both population s. Use of local data to provide evidence for practice guidelines should be encouraged , and may promote ongoing improvements in the quality of research and study reporting
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"Rationale The relative effectiveness of the atypical antipsychotic drugs and conventional agents in patients with early-stage schizophrenia has not been comprehensively determined . Objectives The aim of our study was to evaluate the efficacy and safety of seven antipsychotic drugs for the maintenance treatment in patients with early-stage schizophrenia . Methods In a 12-month open-label , prospect i ve observational , multicenter study , 1,133 subjects with schizophrenia or schizophreniform disorder within 5 years of onset were monotherapy with chlorpromazine , sulpiride , clozapine , risperidone , olanzapine , quetiapine , or aripiprazole . The primary measure was the rate of treatment discontinuation for any reason . Secondary outcomes included measures for clinical and functional outcomes and tolerability . Results The percentage of patients discontinued treatment within 12 months was 41.4 % for chlorpromazine , 39.5 % for sulpiride , 36.7 % for clozapine , 40.2 % for risperidone , 39.6 % for olanzapine , 46.9 % for quetiapine , and 40.2 % for aripiprazole , a nonsignificant difference ( p = 0.717 ) ; there were no significant differences among these seven treatments on discontinuation due to relapse , intolerability , patient decision , or nonadherence ( all p values ≥ 0.260 ) . Extrapyramidal symptoms were more prominent in chlorpromazine and sulpiride treatment groups . Anticholinergic side effects were most common with clozapine and chlorpromazine . Weight gain was most common with olanzapine and clozapine . Conclusions The efficacy of seven antipsychotic medications for the maintenance treatment appeared similar in early-stage schizophrenia . With regard to the high dropout rate and side effects , special programs are needed to keep efficacy and safety of antipsychotics maintenance treatment for schizophrenia with early",
"Introduction The initially postulated superior neurocognitive effectiveness of second-generation antipsychotics is currently under debate . Methods A prospect i ve , r and omized , open-label study was carried out to compare the long-term neurocognitive effectiveness of haloperidol , olanzapine , and risperidone in the first episode of schizophrenia spectrum disorders . A final sample of 79 patients r and omized to haloperidol ( N = 28 ) , olanzapine ( N = 23 ) , or risperidone ( N = 28 ) who completed clinical and cognitive evaluations at baseline and 3-year follow-up was included in the final analysis . Forty-one healthy individuals were also included in the final analysis . The main outcome measure was cognitive changes at 3-year follow-up . Due to the fact that some of the patients had switched their initially prescribed antipsychotic medication during the course of the study ( 6 out of 28 in haloperidol group , 18 out of 23 in olanzapine group , and 24 out of 28 in risperidone group continued with the initial study drug at 3-year assessment ) , we have also conducted a per protocol analysis . Results Overall , cognitive changes were similar in the three treatment groups and controls , although a greater improvement in Rey Auditory Verbal Learning Test , Digit Symbol , and Iowa Gambling Test was found in the treatment groups . The better performance observed on Rey Auditory Verbal Learning Test and Digit Symbol in olanzapine treatment group was likely explained by the lower prevalence of use of antimuscarinic drugs . These results were essentially similar to those found in the intention-to-treat analysis . Conclusions The major conclusion of this study is that haloperidol , olanzapine , and risperidone have not demonstrated substantial neurocognitive effectiveness , improving cognitive deficits present in the early phases of the illness . The study also underscores the importance of exploring new drugs for the treatment of cognitive impairments and associated functional disabilities in schizophrenia",
"Purpose The aim of this study was to investigate the correlation between changes in symptoms and changes in self-reported quality of life among Chinese patients with schizophrenia who were switched from a typical antipsychotic to olanzapine during usual outpatient care . Patients and methods This post hoc analysis was conducted using data from the Chinese subgroup ( n=475 ) of a multicountry , 12-month , prospect i ve , noninterventional , observational study . The primary publication previously reported the efficacy , safety , and quality of life among patients who switched from a typical antipsychotic to olanzapine . Patients with schizophrenia were included if their symptoms were inadequately controlled with a typical antipsychotic and they were switched to olanzapine . Symptom severity was measured using the Brief Psychiatric Rating Scale ( BPRS ) and the Clinical Global Impressions-Severity scale ( CGI-S ) . Health-Related Quality of Life ( HRQOL ) was assessed using the World Health Organization Quality of Life – Abbreviated ( WHOQOL-BREF ) . Paired t-tests were performed to assess changes from baseline to endpoint . Pearson ’s correlation coefficients ( r ) were used to assess the correlations between change in symptoms ( BPRS and CGI-S scores ) and change in HRQOL ( WHOQOL-BREF scores ) . Results Symptoms and HRQOL both improved significantly over the 12 months of treatment ( P BPRS and the CGI-S and each of the WHOQOL-BREF four domain scores and two overall quality -of-life questions . The correlation coefficients ranged from r=−0.45 to r=−0.53 for the BPRS and WHOQOL-BREF . The correlation coefficients were slightly smaller between the CGI-S and WHOQOL-BREF , ranging from r=−0.33 to r=−0.40 . Conclusion For patients with schizophrenia , assessing quality of life has the potential to add valuable information to the clinical assessment that takes into account the patient ’s own perspective of well-being",
"BACKGROUND In China and other middle-income countries , neuropsychiatric conditions are the most important cause of ill health in men and women , but efforts to scale up mental health services have been hampered by the absence of high- quality , country-specific data for the prevalence , treatment , and associated disability of different types of mental disorders . We therefore estimated these variables from a series of epidemiological studies that were done in four provinces in China . METHODS We used multistage stratified r and om sampling methods to identify 96 urban and 267 rural primary sampling sites in four provinces of China ; the sampling frame of 113 million individuals aged 18 years or older included 12 % of the adult population in China . 63 004 individuals , identified with simple r and om selection methods at the sampling sites , were screened with an exp and ed version of the General Health Question naire and 16,577 were administered a Chinese version of the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV axis I disorders by a psychiatrist . FINDINGS The adjusted 1-month prevalence of any mental disorder was 17.5 % ( 95 % CI 16.6 - 18.5 ) . The prevalence of mood disorders was 6.1 % ( 5.7 - 6.6 ) , anxiety disorders was 5.6 % ( 5.0 - 6.3 ) , substance abuse disorders was 5.9 % ( 5.3 - 6.5 ) , and psychotic disorders was 1.0 % ( 0.8 - 1.1 ) . Mood disorders and anxiety disorders were more prevalent in women than in men , and in individuals 40 years and older than in those younger than 40 years . Alcohol use disorders were 48 times more prevalent in men than in women . Rural residents were more likely to have depressive disorders and alcohol dependence than were urban residents . Among individuals with a diagnosable mental illness , 24 % were moderately or severely disabled by their illness , 8 % had ever sought professional help , and 5 % had ever seen a mental health professional . INTERPRETATION Substantial differences between our results and prevalence , disability , and treatment rate estimates used in the analysis of global burden of disease for China draw attention to the need for low-income and middle-income countries to do detailed , country-specific situation analyses before they scale up mental health services . FUNDING China Medical Board of New York , WHO , and Sh and ong Provincial Bureau of Health",
"Improved drug therapy for schizophrenia may represent the best strategy for reducing the costs of schizophrenia and the recurrent chronic course of the disease . Olanzapine and risperidone are atypical antipsychotic agents developed to meet this need . We report a multicenter , double-blind , parallel , 30-week study design ed to compare the efficacy , safety , and associated re source use for olanzapine and risperidone in Australia and New Zeal and . The study sample consisted of 65 patients who met DSM-IV criteria for schizophrenia , schizoaffective disorder , or schizophreniform disorder . Olanzapine-treated patients showed a significantly greater reduction in Positive and Negative Syndrome Scale ( PANSS ) total , Brief Psychiatric Rating Scale ( BPRS ) total , and PANSS General Psychopathology scores at endpoint compared to the risperidone-treated patients . Response rates through 30 weeks showed a significantly greater proportion of olanzapine-treated patients had achieved a 20 % or greater improvement in their PANSS total score compared to risperidone-treated patients . Olanzapine and risperidone were equivalent in their improvement of PANSS positive and negative scores and Clinical Global Impression-Severity of Illness scale ( CGI-S ) at endpoint . Using generic and disease-specific measures of quality of life , olanzapine-treated patients showed significant within-group improvement in most measures , and significant differences were observed in favor of olanzapine over risperidone in Quality of Life Scale ( QLS ) Intrapsychic Foundation and Medical Outcomes Study Short Form 36-item instrument ( SF-36 ) Role Functioning Limitations -Emotional subscale scores . Despite the relatively small sample size , our study suggests that olanzapine has a superior risk : benefit profile compared to risperidone",
"OBJECTIVE Newer antipsychotic drugs have shown promise in ameliorating neurocognitive deficits in patients with schizophrenia , but few studies have compared newer antipsychotic drugs with both clozapine and conventional agents , particularly in patients who have had suboptimal response to prior treatments . METHOD The authors examined the effects of clozapine , olanzapine , risperidone , and haloperidol on 16 measures of neurocognitive functioning in a double-blind , 14-week trial involving 101 patients . A global score was computed along with scores in four neurocognitive domains : memory , attention , motor function , and general executive and perceptual organization . RESULTS Global neurocognitive function improved with olanzapine and risperidone treatment , and these improvements were superior to those seen with haloperidol . Patients treated with olanzapine exhibited improvement in the general and attention domains but not more than that observed with other treatments . Patients treated with risperidone exhibited improvement in memory that was superior to that of both clozapine and haloperidol . Clozapine yielded improvement in motor function but not more than in other groups . Average effect sizes for change were in the small to medium range . More than half of the patients treated with olanzapine and risperidone experienced \" clinical ly significant \" improvement ( changes in score of at least one-half st and ard deviation relative to baseline ) . These findings did not appear to be mediated by changes in symptoms , side effects , or blood levels of medications . CONCLUSIONS Patients with a history of suboptimal response to conventional treatments may show cognitive benefits from newer antipsychotic drugs , and there may be differences between atypical antipsychotic drugs in their patterns of cognitive effects",
"OBJECTIVE The authors sought to compare the effects of olanzapine , quetiapine , and risperidone on neurocognitive function in patients with early psychosis . METHOD In a 52-week double-blind , multicenter study , 400 patients early in the course of psychotic illness ( were r and omly assigned to treatment with olanzapine ( 2.5 - 20 mg/day ) , quetiapine ( 100 - 800 mg/day ) , or risperidone ( 0.5 - 4 mg/day ) . The mean modal daily dose was 11.7 mg ( SD=5.3 ) for olanzapine , 506 mg ( SD=215 ) for quetiapine , and 2.4 mg ( SD=1.0 ) for risperidone . A total of 224 patients completed neurocognitive assessment s at baseline and at 12 weeks , and 81 patients also completed them at 52 weeks . Neurocognitive composite scores were calculated from the neurocognitive battery used in the Clinical Antipsychotic Trials of Intervention Effectiveness ( CATIE ) and from the Brief Assessment of Cognition in Schizophrenia . RESULTS At week 12 , there was significant improvement in neurocognition for each treatment ( p Composite z score improvements on the CATIE neurocognitive battery were 0.17 for olanzapine , 0.33 for quetiapine , and 0.32 for risperidone . Composite z score improvements on the Brief Assessment of Cognition in Schizophrenia were 0.19 for olanzapine , 0.34 for quetiapine , and 0.22 for risperidone . Statistically significant relationships between improvements in neurocognition and functional outcome were observed at weeks 12 and 52 . CONCLUSIONS Olanzapine , quetiapine , and risperidone all produced significant improvements in neurocognition in early-psychosis patients . Although cognitive improvements were modest , their clinical importance was suggested by relationships with improvements in functional outcome",
"BACKGROUND The relative effects of the atypical antipsychotic drugs and conventional agent on quality of life and psychosocial functioning in patients with early-stage schizophrenia is still uncertain because of an insufficient number of studies examining this issue . METHODS In a 12 months open-label , prospect i ve observational , multicenter study , 1029 subjects with schizophrenia or schizophreniform disorder within 5 years of onset were monotherapy with chlorpromazine , sulpiride , clozapine , risperidone , olanzapine , quetiapine or aripiprazole . The health-related quality of life and psychosocial functioning were assessed using Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) , the Global Assessment Scale ( GAS ) and the Activities of Daily Living Scale ( ADL ) , respectively . RESULTS At 12 months , treatment result ed in significant improvements in all 8 domain scores of SF-36 , GAS and ADL score ( all P-values the role-psychical score of SF-36 and GAS score than did the chlorpromazine group ( all P-values ≤ .002 ) . CONCLUSIONS All antipsychotics may improve quality of life and social function in patients with early-stage schizophrenia , but further studies are needed to determine whether atypical antipsychotics are superior to conventional agents",
"OBJECTIVE To compare the efficacy of risperidone and olanzapine in schizophrenic patients with tardive dyskinesia on treatment with first-generation antipsychotics . METHOD We conducted a 24-week , rater-blinded , flexible-dose study . Sixty patients with DSM-IV schizophrenia ( n = 58 ) or schizoaffective disorder ( n = 2 ) met the DSM-IV research criteria for neuroleptic-induced tardive dyskinesia and were r and omly assigned to a risperidone or olanzapine group . The primary outcome was a comparison of the change in the total scores on the Abnormal Involuntary Movement Scale ( AIMS ) from baseline to study end point between the groups . The study was conducted from July 2000 to June 2004 . RESULTS The mean ± SD doses of risperidone and olanzapine from baseline to study end point were 1.9 ± 0.7 to 4.1 ± 1.4 mg/d and 8.1 ± 2.0 to 12.6 ± 5.4 mg/d , respectively . There were no statistically significant differences in demographic data , severity of tardive dyskinesia , or psychotic symptoms between risperidone and olanzapine groups at baseline assessment . Both groups showed significant improvement in mean ± SD AIMS total scores ( risperidone : −7.4 ± 6.9 , P olanzapine : −6.2 ± 8.0 , P = .0002 ) . However , there was a more statistically significant change in the slope of AIMS total scores in the risperidone group than in the olanzapine group ( P = .0001 ) . CONCLUSIONS Our findings demonstrated that olanzapine may not have better potential for tardive dyskinesia improvement than risperidone did . Double-blinded , fixed dose studies with a larger sample size on schizophrenic patients with tardive dyskinesia from different ethnic groups are needed to confirm the results of our study . TRIAL REGISTRATION clinical trials.gov Identifier",
"BACKGROUND We compared the efficacy and safety of olanzapine vs placebo for the treatment of acute bipolar mania . METHODS Four-week , r and omized , double-blind , parallel study . A total of 115 patients with a DSM-IV diagnosis of bipolar disorder , manic or mixed , were r and omized to olanzapine , 5 to 20 mg/d ( n = 55 ) , or placebo ( n = 60 ) . The primary efficacy measure was the Young-Mania Rating Scale ( Y-MRS ) total score . Response and euthymia were defined , a priori , as at least a 50 % improvement from baseline to end point and as a score of no less than 12 at end point in the Y-MRS total score , respectively . Safety was assessed using adverse events , Extrapyramidal Symptom ( EPS ) rating scales , laboratory values , electrocardiograms , vital signs , and weight change . RESULTS Olanzapine-treated patients demonstrated a statistically significant greater mean ( + /- SD ) improvement in Y-MRS total score than placebo-treated patients ( -14.8 + /- 12.5 and -8.1 + /- 12.7 , respectively ; P Olanzapine-treated patients demonstrated a higher rate of response ( 65 % vs 43 % , respectively ; P = .02 ) and euthymia ( 61 % vs 36 % , respectively ; P = . 01 ) than placebo-treated patients . There were no statistically significant differences in EPSs between groups . However , olanzapine-treated patients had a statistically significant greater mean ( + /- SD ) weight gain than placebo-treated patients ( 2.1 + /- 2.8 vs 0.45 + /- 2.3 kg , respectively ) and also experienced more treatment-emergent somnolence ( 21 patients [ 38.2 % ] vs 5 [ 8.3 % ] , respectively ) . CONCLUSION Olanzapine demonstrated greater efficacy than placebo in the treatment of acute bipolar mania and was generally well tolerated",
"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",
"INTRODUCTION Head-to-head comparisons of antipsychotics have predominantly included patients with chronic conditions . The aim of the present study was to compare the efficacy and tolerability of ziprasidone and olanzapine in patients with recent-onset schizophrenia . METHODS The study was an 8-week , double-blind , parallel-group , r and omized , controlled multicenter trial ( NCT00145444 ) . Seventy-six patients with schizophreniform disorder , schizophrenia or schizoaffective disorder ( diagnosis . Efficacy of ziprasidone ( 80 - 160 mg/d ) and olanzapine 10 - 20 mg was measured using the Positive and Negative Syndrome Scale ( PANSS ) , the Clinical Global Impression ( CGI ) Scale , the Calgary Depression Scale for Schizophrenia ( CDSS ) , and the Heinrich Quality of Life Scale ( HQLS ) ; tolerability assessment s included laboratory assessment s , body weight , and electroencephalogram . RESULTS Olanzapine ( n = 34 ) and ziprasidone ( n = 39 ) showed equal efficacy as measured by the PANSS , CDSS , CGI , and HQLS . However , mean weight gain was significantly higher in the olanzapine group ( 6.8 vs 0.1 kg , P levels of triglycerides , cholesterol , and transaminases , while these parameters increased in the olanzapine group ( all P values fasting glucose and prolactin levels or in cardiac or sexual side effects . Patients on ziprasidone used biperiden for extrapyramidal side effects more frequently ( P ziprasidone and olanzapine have comparable therapeutic efficacy but differ in their side effect profile . However , there is a risk of a type II error with this sample size . Clinical ly significant weight gain and laboratory abnormalities appear early after initiating treatment and are more prominent with olanzapine , while more patients on ziprasidone received anticholinergic drugs to treat extrapyramidal symptoms",
"OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than acupuncture that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries",
"OBJECTIVE This study compares the efficacy of risperidone and olanzapine to that of first-generation antipsychotics ( FGAs ) in patients with schizophrenia , who failed to show a response to initial trials of FGAs . METHOD This study was an 8-week treatment , r and omized , rater-blind , active-control study with 3 treatment arms . 48 patients , who showed inadequate response to 1 FGA , were enrolled and r and omized into risperidone , olanzapine , or FGA ( haloperidol or trifluoperazine ) groups . They were blindly assessed with the Positive and Negative Syndrome Scale ( PANSS ) , the Clinical Global Impression Scale-Severity , and the Extrapyramidal Symptom Rating Scale ( ESRS ) at baseline and biweekly . RESULTS All 3 groups demonstrated a significant decrease in the PANSS total , positive , and general scores from baseline to endpoint ( p-values range from 0.003 to 0.021 ) . There were no significant differences among the 3 groups in score changes . The olanzapine group had significant score reductions than the risperidone and FGAs groups in terms of the ESRS subjective total score and did not experience a significant increase in the dose of anticholinergics . The FGA group demonstrated that extrapyramidal syndrome ( EPS ) worsened under an increased dosage of anti-EPS drugs . Olanzapine was associated with significant body weight gain ( 2.69 ± 4.0 kg , p=0.026 ) , but there were no significant group differences on weight gain . CONCLUSIONS Haloperidol or trifluoperazine demonstrated similar efficacy as risperidone or olanzapine for patients with schizophrenia who had failed their first trial with a FGA . Related double-blind , fixed dose studies with a larger sample size are needed to confirm the results of our study",
"BACKGROUND Relatively little is known about the relationships between medication adherence and long-term functional outcomes in the treatment of schizophrenia . To extend previous research , we prospect ively examined the relationships between adherence with any antipsychotic medication and functional outcomes among schizophrenia patients treated over a 3-year period , assessed the stability of adherence over time , and examined whether adherence in the first year predicts changes in functional outcomes over the following 2 years . METHOD Analyses included 1906 participants with DSM-IV diagnoses of schizophrenia or schizoaffective or schizophreniform disorder in a multi-site , 3-year , prospect i ve , naturalistic study conducted in the United States between July 1997 and September 2003 . Outcome measures were assessed at 6-month intervals using systematic medical record abstract ion and structured interview of patients . Adherence with antipsychotic regimen was assessed using patient-reported adherence and the medication possession ratio ( percent days with prescription for any antipsychotic ) , dichotomized into adherence and non-adherence . Analyses employed generalized estimating equations and mixed models with repeated measures . RESULTS Nonadherence was associated with poorer functional outcomes , including greater risks of psychiatric hospitalizations , use of emergency psychiatric services , arrests , violence , victimizations , poorer mental functioning , poorer life satisfaction , greater substance use , and more alcohol-related problems ( all p Adherence was relatively stable , with 77.3 % of patients maintaining the same adherence status from the first year to the second year . Nonadherence in the first year predicted significantly poorer outcomes in the following 2 years . CONCLUSIONS Findings highlight the importance of adherence with antipsychotic medication in the long-term treatment of schizophrenia and its potential beneficial impact on the mental health and criminal justice delivery systems",
"The efficacy , safety and tolerability of ziprasidone versus the comparators olanzapine , risperidone or quetiapine were investigated in adult patients with chronic schizophrenia , schizoaffective and schizophreniform disorders , with lack of efficacy or intolerance to their previous antipsychotic treatment based on clinical judgement of the investigator . A total of 293 patients were r and omized to 12 weeks treatment with either ziprasidone 80–160 mg/day ( n=147 ) or with one of the comparator drugs ( n=146 ) . In the latter group the investigator could choose between olanzapine 10–20 mg/day ( n=24 ) , risperidone 4–8 mg/day ( n=22 ) or quetiapine 300–750 mg/day ( n=97 ) . The study comprised four visits including a baseline examination prior to r and omization and further examinations at the end of weeks 1 , 4 and 12 . Ziprasidone was non-inferior ( defined as a difference of = 7 units or less on the PANSS scale to the disadvantage of ziprasidone . ) to the composite group ( olanzapine , risperidone or quetiapine ) on the total PANSS score as well as on all subscores ( P in the CGI-S and I and UKU scores . Ziprasidone-treated patients lost an average of 2.1 kg in the 12 weeks of the study , the mean weight for risperidone and quetiapine remained unchanged , and patients receiving olanzapine gained 3.1 kg on average",
"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 relative effectiveness of second-generation ( atypical ) antipsychotic drugs as compared with that of older agents has been incompletely addressed , though newer agents are currently used far more commonly . We compared a first-generation antipsychotic , perphenazine , with several newer drugs in a double-blind study . METHODS A total of 1493 patients with schizophrenia were recruited at 57 U.S. sites and r and omly assigned to receive olanzapine ( 7.5 to 30 mg per day ) , perphenazine ( 8 to 32 mg per day ) , quetiapine ( 200 to 800 mg per day ) , or risperidone ( 1.5 to 6.0 mg per day ) for up to 18 months . Ziprasidone ( 40 to 160 mg per day ) was included after its approval by the Food and Drug Administration . The primary aim was to delineate differences in the overall effectiveness of these five treatments . RESULTS Overall , 74 percent of patients discontinued the study medication before 18 months ( 1061 of the 1432 patients who received at least one dose ) : 64 percent of those assigned to olanzapine , 75 percent of those assigned to perphenazine , 82 percent of those assigned to quetiapine , 74 percent of those assigned to risperidone , and 79 percent of those assigned to ziprasidone . The time to the discontinuation of treatment for any cause was significantly longer in the olanzapine group than in the quetiapine ( P risperidone ( P=0.002 ) group , but not in the perphenazine ( P=0.021 ) or ziprasidone ( P=0.028 ) group . The times to discontinuation because of intolerable side effects were similar among the groups , but the rates differed ( P=0.04 ) ; olanzapine was associated with more discontinuation for weight gain or metabolic effects , and perphenazine was associated with more discontinuation for extrapyramidal effects . CONCLUSIONS The majority of patients in each group discontinued their assigned treatment owing to inefficacy or intolerable side effects or for other reasons . Olanzapine was the most effective in terms of the rates of discontinuation , and the efficacy of the conventional antipsychotic agent perphenazine appeared similar to that of quetiapine , risperidone , and ziprasidone . Olanzapine was associated with greater weight gain and increases in measures of glucose and lipid metabolism",
"OBJECTIVE To assess the effectiveness of olanzapine for treating schizophrenia and to assess if olanzapine promotes a better quality of life than first-generation antipsychotics ( FGAs ) . METHOD Multicenter , naturalistic , r and omized controlled study , comparing olanzapine with FGAs , at hospitalization and during a 9-month follow-up . Outcome assessors were blind to the allocated drug . The dose of antipsychotic was determined by doctors according to their clinical practice routines . Data collection was performed from April 1999 to August 2001 . RESULTS 197 patients with DSM-IV-diagnosed schizophrenia were allocated to olanzapine ( N = 104 ) and FGA ( N = 93 ) . Patients taking olanzapine showed greater improvements in Positive and Negative Syndrome Scale ( PANSS ) negative symptoms ( mean difference = 2.3 , 95 % CI = 0.6 to 4.1 ) and general psychopathology ( mean difference = 4.0 , 95 % CI = 0.8 to 7.2 ) sub-scales and fewer incidences of tardive dyskinesia ( RR = 2.4 , 95 % CI = 1.4 to 4.2 , p Olanzapine was also associated with greater improvement in a number of health-related quality -of-life outcomes on the Medical Outcomes Study 36-item Short-Form Health Survey , including physical functioning ( mean difference = 6.6 , 95 % CI = 1.2 to 11.9 ) , physical role limitations ( mean difference = 13.7 , 95 % CI = 3.0 to 24.3 ) , and emotional role limitations ( mean difference = 12.1 , 95 % CI = 0.7 to 23.5 ) . Patients taking olanzapine gained significantly more weight during the trial than patients taking FGAs , with a correspondent endpoint increase in the body mass index ( BMI ) of 28.7 versus 25.3 ( p FGAs , olanzapine has advantages in terms of improvements of negative symptoms and quality of life . It is also associated with fewer incidences of tardive dyskinesia and greater increases in weight and BMI . These findings are highlighted by the naturalistic approach adopted in this trial",
"BACKGROUND This multicenter , double-blind , r and omized , controlled study conducted in China examined the efficacy and safety of olanzapine versus lithium in the treatment of patients with bipolar manic/mixed episodes . METHODS Patients with bipolar manic or mixed episode ( DSM-IV criteria ) and Young Mania Rating Scale ( YMRS ) score > or = 20 at screening received olanzapine ( 5 - 20 mg/day , n=69 ) or lithium carbonate ( 600 - 1800 mg/day , n=71 ) for 4 weeks . The primary outcome was mean change from baseline in Clinical Global Impressions-Bipolar Version Overall Severity of Illness ( CGI-BP ) score . Secondary efficacy measures included YMRS , Brief Psychiatric Rating Scale ( BPRS ) , and Montgomery-Asberg Depression Rating Scale ( MADRS ) scores . Safety was also assessed . RESULTS A significantly greater mean change was observed in olanzapine versus lithium patients in CGI-BP ( Overall Severity ) ( P=0.009 ) , YMRS ( P=0.013 ) , BPRS ( P=0.032 ) , and CGI-BP ( Severity of Mania ) ( P=0.012 ) scores . More olanzapine than lithium patients experienced at least one adverse event possibly related to study drug ( P=0.038 ) . More olanzapine patients had a clinical ly significant weight increase ( > or = 7 % of baseline weight ) compared to lithium patients ( P=0.009 ) . More olanzapine patients completed the study than lithium patients , although this difference was not statistically significant ( olz , 91.3 % ; lith , 78.9 % ; P=0.057 ) . LIMITATIONS No placebo arm was included ; however both treatments have previously been reported to be more effective than placebo . CONCLUSIONS These results suggest that olanzapine has superior efficacy to lithium in the acute treatment of patients with bipolar mania over a 4-week period . However , adverse events were experienced by a greater number of olanzapine patients than lithium patients",
"INTRODUCTION Although some previous studies have compared the 2 medicines , ziprasidone and olanzapine most selected chronic patients as subjects . Therefore , the present study was design ed to compare the efficacy and safety of ziprasidone vs. olanzapine in naive first-episode schizophrenia . METHODS 80 patients were r and omly assigned to a 6-week treatment either with 80 - 160 mg/day of ziprasidone or 10 - 20 mg/day of olanzapine . The primary efficacy measurements were the Positive and Negative Syndrome Scale and Clinical Global Impression-severity scale scores . The second efficacy measurement was the response rate of treatment . Tolerability assessment s were also performed . RESULTS 79 patients completed the trial . The average dose was 127.5 mg/day with ziprasidone and 19.1 mg/day with olanzapine . No significant differences were found between the 2 groups in primary or secondary efficacy measurements at each visit point ( all p>0.05 ) . Body weight significantly increased with olanzapine , and more extrapyramidal symptoms were observed with ziprasidone ( all p tolerated , and no serious adverse events were observed . CONCLUSION Ziprasidone was as effective as olanzapine in short-term treatment for first-episode schizophrenia , and both medicines were well tolerated",
"Neurocognitive deficits in schizophrenia can reach 1 to 2 st and ard deviations below healthy controls . The comparative effect of typical and atypical antipsychotic medications on neurocognition is controversial , and based primarily on studies with small sample s and large doses of typical comparator medications . The present study assessed neurocognitive efficacy . It was hypothesized that olanzapine treatment would improve neurocognitive deficits to a greater degree than either risperidone or haloperidol treatment . This was a double-blind , r and omized , controlled , parallel study with neurocognition assessed at baseline , and 8 , 24 , and 52 weeks . Per protocol , the haloperidol arm was discontinued . Four hundred and fourteen in patients or out patients with schizophrenia and schizoaffective disorder were treated with oral olanzapine ( n = 159 ) , risperidone ( n = 158 ) , or haloperidol ( n = 97 ) . Individual domains ( executive function , learning and memory , processing speed , attention/vigilance , verbal working memory , verbal fluency , motor function , and visuospatial ability ) were transformed into composite scores and compared between treatment groups . At the 52-week endpoint , neurocognition significantly improved in each group ( p olanzapine and risperidone , p = 0.04 for haloperidol ) , with no significant differences between groups . Olanzapine- and risperidone-treated patients significantly ( p domains of executive function , learning/memory , processing speed , attention/vigilance , verbal working memory , and motor functions . Additionally , risperidone-treated patients improved on domains of visuospatial memory . Haloperidol-treated patients improved only on domains of learning/memory . However , patients able to remain in treatment for the entire 52 weeks benefited more from olanzapine or risperidone treatment than haloperidol treatment",
"OBJECTIVE This international , multicenter double-blind trial was design ed to compare the therapeutic profile of an atypical antipsychotic , olanzapine , with that of a conventional dopamine D2 antagonist , haloperidol . METHOD A total of 1,996 patients at 174 sites in Europe and North America were r and omly assigned to treatment with olanzapine ( N = 1,336 ) or haloperidol ( N = 660 ) over 6 weeks . The primary efficacy analysis involved the mean change from baseline to endpoint in total scores on the Brief Psychiatric Rating Scale ( BPRS ) . Secondary analyses included comparisons of the mean change in positive and negative symptoms , comorbid depression , extrapyramidal symptoms , and overall drug safety . RESULTS Olanzapine demonstrated clinical results superior to those of haloperidol on overall improvement according to the BPRS and on every secondary measure , including depression . Olanzapine was also associated with significantly fewer discontinuations of treatment due to lack of drug efficacy or adverse events . Substantially more olanzapine-treated patients ( 66.5 % ) than haloperidol-treated patients ( 46.8 % ) completed 6 weeks of therapy . Statistically significant advantages of olanzapine treatment were related to 1 ) change in negative symptoms , 2 ) extrapyramidal symptom profile , 3 ) effect on prolactin levels , and 4 ) response rate . CONCLUSIONS Olanzapine shows a superior and broader spectrum of efficacy in the treatment of schizophrenic psychopathology , with a substantially more favorable safety profile , than haloperidol . It meets several of the criteria for a novel atypical antipsychotic agent",
"BACKGROUND There is little information about weight gain induced by antipsychotics at long-term . OBJECTIVE To quantify the weight gain induced by first ( haloperidol ) and second generation antipsychotics ( olanzapine and risperidone ) in a cohort of drug-naïve subjects after 1 year of treatment . METHODS This is a prospect i ve , r and omized clinical trial , including a representative sample of first episode psychotic incident cases from a population area of 555.000 people . The main outcome measures were changes in body weight and body mass index at 3 months and at 12 months . Both a per protocol analysis and an intention to treat analysis were conducted . RESULTS A total of 164 drug-naïve patients were included . At 12 months 144 patients were evaluated . Of them , 66 % completed the protocol and 34 % needed treatment switch . We found statistically significant differences in weight gain at 3 months : 3.8 kg ( + /-4.1 ) for haloperidol , 5.9 kg ( + /-5.1 ) for risperidone and 8.4 kg ( + /-5.0 ) for olanzapine ( F=7.045 ; p=0.002 ) . After 1 year the difference in weight gain had disappeared : 9.7 kg ( + /-5.7 ) for haloperidol , 8.9 kg ( + /-8.8 ) for risperidone and 10.9 kg ( + /-7.2 ) for olanzapine ( F=0.817 ; p=0.445 ) . CONCLUSIONS Drug-naïve patients experience an extraordinary weight gain after 1 year of treatment with haloperidol , olanzapine or risperidone . The main difference among these treatments is the pattern of weight gain but not the final amount of weight gain",
"OBJECTIVE Only a few Chinese medical journals have recommended CONSORT in their \" Instruction for authors or Guide for authors \" . This study aims to evaluate the reporting quality of r and omized controlled trials ( RCTs ) published in the five leading Chinese medical journals indexed by MEDLINE . METHODS We identified RCTs published from 2004 to January 2007 in five leading Chinese medical journals by search ing three important Chinese data bases systematic ally , namely CNKI ( China National Knowledge Infrastructure/Chinese Academic Journals full text Data base ) , VIP ( a full text data base of China ) and CBM disc ( China Biomedicine Data base Disc ) and assessed the quality of each RCT by using the Consoli date d St and ards for Reporting of Trials ( CONSORT ) and the 5-point Jadad scale . RESULTS One hundred and forty two RCTs were included . Based on the items in the revised CONSORT statement , 130 ( 91.55 % ) of the 142 RCTs mentioned \" r and omization \" in the title or abstract , but only 38 ( 26.76 % ) RCTs described the method to generate the r and om sequence ; only 6 RCTs had adequate allocation concealment ; 24 ( 17.61 % ) RCTs mentioned \" masking \" , but only 7 described the process of masking . Three out of 40 items were reported clearly in all included trials , while five items were not mentioned at all . The quality of RCTs was low as assessed by the Jadad scale and 22 RCTs were high- quality research ( > /=3 points ) . CONCLUSIONS The reporting quality of RCTs published in the five leading Chinese medical journals is low . Chinese journals should adopt the CONSORT statement to improve the reporting quality of Chinese r and omized controlled trials",
"Abstract : To determine predictors of substantial weight gain ( SWG ) during treatment of bipolar disorder with olanzapine , data were pooled from 4 long-term r and omized , multicenter studies in patients with bipolar mania or mixed mania ( N = 948 at initiation of olanzapine ) . SWG was defined as gaining 5 kg or 7 % of initial weight in 30 ± 2 weeks . Logistic regression estimated odds ratios associated with early weight gain and baseline risk factors for predicting SWG . A classification system to identify patients at risk for SWG was constructed by recursive data partitioning . Baseline characteristics significantly associated with SWG included younger age , nonwhite ethnicity , lower body mass index ( BMI ) , nonrapid cycling , and psychotic features . Weight gain of 2 or more kg in the first 3 weeks of therapy predicted SWG by 30 weeks ( sensitivity = 57 % ; specificity = 71 % ) . A classification system with thresholds for early weight gain , baseline BMI , and ethnicity further improved SWG predictability ( sensitivity = 79 % ; specificity = 70 % ) . In conclusion , patients with bipolar disorder who gained 2 to 3 kg during the first 3 weeks of treatment with olanzapine , SWG was predicted after 30 weeks of treatment . Patients with less pronounced early weight gain might still be at risk for later SWG if they have close to normal BMI ( ≤27 kg/m2 ) at treatment initiation",
"BACKGROUND Olanzapine has demonstrated efficacy in the treatment of acute mania in 2 double-blind , placebo-controlled trials . We describe the results of the open-label extension from one of these trials . METHOD In a 3-week , double-blind study of patients with DSM-IV bipolar I disorder , olanzapine was superior to placebo for the treatment of acute manic symptoms . Of the 139 patients who entered the double-blind phase of the 3-week study , 113 patients continued into the 49-week open-label extension . Efficacy measurements including the Young Mania Rating Scale ( YMRS ) , the 21-item Hamilton Rating Scale for Depression ( HAM-D-21 ) , the Clinical Global Impressions scale-Bipolar Version , and the Positive and Negative Syndrome Scale and safety measurements including the Simpson-Angus scale , the Barnes Akathisia Scale , and the Abnormal Involuntary Movement Scale were completed throughout . The analysis considered all treatment results , starting with the first olanzapine dose . Adjunctive lithium and fluoxetine were allowed during the open-label extension . RESULTS The mean length of olanzapine treatment was 6.6 months , with a mean modal dose of 13.9 mg/day . A significant mean improvement in the YMRS total score , baseline to endpoint ( -18.01 , p remission of manic symptoms ( YMRS total score relapsed ( YMRS total score > or = 15 ) . Significant improvement in HAM-D-21 scores was observed ( p olanzapine monotherapy . The most common treatment-emergent adverse events reported were somnolence ( 46.0 % ) , depression ( 38.9 % ) , and weight gain ( 36.3 % ) . CONCLUSION During up to 1 year of olanzapine therapy , either as monotherapy or in combination with lithium and /or fluoxetine , patients with bipolar disorder demonstrated significant improvement in mania and depression symptoms with a favorable safety profile . Further double-blind , controlled studies are needed to confirm these results",
"AIM To compare the pharmacokinetic profiles and dose proportionality of olanzapine in Chinese and Caucasian subjects . METHODS R and omized , three-period study with 12 Chinese and 12 Caucasian , healthy , male subjects administered 2.5 , 5 and 10 mg olanzapine . Noncompartmental pharmacokinetic parameters were derived . RESULTS No statistically significant racial differences in the weight-normalized pharmacokinetic parameters were observed except for Vz/Fnorm , which was 17 % lower at the 5- and 10-mg dose in the Chinese group ( 95 % confidence interval 8.49 , 10.1 and 8.05 , 9.73 , respectively ) , compared with the Caucasian group ( 9.53 , 12.8 and 9.39 , 12.0 , respectively ) . Olanzapine 's pharmacokinetics were linear and dose proportional in both racial groups . CONCLUSION The pharmacokinetics of olanzapine are similar in both Chinese and Caucasian racial groups",
"Atypical or second-generation antipsychotics ( SGAs ) are associated with excessive body weight gain ( BWG ) and other components of metabolic syndrome . Among all SGAs , clozapine and olanzapine are known to cause the most significant weight gain , followed by risperidone and quetiapine . The genetic variant of tumor necrosis factor α ( TNF-α ) , -308 G > A polymorphism ( rs1800629 ) , has been implicated in clozapine-induced BWG in several studies . We hypothesized that TNF-α -308 G > A polymorphism has a general effect on SGA-induced BWG . The present study was conducted to examine the association between TNF-α -308 G > A polymorphism and BWG during treatment for schizophrenia using a variety of second generation antipsychotics ( SGAs ) . A total of 500 patients with schizophrenia treated with clozapine ( n=275 ) , olanzapine ( n=79 ) or risperidone ( n=146 ) for an average of 49.9 months were recruited . Subjects with an increase in weight of more than 7 % from the baseline before the current SGA treatment to the weight at the survey point were defined as having BWG . The association between TNF-α -308 G > A polymorphism and BWG was studied , and the effect of non-genetic factors such as baseline BMI , SGA treatment duration and SGA type on the association was controlled by logistic regression . The results revealed that there was no significant association between BWG and TNF-α -308 G > A polymorphism ( GG/GA/AA or GG/GA+AA ) in each separate SGA group or collectively . These findings suggest that TNF-α -308 G > A polymorphism does not play a major role in SGA-induced weight gain",
"OBJECTIVE The safety and efficacy of risperidone and olanzapine were compared in a double-blind trial that used doses widely accepted in clinical practice . METHOD Subjects ( N=377 ) who met DSM-IV criteria for schizophrenia or schizoaffective disorder were r and omly assigned to receive 2 - 6 mg/day of risperidone ( mean modal dose=4.8 mg/day ) or 5 - 20 mg/day of olanzapine ( mean modal dose=12.4 mg/day ) for 8 weeks . RESULTS The two study groups were similar at baseline except that the olanzapine group was slightly younger than the risperidone group . Seventy-five percent of the participants completed the trial , with no between-treatment differences in the proportion of dropouts . Similar proportions of the risperidone and olanzapine groups reported extrapyramidal symptoms ( 24 % and 20 % , respectively ) . Severity of extrapyramidal symptoms was low in both groups , with no between-group differences . Total Positive and Negative Syndrome Scale scores and scores on the five Positive and Negative Syndrome Scale factors were improved in both groups at week 8 ( subjects who completed the study ) and endpoint ( all subjects , including dropouts ) . There were overall between-treatment differences in efficacy . Comparison of individual factors found no significant differences at endpoint ; at week 8 , however , improvements on Positive and Negative Syndrome Scale factors for positive symptoms and anxiety/depression were greater with risperidone than olanzapine . An increase in body weight of > or = 7 % was seen in 27 % of olanzapine participants and 12 % of risperidone participants . CONCLUSIONS Both treatments were well tolerated and efficacious . The frequency and severity of extrapyramidal symptoms were similar in the two treatment groups . Greater reductions in severity of positive and affective symptoms were seen with risperidone than with olanzapine treatment among study completers . There was no measure on which olanzapine was superior . Greater weight gain was associated with olanzapine than with risperidone treatment",
"OBJECTIVE The authors compared the effects of the two most commonly used atypical antipsychotics , risperidone and olanzapine , in elderly patients with schizophrenia . METHODS In an 8-week , international , double-blind study , patients ( out patients , hospital in patients , and residents of nursing or boarding homes ) were r and omly assigned to receive risperidone ( 1 mg to 3 mg/day ) or olanzapine ( 5 mg to 20 mg/day ) . The main outcome measures were changes in Positive and Negative Syndrome Scale ( PANSS ) total scores and rates of extrapyramidal symptoms ( EPS ) . RESULTS Subjects were 175 patients age 60 years or over with schizophrenia or schizoaffective disorder . The mean duration of illness was 36.5 years . Median doses were 2 mg/day of risperidone and 10 mg/day of olanzapine . PANSS total scores and four of the five PANSS factor scores ( positive symptoms , negative symptoms , disorganized thoughts , and anxiety/depression ) improved significantly at all time-points and at endpoint in both groups ; between-treatment differences were not significant . EPS-related adverse events were reported by 9.2 % of patients in the risperidone group and 15.9 % in the olanzapine group ; the between-treatment difference was not significant . Total scores on the Extrapyramidal Symptom Rating Scale were reduced in both groups at endpoint ; between-treatment differences were not significant . Clinical ly relevant weight gain was seen in both groups , but was significantly less frequent in risperidone patients than in olanzapine patients . CONCLUSIONS Stable elderly patients with chronic schizophrenia receiving appropriate doses of risperidone or olanzapine over an 8-week period experienced significant reductions in the severity of psychotic and extrapyramidal symptoms , with a relatively low risk of side effects",
"BACKGROUND Few studies have directly compared the efficacy and tolerability of atypical agents . METHODS This multicenter , r and omized , double-blind study compared the efficacy and tolerability of aripiprazole ( n = 355 ) with olanzapine ( n = 348 ) in patients with schizophrenia experiencing acute relapse . After a 6-week acute treatment phase , patients with Clinical Global Impression-Improvement = 1 - 3 or > or = 20 % reduction in the Positive and Negative Symptom Scale ( PANSS ) Total score could progress to the 46-week outpatient extension phase . Co- primary study objectives were to compare efficacy at Week 6 and weight gain liability from baseline to Week 26 . RESULTS The mean olanzapine dose was 15.4 mg/day compared with a mean aripiprazole dose of 23.0 mg/day . More patients treated with olanzapine ( 47 % ) completed the 52-week study than those treated with aripiprazole ( 39 % ) ; time to discontinuation was significantly in favor of olanzapine ( p change in PANSS Total score ( olanzapine , -29.5 ; aripiprazole , -24.6 [ r and om regression model ] ) showed a treatment difference of 4.9 points . As the pre-specified non-inferiority margin ( 6 points ) was within the 95 % confidence interval ( 2.2 - 7.6 ) for treatment difference , olanzapine proved to be superior to aripiprazole on this measure . More patients experienced significant weight gain at Week 26 with olanzapine ( 40 % ) than with aripiprazole ( 21 % ; p Mean weight gain at Week 26 was significantly greater with olanzapine than with aripiprazole ( + 4.30 kg vs. + .13 kg , respectively ) . CONCLUSIONS Olanzapine had a statistically significant efficacy advantage over aripiprazole , whereas aripiprazole was associated with significantly less weight gain",
"Most prescription pattern surveys have found a high rate of antipsychotic polypharmacy . To date few studies have investigated antipsychotic polypharmacy in Chinese patients with schizophrenia in general and out patients in particular . This study examined the frequency and sociodemographic and clinical correlates of antipsychotic polypharmacy in Hong Kong ( HK ) and Beijing ( BJ ) , China . Three hundred and ninety-eight clinical ly stable out patients with schizophrenia were r and omly selected and interviewed in HK and BJ using st and ardized assessment instruments . Antipsychotic polypharmacy was found in 17.6 % ( N=70 ) of the whole sample and in 28 % and 7.1 % of the HK and BJ sample s , respectively . Polypharmacy was associated with monthly income , severity of negative symptoms and extrapyramidal side effects ( EPS ) , use of depot antipsychotic and anticholinergic drugs , doses of antipsychotics , and the number of hospitalizations . In multiple logistic regression analysis , younger age , number of hospitalizations , site ( HK vs. BJ ) , and the use of depot antipsychotics were all significantly associated with antipsychotic polypharmacy . Although the ethnic and clinical characteristics of the two cohorts were nearly identical , there was a wide variation in the prescription frequency of antipsychotic polypharmacy between HK and BJ , suggesting that sociocultural and economical factors and traditions of psychiatric practice all played a role in determining antipsychotic polypharmacy . Clinicians should bear in mind that , at least for clinical ly stable patients , no scientifically sound therapeutic principles for antipsychotic polypharmacy exist",
"OBJECTIVE In a placebo-controlled , double-blind study , the authors investigated the efficacy and safety of olanzapine as monotherapy in relapse prevention in bipolar I disorder . METHOD Patients achieving symptomatic remission from a manic or mixed episode of bipolar I disorder ( Young Mania Rating Scale [ YMRS ] total score olanzapine were r and omly assigned to double-blind maintenance treatment with olanzapine ( N=225 ) or placebo ( N=136 ) for up to 48 weeks . The primary measure of efficacy was time to symptomatic relapse into any mood episode ( YMRS score > or = 15 , HAM-D score > or = 15 , or hospitalization ) . RESULTS Time to symptomatic relapse into any mood episode was significantly longer among patients receiving olanzapine ( a median of 174 days , compared with a median of 22 days in patients receiving placebo ) . Times to symptomatic relapse into manic , depressive , and mixed episodes were all significantly longer among patients receiving olanzapine than among patients receiving placebo . The relapse rate was significantly lower in the olanzapine group ( 46.7 % ) than in the placebo group ( 80.1 % ) . During olanzapine treatment , the most common emergent event was weight gain ; during the open-label phase , patients who received olanzapine gained a mean of 3.1 kg ( SD=3.4 ) . In double-blind treatment , placebo patients lost a mean of 2.0 kg ( SD=4.4 ) and patients who continued to take olanzapine gained an additional 1.0 kg ( SD=5.2 ) . CONCLUSIONS Compared to placebo , olanzapine delays relapse into subsequent mood episodes in bipolar I disorder patients who responded to open-label acute treatment with olanzapine for a manic or mixed episode",
"OBJECTIVE The efficacy and safety of olanzapine were compared with those of ziprasidone . METHOD This was a multicenter r and omized , double-blind , parallel-group , 28-week study of patients with schizophrenia . Patients were r and omly assigned to treatment with 10 - 20 mg/day of olanzapine or 80 - 160 mg/day of ziprasidone . The primary efficacy measure was the Positive and Negative Syndrome Scale total score . Secondary efficacy and safety measures included Positive and Negative Syndrome Scale subscales as well as mood , quality of life , and extrapyramidal symptom scales . Safety was evaluated by recording treatment-emergent adverse events and measuring vital signs and weight . RESULTS The study was completed by significantly more olanzapine-treated patients ( 165 of 277 , 59.6 % ) than ziprasidone-treated patients ( 115 of 271 , 42.4 % ) . At 28 weeks , the olanzapine-treated patients showed significantly more improvement than the ziprasidone-treated patients on the Positive and Negative Syndrome Scale overall scale and all subscales and on the Clinical Global Impression ratings of severity of illness and improvement . The responder rate was higher for olanzapine than for ziprasidone . Extrapyramidal symptoms were not significantly different between groups in change-to-endpoint analyses , but results favored olanzapine on baseline-to-maximum changes . Weight change was significantly greater with olanzapine ( mean=3.06 kg , SD=6.87 ) than with ziprasidone ( mean=-1.12 kg , SD=4.70 ) . Fasting lipid profiles were significantly superior in the ziprasidone group ; there was no significant difference in fasting glucose level . CONCLUSIONS Olanzapine treatment result ed in significantly greater psychopathology improvement and higher response and completion rates than ziprasidone treatment , while ziprasidone was superior for weight change and lipid profile",
"OBJECTIVES The objectives of this study were : ( 1 ) to investigate , in a clinical practice setting , the effectiveness of olanzapine in the treatment of schizophrenia among partially-responding , symptomatic Asian patients who switch from conventional antipsychotic treatment , ( 2 ) to assess the safety of olanzapine and ( 3 ) to assess the change in quality of life in Asian patients with schizophrenia who switch to olanzapine . METHODS Effectiveness , safety and quality of life were assessed in out patients with schizophrenia ( n=1267 ) who lacked symptomatic control with conventional antipsychotics and were switched to olanzapine therapy . Data for this prospect i ve , observational study were collected for 12 months from Asian patients in China , Hong Kong , the Philippines , South Korea and Taiwan . RESULTS Significant clinical improvements ( P olanzapine treatment and 87.3 % of the subjects responded to treatment at endpoint ( i.e. Brief Psychiatric Rating Scale Total score reduced by > or = 30 % relative to baseline ; last observation carried forward ) . Abnormal involuntary movements ( mean change in Abnormal Involuntary Movement Scale : -3.20 , P quality of life were significantly improved in patients treated with olanzapine . However , some patients experienced significant weight gain ( 3.60+/-4.50 kg , P olanzapine may be effective in improving symptoms , may be well-tolerated and may improve the quality of life in Asian patients who are only partially responsive to treatment with conventional antipsychotics . The pragmatic design and naturalistic setting of this large study make the findings relevant for treating patients from some Asian countries in routine clinical practice",
"The objective of this study was to compare the effects of risperidone and olanzapine in schizophrenic patients with intolerant extrapyramidal side effects ( EPS ) on first generation antipsychotics . We conducted an 8-week , rater-blinded , flexible dose study . Seventy patients with schizophrenia , who met the DSM-IV research criteria of having neuroleptic-induced acute dystonia or parkinsonism , were r and omly assigned to risperidone or olanzapine group . The primary outcome was a comparison of the incidence of concomitant anticholinergic drugs usage between the groups to manage their acute dystonia and parkinsonism . The average doses of risperidone and olanzapine from baseline to study end point were 1.8—3.5 mg/day and 7.7—11.7 mg/day , respectively . There were no significant differences in demographic data , severity of EPS or psychotic symptoms between the groups at baseline assessment . Patients taking risperidone had significantly higher incidence of using anticholinergic drugs to manage acute dystonia or parkinsonism overall during the study ( OR = 5.17 , 95%CI = 1.49—17.88 , P = 0.013 ) . There was no significant between-group difference in the changing of rating scales of EPS and psychotic symptoms . The results of our study favour olanzapine as a better choice in schizophrenic patients with intolerant EPS . Double-blinded , fixed dose and different ethnical study for EPS-intolerant schizophrenic patients is needed to confirm the results of our study",
"The aim of this study was to compare the 12-month effectiveness of several second-generation antipsychotic drugs , with that of haloperidol in never-treated patients with first-episode psychosis . In total , 114 patients without life time exposure to any psychotropic medication were r and omized to haloperidol , olanzapine , risperidone , quetiapine or ziprasidone . Primary outcome was time to all-cause discontinuation . Secondary outcomes included discontinuation rates and symptom change as measured by the Positive and Negative Syndrome Scale ( PANSS ) . The overall discontinuation rate 64 % . At 12 months , the proportion of patients discontinuing treatment was 40.0 % for olanzapine , 56.5 % for quetiapine , 64.0 % for risperidone , 80.0 % for ziprasidone and 85.7 % for haloperidol . Mean time to antipsychotic discontinuation was higher in patients r and omized to second-generation antipsychotics than in those taking haloperidol . Significantly lower discontinuation was noted in patients on olanzapine than on haloperidol , or ziprasidone . Our results suggest that olanzapine might lead to longer treatment continuation in treatment naïve FEP patients than haloperidol and , possibly ziprasidone . Global psychopathology was significantly less reduced by haloperidol than with each individual SGA in this earliest phase of treatment",
"Antipsychotic discontinuation rates are a powerful indicator of medication effectiveness in schizophrenia . We examined antipsychotic discontinuation in the Schizophrenia Outpatient Health Outcomes ( SOHO ) study , a 3-year prospect i ve , observational study in out patients with schizophrenia in 10 European countries . Patients ( n=7728 ) who started antipsychotic monotherapy were analyzed . Medication discontinuation for any cause ranged from 34 % and 36 % for clozapine and olanzapine , respectively , to 66 % for quetiapine . Compared to olanzapine , the risk of treatment discontinuation before 36 months was significantly higher for quetiapine , risperidone , amisulpride , and typical antipsychotics ( oral and depot ) , but similar for clozapine . Longer medication maintenance was associated with being socially active and having a longer time since first treatment contact for schizophrenia , whereas higher symptom severity , treatment with mood stabilizers , substance abuse , having hostile behaviour were associated with lower medication maintenance . Antipsychotic maintenance in SOHO was higher than the results of previous r and omized studies"
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BACKGROUND The composition of the intestinal microflora may be different in individuals with atopic eczema from those without this condition , and such differences may precede the development of eczema . Prebiotics are nondigestible food components that benefit the host by selectively stimulating the growth or activity of non-pathogenic bacteria in the colon . Prebiotics ( commonly oligosaccharides ) added to infant feeds have the potential to prevent sensitisation of infants to dietary allergens . OBJECTIVES To determine the effect of prebiotics given to infants for the prevention of allergic disease or food hypersensitivity . SEARCH STRATEGY This included search es of the Cochrane Central Register of Controlled Trials ( Issue 1 , 2007 ) , MEDLINE ( 1966 - February 2007 ) , EMBASE , PRE MEDLINE , abstract s of conference proceedings and citations of published articles , and expert informants . SELECTION CRITERIA R and omised and quasi-r and omised controlled trials that compared the use of a prebiotic to no prebiotic ; or the use a specific prebiotic compared to a different prebiotic . DATA COLLECTION AND ANALYSIS Assessment of trial quality , data extraction and synthesis of data were performed using st and ard methods of the Cochrane Neonatal Review Group . MAIN RESULTS Seven studies were eligible for inclusion . Only two studies reported an allergic disease outcome for 432 infants . Study quality was reasonable , although Moro 2006 reported 20 % post-r and omisation losses . Moro 2006 enrolled hydrolysed formula fed infants at high risk of allergy and reported a significant reduction in eczema in infants up to six months of age ( RR 0.42 , 95 % CI 0.21 , 0.84 ) . Ziegler 2007 enrolled formula fed infants who were not selected on the basis of risk for allergy and reported no significant difference in eczema up to four months of age ( RR 1.62 , 95 % CI 0.62 , 4.26 ) . Meta- analysis of the two studies found no significant difference in eczema , but significant heterogeneity was detected . Differences were potentially attributable to differences in infant risk , prebiotic formulation or measurement of eczema . Analysis of five studies reporting measures of infant growth found no consistent adverse effects . AUTHORS ' CONCLUSIONS There is insufficient evidence to determine the role of prebiotic supplementation of infant formula for prevention of allergic disease and food hypersensitivity . One small trial of prebiotic oligosaccharides with excess losses reported a reduction in eczema in high risk formula fed infants . Further trials are needed to determine whether this finding persists over a longer period of time , applies to other manifestations of allergic disease , is associated with reductions in allergen sensitisation , and is reproducible
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"OBJECTIVE To determine whether probiotic lactobacilli may alleviate small intestinal inflammation and strengthen the intestinal barrier function in children with atopic dermatitis . STUDY DESIGN In a double-blinded , placebo-controlled , cross-over study , probiotic lactobacilli ( Lactobacillus rhamnosus 19070 - 2 and L reuteri DSM 12246 ) were administered for 6 weeks to 41 children with moderate and severe atopic dermatitis . Gastrointestinal symptoms were registered before and during treatment and small intestinal permeability was measured by the lactulose-mannitol test . RESULTS During Lactobacillus supplementation , there was a significant decrease in the frequency of gastrointestinal symptoms ( 39 % during the placebo period versus 10 % during active treatment , P=.002 ) . There was a positive association between the lactulose to mannitol ratio and the severity of the eczema ( r=0.61 , P=.02 after placebo and r=0.53 , P=.05 after active treatment ) . After probiotic treatment , the lactulose to mannitol ratio was lower ( 0.073 ) than after placebo ( 0.110 , P=.001 ) . CONCLUSIONS Impairment of the intestinal mucosal barrier appears to be involved in the pathogenesis of atopic dermatitis . The study suggests that probiotic supplementation may stabilize the intestinal barrier function and decrease gastrointestinal symptoms in children with atopic dermatitis",
"BACKGROUND The gastrointestinal microflora is an important constituent of the gut mucosal defense barrier . We have previously shown that a human intestinal floral strain , Lactobacillus GG ( ATCC 53103 ) , promotes local antigen-specific immune responses ( particularly in the IgA class ) , prevents permeability defects , and confers controlled antigen absorption . OBJECTIVE The aim of this study was to evaluate the clinical and immunologic effects of cow 's milk elimination without ( n = 14 ) and with ( n = 13 ) the addition of Lactobacillus GG ( 5 x 10(8 ) colony-forming units/gm formula ) in an extensively hydrolyzed whey formula in infants with atopic eczema and cow 's milk allergy . The second part of the study involved 10 breast-fed infants who had atopic eczema and cow 's milk allergy . In this group Lactobacillus GG was given to nursing mothers . METHODS The severity of atopic eczema was assessed by clinical scoring . The concentrations of fecal alpha 1- antitrypsin , tumor necrosis factor-alpha , and eosinophil cationic protein were determined as markers of intestinal inflammation before and after dietary intervention . RESULTS The clinical score of atopic dermatitis improved significantly during the 1-month study period in infants treated with the extensively hydrolyzed whey formula fortified with Lactobacillus GG . The concentration of alpha 1-antitrypsin decreased significantly in this group ( p = 0.03 ) but not in the group receiving the whey formula without Lactobacillus GG ( p = 0.68 ) . In parallel , the median ( lower quartile to upper quartile ) concentration of fecal tumor necrosis factor-alpha decreased significantly in this group , from 709 pg/gm ( 91 to 1131 pg/gm ) to 34 pg/gm ( 19 to 103 pg/gm ) ( p = 0.003 ) , but not in those receiving the extensively hydrolyzed whey formula only ( p = 0.38 ) . The concentration of fecal eosinophil cationic protein remained unaltered during therapy . CONCLUSION These results suggest that probiotic bacteria may promote endogenous barrier mechanisms in patients with atopic dermatitis and food allergy , and by alleviating intestinal inflammation , may act as a useful tool in the treatment of food allergy",
"ABSTRACT A healthy intestinal microbiota is considered to be important for priming of the infants ' mucosal and systemic immunity . Breast-fed infants typically have an intestinal microbiota dominated by different Bifidobacterium species . It has been described that allergic infants have different levels of specific Bifidobacterium species than healthy infants . For the accurate quantification of Bifidobacterium adolescentis , Bifidobacterium angulatum , Bifidobacterium bifidum , Bifidobacterium breve , Bifidobacterium catenulatum , Bifidobacterium dentium , Bifidobacterium infantis , and Bifidobacterium longum in fecal sample s , duplex 5′ nuclease assays were developed . The assays , targeting rRNA gene intergenic spacer regions , were vali date d and compared with conventional PCR and fluorescent in situ hybridization methods . The 5′ nuclease assays were subsequently used to determine the relative amounts of different Bifidobacterium species in fecal sample s from infants receiving a st and ard formula or a st and ard formula supplemented with galacto- and fructo-oligosaccharides ( OSF ) . A breast-fed group was studied in parallel as a reference . The results showed a significant increase in the total amount of fecal bifidobacteria ( 54.8 % ± 9.8 % to 73.4 % ± 4.0 % ) in infants receiving the prebiotic formula ( OSF ) , with a diversity of Bifidobacterium species similar to breast-fed infants . The intestinal microbiota of infants who received a st and ard formula seems to resemble a more adult-like distribution of bifidobacteria and contains relatively more B. catenulatum and B. adolescentis ( 2.71 % ± 1.92 % and 8.11 % ± 4.12 % , respectively , versus 0.15 % ± 0.11 % and 1.38 % ± 0.98 % for the OSF group ) . In conclusion , the specific prebiotic infant formula used induces a fecal microbiota that closely resembles the microbiota of breast-fed infants also at the level of the different Bifidobacterium species",
"OBJECTIVE . The goal was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospect i ve r and omized study would improve symptoms of infantile colic . METHODS . Ninety breastfed colicky infants were assigned r and omly to receive either the probiotic L reuteri ( 108 live bacteria per day ) or simethicone ( 60 mg/day ) each day for 28 days . The mothers avoided cow 's milk in their diet . Parents monitored daily crying times and adverse effects by using a question naire . RESULTS . Eighty-three infants completed the trial : 41 in the probiotic group and 42 in the simethicone group . The infants were similar regarding gestational age , birth weight , gender , and crying time at baseline . Daily median crying times in the probiotic and simethicone groups were 159 minutes/day and 177 minutes/day , respectively , on the seventh day and 51 minutes/day and 145 minutes/day on the 28th day . On day 28 , 39 patients ( 95 % ) were responders in the probiotic group and 3 patients ( 7 % ) were responders in the simethicone group . No adverse effects were reported . CONCLUSIONS . In our cohort , L reuteri improved colicky symptoms in breastfed infants within 1 week of treatment , compared with simethicone , which suggests that probiotics may have a role in the treatment of infantile colic",
"Background : The aim of the study was to investigate the effects of probiotics on moderate or severe atopic dermatitis ( AD ) in young children . Methods : Fifty six children aged 6–18 months with moderate or severe AD were recruited into a r and omised double blind placebo controlled trial in Perth , Western Australia ; 53 children completed the study . The children were given a probiotic ( 1 × 109Lactobacillus fermentum VRI-033 PCC ; Probiomics ) or an equivalent volume of placebo , twice daily for 8 weeks . A final assessment at 16 weeks was performed . Results : The main outcome measures were severity and extent of AD at the end of the study , as measured by the Severity Scoring of Atopic Dermatitis ( SCORAD ) index . The reduction in the SCORAD index over time was significant in the probiotic group ( p = 0.03 ) but not the placebo group . Significantly more children receiving probiotics ( n = 24 , 92 % ) had a SCORAD index that was better than baseline at week 16 compared with the placebo group ( n = 17 , 63 % ) ( p = 0.01 ) . At the completion of the study more children in the probiotic group had mild AD ( n = 14 , 54 % ) compared to the placebo group ( n = 8 , 30 % ) . Conclusion : Supplementation with probiotic L fermentum VRI-003 PCC is beneficial in improving the extent and severity of AD in young children with moderate or severe disease ",
"Perinatal administration of the probiotic Lactobacillus rhamnosus strain GG ( ATCC 53103 ) , reduces incidence of atopic eczema in at-risk children during the first 2 years of life ( infancy ) . We have therefore assessed persistence of the potential to prevent atopic eczema at 4 years . Atopic disease was diagnosed on the basis of a question naire and a clinical examination . 14 of 53 children receiving lactobacillus had developed atopic eczema , compared with 25 of 54 receiving placebo ( relative risk 0.57 , 95 % CI 0.33 - 0.97 ) . Skin prick test reactivity was the same in both groups : ten of 50 children previously given lactobacillus compared with nine of 50 given placebo tested positive . Our results suggest that the preventive effect of lactobacillus GG on atopic eczema extends beyond infancy",
"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",
"ABSTRACT The gastrointestinal microbiota of preterm infants in a neonatal intensive care unit differs from that of term infants . In particular , the colonization of preterm infants by bifidobacteria is delayed . A double-blind , placebo-controlled , r and omized clinical study was performed on 69 preterm infants to investigate the role of Bifidobacterium lactis Bb12 supplementation in modifying the gut microbiota . Both culture-dependent and culture-independent approaches were used to study the gut microbiota . Bifidobacterial numbers , determined by fluorescence in situ hybridization , were significantly higher in the probiotic than in the placebo group ( log10 values per g of fecal wet weight : probiotic , 8.18 + 0.54 [ st and ard error of the mean ] ; placebo , 4.82 + 0.51 ; P bifidobacterial numbers was also obtained with the culture-dependent method . The infants supplemented with Bb12 also had lower viable counts of Enterobacteriaceae ( log10 values of CFU per g of fecal wet weight : probiotic , 7.80 + 0.34 ; placebo , 9.03 + 0.35 ; P = 0.015 ) and Clostridium spp . ( probiotic , 4.89 + 0.30 ; placebo , 5.99 + 0.32 ; P = 0.014 ) than the infants in the placebo group . Supplementation of B. lactis Bb12 did not reduce the colonization by antibiotic-resistant organisms in the study population . However , the probiotic supplementation increased the cell counts of bifidobacteria and reduced the cell counts of enterobacteria and clostridia",
"Background : Recent data have outlined a relationship between the composition of the intestinal microflora and allergic inflammation , and demonstrated the competence of probiotics in downregulation of such inflammation . Aims : Our aims were to characterise the relationship between gut microbes and the extent of allergic sensitisation and to assess whether the efficacy of bifidobacterial supplementation in the treatment of allergy could relate to modulation of the intestinal microbiota . Methods : This r and omised study included 21 infants with early onset atopic eczema of whom eight were intolerant ( highly sensitised group ( HSG ) ) and 13 tolerant ( sensitised group ( SG ) ) to extensively hydrolysed whey formula ( EHF ) . In the SG , six were weaned to EHF without ( placebo group ( PG ) ) and seven to EHF with Bifidobacterium lactis Bb-12 supplementation ( bifidobacteria treated group ( BbG ) ) . The faecal microflora of infants in the HSG was analysed only before weaning whereas in the SG the faecal microflora was analysed both before and after weaning . Results : Infants in the HSG had greater numbers of lactobacilli/enterococci than those in the SG . Serum total IgE concentration correlated directly with Escherichia coli counts in all infants and with bacteroides counts in the HSG , indicating that the presence of these bacteria is associated with the extent of atopic sensitisation . The effect of supplementation was characterised as a decrease in the numbers of Escherichia coli and protection against an increase in bacteroides numbers during weaning . Conclusions : These data indicate that bifidobacterial supplementation appears to modify the gut microbiota in a manner that may alleviate allergic inflammation . Further studies are needed to confirm this conclusion",
"Fructo-oligosaccharides ( FOS ) are widely used in commercial food products . Most studies on FOS concern the health benefits , but some negative effects were recently reported concerning the faecal cytotoxicity and excretion of mucin-type oligosaccharides in combination with a Ca-restricted diet . The present study was performed to investigate whether these effects of FOS are observed in adults consuming a regular diet unrestricted in Ca . The study was a r and omised , double-blind , placebo-controlled crossover trial , involving eleven healthy adults , who consumed 25 - 30 g FOS or maltodextrin ( control ) in a r and om order for 2 weeks in addition to their regular diet . Stools were collected for analysis of pH and SCFA ( as markers of fermentation ) , for the assessment of faecal water cytotoxicity , and for the analysis of alkaline phosphatase activity ( as a marker of epithelial cell turnover ) and O-linked oligosaccharides ( to estimate the excretion of mucin-type oligosaccharides ) . FOS consumption significantly altered bacterial fermentation ( increased percentage of acetate , decreased percentage of butyrate ) and tended to decrease stool pH. Furthermore , FOS consumption result ed in a significantly higher stool frequency and in significantly more complaints of flatulence . No significant differences between the control and FOS period were observed in the mean cytotoxicity of faecal water ( 37.5 ( SEM 6.9)% v. 18.5 ( SEM 6.9)% ; P=0.084 ) , in mean alkaline phosphatase activity ( 27.7 ( SEM 2.9 ) v. 24.6 ( SEM 3.2 ) U/g dry faeces ; P=0.496 ) or in the mean excretion of mucin-type oligosaccharides ( 49.9 ( sem 4.0 ) v. 53.5 ( SEM 4.3 ) mg/g dry faeces ; P=0.553 ) . We conclude that dietary FOS in a dose up to 25 - 30 g/d altered the bacterial fermentation pattern but did not affect faecal cytotoxicity or the faecal concentration of mucin-type oligosaccharides in human adults consuming a regular diet",
"Probiotic bacteria are proposed to alleviate intestinal inflammation in infants with atopic eczema/dermatitis syndrome ( AEDS ) and food allergy . In such infants we investigated effects of probiotic bacteria on faecal IgA , and on the intestinal inflammation markers tumour necrosis factor-alpha ( TNF-alpha ) , alpha1-antitrypsin ( AT ) , and eosinophil cationic protein ( ECP ) . A total of 230 infants with AEDS and suspected cow 's milk allergy ( CMA ) received in a r and omized double-blinded manner , concomitant with elimination diet , Lactobacillus GG ( LGG ) , a mixture of four probiotic strains ( MIX ) , or placebo for 4 wk . Four weeks after treatment , CMA was diagnosed with a double-blind placebo-controlled milk challenge . Faecal sample s of 102 infants , r and omly chosen for analysis , were collected before treatment , after 4-wk treatment , and on the first day of milk challenge . After treatment , IgA levels tended to be higher in probiotic groups than in the placebo group ( LGG vs. placebo , p=0.064 ; MIX vs. placebo , p=0.064 ) , and AT decreased in the LGG group , but not in other treatment groups . After challenge in IgE-associated CMA infants , faecal IgA was higher for LGG than for placebo ( p=0.014 ) , and TNF-alpha was lower for LGG than for placebo , but non-significantly ( p=0.111 ) . In conclusion , 4-wk treatment with LGG may alleviate intestinal inflammation in infants with AEDS and CMA",
"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 Reversal of the progressive increase in frequency of atopic disease would be an important breakthrough for health care and wellbeing in western societies . In the hygiene hypothesis this increase is attributed to reduced microbial exposure in early life . Probiotics are cultures of potentially beneficial bacteria of the healthy gut microflora . We assessed the effect on atopic disease of Lactobacillus GG ( which is safe at an early age and effective in treatment of allergic inflammation and food allergy ) . METHODS In a double-blind , r and omised placebo-controlled trial we gave Lactobacillus GG prenatally to mothers who had at least one first-degree relative ( or partner ) with atopic eczema , allergic rhinitis , or asthma , and postnatally for 6 months to their infants . Chronic recurring atopic eczema , which is the main sign of atopic disease in the first years of life , was the primary endpoint . FINDINGS Atopic eczema was diagnosed in 46 of 132 ( 35 % ) children aged 2 years . Asthma was diagnosed in six of these children and allergic rhinitis in one . The frequency of atopic eczema in the probiotic group was half that of the placebo group ( 15/64 [ 23 % ] vs 31/68 [ 46 % ] ; relative risk 0.51 [ 95 % CI 0.32 - 0.84 ] ) . The number needed to treat was 4.5 ( 95 % CI 2.6 - 15.6 ) . INTERPRETATIONS Lactobacillus GG was effective in prevention of early atopic disease in children at high risk . Thus , gut microflora might be a hitherto unexplored source of natural immunomodulators and probiotics , for prevention of atopic disease",
"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",
"Antibiotics exert deleterious effects on the intestinal microbiota , favoring the emergence of opportunistic bacteria and diarrhea . Prebiotics are nondigestible food components that stimulate the growth of bifidobacteria . Our aim was to evaluate the effects on the intestinal microbiota of a prebiotic-supplemented milk formula after an antibiotic treatment . A r and omized , double-blind , controlled clinical trial was carried out in 140 infants 1–2 y of age distributed into two groups after a 1-wk amoxicillin treatment ( 50 mg/kg/d ) for acute bronchitis . The children received for 3 wk > 500 mL/d of a formula with prebiotics ( 4.5 g/L ) or a control without prebiotics . Fecal sample s were obtained on d –7 ( at the beginning of the antibiotic treatment ) , on d 0 ( end of the treatment and before formula administration ) , and on d 7 and 21 ( during formula administration ) . Counts of Bifidobacterium , Lactobacillus-Enterococcus , Clostridium lituseburiense cluster , Clostridium histolyticum cluster , Escherichia coli , and Bacteroides-Prevotella were evaluated by fluorescent in situ hybridization ( FISH ) and flow cytometry . Tolerance and gastrointestinal symptoms were recorded daily . Amoxicillin decreased total fecal bacteria and increased E. coli . The prebiotic significantly increased bifidobacteria from 8.17 ± 1.46 on d 0 to 8.54 ± 1.20 on d 7 compared with the control 8.22 ± 1.24 on d 0 versus 7.95 ± 1.54 on d 7 . The Lactobacillus population showed a similar tendency while the other bacteria were unaffected . No gastrointestinal symptoms were detected during the prebiotic administration . Prebiotics in a milk formula increase fecal bifidobacteria early after amoxicillin treatment without inducing gastrointestinal symptoms ",
"Objective : To determine whether long-term consumption of a fermented infant formula could influence the incidence of acute diarrhea and its severity in healthy infants . Method : Nine hundred seventy-one infants , ranging in age from 4 to 6 months , were included in a r and omized , double-blind , placebo-controlled trial during a period of 5 months . They consumed daily either a fermented infant formula ( FF ) ( fermentation with Bifidobacterium breve C50 and Streptococcus thermophilus 065 ) or a st and ard infant formula ( SF ) of the same nutritional composition . Evaluation Criteria : Number and duration of acute diarrhea episodes were evaluated . Severity of the episodes was determined by the number of hospital admissions , incidence of dehydration , number of medical consultations , number of oral rehydration solution prescriptions , and number of formula switches . Results : Growth of the infants and acceptability of the formulas were identical in the two groups . Incidence , duration of diarrhea episodes , and number of hospital admissions did not differ significantly between groups . Episodes were less severe in the FF ( fermented formula ) group . There were fewer cases of dehydration 2.5%versus 6.1 % ( P = 0.01 ) , fewer medical consultations ( 46%v 56.6 % , P = 0.003 ) , fewer ORS prescriptions 41.9%v 51.9 % ( P = 0.003 ) and fewer switches to other formulas ( 59.5%v 74.9 % , P = 0.0001 ) in FF infants compared to SF . Conclusion : A fermented formula may reduce the severity of acute diarrhea among healthy young infants . This outcome may be linked to the bifidogenic effects of fermentation products and their interactions with the intestinal immune system",
"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",
"Background : The establishment of a balanced intestinal microflora which may protect against infection is desirable for the preterm infant . Objective : To investigate the effect of a preterm formula milk supplement consisting of oligosaccharides in similar proportions to human milk on the faecal flora and stool characteristics of preterm infants . Study design : To resemble the effect of human milk , an oligosaccharide mixture consisting of 90 % galacto-oligosaccharides and 10 % fructo-oligosaccharides was used to supplement a st and ard preterm formula at a concentration of 10 g/l . This supplemented formula was studied in 15 preterm infants , and the results were compared with those found in 15 infants fed a formula supplemented with maltodextrin as placebo . A group fed fortified mother 's milk was investigated as a reference group ( n = 12 ) . On four days during a 28 day feeding period ( 1 , 7 , 14 , and 28 ) , the faecal flora was investigated , and stool characteristics , growth , and possible side effects were recorded . Results : During the study period , the number of bifidobacteria in the group fed the oligosaccharide supplemented formula increased to the upper range of bifidobacteria counts in the reference group . The difference between the supplemented and non-supplemented groups was highly significant ( p = 0.0008 ) . The stool characteristics were also influenced by the supplement : the stool frequency after 28 days was significantly lower in the control group than in the oligosaccharide supplemented group ( p = 0.0079 ) and the reference group ( p stool consistency in the control group became harder , but remained fairly stable in the other two groups . There was no effect of the different diets on the incidence of side effects ( crying , regurgitation , vomiting ) or on weight gain or length gain . Conclusion : Supplementing preterm formula with a mixture of galacto- and fructo-oligosaccharides at a concentration of 10 g/l stimulates the growth of bifidobacteria in the intestine and results in stool characteristics similar to those found in preterm infants fed human milk . Therefore prebiotic mixtures such as the one studied may help to improve intestinal tolerance to enteral feeding in preterm infants",
"Background : Human milk components , including oligosaccharides , affect the gastrointestinal flora of infants . Previous studies in adults have demonstrated that fructo-oligosaccharides increase potentially beneficial fecal bacteria , including bifidobacteria . The purpose of this study was to determine the prebiotic effect of infant formula supplemented with fructo-oligosaccharides . Methods : Healthy term infants 2 to 6 weeks of age were enrolled in a 5-week , prospect i ve , r and omized , crossover , single-site study with a nonr and omized human milk comparator group . Washout weeks preceded and followed a week of feeding with fructo-oligosaccharide-supplemented formula ( 1.5 or 3.0 g/L ) . Stool specimens were quantitatively cultured weekly for bacteroides , lactobacilli , bifidobacteria , clostridia and enterococci and were tested for Clostridium difficile toxin . Results : Seventy-two of 87 infants completed the trial ; 58 were formula fed and 14 were human milk fed . Mean counts of bifidobacteria and lactobacilli were similar in all groups at entry and no group experienced a significant change in counts with fructo-oligosaccharide supplementation . After 7 days of fructo-oligosaccharide supplementation the bifidobacteria counts were greater in the 1.5 g/L fructo-oligosaccharide formula group than in the human milk fed or 3.0 g/L fructo-oligosaccharide formula groups . Formula-fed infants had higher counts of enterococci and bacteroides before fructo-oligosaccharide supplementation , and these counts did not change after supplementation . Clostridium counts increased 7 days after supplementation in the 1.5 g/L fructo-oligosaccharide formula group ( P = 0.0356 ) . No human milk fed infants had C. difficile toxin in stools . Fructo-oligosaccharide ( 3.0 g/L ) supplementation result ed in more frequent and significantly softer stools . Conclusions : Infant formula supplemented with 1.5 or 3.0 g/L fructo-oligosaccharides was safe but had minimal effect on fecal flora and C. difficile toxin",
"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",
"Screening of total IgE in 1189 cord blood sample s was conducted by Phadebas IgE PRIST in a one-year birth cohort 1983 - 1984 in Viborg , Denmark . 113 children with cord blood IgE levels > or = 0.5 kU/l and 138 children chosen at r and om among those with cord blood IgE levels at 5 years of age . Based upon history and physical examination a diagnosis of definite atopy or no atopy was established . Allergy ( IgE mediated ) was defined as atopic disease combined with increased total IgE levels at 5 years of age . The cumulative prevalence of atopic disease was not influenced by cord blood IgE levels or atopic predisposition . Cord blood IgE levels had a low sensitivity as a predictor of atopic disease . A statistically significant correlation between serum levels of IgE at birth and at 5 years was however found ( p elevated cord blood IgE levels developed allergic disease before 5 years of age ( p total IgE level > 63 kU/l ( geometric mean + 1 SD ) at the age of 5 years can be regarded as being an elevated level . A cord blood IgE level > or = 0.3 kU/l in combination with atopic predisposition was predictive of allergic disease , especially allergic bronchial asthma . With regard to allergic disease , the positive predictive value was 26 % , the sensitivity 33 % and the rate ratio for development of allergic disease 4 . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND The intestinal microflora is a likely source for the induction of immune deviation in infancy . OBJECTIVE The purpose of this study was to prospect ively relate the intestinal microflora to allergy development in 2 countries differing with respect to the prevalence of atopic diseases . METHODS Newborn infants were followed prospect ively through the first 2 years of life in Estonia ( n = 24 ) and Sweden ( n = 20 ) . By that age , 9 Estonian and 9 Swedish infants had developed atopic dermatitis and /or positive skin prick test results . Stool sample s were obtained at 5 to 6 days and at 1 , 3 , 6 , and 12 months , and 13 groups of aerobic and anaerobic microorganisms were cultivated through use of st and ard methods . RESULTS In comparison with healthy infants , babies who developed allergy were less often colonized with enterococci during the first month of life ( 72 % vs 96 % ; P bifidobacteria during the first year of life ( 17 % to 39 % vs 42 % to 69 % ; P counts of clostridia at 3 months ( median value , 10.3 vs 7.2 log(10 ) ; P prevalence of colonization with Staphylococcus aureus was also higher at 6 months ( 61 % vs 23 % ; P counts of Bacteroides were lower at 12 months ( 9.9 vs 10.6 log(10 ) ; P infants who will and infants who will not develop allergy are demonstrable before the development of any clinical manifestations of atopy . Because the observations were made in 2 countries with different st and ards of living , we believe that our findings could indicate a role for the intestinal microflora in the development of and protection from allergy",
"BACKGROUND The immunomodulating mechanisms of Lactobacillus GG ( LGG ) and other probiotics are poorly understood . OBJECTIVE We studied in vivo the immunologic effects of probiotics in infants with atopic eczema-dermatitis syndrome ( AEDS ) and cow 's milk allergy ( CMA ) . METHODS Two hundred thirty infants with AEDS and suspected CMA received , concomitant with elimination diet , either LGG , a mixture of 4 probiotic strains ( MIX ) , or placebo for 4 weeks . All available paired pretreatment and posttreatment plasma sample s ( n = 132 ) were analyzed for concentrations of IL-2 , IL-4 , IL-6 , IL-10 , TNF-alpha , IFN-gamma , soluble intercellular adhesion molecule 1 , soluble E-selectin , TGF-beta1 , TGF-beta2 , and C-reactive protein . RESULTS In infants with IgE-associated AEDS , treatment with LGG induced higher C-reactive protein levels than in the placebo group ( geometric mean , 0.83 microg/mL [ 95 % CI , 0.56 - 0.81 ] vs 0.42 microg/mL [ 95 % CI , 0.27 - 0.65 ] ; P = .021 ) . Concomitantly , IL-6 levels increased after treatment with LGG ( P = .023 ) but not with MIX or placebo . Soluble E-selectin levels were higher after probiotic than after placebo treatment in infants with IgE-mediated CMA ( LGG geometric mean , 86.7 ng/mL [ 95 % CI , 75.2 - 100 ] ; MIX geometric mean , 91.6 ng/mL [ 95 % CI , 74.8 - 111.9 ] ; and placebo geometric mean , 64.9 ng/mL [ 95 % CI , 53 - 79.3 ] ; analysis of covariance , P = .035 ; LGG vs placebo , P = .023 ; MIX vs placebo , P = .020 ) . Use of MIX induced an increase in plasma IL-10 levels ( P = .016 ) . CONCLUSION Probiotics induced systemically detectable low- grade inflammation , which might explain the clinical effects of probiotics in AEDS and CMA",
"AIM The intestinal flora of breast-fed infants is generally dominated by bifidobacteria which have beneficial properties . Their presence is due to various components of breast milk , including prebiotic substances . This prospect i ve double-blind study compared the numbers of bifidobacteria in the stool flora of bottle-fed preterm infants r and omized to receive for 14 days either a formula with prebiotic fructo-oligosaccharides at a concentration of 0.4 g/dL or the same formula with maltodextrin as a placebo . METHODS Within 0 - 14 days after birth , 56 healthy bottle-fed infants were enrolled to receive either the prebiotic or placebo . Faecal sample s were taken at inclusion day and at study day 7 . The number of bifidobacteria in the stools , stool characteristics and somatic growth were recorded during the study . RESULTS In the group fed fructo-oligosaccharides , both the numbers of bifidobacteria in the stools and the proportion of infants colonized with them were significantly higher as compared to the placebo group ( p=0.032 and p=0.030 respectively ) . There was also a higher number of bacteroids in the fructo-oligosaccharide group as compared to the placebo ( p=0.029 ) . At the same time , reduction was noted in the numbers of Escherichia coli and enterococci . ( p=0.029 , and p=0.025 , respectively ) . Supplementation had also significant influence on stool frequency per day ( p=0.0080 ) . CONCLUSION An infant formula containing a small quantity of prebiotic oligosaccharides is well accepted and leads to rapid growth of bifidobacteria in the gut of bottle-fed preterm infants while decreasing the numbers of pathogenic microorganisms",
"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",
"Background : It has been suggested that probiotics can reduce the overgrowth of pathogens in the bowels of preterm infants and contribute to the reduction of the incidence of nosocomial infections in neonatal intensive care units ( NICUs ) . The purpose of this study was to evaluate the effectiveness of Lactobacillus GG supplementation in reducing the incidence of urinary tract infections ( UTIs ) , bacterial sepsis and necrotizing enterocolitis ( NEC ) in preterm infants . Methods : A double-blind study was conducted in 12 Italian NICUs . Newborn infants with a gestational age were r and omized to receive st and ard milk feed supplemented with Lactobacillus GG ( Dicoflor ® , Dicofarm , Rome , Italy ) in a dose of 6 × 109 colony-forming units ( cfu ) once a day until discharge , starting with the first feed or placebo . Results : Five hundred eighty-five patients were studied . The probiotics group ( n = 295 ) and the placebo group ( n = 290 ) exhibited similar clinical characteristics . The duration of Lactobacillus GG and placebo supplementation was 47.3 ± 26.0 and 48.2 ± 24.3 days , respectively . Although UTIs ( 3.4 vs. 5.8 % ) and NEC ( 1.4 vs. 2.7 % ) were found less frequently in the probiotic group compared to the control group , these differences were not significant . Bacterial sepsis was more frequent in the probiotics group ( 4.4 % , n = 11 ) than in the placebo group ( 3.8 % , n = 9 ) , but the difference was not significant . Conclusion : Seven days of Lactobacillus GG supplementation starting with the first feed is not effective in reducing the incidence of UTIs , NEC and sepsis in preterm infants . Further studies are required to confirm our results in lower birthweight population",
"OBJECTIVE To assess impact of probiotics and breastfeeding on gut microecology . STUDY DESIGN Mothers were r and omized to receive placebo or Lactobacillus rhamnosus GG before delivery , with treatment of the infants after delivery . We assessed gut microbiota , humoral immune responses , and measured soluble cluster of differentiation 14 ( sCD14 ) in colostrum in 96 infants . RESULTS Fecal Bifidobacterium and Lactobacillus/Enterococcus counts were higher in breastfed than formula-fed infants at 6 months ; P total number of immunoglobulin (Ig)G-secreting cells in breastfed infants supplemented with probiotics exceeded those in breastfed infants receiving placebo ; P=.05 , and their number correlated with concentration of sCD14 in colostrum . Total numbers of IgM- , IgA- , and IgG-secreting cells at 12 months were higher in infants breastfed exclusively for at least for 3 months and supplemented with probiotics as compared with breastfed infants receiving placebo ; P=.005 , P=.03 and P=.04 , respectively . Again , sCD14 in colostrum correlated with numbers of IgM and IgA cells ; P=.05 in both . CONCLUSIONS We found an interaction between probiotics and breastfeeding on number of Ig-secreting cells , suggesting that probiotics during breastfeeding may positively influence gut immunity",
"Probiotics are immunomodulatory and may thus affect vaccine antibody responses . With the accumulating evidence of their health-promoting effects , probiotics are increasingly administered in allergy-prone infants . Therefore , we studied the effect of probiotics on antibody responses to diphtheria , tetanus and Haemophilus influenzae type b ( Hib ) vaccines in 6-month-old infants participating in a r and omized placebo-controlled double-blind allergy-prevention trial . Mothers of unborn children at increased risk for atopy used a combination of four probiotic strains , or a placebo , for 4 wk before delivery . During 6 months from birth , their infants received the same probiotics and galacto-oligosaccharides , or a placebo . The infants were immunized with a DTwP ( diphtheria , tetanus and whole cell pertussis ) at ages 3 , 4 , and 5 months , and with a Hib polysaccharide conjugate at 4 months . Serum diphtheria , tetanus , and Hib IgG antibodies were measured at 6 months . In the probiotic group , protective Hib antibody concentrations ( > /=1 microg/ml ) occurred more frequently , 16 of 32 ( 50 % ) vs. six of 29 ( 21 % ) ( p = 0.020 ) , and the geometric mean ( inter-quartile range ) Hib IgG concentration tended to be higher 0.75 ( 0.15 - 2.71 ) microg/ml than in the placebo group 0.40 ( 0.15 - 0.92 ) microg/ml ( p = 0.064 ) . In these respective groups , diphtheria , 0.38 ( 0.14 - 0.78 ) vs. 0.47 ( 0.19 - 1.40 ) IU/ml ( p = 0.449 ) , and tetanus , 1.01(0.47 - 1.49 ) vs. 0.81 ( 0.56 - 1.39 ) IU/ml ( p = 0.310 ) , IgG titers were comparable . In conclusion , in allergy-prone infants probiotics seem not to impair antibody responses to diphtheria , tetanus , or Hib , but may improve response to Hib immunization",
"BACKGROUND Colonization by C and ida species is the most important predictor of the development of invasive fungal disease in preterm neonates , and the enteric reservoir is a major site of colonization . We evaluated the effectiveness of an orally supplemented probiotic ( Lactobacillus casei subspecies rhamnosus ; Dicoflor [ Dicofarm spa ] ; 6 x 10(9 ) cfu/day ) in the prevention of gastrointestinal colonization by C and ida species in preterm , very low birth weight ( i.e. , METHODS Over a 12-month period , a prospect i ve , r and omized , blind , clinical trial that involved 80 preterm neonates with a very low birth weight was conducted in a large tertiary neonatal intensive care unit . During the first 3 days of life , the neonates were r and omly assigned to receive either an oral probiotic added to human ( maternal or pooled donors ' ) milk ( group A ) or human milk alone ( group B ) for 6 weeks or until discharge from the NICU , if the neonate was discharged before 6 weeks . On a weekly basis , specimens obtained from various sites ( i.e. , oropharyngeal , stool , gastric aspirate , and rectal specimens ) were collected from all patients for surveillance culture , to assess the occurrence and intensity of fungal colonization in the gastrointestinal tract . RESULTS The incidence of fungal enteric colonization ( with colonization defined as at least 1 positive culture result for specimens obtained from at least 1 site ) was significantly lower in group A than in group B ( 23.1 % vs. 48.8 % ; relative risk , 0.315 [ 95 % confidence interval , 0.120 - 0.826 ] ; P = .01 ) . The numbers of fungal isolates obtained from each neonate ( P = .005 ) and from each colonized patient ( P = .005 ) were also lower in group A than in group B. L. casei subspecies rhamnosus was more effective in the subgroup of neonates with a birth weight of 1001 - 1500 g. There were no changes in the relative proportions of the different C and ida strains . No adverse effects potentially associated with the probiotic were recorded . CONCLUSIONS Orally administered L. casei subspecies rhamnosus significantly reduces the incidence and the intensity of enteric colonization by C and ida species among very low birth weight neonates",
"BACKGROUND Probiotic bacteria are potentially beneficial to maturation of the infant 's immune system . OBJECTIVE To examine the role of probiotic bacteria in treatment of cow 's milk allergy ( CMA ) and IgE-associated dermatitis , we investigated the immunologic effects of Lactobacillus rhamnosus GG ( LGG ) and a mixture of 4 bacterial species ( MIX ) . METHODS In a r and omized , double-blind study design , concomitantly with elimination diet and skin treatment , LGG , MIX , or placebo was given for 4 weeks to infants with suspected CMA . After anti-CD3 ( OKT3 ) and anti-CD28 stimulation of P BMC s , IFN-gamma , IL-4 , IL-5 , and IL-12 levels were measured in culture supernatants by ELISA . Intracellular IFN-gamma , IL-4 , and IL-5 production on CD4 lymphocytes was analyzed with fluorescence-activated cell sorting . RESULTS Secretion of IFN-gamma by P BMC s before the treatment was significantly lower in infants with CMA ( P=.016 ) and in infants with IgE-associated CMA ( P=.003 ) than in non-CMA infants . Among the infants who received LGG , the level of secreted IFN-gamma increased in those with CMA ( P=.006 ) and in those with IgE-associated dermatitis ( P=.017 ) when compared with the placebo group . Secretion of IL-4 increased significantly in infants with CMA in the MIX ( P=.034 ) but not in the LGG group . CONCLUSION Deficiency in IFN-gamma response appears to be related to CMA . LGG raises IFN-gamma production of P BMC in infants with CMA and in infants with IgE-associated dermatitis and may thus provide beneficial TH1 immunomodulatory signals . MIX , although containing LGG , appears to modulate the immune responses differently",
"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 The aim of this study was to evaluate the nutritional efficacy and bifidogenic characteristics of a new infant formula containing partially hydrolyzed whey protein , modified vegetable oil with a high & bgr;-palmitic acid content , prebiotic oligosaccharides , and starch . Methods In a double-blind study , healthy formula-fed term infants aged younger than 2 weeks were r and omized to receive either the new infant formula ( NF ) or a st and ard formula ( SF ) until the age of 12 weeks . Anthropometric measurements were taken at enrollment , 6 weeks , and 12 weeks . In a sub sample of infants , blood sample s were taken at 6 weeks and stool sample s were taken at enrollment and 6 weeks . Blood sample s were analyzed for biochemical measures of protein status and amino acids , and stools were analyzed for total bacteria and bifidobacteria . Mothers completed a feeding diary and question naire at 6 and 10 weeks . Results One hundred fifty-four infants were enrolled in the study ; 102 completed the trial . The growth of infants in both formula groups was in line with published growth curves . During the first 6 weeks , NF girls gained more weight and head circumference than the SF girls . These velocity differences were not maintained throughout the 12-week study period . The NF stools had a higher proportion of bifidobacteria at 6 weeks compared with the SF stools , and they were softer . There were no clinical ly significant differences in the blood biochemical and amino acid values between groups . Both formulas were well tolerated by the infants . Conclusions When compared with a st and ard infant formula , the new formula supported satisfactory growth , led to higher counts of bifidobacteria in the feces , produced blood bio-chemical values typical of formula-fed infants , and was well tolerated",
"OBJECTIVE To test the hypothesis that normalizing the intestinal flora by administration of prophylactic probiotics would provide a natural defense , thereby reducing both the incidence and severity of necrotizing enterocolitis ( NEC ) in preterm neonates . STUDY DESIGN Neonates were r and omized to either receive a daily feeding supplementation with a probiotic mixture ( Bifidobacteria infantis , Streptococcus thermophilus , and Bifidobacteria bifidus ; Solgar , Israel ) of 10(9 ) colony forming units (CFU)/day or to not receive feed supplements . NEC was grade d according to Bell 's criteria . RESULTS For 72 study and 73 control infants , respectively , birth weight ( 1152 + /- 262 g vs 1111 + /- 278 g ) , gestational age ( 30 + /- 3 weeks vs 29 + /- 4 weeks ) , and time to reach full feeds ( 14.6 + /- 8.7 days vs 17.5 + /- 13.6 days ) were not different . The incidence of NEC was reduced in the study group ( 4 % vs 16.4 % ; P=.03 ) . NEC was less severe in the probiotic-supplemented infants ( Bell 's criteria 2.3 + /- 0.5 vs 1.3 + /- 0.5 ; P=.005 ) . Three of 15 babies who developed NEC died , and all NEC-related deaths occurred in control infants . CONCLUSION Probiotic supplementation reduced both the incidence and severity of NEC in our premature neonatal population",
"Background : Probiotic bacteria are suggested to reduce symptoms of the atopic eczema/dermatitis syndrome ( AEDS ) in food‐allergic infants . We aim ed to investigate whether probiotic bacteria have any beneficial effect on AEDS",
"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",
"Objectives : Supplementation of probiotics and supplementation of zinc during acute gastroenteritis in children have been shown to exert positive effects on diarrhea duration and severity . Our aim was to evaluate a new diet enriched with zinc and probiotic bacteria in the treatment of acute gastroenteritis in young children . Methods : In a double blind prospect i ve study , 65 children aged 6–12 months were r and omized to receive 6 × 109 colony forming units of Streptococcus thermophilus , Bifidobacterium lactis , Lactobacillus acidophilus ( 2 × 109 of each strain ) , 10 mg of zinc/day , and 0.3 grams of fructo-oligosaccharides in the supplemented group ( n = 33 ) or placebo ( n = 32 ) , given in a soy protein based rice cereal . For each child , age , sex , weight , degree of dehydration , the presence of fever or vomiting , stool frequency and consistency were recorded daily until diarrhea resolution . Results : Diarrhea resolution occurred after 1.43 ± 0.71 days in the supplemented group vs. 1.96 ± 1.24 in the control group ( p = 0.017 ) . In the subset of children who presented with vomiting , time to vomiting resolution was 0.27 ± 0.59 vs. 0.81 ± 0.91 days in the supplemented and control groups , respectively ( p = 0.06 ) . On day 3 , there was only 1 child with watery stools in the supplemented group versus 10 children in the control group ( p = 0.02 ) . Conclusions : In our series , the feeding of a cereal containing Streptococcus thermophilus , Bifidobacterium lactis , Lactobacillus acidophilus and zinc , reduced the severity and duration of acute gastroenteritis in young children . However , whether this combination is better than either the addition of probiotics or zinc alone is yet to be determined",
"The influence of undernutrition on the effectiveness of a dietary supplement of live lactobacillus regarding prevention and treatment of infantile diarrhoea was studied on 200 children 6 to 24 m old . Children , undernourished ( D ) or controls ( C ) , received for 90 days , in a blind experiment , a fermented milk providing L. Acidofilus y L. Casei ( 10(7)-10(8)/ml ) ( LB ) or an equivalent amount of fluid milk ( L ) . diarrhoea episodes were recorded and classified according duration : 1 - 4 , 5 - 14 days , and protracted diarrhea ( DP ) those lasting beyond 14 days . Study requirements were fulfilled by 119 children : D-L : n=25 ; D-LB : n=32 ; C-L : n=27 y C-LB : n=35 . Preventive aspects were evaluated through number of episodes and through their lasting the therapeutic ones . Episodes recorded were 134 : 29 in D-L ; 48 in D-LB ; 37 in C-L and 20 in C-LB . In the D-LB group over 90 % episodes were very short ( 1 - 4 days ) , percentage far higher to that observed in D-L and similar to C-LB . There were 12 episodes of DP , 9 D and 3 in C , all in the L groups . In conclusion , although the fermented milk prevent half episode in the controls but not in the undernourished , it was able to shorter episodes duration and prevent protracted diarrhoea irrespectively of nutritional status . Therefore , undernutrition impaired the ability of the lactobacillus supplement to prevent children diarrhoea , which implicates immune system , but not curative effects which are the result of local actions",
"BACKGROUND Recent studies suggest that oral bacteriotherapy with probiotics might be useful in the management of atopic dermatitis ( AD ) . OBJECTIVE The purpose of this investigation was to evaluate the clinical and anti-inflammatory effect of probiotic supplementation in children with AD . METHODS In a double-blind , placebo-controlled , crossover study , 2 probiotic Lactobacillus strains ( lyophilized Lactobacillus rhamnosus 19070 - 2 and Lactobacillus reuteri DSM 122460 ) were given in combination for 6 weeks to 1- to 13-year-old children with AD . The patients ' evaluations were registered after each intervention ( ie , better , unchanged , or worse ) . The clinical severity of the eczema was evaluated by using the scoring atopic dermatitis ( SCORAD ) score . As inflammatory markers , eosinophil cationic protein in serum and cytokine production by P BMC s were measured . RESULTS After active treatment , 56 % of the patients experienced improvement of the eczema , whereas only 15 % believed their symptoms had improved after placebo ( P = .001 ) . The total SCORAD index , however , did not change significantly . The extent of the eczema decreased during active treatment from a mean of 18.2 % to 13.7 % ( P = .02 ) . The treatment response was more pronounced in allergic patients ( at least one positive skin prick test response and elevated IgE levels ) , and in this group the SCORAD score decreased ( P = .02 compared with nonallergic patients ) . During active treatment , serum eosinophil cationic protein levels decreased ( P = .03 ) . No significant changes in the production of the cytokines IL-2 , IL-4 , IL-10 , or IFN-gamma were found . CONCLUSIONS A combination of L rhamnosus 19070 - 2 and L reuteri DSM 122460 was beneficial in the management of AD . The effect was more pronounced in patients with a positive skin prick test response and increased IgE levels",
"The prevalence of atopic diseases is increasing throughout the Western world , and means of primary prevention are needed to reverse this trend . The role of breast-feeding , the best source of infant nutrition , in protection against atopic disease remains elusive . In this double-blinded , placebo-controlled study of 62 mother-infant pairs , it is shown that administering probiotics to the pregnant and lactating mother increased the immunoprotective potential of breast milk , as assessed by the amount of anti-inflammatory transforming growth factor beta2 ( TGF-beta2 ) in the milk ( 2885 pg/mL [ 95 % CI , 1624 - 4146 ] in mothers receiving probiotics vs 1340 pg/mL [ 95 % CI , 978 - 1702 ] in mothers receiving placebo ; P = .018 ) . The risk of developing atopic eczema during the first 2 years of life in infants whose mothers received probiotics was significantly reduced in comparison with that in infants whose mothers received placebo ( 15 % and 47 % , respectively ; relative risk , 0.32 [ 95 % CI , 0.12 - 0.85 ] ; P = .0098 ) . Maternal atopy was a clear risk factor for atopic eczema in the infant . The infants most likely to benefit from maternal probiotic supplementation were those with an elevated cord blood IgE concentration . Administering probiotics during pregnancy and breast-feeding thus offers a safe and effective mode of promoting the immunoprotective potential of breast-feeding and provides protection against atopic eczema during the first 2 years of life",
"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 ",
"This article by the ESPGHAN Committee on Nutrition summarizes available information on the effects of adding prebiotic oligosaccharides to infant and follow-on formulae . Currently there are only limited studies evaluating prebiotic substances in dietetic products for infants . Although administration of prebiotic oligosaccharides has the potential to increase the total number of bifidobacteria in feces and may also soften stools , there is no published evidence of clinical benefits of adding prebiotic oligosaccharides to dietetic products for infants . Data on oligosaccharide mixtures in infant formulae do not demonstrate adverse effects , but further evaluation is recommended . Combinations and dosages in addition to those so far studied need to be fully evaluated with respect to both safety and efficacy before their use in commercial infant food products . Well- design ed and carefully conducted r and omized controlled trials with relevant inclusion /exclusion criteria , adequate sample sizes and vali date d clinical outcome measures are needed both in preterm and term infants . Future trials should define optimal quantity and types of oligosaccharides with prebiotic function , optimal dosages and duration of intake , short and long term benefits and safety . At the present time , therefore , the Committee takes the view that no general recommendation on the use of oligosaccharide supplementation in infancy as a prophylactic or therapeutic measure can be made",
"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 . We evaluated the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis ( NEC ) in very low birth weight ( VLBW ) infants . Patients and Methods . A prospect i ve , masked , r and omized control trial was conducted to evaluate the beneficial effects of probiotics in reducing the incidence and severity of NEC among VLBW ( the trial . They were r and omized into 2 groups after parental informed consents were obtained . The infants in the study group were fed with Infloran ( Lactobacillus acidophilus and Bifidobacterium infantis ) with breast milk twice daily until discharged . Infants in the control group were fed with breast milk alone . The clinicians caring for the infants were blinded to the group assignment . The primary outcome was death or NEC ( ≥ stage 2 ) . Results . Three hundred sixty-seven infants were enrolled : 180 in the study group and 187 in the control group . The demographic and clinical variables were similar in both groups . The incidence of death or NEC ( ≥ stage 2 ) was significantly lower in the study group ( 9 of 180 vs 24 of 187 ) . The incidence of NEC ( ≥ stage 2 ) was also significantly lower in the study when compared with the control group ( 2 of 180 vs 10 of 187 ) . There were 6 cases of severe NEC ( Bell stage 3 ) in the control group and none in the study group . None of the positive blood culture grew Lactobacillus or Bifidobacterium species . Conclusion . Infloran as probiotics fed enterally with breast milk reduces the incidence and severity of NEC in VLBW infants",
"Objectives The aim of this study was to assess the efficacy of oral supplementation of viable and heat-inactivated probiotic bacteria in the management of atopic disease and to observe their effects on the composition of the gut microbiota . Methods The study population included 35 infants with atopic eczema and allergy to cow 's milk . At a mean age of 5.5 months , they were assigned in a r and omized double-blind manner to receive either extensively hydrolyzed whey formula ( placebo group ) or the same formula supplemented with viable ( viable LGG group ) or heat-inactivated Lactobacillus GG ( heat-inactivated LGG group ) , respectively . The changes in symptoms were assessed by the SCORAD method and the presence of some predominant bacterial genera in the feces detected with 16S rRNA-specific probes . Results The treatment with heat-inactivated LGG was associated with adverse gastrointestinal symptoms and diarrhea . Consequently , the recruitment of patients was stopped after the pilot phase . Within the study population , atopic eczema and subjective symptoms were significantly alleviated in all the groups ; the SCORAD scores ( interquartile range ) decreased from 13 ( range , 4–29 ) to 8 ( range , 0–29 ) units in the placebo group , from 19 ( range , 4–47 ) to 5 ( range , 0–18 ) units in the viable LGG group , and from 15 ( range , 0–29 ) to 7 ( range , 0–26 ) units in the heat-inactivated LGG group . The decrease in the SCORAD scores within the viable LGG group tended to be greater than within the placebo group . The treatments did not appear to affect the bacterial numbers within the genera enumerated . Conclusions Supplementation of infant formulas with viable but not heat-inactivated LGG is a potential approach for the management of atopic eczema and cow 's milk allergy",
"STUDY OBJECTIVES We sought to identify early life factors ( ie , first 4 years ) associated with wheeze , asthma , and bronchial hyperresponsiveness ( BHR ) at age 10 years , comparing their relative influence for these conditions . METHODS Children were seen at birth , and at 1 , 2 , 4 , and 10 years of age in a whole- population birth cohort study ( 1,456 subjects ) . Information was collected prospect ively on genetic and environmental risk factors . Skin-prick testing was performed at 4 years of age . Current wheeze ( in the last 12 months ) and currently diagnosed asthma ( CDA ) [ ie , current wheeze and ever-diagnosed asthmatic subject ] were recorded at 10 years of age when BHR was measured at bronchial challenge . Independent significant risk factors for these outcomes were identified by logistic regression . RESULTS Independent significance for current wheeze occurred with maternal asthma ( odds ratio [ OR ] , 2.08 ; 95 % confidence interval [ CI ] , 1.27 to 3.41 ) and paternal asthma ( OR , 2.12 ; 95 % CI 1.29 to 3.51 ) , recurrent chest infections at 2 years ( OR , 3.98 ; 95 % CI , 2.36 to 6.70 ) , atopy at 4 years of age ( OR , 3.69 ; 95 % CI , 2.36 to 5.76 ) , eczema at 4 years of age ( OR , 2.15 ; 95 % CI , 1.24 to 3.73 ) , and parental smoking at 4 years of age ( OR , 2.18 ; 95 % CI , 1.25 to 3.81 ) . For CDA , significant factors were maternal asthma ( OR , 2.26 ; 95 % CI , 1.24 to 3.73 ) , paternal asthma ( OR , 2.30 ; 95 % CI , 1.17 to 4.52 ) , and sibling asthma ( OR , 2.00 ; 95 % CI , 1.16 to 3.43 ) , recurrent chest infections at 1 year of age ( OR , 2.67 ; 95 % CI , 1.12 to 6.40 ) and 2 years of age ( OR , 4.11 ; 95 % CI , 2.06 to 8.18 ) , atopy at 4 years of age ( OR , 7.22 ; 95 % CI , 4.13 to 12.62 ) , parental smoking at 1 year of age ( OR , 1.99 ; 95 % CI , 1.15 to 3.45 ) , and male gender ( OR , 1.72 ; 95 % CI , 1.01 to 2.95 ) . For BHR , atopy at 4 years of age ( OR , 5.38 ; 95 % CI , 3.06 to 9.47 ) and high social class at birth ( OR , 2.03 ; 95 % CI , 1.16 to 3.53 ) proved to be significant . CONCLUSIONS Asthmatic heredity , predisposition to early life atopy , plus early passive smoke exposure and recurrent chest infections are important influences for the occurrence of wheeze and asthma at 10 years of age . BHR at 10 years of age has a narrower risk profile , suggesting that factors influencing wheezing symptom expression may differ from those predisposing the patient to BHR",
"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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CONTEXT Different types of behavioural , dietary , interventional , pharmacologic , and surgical therapies have been used to treat painful bladder syndrome/interstitial cystitis ( PBS/IC ) . Because of the paucity of r and omised placebo-controlled studies on different treatments , an evidence -based management approach has not yet been developed . OBJECTIVE To critically review and synthesize data from a wide range of current therapeutic approaches to PBS/IC , to quantify the effect size from r and omised controlled trials ( RCTs ) , and to reach clinical agreement on the efficacy of treatments for PBS/IC . EVIDENCE ACQUISITION We performed a systematic review of the literature to identify articles published between 1990 and September 2010 on the management of PBS/IC . We included articles restricted to the English language published since 1990 to date that reported on oral and intravesical treatment , multimodal or combined treatment , and surgical treatment . For all RCTs , st and ardised mean differences ( SMDs ) were extracted and combined in a meta- analysis applying a r and om-effect model that incorporated the heterogeneity of effects . The four outcomes assessed in all studies were a change in the Interstitial Cystitis Symptom Index ( ICSI ) , pain , urgency , and frequency . Non- RCTs ( n RCTs ) were analysed with a narrative synthesis of the evidence from all research design s. EVIDENCE SYNTHESIS We included 7709 adult patients from 29 RCTs and 57 n RCTs . Meta- analysis of RCTs showed that only cyclosporine A provided a simultaneous great effect size of SMD on ICSI , pain , and frequency . Amitriptyline at different dosages showed a great effect size of SMD on pain and urgency or on ICSI and frequency . The remaining RCTs showed sporadic significant changes in only one of the four considered parameters . The attributed levels of evidence for treatments reported in RCTs were 1b ; grade s of recommendations ranged from A to C. According to the Jadad score , 11 RCTs were high- quality studies . Meta- analysis of RCTs showed a great heterogeneity in the applied method ologies , clinical outcomes assessed , and the obtained results in different studies . The results from the n RCTs showed that the most frequently adopted treatment is oral pentosan polysulfate and that the use of botulinum A toxin intradetrusorial injections in PBS/IC is increasing . A high heterogeneity in drugs and treatment modalities , clinical outcomes , and obtained results was also found for n RCTs . CONCLUSIONS Limited evidence exists for the few treatments for PBS/IC . The lack of definitive conclusions is due to the great heterogeneity in methodology , symptoms assessment , duration of treatment , and follow-up in both RCTs and n RCTs
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"OBJECTIVE To establish the efficacy of a multidrug oral treatment with the tricyclic antidepressant agent doxepin and the cyclooxygenase ( COX ) inhibitor piroxicam in patients with interstitial cystitis ( IC ) , who had failed st and ard therapy in an open , prospect i ve , nonr and omized study . METHODS A total of 37 patients diagnosed with IC received 75 mg doxepin and 40 mg piroxicam daily . The treatment was termed DOXCAM . Effectiveness of therapy was assessed with frequency-volume charts , an IC symptom score and with cystometry prior to treatment , 8 weeks after the start and 4 weeks after termination of drug treatment . RESULTS Medication was not tolerated by five patients . Twenty-six of 32 patients have experienced virtual total remission of symptoms ( 81 % ) and six patients had significant relief ( 19 % ) . DOXCAM treatment result ed in a significant percent decrease in pain ( 65 % versus 21 % ) . Daytime frequency decreased from 17.6+/-5.7 to 11.3+/-3.6 voids while nocturia did not improve significantly . Twenty-three of the 26 patients who became symptom free and four of the six patients who showed significant improvement had a return of symptoms after cessation of therapy . CONCLUSION It is reasonable to consider oral treatment with DOXCAM in those patients who have failed first-line therapies",
"PURPOSE In a previous retrospective analysis , cyclosporine A ( CyA ) was highly efficient in treating patients with interstitial cystitis . A prospect i ve r and omized study with this immunosuppressive agent was warranted . We compared CyA to pentosan polysulfate sodium ( PPS ) in patients with interstitial cystitis . MATERIAL S AND METHODS A total of 64 patients with interstitial cystitis meeting the National Institute of Diabetes and Digestive and Kidney Diseases criteria were enrolled in a r and omized prospect i ve study . Patients were r and omized in a 1:1 ratio to 1.5 mg/kg CyA twice daily ( 27 women , 5 men ) or 100 mg PPS 3 times daily ( 26 women , 6 men ) for a period of 6 months . The primary end point was daily micturition frequency , and secondary end points were mean and maximal voided volume , number of nocturia episodes , O'Leary-Sant symptom and problem indexes , visual analogue scale for pain , and subjective global response assessment . RESULTS CyA was superior to PPS in all clinical outcome parameters measured at 6 months . Micturition frequency in 24 hours was significantly reduced in the CyA arm compared to the PPS arm ( -6.7 + /- 4.7 vs -2.0 + /- 5.1 times ) . The clinical response rate ( according to global response assessment ) was 75 % for CyA compared to 19 % for PPS ( p adverse events in the CyA arm than in the PPS arm , 29 patients completed the 6-month followup in both groups . CONCLUSIONS CyA is more effective than PPS in interstitial cystitis",
"Interstitial cystitis ( IC ) is a disorder of the urinary bladder characterized by urgency , frequency , nocturia and suprapubic pain . IC occurs primarily in women and symptoms are exacerbated by stress , ovulatory hormones and certain foods . IC pathogenesis is unknown , but the most consistent findings involve some dysfunction of the bladder glycosaminoglycan ( GAG ) protective layer and a high number of activated bladder mast cells . There is no effective therapy even through intravesical administration of dimethylsulfoxide ( DMSO ) or oral pentosanpolysulfate ( PPS ) have had variable success . A dietary supplement , CystoProtek ® , was formulated with the natural GAG components chondroitin sulfate and sodium hyaluronate to provide urothelial cytoprotection , together with the flavonoid quercetin that has anti-inflammatory properties and inhibits activation of mast cells . Thirty-seven female patients diagnosed by the NIDDK criteria who had failed all forms of therapy took six softgel CystoProtek ® capsules per day for 6 months . Global assessment scale was reduced from 9.0 ± 2.9 to 4.3 ± 2.1 ( p moreover , the O'Leary/Sant Symptom Index decreased from 16.3 ± 3.1 to 6.9 ± 4.2 ( p Problem Index from 13.1 ± 3.7 to 5.4 ± 4.0 ( p < 0.05 ) . These results are very promising and warrant a larger study that may permit further analyses with respect to other , especially atopic , comorbid diseases",
"PURPOSE Interstitial cystitis ( IC ) is a disorder of unknown etiology with few effective therapies . Oral bioflavonoid therapy utilizing quercetin recently proved to be clinical ly effective in men with chronic pelvic pain syndrome , a disorder with similarities to IC . We therefore tested in an open-label trial a quercetin-based supplement in patients with clinical ly proven IC . MATERIAL S AND METHODS Twenty-two patients ( 5 men and 17 women ; average age 53.1 years ) with classically documented IC received one capsule of Cysta-Q complex ( equivalent to 500 mg of quercetin ) twice a day for 4 weeks . Symptoms were assessed before and after therapy by the IC problem and symptom indices as well as by global assessment of pain ( range 0 - 10 ) . RESULTS Two patients did not complete the study . In the remaining 20 patients , improvement was seen in all three parameters tested . After 4 weeks of treatment , the mean ( + /- SEM ) problem index improved from 11.3 + /- 0.6 to 5.1 + /- 0.7 ( p = .000001 ) , the mean symptom index improved from 11.9 + /- 0.9 to 4.5 + /- 0.5 ( p = .000001 ) , and the mean global assessment score improved from 8.2 + /- 0.4 to 3.5 + /- 0.4 ( p = .000001 ) . None of the patients experienced any negative side effects , and all but one patient had at least some improvement in every outcome measure . CONCLUSION Oral therapy with the quercetin supplement Cysta-Q was well tolerated and provided significant symptomatic improvement in patients with IC . Larger , r and omized , placebo-controlled trials appear warranted based on these preliminary open-label results",
"ABSTRACT Objective : To evaluate the relationship between symptom reduction and satisfaction with pentosan polysulfate sodium ( PPS ) therapy in subjects with interstitial cystitis ( IC ) . Methods : A secondary analysis was conducted in 128 subjects treated with PPS 300 mg/day ( US Food and Drug Administration-approved dose ) from a 32-week multicenter , r and omized , double-blind study of 380 subjects with IC who were treated with PPS 300 mg/day , 600 mg/day , or 900 mg/day . Self-rated outcome measures included the O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) and a treatment satisfaction question naire . Treatment responders were defined as subjects having ≥30 % reduction in ICSI from baseline to study end point . Results : A reduction in IC symptoms was associated with significantly higher satisfaction with PPS ( p reduction in ICSI were more likely to be pleased with PPS for IC symptoms , to have benefited from PPS for their IC symptoms , to recommend PPS for IC symptoms to others with the same condition , and to say that PPS provides better relief , based on prior experience with other IC treatments . Among all subjects at week 32 , 75 % said they would recommend PPS therapy for IC symptoms to others with the condition . Conclusion : Despite limitations ( lack of placebo control , use of a nonvali date d instrument ) , this analysis demonstrated significantly increased treatment satisfaction with PPS therapy among treatment responders versus nonresponders . There was a significant positive correlation between ICSI scores and response on the treatment satisfaction question naire . Treatment response and patient satisfaction with treatment are important clinical considerations in the management of patients with IC",
"PURPOSE Cyclosporine is a widely used immunosuppressive drug in organ transplantation and recently it has been used in several autoimmune disorders with good results . Because interstitial cystitis may have an autoimmune etiology , we wished to determine whether cyclosporine has any effect on symptoms in patients with severe interstitial cystitis . MATERIAL S AND METHODS A total of 11 patients , who fulfilled the criteria for interstitial cystitis according to an international accrual form , received cyclosporine for 3 to 6 months at an initial dose of 2.5 to 5 mg./kg . daily and a maintenance dose of 1.5 to 3 mg./kg . daily . Blood pressure , serum creatinine and cyclosporine concentrations were monitored regularly . The patients completed frequency-volume charts at 2-week intervals . RESULTS The frequency-volume charts showed favorable effects . Micturition frequency decreased ( p mean and maximum voided volumes increased significantly ( p Bladder pain decreased or disappeared in 10 patients , allowing for storage of large urine volumes . Serum creatinine did not change with the dosages used . Mild hypertension occurred in 2 patients and resolved after the cyclosporine dose was lowered . After cessation of treatment symptoms recurred in the majority of patients . CONCLUSIONS The findings revive the concept of interstitial cystitis as an autoimmune disease",
"INTRODUCTION AND AIM We report the 2-year efficacy and tolerability of intravesical botulinum A toxin ( BoNT/A ) injections in patients with painful bladder syndrome ( PBS ) associated with increased urinary frequency refractory to conventional treatments . MATERIAL S AND METHODS Thirteen women were prospect ively included in the study . The preliminary assessment included voiding diary , urodynamics , urinary tract ultrasound and the visual analog scale ( VAS ) for pain quantification . All patients received multiple injections of 200 U commercially available BoNT/A diluted in 20 ml 0.9 % NaCl , under cystoscopic guidance . Clinical evaluation , urodynamics , urinary tract ultrasound and VAS were repeated at least two times per year throughout the follow-up . RESULTS A total of 58 injections were administered with a mean of 4.8 + /- 0.8 injections per patient . The mean interval between two consecutive injections was 5.25 + /- 0.75 months . At 1 and 4 mo follow up ten patients reported a subjective improvement . Mean VAS scores , mean daytime and night-time urinary frequency decreased significantly . Nine patients at 1 month and seven at the 4-month check-up complained of dysuria . The three non-responders to the first intravesical treatment session underwent another three months later with satisfactory results . At 1 and 2 years follow up the beneficial effects persisted in all patients . We did not observe any systemic side effects during the observation time . CONCLUSIONS Intravesically injected BoNT/A is effective and safe in the medium-term management of patients with PBS . As the beneficial effect decreased progressively within a few months after treatment , repeat injections of the neurotoxin were needed over time",
"OBJECTIVES To present clinical evidence with botulinum toxin A ( BTX-A ) suggesting an antinociceptive role in patients with interstitial cystitis ( IC ) . Intriguing evidence in a somatic pain model has suggested that BTX-A injection may have an antinociceptive effect on both acute and chronic ( inflammatory ) pain . METHODS Thirteen female patients ( 6 in the United States and 7 in Pol and ) with IC according to the criteria of the National Institute of Diabetes , Digestive and Kidney Disease were included . Under short general anesthesia or sedation , 100 to 200 U of Dysport ( Polish patients ) or Botox ( U.S. patients ) was injected through a cystoscope into 20 to 30 sites submucosally in the trigone and floor of the bladder . Patients were evaluated with the O'Leary-Sant vali date d IC question naire or with voiding charts and a visual analog pain scale 1 month postoperatively and at subsequent 3-month intervals . The Polish patients also underwent pretreatment and post-treatment urodynamic evaluations . RESULTS Overall , 9 ( 69 % ) of 13 patients noted subjective improvement after BTX-A treatment . The Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index mean scores improved by 71 % and 69 % , respectively ( P Daytime frequency , nocturia , and pain by visual analog scale decreased by 44 % , 45 % , and 79 % , respectively ( P first desire to void and maximal cystometric capacity increased by 58 % and 57 % , respectively ( P BTX-A has an antinociceptive effect on bladder afferent pathways in patients with IC , producing both symptomatic and functional ( ie , urodynamic ) improvements",
"PURPOSE This pilot study was design ed to evaluate the feasibility of a multicenter , r and omized , clinical trial in interstitial cystitis ( IC ) . Secondary objectives were to evaluate the safety and efficacy of oral pentosan polysulfate sodium ( PPS ) , hydroxyzine , and the combination to consider their use in a larger r and omized clinical trial . MATERIAL S AND METHODS A 2 x 2 factorial study design was used to evaluate PPS and hydroxyzine . Participants met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC and reported at least moderate pain and frequency for a minimum of 6 months before study entry . The primary end point was a patient reported global response assessment . Secondary end points included vali date d symptom indexes and patient reports of pain , urgency and frequency . The target sample size was 136 participants recruited during 10 months . RESULTS A total of 121 ( 89 % of goal ) participants were r and omized over 18 months and 79 % provided complete followup data . The response rate for hydroxyzine was 31 % for those treated and 20 % for those not treated ( p = 0.26 ) . A nonsignificant trend was seen in the PPS treatment groups ( 34 % ) as compared to no PPS ( 18 % , p = 0.064 ) . There were no treatment differences for any of the secondary end points . Adverse events were mostly minor and similar to those in previous reports . CONCLUSIONS The low global response rates for PPS and hydroxyzine suggest that neither provided benefit for the majority of patients with IC . This trial demonstrated the feasibility of conducting a multicenter r and omized clinical trial in IC using uniform procedures and outcomes . However , slow recruitment underscored the difficulties of evaluating commonly available IC drugs",
"Purpose Bladder pain syndrome is a chronic disease that manifests as bladder pain , frequency , nocturia , and urgency . Gabapentin , amitriptyline , and nonsteroidal anti-inflammatory drugs are efficacious treatments for bladder pain syndrome . Here , we assessed the effect of triple therapy with these drugs in women with bladder pain syndrome . Methods Between May 2007 and May 2010 , we conducted a prospect i ve nonr and omized study on 74 patients with bladder pain syndrome . Of these patients , 38 ( 11 men and 27 women ; mean age , 55.9 years ; range , 25 to 77 years ; mean follow-up , 12.6 months ) were administered the interstitial cystitis ( IC ) symptom scales ( O'Leary-Sant Symptom Index ) and visual analog scale ( VAS ) 1 , 3 , and 6 months after treatment to assess the efficacy of triple therapy . Results The pretreatment O'Leary-Sant IC symptom score was 11.7 , and the post-treatment scores were 4.4 , 3.8 , and 4.0 at 1 , 3 , and 6 months , respectively ; the pretreatment problem index score was 10.5 , and the post-treatment scores were 3.7 , 2.7 , and 2.9 at 1 , 3 , and 6 months , respectively . The pretreatment VAS score was 6.7 , and the post-treatment scores were 1.8 , 1.5 , and 1.7 at 1 , 3 , and 6 months , respectively . The O'Leary-Sant IC symptom index and problem index and VAS scores improved considerably 1 month after treatment ( P0.05 ) . Conclusions Triple therapy was sufficiently effective in patients with bladder pain syndrome and caused no significant adverse effects . However , large-scale studies should be performed to verify our findings",
"PURPOSE In this r and omized , double-blind , placebo controlled phase 2 study we investigated tanezumab , a humanized monoclonal antibody that specifically inhibits nerve growth factor as a treatment for interstitial cystitis pain . MATERIAL S AND METHODS Patients with interstitial cystitis received a single intravenous dose of 200 μg/kg tanezumab or placebo . Patients recorded daily pain scores ( on an 11-point numerical rating scale ) 7 days before attending study visits and completed a urinary symptom diary for 3 of those days . Patients also completed the Interstitial Cystitis Symptom Index question naire and a global response assessment . The primary end point was change in average daily numerical rating scale pain score from baseline to week 6 . Secondary end points included global response assessment , Interstitial Cystitis Symptom Index score , micturition and urgency episode frequency per 24 hours , and mean voided volume per micturition . The incidence of adverse events was also assessed . RESULTS A total of 34 patients received tanezumab and 30 received placebo . At week 6 tanezumab produced a significant reduction from baseline in average daily pain score vs placebo ( treatment difference [ LS mean , 90 % CI ] was -1.4 [ -2.2 , -0.5 ] ) . A significantly higher proportion of patients on tanezumab responded as improved in the global response assessment and tanezumab also significantly reduced urgency episode frequency vs placebo . Tanezumab had no significant effect on Interstitial Cystitis Symptom Index score , micturition frequency or mean voided volume per micturition . The most common adverse events were headache ( tanezumab 20.6 % , placebo 16.7 % ) and paresthesia ( tanezumab 17.6 % , placebo 3.3 % ) . CONCLUSIONS Tanezumab has shown preliminary efficacy in the treatment of pain associated with interstitial cystitis",
"PURPOSE Interstitial cystitis is a severe debilitating bladder disease characterized by unrelenting pelvic pain and urinary frequency . A prospect i ve , double-blind , placebo controlled study of the use of intravesical bacillus Calmette-Guerin ( BCG ) in the treatment of interstitial cystitis was recently completed with a mean followup of 8 months . Results demonstrated a 60 % BCG response rate , compared to a 27 % placebo response rate . We now report the long-term followup results of those patients who received intravesical BCG . MATERIAL S AND METHODS Subjects r and omized to receive BCG were followed at routine intervals with question naires and voiding diaries identical to those in the blinded study . Adverse events were closely monitored in the treatment and followup phases of the study . Subject baseline values were compared to followup data . RESULTS Of the BCG responders mean followup was 27 months ( range 24 to 33 ) , and 8 of 9 ( 89 % ) continue to have an excellent response in all parameters measured . The global interstitial cystitis survey improved 70 % , daily voids decreased 31 % , nocturia improved 54 % , mean voided volume increased 61 % , pelvic pain decreased 81 % , vaginal pain decreased 71 % , urgency decreased 71 % and dysuria decreased 82 % . Overall well-being improved 54 % and the R and -36 quality of life survey overall improved 64 % . In 86 % of the patients ( 6 of 7 ) dyspareunia resolved . Of the initial BCG nonresponders there was no significant difference in interstitial cystitis symptomatology from baseline to last followup , suggesting that BCG does not worsen interstitial cystitis symptoms . No long-term adverse events from BCG were noted . CONCLUSIONS Intravesical Tice BCG is safe , effective and durable in the treatment of interstitial cystitis . Of those patients who received only 6 weekly treatments and responded favorably 89 % continue to have an excellent response with followup ranging from 24 to 33 months",
"A r and omized , prospect i ve , double-blind , placebo-controlled study was conducted at 7 clinical centers on 148 patients . Patients received orally either 100 mg . pentosanpolysulfate ( a synthetic polysaccharide ) 3 times per day or a placebo . Of the patients on drug therapy 32 % showed significant improvement compared to 16 % of those on placebo ( p = 0.01 ) . This study provides a model to assess this disease quantitatively in a prospect i ve manner using a method whereby the patients globally assess their symptoms as either worse or improved by 0 , 25 , 50 , 75 or 100 % . Patients on drug therapy also experienced a significant decrease in pain and urgency ( p = 0.04 and 0.01 ) on analogue scales when compared to placebo and also more drug patients showed an average increase of more than 20 ml . in voided volume than did placebo patients ( p = 0.02 ) . All adverse effects were minor , with 7 in the drug group and 10 in the placebo group . The results support the concept that some patients with the interstitial cystitis syndrome may have abnormal bladder surface glycosaminoglycans",
"PURPOSE We examined the safety and the efficacy of a combination of intravesical and oral pentosan polysulfate sodium in comparison to only oral pentosan polysulfate sodium in treating interstitial cystitis . MATERIAL S AND METHODS A total of 41 females diagnosed with interstitial cystitis were r and omized to receive a combination of intravesical pentosan polysulfate sodium plus oral pentosan polysulfate sodium ( 21 in treatment group ) or intravesical placebo plus oral pentosan polysulfate sodium ( 20 in placebo group ) for 6 weeks . All subjects continued to receive oral pentosan polysulfate sodium for another 12 weeks . The primary outcome was the change in the O'Leary-Sant Interstitial Cystitis Symptoms/Problem Index from baseline to week 6 , 12 , and 18 . Other outcomes included : the changes in Pelvic Pain and Urgency Frequency question naire , Health Related Quality of Life index : SF-36 , pain scale , urgency scale , voiding log , patient global assessment , and sexual function scales . RESULTS The change in the total score of O'Leary-Sant Interstitial Cystitis Symptoms/Problems Index from baseline to week 12 among the treatment group ( median -12 or approximately a 46 % reduction ) was significantly greater compared to the placebo group ( median -5.5 or approximately a 24 % reduction , p = 0.04 ) . At week 18 the treatment group showed statistically significant improvement in all Health Related Quality of Life domains compared to the baseline ( p Health Related Quality of Life domains , ( p adverse events between treated and placebo groups . CONCLUSIONS The use of intravesical pentosan polysulfate sodium simultaneously with oral pentosan polysulfate sodium is a safe and effective therapeutic option . These findings will open a new option for patients with interstitial cystitis to reduce their severely devastating symptoms and to improve their quality of life and well-being",
"PURPOSE We have conducted a prospect i ve open-label study to examine the safety and efficacy of the long-term administration of the tricyclic antidepressant amitriptyline in patients with interstitial cystitis ( IC ) . METHODS Patients were stratified into 2 groups : an NIDDK group including patients fulfilling the NIDDK criteria for IC and a non-NIDDK group encompassing patients who presented the characteristic IC symptoms but met at least one of the NIDDK exclusion criteria . Amitriptyline was taken strictly at bedtime following an established self-titration protocol without a limitation of the maximum daily dosage . Patients reporting improvement in a global response assessment question naire were defined as treatment responders . Further efficacy measures included changes of pain and urgency , functional bladder capacity and frequency . Changes in the O'Leary-Sant IC index and rating of overall satisfaction with the therapeutic outcome are reported as well . RESULTS The mean follow-up of the study was 19.0 + /- 12.5 months . The response rate was 64 % ( 60 patients ) . Overall mean dosage was 55 mg ( range : 12.5 - 150 mg ) . Side effects occurred in 79 patients ( 84 % ) ( dry mouth : 79 % , weight gain : 59 % ) . Patient overall satisfaction with the therapeutic result was either excellent or good in 43 patients ( 46 % ) . The drop-out rate was 31 % ( 29 patients ) after a mean treatment period of 6 weeks at a mean dosage of 70 mg . Non-response to treatment was the primary reason for drop-out in all cases , side effects contributed to drop-out in 25 patients ( 86 % ) . The various IC symptoms improved statistically significant compared with baseline . CONCLUSIONS Long-term administration of amitriptyline is a feasible , safe and effective treatment for IC provided that the drug is used judiciously to minimise adverse effects . The therapeutic response to amitriptyline was uniformly observed in patients fulfilling the NIDDK criteria and in those patients with the pure clinical diagnosis of IC ",
"Abstract Objective . Male chronic pelvic pain syndrome ( CPPS ) has been the subject of numerous clinical trials , but so far , no uniformly effective treatment has been identified . A commonly reported tender spot in men with CPPS is the bulbospongiosus muscle . A r and omized placebo controlled pilot trial of botulinum toxin A ( BTX-A ) injection into the perineal skeletal musculature for the treatment CPPS was conducted . Material and methods . Twenty-nine men with CPPS were identified from a urology clinic . Symptom evaluation was performed using a Global Response Assessment ( GRA ) and the Chronic Prostatitis Symptom Index ( CPSI ) . All subjects were r and omized to receive either BTX-A 100 U or normal saline injected into the perineal body and bulbospongiosus muscle . Results . BTX-A injection was administered in 13 men . At the 1 month follow-up there was a 30 % response rate for BTX-A treatment compared with 13 % for placebo ( p = 0.0002 ) , based on GRA results . Total CPSI score did not reach significance in the BTX-A-treated group , compared with controls . The CPSI pain subdomain score reached statistical significance in the BTX-A patients compared with controls ( p = 0.05 ) . The injections were well tolerated . There were no complications from the injections and no patients reported side-effects . Conclusions . BTX-A injection into the perineal body and bulbospongiosus muscle results in a modest response rate on the GRA compared with placebo for overall symptoms associated with CPPS . The treatment is well tolerated and safe . BTX-A use may enhance polytherapeutic pain management",
"To assess the immediate and sustained relief of the symptoms of interstitial cystitis/painful bladder syndrome ( IC/PBlS ) after a consecutive 5‐day course of treatment with intravesical alkalinized lidocaine ( PSD597 ) , and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients",
"PURPOSE We conducted a double-blind , sham controlled study to evaluate the safety , efficacy and feasibility of hyperbaric oxygenation for interstitial cystitis . MATERIAL S AND METHODS A total of 21 patients with interstitial cystitis were r and omized to 90 minutes treatment in a hyperbaric chamber pressurized with 100 % O2 to 2.4 atmosphere absolute for 30 treatments sessions or 1.3 atmosphere absolute , breathing normal air in the control group . Moderate or marked improvement in a global response assessment question naire was defined as treatment response ( primary outcomes ) . Secondary measurements included changes of pain and urgency evaluated by visual analog scales , functional bladder capacity and frequency . Changes in the O'Leary-Sant Interstitial Cystitis Index and rating of overall satisfaction with the therapeutic outcome were also reported . RESULTS There were 3 of 14 patients on verum and no control patients who were identified as responders ( p oxygenation result ed in a decrease of baseline urgency intensity from 60.2 + /- 15.0 to 49.9 + /- 35.2 mm at 3 months and decrease of pain intensity from 43.1 + /- 20.5 to 31.2 + /- 19.8 mm , respectively ( p Interstitial Cystitis Symptom Index score sum decreased from 25.7 to 19.9 points in patients on verum . Sham treatment did not result in improvement of the baseline parameters . CONCLUSIONS A total of 30 treatment sessions of hyperbaric oxygenation appear to be a safe , effective and feasible therapeutic approach to interstitial cystitis . In the treatment responders application of hyperbaric oxygenation result ed in a sustained decrease of interstitial cystitis symptoms with a discordant profile regarding the peak amelioration of the various interstitial cystitis symptoms compared with a normobaric , normoxic sham treatment",
"Objective : To assess the efficacy of the oral prostagl and in analogue misoprostol in controlling the symptoms of interstitial cystitis in patients with refractory disease . Methods : Twenty-five patients were commenced on misoprostol 600 µg daily for 3 months . Patients who responded to therapy were offered treatment for a further 6 months . Assessment of the response was by a voiding log and an interstitial cystitis symptom score . Results : At 3 months , 14 patients ( 56 % ) had significantly improved , and after a further 6 months , 12 patients ( 48 % ) had a sustained response . The incidence of adverse drug effects was 64 % . Most side effects were minimal , and the response rate in patients who were able to tolerate the drug was 87 % at 3 months and 75 % at 9 months . Conclusions : The oral prostagl and in analogue misoprostol is effective in treating the symptoms of interstitial cystitis . It is possible that prostagl and ins have a cytoprotective action in the urinary bladder",
"OBJECTIVE To evaluate the therapeutic efficacy of intravesical pentosanpolysulphate ( PPS ) compared with placebo in patients with interstitial cystitis ( IC ) . PATIENTS AND METHODS Twenty patients who fulfilled the diagnostic criteria for IC participated in a double-blind placebo-controlled study ; 10 received intravesical PPS ( 300 mg in 50 mL of 0.9 % sodium chloride ) applied twice a week for 3 months and the other 10 received a placebo . Symptomatic relief and objective variables ( bladder capacity voiding volumes and urinary frequency ) were assessed after 3 months and the long-term outcome of those continuing treatment was determined . RESULTS Of the patients treated with PPS , four gained significant symptomatic relief compared with only two receiving placebo . Only the urodynamic bladder capacity showed a statistically significant increase in patients treated with PPS ( P = 0.047 ) . At 18 months from the start of the study , the symptoms were relieved in eight patients while still receiving PPS instillations and in four without treatment . CONCLUSIONS These results suggest that intravesical PPS is an effective option for the treatment of IC and shows that the intravesical application of PPS is a safe treatment with no important side-effects",
"Pentosan polysulfate sodium ( PPS ) was compared with placebo for the symptomatic therapy of interstitial cystitis in a double-blind , multicenter study . A total of 110 patients were enrolled and treated for three months . In this study , overall improvement of greater than 25 percent was reported by 28 percent of the PPS-treated patients and by 13 percent of the placebo-treated patients ( p = 0.03 ) . The investigators ' overall evaluation provided similar results , 26 percent vs 11 percent in favor of PPS ( p = 0.04 ) . Improvement in pain and pressure to urinate also favored PPS over placebo and approached statistical significance ( p = 0.07 and 0.08 ) . The incidence of adverse reactions was 6 percent in the PPS-treated group and 13 percent in the placebo-treated group . All adverse reactions were minor , and treatment was discontinued by 1 patient in the PPS group and 2 in the placebo group . In this study , PPS was found to be significantly more effective than , and equally as safe as , placebo",
"OBJECTIVES An oral preparation of pentosanpolysulfate sodium ( PPS ) was recently approved by the Food and Drug Administration for interstitial cystitis ( IC ) . Previously published articles have documented improvement in symptoms in 28 % to 63 % of patients , but no long-term studies have been published . No unique characteristics except for Hunner 's ulcer have been found in patients experiencing relief from PPS . We report our experience with PPS following patients up to 116 months and analyze baseline parameters in an attempt to characterize long-term responders . METHODS Baseline and follow-up data from 97 patients with IC and enrolled in a compassionate use study with PPS at the University of Wisconsin from 1987 to 1995 are analyzed . Previous treatments had failed , and patients had to pay for PPS . Patients continuing treatment with PPS were monitored every 3 months with question naires and laboratory tests . In 1996 an up date on medication and a question naire developed by the National Institutes of Health Interstitial Cystitis Data base were sent to patients who had discontinued treatment . RESULTS By the end of the study period 11 ( 11.3 % ) of the patients were still taking PPS , with 6 ( 6.2 % ) doing so continuously for more than 18 months . Three ( 3 % ) patients who discontinued PPS were in long-term remission . An additional 15 % had remission for a substantial period . Except for a weak correlation between less constant pain ( P = 0.0439 ) , no correlations were found between baseline parameters and duration of treatment with PPS . CONCLUSIONS On a long-term basis , between 6.2 % and 18.7 % of patients with IC benefit from PPS . The only baseline factor predicting response to PPS was less constant pain",
"OBJECTIVES To determine the usefulness of oral hydroxyzine for the treatment of symptomatic interstitial cystitis . METHODS This study was an open-label , nonconsecutive case series of patients treated by their local physicians , in consultation with the authors . A case-report form using visual analog scales was used to assess outcomes . RESULTS Out of 140 patients , 90 ( 65 % ) returned the case-report forms . A 40 % reduction in symptom scores was reported . This rose to 55 % in patients with a history of allergies . CONCLUSIONS Hydroxyzine is a useful drug for the symptomatic treatment of IC , especially in patients with documented allergies and /or evidence of bladder mast cell activation",
"Background : Current medications used in the treatment of interstitial cystitis ( IC ) have limited efficacy . This prospect i ve study investigated the efficacy of multiple intravesical instillations of resiniferatoxin ( RTX ) at the concentration of 10 nM. Methods : Patients with proven IC previously treated with traditional medications for more than 6 months without clinical benefit were enrolled . They were excluded if bladder outlet obstruction or urinary tract infection was present . Intravesical instillation of low-dose RTX ( 10 nM ) once weekly for 4 weeks was performed at the outpatient department . International Prostate Symptom Score ( IPSS ) , 5-Point Pain Scale , and Quality of Life Index ( QOL Index ) were recorded . A videourodynamic study was done at baseline and 3 months after treatment . Results : The therapeutic results and urodynamic parameters were compared between baseline and 3 months . Thirteen patients , including 10 women and 3 men , were enrolled in this study . The mean duration of IC symptoms was 4.4 ± 2.5 years . The mean duration of active treatment was 15.3 ± 8.6 months . One female patient dropped out due to severe bladder pain after RTX instillation . Among the 12 patients who completed the study treatment , subjective assessment revealed that 2 had an excellent therapeutic result , 5 had an improved result and 5 remained unchanged from baseline . The overall satisfactory rate was 58.3 % . IPSS , 5-Point Pain Scale , and QOL Index were significantly decreased after RTX treatment . There was no significant increase in mean functional bladder capacity or change in urodynamic parameters . No serious adverse event occurred after RTX treatment . Conclusions : This study suggests that multiple intravesical instillations of RTX at the concentration of 10 nM are effective in relieving lower urinary tract symptoms in patients with refractory IC . The treatment is tolerable and suitable for use on an outpatient clinic basis",
"PURPOSE Present therapeutic approaches to control hypersensitive disorder of the lower urinary tract and bladder pain are clinical ly and scientifically unsatisfactory . We performed a r and omized placebo controlled study with followup after 1 and 3 months using intravesical resiniferatoxin to treat hypersensitive disorder and bladder pain . MATERIAL S AND METHODS We prospect ively r and omized 18 patients into 2 groups to receive a single dose of 10 nM. resiniferatoxin intravesically ( group 1 ) or a placebo saline solution only ( group 2 ) . All patients had at least a 6-month history of frequency , nocturia , urgency and symptoms of pelvic pain as well as no urinary tract infection within the last 3 months , functional disorders of the lower urinary tract , or other vesical or urethral pathology . Pretreatment voiding pattern and pain score were recorded . Patients were evaluated after 30 days ( primary end point ) and 3 months ( secondary end point ) . RESULTS The 2 groups were adequately homogeneous in regard to patient age , sex ratio , disease duration , voiding pattern and pain score . At the primary end point mean frequency plus or minus st and ard error of mean was decreased from 12 . 444 + /- 0.70 voids to 7.111 + /- 0.67 and nocturia from 3.777 + /- 0 . 27 to 1.666 + /- 0.16 ( p mean frequency in group 1 at the secondary end point to 10.444 + /- 0.94 voids ( p placebo . Mean pain score significantly decreased in group 1 at the primary end point from 5.555 + /- 0.29 to 2.666 + /- 0.23 ( p 0.05 ) . No statistically significant improvement in mean pain score was observed in placebo group 2 . During resiniferatoxin infusion 4 group 1 patients noticed a light warm or burning sensation at the suprapubic and /or urethral level . CONCLUSIONS Intravesical resiniferatoxin may significantly improve the voiding pattern and pain score in patients with hypersensitive disorder and bladder pain . Because resiniferatoxin did not cause a significant warm or burning sensation at the suprapubic and /or urethral level , it may be considered a new strategy for treating hypersensitive disorder and bladder pain . However , further studies are necessary to confirm our results and define the resiniferatoxin mechanism of action , dose and necessary treatment schedule",
"Objectives To determine , in a double‐blind placebo‐controlled crossover study , whether l‐arginine improves the symptoms of interstitial cystitis ( IC ) , a chronic condition in which nitric oxide ( NO ) may be important , as previous open pilot studies suggested that l‐arginine reduced the pain and frequency associated with IC",
"PURPOSE We evaluated the effectiveness of combining behavioral therapy , pharmacologic therapy and endoscopic hydrodistension for treating painful bladder syndrome / interstitial cystitis ( PBS/IC ) . MATERIAL S AND METHODS Twenty-five patients with PBS/IC were prospect ively enrolled in a pilot multimodal behavioral , pharmacologic and endoscopic treatment protocol . Behavioral modification included diet recommendations , fluid restriction to 64 oz . /day , progressive timed voiding and Kegel exercises . Oral pharmacologic therapy consisted of daily doses of macrodantin 100 mg , hydroxyzine 10 - 20 mg and urised 4 tablets . Patients underwent endoscopic bladder hydrodistention under anesthesia at least 2 weeks after protocol enrollment . Behavioral and pharmacological treatments were continued after the hydrodistention . O'Leary-Sant question naire scores were recorded before starting the protocol , after pharmacologic/behavioral therapy , 2 months post-hydrodistension , and at scheduled follow-up . RESULTS Eighteen patients ( 72 % ) completed the pilot multimodal treatment protocol and were followed for a mean of 10.2 months . All patients were female with a median age of 36.3 years and had mean bladder capacity under anesthesia of 836 milliliters . Mean O'Leary-Sant symptom index scores for baseline symptoms , after behavioral/pharmacologic treatment , post-hydrodistension and during follow up were 12.5 , 8.6 , 7.0 , and 6.7 ( p Mean O'Leary-Sant problem index scores for baseline , after behavioral/pharmacologic treatment , post-hydrodistention and during follow up were 12.7 , 8.9 , 6.7 , and 7.7 ( p behavioral modification , pharmacologic therapy and endoscopic hydrodistention demonstrated a significant progressive improvement in PBS/IC quality of life scores , compared to a pre-treatment baseline . These results should be vali date d in a larger , placebo controlled trial",
"PURPOSE We compared intravesical bacillus Calmette-Guerin ( BCG ) to placebo instillations in patients with treatment refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC , and reported at least moderate pain and frequency for a minimum of 6 months before study entry , were r and omized to 6 weekly double-blinded intravesical instillations of either BCG or placebo , and then followed for a total of 34 weeks . The primary outcome was a patient reported global response assessment at week 34 , supplemented with medications for IC during weeks 31 to 34 . Secondary outcomes included a 24-hour voiding diary , pain , urgency , vali date d IC symptom indexes and adverse events . The target sample size was 260 participants , design ed to detect a difference in response rates between placebo and BCG of 30 % and 50 % , respectively . RESULTS A total of 265 participants were r and omized and 17 ( 6 % ) patients withdrew from study . The response rates for the primary outcome were 12 % for placebo and 21 % for BCG ( p = 0.062 ) . Small improvements were observed for all secondary outcomes , some more so with BCG , but these differences were of borderline statistical significance . Although a large number of adverse events were reported in the BCG arm , there was no statistically significant difference between the treatment arms in overall adverse event rates . CONCLUSIONS Although the BCG safety profile was acceptable , the response rate for the primary outcome was low . Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive",
"OBJECTIVES To evaluate the effectiveness of transvaginal manual therapy of the pelvic floor musculature ( Thiele massage ) in symptomatic female patients with interstitial cystitis and high-tone dysfunction of the pelvic floor . METHODS A total of 21 women with documented interstitial cystitis and high-tone pelvic floor dysfunction underwent transvaginal massage using the Thiele technique twice a week for 5 weeks . Symptoms were evaluated before massage , at protocol conclusion , and at a mean of 4.5 months after therapy completion ( long-term follow-up ) . The response to treatment was evaluated through the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes , Likert Visual Analogue Scales for urgency and pain , and Short-Form 12-item ( SF-12 ) Quality -of-Life Scale , and through changes in the physical examination findings using a 5-point modified Oxford Scale to document pelvic floor tenderness . RESULTS A statistically significant improvement was seen in the Symptom and Problem Indexes of the O'Leary-Sant Question naire ( P = 0.015 and P = 0.039 , respectively ) , Likert Visual Analogue Scales for urgency and pain ( P = 0.001 and P = 0.005 , respectively ) , the Physical and Mental Component Summary from the SF-12 Quality -of-Life Scale ( P = 0.049 and P = 0.044 , respectively ) , and the modified Oxford Scale ( P O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes ( P = 0.049 and P = 0.02 , respectively ) , Likert Visual Analogue Scales for urgency and pain ( P = 0.004 and P = 0.005 , respectively ) , and modified Oxford Scale for three of four muscles in the pelvic floor ( P Thiele massage appears to be very helpful in improving irritative bladder symptoms in patients with interstitial cystitis and high-tone pelvic floor dysfunction in addition to decreasing pelvic floor muscle tone",
"OBJECTIVES To test the efficacy of a new intravesical therapeutic solution in relieving urgency/frequency and pain in interstitial cystitis ( IC ) . METHODS A solution of 40,000 U heparin , 8 mL 1 % lidocaine ( 80 mg ; group 1 ) or 2 % lidocaine ( 160 mg ; group 2 ) , and 3 mL 8.4 % sodium bicarbonate was administered intravesically in patients with newly diagnosed IC with significant frequency , urgency , and pain . Using the Patient Overall Rating of Improvement of Symptoms , the response to treatment was evaluated within 20 minutes of instillation in all patients , after 24 to 48 hours in group 2 , and after three treatments per week for 2 weeks in group 2 patients who elected to receive additional instillations . Significant symptom relief was defined as 50 % or greater symptom improvement . RESULTS After one instillation , 35 ( 75 % ) of 47 patients in group 1 ( 1 % lidocaine ) and 33 ( 94 % ) of 35 in group 2 ( 2 % lidocaine ) reported significant immediate symptom relief . The difference in the response rates was statistically significant ( P symptom relief from the single instillation , and 16 ( 80 % ) of 20 reported significant sustained symptom relief after 2 weeks of treatment . CONCLUSIONS Intravesical treatment with combined heparin and alkalinized lidocaine immediately reduced the pain and urgency of IC in most patients treated for newly diagnosed IC . Symptom relief lasted beyond the duration of the local anesthetic activity of lidocaine , suggesting the solution suppresses neurologic upregulation . In IC treatment , this new intravesical solution may be helpful in the interval before heparinoid therapy reaches its full effect",
"OBJECTIVES To compare the current recommended dose of pentosan polysulfate sodium ( PPS ) with doses two to three times higher . METHODS We evaluated three dosages ( 300 , 600 , and 900 mg ) of PPS in a r and omized , double-blind , double-dummy , parallel-group , multicenter , 32-week study . Adults ( n = 380 ) with a diagnosis of interstitial cystitis ( IC ) as determined by a positive cystoscopic examination combined with bladder pain and urgency or a history of IC symptoms for at least 6 months were enrolled . Participants completed the Patient 's Overall Rating of Symptom Index ( PORIS ) and the O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) at baseline ( ICSI only ) and during follow-up visits at 4 , 8 , 12 , 16 , 24 , and 32 weeks . RESULTS Mean ICSI scores improved significantly during the 32 weeks for all dosages ( baseline 11.2 , 11.9 , and 11.9 to endpoint 8.2 , 8.1 , 8.6 for 300 , 600 , and 900 mg , respectively ; P mild , moderate , and severe symptoms , respectively , as assessed by the ICSI . At study end , 27.5 % , 56.9 % , and 15.7 % reported mild , moderate , and severe symptoms , respectively . The PORIS scores improved within 4 weeks with 15.8 % to 21.1 % of all patients classified as responders ( 50 % or greater improvement on PORIS ) . At 32 weeks , 49.6 % , 49.6 % , and 45.2 % of all patients were responders at a dose of 300 , 600 , and 900 mg , respectively . Most adverse events were mild and resolved without intervention . CONCLUSIONS For all three dosages of PPS , a clinical ly significant but similar response was demonstrated . The duration of therapy appears to be more important than the dosage",
"OBJECTIVES The long-term efficacy and safety of Elmiron ( oral pentosan polysulfate sodium ) in relieving recurring symptoms of interstitial cystitis ( IC ) were investigated in a long-term , open-label physician 's usage study . METHODS Patients with diagnosed interstitial cystitis who met the study entry criteria received shipments of Elmiron for 3 months at a dose of 100 mg 3 times a day and for the consecutive 3-month periods , provided they completed and returned question naires about their disease symptoms , reported any adverse events , and had laboratory data collected before each new shipment . Patients were required to purchase the medication . Responses to question naires provided the data reported here . Several symptomatic parameters of the disease ( overall improvement , overall improvement in pain and urgency , urinary frequency , and nocturia ) were recorded in this way and used to evaluate efficacy . RESULTS Elmiron usage was correlated with improvements in some symptoms , and these improvements increased with duration of treatment . Some symptoms were improved within 5 months , although most continued to show improvements in both severity rating and in percentage of positive responders over 1 to 2 years . Population s of patients receiving extended treatment , some for > 90 months , showed no further improvement or worsening in symptom values . Forty-six percent of patients dropped out of the study within the first 3 months of Elmiron treatment . The frequency of adverse events was adverse events were reversible alopecia , diarrhea , nausea , headache , and rash . CONCLUSIONS Elmiron appears to be an efficacious long-term treatment for reducing a constellation of debilitating symptoms associated with interstitial cystitis in some patients . Patients with a positive response to Elmiron appear to maintain this response over time",
"Nifedipine is a calcium channel antagonist known to inhibit smooth muscle contraction and cell-mediated immunity . The clinical and local immune response to nifedipine was investigated in an open trial with 10 female interstitial cystitis patients , whose disease was diagnosed according to the consensus criteria developed in 1987 at a National Institutes of Health workshop . To evaluate the symptoms and clinical response of the patients objective ly we scored the symptoms of frequency , urgency , nocturia , dysuria and suprapubic pain on a scale of 0 to 2 . Nifedipine was administered as a single daily dose determined by a dose-titration test . Urinary interleukin-2 inhibitor activity , a marker of cell-mediated inflammation , was measured using a murine interleukin-2 dependent cell line . Before nifedipine therapy the symptom scores ( total of the 5 symptoms ) ranged between 5 and 9 , and after 2 months they ranged between 0 and 6 . Of the 9 patients followed for at least 4 months only 1 failed to have a significant clinical improvement , 5 showed at least a 50 % decrease in symptom scores and 3 were asymptomatic . Drug side effects were minimal . Urinary interleukin-2 inhibitor activity before nifedipine therapy confirmed the presence of cell-mediated inflammation . After 4 months of therapy interleukin-2 inhibitor activity was normal in 7 of 9 patients regardless of the severity of symptoms , which indicated that nifedipine exerted an immunosuppressive effect . Although our data suggest that nifedipine is an efficacious , well tolerated , convenient oral medication for the treatment of interstitial cystitis , the true value of nifedipine for patients with this disease must be determined by a prospect i ve , r and omized trial of nifedipine versus placebo",
"To report a multicentre , community based open‐label study design ed to assess the efficacy and safety of intravesical sodium chondroitin sulphate in the treatment of patients with the clinical diagnosis of interstitial cystitis ( IC ) . Chondroitin sulphate is a naturally occurring glycosaminoglycan ( GAG ) in the bladder mucus layer and changes in this GAG have been implicated in the pathogenesis of IC , and small single‐centre studies have suggested that intravesical chondroitin sulphate may have efficacy in IC",
"PURPOSE Interstitial cystitis is a debilitating bladder disease of unknown etiology with no cure . A recent report suggested that bacillus Calmette-Guerin ( BCG ) may be effective in the treatment of interstitial cystitis . A r and omized , prospect i ve , double-blind , placebo controlled trial to evaluate the safety and efficacy of intravesical BCG in treating interstitial cystitis was done . MATERIAL S AND METHODS Patients meeting the National Institute of Arthritis , Diabetes and Digestive and Kidney Diseases criteria for interstitial cystitis received 6 weekly instillations of Tice strain BCG or placebo . Periodic question naires , voiding diaries and cystometrograms were obtained . A total of 30 evaluable subjects was enrolled in the study with a mean followup of 8 months ( range 6 to 13 ) . Based on an exit question naire a responder was defined as one who rated the interstitial cystitis symptoms as moderately improved or better . RESULTS A 60 % BCG response rate was noted , compared to a 27 % placebo response rate . Minimum voided volume and quality of life improved in the BCG group compared to placebo . Adverse events were similar in each group , mostly irritative in nature , and no significant systemic events were noted . CONCLUSIONS Intravesical Tice strain BCG appears to be safe and efficacious in the treatment of interstitial cystitis . Additional studies must be performed to confirm the results of this pilot study",
"PURPOSE We evaluated the longer term response in patients with interstitial cystitis who initially responded to intravesical bacillus Calmette-Guerin or placebo in a r and omized clinical trial . MATERIAL S AND METHODS Patients with interstitial cystitis who responded positively to treatment with bacillus Calmette-Guerin or placebo after 34 weeks of followup in a double-blind clinical trial were followed for an additional 34 weeks in an observational study to assess response durability . Outcomes at 68 weeks included a patient reported global response assessment , 24-hour voiding diary , and pain , urgency and vali date d interstitial cystitis symptom indexes . RESULTS Of responders to bacillus Calmette-Guerin or placebo in the clinical trial 38 continued extended followup in the observational study . A total of 12 ( 75 % ) responders who received placebo and 19 ( 86 % ) who received bacillus Calmette-Guerin considered themselves to remain moderately or markedly improved at week 68 . Improved symptom outcomes were also generally maintained during followup in the 2 groups . CONCLUSIONS Most patients who respond to therapy with intravesical bacillus Calmette-Guerin or placebo maintain improved symptoms for up to 68 weeks after the initiation of therapy . However , initial response rates are low and placebo responders demonstrated essentially the same durability of response as bacillus Calmette-Guerin responders . These results argue against the routine use of bacillus Calmette-Guerin in this patient group",
"Objective . Interstitial cystitis is a condition with a poorly understood etiology and , consequently , various treatment options have been described in the literature , with a less than optimal outcome . The aim of this study was to examine the role of a combination of intravesical hydrocortisone and heparin , together with oral bladder sedatives and systemic triamcinolone , for the treatment of interstitial cystitis . Material and methods . A total of 26 patients who were diagnosed as having interstitial cystitis were treated with weekly intravesical hydrocortisone ( 200 mg ) and heparin ( 25 000 IU ) in physiological saline for 6 weeks . In addition , they were given oral bladder sedatives such as oxybutynin or tolterodine . Ulcerative , refractory and recurrent cases were treated with intramuscular triamcinolone ( 40 mg ) weekly for 6 weeks . Results . All patients experienced an improvement in symptoms within 48 h of their first intravesical instillation . While 19 patients ( 73 % ) experienced almost complete pain relief , five of the remaining seven patients improved with intramuscular triamcinolone . Frequency reduced from a mean of 23.2 to 10.9 voids per day and was acceptable in 21 patients ( 80 % ) . Six patients ( 23 % ) had a relapse of symptoms in the form of pain and were treated satisfactorily by means of intramuscular triamcinolone . The mean duration of follow-up was 18.3 months . Conclusion . A combination of intravesical hydrocortisone and heparin , along with oral bladder sedatives and systemic steroids , has been used with encouraging results in a small group of patients with interstitial cystitis",
"INTRODUCTION The aim of this study was to examine the efficacy and safety of intravesical Bacillus Calmette-Guerin ( BCG ) in the treatment of refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Thirteen patients with refractory IC were enrolled in the study . They were scheduled to receive 6 weekly courses of treatment with intravesical BCG . Variables including the frequency , nocturia , urgency , pelvic pain , dyspareunia , dysuria , IC symptom index , IC problem index , and average voided volume were assessed every 6 months after the BCG therapy . RESULTS Thirteen patients received the complete course of intravesical BCG therapy . Twenty-four months after the treatment a mean improvement of 51.9 % was seen in frequency ( P=.001 ) , 43.2 % in nocturia ( P=.002 ) , 28.7 % in urgency ( P=.004 ) , 43.1 % in pelvic pain ( P=.001 ) , 58.3 % in dyspareunia ( P=.003 ) , 6.5 % in dysuria ( P=.16 ) , 57.7 % in the O'Leary-Sant IC symptom index ( P=.001 ) , and 61.8 % in the O'Leary-Sant IC problem index ( P=.001 ) scores . A significant improvement was seen in the mean average voided volume at the 24th follow-up month ( 89.5 % ; P=.001 ) . CONCLUSION Intravesical BCG is a relatively effective treatment in patients with refractory IC . Its efficacy seems to be modest and lasts for at least 24 months in majority of the patients . It is also safe and well tolerated",
"PURPOSE Interstitial cystitis is a disorder of the bladder characterized by urgency and frequency of urination , and pelvic pain . The classic type of interstitial cystitis is characterized by Hunner 's ulcers , which are focal regions of severe bladder inflammation . Patients with Hunner 's ulcers tend to have more severe symptoms and are often refractory to medical management . We present a prospect i ve series of patients who underwent ablative therapy of Hunner 's ulcers using a neodymium (Nd):YAG laser . MATERIAL S AND METHODS A total of 24 patients with interstitial cystitis underwent ablative therapy for Hunner 's ulcers . Medical therapy had failed in all cases . Using regional or general anesthesia the Nd : YAG laser under cystoscopic control was used to ablate the ulcers . The power setting was 15 W. with a firing duration of between 1 and 3 seconds . The procedure was performed on an outpatient basis . Symptoms were noted preoperatively and postoperatively . RESULTS All patients had symptom improvement within 2 to 3 days . The mean pain scores decreased from 9.1 to 1.2 ( p mean urgency score decreased from 8.2 to 1.9 ( p mean voiding interval increased from every 30 minutes to every 102 ( p nocturia decreased from a mean of 7.9 voids per night to 2.9 ( p complications . Mean followup was 23 months . However , relapse in 11 patients required 1 to 4 additional treatments . The re-treatment response was similar to the initial treatment . CONCLUSIONS Nd : YAG laser ablation of Hunner 's ulcers is an excellent , minimally invasive method of treating interstitial cystitis . While it is not a cure , it offers patients an opportunity to have decreased symptoms for an extended period and it may be repeated as necessary",
"PURPOSE Amitriptyline is frequently used to treat patients with interstitial cystitis/painful bladder syndrome . The evidence to support this practice is derived mainly from a small , single site clinical trial and case reports . MATERIAL S AND METHODS We conducted a multicenter , r and omized , double-blind , placebo controlled clinical trial of amitriptyline in subjects with interstitial cystitis/painful bladder syndrome who were naïve to therapy . Study participants in both treatment arms received a st and ardized education and behavioral modification program . The drug dose was increased during a 6-week period from 10 up to 75 mg once daily . The primary outcome was a patient reported global response assessment of symptom improvement evaluated after 12 weeks of treatment . RESULTS A total of 271 subjects were r and omized and 231 ( 85 % ) provided a global response assessment at 12 weeks of followup . Study participants were primarily women ( 83 % ) and white ( 74 % ) , with a median age of 38 years . In an intent to treat analysis ( 271 ) the rate of response of subjects reporting moderate or marked improvement from baseline in the amitriptyline and placebo groups was 55 % and 45 % , respectively ( p = 0.12 ) . Of the subgroup of subjects ( 207 ) who achieved a drug dose of at least 50 mg , a significantly higher response rate was observed in the amitriptyline group ( 66 % ) compared to placebo ( 47 % ) ( p = 0.01 ) . CONCLUSIONS When all r and omized subjects were considered , amitriptyline plus an education and behavioral modification program did not significantly improve symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome . However , amitriptyline may be beneficial in persons who can achieve a daily dose of 50 mg or greater , although this subgroup comparison was not specified in advance",
"PURPOSE We conducted a prospect i ve , double-blind study with a crossover design of intravesical bacillus Calmette-Guerin ( BCG ) and dimethyl sulfoxide to determine whether patients with classic and nonulcer interstitial cystitis , respectively , might benefit from either regimen . MATERIAL S AND METHODS A total of 21 patients , including 11 with classic and 10 with nonulcer interstitial cystitis , r and omly underwent treatments with intravesical BCG or dimethyl sulfoxide and , if not improved , were treated with the other substance after a washout period . All 21 patients were evaluated with symptom question naires , including a visual analog pain scale and voiding diaries . RESULTS Regardless of regimen , there was no improvement in maximal functional capacity . There was a reduction in urinary frequency following dimethyl sulfoxide treatment but only in the classic subtype ( p pain decrease was noted in classic ( p maximal functional capacity but result ed in a significant reduction in pain and urinary frequency , although only in patients with classic interstitial cystitis",
"OBJECTIVES To evaluate the efficacy of intravesical instillation of hyaluronic acid ( HA ) after hydrodistention for the treatment of patients with interstitial cystitis ( IC ) having small bladder capacity . METHODS A total of 47 patients with IC ( aged 27 - 76 years ) whose functional bladder capacity was less than 200 mL received bladder hydrodistention . Thereafter , 20 patients received intravesical instillation of 40 mg HA weekly in the first month and then monthly in the following 2 months . Sixteen patients received intravesical heparin instead and 11 patients received hydrodistention alone as the control . Mean voids per day , visual analog scale for pain , and functional bladder capacity were measured before hydrodistention and 3 and 6 months after hydrodistention in all 3 groups and 9 months after hydrodistention in HA and heparin groups . RESULTS Two patients in the HA group and 1 in the heparin group failed to complete the treatment . Three months after hydrodistention , there was no improvement in the control group . Six and 9 months after hydrodistention , rate of improvement was significantly higher in the HA group than in the heparin group ( 77.8 % vs 33.3 % , P heparin treatment did not show any improvement . Improvement in voids per day ( -1.8 + /- 2.5 , P visual analog scale ( -0.9 + /- 1.1 , P bladder capacity ( 16 + /- 18 mL , P HA group . CONCLUSIONS Intravesical instillation of HA may obviously prolong the effect of bladder hydrodistention in patients with severe IC . Its effect was better than heparin ",
"PURPOSE Urinary nitric oxide synthase activity is decreased in patients with interstitial cystitis . Since nitric oxide may be an important determinant of the symptoms and immunological responses associated with interstitial cystitis , patients with this disease were treated with oral L-arginine , the substrate for nitric oxide synthase . MATERIAL S AND METHODS Ten patients took 1.5 gm . L-arginine orally daily for 6 months . Interstitial cystitis symptoms were surveyed before and during the 6-month trial . RESULTS Oral L-arginine treatment result ed in a significant decrease in urinary voiding discomfort , lower abdominal pain and vaginal/urethral pain . Urinary frequency during the day and night also significantly decreased . CONCLUSIONS This self-controlled study provides evidence that long-term oral L-arginine improves interstitial cystitis related symptoms",
"PURPOSE Interstitial cystitis is a chronic disease of unknown etiology characterized by bladder pain , urgency and frequency . Although a single microbe has not been implicated as a cause of interstitial cystitis , several groups noted various organisms in the urine of some women with interstitial cystitis and some patients reported that antibiotics decrease symptoms . Consequently we performed a prospect i ve , r and omized , double-blinded , placebo controlled pilot study of sequential oral antibiotics . MATERIAL S AND METHODS We r and omized 50 patients with interstitial cystitis to receive 18 weeks of placebo or antibiotics , including rifampin plus a sequence of doxycycline , erythromycin , metronidazole , clindamycin , amoxicillin and ciprofloxacin for 3 weeks each . RESULTS Intent to treat analysis demonstrated that 12 of 25 patients ( 48 % ) in the antibiotic and 6 of 25 ( 24 % ) in the placebo group reported overall improvement ( p = 0.14 ) , while 10 and 5 , respectively , noticed improvement in pain and urgency ( p = 0.22 ) . In the antibiotic group 20 participants ( 80 % ) had adverse effects compared with 10 ( 40 % ) in the placebo group ( p = 0.009 ) . CONCLUSIONS Our findings suggest that these antibiotics alone or in combination may sometimes be associated with decreased symptoms in some patients but they do not represent a major advance in therapy for interstitial cystitis",
"INTRODUCTION To assess the impact of intravesically injected botulinum A toxin ( BoNT/A ) upon bladder pain , urological complaints , symptoms of anxiety and depression , and Quality of Life ( QoL ) in patients with painful bladder symptoms ( PBS ) refractory to conventional treatment . PATIENTS AND METHODS In this prospect i ve study 14 patients received one injection of BoNT/A ( 200 U diluted in 20 ml 0.9 % NaCl ) , under cystoscopic guidance . At pre- and 3 months post- treatment all patients underwent an urological assessment ( voiding diary , urodynamics ) , a pain quantification on a visual analog scale ( VAS ) , an evaluation with the 14-item Hamilton Anxiety Rating Scale ( HAM-A ) to assess symptoms of psychic and somatic anxiety , an evaluation with the Hamilton Depression Rating Scale ( HAM-D ) to assess depression , and the 36-item Medical Outcomes Study Short Form ( SF-36 ) to assess QoL. Results . At pre-treatment all 14 patients had increased daytime and nighttime urinary frequency and high VAS scores . Nine patients had pathological HAM-A scores and all had pathological HAM-D scores . At the 3-month follow-up 10/14 patients reported a subjective improvement in pain . Mean VAS score , mean daytime and nighttime urinary frequency decreased significantly ( p SF-36 and HAM-A significantly improved ( p weight and sleep disorders , significantly improved in HAM-D , particularly somatoform symptoms ( p cognitive performance ( p circadian variations ( p patients with refractory PBS with symptoms of anxiety , depression and poor QoL , BoNT/A intravesical treatment reduced bladder pain , improved psychological functioning , and well-being",
"PURPOSE The efficacy of sacral neuromodulation for the treatment of symptoms in patients with refractory interstitial cystitis was evaluated . MATERIAL S AND METHODS A total of 25 patients with a mean age of 47 years and refractory interstitial cystitis were prospect ively evaluated with a trial of sacral nerve stimulation . Patients who demonstrated 50 % improvement in frequency , nocturia , voided volume and average pain qualified for permanent sacral nerve stimulator implantation . Treatment success was measured by voiding diary , report of average pain , and response to the Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index . RESULTS Of the 25 patients 17 qualified for permanent sacral nerve stimulator implantation . At an average of 14 months followup mean daytime frequency and nocturia improved from 17.1 to 8.7 and 4.5 to 1.1 , respectively ( p Mean voided volume increased from 111 to 264 ml . ( p of average pain decreased from 5.8 to 1.6 points on a scale of 0 to 10 ( p Interstitial Cystitis Symptom and Problem Index scores decreased from 16.5 to 6.8 and 14.5 to 5.4 , respectively ( p sacral neuromodulation is a safe and effective treatment for the dysfunctional voiding and pelvic pain in patients with interstitial cystitis who are refractory to other forms of treatment",
"We evaluated the efficacy of bilateral caudal epidural sacral neuromodulation for the treatment of refractory chronic pelvic pain ( CPP ) , painful bladder syndrome , and interstitial cystitis ( IC ) . Thirty consecutive patients ( 21 female , 9 male ) with severe refractory symptoms underwent bilateral S2-S4 sacral neuromodulation for CPP/IC . Patients were evaluated with the O'Leary IC symptom and problem index ( ICSI , ICPI ) , the short form of the Urogenital Distress Inventory ( UDI-6 ) , and the R AND 36-item health survey ( SF-36 ) preoperatively and 6 months postoperatively . The mean and minimum follow-up were 15 and 6 months , respectively . Of the 30 patients , 23 ( 77 % ) had a successful trial stimulation and were permanently implanted . Among these patients , the ICSI and ICPI scores improved by 35 ( p = 0.005 ) and 38 % ( p = 0.007 ) , respectively . The pain score improved by 40 % ( p = 0.04 ) and the UDI-6 score by 26 % ( p = 0.05 ) . On average , patients reported a 42 % improvement in their symptoms . SF-36 scores did not improve significantly . In refractory patients , bilateral caudal epidural sacral neuromodulation is another possible mode of treatment , which appears to improve both pelvic pain and voiding symptoms",
"PURPOSE We assess the efficacy of intravesical administration of oxybutynin chloride in patients with interstitial cystitis . MATERIAL S AND METHODS The study included 36 women with a mean age of 45 years with a diagnosis of interstitial cystitis . Patients were treated with gradual intravesical instillation of saline oxybutynin solution ( oxybutynin group ) or gradual filling of simple saline ( control group ) . Evaluation parameters consisted of symptom problem index , voids per day , volume per void , functional bladder capacity , volume at first sensation , cystometric bladder capacity and cystometric volume at first sensation . RESULTS Statistically significant improvement of all evaluated parameters was found in both groups . When comparing the outcomes statistically significant improvement of parameters favored the oxybutynin group . CONCLUSIONS Bladder training alone produces a satisfactory result by gradually exp and ing the bladder , and an additional statistically significant improvement is evident with intravesical oxybutynin",
"PURPOSE We examined the efficacy of Suplatast Tosilatedouble dagger ( IPD-1151 T ) , a new immunoregulator that suppresses helper T cell mediated allergic responses , including IgE production and eosinophilic inflammation for treating patients with interstitial cystitis . MATERIAL S AND METHODS A total of 14 women ( average age 43.7 years ) with interstitial cystitis , which was nonulcerative in 13 and ulcerative in 1 , were treated with 300 mg . IPD-1151 T orally daily for 12 months . All patients received laboratory assessment s , including hematology ( eosinophils and CD20 positive cells ) and serum chemistry ( IgE , and interleukin-4 ( IL-4 ) and 5 , and immunohistochemical analyses of urine leukocytes ( CD45RO positive cells as a T cell marker ) before treatment . These parameters were also measured 4 and 12 months after continuous treatment . The voiding chart , and interstitial cystitis symptom and problem indexes were evaluated before and after IPD-1151 T treatment . RESULTS IPD-1151 T treatment for 1 year result ed in a significantly increased bladder capacity and decreased symptoms , such as urinary urgency , frequency and lower abdominal pain , in patients with nonulcerative interstitial cystitis . These effects also correlated with a reduction in blood eosinophils , CD20 positive cells and IgE , and urine CD45RO positive memory T cells . No major side effects were observed . CONCLUSIONS Our study suggests that immunological responses are involved in the development of interstitial cystitis symptoms . IPD-1151 T could be a new oral agent for treatment of voiding symptoms and bladder pain in patients with interstitial cystitis",
"PURPOSE We evaluated the safety and efficacy of intravesical liposomes , a mucosal protective agent , compared to oral pentosan polysulfate sodium for interstitial cystitis/painful bladder syndrome . MATERIAL S AND METHODS We performed a prospect i ve longitudinal study of the effect of 2 independent treatments ( intravesical liposomes and oral pentosan polysulfate sodium ) in patients with interstitial cystitis/painful bladder syndrome . Ten possible responses ( or measures ) to treatment were monitored at 3 time points , including baseline , and weeks 4 and 8 . A total of 24 patients with interstitial cystitis/painful bladder syndrome were evaluated in a 1:1 ratio to intravesical liposomes ( 80 mg/40 cc distilled water ) once weekly or to oral pentosan polysulfate sodium ( 100 mg ) 3 times daily for 4 weeks each . RESULTS No patient had urinary incontinence , retention or infection due to liposome instillation . There were no unanticipated adverse events and no significant worsening of symptoms during followup . Statistically significant decreases in urinary frequency and nocturia were observed in each treatment group . Statistically significant decreases in pain , urgency and the O'Leary-Sant symptom score were observed in the liposome group . Decreased urgency in the liposome group had the most profound effect of the ordinal measures . CONCLUSIONS Each glycosaminoglycan directed treatment seemed beneficial . Liposome intravesical instillation is safe for interstitial cystitis/painful bladder syndrome with potential improvement after 1 course of therapy for up to 8 weeks . Intravesical liposomes achieved efficacy similar to that of oral pentosan polysulfate sodium . Further large-scale placebo controlled studies are needed . Intravesical liposomes appear to be a promising new treatment for interstitial cystitis/painful bladder syndrome",
"Objective To evaluate the efficacy of oral cimetidine as a treatment for painful bladder disease ( PBD , variously described as a ‘ symptom complex ’ of suprapubic pain , frequency , dysuria and nocturia in the absence of overt urine infection ) by assessing symptom relief and histological changes in the bladder wall tissue components , compared with placebo",
"PURPOSE We evaluated the 1-year efficacy and tolerability of botulinum A toxin intravesically injected in patients with painful bladder symptoms associated with increased urinary frequency , refractory to conventional treatments . MATERIAL S AND METHODS Three men and 12 women were prospect ively included in the study . Under short general anesthesia the patients were given injections of 200 U commercially available botulinum A toxin diluted in 20 ml 0.9 % NaCl . Injections were performed submucosally in the bladder trigone and lateral walls under cystoscopic guidance . A voiding chart and the visual analog scale for pain were used , and urodynamics were performed before treatment , and 1 , 3 , 5 and 12 months later . RESULTS Overall 13 patients ( 86.6 % ) reported subjective improvement at the 1 and 3-month followups . The mean visual analog scale score , and daytime and nighttime urinary frequency were significantly decreased ( p beneficial effects persisted in 26.6 % of cases but increased daytime and nighttime urinary frequency , and an increased visual analog scale score were observed compared to baseline . At 12 months after treatment pain recurred in all patients . Nine patients complained of dysuria 1 month after treatment . Dysuria persisted in 4 cases at the 3-month followup and in 2 at the 5-month followup . CONCLUSIONS Intravesically injected botulinum toxin A is effective for short-term management of refractory painful bladder syndrome . The beneficial effects decreased progressively within a few months after treatment . Thus , repeat injections of the neurotoxin are required for efficacious treatment in patients with the disease",
"PURPOSE Nitric oxide synthase activity is decreased in the urine of patients with interstitial cystitis compared to the urine of controls . In a preliminary trial oral L-arginine , the substrate for nitric oxide synthase , increased urinary nitric oxide synthase activity and improved interstitial cystitis symptoms . This r and omized , double-blind , placebo controlled study further investigates the efficacy of L-arginine treatment for interstitial cystitis . MATERIAL S AND METHODS A total of 53 interstitial cystitis patients were assigned to receive daily 1,500 mg . L-arginine or placebo orally for 3 months . Interstitial cystitis symptoms were assessed by interviews at 2 weeks , and 1 , 2 and 3 months . RESULTS The trial was completed by 21 of 27 patients in the L-arginine group and 25 of 26 in the placebo group . Using per protocol analysis 29 % ( 6 of 21 patients ) in the L-arginine group and 8 % ( 2 of 25 ) in the placebo group were clinical ly improved by the end of the trial ( p = 0.07 ) . A Likert scale showed greater global improvement in the L-arginine group ( 48 % , 10 of 21 ) compared to the placebo group ( 24 % , 6 of 25 ) at 3 months ( p = 0.05 ) with a decrease in pain intensity ( p = 0.04 ) , and tendency toward improvement in urgency ( p = 0.06 ) and frequency of pain ( p = 0.09 ) . Using an intention to treat approach to analysis there were no differences between groups . CONCLUSIONS Oral L-arginine ( 1,500 mg . daily ) may decrease pain and urgency in a subset of interstitial cystitis patients",
"PURPOSE We report an observational study to evaluate the efficacy and tolerability of duloxetine for interstitial cystitis . MATERIAL S AND METHODS A total of 48 women were prospect ively treated for 2 months following an uptitration protocol to the target dose of 2 x 40 mg duloxetine per day . Patients received the target dose for 5 weeks . The efficacy of duloxetine treatment was assessed at week 8 . The primary end point was a change in the overall well-being evaluated by a patient reported global response assessment . Secondary end points were changes in pain and urgency ( visual analog scales ) , frequency and functional bladder capacity ( 48-hour voiding log ) , and changes in overall symptom severity ( O'Leary-Sant index ) . RESULTS There were 5 patients ( 10.4 % ) who were identified as responders and 17 patients ( 35.4 % ) who dropped out of the study exclusively due to side effects , with nausea present in all dropouts . No severe adverse events were reported . All 5 responders reported onset of symptom improvement but not until they had reached the target dose . Regarding secondary outcome parameters , duloxetine treatment did not result in statistically significant improvement of symptoms . Maximum urinary flow rate and residual volume were influenced more prominently in patients at the target dose , however , the changes did not appear to be clinical ly meaningful . CONCLUSIONS Treatment of interstitial cystitis with duloxetine did not result in significant improvement of symptoms . The drug administration was safe but the tolerability of the drug was poor mainly due to nausea occurring with the starting dose of 20 mg per day . Based on the preliminary data of this observational trial we currently can not recommend duloxetine as a therapeutic approach for interstitial cystitis",
"OBJECTIVES Interstitial cystitis ( IC ) is a chronic , debilitating condition that is often associated with late diagnosis and a delay in initiation of appropriate IC-specific therapy . The purpose of this study was to determine whether the length of time from initial diagnosis to start of treatment impacts subsequent symptom improvement . METHODS A retrospective analysis was conducted in 128 patients with IC who had been treated with pentosan polysulfate sodium ( PPS ) 300 mg/day for 32 weeks in a multicenter , r and omized , double-blind , parallel-group clinical trial . Outcome measures included the O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) and the O'Leary-Sant Interstitial Cystitis Problem Index ( ICPI ) . Early treatment was defined as treatment initiation 6 months or less after IC diagnosis , whereas late treatment was defined as treatment initiation 24 months or more after IC diagnosis . Efficacy data were analyzed by using the intent-to-treat , last-observation-carried-forward population . RESULTS At the end of the study , mean changes from baseline in total ICSI and ICPI scores ( + /- SEM ) for early treatment ( 6 months or less ) versus late treatment ( 24 months or more ) were 3.97 + /- 0.59 versus 2.15 + /- 0.70 ( P = 0.0472 ) and 3.94 + /- 0.56 versus 1.77 + /- 0.63 ( P = 0.0117 ) , respectively . Similar trends for both measures were observed when examining other times from IC diagnosis ( 3 months or less versus 24 months or more , 3 months or less versus 36 months or more , and 6 months or less versus 36 months or more ) . CONCLUSIONS Initiation of PPS treatment within 6 months of establishing the diagnosis of IC may be associated with greater improvement in patient symptoms and symptom bother",
"OBJECTIVE The goal of this pilot study was to gather information on differences between intravesical chondroitin sulfate and inactive vehicle control for treatment of interstitial cystitis/painful bladder syndrome ( IC/PBS ) . METHODS This was a prospect i ve , r and omized , double-blind , inactive vehicle-controlled , 12-week study ( 6-week treatment period , followed by a 6-week follow-up period ) in patients with IC/PBS . Patients were r and omized to weekly intravesical treatment with 2.0 % sodium chondroitin sulfate in phosphate-buffered saline or intravesical vehicle control . Primary efficacy analysis compared responders ( moderately or markedly improved ) according to the 7-point Global Response Assessment . Secondary endpoints include question naires focused on symptoms and quality of life . RESULTS Sixty-five evaluable patients were r and omized . At the primary endpoint analysis ( week 7 ) , 22.6 % of the vehicle control group were responders compared with 39.4 % of the active therapy group ( P = .15 ) . There was no statistically significant difference for any of the secondary endpoints . Overall , 76.9 % of the patients in the study reported at least 1 adverse event ; most were mild or moderate , the majority associated with the vehicle control treatment . Nine nonserious intervention-related adverse events were reported in 3 patients in the vehicle control group compared with 2 in 1 patient in the active treatment group . CONCLUSION The difference in treatment effect in this small underpowered study was not statistically significant , although twice as many patients reported a clinical ly significant benefit with intravesical chondroitin sulfate treatment compared with vehicle control treatment . This trial provides data required to design a well-powered r and omized vehicle-controlled trial to determine the true efficacy of this potentially promising therapy"
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4117dea8-06ff-11f0-808a-c43d1ab1c353
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Objective : To determine the evidence regarding the effectiveness of goal planning in clinical rehabilitation . Design : Systematic review . Method : MEDLINE , EMBASE , PsycINFO , CINAHL , AMED , Cochrane Central Register of Controlled Trials , Cochrane Data base of Systematic Review s , American College of Physicians ( ACP ) Journal Club , and the Data base of Abstract s of Review s of Effects ( DARE ) were search ed for r and omized controlled trials on the therapeutic effectiveness of goal planning in the rehabilitation of adults with acquired disability . Studies were categorized by patient population and the clinical context of the study . Data were analysed using best- research synthesis , based on method ological quality determined by Physiotherapy Evidence Data base ( PEDro ) scale scores . Results : Nineteen studies were included in this review . Study population s in these papers included patients with neurological disorders , psychiatric disorders , musculoskeletal disorders , cardiovascular disorders , respiratory disorders and dietary/endocrine disorders . Six studies investigated the immediate effects of goal planning on patient behaviour . Thirteen studies investigated the effects of goal planning in the context of a rehabilitation programme lasting more than one week . Some limited evidence was identified that goal planning can influence patient adherence to treatment regimes and strong evidence that prescribed , specific , challenging goals can improve immediate patient performance in some specific clinical context s. However , evidence regarding how these effects translated to improved outcomes following rehabilitation programmes was inconsistent . Conclusions : This review identified that while some studies demonstrated positive effects associated with goal planning in local context s , the best available empirical evidence regarding the generalizable effectiveness of goal planning was inconsistent and compromised by method ological limitations
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[
"Weight losses and psychological well-being were examined at 30 months in 69 men and 61 women initially treated with behavior therapy as a function of ( a ) initial weight loss and ( b ) weight-loss goals . Initial weight losses were positively , not negatively , related to weight loss at 30 months . Weight loss goals did not predict short-term or long-term weight loss . People who reached weight goals had better long-term weight losses than those who did not , but this finding was largely due to differences in initial weight loss . Psychological well-being at 30 months was not related to initial weight losses or goals . Although correlational rather than experimental , these results do not support the hypothesis that obese patients should be encouraged to set lower weight-loss goals",
"The purpose of this study was to investigate the role played by goal difficulty and goal origin ( i.e. , self-set vs. assigned ) on the performance of patients with brain injuries in a simple arithmetic task . Eighty-seven patients with either cerebral vascular accidents or traumatic brain injuries were investigated . Patients were r and omly assigned to one of three conditions : ( 1 ) one in which a specific , high goal was assigned , ( 2 ) one in which a “ do your best ” goal was given , and ( 3 ) one in which a personal goal has to be stated . The results indicate that both goal difficulty and goal origin had an influence on performance . Assigned difficult goals lead to better performance than assigned easy goals . Self- setting a goal did not increase performance to the same level than the assignment of a difficult goal . This lower performance increase with self-set goals can be explained by the fact that participants selected goals which were not as difficult as the assigned difficult goal . Self-set goals were attained by most of the patients and only 1 patient showed a high discrepancy between self-set goal and actual performance . These findings suggest that goal origin and goal difficulty are important moderators in the goal setting process . Furthermore , patients with brain injuries do not necessarily set unrealistic high goals",
"The effectiveness of three nursing approaches in fostering self-care behaviors in elderly nursing home residents was compared . The study was conducted in three intermediate care nursing homes . Each home was r and omly assigned to one of three conditions : a combination of behavior modification and mutual goal setting ( Condition 1 ) , mutual goal setting only ( Condition 2 ) , and routine nursing care ( Condition 3 ) . Seventy-nine subjects completed the study . In-service training was provided to nursing staff in Conditions 1 and 2 but not in Condition 3 . Over a period of 22 weeks , nursing staff encouraged subjects to departs of their morning activities of daily living ( ADLs ) independently . When the groups were compared on self-care behaviors at the end of the 22 weeks , subjects who received the combination treatment performed significantly more self-care behaviors than those in the other two groups",
"The purpose of this study was to determine how an exercise adherence intervention affects the physiological , functional , and quality of life outcomes of patients with heart failure ( HF ) . Sixteen HF patients were r and omly assigned to an exercise-only group ( n = 8) or to an exercise-with-adherence group ( n = 8) . Two of the 16 people died from nonexercise related causes during the study and were not included in the analysis . The intervention was tested over a 24-week period in which patients participated in a 12-week supervised exercise program ( Phase 1 ) followed by 12 weeks of unsupervised home exercise ( Phase 2 ) . The intervention format was one of individualized graphic feedback on exercise goals and participation and problem-solving support by nurses . Results indicate that patients who received the intervention exercised more frequently and experienced improved outcomes during both phases . The adherence intervention may encourage HF patients to continue to exercise and thereby maintain the health benefits gained in both phases of an exercise program",
"Prerequisites for translating intervention research findings into practice are maintenance of results , generalization of effects and consistency of implementation . This report presents 12 months follow-up information on a r and omized 2x2 factorial trial evaluating the incremental effects of adding ( 1 ) telephone follow-up or ( 2 ) a community re sources utilization component to a basic touchscreen computer-assisted dietary goal - setting intervention for 320 type 2 diabetes patients . All conditions evidence d significant improvement from baseline to the 12 months follow-up across behavioral , biological and psychosocial measures . There were few consistent differences between conditions , but results were robust across interventionists and clinics . The telephone follow-up component appeared to enhance long-term results on some measures . When considered along with earlier results from a r and omized trial that included a control condition without goal setting , it is concluded that this basic goal - setting intervention can be consistently implemented by a variety of interventionists and produce lasting improvements",
"Objectives .The objective of this work was to evaluate the reach , effectiveness , adoption , and implementation of a brief behavioral dietary intervention and 2 supplemental components of diabetes self-management support : telephone follow-up calls and community re sources enhancement . Design and Subjects . This was a 2 × 2 r and omized , controlled trial investigating the incremental effects of telephone follow-up and community re sources enhancement with 320 adult type 2 diabetes out patients . Methods .Key outcomes included behavioral ( dietary patterns , fat intake ) , physiologic ( HbA1C , lipids ) , and quality -of-life/patient satisfaction measures and were collected at baseline and 3- and 6-month follow-up . Results .Despite high reach ( 76 % patient participation ) , excellent adoption ( all 12 primary care practice s approached participated ) , and good implementation , there were few outcome differences among treatment conditions . There was significant improvement across conditions in most outcomes in each category at both follow-ups . Conclusions .A brief , computer-assisted , dietary goal – setting intervention basic treatment condition was moderately successful in producing dietary improvements but less so in producing biologic or quality -of-life outcomes . Additions of follow-up phone calls or a community re sources enhancement component did not produce incremental improvements over this basic intervention",
"OBJECTIVE There is a pressing need for brief practical interventions that address diabetes management . Using a r and omized design , we evaluated a medical office-based intervention focused on behavioral issues relevant to dietary self-management . RESEARCH DESIGN AND METHODS There were 206 adult diabetes patients r and omized to usual care or brief intervention , which consisted of touchscreen computer-assisted assessment to provide immediate feedback on key barriers to dietary self-management , and goal setting and problem-solving counseling for patients . Follow-up components to the single session intervention included phone calls and interactive video or videotape instruction as needed . RESULTS Multivariate analyses of covariance revealed that the brief intervention produced greater improvements than usual care on a number of measures of dietary behavior ( e.g. , fewer calories from saturated fat , fewer high-fat eating habits and behaviors ) at the 3-month follow-up . There were also significant differences favoring intervention on changes in serum cholesterol levels and patient satisfaction but not on glycosylated hemoglobin . The intervention effects were relatively robust across a variety of patient characteristics , the two participating physicians , and intervention staff members . CONCLUSIONS If the long-term results are equally positive and generalize to other setting , this intervention could provide a prototype for a feasible cost-effective way to integrate patient views and behavioral management into office-based care for diabetes",
"In a study design ed to maximize the effectiveness of treatment by allowing participants to select the target of treatment , 40 depressed older adults were r and omly assigned to a waiting-list control condition or to conditions in which the target of treatment was either chosen or assigned . All participants received self-management therapy and the choice was between changing behavior or changing cognition . It was found that individually administered self-management therapy was effective in treating depression for older adults . There were no differences in outcome between versions of self-management therapy that targeted behavioral or cognitive change . Among those who completed treatment , there were no differences in outcome between those who received a choice and those who did not . Individuals who were given a choice of treatment options , however , were less likely to drop out of treatment prematurely",
"Two studies assessed the effects of a training procedure ( Goal Management Training , GMT ) , derived from Duncan 's theory of goal neglect , on disorganized behavior following TBI . In Study 1 , patients with traumatic brain injury ( TBI ) were r and omly assigned to brief trials of GMT or motor skills training . GMT , but not motor skills training , was associated with significant gains on everyday paper- and -pencil tasks design ed to mimic tasks that are problematic for patients with goal neglect . In Study 2 , GMT was applied in a postencephalitic patient seeking to improve her meal-preparation abilities . Both naturalistic observation and self-report measures revealed improved meal preparation performance following GMT . These studies provide both experimental and clinical support for the efficacy of GMT toward the treatment of executive functioning deficits that compromise independence in patients with brain damage",
" Residents and staff of a nursing home in a metropolitan area were r and omly assigned to three conditions to : ( a ) test whether staff 's use of operant behavioural management strategies ( Condition 1 ) would cause a greater increase in residents ' self-care behaviour than staff 's use of mutual goal setting ( Condition 2 ) or routine nursing care ( Condition 3 ) , and ( b ) examine how useful group scores were , compared to individual scores , in determining change in individual residents ' behaviour due to treatment . In-service training was provided to staff in Conditions 1 and 2 but not in Condition 3 . Over a period of 22 weeks , nursing staff encouraged subjects to perform targeted self-care tasks independently . Data analysis indicated significantly greater change in self-care behaviours for subjects in Condition 1 than for subjects in Conditions 2 and 3 . However , visual inspection of data for each case revealed that individual scores were more useful than averages and differences between groups for determining the effectiveness of the clinical interventions",
"Heart failure ( HF ) is a progressive , debilitating syndrome with significant physical and psychological comorbidities . As psychosocial variables have been found to contribute to HF morbidity and mortality , methods to improve mental health and quality of life have been explored . This study examined the effects of mutual goal setting and supportive-educative nursing interventions on mental health and quality of life . An experimental , repeated- measures design with a convenience sample of 88 participants was used . The mutual goal setting nursing intervention was found to significantly support improved mental health and quality of life in this population over a 6-month period",
"Purpose . To use a taxonomy of goal content , developed in community-based brain injury rehabilitation to examine and compare the content of goals set within two different service setting s ; and to further examine the potential of the taxonomy to be a reliable and comprehensive framework for classifying goals . Method . Qualitative analysis and categorization of 1492 goal statements extracted from a community-based brain injury rehabilitation service over two time periods ( 1996 – 97 , 1998 – 99 ) , and cross-organizational comparison of ratings of goal classifications using a r and om sample of 100 goal statements drawn from this data set and the original 1765 goal statements used in developing the taxonomy . Results . Application of the taxonomy beyond the original service setting in which it was developed indicated a strong inter-rater reliability , with a high test-retest agreement reported over time . For both services , a small number of categories accounted for a substantial proportion of goals set within the two time periods , while considerable change was evident in goals between the two periods for one service . Further , both placed emphasis on individually focused goals rather than relationship or family-related goals . Conclusion . The taxonomy provides a reliable means for classifying goals and is a useful tool for exploration of the multiple influences on goal setting . Further application of the taxonomy to examine the relative influence on goal setting of client factors versus a range of organizational factors would be beneficial",
"Two diabetes education programs were compared to a control condition . Seventy-eight type II ( non-insulindependent ) diabetic out patients were r and omly assigned to nutrition education , nutrition education plus social learning intervention , or wait-list control conditions . Both interventions involved five weekly meetings that focused on reducing calorie intake , increasing dietary fiber , and decreasing fat consumption . The social learning condition also included individualized goal setting and feedback and training in problem-solving and relapse prevention . Within-group analyses and between-group comparisons generally revealed greater improvement in targeted goals ( e.g. , calorie intake , fat reduction ) among intervention conditions than the control condition . There were few differences in more distal measures of outcome such as weight or glycosylated hemoglobin . The social learning component did not improve outcome more than the nutrition education program . Possible reasons for the observed findings and the advantages and limitations of focused time-limited diabetes education efforts are discussed",
"& NA ; Setting goals is a useful strategy for changing behavior . The purpose of this study was to examine the effectiveness of a wellness intervention for women with multiple sclerosis ( MS ) on achieving health‐related goals set individually by each participant in the experimental group ( N = 57 ) using goal attainment scaling . The two‐phase intervention included lifestyle‐change classes over 8 weeks , then telephone follow‐up over 3 months . Participants were followed over an 8‐month period . Goal achievement was assessed at baseline , 2 months ( following class ) , 3 1/2 months ( 6 weeks after class ) . 5 months ( following 3 months of telephone follow‐up ) , and at 8 months . The majority of the women met or exceeded all their individualized goals for changing behavior at the 6‐week postclass assessment . Achievement and maintenance of individual goals remained high ( 59%‐84 % ) over the 5 months after class follow‐ups . These data support the positive effects of wellness interventions for helping women with MS to meet their own individualized health goals . Setting goals with incremental steps helped participants to articulate their individual goals and monitor achievement over time",
"A mental health enterprise may be described by either ( a ) rather general philosophical total mental health goals , or ( b ) highly diverse and individualized patient-therapist goals . Goals a. have not provided a workable framework for program evaluation . This paper proposes that evaluation be done in the framework of goals b. by setting up , before treatment , a measurable scale for each patient-therapist goal , and specifying , for each patient , a transformation of his overall goal attainment into a st and ardized T-score . This method , together with r and om assignment of patients to treatment modes , was devised to permit comparison of treatment modes within a program , but it also provides a good basis for a judgmental evaluation of the total program",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"Study Design . An economic evaluation was conducted alongside a r and omized controlled trial . Summary of Background Data . Little is known about the effectiveness of cognitive-behavioral treatment options for patients following lumbar disc surgery . If the knowledge available was supported by an economic evaluation , the information could then be used to make recommendations for the implementation of cognitive-behavioral treatment in the routine of rehabilitation following lumbar disc surgery . Objective . To examine the cost-effectiveness of a behavioral- grade d activity program , which is an operant treatment , compared to usual care as delivered by a physical therapist for patients following first-time lumbar disc surgery . Methods . For the economic evaluation , a societal viewpoint was applied . The primary outcome measures ( measured at the 12-month follow-up ) were global perceived effect and functional status . To evaluate the economic consequences of the treatments , direct health care and non-health care costs were considered , as well as indirect costs . Results . The clinical outcomes showed no relevant differences between behavioral- grade d activity ( n = 52 ) and UC ( n = 53 ) . Treatment costs were almost identical in the two intervention groups . The difference in direct health care costs was , although not statistically significant , 264 EURO [ 95 % CI : −3–525 ] higher in behavioral- grade d activity than in usual care per patient-year . It was mainly the excess cost of visiting the physiotherapist in the behavioral- grade d activity group that accounted for this difference . The difference in direct non-health care costs , although not statistically significant , was 388 EURO [ 95 % CI : −217 ; 992 ] lower in the usual care group due to unpaid help by friends or family . Consequently , although again not statistically significant , the total direct costs in behavioral- grade d activity are 639 EURO [ 95 % CI : −91 ; 1368 ] higherthan in usual care . For the indirect costs , there was a statistically significant difference , behavioral- grade d activity being more expensive . The sensitivity analysis showed that these results are fairly robust . Conclusions . This study concludes that there are no differences between the two treatment conditions on any of the clinical outcome measures but that behavioral- grade d activity is associated with higher costs . Consequently , there is no reason for the implementation of behavioral- grade d activity as the st and ard treatment for patients following lumbar disc surgery",
"The purpose of this investigation was to test the effectiveness of an adherence facilitation intervention consisting of goal setting , graphic feedback , and provider guidance to support adherence to home exercise in a sample of patients with heart failure who had completed a supervised exercise program . The sample consisted of 13 patients with an ejection fraction of 40 % or less who were r and omly assigned to either the exercise only group ( n=6 ) or the exercise with adherence facilitation group ( n=7 ) . The format of the intervention was graphic depiction of each patient 's exercise goals in comparison to each patient 's exercise participation . Graphs were mailed at 3-week intervals for 12 weeks . Results indicate that patients who received the intervention demonstrated higher exercise adherence and greater confidence in continuing to exercise in the future . The adherence facilitation intervention may be helpful to heart failure patients in adapting to a program of home exercise . (c)2002 CHF ,",
"Study Design and Objectives . In a r and omized clinical trial , the effectiveness of behavioral grade d activity was assessed as compared to usual care provided by physiotherapists for patients after first-time lumbar disc surgery ( n = 105 ) . Summary of Background Data . Little is known about the effectiveness of rehabilitation programs following lumbar disc surgery . Most programs focus on biomechanical aspects , whereas psychosocial factors are hardly addressed . The aim of the behavioral grade d activity program , which is an operant treatment , is to alter psycho-social factors such as fear of movement and pain catastrophizing , which might subsequently lead to improved functional status and higher rates of recovery . Behavioral treatments for patients following lumbar disc surgery have not yet been assessed in a r and omized clinical trial . Methods . Inclusion criteria : age between 18 and 65 years ; first-time lumbar disc surgery ; restrictions in normal activities of daily living . Exclusion criteria : surgical complications and confirmed and relevant underlying diseases . Outcome assessment took place at 6 and 12 months after r and omization . Results . Six months after r and omization , 62 % of the patients had recovered following usual care versus 65 % of the patients following behavioral grade d activity . After 12 months , 73 % and 75 % , respectively , had recovered . Differences between intervention groups , 3 % and 2 % respectively , after 6 and 12 months are not statistically significant . Furthermore , there were no differences between the two groups regarding functional status , pain , pain catastrophizing , fear of movement , range of motion , general health , social functioning or return to work . After 1 year , 4 of the behavioral grade d activity cases had undergone another operation versus 2 of usual care cases . Conclusion . Both fear of movement and pain catastrophizing seem to be unaffected by either treatment in these patients . It is concluded that treatment principles derived from theories within the field of chronic low back pain might not apply to these patients . After 1 year of follow-up , there were no statistically significant or clinical ly relevant differences between the behavioral grade d activity program and usual care as provided by physiotherapists for patients following first-time lumbar disc surgery",
"A goal - setting approach was used to examine the way in which 62 patients with closed head injuries or cerebral vascular accidents and 47 orthopedic control patients alter their performance on a four-choice reaction time ( RT ) task . Both patient groups were r and omly assigned to two conditions : one in which a specific and high goal was assigned and one in which a do your best goal was given . Statistical analysis indicated that patients with a specific and high goal responded faster than patients with a do your best goal . No clinical or neuropsychological variables ( e.g. , attention , memory ) had a moderating influence on the goal setting effect . These results demonstrate that goal setting as a motivational technique is a reliable and robust technique and can enhance performance ( intensity of behavior ) not only in healthy participants but also in brain-damaged patients",
"Although behavior modification of obesity is usually described as a behavior change procedure , measurement is most often limited to the outcome variable of weight loss . The present investigation employed detailed behavior monitoring forms in half of 16 obesity groups ( n = 173 ) matched across four different therapists . The percentage of compliance for nine specific treatment behaviors was charted from these monitoring forms . At the end of treatment , the eight groups that had the behavior monitoring treatment averaged over 6 pounds more weight lost than the matched control groups as well as showing significantly better attendance . The between group weight loss differences were still evident 3 months after treatment",
"This paper describes PEDro , the Physiotherapy Evidence Data base . PEDro is a web-based data base of r and omized controlled trials and systematic review s in physiotherapy . It can be accessed free of charge at http://ptwww.cchs.usyd.edu.au/pedro . The data base contains bibliographic details and abstract s of most English- language r and omized trials and systematic review s in physiotherapy , and of many trials and review s in other language s. Trials on the data base are rated on the basis of their method ological quality so that users of the data base can quickly identify trials of high quality . Trials and systematic review s are extensively indexed to facilitate search ing . PEDro provides an important information re source to support evidence -based clinical practice",
"There is a pressing need for brief , practical interventions that address diabetes management . We have developed an office-based intervention to prompt both patients and providers to focus on behavioral issues relevant to dietary self-management that is being evaluated in a r and omized trial . The intervention is design ed to be broadly applicable to the majority of adult diabetes out patients during medical visits ; uses touchscreen computer assessment to provide immediate feedback on key issues to patients and providers just prior to their interaction ; and provides goal setting and problem-solving assistance to patients following their meeting with the physician . Follow-up components include phone calls and videotape or interactive video instruction as needed . The program is described , and demographic and behavioral characteristics of participants are presented for the first 95 patients r and omized . Initial process results suggest success in producing modest , targeted behavior changes among a broad cross-section of patients . If the long-term results are equally positive , this intervention could provide a prototype for a feasible , cost-effective way to integrate patient views and behavioral management into office-based care for diabetes"
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4117dee4-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To investigate whether vitamin D supplementation is associated with lower mortality in adults . DESIGN Systematic review and meta- analysis of r and omised controlled trials . DATA SOURCES Medline , Embase , and the Cochrane Central Register from their inception to 26 December 2018 . ELIGIBILITY CRITERIA FOR SELECTING STUDIES R and omised controlled trials comparing vitamin D supplementation with a placebo or no treatment for mortality were included . Independent data extraction was conducted and study quality assessed . A meta- analysis was carried out by using fixed effects and r and om effects models to calculate risk ratio of death in the group receiving vitamin D supplementation and the control group . MAIN OUTCOME MEASURES All cause mortality . RESULTS 52 trials with a total of 75 454 participants were identified . Vitamin D supplementation was not associated with all cause mortality ( risk ratio 0.98 , 95 % confidence interval 0.95 to 1.02 , I2=0 % ) , cardiovascular mortality ( 0.98 , 0.88 to 1.08 , 0 % ) , or non-cancer , non-cardiovascular mortality ( 1.05 , 0.93 to 1.18 , 0 % ) . Vitamin D supplementation statistically significantly reduced the risk of cancer death ( 0.84 , 0.74 to 0.95 , 0 % ) . In subgroup analyses , all cause mortality was significantly lower in trials with vitamin D3 supplementation than in trials with vitamin D2 supplementation ( P for interaction=0.04 ) ; neither vitamin D3 nor vitamin D2 was associated with a statistically significant reduction in all cause mortality . CONCLUSIONS Vitamin D supplementation alone was not associated with all cause mortality in adults compared with placebo or no treatment . Vitamin D supplementation reduced the risk of cancer death by 16 % . Additional large clinical studies are needed to determine whether vitamin D3 supplementation is associated with lower all cause mortality . STUDY REGISTRATION PROSPERO registration number CRD42018117823
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"OBJECTIVES A high prevalence of hip and other fractures in elderly patients with Parkinson ’s disease has been linked to reduced bone mass arising from a defect of renal synthesis of 1 , 25-dihydroxyvitamin D ( 1 , 25-[OH]2D ) . Treatment with 1α-hydroxyvitamin D3 ( 1α(OH)D3 ; an active form of vitamin D ) was evaluated for maintaining bone mass and reducing the incidence of hip and other non-vertebral fractures in patients with Parkinson ’s disease . METHODS In a double blind , r and omised trial , 86 elderly patients with Parkinson ’s disease ( mean Hoehn and Yahr stage , 3 ; mean age 70.6 years ) were r and omised to receive either 1 μg 1α(OH)D3 daily ( treatment group , n=43 ) or a placebo ( n=43 ) for 18 months . Bone mineral densities in the second metacarpals were determined by computed radiographic densitometry . Serum bone turnover indices were measured serially , and incidence of non-vertebral fractures was recorded . RESULTS Bone mineral densities decreased 1.2 % in the treatment group compared with 6.7 % in the placebo group during 18 months ( p groups , the serum concentration of 1 , 25-[OH]2D was reduced . Parathyroid hormone was abnormally increased in 15 patients ( 17 % ) and correlated negatively with serum 25-hydroxyvitamin D , indicating compensatory hyperparathyroidism . Eight patients sustained fractures ( six at the hip and two at other sites ) in the placebo group , and one hip fracture occurred among treated patients ( odds ratio 9.8 ; p=0.0028 ) . CONCLUSION By increasing serum 1 , 25-[OH]2D concentrations , treatment with 1α(OH)D3 can reduce the risk of hip and other non-vertebral fractures in osteoporotic elderly patients with Parkinson ’s disease by slowing the loss of bone mineral densities",
"BACKGROUND Low serum 25-hydroxyvitamin D ( 25-[OH]D ) levels have been associated with lower FEV(1 ) , impaired immunologic control , and increased airway inflammation . Because many patients with chronic obstructive pulmonary disease ( COPD ) have vitamin D deficiency , effects of vitamin D supplementation may extend beyond preventing osteoporosis . OBJECTIVE To explore whether supplementation with high doses of vitamin D could reduce the incidence of COPD exacerbations . DESIGN R and omized , single-center , double-blind , placebo-controlled trial . ( Clinical Trials.gov registration number : NCT00666367 ) SETTING University Hospitals Leuven , Leuven , Belgium . PATIENTS 182 patients with moderate to very severe COPD and a history of recent exacerbations . INTERVENTION 100,000 IU of vitamin D supplementation or placebo every 4 weeks for 1 year . MEASUREMENTS The primary outcome was time to first exacerbation . Secondary outcomes were exacerbation rate , time to first hospitalization , time to second exacerbation , FEV(1 ) , quality of life , and death . RESULTS Mean serum 25-(OH)D levels increased significantly in the vitamin D group compared with the placebo group ( mean between-group difference , 30 ng/mL [ 95 % CI , 27 to 33 ng/mL ] ; P median time to first exacerbation did not significantly differ between the groups ( hazard ratio , 1.1 [ CI , 0.82 to 1.56 ] ; P = 0.41 ) , nor did exacerbation rates , FEV(1 ) , hospitalization , quality of life , and death . However , a post hoc analysis in 30 participants with severe vitamin D deficiency ( serum 25-[OH]D levels exacerbations in the vitamin D group ( rate ratio , 0.57 [ CI , 0.33 to 0.98 ] ; P = 0.042 ) . LIMITATION This was a single-center study with a small sample size . CONCLUSION High-dose vitamin D supplementation in a sample of patients with COPD did not reduce the incidence of exacerbations . In participants with severe vitamin D deficiency at baseline , supplementation may reduce exacerbations . PRIMARY FUNDING SOURCE Applied Biomedical Research Program , Agency for Innovation by Science and Technology ( IWT-TBM )",
"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",
"Background —Low 25-hydroxyvitamin D levels , commonly found in older patients with heart failure , may contribute to the chronic inflammation and skeletal myopathy that lead to poor exercise tolerance . We tested whether vitamin D supplementation of patients with heart failure and vitamin D insufficiency can improve physical function and quality of life . Methods and Results —In a r and omized , parallel group , double-blind , placebo-controlled trial , patients with systolic heart failure aged ≥70 years with 25-hydroxyvitamin D levels received 100000 U of oral vitamin D2 or placebo at baseline and 10 weeks . Outcomes measured at baseline , 10 weeks , and 20 weeks were 6-minute walk distance , quality of life ( Minnesota score ) , daily activity measured by accelerometry , Functional Limitations Profile , B-type natriuretic peptide , and tumor necrosis factor-&agr;. Participants in the vitamin D group had an increase in their 25-hydroxyvitamin D levels compared with placebo at 10 weeks ( 22.9 versus 2.3 nmol/L [ 9.2 versus 0.9 ng/mL ] ; P The 6-minute walk did not improve in the treatment group relative to placebo . No significant benefit was seen on timed up and go testing , subjective measures of function , daily activity , or tumor necrosis factor . Quality of life worsened by a small , but significant amount in the treatment group relative to placebo . B-type natriuretic peptide decreased in the treatment group relative to placebo ( −22 versus + 78 pg/mL at 10 weeks ; P=0.04 ) . Conclusions —Vitamin D supplementation did not improve functional capacity or quality of life in older patients with heart failure with vitamin D insufficiency . Clinical Trial Registration —www.controlled-trials.com . Identifier : IS RCT N51372896",
"Estrogen deficiency and declining calcium absorption due to reduced calcitriol levels or intestinal resistance to calcitriol , are important factors in the pathogenesis of age-related bone loss . The main objective of this study was to examine the effect of estrogen and 1,25-dihydroxyvitamin D therapy given individually or in combination on bone loss in elderly women . Four hundred eighty-nine elderly women with normal bone density for their age , aged 65 - 77 yr , were entered into a r and omized double blind , placebo-controlled trial . Women were r and omized to one of four groups : conjugated estrogens ( 0.625 mg , daily ) to women without a uterus ( estrogen replacement therapy ) plus medroxyprogesterone acetate ( 2.5 mg , daily ) to women with a uterus ( hormone replacement therapy ) , calcitriol ( 0.25 microg twice daily ) , a combination of hormone replacement therapy/estrogen replacement therapy plus calcitriol , or placebos for 3 yr . The primary outcome was the change in bone mineral density of the femoral neck and spine . In the intent to treat analysis , hormone therapy ( hormone replacement therapy/estrogen replacement therapy ) produced a mean ( + /-1 SD ) increase in bone mineral density of 2.98 % ( + /-5.45 % ) at the femoral neck ( P total hip and trochanter bone mineral density . Calcitriol increased bone mineral density 0.10 % ( + /- 4.27 % ) at the femoral neck ( P = 0.57 ) and 1.65 % ( + /- 4.83 % ) at the spine ( P of hormone replacement therapy/estrogen replacement therapy + calcitriol increased bone mineral density 3.80 % ( + /-4.95 % ) at the femoral neck ( P hip and trochanter . All three treatment groups differed significantly from placebo at the spine and for the hormone replacement therapy/estrogen replacement therapy groups at the femoral neck , spine , total hip and trochanter . There were no significant differences between combination therapy and hormone replacement therapy/estrogen replacement therapy alone on bone mineral density at any site in the intent to treat analysis . In a secondary analysis of the effect in women who were adherent to treatment , calcitriol had a more significant effect on spine ( P = 0.003 ) and total hip ( P = 0.004 ) . The increase in bone mineral density in the adherent groups of women was always higher compared with the intent to treat groups . Combination therapy compared with hormone replacement therapy/estrogen replacement therapy alone produced a significantly greater response in trochanter ( P = 0.007 ) and total hip bone mineral density ( P = 0.0017 ) . In summary , hormone replacement therapy/estrogen replacement therapy alone and in combination with calcitriol therapy was highly effective in reducing bone resorption and increasing bone mineral density at the hip and other clinical ly relevant sites in a group of elderly women , with normal bone density for their age . Calcitriol was effective in increasing spine bone mineral density . In the adherent women , combination therapy with hormone replacement therapy/estrogen replacement therapy and calcitriol increased bone mineral density significantly more in the total hip and trochanter than did hormone replacement therapy/estrogen replacement therapy alone",
"IMPORTANCE Observational studies suggest that vitamin D supplementation is associated with benefits for knee osteoarthritis , but current trial evidence is contradictory . OBJECTIVE To compare the effects of vitamin D supplementation vs placebo on knee pain and knee cartilage volume in patients with symptomatic knee osteoarthritis and low vitamin D levels . DESIGN , SETTING , AND PARTICIPANTS A multicenter r and omized , double-blind , placebo-controlled clinical trial in Tasmania and Victoria , Australia . Participants with symptomatic knee osteoarthritis and low 25-hydroxyvitamin D ( 12.5 - 60 nmol/L ) were enrolled from June 2010 to December 2011 . The trial was completed in December 2013 . INTERVENTIONS Participants were r and omly assigned to receive monthly treatment with oral vitamin D3 ( 50,000 IU ; n = 209 ) or an identical placebo ( n = 204 ) for 2 years . MAIN OUTCOMES AND MEASURES Primary outcomes were change in tibial cartilage volume ( assessed using magnetic resonance imaging [ MRI ] ) and change in the Western Ontario and McMaster Universities Arthritis Index ( WOMAC ) pain score ( 0 [ no pain ] to 500 [ worst pain ] ) from baseline to month 24 . Secondary outcomes were cartilage defects and bone marrow lesions ( assessed using MRI ) . RESULTS Of 413 enrolled participants ( mean age , 63.2 years ; 50 % women ) , 340 ( 82.3 % ) completed the study . The level of 25-hydroxyvitamin D increased more in the vitamin D group ( 40.6 nmol/L ) than in the placebo group ( 6.7 nmol/L ) ( P of tibial cartilage volume or WOMAC pain score . There were no significant differences in change of tibiofemoral cartilage defects or change in tibiofemoral bone marrow lesions . Adverse events ( ≥ 1 per patient ) occurred in 56 participants in the vitamin D group and in 37 participants in the placebo group ( P = .04 ) . [ table : see text ] . CONCLUSIONS AND RELEVANCE Among patients with symptomatic knee osteoarthritis and low serum 25-hydroxyvitamin D levels , vitamin D supplementation , compared with placebo , did not result in significant differences in change in MRI-measured tibial cartilage volume or WOMAC knee pain score over 2 years . These findings do not support the use of vitamin D supplementation for preventing tibial cartilage loss or improving WOMAC knee pain in patients with knee osteoarthritis . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01176344 ; anzctr.org.au Identifier : ACTRN12610000495022",
"A significant reduction in bone mineral density occurs in stroke patients on the hemiplegic side , correlating with the degree of paralysis and vitamin D deficiency due to malnutrition , sunlight deprivation , and immobilization-induced hypercalcemia , and increases the risk of hip fracture . We evaluated the effect of ipriflavone and 1alpha-hydroxyvitamin D3 [ 1alpha(OH)D3 ; vitamin D3 ] administration on bone mineral density preservation as compared with untreated controls . In a r and omized and prospect i ve study of 103 patients with hemiplegia after stroke ( the mean duration of illness was 4.8 yr ) , 68 ( 34 patients in each group ) were given 600 mg ipriflavone or 1 microg vitamin D3 daily for 12 mo , whereas the remaining 35 patients received no drug . Bone mineral density on the hemiplegic side decreased by 1.4 % in the ipriflavone group , 3.8 % in the vitamin D3 group , and 5.4 % in the control group ( P 25-hydroxyvitamin D insufficiency , increased serum ionized calcium , and low levels of 1 , 25-dihydroxyvitamin D , suggesting immobilization-induced hypercalcemia and inhibition of renal synthesis of 1 , 25-dihydroxyvitamin D. After treatment , the serum 1 , 25-dihydroxyvitamin D level increased by 139.9 % in the ipriflavone group and by 26.9 % in the vitamin D3 group . Significant decreases in the serum ionized calcium and pyridinoline cross-linked carboxyterminal telopeptide of type I collagen , and increases in parathyroid hormone and bone Gla protein were observed in the ipriflavone group , whereas no changes occurred in the other two groups . One patient in the untreated group suffered a hip fracture , compared with none in the ipriflavone and vitamin D3 groups . These results suggest that ipriflavone is more efficacious than vitamin D3 in the prevention of decreased bone mineral density in hemiplegic stroke patients because it decreases serum calcium levels through inhibition of bone resorption and cause a subsequent increase in 1 , 25-dihydroxyvitamin D concentration",
"Importance Cohort studies have reported increased incidence of cardiovascular disease ( CVD ) among individuals with low vitamin D status . To date , r and omized clinical trials of vitamin D supplementation have not found an effect , possibly because of using too low a dose of vitamin D. Objective To examine whether monthly high-dose vitamin D supplementation prevents CVD in the general population . Design , Setting , and Participants The Vitamin D Assessment Study is a r and omized , double-blind , placebo-controlled trial that recruited participants mostly from family practice s in Auckl and , New Zeal and , from April 5 , 2011 , through November 6 , 2012 , with follow-up until July 2015 . Participants were community-resident adults aged 50 to 84 years . Of 47 905 adults invited from family practice s and 163 from community groups , 5110 participants were r and omized to receive vitamin D3 ( n = 2558 ) or placebo ( n = 2552 ) . Two participants retracted consent , and all others ( n = 5108 ) were included in the primary analysis . Interventions Oral vitamin D3 in an initial dose of 200 000 IU , followed a month later by monthly doses of 100 000 IU , or placebo for a median of 3.3 years ( range , 2.5 - 4.2 years ) . Main Outcomes and Measures The primary outcome was the number of participants with incident CVD and death , including a prespecified subgroup analysis in participants with vitamin D deficiency ( baseline deseasonalized 25-hydroxyvitamin D [ 25(OH)D ] levels myocardial infa rct ion , angina , heart failure , hypertension , arrhythmias , arteriosclerosis , stroke , and venous thrombosis . Results Of the 5108 participants included in the analysis , the mean ( SD ) age was 65.9 ( 8.3 ) years , 2969 ( 58.1 % ) were male , and 4253 ( 83.3 % ) were of European or other ethnicity , with the remainder being Polynesian or South Asian . Mean ( SD ) baseline deseasonalized 25(OH)D concentration was 26.5 ( 9.0 ) ng/mL , with 1270 participants ( 24.9 % ) being vitamin D deficient . In a r and om sample of 438 participants , the mean follow-up 25(OH)D level was greater than 20 ng/mL higher in the vitamin D group than in the placebo group . The primary outcome of CVD occurred in 303 participants ( 11.8 % ) in the vitamin D group and 293 participants ( 11.5 % ) in the placebo group , yielding an adjusted hazard ratio of 1.02 ( 95 % CI , 0.87 - 1.20 ) . Similar results were seen for participants with baseline vitamin D deficiency and for secondary outcomes . Conclusions and Relevance Monthly high-dose vitamin D supplementation does not prevent CVD . This result does not support the use of monthly vitamin D supplementation for this purpose . The effects of daily or weekly dosing require further study . Trial Registration clinical trials.gov Identifier :",
"Aims Circulating 25-hydroxyvitamin D ( 25OHD ) levels oral vitamin D supplementation reduces mortality in patients with advanced HF . Methods and results Four hundred HF patients with 25OHD levels to receive 4000 IU vitamin D daily or matching placebo for 3 years . Primary endpoint was all-cause mortality . Key secondary outcome measures included hospitalization , resuscitation , mechanical circulatory support ( MCS ) implant , high urgent listing for heart transplantation , heart transplantation , and hypercalcaemia . Initial 25OHD levels were on average Mortality was not different in patients receiving vitamin D ( 19.6 % ; n = 39 ) or placebo ( 17.9 % ; n = 36 ) with a hazard ratio ( HR ) of 1.09 [ 95 % confidence interval ( CI ) : 0.69 - 1.71 ; P = 0.726 ] . The need for MCS implant was however greater in patients assigned to vitamin D ( 15.4 % , n = 28 ) vs. placebo [ 9.0 % , n = 15 ; HR : 1.96 ( 95 % CI : 1.04 - 3.66 ) ; P = 0.031 ] . Other secondary clinical endpoints were similar between groups . The incidence of hypercalcaemia was 6.2 % ( n = 10 ) and 3.1 % ( n = 5 ) in patients receiving vitamin D or placebo ( P = 0.192 ) . Conclusion A daily vitamin D dose of 4000 IU did not reduce mortality in patients with advanced HF but was associated with a greater need for MCS implants . Data indicate caution regarding long-term supplementation with moderately high vitamin D doses . Trial Registration Information clinical trials.gov Idenitfier : NCT01326650",
"BACKGROUND Numerous observational studies have found supplemental calcium and vitamin D to be associated with reduced risk of common cancers . However , interventional studies to test this effect are lacking . OBJECTIVE The purpose of this analysis was to determine the efficacy of calcium alone and calcium plus vitamin D in reducing incident cancer risk of all types . DESIGN This was a 4-y , population -based , double-blind , r and omized placebo-controlled trial . The primary outcome was fracture incidence , and the principal secondary outcome was cancer incidence . The subjects were 1179 community-dwelling women r and omly selected from the population of healthy postmenopausal women aged > 55 y in a 9-county rural area of Nebraska centered at latitude 41.4 degrees N. Subjects were r and omly assigned to receive 1400 - 1500 mg supplemental calcium/d alone ( Ca-only ) , supplemental calcium plus 1100 IU vitamin D3/d ( Ca + D ) , or placebo . RESULTS When analyzed by intention to treat , cancer incidence was lower in the Ca + D women than in the placebo control subjects ( P unadjusted relative risks ( RR ) of incident cancer in the Ca + D and Ca-only groups were 0.402 ( P = 0.01 ) and 0.532 ( P = 0.06 ) , respectively . When analysis was confined to cancers diagnosed after the first 12 mo , RR for the Ca + D group fell to 0.232 ( CI : 0.09 , 0.60 ; P treatment and serum 25-hydroxyvitamin D concentrations were significant , independent predictors of cancer risk . CONCLUSIONS Improving calcium and vitamin D nutritional status substantially reduces all-cancer risk in postmenopausal women . This trial was registered at clinical trials.gov as NCT00352170",
"BACKGROUND Increased vitamin D intake may preserve or increase bone mineral density ( BMD ) in older persons . OBJECTIVE A 2-y double-blind study was undertaken to determine whether weekly administration of 10 000 units of vitamin D(2 ) maintained or increased BMD in younger postmenopausal women more efficiently than did calcium supplements alone . DESIGN One hundred eighty-seven women who were > or= 1 y postmenopausal were r and omly assigned to take either 1000 mg Ca/d after the evening meal or 1000 mg Ca/d plus 10 000 U vitamin D(2)/wk in a double-blind , placebo-controlled format . The BMD of the proximal forearm , lumbar spine , femoral neck , Ward 's triangle , and femoral trochanter was measured at 6-mo intervals by osteodensitometry . RESULTS During the 2-y period , there was no significant difference in the change in BMD at any site between the subjects taking calcium supplements and those taking calcium plus vitamin D(2 ) . Both groups significantly ( P gained BMD in Ward 's triangle and the femoral trochanter but significantly ( P lost bone in the proximal radius . There was no significant change in the lumbar spine or femoral neck BMD . CONCLUSION In younger postmenopausal women ( age : 56 y ) whose average baseline serum 25-hydroxyvitamin D concentration was well within the normal range , the addition of 10 000 U vitamin D(2)/wk to calcium supplementation at 1000 mg/d did not confer benefits on BMD beyond those achieved with calcium supplementation alone",
"BACKGROUND Elevated circulating concentrations of proinflammatory cytokines may contribute to the pathogenesis of congestive heart failure ( CHF ) . In vitro studies suggest that vitamin D suppresses proinflammatory cytokines and increases antiinflammatory cytokines . OBJECTIVE We evaluated the effect of vitamin D supplementation on the survival rate and different biochemical variables in patients with CHF . DESIGN One hundred twenty-three patients r and omly received either 50 mug vitamin D(3)/d plus 500 mg Ca/d [ D(+ ) group ] or placebo plus 500 mg Ca/d [ D(- ) group ] for 9 mo . Biochemical variables were assessed at baseline and after 9 mo . The survival rate was calculated for a follow-up period of 15 mo . RESULTS Ninety-three patients completed the study . Significant treatment effects were observed on logarithmic-transformed serum concentrations of 25-hydroxyvitamin D ( P = 0.001 ) , parathyroid hormone ( P = 0.007 ) , tumor necrosis factor alpha ( P = 0.006 ) , and interleukin 10 ( P = 0.042 ) . 25-Hydroxyvitamin D increased by 26.8 ng/mL in the D(+ ) group but increased only by 3.6 ng/mL in the D(- ) group . Compared with baseline , parathyroid hormone was significantly lower and the antiinflammatory cytokine interleukin 10 was significantly higher in the D(+ ) group after 9 mo . The proinflammatory cytokine tumor necrosis factor alpha increased in the D(- ) group but remained constant in the D(+ ) group . The survival rate did not differ significantly between the study groups during the follow-up period . CONCLUSIONS Vitamin D(3 ) reduces the inflammatory milieu in CHF patients and might serve as a new antiinflammatory agent for the future treatment of the disease . Our data provide evidence for the involvement of an impaired vitamin D-parathyroid hormone axis in the progression of CHF",
"Introduction Osteoporotic fractures in older people are a major and increasing public health problem . We examined the effect of vitamin D supplementation on fracture rate in people living in sheltered accommodation . Methods In a pragmatic double blind r and omised controlled trial of 3 years duration , we examined 3,440 people ( 2,624 women and 816 men ) living in residential or care home . We used four-monthly oral supplementation using 100,000 IU vitamin D2 ( ergocalciferol ) . As a main outcome measure , we used the incidence of first fracture using an intention to treat analysis . This was a multicentre study in 314 care homes or sheltered accommodation complexes in South Wales , UK . Results The vitamin D and placebo groups had similar baseline characteristics . In intention-to-treat analysis , 205 first fractures occurred in the intervention group during a total of 2,846 person years of follow-up ( 7 fractures per 100 people per year of follow-up ) , with 218 first fractures in the control group over 2,860 person years of follow-up . The hazard ratio of 0.95 ( 95 % confidence interval 0.79–1.15 ) for intervention compared to control was not statistically significant . ConclusionS upplementation with four-monthly 100,000 IU of oral vitamin D2 is not sufficient to affect fracture incidence among older people living in institutional care",
"Summary This trial compared the effects of daily treatment with vitamin D or placebo for 1 year on blood tests of vitamin D status . The results demonstrated that daily 4000 IU vitamin D3 is required to achieve blood levels associated with lowest disease risks , and this dose should be tested in future trials for fracture prevention . Introduction The aim of this trial was to assess the effects of daily supplementation with vitamin D3 4000 IU ( 100 μg ) , 2000 IU ( 50 μg ) or placebo for 1 year on biochemical markers of vitamin D status in preparation for a large trial for prevention of fractures and other outcomes . Methods This is a r and omized placebo-controlled trial in 305 community-dwelling people aged 65 years or older in Oxfordshire , UK . Outcomes included biochemical markers of vitamin D status ( plasma 25-hydroxy-vitamin D [ 25[OH]D ] , parathyroid hormone [ PTH ] , calcium and alkaline phosphatase ) , cardiovascular risk factors and tests of physical function . Results Mean ( SD ) plasma 25(OH)D levels were 50 ( 18 ) nmol/L at baseline and increased to 137 ( 39 ) , 102 ( 25 ) and 53 ( 16 ) nmol/L after 12 months in those allocated 4000 IU , 2000 IU or placebo , respectively ( with 88 % , 70 % and 1 % of these groups achieving the pre-specified level of > 90 nmol/L ) . Neither dose of vitamin D3 was associated with significant deviation outside the normal range of PTH or albumin-corrected calcium . The additional effect on 25(OH)D levels of 4000 versus 2000 IU was similar in all subgroups except for body mass index , for which the further increase was smaller in overweight and obese participants compared with normal-weight participants . Supplementation with vitamin D had no significant effects on cardiovascular risk factors or on measures of physical function . Conclusions After accounting for average 70 % compliance in long-term trials , doses of 4000 IU vitamin D3 daily may be required to achieve plasma 25(OH)D levels associated with lowest disease risk in observational studies",
"BACKGROUND Ergocalciferol ( vitamin D(2 ) ) supplementation plays a role in fall prevention , but the effect in patients living in the community in sunny climates remains uncertain . We evaluated the effect of ergocalciferol and calcium citrate supplementation compared with calcium alone on the risk of falls in older women at high risk of falling . METHODS A 1-year population -based , double-blind , r and omized controlled trial of 302 community-dwelling ambulant older women aged 70 to 90 years living in Perth , Australia ( latitude , 32 degrees S ) , with a serum 25-hydroxyvitamin D concentration of less than 24.0 ng/mL and a history of falling in the previous year . Participants were r and omized to receive ergocalciferol , 1000 IU/d , or identical placebo ( hereinafter , ergocalciferol and control groups , respectively ) . Both groups received calcium citrate , 1000 mg/d . Fall data were collected every 6 weeks . RESULTS Ergocalciferol therapy reduced the risk of having at least 1 fall over 1 year after adjustment for baseline height , which was significantly different between the 2 groups ( ergocalciferol group , 53.0 % ; control group , 62.9 % ; odds ratio [ OR ] , 0.61 ; 95 % confidence interval [ CI ] , 0.37 - 0.99 ) . When those who fell were grouped by the season of first fall or the number of falls they had , ergocalciferol treatment reduced the risk of having the first fall in winter and spring ( ergocalciferol group , 25.2 % ; control group , 35.8 % ; OR , 0.55 ; 95 % CI , 0.32 - 0.96 ) but not in summer and autumn , and reduced the risk of having 1 fall ( ergocalciferol group , 21.2 % ; control group , 33.8 % ; OR , 0.50 ; 95 % CI , 0.28 - 0.88 ) but not multiple falls . CONCLUSION Patients with a history of falling and vitamin D insufficiency living in sunny climates benefit from ergocalciferol supplementation in addition to calcium , which is associated with a 19 % reduction in the relative risk of falling , mostly in winter",
"CONTEXT Vitamin D deficiency is associated with insulin resistance and risk of future diabetes . OBJECTIVE The objective of the study was to test whether supplementation with vitamin D to subjects with prediabetes will prevent progression to type 2 diabetes mellitus ( T2DM ) . DESIGN This was a r and omized controlled trial performed in 2008 through 2015 . SETTING The study was conducted at the clinical research unit at a teaching hospital . PATIENTS Five hundred eleven subjects ( mean age 62 y , 314 males ) with prediabetes diagnosed with an oral glucose tolerance test as part of the Tromsø Study 2007–2008 were included . A total of 256 were r and omized to vitamin D and 255 to placebo . Twenty-nine subjects in the vitamin D and 24 in the placebo group withdrew because of adverse events . INTERVENTIONS Interventions included vitamin D ( cholecalciferol ) 20 000 IU/wk vs placebo for 5 years . Annual oral glucose tolerance tests were performed . MAIN OUTCOME MEASURE Progression to T2DM was the main outcome measure . Secondary outcomes were change in glucose levels , insulin resistance , serum lipids , and blood pressure . RESULTS The mean baseline serum 25-hydroxyvitamin D level was 60 nmol/L ( 24 ng/mL ) . One hundred three in the vitamin D and 112 in the placebo group developed T2DM ( hazard risk 0.90 ; 95 % confidence interval 0.69–1.18 , Cox regression , P = .45 , intention to treat analysis ) . No consistent significant effects on the other outcomes were seen . Subgroup analyses in subjects with low baseline 25-hydroxyvitamin D yielded similar results . No serious side effects related to the intervention were recorded . CONCLUSIONS In subjects without vitamin D deficiency , vitamin D supplementation is unlikely to prevent progression from prediabetes to diabetes . Very large studies with inclusion of vitamin D-deficient subjects will probably be needed to show such a putative effect . This study tested if supplementation with vitamin D to subjects with prediabetes will prevent progression to type 2 diabetes ( T2DM )",
"OBJECTIVE Epidemiological data suggest low serum 25-hydroxyvitamin D3 ( 25-OH-D3 ) levels are associated with radiological progression of knee osteoarthritis ( OA ) . This study aim ed to assess whether vitamin D supplementation can slow the rate of progression . METHOD A 3-year , double-blind , r and omised , placebo-controlled trial of 474 patients aged over 50 with radiographically evident knee OA comparing 800 IU cholecalciferol daily with placebo . Primary outcome was difference in rate of medial joint space narrowing ( JSN ) . Secondary outcomes included lateral JSN , Kellgren & Lawrence grade , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain , function , stiffness and the Get up and Go test . RESULTS Vitamin D supplementation increased 25-OH-D3 from an average of 20.7 ( st and ard deviation ( SD ) 8.9 ) μg/L to 30.4 ( SD 7.7 ) μg/L , compared to 20.7 ( SD 8.1 ) μg/L and 20.3 ( SD 8.1 ) μg/L in the placebo group . There was no significant difference in the rate of JSN over 3 years in the medial compartment of the index knee between the treatment group ( average -0.01 mm/year ) and placebo group ( -0.08 mm/year ) , average difference 0.08 mm/year ( 95 % confidence interval ( CI ) [ -0.14 - 0.29 ] , P = 0.49 ) . No significant interaction was found between baseline vitamin D levels and treatment effect . There were no significant differences for any of the secondary outcome measures . CONCLUSION Vitamin D supplementation did not slow the rate of JSN or lead to reduced pain , stiffness or functional loss over a 3-year period . On the basis of these findings we consider that vitamin D supplementation has no role in the management of knee OA",
"OBJECTIVES To determine the effect of four vitamin D supplement doses on falls risk in elderly nursing home residents . DESIGN Secondary data analysis of a previously conducted r and omized clinical trial . SETTING Seven hundred twenty-five-bed long-term care facility . PARTICIPANTS One hundred twenty-four nursing home residents ( average age 89 ) . INTERVENTION Participants were r and omly assigned to receive one of four vitamin D supplement doses ( 200 IU , 400 IU , 600 IU , or 800 IU ) or placebo daily for 5 months . MEASUREMENTS Number of fallers and number of falls assessed using facility incident tracking data base . RESULTS Over the 5-month study period , the proportion of participants with falls was 44 % in the placebo group ( 11/25 ) , 58 % ( 15/26 ) in the 200 IU group , 60 % ( 15/25 ) in the 400 IU group , 60 % ( 15/25 ) in the 600 IU group , and 20 % ( 5/23 ) in the 800 IU group . Participants in the 800 IU group had a 72 % lower adjusted-incidence rate ratio of falls than those taking placebo over the 5 months ( rate ratio=0.28 ; 95 % confidence interval=0.11 - 0.75 ) . No significant differences were observed for the adjusted fall rates compared to placebo in any of the other supplement groups . CONCLUSION Nursing home residents in the highest vitamin D group ( 800 IU ) had a lower number of fallers and a lower incidence rate of falls over 5 months than those taking lower doses . Adequate vitamin D supplementation in elderly nursing home residents could reduce the number of falls experienced by this high falls risk group",
"CONTEXT Effects of long-term calcium , with or without vitamin D , on hip bone mineral density ( BMD ) and bone turnover in sunny climates have not been reported . OBJECTIVE The aim was to evaluate the effect of vitamin D added to calcium supplementation on hip dual-energy x-ray absorptiometry BMD and calcium-related analytes . DESIGN , SETTING , AND PARTICIPANTS The study was a 5-yr r and omized , controlled , double-blind trial of 120 community-dwelling women aged 70 - 80 yr . INTERVENTIONS The interventions were 1200 mg/d calcium with placebo vitamin D ( Ca group ) or with 1000 IU/d vitamin D2 ( CaD group ) , or double placebo ( control ) . MAIN OUTCOME MEASURES Hip BMD , plasma 25-hydroxyvitamin D , biomarkers of bone turnover , PTH , and intestinal calcium absorption were measured . RESULTS Hip BMD was preserved in CaD ( -0.17 % ) and Ca ( 0.19 % ) groups but not controls ( -1.27 % ) at yr 1 and maintained in the CaD group only at yr 3 and 5 . The beneficial effects were mainly in those with baseline 25-hydroxyvitamin D levels below the median ( 68 nmol/liter ) . At yr 1 , compared with controls , the Ca and CaD groups had 6.8 and 11.3 % lower plasma alkaline phosphatase , respectively ( P urinary deoxypyridinoline to creatinine ratio , respectively ( P PTH at 3 and 5 yr cf . controls ( 27.8 and 31.3 % , P PTH levels above the median ( 3.6 pmol/liter ) . Therapy did not affect intestinal calcium absorption at high carrier loads . CONCLUSIONS Addition of vitamin D to calcium has long-term beneficial effects on bone density in elderly women living in a sunny climate , probably mediated by a long-term reduction in bone turnover rate",
"In a double-blind trial , 327 patients ( 57 men ) over 65 ( mean age 79.5 ) years received all possible combinations of calcium carbonate 3 g , vitamin D3 1000 iu , meth and ienone 2.5 mg and /or placebos daily for 9 months . The higher incidence of bone fractures in the placebo group was not significant . Serum calcium , phosphorus , creatinine , aspartate aminotransferase and alkaline phosphatase were followed : the greatest changes occurred with meth and ienone , which thus reduced osteoporotic activity and increased the muscular mass most effectively ; calcium carbonate had the poorest effect . Surprisingly , coronary mortality was higher among those taking all three active substances . With two treatments the increase was not significant , but when both the groups receiving a combination of any two of the treatments were compared with those taking only one or neither of these two treatments , a significant increase in coronary deaths was seen , most significant ( P less than 0.001 ) in those receiving vitamin D3 and meth and ienone",
"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 The 2009 KDIGO ( Kidney Disease : Improving Global Outcomes ) chronic kidney disease-mineral and bone disorder clinical practice guideline suggests correcting 25-hydroxyvitamin D3 ( 25[OH]D ) levels patients treated with maintenance hemodialysis , but does not provide a specific treatment protocol . STUDY DESIGN 2-center , double-blind , r and omized , 13-week , controlled trial followed by a 26-week open-label study . SETTING & PARTICIPANTS 55 adult maintenance hemodialysis patients with 25(OH)D levels INTERVENTION Cholecalciferol , 25,000IU , per week orally versus placebo for 13 weeks , then 26 weeks of individualized cholecalciferol prescription based on NKF-KDOQI ( National Kidney Foundation-Kidney Disease Outcomes Quality Initiative ) guidelines . OUTCOMES Primary end point was the percentage of patients with 25(OH)D levels≥30ng/mL at 13 weeks . Secondary outcomes included the percentage of patients with normal calcium , phosphorus , and intact parathyroid hormone ( iPTH ) blood levels . Safety measures included incidence of hypercalcemia and hypervitaminosis D. MEASUREMENTS Blood calcium and phosphate were measured weekly ; iPTH , 25(OH)D , 1,25-dihydroxyvitamin D3 ( 1,25[OH]2D ) , and bone turnover markers , trimonthly ; fetuin A and fibroblast growth factor 23 ( FGF-23 ) serum levels and aortic calcification scores were determined at weeks 0 and 39 . RESULTS The primary end point significantly increased in the treatment group compared with the placebo group ( 61.5 % vs 7.4 % ; P well as 1,25(OH)2D levels ( 22.5 [ IQR , 15 - 26 ] vs 11 [ IQR , 10 - 15]pg/mL ; P proportion of patients achieving the target calcium level ( 76.9 % vs 48.2 % ; P=0.03 ) . Incidence of hypercalcemia and phosphate and iPTH levels were similar between groups . The second 26-week study phase did not significantly modify the prevalence of 25(OH)D level≥30ng/mL in patients issued from the placebo group . LIMITATIONS Small size of the study population . CONCLUSIONS Oral weekly administration of 25,000IU of cholecalciferol for 13 weeks is an effective , safe , inexpensive , and manageable way to increase 25(OH)D and 1,25(OH)2D levels in hemodialysis patients . Further evaluation of clinical end points is suggested",
"STUDY OBJECTIVE To determine if calcitriol is an effective treatment in postmenopausal osteoporosis . DESIGN Double-blind , r and omized clinical trial of 2 years ' duration . SETTING University medical center with patients recruited by media announcements . PATIENTS Eighty-six postmenopausal women with vertebral compression fractures . INTERVENTIONS Patients were treated with calcitriol or placebo . Mean dose was 0.43 micrograms/d . Dietary calcium was 1000 mg/d ( 24.9 mmol/d ) . The medication dose and dietary calcium were adjusted for hypercalciuria or hypercalcemia . MEASUREMENTS AND MAIN RESULTS No significant differences between placebo and control groups were seen in the percent change in total body calcium ( 0.4 % + /- 1.0 compared with 0.0 % + /- 0.9 ) , single photon absorptiometry ( -0.5 % + /- 1.2 compared with -3.1 % + /- 0.9 ) or dual photon absorptiometry ( 0.0 % + /- 1.7 compared with -1.0 % + /- 2.2 ) . New fractures were seen in 16 % of the placebo group and 26 % of the calcitriol groups , so the difference in percent fractures was 10 % ( 95 % CI , -5.7 % to 25.7 % ) . Bone biopsies did not show changes in either group . The calcitriol group had significantly higher serum and urine calcium values , but renal function was not worse than in the placebo group . CONCLUSIONS Calcitriol is not an effective treatment for established postmenopausal osteoporosis",
"Abstract Objective : To determine the effect of four monthly vitamin D supplementation on the rate of fractures in men and women aged 65 years and over living in the community . Design : R and omised double blind controlled trial of 100 000 IU oral vitamin D3 ( cholecalciferol ) supplementation or matching placebo every four months over five years . Setting and participants : 2686 people ( 2037 men and 649 women ) aged 65 - 85 years living in the general community , recruited from the British doctors register and a general practice register in Suffolk . Main outcome measures : Fracture incidence and total mortality by cause . Results : After five years 268 men and women had incident fractures , of whom 147 had fractures in common osteoporotic sites ( hip , wrist or forearm , or vertebrae ) . Relative risks in the vitamin D group compared with the placebo group were 0.78 ( 95 % confidence interval 0.61 to 0.99 , P=0.04 ) for any first fracture and 0.67 ( 0.48 to 0.93 , P=0.02 ) for first hip , wrist or forearm , or vertebral fracture . 471 participants died . The relative risk for total mortality in the vitamin D group compared with the placebo group was 0.88 ( 0.74 to 1.06 , P=0.18 ) . Findings were consistent in men and women and in doctors and the general practice population . Conclusion : Four monthly supplementation with 100 000 IU oral vitamin D may prevent fractures without adverse effects in men and women living in the general community . What is already known in this topic Vitamin D and calcium supplements are effective in preventing fractures in elderly women Whether isolated vitamin D supplementation prevents fractures is not clear What this paper adds Four monthly oral supplementation with 100 000 IU vitamin D reduces fractures in men and women aged over 65 living in the general community Total fracture incidence was reduced by 22 % and fractures in major osteoporotic sites by 33",
"Summary 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",
"OBJECTIVE Vitamin D supplementation is suggested to reduce the risk of falls among ambulatory or institutionalized elderly subjects . The present study was undertaken to address the reduced risk of falls and hip fractures in patients with long-st and ing stroke by vitamin D supplementation . METHODS Ninety-six elderly women with poststroke hemiplegia were followed for two years . Patients were r and omly assigned to one of the two groups , and 48 patients received 1,000 IU ergocalciferol daily , and the remaining 48 received placebo . The number of falls per person and incidence of hip fractures were compared between the two groups . Strength and tissue ATPase of skeletal muscles on the nonparetic side were assessed before and after the study . RESULTS At baseline , serum 25-hydroxyvitamin D levels were in the deficient range ( vitamin D treatment enhanced serum 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D levels . Vitamin D treatment accounted for a 59 % reduction in falls ( 95 % CI , 28 - 81 % ; p = 0.003 ) . There were increases in the relative number and size of type II muscle fibers and improved muscle strength in the vitamin D-treated group . Hip fractures occurred in 4 of 48 placebo group and 0 in 48 vitamin D2 group during the 2-year study period ( log-rank , p = 0.049 ) . CONCLUSION Vitamin D may increase muscle strength by improving atrophy of type II muscle fibers , which may lead to decreased falls and hip fractures",
"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 and aims : Insufficient vitamin D status , commonly found in older people , has been associated with muscle weakness which , in old age , impairs mobility and is a risk factor for falling . In a r and omized , double-blind placebo-controlled trial , we tested the hypothesis that vitamin D + calcium supplementation improves muscle strength and mobility , compared with calcium mono-therapy in vitamin D-insufficient female geriatric patients . Methods : Seventy female geriatric patients > 65 years of age with serum 25-hydroxyvitamin D3 ( 25OHD ) concentrations between 20 and 50 nmol/L , visiting an outpatient geriatric department , were included . Participants received either cholecalciferol 400 IU/day + calcium 500 mg/day ( D/Cal group ) or a placebo + calcium 500 mg/day ( Plac/Cal group ) for 6 months . At baseline and 6 months , muscle strength , power and functional mobility were tested . Results : At baseline , 25OHD was significantly ( p with knee extension strength ( r=0.42 ) , h and grip strength ( r=0.28 ) , leg extension power ( r=0.34 ) , Timed Get Up and Go ( r=−0.31 ) and Modified Cooper test ( r=0.44 ) . At 6 months , a significant difference in 25OHD ( 77.2 vs 41.6 nmol/L , p and 1,25OHD was found between the two groups . Significantly improving vitamin D status in the D/Cal group compared with the Plac/Cal group did not result in a significant difference in strength or functional mobility between the two groups . Conclusions : Daily 400IU vitamin D + 500 mg calcium supplementation is not enough to significantly improve strength or mobility in vitamin D-insufficient female geriatric patients",
"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",
"BACKGROUND Patients with chronic obstructive pulmonary disease ( COPD ) often have vitamin D deficiency , which is associated with increased susceptibility to upper respiratory infection-a major precipitant of exacerbation . Multicentre trials of vitamin D supplementation for prevention of exacerbation and upper respiratory infection in patients with COPD are lacking . We therefore investigated whether vitamin D3 ( colecalciferol ) supplementation would reduce the incidence of moderate or severe COPD exacerbations and upper respiratory infections . METHODS We did a r and omised , double-blind , placebo-controlled trial of vitamin D3 supplementation in adults with COPD in 60 general practice s and four Acute National Health Service Trust clinics in London , UK . Patients were allocated to receive six 2-monthly oral doses of 3 mg vitamin D3 or placebo over 1 year in a 1:1 ratio using computer-generated permuted block r and omisation . Participants and study staff were masked to treatment assignment . Co primary outcomes were time to first moderate or severe exacerbation and first upper respiratory infection . Analysis was by intention to treat . A prespecified subgroup analysis was done to assess whether effects of the intervention on the co primary outcomes were modified by baseline vitamin D status . This trial is registered with Clinical Trials.gov , number NCT00977873 . FINDINGS 240 patients were r and omly allocated to the vitamin D3 group ( n=122 ) and placebo group ( n=118 ) . Vitamin D3 compared with placebo did not affect time to first moderate or severe exacerbation ( adjusted hazard ratio 0·86 , 95 % CI 0·60 - 1·24 , p=0·42 ) or time to first upper respiratory infection ( 0·95 , 0·69 - 1·31 , p=0·75 ) . Prespecified subgroup analysis showed that vitamin D3 was protective against moderate or severe exacerbation in participants with baseline serum 25-hydroxyvitamin D concentrations of less than 50 nmol/L ( 0·57 , 0·35 - 0·92 , p=0·021 ) , but not in those with baseline 25-hydroxyvitamin D levels of at least 50 nmol/L ( 1·45 , 0·81 - 2·62 , p=0·21 ; p=0·021 for interaction between allocation and baseline serum 25-hydroxyvitamin D status ) . Baseline vitamin D status did not modify the effect of the intervention on risk of upper respiratory infection ( pinteraction=0·41 ) . INTERPRETATION Vitamin D3 supplementation protected against moderate or severe exacerbation , but not upper respiratory infection , in patients with COPD with baseline 25-hydroxyvitamin D levels of less than 50 nmol/L. Our findings suggest that correction of vitamin D deficiency in patients with COPD reduces the risk of moderate or severe exacerbation . FUNDING UK National Institute for Health Research",
"IMPORTANCE Observational data link low 25-hydroxyvitamin D levels to both prevalent blood pressure and incident hypertension . No clinical trial has yet examined the effect of vitamin D supplementation in isolated systolic hypertension , the most common pattern of hypertension in older people . OBJECTIVE To test whether high-dose , intermittent cholecalciferol supplementation lowers blood pressure in older patients with isolated systolic hypertension . DESIGN Parallel group , double-blind , placebo-controlled r and omized trial . SETTING Primary care clinics and hospital clinics . PARTICIPANTS Patients 70 years and older with isolated systolic hypertension ( supine systolic blood pressure > 140 mm Hg and supine diastolic blood pressure INTERVENTIONS A total of 100,000 U of oral cholecalciferol or matching placebo every 3 months for 1 year . MAIN OUTCOMES AND MEASURES Difference in office blood pressure , 24-hour blood pressure , arterial stiffness , endothelial function , cholesterol level , insulin resistance , and b-type natriuretic peptide level during 12 months . RESULTS A total of 159 participants were r and omized ( mean age , 77 years ) . Mean baseline office systolic blood pressure was 163/78 mm Hg . Mean baseline 25-hydroxyvitamin D level was 18 ng/mL. 25-Hydroxyvitamin D levels increased in the treatment group compared with the placebo group ( + 8 ng/mL at 1 year , P ) office blood pressure ( −1 [ −6 to 4]/−2 [ −4 to 1 ] mm Hg at 3 months and 1 [ −2 to 4]/0 [ −2 to 2 ] mm Hg overall treatment effect ) . No significant treatment effect was evident for any of the secondary outcomes ( 24-hour blood pressure , arterial stiffness , endothelial function , cholesterol level , glucose level , and walking distance ) . There was no excess of adverse events in the treatment group , and the total number of falls was nonsignificantly lower in the group receiving vitamin D ( 36 vs 46 , P = .24 ) . CONCLUSIONS AND RELEVANCE Vitamin D supplementation did not improve blood pressure or markers of vascular health in older patients with isolated systolic hypertension . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N92186858",
"Daily vitamin D in addition to calcium supplementation reduces falls and fractures in older women . However , poor adherence to therapy is a common clinical problem . To examine the effects of supervised oral 3-monthly vitamin D therapy on falls , muscle strength , and mobility , we conducted a 9-month r and omized , double-blind , placebo-controlled trial in 686 community-dwelling ambulant women aged over 70 years . Participants received either oral cholecalciferol 150,000 IU every 3 months ( n = 353 ) or an identical placebo ( n = 333 ) . All participants were advised to increase dietary calcium intake . Falls data were collected 3-monthly . At baseline , 3 , 6 , and 9 months , muscle strength was measured by a h and held dynamometer and mobility by the Timed Up and Go ( TUG ) test . Serum 25 hydroxyvitamin D ( 25OHD ) was measured in a subgroup of 40 subjects . Mean age at baseline was 76.7 ± 4.1 years . The average serum 25OHD value at baseline was 65.8 ± 22.7 nmol/L. By 3 , 6 , and 9 months after supplementation , 25OHD levels of the vitamin D group were approximately 15 nmol/L higher than the placebo group . Calcium intake did not change significantly between baseline ( 864 ± 412 mg/day ) and 9 months ( 855 ± 357 mg/day ) . Faller rates in the two groups did not differ : vitamin D group , 102 of 353 ( 29 % ) ; placebo group , 89 of 333 ( 27 % ) . At 9 months , compared to placebo or baseline , muscle strength , and TUG were not altered by vitamin D. In conclusion , oral cholecalciferol 150,000 IU therapy administered 3-monthly had neither beneficial nor adverse effects on falls or physical function . These data together with previous findings confirm that intermittent large doses of vitamin D are ineffective or have a deleterious effect on falls . Thus despite adherence issues with daily vitamin D replacement , an intermittent , high-dose vitamin D regimen can not be supported as a strategy to reduce falls and fractures",
"OBJECTIVES To determine whether vitamin D supplementation reduces the risk of fracture or falls in elderly people in care home accommodation . DESIGN A r and omised controlled trial of cluster design . SETTING AND SUBJECTS 223 Residential units ( mainly identical 30-bedded units ) , within 118 homes for elderly people throughout Britain , with 3,717 participating residents ( 76 % women , average age 85 years ) . The units provided mainly or entirely residential care ( 35 % of residents ) , nursing care ( 42 % ) or care for elderly mentally infirm ( EMI ) residents ( 23 % ) . METHODS Participants were r and omly allocated by residential unit ( cluster design ) to a treated group offered ergocalciferol 2.5 mg every 3 months ( equivalent to a daily dose of 1,100 IU ) , or to a control group . Fractures were reported by staff and confirmed in hospital , and routinely collected data on reported falls were obtained . RESULTS After median follow-up of 10 months ( interquartile range 7 - 14 months ) , 64 ( 3.6 % ) of 1,762 vitamin D-treated residents and 51 ( 2.6 % ) of 1,955 controls had one or more non-vertebral fractures , and 24 ( 1.3 % ) and 20 ( 1.0 % ) , respectively , had a hip fracture . The proportion reporting at least one fall was 44 % in vitamin D-treated and 43 % in control residents . The differences between the vitamin D and control groups were not statistically significant . The incidence of all non-vertebral fractures in the care homes ( 3.2 % per year ) and of hip fractures ( 1.1 % per year ) was low , similar to rates in elderly people in sheltered accommodation , and the pre-treatment serum 25-hydroxy vitamin D concentration was high [ median 47 nmol/l , measured in a 1 % ( n = 18 ) sample ] . CONCLUSIONS We found no evidence that vitamin D prevents fractures or falls in elderly people in care home accommodation",
"OBJECTIVES To determine whether vitamin D supplementation can reduce the incidence of falls and fractures in older people in residential care who are not classically vitamin D deficient . DESIGN R and omized , placebo-controlled double-blind , trial of 2 years ' duration . SETTING Multicenter study in 60 hostels ( assisted living facilities ) and 89 nursing homes across Australia . PARTICIPANTS Six hundred twenty-five residents ( mean age 83.4 ) with serum 25-hydroxyvitamin D levels between 25 and 90 nmol/L. INTERVENTION Vitamin D supplementation ( ergocalciferol , initially 10,000 IU given once weekly and then 1,000 IU daily ) or placebo for 2 years . All subjects received 600 mg of elemental calcium daily as calcium carbonate . MEASUREMENTS Falls and fractures recorded prospect ively in study diaries by care staff . RESULTS The vitamin D and placebo groups had similar baseline characteristics . In intention-to-treat analysis , the incident rate ratio for falling was 0.73 ( 95 % confidence interval (CI)=0.57 - 0.95 ) . The odds ratio for ever falling was 0.82 ( 95 % CI=0.59 - 1.12 ) and for ever fracturing was 0.69 ( 95 % CI=0.40 - 1.18 ) . An a priori subgroup analysis of subjects who took at least half the prescribed capsules ( n=540 ) , demonstrated an incident rate ratio for falls of 0.63 ( 95 % CI=0.48 - 0.82 ) , an odds ratio ( OR ) for ever falling of 0.70 ( 95 % CI=0.50 - 0.99 ) , and an OR for ever fracturing of 0.68 ( 95 % CI=0.38 - 1.22 ) . CONCLUSION Older people in residential care can reduce their incidence of falls if they take a vitamin D supplement for 2 years even if they are not initially classically vitamin D deficient",
"OBJECTIVES To study the effect of alfacalcidol ( 1alpha(OH)D3 ) on fall risk in community-dwelling elderly men and women . DESIGN R and omized , double-blind , placebo-controlled intervention trial . SETTING Basel , Switzerl and . PARTICIPANTS Three hundred seventy-eight community-dwelling elderly ( 191 women/187 men ) . INTERVENTION Participants were r and omly assigned to receive 1 microg of alfacalcidol or matched placebo daily for 36 weeks . MEASUREMENTS Serum 25-hydoxyvitamin D3 ( 25(OH ) D,1,25-dihydroxyvitamin D3 ( D-hormone ) , and intact parathormone ( iPTH ) levels were measured using radioimmunoassay at baseline and every 12 weeks . Numbers of fallers and falls were assessed using a question naire during each study site visit . Dietary calcium intake was assessed at baseline using a food frequency question naire . RESULTS At baseline , participants had , on average , normal vitamin D and D-hormone serum levels . Over 36 weeks , alfacalcidol treatment was associated with fewer fallers ( odds ratio (OR)=0.69 , 95 % confidence interval (CI)=0.41 - 1.16 ) than placebo . In a post hoc subgroups analysis by medians of total calcium intake , this reduction reached significance in alfacalcidol-treated subjects with a total calcium intake of more than 512 mg/d ( OR=0.45 , 95 % CI=0.21 - 0.97 , P=.042 ) but not in those who consumed less than 512 mg/d ( OR=1.00 , 95 % CI= 0.47 - 2.11 , P=.998 ) . Alfacalcidol treatment was also , independent of total calcium intake , associated with a significant 37.9 % reduction in iPTH serum levels ( P hypercalcemia were observed . CONCLUSION Provided a minimal calcium intake of more than 512 mg/d , alfacalcidol treatment significantly and safely reduces number of fallers in an elderly community dwelling population",
"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",
"BACKGROUND Vitamin D deficiency is common in older people and may increase risk of falls and fracture . Hospital in patients are at particular risk of falling . Previous studies suggest that vitamin D improves neuromuscular function and reduces falls . OBJECTIVE To determine whether routine supplementation with vitamin D plus calcium reduces numbers of fallers and falls in a cohort of hospital admissions while they are in patients . DESIGN R and omised , double-blind , controlled study . PARTICIPANTS two hundred and five acute admissions > 65 years to a geriatric medical unit . METHODS Patients were r and omised to intervention of daily vitamin D 800 iu plus calcium 1,200 mg or control group of daily calcium 1,200 mg , until discharge or death . RESULTS Baseline characteristics were similar in both groups with a median age 84 years and a median length of stay = 30 days ( IQR 14.75 - 71.00 ) . In a pre-selected sub-group ( 54/205 participants ) , median admission vitamin D level = 22.00 nmol/l ( IQR 15.00 - 30.50 ) . This did not significantly increase in the treatment versus control group . Median study drug adherence = 88 % , with no significant difference between study groups ( Mann-Whitney : P = 0.711 ) . Although there were fewer fallers in the vitamin D cohort , this did not reach statistical significance ( vitamin D : calcium = 36:45 fallers ; RR 0.82 ( CI 0.59 - 1.16 ) . Neither the mean number of falls ( vitamin D : calcium = 1.040:1.155 ; Mann-Whitney P = 0.435 ) or time to first fall ( Log-rank test P = 0.377 ) differed between groups . CONCLUSIONS In a population of geriatric hospital in patients , vitamin D did not reduce the number of fallers . Routine supplementation can not be recommended to reduce falls in this group",
"OBJECTIVES Low trauma fractures in older people incur enormous physical , social and economic costs . Previous research indicates that an annual intramuscular injection of vitamin D may reduce fracture rates in this group . This strategy requires validation in a population setting . METHODS R and omized , double-blind , placebo-controlled trial of 300,000 IU intramuscular ( i.m . ) vitamin D2 ( ergocalciferol ) injection or matching placebo every autumn over 3 years . 9440 people ( 4354 men and 5086 women ) aged 75 yrs and over were recruited from general practice registers in Wessex , Engl and . Primary outcome measure was all non-vertebral fracture . Secondary outcomes were hip and wrist fractures , and all falls . RESULTS 585 subjects had incident non-spine fractures ( hip 110 , wrist 116 , ankle 37 ) . Hazard ratios ( HRs ) for fracture in the vitamin D group were : 1.09 [ 95 % confidence interval ( CI ) 0.93 - 1.28 , P = 0.29 ] for any first fracture , 1.49 ( 95 % CI 1.02 - 2.18 , P = 0.04 ) for hip and 1.22 ( 95 % CI 0.85 - 1.76 , P = 0.28 ) for wrist . There was no effect on falls : HR 0.98 ( 0.93 - 1.04 ) . No protective effect was observed in any subgroup when the cohort was stratified by sex , age , previous fracture or mobility . CONCLUSIONS An annual i.m . injection of 300,000 IU vitamin D2 is not effective in preventing non-vertebral fractures among elderly men and women resident in the general population",
"OBJECTIVES To determine the effectiveness of vitamin D supplementation in preventing decline in physical function in older men . DESIGN R and omized , double-blind , placebo-controlled clinical trial . SETTING Single-center study conducted at a Veterans Affairs Healthcare System . PARTICIPANTS Sedentary men aged 65 to 90 ( mean 72.4 ± 6.8 ) with baseline 25-hydroxyvitamin D ( 25(OH)D levels of less than 30 ng/mL and Short Physical Performance Battery ( SPPB ) test scores of 9 or less ( N = 130 ) . INTERVENTION Daily capsule containing cholecalciferol 4,000 IU daily or placebo for 9 months . MEASUREMENTS Main outcomes were SPPB score and gait speed . RESULTS After the intervention , serum 25(OH)D increased from 23.1 ± 5.0 ng/mL to 46.2 ± 12.7 ng/mL in the cholecalciferol group and from 22.5 ± 5.3 ng/mL to 24.0 ± 7.2 ng/mL in the placebo group . At study end , improvements in SPPB score and gait speed were not significantly greater in men receiving cholecalciferol than in those receiving placebo . No differences were found in adverse events or numbers of falls . CONCLUSION Daily cholecalciferol 4,000 IU for 9 months result ed in significant increases in 25(OH)D concentrations , but achieving these higher levels did not result in improvements in SPPB score or gait speed . These data do not support prescribing vitamin D supplements to older sedentary men to prevent physical function decline",
"BACKGROUND We conducted a r and omized , placebo-controlled , double-blind trial to test the hypothesis that vitamin D(3 ) supplementation would prevent bone loss in calcium-replete , African American postmenopausal women . METHODS Two hundred eight healthy black postmenopausal women , 50 to 75 years of age , were assigned to receive either placebo or 20 microg/d ( 800 IU ) of vitamin D(3 ) . Calcium supplements were provided to ensure a total calcium intake of 1200 to 1500 mg/d . After 2 years , the vitamin D(3 ) dose was increased to 50 microg/d ( 2000 IU ) in the active group , and the study continued for an additional year . Bone mineral density ( BMD ) was measured every 6 months . Markers of bone turnover , vitamin D metabolites , and parathyroid hormone ( PTH ) levels were measured in serum . RESULTS There were no significant differences in BMD between the active and control groups throughout the study . There was also no relationship between serum 25-hydroxyvitamin D levels attained and rates of bone loss . There was an increase in BMD of the total body , hip , and radius at 1 year in both groups . Over the 3 years , BMD declined at these sites by 0.26 % to 0.55 % per year . The BMD of the lumbar spine increased slightly in the placebo and active groups . There were no persistent changes in serum PTH levels or the markers of bone turnover , although there was a transient decline in PTH in both groups at 3 months . No significant adverse events were attributed to vitamin D supplementation . CONCLUSIONS There was no observed effect of vitamin D(3 ) supplementation on bone loss or bone turnover markers in calcium-replete , postmenopausal African American women . Further studies are needed to determine if these findings are applicable to women of other ethnic groups",
"CONTEXT Vitamin D or calcium supplementation may have effects on vascular disease and cancer . OBJECTIVE Our objective was to investigate whether vitamin D or calcium supplementation affects mortality , vascular disease , and cancer in older people . DESIGN AND SETTING The study included long-term follow-up of participants in a two by two factorial , r and omized controlled trial from 21 orthopedic centers in the United Kingdom . PARTICIPANTS Participants were 5292 people ( 85 % women ) aged at least 70 yr with previous low-trauma fracture . INTERVENTIONS Participants were r and omly allocated to daily vitamin D(3 ) ( 800 IU ) , calcium ( 1000 mg ) , both , or placebo for 24 - 62 months , with a follow-up of 3 yr after intervention . MAIN OUTCOME MEASURES All-cause mortality , vascular disease mortality , cancer mortality , and cancer incidence were evaluated . RESULTS In intention-to-treat analyses , mortality [ hazard ratio ( HR ) = 0.93 ; 95 % confidence interval ( CI ) = 0.85 - 1.02 ] , vascular disease mortality ( HR = 0.91 ; 95 % CI = 0.79 - 1.05 ) , cancer mortality ( HR = 0.85 ; 95 % CI = 0.68 - 1.06 ) , and cancer incidence ( HR = 1.07 ; 95 % CI = 0.92 - 1.25 ) did not differ significantly between participants allocated vitamin D and those not . All-cause mortality ( HR = 1.03 ; 95 % CI = 0.94 - 1.13 ) , vascular disease mortality ( HR = 1.07 ; 95 % CI = 0.92 - 1.24 ) , cancer mortality ( HR = 1.13 ; 95 % CI = 0.91 - 1.40 ) , and cancer incidence ( HR = 1.06 ; 95 % CI = 0.91 - 1.23 ) also did not differ significantly between participants allocated calcium and those not . In a post hoc statistical analysis adjusting for compliance , thus with fewer participants , trends for reduced mortality with vitamin D and increased mortality with calcium were accentuated , although all results remain nonsignificant . CONCLUSIONS Daily vitamin D or calcium supplementation did not affect mortality , vascular disease , cancer mortality , or cancer incidence",
"BACKGROUND Severe vitamin D deficiency causes osteomalacia , yet trials of vitamin D supplementation in the community have not on average demonstrated benefit to bone mineral density ( BMD ) or fracture risk in adults . OBJECTIVE To determine whether monthly high-dose vitamin D supplementation influences BMD in the general population and in those with low 25-hydroxyvitamin D levels . METHODS Two-year sub study of a trial in older community-resident adults . A total of 452 participants were r and omized to receive monthly doses of vitamin D3 100 000 IU , or placebo . The primary end-point was change in lumbar spine BMD . Exploratory analyses to identify thresholds of baseline 25-hydroxyvitamin D for vitamin D effects on BMD were prespecified . RESULTS Intention-to-treat analyses showed no significant treatment effect in the lumbar spine ( between-groups difference 0.0071 g cm-2 , 95%CI : -0.0012 , 0.0154 ) or total body but BMD loss at both hip sites was significantly attenuated by ~1/2 % over 2 years . There was a significant interaction between baseline 25-hydroxyvitamin D and treatment effect ( P = 0.04 ) . With baseline 25-hydroxyvitamin D ≤ 30 nmol L-1 ( n = 46 ) , there were between-groups BMD changes at the spine and femoral sites of ~2 % , significant in the spine and femoral neck , but there was no effect on total body BMD . When baseline 25-hydroxyvitamin D was > 30 nmol L-1 , differences were ~1/2 % and significant only at the total hip . CONCLUSIONS This sub study finds no clinical ly important benefit to BMD from untargeted vitamin D supplementation of older , community-dwelling adults . Exploratory analyses suggest meaningful benefit in those with baseline 25-hydroxyvitamin D ≤ 30 nmol L-1 . This represents a significant step towards a trial-based definition of vitamin D deficiency for bone health in older adults ",
"In a double-blind clinical trial on 49 patients with rheumatoid arthritis , calciferol was given in a dose of 100 000 IU per day for 1 year to 24 patients , while the remaining 25 received placebo . Objective and subjective improvement was noted in 67 % of the calciferol group and in 36 % of the control group , while objective and subjective deterioration was noted in 4 % of the calciferol group and in 32 % of the control group . The mean values for sedimentation rate and a2-globulin decreased and the mean hemoglobin level increased in the calciferol group . The consumption of analgesics and antiinflammatory medicines decreased significantly in the calciferol group and after 1 year morning stiffness had eased and h and strength had increased in this group",
"IMPORTANCE Experts debate optimal 25-hydroxyvitamin D ( 25[OH]D ) levels for musculoskeletal health . OBJECTIVE To compare the effects of placebo , low-dose cholecalciferol , and high-dose cholecalciferol on 1-year changes in total fractional calcium absorption , bone mineral density , Timed Up and Go and five sit-to-st and tests , and muscle mass in postmenopausal women with vitamin D insufficiency . DESIGN , SETTING , AND PARTICIPANTS This r and omized , double-blind , placebo-controlled clinical trial was conducted at a single center in Madison , Wisconsin , from May 1 , 2010 , through July 31 , 2013 , and the final visit was completed on August 8 , 2014 . A total of 230 postmenopausal women 75 years or younger with baseline 25(OH)D levels of 14 through 27 ng/mL and no osteoporosis were studied . INTERVENTIONS Three arms included daily white and twice monthly yellow placebo ( n=76 ) , daily 800 IU vitamin D3 and twice monthly yellow placebo ( n=75 ) , and daily white placebo and twice monthly 50,000 IU vitamin D3 ( n=79 ) . The high-dose vitamin D regimen achieved and maintained 25(OH)D levels≥30 ng/mL. MAIN OUTCOMES AND MEASURES Outcome measures were 1-year change in total fractional calcium absorption using 2 stable isotopes , bone mineral density and muscle mass using dual energy x-ray absorptiometry , Timed Up and Go and five sit-to-st and tests , functional status ( Health Assessment Question naire ) , and physical activity ( Physical Activity Scale for the Elderly ) , with Benjamini-Hochberg correction of P values to control for the false discovery rate . RESULTS After baseline absorption was controlled for , calcium absorption increased 1 % ( 10 mg/d ) in the high-dose arm but decreased 2 % in the low-dose arm ( P = .005 vs high-dose arm ) and 1.3 % in the placebo arm ( P = .03 vs high-dose arm ) . We found no between-arm changes in spine , mean total-hip , mean femoral neck , or total-body bone mineral density , trabecular bone score , muscle mass , and Timed Up and Go or five sit-to-st and test scores . Likewise , we found no between-arm differences for numbers of falls , number of fallers , physical activity , or functional status . CONCLUSIONS AND RELEVANCE High-dose cholecalciferol therapy increased calcium absorption , but the effect was small and did not translate into beneficial effects on bone mineral density , muscle function , muscle mass , or falls . We found no data to support experts ' recommendations to maintain serum 25(OH)D levels of 30 ng/mL or higher in postmenopausal women . Instead , we found that low- and high-dose cholecalciferol were equivalent to placebo in their effects on bone and muscle outcomes in this cohort of postmenopausal women with 25(OH)D levels less than 30 ng/mL. TRIAL REGISTRATION clinical trials.gov Identifier : NCT00933244",
"OBJECTIVES To determine the effectiveness of vitamin D and home-based quadriceps resistance exercise on reducing falls and improving the physical health of frail older people after hospital discharge . DESIGN Multicenter , r and omized , controlled trial with a factorial design . SETTING Five hospitals in Auckl and , New Zeal and , and Sydney , Australia . PARTICIPANTS Two hundred forty-three frail older people . INTERVENTIONS Patients were r and omized to receive a single dose of vitamin D ( calciferol , 300,000 IU ) or placebo tablets and 10 weeks of high-intensity home-based quadriceps resistance exercise or frequency-matched visits . MEASUREMENTS The primary endpoints were physical health according to the short-form health survey at 3 months and falls over 6 months . Physical performance and self-rated function were secondary endpoints . Assessment s took place in the participants ' homes at 3 and 6 months after r and omization and were performed by blinded assessors . RESULTS There was no effect of either intervention on physical health or falls , but patients in the exercise group were at increased risk of musculoskeletal injury ( risk ratio = 3.6 , 95 % confidence interval = 1.5 - 8.0 ) . Vitamin D supplementation did not improve physical performance , even in those who were vitamin D deficient ( vitamin D supplementation nor a home-based program of high-intensity quadriceps resistance exercise improved rehabilitation outcomes in frail older people after hospitalization . There was no effect of vitamin D on physical performance , and the exercises increased the risk of musculoskeletal injury . These findings do not support the routine use of these interventions at these dosages in the rehabilitation of frail older people",
"R and omized controlled trials have shown that a combination of vitamin D and calcium can prevent fragility fractures in the elderly . Whether this effect is attributed to the combination of vitamin D and calcium or to one of these nutrients alone is not known . We studied if an intervention with 10 microg of vitamin D3 per day could prevent hip fracture and other osteoporotic fractures in a double-blinded r and omized controlled trial . Residents from 51 nursing homes were allocated r and omly to receive 5 ml of ordinary cod liver oil ( n = 569 ) or 5 ml of cod liver oil where vitamin D was removed ( n = 575 ) . During the study period of 2 years , fractures and deaths were registered , and the principal analysis was performed on the intention-to-treat basis . Biochemical markers were measured at baseline and after 1 year in a sub sample . Forty-seven persons in the control group and 50 persons in the vitamin D group suffered a hip fracture . The corresponding figures for all nonvertebral fractures were 76 persons ( control group ) and 69 persons ( vitamin D group ) . There was no difference in the incidence of hip fracture ( p = 0.66 , log-rank test ) , or in the incidence of all nonvertebral fractures ( p = 0.60 , log-rank test ) in the vitamin D group compared with the control group . Compared with the control group , persons in the vitamin D group increased their serum 25-hydroxyvitamin D concentration with 22 nmol/liter ( p = 0.001 ) . In conclusion , we found that an intervention with 10 microg of vitamin D3 alone produced no fracture-preventing effect in a nursing home population of frail elderly people",
"OBJECTIVES To determine the prevalence of hypovitaminosis D ( serum 25-hydroxyvitamin D population of elderly veterans and conduct a preliminary assessment of the efficacy of supplementation with cholecalciferol in correcting HVD . DESIGN R and omized , double-blind , placebo-controlled clinical trial . SETTING Geriatric clinic at the Bruce W. Carter Veterans Affairs Medical Center , Miami , Florida . PARTICIPANTS Veterans aged 70 and older . INTERVENTION Oral cholecalciferol 2,000 IU daily or placebo for 6 months . MEASUREMENTS Serum calcium , 25-hydroxyvitamin D , parathyroid hormone , and 24-hour urinary calcium . RESULTS Of the 34 participants who completed the study , 62 % had HVD at baseline . In the treatment group , mean serum 25-hydroxyvitamin D level rose from 28.4±7.9 ng/mL at baseline to 42.7±10.5 ng/mL at the end of the trial , but levels remained less than 32 ng/mL in three of 17 ( 18 % ) of the participants . In the placebo group , the baseline level of 27.7±8.3 ng/mL remained unchanged ( 28.8±8.7 ng/mL ) . Supplementation did not alter serum or urinary calcium levels and did not result in any adverse events . CONCLUSION These initial observations suggest that , in older veterans , cholecalciferol 2,000 IU daily for 6 months is generally safe and corrects HVD in most but not all individuals",
"BACKGROUND survivors of hip fracture are at 5- to 10-fold risk of a second hip fracture . There is little consensus about secondary prevention . Many are given calcium and vitamin D , but the evidence supporting this is circumstantial . OBJECTIVE to compare the effects of different calcium and vitamin D supplementation regimens on bone biochemical markers , bone mineral density and rate of falls in elderly women post-hip fracture . DESIGN r and omised controlled trial . SETTING orthogeriatric rehabilitation ward . METHODS 150 previously independent elderly women , recruited following surgery for hip fracture , were assigned to receive a single injection of 300,000 units of vitamin D(2 ) , injected vitamin D(2 ) plus 1 g/day oral calcium , 800 units/day oral vitamin D(3 ) plus 1 g/day calcium , or no treatment . Follow-up was one year , with measurement of 25-hydroxyvitamin D , parathyroid hormone , bone mineral density , and falls . RESULTS mean 25-hydroxyvitamin D increased and mean parathyroid hormone was suppressed in all the actively treated groups , more so in the group receiving combined oral vitamin D and calcium . Twenty per cent of participants injected with vitamin D were deficient in 25-hydroxyvitamin D a year later . Bone mineral density showed small but statistically significant differences of up to 4.6 % between actively treated groups and placebo . Relative risk of falling in the groups supplemented with vitamin D was 0.48 ( 95 % CI 0.26 - 0.90 ) compared with controls . CONCLUSION Vitamin D supplementation , either orally or with injected vitamin D , suppresses parathyroid hormone , increases bone mineral density and reduces falls . Effects may be more marked with calcium co-supplementation . The 300,000 units of injected vitamin D may not last a whole year",
"BACKGROUND AND PURPOSE It has been demonstrated that bone mass was significantly reduced on the hemiplegic side of stroke patients , which might increase their risk of hip fracture . We evaluated the efficacy of 1 alpha-hydroxyvitamin D3 [ 1 alpha (OH)D3 ] and supplemental elemental calcium in maintaining bone mass and decreasing the incidence of hip fractures after hemiplegic stroke . METHODS In a r and omized study , 64 patients with hemiplegia after stroke with a mean duration of illness of 4.8 years received either 1 microgram 1 alpha (OH)D3 daily ( treatment group , n = 30 ) or an inactive placebo ( placebo group , n = 34 ) for 6 months and were observed for this duration . Both groups received 300 mg of elemental calcium daily . The bone mineral density ( BMD ) and metacarpal index ( MCI ) in the second metacarpals were determined by computed x-ray densitometry . The incidence of hip fractures in these patients was recorded . RESULTS BMD on the hemiplegic side decreased by 2.4 % in the treatment group and 8.9 % in the placebo group ( P = .0021 ) , while BMD on the intact side increased by 3.5 % and decreased by 6.3 % in the treated and placebo groups , respectively ( P = .0177 ) . In the treatment group , the difference in BMD between hemiplegic and nonhemiplegic sides decreased significantly compared with that before r and omization . This difference increased in the placebo group . We observed a similar improvement in MCI in the treatment group but not in the placebo group . Four patients in the placebo group suffered a hip fracture compared with none in the treatment group ( P = .0362 ) . CONCLUSIONS Treatment with 1 alpha (OH)D3 and supplemental elemental calcium can reduce the risk of hip fractures and can prevent further decreases in BMD and MCI on the hemiplegic side of patients with a long-st and ing stroke . Treatment also may improve these indices on the intact side",
"Vitamin D recently has been proposed to play an important role in a broad range of organ functions , including cardiovascular ( CV ) health ; however , the CV evidence -base is limited . We prospect ively analyzed a large electronic medical records data base to determine the prevalence of vitamin D deficiency and the relation of vitamin D levels to prevalent and incident CV risk factors and diseases , including mortality . The data base contained 41,504 patient records with at least one measured vitamin D level . The prevalence of vitamin D deficiency ( ≤30 ng/ml ) was 63.6 % , with only minor differences by gender or age . Vitamin D deficiency was associated with highly significant ( p prevalence of diabetes , hypertension , hyperlipidemia , and peripheral vascular disease . Also , those without risk factors but with severe deficiency had an increased likelihood of developing diabetes , hypertension , and hyperlipidemia . The vitamin D levels were also highly associated with coronary artery disease , myocardial infa rct ion , heart failure , and stroke ( all p with incident death , heart failure , coronary artery disease/myocardial infa rct ion ( all p stroke ( p = 0.003 ) , and their composite ( p vitamin D deficiency in the general healthcare population and an association between vitamin D levels and prevalent and incident CV risk factors and outcomes . These observations lend strong support to the hypothesis that vitamin D might play a primary role in CV risk factors and disease . Given the ease of vitamin D measurement and replacement , prospect i ve studies of vitamin D supplementation to prevent and treat CV disease are urgently needed",
"Purpose : Higher serum 25-hydroxyvitamin D ( 25(OH)D ) levels are reportedly associated with better survival in early-stage non – small cell lung cancer ( NSCLC ) . Therefore , whether vitamin D supplementation can improve the prognosis of patients with NSCLC was examined ( UMIN000001869 ) . Patients and Methods : A r and omized , double-blind trial comparing vitamin D supplements ( 1,200 IU/day ) with placebo for 1 year after operation was conducted . The primary and secondary outcomes were relapse-free survival ( RFS ) and overall survival ( OS ) , respectively . Prespecified subgroup analyses were performed with stratification by stage ( early vs. advanced ) , pathology ( adenocarcinoma vs. others ) , and 25(OH)D levels ( low , Polymorphisms of vitamin D receptor ( VDR ) and vitamin D – binding protein ( DBP ) and survival were also examined . Results : Patients with NSCLC ( n = 155 ) were r and omly assigned to receive vitamin D ( n = 77 ) or placebo ( n = 78 ) and followed for a median of 3.3 years . Relapse and death occurred in 40 ( 28 % ) and 24 ( 17 % ) patients , respectively . In the total study population , no significant difference in either RFS or OS was seen with vitamin D compared with the placebo group . However , by restricting the analysis to the subgroup with early-stage adenocarcinoma with low 25(OH)D , the vitamin D group showed significantly better 5-year RFS ( 86 % vs. 50 % , P = 0.04 ) and OS ( 91 % vs. 48 % , P = 0.02 ) than the placebo group . Among the examined polymorphisms , DBP1 ( rs7041 ) TT and CDX2 ( rs11568820 ) AA/AG genotypes were markers of better prognosis , even with multivariate adjustment . Conclusions : In patients with NSCLC , vitamin D supplementation may improve survival of patients with early-stage lung adenocarcinoma with lower 25(OH)D levels . Clin Cancer Res ; 24(17 ) ; 4089–97 . © 2018 AACR",
"BACKGROUND Epidemiologic and pre clinical data suggest that higher intake and serum levels of vitamin D and higher intake of calcium reduce the risk of colorectal neoplasia . To further study the chemopreventive potential of these nutrients , we conducted a r and omized , double-blind , placebo-controlled trial of supplementation with vitamin D , calcium , or both for the prevention of colorectal adenomas . METHODS We recruited patients with recently diagnosed adenomas and no known colorectal polyps remaining after complete colonoscopy . We r and omly assigned 2259 participants to receive daily vitamin D3 ( 1000 IU ) , calcium as carbonate ( 1200 mg ) , both , or neither in a partial 2 × 2 factorial design . Women could elect to receive calcium plus r and om assignment to vitamin D or placebo . Follow-up colonoscopy was anticipated to be performed 3 or 5 years after the baseline examinations , according to the endoscopist 's recommendation . The primary end point was adenomas diagnosed in the interval from r and omization through the anticipated surveillance colonoscopy . RESULTS Participants who were r and omly assigned to receive vitamin D had a mean net increase in serum 25-hydroxyvitamin D levels of 7.83 ng per milliliter , relative to participants given placebo . Overall , 43 % of participants had one or more adenomas diagnosed during follow-up . The adjusted risk ratios for recurrent adenomas were 0.99 ( 95 % confidence interval [ CI ] , 0.89 to 1.09 ) with vitamin D versus no vitamin D , 0.95 ( 95 % CI , 0.85 to 1.06 ) with calcium versus no calcium , and 0.93 ( 95 % CI , 0.80 to 1.08 ) with both agents versus neither agent . The findings for advanced adenomas were similar . There were few serious adverse events . CONCLUSIONS Daily supplementation with vitamin D3 ( 1000 IU ) , calcium ( 1200 mg ) , or both after removal of colorectal adenomas did not significantly reduce the risk of recurrent colorectal adenomas over a period of 3 to 5 years . ( Funded by the National Cancer Institute ; Clinical Trials.gov number , NCT00153816 . )",
"OBJECTIVES To examine the effect of 25-hydroxyvitamin D ( 25(OH)D ) levels recommended by Endocrine Society guidelines ( > 30 ng/mL ) on cognition in healthy older African-American women over 3 years . DESIGN R and omized , double-blind , placebo-controlled clinical trial . SETTING Bone Mineral Research Center at New York University Winthrop Hospital . PARTICIPANTS Healthy postmenopausal African American women aged 65 and older ( N=260 ; mean age 68.2 ± 4.9 ; 46 % college education or higher ) . INTERVENTION Half of the women were r and omized to receive vitamin D ( adjusted to achieve a serum level > 30 ng/mL ) with calcium ( diet and supplement total of 1,200 mg ) , and half were r and omized to receive placebo with calcium ( 1,200 mg ) . MEASUREMENTS Cognitive assessment s every 6 months using the Mini-Mental State Examination ( MMSE ) to detect cognitive decline . Mean MMSE scores were calculated over time for both groups . Those with MMSE scores less than 21 at baseline were excluded . RESULTS The average dose of vitamin D3 was 3,490 ± 1,465 IU per day , and average serum 25(OH)D at 3 years was 46.8 ± 1.2 ng/mL in the active group and 20.7 ± 1.1 ng/mL in the placebo group . Serum 25(OH)D concentration was maintained at greater than 30 ng/mL in 90 % of the active group . Over the 3-year period , MMSE scores increased in both groups ( p groups . No adverse events associated with vitamin D were observed . CONCLUSION There was no difference in cognition over time between older African-American women with serum concentrations of 25(OH)D of 30 ng/mL and greater than those taking placebo . There is no evidence to support vitamin D intake greater than the recommended daily allowance in this population for preventing cognitive decline . J Am Geriatr Soc 67:81 - 86 , 2019",
"IMPORTANCE While vitamin D supplementation and exercise are recommended for prevention of falls for older people , results regarding these 2 factors are contradictory . OBJECTIVE To determine the effectiveness of targeted exercise training and vitamin D supplementation in reducing falls and injurious falls among older women . DESIGN , SETTING , AND PARTICIPANTS A 2-year r and omized , double-blind , placebo-controlled vitamin D and open exercise trial conducted between April 2010 and March 2013 in Tampere , Finl and . Participants were 409 home-dwelling women 70 to 80 years old . The main inclusion criteria were at least 1 fall during the previous year , no use of vitamin D supplements , and no contraindication to exercise . INTERVENTIONS Four study groups , including placebo without exercise , vitamin D ( 800 IU/d ) without exercise , placebo and exercise , and vitamin D ( 800 IU/d ) and exercise . MAIN OUTCOMES AND MEASURES The primary outcome was monthly reported falls . Injurious falls and the number of fallers and injured fallers were reported as secondary outcomes . In addition , bone density , physical functioning ( muscle strength , balance , and mobility ) , and vitamin D metabolism were assessed . RESULTS Intent-to-treat analyses showed that neither vitamin D nor exercise reduced falls . Fall rates per 100 person-years were 118.2 , 132.1 , 120.7 , and 113.1 in the placebo without exercise , vitamin D without exercise , placebo and exercise , and vitamin D and exercise study groups , respectively ; however , injurious fall rates were 13.2 , 12.9 , 6.5 , and 5.0 , respectively . Hazard ratios for injured fallers were significantly lower among exercisers with vitamin D ( 0.38 ; 95 % CI , 0.17 - 0.83 ) and without vitamin D ( 0.47 ; 95 % CI , 0.23 - 0.99 ) . Vitamin D maintained femoral neck bone mineral density and increased tibial trabecular density slightly . However , only exercise improved muscle strength and balance . Vitamin D did not enhance exercise effects on physical functioning . CONCLUSIONS AND RELEVANCE The rate of injurious falls and injured fallers more than halved with strength and balance training in home-dwelling older women , while neither exercise nor vitamin D affected the rate of falls . Exercise improved physical functioning . Future research is needed to determine the role of vitamin D in the enhancement of strength , balance , and mobility . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00986466",
"OBJECTIVE This study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2 g/vitamin D₃ 1000 IU daily vs strontium ranelate 2 g daily for correcting vitamin D insufficiency in osteoporosis . DESIGN A 6-month international , r and omized , double-blind , parallel-group , phase 3 study . METHODS A total of 518 men and postmenopausal women aged ≥50 years with primary osteoporosis ( T-score ≤-2.5 s.d . ) and serum 25-hydroxyvitamin D ( 25(OH)D ) > 22.5 nmol/l were included . Patients were allocated to strontium ranelate 2 g/vitamin D₃ 1000 IU daily ( n=413 ) or strontium ranelate 2 g daily ( n=105 ) . The participants received calcium 1 g daily . The primary endpoint was serum 25(OH)D at last post-baseline evaluation during 3 months . RESULTS Both groups were comparable at baseline . Mean baseline of 25(OH)D was 44.1 ± 14.6 nmol/l . After 3 months , the percentage of patients with 25(OH)D ≥50 nmol/l was higher with strontium ranelate/vitamin D₃ vs strontium ranelate ( 84 vs 44 % , P , 4.2 - 10.9 ) . The efficacy of the fixed-dose combination on 25(OH)D was maintained at 6 months ( 86 vs 40 % , P Mean 25(OH)D was 65.1 and 49.5 nmol/l , respectively , after 3 months and 66.9 and 45.4 nmol/l after 6 months . Physical performance improved in both groups . Falls were 17 and 20 % in the strontium ranelate/vitamin D₃ and strontium ranelate groups respectively . Parathyroid hormone levels were inversely correlated with 25(OH)D. No clinical ly relevant differences in safety were observed . CONCLUSIONS This study confirms the efficacy and safety of fixed-dose combination of strontium ranelate 2 g/vitamin D₃ 1000 IU for correction of vitamin D insufficiency in osteoporotic patients"
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OBJECTIVE Iron supplementation in iron-deficiency anaemia is st and ard practice , but the benefits of iron supplementation in iron-deficient non-anaemic ( IDNA ) individuals remains controversial . Our objective is to identify the effects of iron therapy on fatigue and physical capacity in IDNA adults . DESIGN Systematic review and meta- analysis of r and omised controlled trials ( RCTs ) . SETTING Primary care . PARTICIPANTS Adults ( ≥18 years ) who were iron deficient but non-anaemic . INTERVENTIONS Oral , intramuscular or intravenous iron supplementation ; all therapy doses , frequencies and duration s were included . COMPARATORS Placebo or active therapy . RESULTS We identified RCTs in Medline , Embase , Cochrane Central Register of Controlled Trials , Cumulative Index of Nursing and Allied Health , SportD iscus and CAB Abstract s from inception to 31 October 2016 . We search ed the WHO 's International Clinical Trials Registry Platform for relevant ongoing trials and performed forward search es of included trials and relevant review s in Web of Science . We assessed internal validity of included trials using the Cochrane Risk of Bias tool and the external validity using the Grading of Recommendations Assessment , Development and Evaluation methodology . From 11 580 citations , we included 18 unique trials and 2 companion papers enrolling 1170 patients . Using a Mantel-Haenszel r and om-effects model , iron supplementation was associated with reduced self-reported fatigue ( st and ardised mean difference ( SMD ) -0.38 ; 95 % CI -0.52 to -0.23 ; I2 0 % ; 4 trials ; 714 participants ) but was not associated with differences in objective measures of physical capacity , including maximal oxygen consumption ( SMD 0.11 ; 95 % CI -0.15 to 0.37 ; I2 0 % ; 9 trials ; 235 participants ) and timed methods of exercise testing . Iron supplementation significantly increased serum haemoglobin concentration ( MD 4.01 g/L ; 95 % CI 1.22 to 6.81 ; I2 48 % ; 12 trials ; 298 participants ) and serum ferritin ( MD 9.23 µmol/L ; 95 % CI 6.48 to 11.97 ; I2 58 % ; 14 trials ; 616 participants ) . CONCLUSION In IDNA adults , iron supplementation is associated with reduced subjective measures of fatigue but not with objective improvements in physical capacity . Given the global prevalence of both iron deficiency and fatigue , patients and practitioners could consider consumption of iron-rich foods or iron supplementation to improve symptoms of fatigue in the absence of documented anaemia . PROSPERO REGISTRATION NUMBER CRD42014007085
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"Our objective was to investigate the effects of iron depletion on adaptation to aerobic exercise , assessed by time to complete a 15-km cycle ergometer test . Forty-two iron-depleted ( serum ferritin 12 g/dl ) women ( 18 - 33 yr old ) received 100 mg of ferrous sulfate ( S ) or placebo ( P ) per day for 6 wk in a r and omized , double-blind trial . Subjects trained for 30 min/day , 5 days/wk at 75 - 85 % of maximum heart rate for the final 4 wk of the study . There were no group differences in baseline iron status or in 15-km time . Iron supplementation increased serum ferritin and decreased transferrin receptors in the S compared with the P group . The S and P groups decreased 15-km time and respiratory exchange ratio and increased work rate during the 15-km time trial after training . The decrease in 15-km time was greater in the S than in the P group ( P = 0.04 ) and could be partially attributed to increases in serum ferritin and Hb . These results indicate that iron deficiency without anemia impairs favorable adaptation to aerobic exercise ",
"BACKGROUND Iron deficiency without anemia has been shown to reduce both muscle-tissue oxidative capacity and endurance in animals . However , the consequences of iron deficiency in humans remain unclear . OBJECTIVE We investigated the effects of iron supplementation on adaptation to aerobic training among marginally iron-depleted women . We hypothesized that iron supplementation for 6 wk would significantly improve iron status and maximal oxygen uptake ( VO(2)max ) after 4 wk of concurrent aerobic training . DESIGN Forty-one untrained , iron-depleted , nonanemic women were r and omly assigned to receive either 50 mg FeSO(4 ) or a placebo twice daily for 6 wk in a double-blind trial . All subjects trained on cycle ergometers 5 d/wk for 4 wk , beginning on week 3 of the study . RESULTS Six weeks of iron supplementation significantly improved serum ferritin and serum transferrin receptor ( sTfR ) concentrations and transferrin saturation without affecting hemoglobin concentrations or hematocrit . Average VO(2)max and maximal respiratory exchange ratio improved in both the placebo and iron groups after training ; however , the iron group experienced significantly greater improvements in VO(2)max . Both iron-status and fitness outcomes were analyzed after stratifying by baseline sTfR concentration ( > and sTfR status impairs aerobic adaptation among previously untrained women and that this can be corrected with iron supplementation",
"Zinc and iron compete during intestinal absorption , but postabsorptive interactions between these nutrients are less clear . Underst and ing these interactions is important to determine when supplementation with iron or zinc is proposed . The effect of zinc supplementation ( 22 mg Zn/d as zinc gluconate ) or of iron supplementation ( 100 mg Fe/d as ferrous sulfate ) for 6 wk on iron and zinc metabolism and absorption was evaluated in young women with low iron reserves . Young adult women ( ages 20 - 28 y ) , nonanemic but with low iron stores ( plasma ferritin The women were divided in two groups ( zinc-supplemented , n = 11 ; iron-supplemented , n = 12 ) . The supplements were taken at bedtime . Iron and zinc biochemical indices and intestinal absorption were measured on d 1 and 56 . Radioiron and stable isotopes of zinc were used to measure iron and zinc absorption from a test meal . In the iron-supplemented group , blood hemoglobin , plasma ferritin and the percentage of transferrin saturation increased ( P Zinc indices did not change . In the zinc-supplemented group , plasma ferritin and the percentage of transferrin saturation decreased ( P plasma transferrin receptor and erythrocyte zinc protoprophyrin levels increased ( P Plasma and urinary zinc also increased ( P Iron absorption ( % ) from the test meal increased ( P zinc absorption ( % ) decreased ( P iron supplements in women with marginal iron status improves iron indices with no effect on zinc status . However , use of a modest zinc supplement improves zinc indices , but also appears to induce a cellular iron deficiency and , possibly , further reduce iron status",
"BACKGROUND Tissue iron depletion may negatively affect endurance performance and muscle fatigability . OBJECTIVE We investigated tissue-level iron depletion and progressive fatigue of the quadriceps during dynamic knee-extension exercise in young women . DESIGN Twenty iron-depleted ( serum ferritin 110 g/L ) women ( macro x + /- SEM age : 29.1 + /- 1.2 y ) received iron ( iron group ) or placebo ( placebo group ) for 6 wk in a r and omized , double-blind trial ( n = 10 per group ) . A protocol integrating 2 - 3-s maximal voluntary static contractions ( MVCs ) with dynamic knee extensions was used to assess fatigue . RESULTS No significant differences between the groups in baseline iron status , MVC at rest , or MVC at the end of the protocol were observed . After treatment , serum iron and transferrin saturation increased significantly in the iron group ( P = 0.02 and P = 0.03 , respectively ) . Serum transferrin receptor concentrations increased significantly in the placebo group ( P MVC was attenuated in the iron group but not in the placebo group ( P = 0.01 ) . In the iron group , MVC at the sixth minute of the fatigue protocol and MVC at the end of the protocol were approximately 15 % ( P = 0.04 ) and approximately 27 % higher ( P iron-status indexes or tissue iron stores , although power was low ( muscle fatigability . Interpretation regarding the direct role of tissue iron status is limited by the study 's low power to detect relations between tissue iron improvement and decreased muscle fatigue",
"This is the first study to investigate the efficacy of intravenous iron in treating fatigue in nonanemic patients with low serum ferritin concentration . In a r and omized , double-blinded , placebo-controlled study , 90 premenopausal women presenting with fatigue , serum ferritin ≤ 50 ng/mL , and hemoglobin ≥ 120 g/L were r and omized to receive either 800 mg of intravenous iron (III)-hydroxide sucrose or intravenous placebo . Fatigue and serum iron status were assessed at baseline and after 6 and 12 weeks . Median fatigue at baseline was 4.5 ( on a 0 - 10 scale ) . Fatigue decreased during the initial 6 weeks by 1.1 in the iron group compared with 0.7 in the placebo group ( P = .07 ) . Efficacy of iron was bound to depleted iron stores : In patients with baseline serum ferritin ≤ 15 ng/mL , fatigue decreased by 1.8 in the iron group compared with 0.4 in the placebo group ( P = .005 ) , and 82 % of iron-treated compared with 47 % of placebo-treated patients reported improved fatigue ( P = .03 ) . Drug-associated adverse events were observed in 21 % of iron-treated patients and in 7 % of placebo-treated patients ( P = .05 ) ; none of these events was serious . Intravenous administration of iron improved fatigue in iron-deficient , nonanemic women with a good safety and tolerability profile . The efficacy of intravenous iron was bound to a serum ferritin concentration ≤ 15 ng/mL. This study was registered at the International St and ard R and omized Controlled Trial Number Register ( www.is rct n.org ) as IS RCT N78430425",
"Background Unexplained fatigue is often left untreated or treated with antidepressants . This r and omized , placebo-controlled , single-blinded study evaluated the efficacy and tolerability of single-dose intravenous ferric carboxymaltose ( FCM ) in iron-deficient , premenopausal women with symptomatic , unexplained fatigue . Methods Fatigued women ( Piper Fatigue Scale [ PFS ] score ≥5 ) with iron deficiency ( ferritin and , blinded to the study drug and r and omized ( computer-generated r and omization sequence ) to a single FCM ( 1000 mg iron ) or saline ( placebo ) infusion . Primary endpoint was the proportion of patients with reduced fatigue ( ≥1 point decrease in PFS score from baseline to Day 56 ) . Results The full analysis included 290 women ( FCM 144 , placebo 146 ) . Fatigue was reduced in 65.3 % ( FCM ) and 52.7 % ( placebo ) of patients ( OR 1.68 , 95%CI 1.05–2.70 ; p = 0.03 ) . A 50 % reduction of PFS score was achieved in 33.3 % FCM- vs. 16.4 % placebo-treated patients ( p had hemoglobin levels ≥120 g/L ( vs. 87 % at baseline ) ; with placebo , the proportion decreased from 86 % to 81 % . Mental quality -of-life ( SF-12 ) and the cognitive function scores improved better with FCM . ‘ Power of attention ’ improved better in FCM-treated patients with ferritin µg/L. Treatment-emergent adverse events ( placebo 114 , FCM 209 ; most frequently headache , nasopharyngitis , pyrexia and nausea ) were mainly mild or moderate . Conclusion A single infusion of FCM improved fatigue , mental quality -of-life , cognitive function and erythropoiesis in iron-deficient women with normal or borderline hemoglobin . Although more side effects were reported compared to placebo , FCM can be an effective alternative in patients who can not tolerate or use oral iron , the common treatment of iron deficiency . Overall , the results support the hypothesis that iron deficiency can affect women ’s health , and a normal iron status should be maintained independent of hemoglobin levels . Trial Registration Clinical Trials.gov",
"This study was conducted to examine the relationship between anemia , supplementation with iron and vitamin C , and productivity . Using the cyanmethemoglobin method , 671 female garment factory workers were examined . On the basis of the World Health Organization ( WHO ) st and ard , 98 were found to be mildly or moderately/severely anemic . An equal number was r and omly chosen from the nonanemic workers . The subjects were then r and omly assigned to either the placebo group or the group receiving 525 mg of ferrous sulfate ( 105 mg elemental iron ) and 500 mg ascorbic acid . Only 118 of the 196 subjects completed the three-month study . The mean hemoglobin ( Hb ) and work output , as indicated by efficiency rating ( ER ) , of the placebo group did not change significantly . Mildly anemic workers with supplements showed a significant improvement in mean Hb , but not in mean ER . The moderately/severely anemic group receiving supplements had significant increases in both Hb and ER",
"PURPOSE The purpose of this study was to find out whether iron repletion leads to an increase in red blood cell volume ( RBV ) and performance capacity in iron-deficient nonanemic athletes . METHODS 40 young elite athletes ( 13 - 25 yr ) with low serum ferritin ( 13.5 g.dL-1 , females > 11.7 g.dL-1 ) were r and omly assigned to 12-wk treatment with either twice a day ferrous iron ( equivalent to 2 x 100 mg elemental iron ) or with placebo using a double blind method . Before and after treatment , hematological measures and parameters of iron status were determined in venous blood . RBV , blood volume ( BV ) , and plasma volume ( PV ) were measured by CO rebreathing . For determination of the aerobic and anaerobic capacity ( maximal accumulated oxygen deficit , MAOD ) , the athletes performed an incremental as well as a highly intensive treadmill test . RESULTS After 12 wk , ferritin levels were within the normal range in the iron-treated group ( IG ) with a significant ( P RBV did not change significantly in either group nor did any of the hematological measures . However , only in IG there were significant increases in VO2max and in O2 consumption in the MAOD test . MAOD and maximal capillary lactate concentration remained unchanged in both treatment groups . CONCLUSIONS The results indicate that in young elite athletes with low serum ferritin and normal hemoglobin concentration iron supplementation leads to an increase in maximal aerobic performance capacity without an augmentation of RBV",
"BACKGROUND No treatment is known to permanently increase salivary flow in patients with hyposalivation . The objective of this study was to investigate the effect of iron supplementation on salivary flow rate . METHODS A double-blind , r and omized , placebo-controlled trial was carried out on 50 individuals with a low unstimulated whole salivary flow rate and low serum ferritin . Half the individuals received 60 mg iron orally twice a day for 3 months , while the other half received placebo . RESULTS No statistically significant difference was found between the groups after treatment for the unstimulated flow rate and in the subjective assessment s of oral dryness . The serum ferritin values increased significantly in the iron group but not in the placebo group . CONCLUSION Oral supplementation with iron for 3 months has no effect on salivary flow rate among individuals with hyposalivation and low serum ferritin values",
"Rates of iron deficiency are high amongst healthy young women . Cognitive impairment occurs secondary to iron deficiency in infants and children , but evaluation of the impact on cognition among young women is inconsistent . The aim was to determine the suitability of the IntegNeuro test battery for assessing cognitive function in iron-deficient and iron-sufficient young women . A pilot double-blinded , placebo-controlled intervention trial was conducted in iron-deficient ( serum ferritin ≤ 20 μg/L and haemoglobin > 120 g/L ) and iron-sufficient young women ( 18–35 years ) . Cognitive function and haematological markers of iron status were measured at baseline and follow-up . Iron-deficient participants ( n = 24 ) were r and omised to receive placebo , 60 mg or 80 mg elemental iron daily supplements for 16 weeks . A control group of iron-sufficient participants ( n = 8) was allocated to placebo . Change scores for Impulsivity and Attention were significantly greater in plasma ferritin improvers than in non-improvers ( p = 0.004 , p = 0.026 ) . IntegNeuro was easy to administer and acceptable to young women . Based on the differences in Memory and Attention scores between iron-deficient participants on iron treatment and those on placebo , it was decided that between 26 and 84 participants would be required in each iron treatment group for an adequately powered extension of this pilot RCT",
"Adherence to iron supplementation can be compromised due to side effects , and these limit blinding in studies of iron deficiency . No studies have reported an efficacious iron dose that allows participants to remain blinded . This pilot study aim ed to determine a ferrous sulfate dose that improves iron stores , while minimising side effects and enabling blinding . A double-blinded RCT was conducted in 32 women ( 18–35 years ) : 24 with latent iron deficiency ( serum ferritin were r and omised to 60 mg or 80 mg elemental iron or to placebo , for 16 weeks . The iron sufficient control group took placebo . Treatment groups ( 60 mg n = 7 and 80 mg n = 6 ) had significantly higher ferritin change scores than placebo groups ( iron deficient n = 5 and iron sufficient n = 6 ) , F(1 , 23 ) = 8.46 , p ≤ 0.01 . Of the 24 who completed the trial , 10 participants ( 77 % ) on iron reported side effects , compared with 5 ( 45 % ) on placebo , but there were no differences in side effects ( p = 0.29 ) , or compliance ( p = 0.60 ) between iron groups . Nine ( 69 % ) participants on iron , and 11 ( 56 % ) on placebo correctly guessed their treatment allocation . Both iron doses were equally effective in normalising ferritin levels . Although reported side-effects were similar for both groups , a majority of participants correctly guessed their treatment group",
"Abstract Objective To determine the subjective response to iron therapy in non-anaemic women with unexplained fatigue . Design Double blind r and omised placebo controlled trial . Setting Academic primary care centre and eight general practice s in western Switzerl and . Participants 144 women aged 18 to 55 , assigned to either oral ferrous sulphate ( 80 mg/day of elemental iron daily ; n=75 ) or placebo ( n=69 ) for four weeks . Main outcome measures Level of fatigue , measured by a 10 point visual analogue scale . Results 136 ( 94 % ) women completed the study . Most had a low serum ferritin concentration ; ≤ 20 μg/l in 69 ( 51 % ) women . Mean age , haemoglobin concentration , serum ferritin concentration , level of fatigue , depression , and anxiety were similar in both groups at baseline . Both groups were also similar for compliance and dropout rates . The level of fatigue after one month decreased by −1.82/6.37 points ( 29 % ) in the iron group compared with −0.85/6.46 points ( 13 % ) in the placebo group ( difference 0.95 points , 95 % confidence interval 0.32 to 1.62 ; P=0.004 ) . Subgroups analysis showed that only women with ferritin concentrations ≤ 50 μg/l improved with oral supplementation . Conclusion Non-anaemic women with unexplained fatigue may benefit from iron supplementation . The effect may be restricted to women with low or borderline serum ferritin concentrations",
"The purpose of this investigation was to examine the effects of oral iron supplementation on endurance performance in initially iron-depleted , nonanemic female distance runners . Eighteen iron-depleted ( serum ferritin less than 20 ng.ml-1 , hemoglobin greater than or equal to 12 g.dl-1 ) women ( 22 - 39 yr ) performed a VO2max test and an endurance run to exhaustion . Subjects were pair-matched on the basis of endurance time and then r and omly assigned to an iron supplement or a placebo group . Following supplementation , the iron group had a significantly higher ( P = 0.03 ) mean serum ferritin concentration ( 23.4 vs 15.7 ng.ml-1 ) and lower ( P = 0.04 ) mean total iron-binding capacity than the placebo group . Both groups increased their time to exhaustion ( 25.5 % and 22.2 % for the iron and placebo groups , respectively ) but were not significantly different ( P = 0.72 ) from each other . There were also no differences ( P greater than 0.05 ) between the groups with respect to lactate concentrations and physiological measures taken during the two exercise tests . The results of this study suggest that 8 wk of oral iron supplementation improves iron status in iron-depleted female distance runners , but does not enhance endurance capacity",
"Objective : To determine the effect of iron supplementation on iron status and endurance capacity . Design : R and omized , double-blind iron supplementation . Setting : University of Missouri-Columbia and surrounding community . Subjects : Twenty iron-deficient ( serum ferritin , sFer8.0 mg/l ; or sTfR/log sFer index > 4.5 ) , nonanemic ( hemoglobin , Hb>120 g/l , women ; > 130 g/l , men ) men and women ( 18–41 years ) were recruited via fliers and newspaper advertisements ; 20 of 31 eligible subjects participated . Interventions : A 30 mg measure of elemental iron as ferrous sulfate or placebo daily for 6 weeks . Results : Dietary iron intake and physical activity did not differ between groups before or after supplementation . Iron supplementation significantly increased sFer compared to placebo ( P=0.01 ) , but did not affect Hb or hematocrit . Iron supplementation prevented the decline in ventilatory threshold ( VT ) observed in the placebo group from pre- to post-supplementation ( P=0.01 ) ; this effect was greater in individuals with lower sFer before intervention ( P . Changes in sFer from pre- to post-treatment were positively correlated with changes in VT ( P=0.03 ) , independent of supplementation . The iron group significantly increased gross energetic efficiency during the submaximal test ( P=0.04 ) . Changes in sFer were negatively correlated with changes in average respiratory exchange ratio during the submaximal test ( P Conclusions : Iron supplementation significantly improves iron status and endurance capacity in iron-deficient , nonanemic trained male and female subjects . Sponsorship : Missouri University Alumni Association , by the Elizabeth Hegarty Foundation and by the Department of Nutritional Sciences",
"Background : The true benefit of iron supplementation for nonanemic menstruating women with fatigue is unknown . We studied the effect of oral iron therapy on fatigue and quality of life , as well as on hemoglobin , ferritin and soluble transferrin receptor levels , in nonanemic iron-deficient women with unexplained fatigue . Methods : We performed a multicentre , parallel , r and omized controlled , closed-label , observer-blinded trial . We recruited from the practice s of 44 primary care physicians in France from March to July 2006 . We r and omly assigned 198 women aged 18–53 years who complained of fatigue and who had a ferritin level of less than 50 ug/L and hemoglobin greater than 12.0 g/dL to receive either oral ferrous sulfate ( 80 mg of elemental iron daily ; n = 102 ) or placebo ( n = 96 ) for 12 weeks . The primary outcome was fatigue as measured on the Current and Past Psychological Scale . Biological markers were measured at 6 and 12 weeks . Results : The mean score on the Current and Past Psychological Scale for fatigue decreased by 47.7 % in the iron group and by 28.8 % in the placebo group ( difference –18.9 % , 95 % CI −34.5 to −3.2 ; p = 0.02 ) , but there were no significant effects on quality of life ( p = 0.2 ) , depression ( p = 0.97 ) or anxiety ( p = 0.5 ) . Compared with placebo , iron supplementation increased hemoglobin ( 0.32 g/dL ; p = 0.002 ) and ferritin ( 11.4 μg/L ; p decreased soluble transferrin receptor ( −0.54 mg/L ; p Interpretation : Iron supplementation should be considered for women with unexplained fatigue who have ferritin levels below 50 μg/L. We suggest assessing the efficiency using blood markers after six weeks of treatment . Trial registration no. EudraCT 2006–000478–56",
"To determine the effects of an 8-wk dietary iron supplementation ( 100 mg.d-1 ) on low plasma ferritin concentration ( 20 active women ( 19 - 35 yr ) were studied while performing a VO2max test and an endurance test ( 80 % VO2max ) on a cycle ergometer . Subjects were r and omly placed in an iron supplement ( IG ) or a placebo group ( PG ) using a double-blind method . After treatment in the IG , ferritin levels were higher ( 22.5 + /- 3.4 vs 14.3 + /- 2.2 ng.ml-1 ; P Hb increased ( 12.8 + /- 0.4 to 14.1 + /- 0.2 g.dl-1 ; P TIBC decreased ( 366.2 + /- 24.8 to 293.8 + /- 14.0 micrograms.dl-1 ; P IG 's VO2max was significantly greater ( P postendurance blood lactate decreased ( 5.03 + /- 0.44 to 3.85 + /- 0.6 mM.l-1 ; P Endurance time to exhaustion increased 38 % ( 37.28 + /- 5.03 to 51.4 + /- 7.45 min ) following iron treatment ; however , this change was not statistically significant . The results suggest that this level of iron supplementation can reverse mild anemia , increase VO2max , and reduce blood lactate concentration after submaximal exercise",
"Low serum ferritin concentrations are commonly found in female athletes . By study ing the effects of an 8-week iron or placebo supplementation in 31 female athletes ( aged 17 - 31 years ) , with an initial serum ferritin concentration less than or equal to 25 micrograms/l and blood hemoglobin 120 g/l , we investigated whether low serum ferritin values hinder aerobic performance . Serum ferritin concentration increased from 14 ( 25th and 75th percentile : 11 , 21 ) to 26 ( 18 , 36 ) micrograms/l in the iron-supplemented group , but remained at a low 11 ( 9 , 17 ) micrograms/l in the placebo group ( group difference after supplementation : p = 0.001 ) . Before supplementation , blood hemoglobin concentration was not different in the two groups . After supplementation , however , the concentration in the iron group was 139 ( 135 , 144 ) g/l and 128 ( 126 , 134 ) g/l in the placebo group ( group difference : p = 0.001 ) . Iron supplementation did not affect blood lactate concentration or VO2max during an incremental ergometer test . Hence , aerobic performance was not impaired in nonanemic female athletes with serum ferritin 25 micrograms/l",
"In order to examine the effects of mild iron deficiency on physical work capacity , 40 prelatent iron-deficient female endurance runners were studied before and after 8 wk of supplementation with either oral iron ( 320 mg ferrous sulfate ) or a matching placebo . Subjects underwent the following physical work capacity tests : the Wingate cycle ergometer test , the anaerobic speed test , the ventilatory threshold , VO2max , and maximal treadmill velocity during the VO2max test . Muscle biopsy sample s pre- and post-treatment were obtained from 17 of the subjects , and these were assayed for citrate synthase and cytoplasmic alpha-glycerophosphate dehydrogenase activity . Subjects were r and omly assigned to one of the treatment groups , and a double-blind method of administration of the supplements was used . The differences in improvement scores between the two groups on the work capacity and enzyme activity variables were statistically nonsignificant ( P greater than 0.05 ) . Serum ferritin values rose from a mean of 12.4 + /- 4.5 to 37.7 + /- 19.7 ng.ml-1 for the experimental group and from 12.2 + /- 4.3 to 17.2 + /- 8.9 ng.ml-1 for the controls ( P = 0.0025 ) , whereas hemoglobin levels remained fairly constant for both groups ( P = 0.6 ) . Eight weeks of iron supplementation to prelatent/latent iron-deficient , physically active females did not significantly enhance work capacity . Within the limitations of this study , the presence of a serum ferritin below 20 ng.ml-1 does not pose a significant h and icap to physical work capacity",
"This investigation examined the effect of intramuscular iron injections on aerobic-exercise performance in iron-deficient women . Sixteen athletes performed a 10-min steady-state submaximal economy test , a VO2max test , and a timed test to exhaustion at VO2max workload . Subjects were r and omly assigned to an iron-supplemented group ( IG ) receiving intramuscular iron injections or to a placebo group ( PG ) . Twenty days after the first injection , exercise and blood testing were repeated . A final blood test occurred on Day 28 . Post supplementation , no differences were found between the groups ' submaximal or maximal VO2 , heart rate , or blood lactate ( P > 0.05 ) . Time to exhaustion was increased in the IG ( P 0.05 ) . The IG 's serum ferritin ( SF ) was significantly increased on Days 20 and 28 ( mean + /- st and ard error : 19 + /- 3 to 65 + /- 11 to 57 + /- 12 microg/L ; P SF without enhancing submaximal or maximal aerobic-exercise performance in iron-depleted female athletes"
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IMPORTANCE Surgical site infection ( SSI ) complicates 2 - 5 % of surgeries in the United States . Severity of SSI ranges from superficial skin infection to life-threatening conditions such as severe sepsis , and SSIs are responsible for increased morbidity , mortality , and economic burden associated with surgery . Staphylococcus aureus ( S. aureus ) is a commonly-isolated organism for SSI , and methicillin-resistant S. aureus SSI incidence is increasing globally . OBJECTIVE The objective of this systematic review was to characterize risk factors for SSI within observational studies describing incidence of SSI in a real-world setting . EVIDENCE REVIEW An initial search identified 328 titles published in 2002 - 2012 ; 57 were identified as relevant for data extraction . Extracted information included study design and methodology , reported cumulative incidence and post-surgical time until onset of SSI , and odds ratios and associated variability for all factors considered in univariate and /or multivariable analyses . FINDINGS Median SSI incidence was 3.7 % , ranging from 0.1 % to 50.4 % . Incidence of overall SSI and S. aureus SSI were both highest in tumor-related and transplant surgeries . Median time until SSI onset was 17.0 days , with longer time-to-onset for orthopedic and transplant surgeries . Risk factors consistently identified as associated with SSI included co-morbidities , advanced age , risk indices , patient frailty , and surgery complexity . Thirteen studies considered diabetes as a risk factor in multivariable analysis ; 85 % found a significant association with SSI , with odds ratios ranging from 1.5 - 24.3 . Longer surgeries were associated with increased SSI risk , with a median odds ratio of 2.3 across 11 studies reporting significant results . CONCLUSIONS AND RELEVANCE In a broad review of published literature , risk factors for SSI were characterized as describing reduced fitness , patient frailty , surgery duration , and complexity . Recognition of risk factors frequently associated with SSI allows for identification of such patients with the greatest need for optimal preventive measures to be identified and pre-treatment prior to surgery
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"Background . Although risk factors for surgical site infection ( SSI ) after cardiovascular ( CV ) surgery have been well-documented among adults , few studies have been conducted in children . We performed a case-control study to identify risk factors for hospitalized SSI in children undergoing CV surgery . Methods . National Nosocomial Infections Surveillance System criteria were used prospect ively to identify cases of hospitalized SSI in patients who underwent CV surgery . Seventy-nine patients who underwent CV surgery without hospitalized SSI were r and omly selected as controls . Cases were compared with controls to determine preoperative , intraoperative and postoperative risk factors for hospitalized SSI . Multivariable logistic regression was performed . Results . An SSI developed in 19 of the 826 patients who underwent CV surgery ( 2.3 cases per 100 surgeries ) during the study period . Infection was limited to soft tissue in 12 , whereas deeper infection occurred in 7 . Causative agents included Staphylococcus aureus ( 11 ) , coagulase-negative Staphylococcus ( 5 ) and Escherichia coli ( 2 ) . One patient did not have a pathogen isolated . In a multivariable analysis , duration of surgery ( odds ratio , 1.4 ; 95 % confidence interval , 1.2 to 1.8 ) and age SSI . Conclusions . Age hospitalized SSI after CV surgery in children",
"A prospect i ve open-cohort study was performed in 838 adults undergoing coronary revascularization or valve surgery to define the risk factors for development of surgical site infections . Patients diagnosed with mediastinitis or endocarditis during follow-up were compared with patients with no such infection . After 1 year of follow-up , 22 ( 2.6 % ) patients had developed mediastinitis or endocarditis . No preoperative or intraoperative variables were identified as risk factors . By multivariate analysis of postoperative variables , respiratory insufficiency , microorganisms in blood cultures , and intensive care unit stay were independent risk factors for the development of these complications . The type of antibiotic prophylaxis had no influence on the incidence of organ or space infections after cardiac surgery",
"OBJECTIVES To identify risk factors for surgical site infection ( SSI ) in older people and to test a priori hypotheses regarding particular variables and SSI risk . DESIGN Case-control study . SETTING Duke University Medical Center and seven community hospitals in North Carolina and Virginia . PARTICIPANTS Elderly patients ( > or = 65 ) who underwent surgery between 1991 and 2002 at the study hospitals . Cases were elderly patients with SSI ; controls were elderly operative patients without SSI . Infection control practitioners prospect ively identified patients . MEASUREMENTS Data were collected retrospectively . Case patients who developed SSI were compared with control patients who did not develop SSI . RESULTS Five hundred sixty-nine SSI cases were identified , and 589 uninfected controls were selected . In multivariate analysis , independent predictors of SSI included obesity ( odds ratio (OR)=1.77 , 95 % confidence interval (CI)=1.34 - 2.32 ) , chronic obstructive pulmonary disease ( COPD ) ( OR=1.66 , 95 % CI=1.17 - 2.34 ) , and a wound class classified as contaminated or dirty ( OR=1.65 , 95 % CI=1.01 - 2.72 ) . Having private insurance was associated with lower risk ( OR=0.29 , 95 % CI=0.12 - 0.68 ) . CONCLUSION This study identified several independent predictors of SSI in older people , including comorbid conditions ( COPD and obesity ) , perioperative variables ( wound class ) , and socioeconomic factors ( private insurance , which was associated with lower risk ) . The results from this study can be used to design and implement interventions for SSI prevention in high-risk older people",
"Purpose To investigate the incidence and risk factors associated with the development of surgical site infections ( SSIs ) using the National Nosocomial Infection Surveillance ( NNIS ) . Methods A prospect i ve cohort study was conducted at a tertiary health care center . Infection control personnel collected general and health care related data about patients . The NNIS risk index was calculated on the basis of data relating to the operation : wound contamination class , duration of surgery , and the American Society of Anesthesiologists ( ASA ) score . Results A total of 5109 surgical procedures were included in the study . The overall cumulative incidence rate was 6.3 % . The incidence of SSIs was 2.3 % ( 63.5 % of operative procedures ) , 8.3 % ( 29.7 % ) , 34.6 % ( 6.2 % ) , and 43.3 % ( 0.6 % ) , in patients with 0 , 1 , 2 , and 3 risk index , respectively . The length of hospital stay ( OR : 1.0 ; 95 % CI : 1.053–1.075 ) , preoperative length of stay ( odds ratio [ OR ] : 1.9 ; 95 % confidence interval [ CI ] : 1.953–1.981 ) , antibiotic prophylaxis ( OR : 2.5 ; 95 % CI : 1.421–4.628 ) , drainage ( OR : 1.7 ; 95 % CI : 1.360–2.353 ) , ASA score ( OR : 1.5 ; 95 % CI : 1.235–1.946 ) , class of wound contamination ( OR : 2.0 ; 95 % CI : 1.745–2.003 ) , and NNIS risk index ( OR : 1.3 ; 95 % CI : 1.063–1.7 ) were independently associated with an increased risk for SSIs . Staphylococcus aureus was the most frequently isolated microorganism , 64 % of them being methicillin-resistant . Conclusion The aim of this study was to investigate the most important risk factors associated with the development of surgical site infections ( SSIs ) . Therefore , greater attention has been given to adherence to recommendations for the prevention and control of SSIs as well as to antibiotic prophylaxis protocol",
"OBJECTIVE To identify risk factors associated with surgical-site infection according to the depth of infection , the cardiac procedure , and the National Nosocomial Infections Surveillance System risk index . DESIGN Prospect i ve survey conducted during a 12-month period . SETTING A 48-bed cardiac surgical department in a teaching hospital . PATIENTS Patients admitted for cardiac surgery between February 2002 and January 2003 . RESULTS Surgical-site infections were diagnosed in 3 % of the patients ( 38 of 1,268 ) . Of the 38 surgical-site infections , 20 were superficial incisional infections and 18 were mediastinitis for incidence rates of 1.6 % and 1.4 % , respectively . Cultures were positive in 28 cases and the most commonly isolated pathogen was Staphylococcus . A National Nosocomial Infections Surveillance System risk index score of 2 or greater was associated with a risk of surgical-site infection ( relative risk , 2.4 ; P Heart transplantation , mechanical circulatory assistance , coronary artery bypass graft with the use of internal mammary artery , and reoperation for cardiac tamponade or pericard effusion were independent risk factors associated with surgical-site infection . CONCLUSIONS Data surveillance using incidence rates stratified by cardiac procedure and type of infection is relevant to improving infection control efforts . Risk factors in patients who developed superficial infection were different from those in patients who developed mediastinitis . Coronary artery bypass graft using internal mammary artery was associated with a high risk of surgical-site infection , and independent factors such as reoperation for cardiac tamponade or pericard effusion increased the risk of infection",
"OBJECT The purpose of this study was to determine the incidence rate and risk factors of surgical site infections ( SSIs ) in neurosurgery for any type of surgery and any American Society of Anesthesiologists class . METHODS The authors undertook an exhaustive 18-month prospect i ve survey including patients who underwent neurosurgery . In particular , a 30-day follow-up was completed in patients whose surgery did not involve placement of a prosthesis or implant , and 1-year follow-up was completed for patients who underwent surgery to place a prosthesis or implant . The Centers for Disease Control definition of SSI was used . Univariate and multivariate analyses were conducted ; all dependent variables found in univariate analysis were entered in the multiple regression model . A stepwise multiple logistic regression method was used . RESULTS Of the 844 patients studied , 35 SSIs were diagnosed , yielding an incidence rate of 4.1 % ( 95 % confidence interval 3.6 - 4.5 ) . Independent predictive risk factors for infection were cerebrospinal fluid leakage , external shunt , Altemeier class , and further neurosurgery . A lack of antibiotic prophylaxis was not found to be a risk factor . CONCLUSIONS Infection risk factors occur mainly during the postoperative period",
"Background Although nasal carriage of MRSA has been identified as one of the risk factors for surgical site infection ( SSI ) with MRSA , there have been no reports of this in the orthopedics field . Methods This prospect i ve observational cohort study included 2,423 consecutive patients who were admitted to our department over 26 months and who underwent orthopedic surgery . We examined the relationship between pre-existing nasal MRSA and subsequent occurrence of SSI with MRSA . Results 63 patients ( 2.6 % ) had a positive nasal MRSA culture . 15 patients ( 0.6 % ) developed SSI with MRSA . The occurrence of SSI with MRSA in nasal MRSA carriers was significantly higher than that in non-carriers ( 4 out of 63 ( 6.3 % ) vs. 11 out of 2,360 ( 0.5 % ) ; p < 0.001 ) ( adjusted OR : 11 ; 95 % CI : 3–37 ; p = 0.001 ) . Interpretation We recommend appropriate treatment of patients who are nasal carriers of MRSA before orthopedic surgery",
"Background Surgical site infection ( SSI ) continues to be a major source of morbidity and mortality in developing countries despite recent advances in aseptic techniques . There is no baseline information regarding SSI in our setting therefore it was necessary to conduct this study to establish the prevalence , pattern and predictors of surgical site infection at Bug and o Medical Centre Mwanza ( BMC ) , Tanzania . Methods This was a cross-sectional prospect i ve study involving all patients who underwent major surgery in surgical wards between July 2009 and March 2010 . After informed written consent for the study and HIV testing , all patients who met inclusion criteria were consecutively enrolled into the study . Pre-operative , intra-operative and post operative data were collected using st and ardized data collection form . Wound specimens were collected and processed as per st and ard operative procedures ; and susceptibility testing was done using disc diffusion technique . Data were analyzed using SPSS software version 15 and STATA . Results Surgical site infection ( SSI ) was detected in 65 ( 26.0 % ) patients , of whom 56 ( 86.2 % ) and 9 ( 13.8 % ) had superficial and deep SSI respectively . Among 65 patients with clinical SSI , 56(86.2 % ) had positive aerobic culture . Staphylococcus aureus was the predominant organism 16/56 ( 28.6 % ) ; of which 3/16 ( 18.8 % ) were MRSA . This was followed by Escherichia coli 14/56 ( 25 % ) and Klebsiella pneumoniae 10/56 ( 17.9 % ) . Among the Escherichia coli and Klebsiella pneumoniae isolates 9(64.3 % ) and 8(80 % ) were ESBL producers respectively . A total of 37/250 ( 14.8 % ) patients were HIV positive with a mean CD4 count of 296 cells/ml . Using multivariate logistic regression analysis , presence of pre-morbid illness ( OR = 6.1 ) , use of drain ( OR = 15.3 ) , use of iodine alone in skin preparation ( OR = 17.6 ) , duration of operation ≥ 3 hours ( OR = 3.2 ) and cigarette smoking ( OR = 9.6 ) significantly predicted surgical site infection ( SSI ) ConclusionS SI is common among patients admitted in surgical wards at BMC and pre-morbid illness , use of drain , iodine alone in skin preparation , prolonged duration of the operation and cigarette smoking were found to predict SSI . Prevention strategies focusing on factors associated with SSI is necessary in order to reduce the rate of SSI in our setting",
"Background Sternal wound infection ( SWI ) is an uncommon but potentially life-threatening complication of cardiac surgery . Predisposing factors for SWI are multiple with varied frequencies in different studies . The purpose of this study was to assess the incidence , risk factors , and mortality of SWI after coronary artery bypass grafting ( CABG ) at Tehran Heart Center . Methods This study prospect ively evaluated multiple risk factors for SWI in 9201 patients who underwent CABG at Tehran Heart Center between January 2002 and February 2006 . Cases of SWI were confirmed based on the criteria of the Centers for Disease Control and Prevention . Deep SWI ( bone and mediastinitis ) was categorized according to the Oakley classification . Results In the study period , 9201 CABGs were performed with a total SWI rate of 0.47 percent ( 44 cases ) and deep SWI of 0.22 percent ( 21 cases ) . Perioperative ( in-hospital ) mortality was 9.1 % for total SWI and about 14 % for deep SWI versus 1.1 % for non-SWI CABG patients . Female gender , preoperative hypertension , high functional class , diabetes mellitus , obesity , prolonged intubation time ( more than 48 h ) , and re-exploration for bleeding were significant risk factors for developing SWI ( p = 0.05 ) in univariate analysis . In multivariate analysis , hypertension ( OR = 10.7 ) , re-exploration ( OR = 13.4 ) , and female gender ( OR = 2.7 ) were identified as significant predictors of SWI ( p rate of SWI was relatively similar in 3 groups of prophylactic antibiotic regimen ( Cefazolin , Cefazolin + Gentamycin and Cefazolin + Amikacin : 0.5 % , 0.5 % , and 0.34 % respectively ) . Conclusion Rarely reported previously , the two risk factors of hypertension and the female gender were significant risk factors in our study . Conversely , some other risk factors such as cigarette smoking and age mentioned as significant in other reports were not significant in our study . Further studies are needed for better documentation",
"Studies of patient safety and comparative effectiveness entail unique method ologic challenges . These studies may be susceptible to systematic error , including selection bias , exposure misclassification , and outcome misclassification . They may also be vulnerable to r and om error , or confounding by a variable such as another drug , a disease , or the drug indication itself . Finally , special logistical issues can arise , including data access problems , difficulties in conveying the need for studies of certain interventions , and obstacles to gaining institutional review board approval . This article provides a conceptual overview of these method ologic issues",
"AIM Infection following coronary artery bypass grafting ( CABG ) is a leading cause of morbidity , mortality , and increased length of hospital stay . Many studies have investigated the predictive value of known risk factors for infection in patients following CABG and conclusions have been variable and may reveal regional or institution-specific influence . The purpose of this prospect i ve study was to determine the pre- and peri-operative risk factors for infection in patients undergoing coronary artery bypass surgery in a developing country . METHODS A prospect i ve study was undertaken to collect data on 12 reported risk factors for all patients undergoing CABG during a five-year period at The Aga Khan University Hospital , Pakistan . The relationship of these risk factors to infection following CABG was evaluated . RESULTS Out of 767 consecutive patients admitted for CABG , a total of 73 ( 9.51 % ) developed 92 infections following surgery . Sternal Surgical Site Infection ( SSI ) developed in 30 patients ( 3.91 % ) , of which 29 ( 96.7 % ) were superficial and 1 ( 3.33 % ) was deep . There were 37 leg wound infections at the site of conduit harvest , and 2 cases of infection at the intra-aortic balloon pump . There were 12 cases of sepsis and 11 urinary tract infections . There were 26 cases ( 35.6 % ) of leukocytosis and 17 patients ( 23.3 % ) showed elevated erythrocyte sedimentation rate ( ESR ) . Staphylococcus aureus was the most frequently isolated pathogen ( 39.7 % ) . Bacteremia data was not collected . Of the total cases of infection following CABG , 59 required prolonged hospitalization or readmission . Univariate analysis was performed using a p-value of mechanical ventilation ( P= patients undergoing CABG . Early and strict diabetic control and pre-operative weight reduction may reduce the incidence of infection following CABG . Contamination of these patients may occur before , during and after the operation and efforts to curb such contamination must be intensive . Further prospect i ve studies need to be undertaken to identify and establish these and other risk factors for infection in the region and elsewhere",
"BACKGROUND This prospect i ve study aim ed to determine the spectrum and the main risk factors of surgical site infection ( SSI ) after neurosurgical procedures in our clinic . METHODS Consecutive patients undergoing neurosurgery between November 1 , 2001 , and November 1 , 2002 , were recruited for the study . All patients were followed for a minimum of 2 weeks postoperatively and all SSIs were recorded . The complete medical records of each case were review ed , and data on 14 possible risk factors were extracted . Statistical analyses were performed to identify the risk factors for SSIs . RESULTS A total of 31 postoperative SSIs were identified among 503 cases included in the study , with a result ing overall infection rate of 6.2 % . The risk of SSI was increased by age ( odds ratio [ OR ] , 1.1 ; 95 % confidence interval [ CI ] , 1.0 - 1.1 ; P = .039 ) , operation type such as \" shunt operations \" ( OR , 670.4 ; 95 % CI , 2.6 - 171123.1 ; P = .021 ) , presence of foreign body ( OR , 141.0 ; 95 % CI , 2.5 - 7925.9 ; P = .016 ) , presence of diabetes mellitus ( OR , 24.3 ; 95 % CI , 2.1 - 284.9 ; P = .011 ) , and intracranial pressure monitoring ( OR , 4878.9 ; 95 % CI , 23.8 - 1001229 ; P = .002 ) . The predominantly isolated microorganisms in patients with SSIs were Staphylococcus aureus ( 22 [ 71.0 % ] ) , Acinetobacter baumanii ( 5 [ 16.1 % ] ) , and Staphylococcus epidermidis ( 4 [ 12.9 % ] ) . CONCLUSIONS SSIs remain an important problem in neurosurgery . Identification of the risk factors for SSI will help physicians to improve patient care and may decrease mortality , morbidity , and health care costs of neurosurgery patients",
"BACKGROUND No previous multicenter data regarding the incidence of surgical site infection ( SSI ) are available in Thail and . The magnitude of the problem result ing from SSI at the national level could not be assessed . The purpose of this study was to estimate the incidence of SSI in 9 hospitals , together with patterns of surgical antibiotic prophylaxis , risk factors for SSI , and common causative pathogens . METHODS A prospect i ve data collection among patients undergoing surgery in 9 hospitals in Thail and was conducted . The National Nosocomial Infection Surveillance ( NNIS ) system criteria and method were used for identifying and diagnosing SSI . The SSI rates were benchmarked with the NNIS report by means of indirect st and ardization and reported in terms of st and ardized infection ratio ( SIR ) . Antibiotic prophylaxis was categorized into preoperative , intraoperative , and postoperative . Risk factors for SSI were evaluated using multiple logistic regression models . RESULTS From July 1 , 2003 , to February 29 , 2004 , the study included 8764 patients with 8854 major operations and identified 127 SSIs , yielding an SSI rate of 1.4 infections/100 operations and a corresponding SIR of 0.6 ( 95 % CI : 0.5 - 0.8 ) . Of these , 35 SSIs ( 27.6 % ) were detected postdischarge . The 3 most common operative procedures were cesarean section , appendectomy , and hysterectomy . The 3 most common pathogens isolated were Escherichia coli , Staphylococcus aureus , and Pseudomonas aeruginosa , which accounted for 15.3 % , 8.5 % , and 6.8 % of infections , respectively . The 3 most common antibiotics used for prophylaxis were ampicillin/amoxicillin , cefazolin , and gentamicin . The proportion of types of antibiotic prophylaxis administered were 51.6 % preoperative , 24.3 % intraoperative , and 24.1 % postoperative . Factors significantly associated with SSI were high degree of wound contamination , prolonged preoperative hospital stay , emergency operation , and prolonged duration of operation . CONCLUSION Overall SSI rates were less than the average NNIS rates . The causative pathogens of SSI were different from those of other reports . There was a crucial proportion of operations that did not comply with the antibiotic guidelines . The risk factors for SSI identified in this study were consistent with most other reports",
"INTRODUCTION Data regarding the epidemiology , treatment , and outcomes of methicillin-resistant Staphylococcus aureus ( MRSA ) infections in rural and community hospitals are limited . METHODS This cohort study was conducted at 1 tertiary care hospital and 8 community hospitals in the southeastern United States . Patients with a surgical site infection ( SSI ) and /or bacteremia due to MRSA were prospect ively identified at each study hospital during the period 1994 - 2003 . RESULTS A total of 129 patients with SSI and 564 patients with bacteremia due to MRSA were identified . Only 57 patients with SSI ( 44.2 % ) received antibiotics active against MRSA on the initial date of diagnosis ; only 95 ( 73.6 % ) received an agent active against MRSA by day 7 after diagnosis of SSI due to MRSA . Ninety-five patients with SSI due to MRSA ( 73.6 % ) were readmitted to the hospital within 90 days after their original surgery . The 1-year mortality rate among patients with SSI due to MRSA was 22 % . Inadequate therapy was also commonly given to patients with bacteremia : only 216 ( 38.3 % ) received antibiotics active against MRSA on the initial day of infection , and only 383 ( 67.9 % ) received an agent active against MRSA by day 7 after diagnosis . Approximately one-third of patients with bloodstream infection died during their initial hospitalization . Patients hospitalized in community hospitals were less likely to receive effective antimicrobial therapy on both the day of infection and within 7 days after infection , compared with patients in the tertiary care hospital . CONCLUSION Inadequate therapy is commonly administered after diagnosis of SSI and bacteremia due to MRSA in patients in community hospitals",
"OBJECTIVE To identify risk factors for surgical site infection ( SSI ) due to methicillin-resistant Staphylococcus aureus ( MRSA ) . DESIGN Prospect i ve case-control study . SETTING One tertiary and 6 community-based institutions in the southeastern United States . METHODS We compared patients with SSI due to MRSA with 2 control groups : matched uninfected surgical patients and patients with SSI due to methicillin-susceptible S. aureus ( MSSA ) . Multivariable logistic regression was used to determine variables independently associated with SSI due to MRSA , compared with each control group . RESULTS During the 5-year study period , 150 case patients with SSI due to MRSA were identified and compared with 231 matched uninfected control patients and 128 control patients with SSI due to MSSA . Two variables were independently associated with SSI due to MRSA in both multivariable regression models : need for assistance with 3 or more activities of daily living ( odds ratio [ OR ] compared with uninfected patients , 3.97 [ 95 % confidence interval { CI } , 2.18 - 7.25 ] ; OR compared with patients with SSI due to MSSA , 3.88 [ 95 % CI , 1.91 - 7.87 ] ) and prolonged duration of surgery ( OR compared with uninfected patients , 1.98 [ 95 % CI , 1.11 - 3.55 ] ; OR compared with patients with SSI due to MSSA , 2.33 [ 95 % CI , 1.17 - 4.62 ] ) . Lack of independence ( ie , poor functional status ) remained associated with an increased risk of SSI due to MRSA after stratifying by age . CONCLUSIONS Poor functional status was highly associated with SSI due to MRSA in adult surgical patients , regardless of age . A patient 's level of independence can be easily determined , and this information can be used preoperatively to target preventive interventions",
"BACKGROUND There is a dearth of data on surgical site infections ( SSIs ) complicating internal fixation of fractures from Nigeria . AIMS To determine the incidence and risk factors for SSIs following internal fixation of fracture . METHODS A cohort of 90 patients with long bone fractures that were stabilized internally with metallic devices was studied prospect ively and retrospectively . RESULTS The incidence of SSI was 12 % . The isolated organisms were Staphylococcus aureus in four patients , Pseudomonas spp . in three , and Escherichia coli in one patient . Diabetes mellitus and perioperative transfusion with allogeneic blood were not predictive of SSI . Duration of operation longer than 120 minutes was a strong predictor ( OR 2.25 , 95 % CL 0.48 - 10.16 ) . Other risk factors were male sex ( OR 2.01 , 95 % CL 0.44 - 10.45 ) , injury-operation interval less than six months ( OR 2.00 , 95 % CL 0.22 - 46.08 ) , fracture fixation with plates and screws ( OR 1.51 , 95 % CL 0.36 - 6.40 ) , white blood cell count ( WBC ) less than 5,000 per cumm ( OR 1.50 , 95 % CL 0.15 - 16.37 ) , preoperative urinary catheterization ( OR 1.48 , 95 % CL 0.00 - 16.19 ) , and postoperative urinary catheterization ( OR 1.24 , 95 % CL 0.29 - 5.00 ) . CONCLUSION The incidence of SSI after internal fixation of long bone fractures in our centers is 12 % , and this is within the previously reported range . Use of plates and screws , WBC less than 5,000 per cumm , and perioperative urinary catheterization are important risk factors",
"BACKGROUND Surgical site infections ( SSIs ) are complications of surgery that cause significant postoperative morbidity . SSI has been proposed as a potential indicator of the quality of care in the context of clinical governance and monitoring of the performance of NHS organisations against targets . OBJECTIVES We aim ed to address a number of objectives . Firstly , identify risk factors for SSI , criteria for stratifying surgical procedures and evidence about the importance of postdischarge surveillance ( PDS ) . Secondly , test the importance of risk factors for SSI in surveillance data bases and investigate interactions between risk factors . Thirdly , investigate and vali date different definitions of SSI . Lastly , develop models for making risk-adjusted comparisons between hospitals . DATA SOURCES A single hospital surveillance data base was used to address objectives 2 and 3 and the UK Surgical Site Infection Surveillance Service data base to address objective 4 . STUDY DESIGN There were four elements to the research : ( 1 ) systematic review s of risk factors for SSI ( two review ers assessed titles and abstract s of studies identified by the search strategy and the quality of studies was assessed using the Newcastle Ottawa Scale ) ; ( 2 ) assessment of agreement between four SSI definitions ; ( 3 ) validation of definitions of SSI , quantifying their ability to predict clinical outcomes ; and ( 4 ) development of operation-specific risk models for SSI , with hospitals fitted as r and om effects . RESULTS Review s of SSI risk factors other than established SSI risk indices identified other risk ; some were operation specific , but others applied to multiple operations . The factor most commonly identified was duration of preoperative hospital stay . The review of PDS for SSI confirmed the need for PDS if SSIs are to be compared meaningfully over time within an institution . There was wide variation in SSI rate ( SSI% ) using different definitions . Over twice as many wounds were classified as infected by one definition only as were classified as infected by both . Different SSI definitions also classified different wounds as being infected . The two most established SSI definitions had broadly similar ability to predict the chosen clinical outcomes . This finding is paradoxical given the poor agreement between definitions . Elements of each definition not common to both may be important in predicting clinical outcomes or outcomes may depend on only a subset of elements which are common to both . Risk factors fitted in multivariable models and their effects , including age and gender , varied by surgical procedure . Operative duration was an important risk factor for all operations , except for hip replacement . Wound class was included least often because some wound classes were not applicable to all operations or were combined because of small numbers . The American Association of Anesthesiologists class was a consistent risk factor for most operations . CONCLUSIONS The research literature does not allow surgery-specific or generic risk factors to be defined . SSI definitions varied between surveillance programmes and potentially between hospitals . Different definitions do not have good agreement , but the definitions have similar ability to predict outcomes influenced by SSI . Associations between components of the National Nosocomial Infections Surveillance risk index and odds of SSI varied for different surgical procedures . There was no evidence for effect modification by hospital . Estimates of SSI% should be disseminated within institutions to inform infection control . Estimates of SSI% across institutions or countries should be interpreted cautiously and should not be assumed to reflect quality of medical care . Future research should focus on developing an SSI definition that has satisfactory psychometric properties , that can be applied in everyday clinical setting s , includes PDS and is formulated to detect SSIs that are important to patients or health services . FUNDING The National Institute for Health Research Technology Assessment programme",
"Study Design . We conducted a retrospective , case control study on patients undergoing surgery for spinal tumors . Objective . Our aim was to determine the incidence and to identify risk factors for surgical site infections ( SSIs ) in patients undergoing surgery for spinal tumors . Summary of Background Data . SSIs after spinal tumor surgery may be particularly devastating as they may add to substantial surgical morbidity and may further exacerbate already existing neurologic deficits . Incidence and risk factors predisposing to SSIs in patients undergoing surgery for spinal tumors are not well studied yet . Methods . Between January 1995 and February 2008 , 971 procedures for spinal tumors were performed on 739 patients . Excluding sacral tumors from the current study , 895 procedures on 678 patients were review ed to identify those cases with SSIs . Furthermore , 65 infected cases and a r and omly selected subset of 162 controls were analyzed by logistic regression modeling to identify the risk factors associated with SSIs . Results . There were 678 patients that were included in this study with 364 men ( 54 % ) and 314 women ( 46 % ) , with an average age of 47.2 year . Sixty-five patients who developed SSIs underwent a total of 162 procedures including 78 procedures for wound debridement and washout . The incidence of SSIs was 8.89 % for primary nonbony spinal tumors , 9.5 % for metastatic spinal tumors , and 13.7 % for primary bony spinal tumors . Staphylococcus aureus was the most commonly isolated organism ( n = 22 of 65 , 33 % ) . In the multivariate logistic regression model , previous spinal surgeries , complex plastic closures , increasing number of comorbidities , presence of a hospital acquired infection at the time of a previous surgery , and increasing duration of hospital stay during primary surgery were significantly associated with increased likelihood of developing postoperative SSIs . Conclusion . Surgery for spine tumors appears to be associated with a higher incidence of SSI than nontumor spine surgery . Identification of perioperative risk factors will help delineate this subset of patients with high risk for developing SSIs thus potentially allowing perioperative modification for such factors , which may lead to an overall better clinical outcome and patient satisfaction",
"The question of “ when to r and omize ? ” is arguably too complicated to answer , if it can even be answered definitively , in the text of a several-thous and -word article . From a broad perspective , r and omized studies are relevant to activities and decision making in scientific as well as policy setting s , while also encompassing a wide range of intersecting and overlapping topics . Representative situations include how an individual investigator decides that a r and omized trial is warranted to study a particular research question ; when the Patient-Centered Outcomes Research Institute should commission r and omized or non-r and omized research ; and whether the Food and Drug Administration always needs evidence from r and omized trials to approve new drugs . After a brief discussion of scientific terms , evidence based medicine ( EBM ) , and costs and ethical considerations , the remainder of this article will present an overarching framework to help clarify what r and omization accomplishes and what it does not — from a method ological perspective . Specifically , an argument is presented , with representative examples , focusing on comparative effectiveness research ( CER ) and promoting what can be called medicine-based evidence ( MBE ) . This report is conceptual rather than technical , commenting on general issues rather than details , although work on such details is important and available ( e.g. , see other publications from symposia1 sponsored by the Agency for Healthcare Research and Quality ) . Also of note , comments regarding particular articles are not intended to be ad hominem toward the authors , but they are rather part of a scientific discussion to advance underst and ing",
"In the Dutch surveillance for surgical site infections ( SSIs ) , data from 70277 orthopaedic procedures with 1895 SSIs were collected between 1996 and 2003 . The aims of this study were : ( 1 ) to analyse the trends in SSIs associated with Gram-positive and Gram-negative bacteria ; ( 2 ) to estimate patient-related risk factors for deep and superficial SSIs after all orthopaedic procedures , with special attention to primary total hip arthroplasty ( THA ) ; and ( 3 ) to analyse inherent differences in infection risk between hospitals . A r and om effect model was used to estimate the odds ratios of patient-related risk factors for developing an SSI , and to describe the distribution of the most widespread bacterial species responsible for SSIs among hospitals . Gram-positive organisms , mainly staphylococci , were the main cause of both deep ( 84.0 % ) and superficial SSIs ( 69.1 % ) after orthopaedic procedures . The percentage of SSIs after THA caused by coagulase-negative staphylococci decreased over the surveillance period , while the contribution of Staphylococcus aureus increased . Temporary elevations in the incidence of the most widespread pathogen species were observed within hospitals . Patient-related factors such as the National Nosocomial Infections Surveillance System risk index or age had little effect on the predictive power of the r and om effect models . This study underlines the usefulness of a r and om effect model , which adjusts risk estimates for r and om variation between hospitals , in a multicentre study on risk factors for SSIs",
"We prospect ively evaluated 46 possible risk factors for methicillin-resistant Staphylococcus aureus ( MRSA ) surgical site infection ( SSI ) among patients with MRSA carriage in a large intervention study . Of 6,130 study patients , 68 ( 1.1 % ) developed MRSA SSI , which occurred a median of 14 days after surgery . Risk factors associated with MRSA SSI were receipt of emergency surgery , presence of comorbid condition , receipt of immunosuppressive therapy , receipt of contaminated surgery , and a surgical duration longer than the 75th percentile . MRSA carriage on admission did not predict MRSA SSI",
"BACKGROUND Surveillance of surgical site infection ( SSI ) is one of the most effective methods for decreasing the incidence . We determined the risk factors for SSI and the effect of a one-year surveillance program on the rate at a tertiary-care center . METHODS The annual SSI rate before the study period was determined in a preliminary study . Risk factors related to SSI , the bacteria cultured from infected sites , and the effect of surveillance were then analyzed prospect ively . Risk factors were determined by logistic regression analysis , and 95 % confidence intervals were calculated . RESULTS The incidence of SSI decreased from 12.8 % before the study to 8.8 % at the end of the surveillance period . There were 90 SSIs ( 8.8 % ) in 1,017 procedures during the study period , most of which ( 77 ; 69 % ) were detected during the hospital stay . The distribution of superficial incisional , deep incisional , and organ/space SSI was 61.1 % , 33.4 % , and 5.5 % , respectively . Prolonged preoperative hospital stay ( > 8 days ) , abdominal incision , early preoperative hair removal , inappropriate antimicrobial prophylaxis , whole blood transfusion , famotidine treatment , repair with mesh , age > 75 years , wound contamination , high American Society of Anesthesiologists score , malnutrition , diabetes mellitus , emergency surgery , obesity , and coexistent infection proved to be independent risk factors for SSI , whereas the skin closure technique , patient sex , presence of malignancy , smoking history , and duration of operation were not . Staphylococcus aureus and Escherichia coli were the bacteria isolated most frequently . Six infected patients ( 5.4 % ) died , four because of SSI . Development of SSI increased hospital expenses by around 600 US dollars per patient . CONCLUSION Surveillance even for one year decreases the incidence of SSI",
"OBJECTIVE To evaluate the risk factors for surgical site infection ( SSI ) after gastric surgery in patients in Korea . DESIGN A nationwide prospect i ve multicenter study . SETTING Twenty university-affiliated hospitals in Korea . METHODS The Korean Nosocomial Infections Surveillance System ( KONIS ) , a Web-based system , was developed . Patients in 20 Korean hospitals from 2007 to 2009 were prospect ively monitored for SSI for up to 30 days after gastric surgery . Demographic data , hospital characteristics , and potential perioperative risk factors were collected and analyzed , using multivariate logistic regression models . RESULTS Of the 4,238 case patients monitored , 64.9 % ( 2,752 ) were male , and mean age ( ± SD ) was 58.8 ( ± 12.3 ) years . The SSI rates were 2.92 , 6.45 , and 10.87 per 100 operations for the National Nosocomial Infections Surveillance system risk index categories of 0 , 1 , and 2 or 3 , respectively . The majority ( 69.4 % ) of the SSIs observed were organ or space SSIs . The most frequently isolated microorganisms were Staphylococcus aureus and Klebsiella pneumoniae . Male sex ( odds ratio [ OR ] , 1.67 [ 95 % confidence interval ( CI ) , 1.09 - 2.58 ] ) , increased operation time ( 1.20 [ 1.07 - 1.34 ] per 1-hour increase ) , reoperation ( 7.27 [ 3.68 - 14.38 ] ) , combined multiple procedures ( 1.79 [ 1.13 - 2.83 ] ) , prophylactic administration of the first antibiotic dose after skin incision ( 3.00 [ 1.09 - 8.23 ] ) , and prolonged duration ( ≥7 days ) of surgical antibiotic prophylaxis ( SAP ; 2.70 [ 1.26 - 5.64 ] ) were independently associated with increased risk of SSI . CONCLUSIONS Male sex , inappropriate SAP , and operation-related variables are independent risk factors for SSI after gastric surgery",
"Surgical site infections are common bacterial infections in orthotopic liver transplantation . The purpose of this study was to determine the incidence , timing , location , and risk factors , specifically antibiotic prophylaxis , for surgical site infections . A prospect i ve study was performed that included a population of 1222 consecutive patients ( 73.0 % males ) who underwent liver transplantation in Spanish hospitals belonging to the Red de Estudio de la Infección en el Trasplante research network . One hundred seven patients developed surgical site infections . The predominant infection sites were incisional wound ( 53 episodes ) and peritonitis ( 40 episodes ) . The timing of the organ/space surgical site infections was slightly delayed in comparison with incisional surgical site infections . Enterococcus spp . , Escherichia coli , Staphylococcus aureus , and Acinetobacter baumannii were the predominant pathogens . Choledochojejunal or hepaticojejunal reconstruction ( odds ratio , 4.2 ; 95 % confidence interval , 1.6 - 10.7 ) , previous liver or kidney transplant ( odds ratio , 2.6 ; 95 % confidence interval , 1.1 - 6.3 ) , and more than 4 red blood cell units transfused ( odds ratio , 2.0 ; 95 % confidence interval , 1.1 - 3.4 ) were independently associated with the development of surgical site infections . Biliary reconstruction by choledochojejunostomy or hepaticojejunostomy increases the risk of surgical site infections "
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BACKGROUND Bipolar affective disorder has a high rate of comorbidity with a multitude of psychiatric disorders and medical conditions . Among all the potential comorbidities , co-existing anxiety disorders st and out due to their high prevalence . AIMS To determine the lifetime prevalence of comorbid anxiety disorders in bipolar affective disorder under the care of psychiatric services through systematic review and meta- analysis . METHOD R and om effects meta-analyses were used to calculate the lifetime prevalence of comorbid generalised anxiety disorder , panic disorder , social anxiety disorder , specific phobia , agoraphobia , obsessive compulsive disorder and posttraumatic stress disorder in bipolar affective disorder . RESULTS 52 studies were included in the meta- analysis . The rate of lifetime comorbidity was as follows : panic disorder 16.8 % ( 95 % CI 13.7 - 20.1 ) , generalised anxiety disorder 14.4 % ( 95 % CI 10.8 - 18.3 ) , social anxiety disorder13.3 % ( 95 % CI 10.1 - 16.9 ) , post-traumatic stress disorder 10.8 % ( 95 % CI 7.3 - 14.9 ) , specific phobia 10.8 % ( 95 % CI 8.2 - 13.7 ) , obsessive compulsive disorder 10.7 % ( 95 % CI 8.7 - 13.0 ) and agoraphobia 7.8 % ( 95 % CI 5.2 - 11.0 ) . The lifetime prevalence of any anxiety disorders in bipolar disorder was 42.7 % . CONCLUSIONS Our results suggest a high rate of lifetime concurrent anxiety disorders in bipolar disorder . The diagnostic issues at the interface are particularly difficult because of the substantial symptom overlap . The treatment of co-existing conditions has clinical ly remained challenging
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"OBJECTIVE The authors evaluated the efficacy and safety of lurasidone in the treatment of patients with major depressive episodes associated with bipolar I disorder . METHOD Patients were r and omly assigned to receive double-blind treatment with lurasidone ( 20 - 60 mg/day [ N=166 ] or 80 - 120 mg/day [ N=169 ] ) or placebo ( N=170 ) for 6 weeks . Primary and key secondary endpoints were change from baseline to week 6 on the Montgomery-Åsberg Depression Rating Scale ( MADRS ) and depression severity score on the Clinical Global Impressions scale for use in bipolar illness ( CGI-BP ) , respectively . RESULTS Lurasidone treatment significantly reduced mean MADRS total scores at week 6 for both the 20 - 60 mg/day group ( -15.4 ; effect size=0.51 ) and the 80 - 120 mg/day group ( -15.4 ; effect size=0.51 ) compared with placebo ( -10.7 ) . Similarly , lurasidone treatment result ed in significantly greater endpoint reduction in CGI-BP depression severity scores for both the 20 - 60 mg/day group ( -1.8 ; effect size=0.61 ) and the 80 - 120 mg/day group ( -1.7 ; effect size=0.50 ) compared with placebo ( -1.1 ) . Both lurasidone groups also experienced significant improvements compared with placebo in anxiety symptoms and in patient-reported measures of quality of life and functional impairment . Discontinuation rates due to adverse events were similar in the 20 - 60 mg/day ( 6.6 % ) , 80 - 120 mg/day ( 5.9 % ) , and placebo ( 6.5 % ) groups . The most frequent adverse events associated with lurasidone were nausea , headache , akathisia , and somnolence . Minimal changes in weight , lipids , and measures of glycemic control were observed with lurasidone . CONCLUSION Monotherapy with lurasidone in the dosage range of 20 - 120 mg/day significantly reduced depressive symptoms in patients with bipolar I depression . Lurasidone was well tolerated , with few changes in weight or metabolic parameters",
"OBJECTIVE The authors assessed gender differences in the proportion of clinical visits spent depressed , manic , or euthymic in patients with bipolar disorder . METHOD Data were analyzed from 711 patients with bipolar I or II disorder who were followed prospect ively over 7 years ( 13,191 visits ) . The main outcome measures were the presence of symptoms of depression or of hypomania or mania , measured by the Inventory of Depressive Symptomatology and the Young Mania Rating Scale . Data were analyzed using three separate repeated- measures regressions with a logistic link function to model the probability that an individual was depressed , manic , or euthymic . The models controlled for bipolar I or bipolar II diagnosis , rapid cycling , age , time in the study , comorbid anxiety disorders , and comorbid substance use disorders . RESULTS In approximately half of visits , patients had depressive , manic , or hypomanic symptoms . The likelihood of having depressive symptoms was significantly greater for women than for men . This was accounted for by higher rates in women of rapid cycling and anxiety disorders , each of which was associated with increased rates of depression . All patient groups showed an increase in number of euthymic visits and a decrease in number of visits with depressive and manic symptoms with increased time in study . CONCLUSIONS Bipolar patients spend a substantial proportion of their time ill . Significant gender differences exist , with women spending a greater proportion of their visits in the depressive pole . This finding appears to be related to the corresponding differences in rates of rapid cycling and anxiety disorders",
"BACKGROUND The impact of anxiety disorders has not been well delineated in prospect i ve studies of bipolar disorder . AIMS To examine the association between anxiety and course of bipolar disorder , as defined by mood episodes , quality of life and role functioning . METHOD A thous and thous and out- patients with bipolar disorder were followed prospect ively for 1 year . RESULTS A current comorbid anxiety disorder ( present in 31.9 % of participants ) was associated with fewer days well , a lower likelihood of timely recovery from depression , risk of earlier relapse , lower quality of life and diminished role function over I year of prospect i ve study . The negative impact was greater with multiple anxiety disorders . CONCLUSIONS Anxiety disorders , including those present during relative euthymia , predicted a poorer bipolar course . The detrimental effects of anxiety were not simply a feature of mood state . Treatment studies targeting anxiety disorders will help to clarify the nature of the impact of anxiety on bipolar course",
"Background Bipolar disorder is highly recurrent and rates of comorbidity are high . Studies have pointed to anxiety comorbidity as one factor associated with risk of suicide attempts and poor overall outcome . This study aim ed to explore the feasibility and potential benefits of a new psychological treatment ( Mindfulness-based Cognitive Therapy : MBCT ) for people with bipolar disorder focusing on between-episode anxiety and depressive symptoms . Methods The study used data from a pilot r and omized trial of MBCT for people with bipolar disorder in remission , focusing on between-episode anxiety and depressive symptoms . Immediate effects of MBCT versus waitlist on levels of anxiety and depression were compared between unipolar and bipolar participants . Results The results suggest that MBCT led to improved immediate outcomes in terms of anxiety which were specific to the bipolar group . Both bipolar and unipolar participants allocated to MBCT showed reductions in residual depressive symptoms relative to those allocated to the waitlist condition . Limitations Analyses were based on a small sample , limiting power . Additionally the study recruited participants with suicidal ideation or behaviour so the findings can not immediately be generalized to individuals without these symptoms . Conclusions The study , although preliminary , suggests an immediate effect of MBCT on anxiety and depressive symptoms among bipolar participants with suicidal ideation or behaviour , and indicates that further research into the use of MBCT with bipolar patients may be warranted",
"OBJECTIVES The purpose of this cohort study was to determine in patients with Panic Disorder ( PD ) : ( 1 ) . the prevalence of subsyndromal symptoms of hypomania , and ( 2 ) . whether subsyndromal hypomania symptoms affect the outcome of cognitive behavior therapy ( CBT ) for panic . METHODS Using the Diagnostic Interview Schedule , and DSM-III-R criteria we identified 18 individuals with a history of symptoms of hypomania among 56 patients with PD . Patients were treated in an open CBT group program . They were assessed before treatment and 6 and 12 months later . We used the Brief Symptom Inventory ( BSI ) , the Perceived Stress Scale ( PSS ) , the Pearlin-Schooler Mastery Scale ( PMS ) , and the Social Adjustment Scale ( SAS ) at all assessment s. RESULTS The total group significantly improved on all measures . The Clinical ly Significant Change was 71.4 % and the Reliable Change Index 48.2 % . Between 6 and 12 months , there was a trend for the hypomania symptom subgroup ( PH ) to continue to improve on the BSI Depression Scale , the Perceived Stress Scale , the Pearlin-Schooler Mastery Scale , and the Social Adjustment Scale but to lose gains on the BSI Phobic Anxiety and Somatization subscales compared with the group without symptoms of hypomania ( PNH ) . CONCLUSIONS Thirty-two percent of patients with PD had symptoms of hypomania . With CBT for panic , patients with PD and symptoms of hypomania improve as much as those without hypomania symptoms . The presence or absence of symptoms of hypomania might help explain the inconsistent effects of depression and personality disorders on the treatment of PD",
" In order to estimate the prevalence of affective disorders in Hungary a sample of the Hungarian adult population ( 18 - 64 years ) selected at r and om was interviewed using the Diagnostic Interview Schedule ( DIS ) which generated DSM-III-R diagnoses . The lifetime rate for Major Depressive Disorder ( MDD ) was 15.1 % , and for Bipolar Disorders ( BD ) 5.1 % . The female-to-male ratio was 2.7 for MDD and nearly equal for BD . The 1-year and 1-month period prevalence rates were 7.1 % and 2.6 % for MDD and 0.9 % and 0.5 % for manic episodes . A higher rate of divorced or separated persons was found among individuals with a lifetime diagnosis of MDD . Besides these , the lifetime diagnosis of BD coexisted with higher rates of the never-married state . The highest hazard rate for the development of BD or MDD was in the range 15 - 19 years but in MDD another peak was also found in the range 45 - 50 years . The first peak was characteristic of the recurrent , and the other one of the single form of MDD . Insomnia , loss of energy , decreased interest , concentration problems were the most common symptoms during the depressive episode , independent of polarity . Higher rates of lifetime diagnosis of dysthymia and all kinds of anxiety disorder were revealed among persons with MDD . BD was associated with GAD ( Generalized Anxiety Disorder ) , and panic disorder more often than chance",
"OBJECTIVE To evaluate the prevalence of substance abuse dependence and /or alcohol abuse dependence among subjects with bipolar I versus bipolar II disorder in a voluntary registry . METHOD One hundred r and omly selected registrants in a voluntary case registry for bipolar disorder were interviewed , using the Structured Clinical Interview for DSM-IV Axis I Disorders , to vali date the diagnosis of this registry . Corroborative information was obtained from medical records , family members and the treating psychiatrist . Eighty-nine adults ( 18 - 65 years ) met criteria for bipolar disorder ( bipolar I = 71 , bipolar II = 18 ) and were included in this analysis . RESULTS Forty-one ( 57.8 % ) subjects with bipolar I disorder abused , or were dependent on one or more substances or alcohol , 28.2 % abused , or were dependent on , two substances or alcohol , and 11.3 % abused or were dependent on three or more substances or alcohol . Nearly 39 % of bipolar II subjects abused or were dependent on one or more substances , nearly 17 % were dependent on two or more substances or alcohol , and 11 % were dependent on three or more substances or alcohol . Alcohol was the most commonly abused drug among either bipolar I or II subjects . CONCLUSIONS Consistent with other epidemiologic and hospital population studies , this voluntary bipolar disorder registry suggests a high prevalence of comorbidity with alcohol and /or substance abuse dependence . Bipolar I subjects appear to have higher rates of these comorbid conditions than bipolar II subjects ; however , as the number of bipolar II subjects was rather small , this suggestion needs confirmation",
"OBJECTIVE Given the adverse impact of anxiety on treatment outcome in unipolar depression and the paucity of data on the role of anxiety in bipolar disorder , the authors sought to determine the effect of anxiety on the acute treatment response of patients with bipolar I disorder . METHOD The authors examined the correlates of response to the acute treatment of 124 consecutively treated patients with bipolar I disorder . Measures of anxiety included history of panic attacks and a composite variable reflecting current or past anxiety symptoms . RESULTS History of panic attacks proved to be a significant correlate of nonremission . Anxiety , as assessed with the composite variable , was associated with longer time to remission , as was the treatment of depressive versus manic symptoms and mixed versus manic symptoms . Patients with anxiety as assessed with the composite variable and patients with a history of panic attacks reported more severe medication side effects . They also required a greater number of medications , either sequentially or in combination , in order to achieve remission . CONCLUSIONS The findings suggest that anxiety is a clinical ly meaningful correlate of poor outcome in the acute treatment of bipolar I disorder",
"OBJECTIVE Few studies have been reported that support the efficacy of adjunctive therapy for patients with bipolar I depression who have had an insufficient response to monotherapy with mood-stabilizing agents . The authors investigated the efficacy of lurasidone , a novel antipsychotic agent , as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression . METHOD Patients were r and omly assigned to receive 6 weeks of double-blind adjunctive treatment with lurasidone ( N=183 ) or placebo ( N=165 ) , added to therapeutic levels of either lithium or valproate . Primary and key secondary endpoints were change from baseline to week 6 on the Montgomery-Åsberg Depression Rating Scale ( MADRS ) and depression severity score on the Clinical Global Impressions scale for use in bipolar illness ( CGI-BP ) , respectively . RESULTS Lurasidone treatment significantly reduced mean MADRS total score at week 6 compared with the placebo group ( -17.1 versus -13.5 ; effect size=0.34 ) . Similarly , lurasidone treatment result ed in significantly greater endpoint reduction in CGI-BP depression severity scores compared with placebo ( -1.96 versus -1.51 ; effect size=0.36 ) as well as significantly greater improvement in anxiety symptoms and in patient-reported measures of quality of life and functional impairment . Discontinuation rates due to adverse events were 6.0 % and 7.9 % in the lurasidone and placebo groups , respectively . Adverse events most frequently reported for lurasidone were nausea , somnolence , tremor , akathisia , and insomnia . Minimal changes in weight , lipids , and measures of glycemic control were observed during treatment with lurasidone . CONCLUSIONS In patients with bipolar I depression , treatment with lurasidone adjunctive to lithium or valproate significantly improved depressive symptoms and was generally well tolerated",
"OBJECTIVE The authors provide a detailed perspective on the correlates of comorbid anxiety in a large , well-characterized sample of bipolar disorder patients . METHOD Anxiety and its correlates were examined in a cross-sectional sample from the first 500 patients with bipolar I or bipolar II disorder enrolled in the Systematic Treatment Enhancement Program for Bipolar Disorder , a multicenter project funded by the National Institute of Mental Health design ed to evaluate the longitudinal outcome of patients with bipolar disorder . RESULTS Lifetime comorbid anxiety disorders were common , occurring in over one-half of the sample , and were associated with younger age at onset , decreased likelihood of recovery , poorer role functioning and quality of life , less time euthymic , and greater likelihood of suicide attempts . Although substance abuse disorders were particularly prevalent among patients with anxiety disorders , comorbid anxiety appeared to exert an independent , deleterious effect on functioning , including history of suicide attempts ( odds ratio=2.45 , 95 % CI=1.4 - 4.2 ) . CONCLUSIONS An independent association of comorbid anxiety with greater severity and impairment in bipolar disorder patients was demonstrated , highlighting the need for greater clinical attention to anxiety in this population , particularly for enhanced clinical monitoring of suicidality . In addition , it is important to determine whether effective treatment of anxiety symptoms can lessen bipolar disorder severity , improve response to treatment of manic or depressive symptoms , or reduce suicidality",
"Panic disorder , which is found in about 1.5 percent of the population at some time in their lives , includes recurrent episodes of sudden , unpredictable , intense fear accompanied by symptoms such as palpitations , chest pain , and faintness . Panic attacks , which do not meet these diagnostic criteria fully , are two to three times more prevalent . Since panic symptoms can mimic those of other medical disorders , patients with these symptoms use medical services frequently . To determine the risk of suicidal ideation and suicide attempts in panic disorder and attacks , we studied a r and om sample of 18,011 adults drawn from five U.S. communities . Subjects who had panic disorder , as compared with other psychiatric disorders , had more suicidal ideation and suicide attempts , with an adjusted odds ratio for suicide attempts of 2.62 ( 95 percent confidence interval , 1.83 to 3.74 ) . The odds ratio was 17.99 ( 95 percent confidence interval , 12.18 to 26.58 ) when the group with panic disorder was compared with subjects who had no psychiatric disorder . Twenty percent of the subjects with panic disorder and 12 percent of those with panic attacks had made suicide attempts . These results could not be explained by the coexistence of major depression or of alcohol or drug abuse . We conclude that panic disorder and attacks are associated with an increased risk of suicidal ideation and suicide attempts . Physicians working in general medical setting s and emergency departments should be alert to this problem",
"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 .",
"OBJECTIVES Because use of benzodiazepines may exacerbate existing substance use disorders or become abused substances , prescription of benzodiazepines for patients with severe mental illness ( schizophrenia or bipolar disorder ) and co-occurring substance use disorders ( abuse or dependence ) is controversial . The authors examined benzodiazepine use and associated psychiatric , substance abuse , and institutional outcomes in a six-year longitudinal study of patients with co-occurring disorders . METHODS At baseline and yearly follow-up for six years , 203 patients with co-occurring severe mental illness and substance use disorder were prospect ively assessed for medication use , substance use , psychiatric symptoms , use of hospitalization , and quality of life . RESULTS Almost one-half of the patients ( 43 percent ) reported taking prescribed benzodiazepines at the time of at least one assessment . Patients taking prescribed benzodiazepines were more likely to have high scores on measures of overall symptoms and affective symptoms ( anxiety and depression ) and low ratings for general quality of life throughout the study . Benzodiazepine use was unrelated to remission of substance use disorder or hospitalization , but a greater proportion of patients who were prescribed benzodiazepines developed benzodiazepine abuse , compared with those who were not prescribed benzodiazepines ( 15 percent compared with 6 percent ) . CONCLUSIONS Prescription benzodiazepine use was common among patients with co-occurring severe mental illness and a substance use disorder and was not associated with any of the measured outcomes other than increasing the likelihood of benzodiazepine abuse . Physicians should consider other treatments for anxiety in this population",
"BACKGROUND Given the observed association between panic disorder and bipolar disorder and the potential negative influence of panic symptoms on the course of bipolar illness , we were interested in the effects of what we have defined as \" panic spectrum \" conditions on the clinical course and treatment outcome in patients with bipolar I ( BPI ) disorder . We hypothesized that lifetime panic spectrum features would be associated with higher levels of suicidal ideation and a poorer response to acute treatment of the index mood episode in this patient population . METHODS A sample of 66 patients with BPI disorder completed a self-report measure of lifetime panic-agoraphobic spectrum symptoms . Patients falling above and below a predefined clinical threshold for panic spectrum were compared for clinical characteristics , the presence of suicidal ideation during acute treatment , and acute treatment response . RESULTS Half of this outpatient sample reported panic spectrum features above the predefined threshold . These lifetime features were associated with more prior depressive episodes , higher levels of depressive symptoms , and greater suicidal ideation during the acute-treatment phase . Patients with BPI disorder who reported high lifetime panic-agoraphobic spectrum symptom scores took 27 weeks longer than those who reported low scores to remit with acute treatment ( 44 vs 17 weeks , respectively ) . CONCLUSIONS The presence of lifetime panic spectrum symptoms in this sample of patients with BPI disorder was associated with greater levels of depression , more suicidal ideation , and a marked ( 6-month ) delay in time to remission with acute treatment . Alternate treatment strategies are needed for patients with BPI disorder who endorse lifetime panic spectrum features",
"CONTEXT Numerous studies have pointed to the failure of prophylaxis with pharmacotherapy alone in the treatment of bipolar I disorder . Recent investigations have demonstrated benefits from the addition of psychoeducation or psychotherapy to pharmacotherapy in this population . OBJECTIVE To compare 2 psychosocial interventions : interpersonal and social rhythm therapy ( IPSRT ) and an intensive clinical management ( ICM ) approach in the treatment of bipolar I disorder . DESIGN R and omized controlled trial involving 4 treatment strategies : acute and maintenance IPSRT ( IPSRT/IPSRT ) , acute and maintenance ICM ( ICM/ICM ) , acute IPSRT followed by maintenance ICM ( IPSRT/ICM ) , or acute ICM followed by maintenance IPSRT ( ICM/IPSRT ) . The preventive maintenance phase lasted 2 years . SETTING Research clinic in a university medical center . PARTICIPANTS One hundred seventy-five acutely ill individuals with bipolar I disorder recruited from inpatient and outpatient setting s , clinical referral , public presentations about bipolar disorder , and other public information activities . INTERVENTIONS Interpersonal and social rhythm therapy , an adaptation of Klerman and Weissman 's interpersonal psychotherapy to which a social rhythm regulation component has been added , and ICM . MAIN OUTCOME MEASURES Time to stabilization in the acute phase and time to recurrence in the maintenance phase . RESULTS We observed no difference between the treatment strategies in time to stabilization . After controlling for covariates of survival time , we found that participants assigned to IPSRT in the acute treatment phase survived longer without a new affective episode ( P = .01 ) , irrespective of maintenance treatment assignment . Participants in the IPSRT group had higher regularity of social rhythms at the end of acute treatment ( P increase regularity of social rhythms during acute treatment was associated with reduced likelihood of recurrence during the maintenance phase ( P = .05 ) . CONCLUSION Interpersonal and social rhythm therapy appears to add to the clinical armamentarium for the management of bipolar I disorder , particularly with respect to prophylaxis of new episodes",
"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 Numerous studies have observed that offspring of bipolar parents manifest a broad spectrum of psychiatric disorders . We tested the hypothesis that in high risk offspring , bipolar disorder evolves in a predictable clinical sequence from non-specific ( non-mood ) to specific ( mood ) psychopathology . METHODS Offspring from well-characterized families with one bipolar parent ( high risk ) or two well parents ( controls ) were assessed annually or at anytime symptoms developed using KSADS-PL interviews for up to 15 years . DSM-IV diagnoses were made on blind consensus review using all available clinical material . We compared the age-adjusted risks of lifetime psychopathology between high risk and control subjects and assessed the conditional probability of developing a mood disorder given a history of non-mood disorders . In subjects meeting full DSM-IV criteria for bipolar disorder , we assessed the sequence of psychopathology against a clinical staging model . RESULTS High risk offspring manifest higher rates of anxiety and sleep disorders , as well as major mood and substance use disorders compared to controls . Antecedent anxiety increased the age-adjusted risk of mood disorder from 40 to 85 % ( hazard ratio of 2.6 ) . High risk subjects who developed a mood disorder had an increased risk of a substance use disorder ( hazard ratio of 2.4 ) , typically meeting diagnostic criteria during or after the first major mood episode . The evolution of psychopathology leading to bipolar disorder generally followed the proposed sequence , although not all subjects manifest all stages . LIMITATIONS Larger numbers of high risk offspring prospect ively assessed over the risk period would allow confirmation of these preliminary findings . CONCLUSIONS Clinical staging may be a useful approach to refine the early diagnosis and facilitate research into the evolution of bipolar disorder in those at familial risk",
"OBJECTIVE At least 50 % of individuals with bipolar disorder have a lifetime anxiety disorder . Individuals with both bipolar disorder and a co-occurring anxiety disorder experience longer illness duration , greater illness severity , and poorer treatment response . The study explored whether comorbid lifetime anxiety in bipolar patients moderates psychotherapy treatment outcome . METHOD In the Systematic Treatment Enhancement Program r and omized controlled trial of psychotherapy for bipolar depression , participants received up to 30 sessions of intensive psychotherapy ( family-focused therapy , interpersonal and social rhythm therapy , or cognitive-behavioral therapy ) or collaborative care , a three-session comparison treatment , plus pharmacotherapy . Using the number needed to treat , we computed effect sizes to analyze the relationship between lifetime anxiety disorders and rates of recovery across treatment groups after 1 year . RESULTS A total of 269 patients ( 113 women ) with a comorbid lifetime anxiety disorder ( N=177 ) or without a comorbid lifetime anxiety disorder ( N=92 ) were included in the analysis . Participants with a lifetime anxiety disorder were more likely to recover with psychotherapy than with collaborative care ( 66 % compared with 49 % recovered over 1 year ; number needed to treat=5.88 , small to medium effect ) . For patients without a lifetime anxiety disorder , there was no difference between rates of recovery in psychotherapy compared with collaborative care ( 64 % compared with 62 % recovered ; number needed to treat=50 , small effect ) . Participants with one lifetime anxiety disorder were likely to benefit from intensive psychotherapy compared with collaborative care ( 84 % compared with 53 % recovered ; number needed to treat=3.22 , medium to large effect ) , whereas patients with multiple anxiety disorders exhibited no difference in response to the two treatments ( 54 % compared with 46 % recovered ; number needed to treat=12.5 , small effect ) . CONCLUSIONS Depressed patients with bipolar disorder and comorbid anxiety may be in particular need of additional psychotherapy for treating acute depression . These results need to be replicated in studies that stratify bipolar patients to treatments based on their anxiety comorbidity status",
"BACKGROUND Despite the longer duration of the depressive phase in bipolar disorder and the frequent clinical use of antidepressants combined with antipsychotics or mood stabilizers , relatively few controlled studies have examined treatment strategies for bipolar depression . OBJECTIVE To examine the use of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression . DESIGN Double-blind , 8-week , r and omized controlled trial . SETTING Eighty-four sites ( inpatient and outpatient ) in 13 countries . Patients A total of 833 r and omized adults with bipolar I depression with a Montgomery-Asberg Depression Rating Scale ( MADRS ) score of at least 20 . Intervention Patients were r and omly assigned to receive placebo ( n = 377 ) ; olanzapine , 5 to 20 mg/d ( n = 370 ) ; or olanzapine-fluoxetine combination , 6 and 25 , 6 and 50 , or 12 and 50 mg/d ( n = 86 ) . MAIN OUTCOME MEASURE Changes in MADRS total scores using mixed-effects model repeated- measures analyses . RESULTS During all 8 study weeks , the olanzapine and olanzapine-fluoxetine groups showed statistically significant improvement in depressive symptoms vs the placebo group ( P olanzapine-fluoxetine group also showed statistically greater improvement than the olanzapine group at weeks 4 through 8 . At week 8 , MADRS total scores were lower than at baseline by 11.9 , 15.0 , and 18.5 points in the placebo , olanzapine , and olanzapine-fluoxetine groups , respectively . Remission criteria were met by 24.5 % ( 87/355 ) of the placebo group , 32.8 % ( 115/351 ) of the olanzapine group , and 48.8 % ( 40/82 ) of the olanzapine-fluoxetine group . Treatment-emergent mania ( Young Mania Rating Scale score or = 15 subsequently ) did not differ among groups ( placebo , 6.7 % [ 23/345 ] ; olanzapine , 5.7 % [ 19/335 ] ; and olanzapine-fluoxetine , 6.4 % [ 5/78 ] ) . Adverse events for olanzapine-fluoxetine therapy were similar to those for olanzapine therapy but also included higher rates of nausea and diarrhea . CONCLUSIONS Olanzapine is more effective than placebo , and combined olanzapine-fluoxetine is more effective than olanzapine and placebo in the treatment of bipolar I depression without increased risk of developing manic symptoms"
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Background Oral iron supplementation is used widely in older people despite observational studies suggesting it is ineffective . Objective The aim of this systematic review was to determine if oral iron therapy is effective in elderly people with iron deficiency anaemia . Data Sources MEDLINE , EMBASE and The Cochrane Library data bases were search ed from inception to 23 January 2014 . Study Selection R and omised controlled trials comparing oral iron with no iron supplementation or placebo and measuring the change in haemoglobin levels in elderly patients with anaemia were included . Titles and abstract s were review ed and publications were screened by both authors independently to exclude articles that did not satisfy the inclusion criteria . Study Appraisal and Synthesis Risk of bias was systematic ally assessed independently by both authors using the Cochrane risk of bias tool . Data on the increase in haemoglobin level after therapy was either collected from original publications or by contacting the corresponding authors . Length of hospitalisation , mortality and adverse effect data were also analysed . Results A total of 6,163 citations were screened , but only three studies ( a total of 440 participants with a mean age ranging between 70 and 83 years ) met the inclusion criteria . Meta- analysis showed oral iron supplementation increased haemoglobin levels more than placebo or no treatment after 4–6 weeks of treatment ( mean difference 0.35 g/dL , 95 % CI 0.12–0.59 , p = 0.003 ) . There were no statistically significant differences in adverse effects , length of hospitalisation or mortality . Limitations Only one of the three studies was specific to older people and all studies involved patients in orthopaedic setting s. The mean age of participants was different , and the dosage and frequency of ferrous sulphate differed . Conclusion Oral iron raises haemoglobin levels in elderly people with iron deficiency anaemia by 0.35 g/dL after 4–6 weeks , but it is unclear if this results in tangible health benefits
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"BACKGROUND Preliminary clinical evidence suggests that heme iron polypeptide ( HIP ) might represent a promising , novel oral iron supplementation strategy in chronic kidney disease . The aim of this multi-centre r and omized controlled trial was to determine the ability of HIP administration to augment iron stores in darbepoetin (DPO)-treated patients compared with conventional oral iron supplementation . METHODS Adult peritoneal dialysis ( PD ) patients treated with DPO were r and omized 1:1 to receive two capsules daily of either HIP or ferrous sulphate per os for 6 months . The primary outcome measure was transferrin saturation ( TSAT ) . Secondary outcomes comprised serum ferritin , haemoglobin , DPO dose and responsiveness , and adverse events . RESULTS Sixty-two patients were r and omized to HIP ( n = 32 ) or ferrous sulphate ( n = 30 ) . On intention-to-treat analysis , the median ( inter-quartile range ) TSAT was 22 % ( 16 - 29 ) in the HIP group compared with 20 % ( 17 - 26 ) in controls ( P = 0.65 ) . HIP treatment was not significantly associated with TSAT at 6 months on multivariable analysis ( P = 0.95 ) . Similar results were found on per- protocol analysis and subgroup analysis in iron-deficient patients . Serum ferritin levels at 6 months were significantly lower in the HIP group ( P = 0.003 ) , while the cost of HIP was 7-fold higher than that of ferrous sulphate . No other differences in secondary outcomes were observed . CONCLUSIONS HIP showed no clear safety or efficacy benefit in PD patients compared with conventional oral iron supplements . The reduction in serum ferritin levels and high costs associated with HIP therapy suggest that this agent is unlikely to have a significant role in iron supplementation in PD patients",
"After total hip and knee replacement arthroplasty , patients may become anaemic and may be prescribed oral iron . There is , however , no published evidence that this is of benefit when used postoperatively . We treated 72 patients who were anaemic after primary total hip and knee arthroplasty by r and omly allocating them to receive six weeks of either oral ferrous sulphate ( 35 patients ) or a placebo ( 37 patients ) . Both groups of patients were similar in all aspects except for the treatment given . There was no statistically significant difference in the change of haemoglobin levels between the two groups . We therefore believe that the prescription of iron to all anaemic patients post-operatively should be avoided . The level of serum ferritin should be monitored at preoperative assessment",
"Background Anaemia is a known risk factor for cardiovascular disease and treating anaemia in chronic kidney disease ( CKD ) may improve outcomes . However , little is known about the scope to improve primary care management of anaemia in CKD . Methods An observational study ( N = 1,099,292 ) with a nationally representative sample using anonymised routine primary care data from 127 Quality Improvement in CKD trial practice s ( IS RCT N5631023731 ) . We explored variables associated with anaemia in CKD : eGFR , haemoglobin ( Hb ) , mean corpuscular volume ( MCV ) , iron status , cardiovascular comorbidities , and use of therapy which associated with gastrointestinal bleeding , oral iron and deprivation score . We developed a linear regression model to identify variables amenable to improved primary care management . Results The prevalence of Stage 3–5 CKD was 6.76 % . Hb was lower in CKD ( 13.2 g/dl ) than without ( 13.7 g/dl ) . 22.2 % of people with CKD had World Health Organization defined anaemia ; 8.6 % had Hb ≤ 11 g/dl ; 3 % Hb ≤ 10 g/dl ; and 1 % Hb ≤ 9 g/dl . Normocytic anaemia was present in 80.5 % with Hb ≤ 11 ; 72.7 % with Hb ≤ 10 g/dl ; and 67.6 % with Hb ≤ 9 g/dl ; microcytic anaemia in 13.4 % with Hb ≤ 11 g/dl ; 20.8 % with Hb ≤ 10 g/dl ; and 24.9 % where Hb ≤ 9 g/dl . 82.7 % of people with microcytic and 58.8 % with normocytic anaemia ( Hb ≤ 11 g/dl ) had a low ferritin ( 100ug/mL ) . Hypertension ( 67.2 % vs. 54 % ) and diabetes ( 30.7 % vs. 15.4 % ) were more prevalent in CKD and anaemia ; 61 % had been prescribed aspirin ; 73 % non-steroidal anti-inflammatory drugs ( NSAIDs ) ; 14.1 % warfarin 12.4 % clopidogrel ; and 53.1 % aspirin and NSAID . 56.3 % of people with CKD and anaemia had been prescribed oral iron . The main limitations of the study are that routine data are inevitably incomplete and definitions of anaemia have not been st and ardised . Conclusions Medication review is needed in people with CKD and anaemia prior to considering erythropoietin or parenteral iron . Iron stores may be depleted in over > 60 % of people with normocytic anaemia . Prescribing oral iron has not corrected anaemia",
"Background Anemia secondary to iron deficiency is common in patients with non-dialysis dependent chronic kidney disease ( ND-CKD ) but it is unclear if oral supplementation is as effective as intravenous ( IV ) supplementation in re-establishing iron stores . The purpose of this study was to determine if oral Heme Iron Polypeptide ( HIP ) is as effective as IV iron sucrose in the treatment of iron-deficiency anemia for patients with ND-CKD . Methods Forty ND-CKD patients were r and omized ; 18 to HIP 11 mg orally 3 times per day and 22 to IV iron sucrose 200 mg monthly for 6 months . Baseline clinical and laboratory data were collected for all patients . The primary and secondary outcomes for the study were hemoglobin ( Hgb ) concentration and iron indices [ ferritin and percentage transferrin saturation ( TSAT ) ] at the end of 6 months respectively . Adverse events were also compared . Results The baseline demographic characteristics and laboratory values were similar for the two groups . After 6 months of treatment , Hb in the HIP group was 117 g/L and 113 g/L in the IV sucrose group ( p = 0.37 ) . The TSAT at 6 months was not different between the two groups { p = 0.82}but the serum ferritin was significantly higher in the IV iron sucrose group { 85.5 ug/L in HIP and 244 ug/L ; p = 0.004}. Overall adverse events were not different between the groups . Conclusion HIP is similar in efficacy to IV iron sucrose in maintaining hemoglobin in ND-CKD patients with no differences in adverse events over 6 months . It is unclear if the greater ferritin values in the IV iron sucrose group are clinical ly significant . Trial registration Clinical Trials.gov :",
"BACKGROUND Although iron deficiency frequently complicates anemia in patients with nondialysis-dependent CKD ( ND-CKD ) , the comparative treatment value of IV iron infusion and oral iron supplementation has not been established . METHODS In a r and omized , controlled multicenter trial , we compared the efficacy of iron sucrose , given as 1 g in divided IV doses over 14 days , with that of ferrous sulfate , given 325 mg orally thrice daily for 56 days in patients with ND-CKD stages 3 to 5 , Hb Epoetin/darbepoetin therapy , if any , was not changed for eight weeks prior to or during the study . RESULTS The proportion of patients achieving the primary outcome ( Hb increase > or = 1 g/dL ) was greater in the IV iron treatment group than in the oral iron treatment group ( 44.3 % vs. 28.0 % , P= 0.0344 ) , as was the mean increase in Hb by day 42 ( 0.7 vs. 0.4 g/dL , P= 0.0298 ) . Compared to those in the IV iron group , patients in the oral iron treatment group showed a greater decline in GFR during the study ( -4.40 vs. -1.45 mL/min/1.73m2 , P= 0.0100 ) . No serious adverse drug events ( ADE ) were seen in patients administered IV iron sucrose as 200 mg IV over two to five minutes , but drug-related hypotension , including one event considered serious , occurred in two females weighing less than 65 kg after 500 mg doses were given over four hours . CONCLUSION IV iron administration using 1000 mg iron sucrose in divided doses is superior to oral iron therapy in the management of ND-CKD patients with anemia and low iron indices",
"Patients undergoing total hip or knee replacement frequently receive blood transfusion . Homologous blood transfusion carries appreciable risks and should therefore be reduced to a minimum . We have investigated the use of preoperative oral iron supplements to optimize haemoglobin concentration and iron stores prior to surgery . All patients attending a preadmission clinic 4 weeks prior to primary hip or knee replacement had a haemoglobin measurement . If the haemoglobin concentration ( Hb ) was less than 12 g dL-1 they were given a four week course of ferrous sulphate . If it was greater than or equal to 12 g dL-1 they were r and omized to a control group or given a supplementation course of ferrous sulphate . One hundred patients were seen . Of these 18 ( 18 % ) had haemoglobin less than 12 g dL-1 and 16 were treated with iron . The mean Hb was 10.8 g dL-1 and mean cell volume ( MCV ) 86 . These patients increased their Hb by a mean 1.1 g dL-1 prior to admission ( P = 0.008 ) . MCV was the best predictor of response ( r = -0.63 , P dropped their haemoglobin by a mean 1.4 g dL-1 in the first post-operative week . In the study groups there was no significant preoperative rise in Hb . However , the control group dropped their Hb by a mean 1.3 g dL-1 in the week following surgery compared with 0.4 g dL-1 in the group which had received iron supplements ( P patients attending for hip or knee replacement in this region are frankly anaemic and benefit significantly from preoperative iron supplements over 4 weeks . Iron supplementation in patients without obvious anaemia protects against a fall in Hb during the immediate post-operative period , suggesting a widespread underlying depletion of iron stores in this group despite a normal Hb . Preoperative iron supplements may reduce transfusion requirements as part of a co-ordinated strategy in this group of patients",
"Background : In patients with inflammatory bowel disease , oral iron is anecdotally reported to be less effective and less well tolerated than in those without inflammatory bowel disease , and to increase disease activity",
"Background : Oral iron therapy is often used after orthopaedic surgery to improve haemoglobin levels . The aim of the present trial was to determine if administration of oral iron after orthopaedic surgery results in a better improvement of haemoglobin levels than a control treatment",
"BACKGROUND Anemia in heart failure patients and has been associated with increased morbi-mortality . Previous studies have treated anemia in heart failure patients with either erythropoietin alone or combination of erythropoietin and intravenous ( i.v . ) iron . However , the effect of i.v . or oral ( p.o . ) iron supplementation alone in heart failure patients with anemia was virtually unknown . AIM To compare , in a double-blind design , the effects of i.v . iron versus p.o . iron in anemic heart failure patients . METHODS IRON-HF study was a multicenter , investigator initiated , r and omized , double-blind , placebo controlled trial that enrolled anemic heart failure patients with preserved renal function , low transferrin saturation ( TSat ) and low-to-moderately elevated ferritin levels . Interventions were Iron Sucrose i.v . 200 mg , once a week , for 5 weeks , ferrous sulfate 200 mg p.o . TID , for 8 weeks , or placebo . Primary endpoint was variation of peak oxygen consumption ( peak VO2 ) assessed by ergospirometry over 3 month follow-up . RESULTS Eighteen patients had full follow-up data . There was an increment of 3.5 ml/kg/min in peak VO2 in the i.v . iron group . There was no increment in peak VO2 in the p.o . iron group . Patients ' ferritin and TSat increased significantly in both treated groups . Hemoglobin increased similarly in all groups . CONCLUSION I.v . iron seems to be superior in improving functional capacity of heart failure patients . However , correction of anemia seems to be at least similar between p.o . iron and i.v . iron supplementation",
"Aging is associated with increased risk of developing anaemia and micronutrient deficiencies . The purpose of this study was to evaluate the daily intake of micronutrient whose deficient in diet could cause anaemia ( iron , folic acid , vitamin B12 ) and vitamin C to establish the prevalence of anaemia in a group of institutionalized of 124 elderly subjects residing in five nursing homes in León ( Spain ) . A precise weighing method was used to conduct the control of food intake covering seven days . Energy , alcohol , iron , folate , vitamin B12 , and vitamin C intake were obtained . Weight , and Height also were measured . Serum iron , serum ferritin , haemoglobin and hematocrit were also measured . Average daily iron intake was higher than the 10 mg recommended by the National Academy of Science although significantly higher ( p vitamin C intake in all subjects is high ( 118.8 + /- 43.7 mg ) and higher than Spanish RDA ( 198 % ) . Average intakes of folate and vitamin B12 in the present study exceeded the RDA , ( 103 % and 144 % ) . However , 45.83 % of males and 5.97 % of females showed deficiencies in vitamin B12 and 53.91 % of the subjects showed deficiencies in folic acid . The average haemoglobin concentration ( 14.28 + /- 1.33 g/dL ) , hematocrit percentage ( 43.71 + /- 6.31 ) , ferritin concentration ( 87.01 + /- 59.74 ng/mL ) and serum iron ( 85.36 + /- 33.98 micrograms/dL ) showed similar figures to the results obtained in other studies carried out on elderly population s. It would be necessary to adequately compose the menus given in nursing homes , decreasing energy contribution , and supplying micronutrient rich foods or fortified foods",
"BACKGROUND Anemia as a consequence of surgery is often treated with iron therapy . The evidence base for this practice is limited . To determine if oral iron therapy is beneficial for the treatment of anemia after surgery for the treatment of a hip fracture , we undertook a prospect i ve , r and omized controlled trial . METHODS Three hundred patients with a hemoglobin level of to receive either a twenty-eight-day course of ferrous sulfate therapy or no iron therapy . Hemoglobin levels were measured at six weeks after surgery . The length of the hospital stay and the mortality rate at one year were compared between groups . RESULTS The mean rise in hemoglobin levels six weeks after discharge from the hospital was 21 g/L in the iron group , compared with 18 g/L in the no-iron group ( p = 0.07 ) . There was no significant difference between the two groups with regard to the length of hospital stay or the mortality rate . Seventeen percent of the patients who were allocated to iron therapy reported adverse effects of the medication . CONCLUSIONS The present study demonstrated that iron therapy had no clinical ly relevant benefit when used to treat anemia associated with a hip fracture",
"In cancer patients mild-moderate non-chemotherapy-induced iron deficiency anemia ( IDA ) is usually treated with oral iron salts , mostly ferrous sulfate . In this study , we compare efficacy and toxicity of oral ferrous bisglycinate chelate and ferrous sulfate in cancer patients with mild IDA . Twenty-four patients operated on for solid tumors ( 10 breast , 12 colorectal , 2 gastric ) , aged 61±10 years ( range 45 - 75 ) , with non-chemotherapy-induced hemoglobin ( Hb ) values between 10 and 12 g/dL and ferritin lower than 30 ng/mL were r and omized to receive oral ferrous bisglycinate chelate , 28 mg per day for 20 days , and then 14 mg per day for 40 days ( 12 patients ) ( A group ) or oral ferrous sulphate , 105 mg per day for 60 days ( 12 patients ) ( B group ) . Values of hemoglobin and ferritin obtained at diagnosis , 1 and 2 months from the beginning of treatment were compared . Adverse events ( AEs ) related to the two treatments were recorded . In the 12 patients treated with ferrous bisglycinate chelate , basal hemoglobin and ferritin values ( mean±SD ) were 11.6±0.8 g/dL and 16.1±8.0 ng/mL. After 2 months of treatment , they were 13.0±1.4 g/dL and 33.8±22.0 ng/mL , respectively ( P=0.0003 and P=0.020 ) . In the group treated with ferrous sulphate , hemoglobin and ferritin mean values were 11.3±0.6 g/dL and 19.0±6.4 ng/mL basally , and 12.7±0.70 g/dL and 40.8±28.1 ng/mL ( P 2 months of treatment . AEs occurred in six cases . In all these six cases , two ( 17 % ) treated with ferrous bisglycinate chelate and four ( 33 % ) with ferrous sulphate , toxicity was grade 1 . In conclusion , these data suggest that ferrous bisglycinate chelate has similar efficacy and likely lower GI toxicity than ferrous sulphate given at the conventional dose of 105 mg per day for the same time",
"Objective . Patients with inflammatory bowel disease ( IBD ) often have low iron stores or anaemia . There is controversy about whether iron should be supplemented orally or intravenously ( i.v . ) . The purpose of this study was to investigate whether treatment with intravenous iron is superior to treatment with oral iron . The primary end-points were response and remaining anaemia at the end of treatment ( EOT ) . Material and methods . Ninety-one patients with IBD and anaemia ( B-Hb were r and omized to oral iron sulphate ( n=46 ) or intravenous iron sucrose ( n=45 ) treatment for 20 weeks . Results . Forty-three patients in the intravenous iron group completed the study compared to 35 patients in the oral iron group ( p=0.0009 ) . Only 22 patients ( 48 % ) tolerated the prescribed oral dose , and 52 % reduced the dose or withdrew from treatment because of poor tolerance . At EOT , 47 % patients in the oral iron group increased their B-Hb by ≥20 g/L , compared with 66 % in the intravenous iron group ( p=0.07 ) . In the oral iron group , 41 % still had anaemia versus 16 % of the patients in the intravenous iron group ( p=0.007 ) , and 22 % versus 42 % reached their reference B-Hb level ( p=0.04 ) . Treatment with intravenous iron sucrose improved iron stores faster and more effectively than oral iron ( p=0.002 ) . Under treatment with intravenous iron , 74 % of the patients had no anaemia and normal S-ferritin levels ( > 25 µg/L ) at EOT compared with 48 % of patients receiving oral iron ( p=0.013 ) . Conclusions . Treatment with intravenous iron sucrose is effective , safe , well tolerated and superior to oral iron in correcting haemoglobin and iron stores in patients with IBD",
"INTRODUCTION Pre-operative anaemia is well recognised in patients presenting with colorectal cancer ( CRC ) . While the benefits of long-term FeSO4 supplementation on Fe deficiency anaemia are well established , it is not known if short-course supplementation ( 2 - 3 weeks ) impacts significantly on pre-operative haemoglobin ( Hb ) levels . This study examines the impact of short-term , oral FeSO4 supplementation on patients undergoing surgery for CRC . PATIENTS AND METHODS All patients with CRC presenting to a single surgeon were included . At diagnosis , baseline Hb and blood film were checked on all patients who then received 200 mg tds of FeSO4 . Haemoglobin was rechecked pre-operatively and daily postoperatively . Patients requiring pre-operative blood transfusions were excluded from analysis . RESULTS Between 1 January 2004 and 31 December 2006 , 117 patients were identified , 14 of whom were excluded . Patients received a median of 39 days ' treatment with FeSO4 . Fifty-eight ( 56.3 % ) patients were anaemic at presentation gaining a mean of 1.73 g/dl ( P short-course FeSO4 supplementation . Right-sided tumours ( lower mean Hb at presentation ; P=0.008 ) responded more to FeSO4 when compared to left-sided tumours ( P in Hb was unrelated to pathological stage . The transfusion rate for all curative resections was 0.69 units/patient . For the historical cohort ( patients undergoing curative resection between 1 January 2001 and 31 December 2003 ) , the mean transfusion rate fell from 1.69 units/patient . CONCLUSIONS Routine short-course supplementation with iron offers improved pre-operative Hb prior to surgery in CRC , especially in right-sided lesions and those with presenting anaemia",
"OBJECTIVE To assess the efficacy of oral iron therapy in the recovery of patients ' hemoglobin levels after major surgery . DESIGN R and omized controlled trial . SETTING Private orthopedic practice confined to one large community hospital . PATIENTS One hundred seventy consecutive elderly patients undergoing hip surgery ; 75 failed to meet entry hematologic or medical criteria ; 95 were r and omized , with 16 withdrawn because of complications . INTERVENTION Thirty-seven patients received ferrous sulfate orally four times a day for the duration of their hospitalization . Forty-two patients who received no iron supplement served as the control group . MAIN OUTCOME MEASURES Changes in hemoglobin levels and reticulocyte counts over the 2- to 3-week follow-up period . RESULTS There was no significant difference in mean hemoglobin levels between the treatment and control groups ( 95 % confidence interval [ CI ] for difference of -6.6 to 5.4 g/L ) . Corrected reticulocyte fractions increased equally in both groups ( 95 % CI for difference of -9 x 10(3 ) to 2 x 10(-3 ) . The study was design ed to detect a difference in mean hemoglobin levels of 8.5 g/L or greater or a difference in mean reticulocyte fraction of 10 x 10(-3 ) between the two groups with a power of 0.80 at the .05 ( two-sided ) level of significance . CONCLUSION The administration of oral iron supplements to elderly , healthy orthopedic patients postoperatively did not hasten the recovery of hemoglobin levels , provided adequate tissue iron stores were present",
"PURPOSE Elderly patients are vulnerable to the dose-dependent adverse effects of iron replacement therapy . Our study examines whether low-dose iron therapy can efficiently resolve iron-deficiency anemia in patients over the age of 80 years and reduce adverse effects . SUBJECTS AND METHODS Ninety hospitalized patients with iron-deficiency anemia were r and omized to receive elemental iron in daily doses of 15 mg or 50 mg as liquid ferrous gluconate or 150 mg of ferrous calcium citrate tablets for 60 days . Thirty control patients without anemia were given 15 mg of iron for 60 days . A 2-hour iron absorption test was performed after the initial dose . Hemoglobin and ferritin levels were measured on day 1 , 30 , and 60 after initiating therapy . Each patient completed a weekly question naire regarding drug-induced adverse effects . RESULTS Serum iron rose significantly in the anemic patients beginning 15 minutes after the first dose but not in nonanemic patients . Two months of iron treatment significantly increased hemoglobin and ferritin concentrations similarly in all 3 groups of iron-deficiency anemia patients ( for example , hemoglobin levels rose from 10.0 g/dL to 11.3 g/dL with 15 mg/d of iron therapy and from 10.2 g/dL to 11.6 g/dL with 150 mg/d ) . Abdominal discomfort , nausea , vomiting , changes in bowel movements , and black stools were significantly more common at higher iron doses . CONCLUSIONS Low-dose iron treatment is effective in elderly patients with iron-deficiency anemia . It can replace the commonly used higher doses and can significantly reduce adverse effects",
"A prospect i ve r and omised controlled trial was performed to establish the effect of oral iron supplementation on haemoglobin level at 4 weeks post-operative in elderly patients with fractured neck of femur undergoing surgical treatment . We single blindly r and omised 68 patients into two groups . Thirty-four patients in the treatment group were compared with 32 in the control group . The treatment group received 200 mg of oral iron tablets 3 times a day for 4 weeks in the post-operative period compared to nothing for the control group . The groups were comparable in all other aspects . The iron treatment result ed in significantly increased haemoglobin value at 4 weeks ; 0.76 g% higher than the control group ( 95 % CI of + 0.01 to + 1.51 ) which is statistically significant ( P no major complication . We recommend oral iron supplementation in elderly anaemic patients with hip fracture in the post-operative period"
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4117e01a-06ff-11f0-808a-c43d1ab1c353
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Despite the popularity of the PTSD Checklist ( PCL ) as a clinical screening test , there has been no comprehensive quality review of studies evaluating its diagnostic accuracy . A systematic quality assessment of 22 diagnostic accuracy studies of the English- language PCL using the Quality Assessment of Diagnostic Accuracy Studies ( QUADAS ) assessment tool was conducted to examine ( a ) the quality of diagnostic accuracy studies of the PCL , and ( b ) whether quality has improved since the 2003 ST And ards for the Reporting of Diagnostic accuracy studies ( STARD ) initiative regarding reporting guidelines for diagnostic accuracy studies . Three raters independently applied the QUADAS tool to each study , and a consensus among the 4 authors is reported . Findings indicated that although studies generally met st and ards in several quality areas , there is still room for improvement . Areas for improvement include establishing representativeness , adequately describing clinical and demographic characteristics of the sample , and presenting better descriptions of important aspects of test and reference st and ard execution . Only 2 studies met each of the 14 quality criteria . In addition , study quality has not appreciably improved since the publication of the STARD Statement in 2003 . Recommendations for the improvement of diagnostic accuracy studies of the PCL are discussed
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"Although Post-traumatic Stress Disorder ( PTSD ) is common among patients seeking care at medical clinics , little is known about the performance of screening instruments for this disorder in these setting s. Previous studies of acute trauma population s using the PTSD Checklist ( PCL ) have suggested that scores of 45 - 50 provide the best discrimination between cases and noncases . We gave the PCL to 1,225 r and omly selected women enrolled in an HMO . After interviewing a sample of 261 of these women using a structured , clinician-administered PTSD interview , we compared the results of the PCL to the clinician interviews over a range of possible cut scores using Receiver Operating Characteristic analysis . The optimum balance of sensitivity and specificity for this population was a score of 30 , yielding a sensitivity of.82 and specificity of.76 . The positive and negative likelihood ratios for this cut score were 3.40 and 0.24 , respectively . By comparison , the use of 45 as a cut score would result in very low sensitivity ( .36 ) in this setting . The lower cut score found in this study may indicate that the use of previously published cut scores of 45 - 50 may not optimize the function of the PCL as a screening tool outside of acute trauma setting s due to an unacceptably high number of false negative cases",
"OBJECTIVE To examine posttraumatic stress disorder ( PTSD ) in mothers of survivors of childhood cancer . Comorbidity of anxiety and depressive disorders , prevalence of sub clinical PTSD , and the utility of a self-report measure as a screening instrument for PTSD were also investigated . METHOD Mothers ( n = 65 ) completed a question naire self-report PTSD checklist ( PCL-C ) . Mothers were administered several modules of the SCID : nonpatient edition by telephone , including the PTSD , Generalized Anxiety , and Major Depressive Disorder modules . RESULTS We diagnosed 6.2 % of the sample with current PTSD . An additional 20 % had sub clinical PTSD . One of four mothers with PTSD diagnoses had a comorbid diagnosis of an anxiety and depressive disorder . The PCL-C evidence d diagnostic utility as a screening instrument . However , a moderate number of false-positives would result if the recommended cut-off on the instrument was used . CONCLUSIONS The PCL-C had diagnostic utility in screening mothers of childhood cancer survivors . The presence of comorbid diagnoses such as anxiety and depression should be examined",
"We examined the psychometric properties of the PTSD Checklist ( PCL ) , a self-report instrument design ed to assess symptoms of posttraumatic stress disorder . Three hundred ninety-two participants recruited in a university setting completed the PCL in addition to several well-established self-report instruments design ed to assess various forms of psychopathology ( e.g. , depression , general anxiety , PTSD ) . Ninety participants returned for readministration of selected measures . Findings provided support for psychometric properties of the PCL , including internal consistency , test – retest reliability , convergent validity , and discriminant validity . Additional strengths of the PCL are discussed",
"PURPOSE This article evaluates the comparability of the telephone and in-person Structured Clinical Interview for DSM-IV ( SCID ) interviews in assessing patients with social anxiety disorder ( SAD ) as an independent anxiety diagnosis . DESIGN AND METHODS One hundred subjects were r and omly selected and interviewed with the SCID , once by telephone and once in person ( 1 - 3 months later ) . FINDINGS The prevalence of SAD assessed with the telephone interviews was 56 % , whereas the in-person prevalence was 52 % , with no statistically significant difference . The test-retest kappa for the 200 interviews was .84 , indication of excellent agreement . PRACTICE IMPLICATION S These findings , along with the existing evidence of their validity , should encourage the use of SCID by telephone for SAD diagnostic interviews",
"The SCID was administered twice , once by telephone and once in person ( 1 week later ) to 41 college age men . For major depression ( lifetime K = .64 , current K = .66 ) , results indicated good agreement . The lifetime occurrence estimate based on the telephone SCID diagnosis was lower than the in-person SCID estimate . Kappas for specific diagnoses were calculable for simple phobia ( lifetime K = .47 , current K = -.03 ) and social phobia ( lifetime K = .29 ) . Base rates were less than 10 % for all individual diagnoses except lifetime major depression ; therefore , the kappas may be unstable . For all diagnoses where there were any positive cases , percentages of negative agreement and specificity were high , whereas percentages of positive agreement and sensitivity were lower . Overall agreement was fair for specific lifetime diagnoses but poor for current diagnoses . These results suggest caution in assuming comparability of in-person and telephone SCID diagnoses . Circumstances under which a telephone SCID may be useful and ways to improve reliability are discussed",
"OBJECTIVE This study assessed the psychopathological effects of combat in veterans with and without combat stress reaction . METHOD Veterans ( N=214 ) from the 1982 Lebanon War were assessed in a prospect i ve longitudinal design : 131 suffered from combat stress reaction during the war , and 83 did not . They were evaluated 1 , 2 , 3 , and 20 years after the war . RESULTS Combat stress reaction is an important vulnerability marker . Veterans with combat stress reaction were 6.6 times more likely to endorse posttraumatic stress disorder ( PTSD ) at all four measurements , their PTSD was more severe , and they were at increased risk for exacerbation/reactivation . A qualitative analysis of the profile of PTSD symptoms revealed some time-related changes in the symptom configuration of veterans who did not suffer from combat stress reaction . In both groups , the course fluctuated ; PTSD rates dropped 3 years postwar and rose again 17 years later ; 23 % of veterans without combat stress reaction reported delayed PTSD . CONCLUSIONS These findings suggest that the detrimental effects of combat are deep and enduring and follow a complex course , especially in combat stress reaction casualties . The implication s of aging and ongoing terror in impeding recovery from the psychological wounds of war are discussed",
"PTSD affects a substantial number of women in medical setting s and is associated with significant distress and impairment . There are effective methods of treating trauma-related distress , but a minority seek such care . Thus , primary care is an important setting in which to identify individuals with PTSD . We sent question naires , including the PTSD Checklist — Civilian Version ( PCL-C ) , to 419 female veterans who were seen in our primary care clinic in 1998 ; 56 % ( N = 221 ) returned the measures . A r and om subset ( n = 49 ) was interviewed to establish psychiatric diagnoses . The results provide qualified support for the use of the PCL-C total score with a lowered cutoff score as a screening measure for PTSD in female veterans in primary care",
"RATIONALE AND OBJECTIVES Quality Assessment of Diagnostic Accuracy Studies ( QUADAS ) is a new tool to measure the method ological quality of diagnostic accuracy studies in systematic review s. We used data from a systematic review of magnetic resonance spectroscopy ( MRS ) in the characterization of suspected brain tumors to provide a preliminary evaluation of the inter-rater reliability of QUADAS . MATERIAL S AND METHODS A structured literature search identified 19 diagnostic accuracy studies . These publications were distributed r and omly to primary and secondary review ers for dual independent assessment . Review ers recorded method ological quality by using QUADAS on a custom- design ed spreadsheet . We calculated correlation , percentage of agreement , and kappa statistic to assess inter-rater reliability . RESULTS Most studies in our review were judged to have used an accurate reference st and ard . Conversely , the MRS literature frequently failed to specify the length of time between index and reference tests or that the clinicians were unaware of the index test findings when reporting the reference st and ard . There was good correlation ( rho = 0.78 ) between review ers in assessment of the overall number of quality criteria met . However , mean agreement for individual QUADAS questions was only fair ( kappa = 0.22 ) and ranged from no agreement beyond chance ( kappa Inter-rater reliability in our study was relatively low . Nevertheless , we believe that QUADAS potentially is a useful tool for highlighting the strengths and weaknesses of existing diagnostic accuracy studies . Low reliability suggests that different review ers will reach different conclusions if QUADAS is used to exclude \" low- quality \" articles from meta-analyses . We discuss methods for improving the validity and reliability of QUADAS"
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4117e056-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Fibromyalgia is characterized by chronic widespread pain that leads to reduced physical function . Exercise training is commonly recommended as a treatment for management of symptoms . We examined the literature on resistance training for individuals with fibromyalgia . Resistance training is exercise performed against a progressive resistance with the intention of improving muscle strength , muscle endurance , muscle power , or a combination of these . OBJECTIVES To evaluate the benefits and harms of resistance exercise training in adults with fibromyalgia . We compared resistance training versus control and versus other types of exercise training . SEARCH METHODS We search ed nine electronic data bases ( The Cochrane Library , MEDLINE , EMBASE , CINAHL , PEDro , Dissertation Abstract s , Current Controlled Trials , World Health Organization ( WHO ) International Clinical Trials Registry Platform , AMED ) and other sources for published full-text articles . The date of the last search was 5 March 2013 . Two review authors independently screened 1856 citations , 766 abstract s and 156 full-text articles . We included five studies that met our inclusion criteria . SELECTION CRITERIA Selection criteria included : a ) r and omized clinical trial , b ) diagnosis of fibromyalgia based on published criteria , c ) adult sample , d ) full-text publication , and e ) inclusion of between-group data comparing resistance training versus a control or other physical activity intervention . DATA COLLECTION AND ANALYSIS Pairs of review authors independently assessed risk of bias and extracted intervention and outcome data . We resolved disagreements between the two review authors and questions regarding interpretation of study methods by discussion within the pairs or when necessary the issue was taken to the full team of 11 members . We extracted 21 outcomes of which seven were design ated as major outcomes : multidimensional function , self reported physical function , pain , tenderness , muscle strength , attrition rates , and adverse effects . We evaluated benefits and harms of the interventions using st and ardized mean differences ( SMD ) or mean differences ( MD ) or risk ratios or Peto odds ratios and 95 % confidence intervals ( CI ) . Where two or more studies provided data for an outcome , we carried out a meta- analysis . MAIN RESULTS The literature search yielded 1865 citations with five studies meeting the selection criteria . One of the studies that had three arms contributed data for two comparisons . In the included studies , there were 219 women participants with fibromyalgia , 95 of whom were assigned to resistance training programs . Three r and omized trials compared 16 to 21 weeks of moderate- to high-intensity resistance training versus a control group . Two studies compared eight weeks of progressive resistance training ( intensity as tolerated ) using free weights or body weight resistance exercise versus aerobic training ( ie , progressive treadmill walking , indoor and outdoor walking ) , and one study compared 12 weeks of low-intensity resistance training using h and weights ( 1 to 3 lbs ( 0.45 to 1.36 kg ) ) and elastic tubing versus flexibility exercise ( static stretches to major muscle groups).Statistically significant differences ( MD ; 95 % CI ) favoring the resistance training interventions over control group(s ) were found in multidimensional function ( Fibromyalgia Impact Question naire ( FIQ ) total decreased 16.75 units on a 100-point scale ; 95 % CI -23.31 to -10.19 ) , self reported physical function ( -6.29 units on a 100-point scale ; 95 % CI -10.45 to -2.13 ) , pain ( -3.3 cm on a 10-cm scale ; 95 % CI -6.35 to -0.26 ) , tenderness ( -1.84 out of 18 tender points ; 95 % CI -2.6 to -1.08 ) , and muscle strength ( 27.32 kg force on bilateral concentric leg extension ; 95 % CI 18.28 to 36.36).Differences between the resistance training group(s ) and the aerobic training groups were not statistically significant for multidimensional function ( 5.48 on a 100-point scale ; 95 % CI -0.92 to 11.88 ) , self reported physical function ( -1.48 units on a 100-point scale ; 95 % CI -6.69 to 3.74 ) or tenderness ( SMD -0.13 ; 95 % CI -0.55 to 0.30 ) . There was a statistically significant reduction in pain ( 0.99 cm on a 10-cm scale ; 95 % CI 0.31 to 1.67 ) favoring the aerobic groups . Statistically significant differences were found between a resistance training group and a flexibility group favoring the resistance training group for multidimensional function ( -6.49 FIQ units on a 100-point scale ; 95 % CI -12.57 to -0.41 ) and pain ( -0.88 cm on a 10-cm scale ; 95 % CI -1.57 to -0.19 ) , but not for tenderness ( -0.46 out of 18 tender points ; 95 % CI -1.56 to 0.64 ) or strength ( 4.77 foot pounds torque on concentric knee extension ; 95 % CI -2.40 to 11.94 ) . This evidence was classified low quality due to the low number of studies and risk of bias assessment . There were no statistically significant differences in attrition rates between the interventions . In general , adverse effects were poorly recorded , but no serious adverse effects were reported . Assessment of risk of bias was hampered by poor written descriptions ( eg , allocation concealment , blinding of outcome assessors ) . The lack of a priori protocol s and lack of care provider blinding were also identified as method ologic concerns . AUTHORS ' CONCLUSIONS The evidence ( rated as low quality ) suggested that moderate- and moderate- to high-intensity resistance training improves multidimensional function , pain , tenderness , and muscle strength in women with fibromyalgia . The evidence ( rated as low quality ) also suggested that eight weeks of aerobic exercise was superior to moderate-intensity resistance training for improving pain in women with fibromyalgia . There was low- quality evidence that 12 weeks of low-intensity resistance training was superior to flexibility exercise training in women with fibromyalgia for improvements in pain and multidimensional function . There was low- quality evidence that women with fibromyalgia can safely perform moderate- to high-resistance training
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"The purpose of this study was to compare the effects of aerobic training with a muscle-strengthening program in patients with fibromyalgia . Thirty women with fibromyalgia were r and omized to either an aerobic exercise ( AE ) program or a strengthening exercise ( SE ) program for 8 weeks . Outcome measures included the intensity of fibromyalgia-related symptoms , tender point count , fitness ( 6-min walk distance ) , hospital anxiety and depression ( HAD ) scale , and short-form health survey ( SF-36 ) . There were significant improvements in both groups regarding pain , sleep , fatigue , tender point count , and fitness after treatment . HAD-depression scores improved significantly in both groups while no significant change occurred in HAD-anxiety scores . Bodily pain subscale of SF-36 and physical component summary improved significantly in the AE group , whereas seven subscales of SF-36 , physical component summary , and mental component summary improved significantly in the SE group . When the groups were compared after treatment , there were no significant differences in pain , sleep , fatigue , tender point count , fitness , HAD scores , and SF-36 scores . AE and SE are similarly effective at improving symptoms , tender point count , fitness , depression , and quality of life in fibromyalgia",
"OBJECTIVE A subset of fibromyalgia ( FM ) patients have a dysfunctional hypothalamic-pituitary-insulin-like growth factor 1 ( IGF-1 ) axis , as evidence d by low serum levels of IGF-1 and a reduced growth hormone ( GH ) response to physiologic stimuli . There is evidence that pyridostigmine ( PYD ) improves the acute response of GH to exercise in FM patients . The purpose of this study was to evaluate the clinical effectiveness of 6 months of PYD and group exercise on FM symptoms . METHODS FM patients were r and omized to 1 of the following 4 groups : PYD plus exercise , PYD plus diet recall but no exercise , placebo plus exercise , and placebo plus diet recall but no exercise . The primary outcome measures were the visual analog scale ( VAS ) score for pain , tender point count , and total myalgic score . Secondary outcome measures were the total score on the Fibromyalgia Impact Question naire ( FIQ ) and FIQ VAS scores for individual symptoms ( fatigue , poor sleep , stiffness , and anxiety ) , as well as quality of life ( QOL ) and physical fitness ( lower body strength/endurance , upper and lower body flexibility , balance , and time on the treadmill ) . RESULTS A total of 165 FM patients completed baseline measurements ; 154 ( 93.3 % ) completed the study . The combination of PYD and exercise did not improve pain scores . PYD groups showed a significant improvement in sleep and anxiety in those who completed the study and in QOL in those who complied with the therapeutic regimen as compared with the placebo groups . Compared with the nonexercise groups , the 2 exercise groups demonstrated improvement in fatigue and fitness . PYD was generally well tolerated . CONCLUSION Neither the combination of PYD plus supervised exercise nor either treatment alone yielded improvement in most FM symptoms . However , PYD did improve anxiety and sleep , and exercise improved fatigue and fitness . We speculate that PYD may have improved vagal tone , thus benefiting sleep and anxiety ; this notion warrants further study",
"OBJECTIVE To compare scales measuring exercise-induced changes in mood . METHODS Mood changes in a r and omized , 23-week controlled trial of exercise were assessed using the Beck Depression Inventory ( BDI ) , Center for Epidemiologic Studies Depression Scale ( CES-D ) , State Trait Anxiety Inventory ( STAI ) , Fibromyalgia Impact Question naire , and the Mental Health Inventory ( MHI ) . Effect sizes and t-tests were computed on 23-week change scores . Scales were deemed to be confounded if items addressed sleep disturbances , fatigue , or effort ( symptoms of both mood disturbances and fibromyalgia ) . RESULTS Efficacy ( 15 exercise subjects ) and intent-to-treat analyses ( 27 exercise subjects ) generated medium effects for BDI ( total , cognitive ) , MHI depression ( efficacy only ) , and CES-D ( intent-to-treat only ) scales . BDI ( total , cognitive ) , MHI ( depression , positive affect , total [ MHI-5 ] ) , and STAI scales distinguished exercise from control subjects at 23 weeks in all analyses . BDI somatic and CES-D scales were deemed to be confounded . CONCLUSION We recommend the BDI cognitive , STAI , and MHI-5 scales to measure depression , anxiety , and general mood , respectively , in patients with fibromyalgia",
"Objectives : Published preliminary findings from a r and omized-controlled trial suggest that an 8-week Yoga of Awareness intervention may be effective for improving symptoms , functional deficits , and coping abilities in fibromyalgia . The primary aims of this study were to evaluate the same intervention ’s posttreatment effects in a wait-list group and to test the intervention ’s effects at 3-month follow-up in the immediate treatment group . Methods : Unpaired t tests were used to compare data from a per protocol sample of 21 women in the immediate treatment group who had completed treatment and 18 women in the wait-list group who had completed treatment . Within-group paired t tests were performed to compare posttreatment data with 3-month follow-up data in the immediate treatment group . The primary outcome measure was the Fibromyalgia Impact Question naire Revised ( FIQR ) . Multilevel r and om-effects models were also used to examine associations between yoga practice rates and outcomes . Results : Posttreatment results in the wait-list group largely mirrored results seen at posttreatment in the immediate treatment group , with the FIQR Total Score improving by 31.9 % across the 2 groups . Follow-up results showed that patients sustained most of their posttreatment gains , with the FIQR Total Score remaining 21.9 % improved at 3 months . Yoga practice rates were good , and more practice was associated with more benefit for a variety of outcomes . Discussion : These findings indicate that the benefits of Yoga of Awareness in fibromyalgia are replicable and can be maintained",
"ABSTRACT Objective : Fibromyalgia ( FM ) patients present with widespread chronic pain and other symptoms . Some studies in the literature have reported inconsistent results after a Qigong exercise intervention in patients with FM . The purpose of this study was to test the feasibility of a home-based Qigong exercise in patients with FM . Methods : A total of 14 subjects were r and omly assigned into one of two groups . The experimental group went through a six-week Qigong exercise program involving meditation , deep breathing , and synchronized rhythmic body movements . The control group took part in a sham Qigong exercise program using the same body movements also for six weeks . Clinical assessment s at baseline and end of intervention used the Short-Form McGill Pain Question naire , Multidimensional Fatigue Inventory , Pittsburgh Sleep Quality Index , and Fibromyalgia Impact Question naire . Results : Group mean scores of four measurements were significantly ( p changes in the four measurements were 44.2 % , 24.8 % , 37.3 % , and 44.3 % in the intervention group , and 10.1 % , 6.3 % , 9.9 % , and 11.8 % in the control group . Conclusion : Qigong exercise may potentially be an effective self-management approach in controlling FM symptoms . In this pilot study , regular daily Qigong exercise , accumulated number of exercise sessions , and the specific form of Qigong exercise may all be important factors for the significant improvement in the study subjects . Future research is required to determine whether the same benefit can be obtained in a larger sample",
"Objectives : To assess the effectiveness of multidisciplinary rehabilitation in the treatment of fibromyalgia in comparison to st and ard medical care . Methods : Seventy-nine men and women were r and omly assigned to one of two groups . The intervention group consisted of a rheumatologist and physical therapist intake and discharge , 18 group supervised exercise therapy sessions , 2 group pain and stress management lectures , 1 group education lecture , 1 group dietary lecture , and 2 massage therapy sessions . The control group consisted of st and ard medical care with the patients ' family physician . Outcome measures included self-perceived health status , pain-related disability , average pain intensity , depressed mood , days in pain , hours in pain , prescription and nonprescription medication usage , and work status . Outcomes were measured at the end of the 6-week intervention and at 15-month follow-up . Results : Thirty-five out of 43 patients from the intervention group and 36 out of 36 patients from the control group completed the study . There were no statistically significant differences between the 2 groups prior to intervention . Intention-to-treat analysis revealed that the intervention group , in comparison to the control group , experienced statistically significant changes at intervention completion in self-perceived health status , average pain intensity , pain related disability , depressed mood , days in pain , and hours in pain , but no significant differences in nonprescription drug use , prescription drug use , or work status . At 15 months , all health outcomes retained their significance except health status . Nonprescription and prescription drug use demonstrated significant reductions at 15 months . Binary logistic regression indicated that long-term changes in Pain Disability Index were influenced by long-term exercise adherence and income status . Conclusions : Positive health-related outcomes in this mostly unresponsive condition can be obtained with a low-cost , group multidisciplinary intervention in a community-based , non clinical setting",
"A quasi-experimental design was used to assess a multimodal pain treatment program for female patients with fibromyalgia to ascertain immediate and long-term effects . Laboratory and self-report pain measures together with psychological measures were obtained from patients who were tested up to 6 months after treatment . Comparison data were also obtained from fibromyalgia patients who failed to qualify for the treatment program because of insurance coverage . Immediate and long-term treatment effects were evident with the psychological measures and the subjective pain measures but not with the laboratory pain measures . Participants who attended the month-long multimodal program achieved significant and positive changes on most of the outcome measures . However , relapse prevention must be addressed",
"OBJECTIVE To assess the efficiency of a treatment composed of muscle stretching exercises , associated or not to laser therapy at tender points , for patients with fibromyalgia ( FM ) , in view of bettering their quality of life . METHODS Twenty FM patients were r and omly assigned to two groups : one su bmi tted to laser therapy and stretching ( LSG , n=10 ) , and the other only to stretching exercises ( SG , n=10 ) . The visual analog scale of pain ( VAS ) and dolorimetry at tender points were used to assess pain ; life quality was evaluated by means of the Fibromyalgia Impact Question naire ( FIQ ) and the 36-item Short-Form Health Survey ( SF-36 ) . RESULTS After the treatment program , both in LSG and SG were detected pain reduction , higher pain threshold at tender points ( all p lower mean FIQ scores , and higher SF-36 mean scores ( all p stretching exercises program proposed is efficient to reduce pain and painful sensibility at tender points , thus enhancing patients ' quality of life . Laser therapy has not shown advantages when added to muscle stretching exercises",
"OBJECTIVE To test the hypothesis that autonomic modulation after resistance exercise ( RE ) would be reduced in women with fibromyalgia ( FM ) compared with controls . DESIGN Before-after trial . SETTING Testing occurred in a university setting . PARTICIPANTS Women with FM ( n=9 ) and healthy controls ( n=9 ) underwent testing before ( pre ) and 20 minutes after ( post ) RE . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Normalized low-frequency ( LFnu ) and normalized high-frequency ( HFnu ) oscillations and the LFnu/HFnu ratio were indicative of sympathetic modulation , parasympathetic modulation , and sympathovagal balance , respectively . Baroreceptor reflex sensitivity ( BRS ) was also measured . RESULTS Variables were similar in both groups at rest . HFnu decreased in controls ( pre , 55.0+/-4.2 % ; post , 35.0+/-4.7 % ; P women with FM ( pre , 57.0+/-5.7 % ; post , 63.2+/-4.6 % ; P LFnu increased in controls ( pre , 43.3+/-4.4 % ; post , 63.2+/-4.8 % ; P FM ( pre , 41.8+/-5.6 % ; post , 35.6+/-4.7 % ; P LFnu/HFnu ratio increased in controls ( pre , 0.89+/-0.17 ; post , 2.43+/-0.64 ; P FM ( pre , 0.90+/-0.22 ; post , 0.64+/-0.13 ; P=.13 ) . BRS decreased in controls ( pre , 8.78+/-1.42 ms/mmHg ; post , 5.49+/-0.66 ms/mmHg ; P . These postexercise responses may be attributed to the altered autonomic responsiveness to physiologic stress that characterizes FM",
"OBJECTIVE To evaluate the feasibility of 8 months of supervised exercise therapy in warm water and its effects on the impact of fibromyalgia on physical and mental health and physical fitness in affected women . METHODS Thirty women with fibromyalgia were r and omly assigned to an exercise therapy group ( n = 15 ) or a control group ( inactive ) ( n = 15 ) . The impact of fibromyalgia on physical and mental health was assessed using the Fibromyalgia Impact Question naire and the anxiety state with State-Trait Anxiety Inventory . Physical fitness was measured using the following tests : Canadian Aerobic Fitness ; h and -grip dynamometry ; 10-metre walking ; 10-step stair-climbing and blind 1-leg stance . RESULTS After 8 months of training , the exercise therapy group improved compared with the control group in terms of physical function ( 20 % ) , pain ( 8 % ) , stiffness ( 53 % ) , anxiety ( 41 % ) , depression ( 27 % ) , Fibromyalgia Impact Question naire total scores ( 18 % ) , State-Trait Anxiety Inventory score ( 22 % ) , aerobic capacity ( 22 % ) , balance ( 30 % ) , functional capacity for walking ( 6 % ) , stair-climbing with no extra weight ( 14 % ) and stair-climbing 10 kg-weighted ( 25 % ) . CONCLUSION Eight months of supervised exercise in warm water was feasible and led to long-term improvements in physical and mental health in patients with fibromyalgia at a similar magnitude to those of shorter therapy programmes",
"OBJECTIVE To evaluate the effects of pool exercise in patients with fibromyalgia and chronic widespread pain and to determine characteristics influencing the effects of treatment . METHODS A total of 134 women with fibromyalgia and 32 with chronic widespread pain were r and omized to a 20-session pool exercise and a 6-session education programme or to a control group undertaking the same education programme . The primary outcomes were the Fibromyalgia Impact Question naire ( FIQ ) total score and the 6-minute walk test ( 6MWT ) . FIQ Pain and other health variables were included . RESULTS The FIQ total ( p = 0.04 ) improved in the intervention group , with an effect size of 0.32 . Patients who had participated in at least 60 % of the exercise sessions improved in the FIQ total ( effect size 0.44 ) , the 6MWT ( effect size 0.43 ) and FIQ Pain ( effect size 0.69 ) compared with controls ( p 6MWT among the active participants ( p patients with milder stress , pain or depression improved most by treatment on the FIQ total ( effect size > 0.50 , p exercise-education programme showed significant , but small , improvement in health status in patients with fibromyalgia and chronic widespread pain , compared with education only . Patients with milder symptoms improved most with this treatment",
"We tested the hypothesis that exercise would improve subjective sleep quality and activity in depressed elders . A 10-week r and omized controlled trial was utilized . Participants consisted of a volunteer sample , aged > 60 with a diagnosis of major or minor depression or dysthymia . A total of 32 subjects aged 60 - 84 years with a mean age of 71.3 + /- 1.2 years was used . Intervention consisted of a supervised weight-training program three times a week or an attention-control group . Main outcome measures were Pittsburgh Subjective Sleep Quality Index ( PSQI ) , Likert Scale of Subjective Sleep Quality and Quantity . Paffenbarger Activity Index . Geriatric Depression Scale ( GDS ) . Beck Depression Inventory ( BDI ) , Hamilton Rating Scale of Depression ( HRSD ) , and the Medical Outcomes Survey Short Form 36 ( SF-36 ) . Results showed that exercise significantly improved all subjective sleep- quality and depression measures . Depression measures were reduced by approximately twice that of controls . Habitual activity was not significantly increased by exercise . Quality of life subscales significantly improved . In a forward stepwise multiple regression , percent improvement in GDS and percent increase in strength remained significant predictors of the improvement in total PSQI score ( r = 0.71 , p = 0.0002 ) . In conclusion , weight lifting exercise was effective in improving subjective sleep quality , depression , strength , and quality of life without significantly changing habitual activity",
"Introduction Although exercise is therapeutic for adults with fibromyalgia ( FM ) , its symptoms often create obstacles that discourage exercise . We evaluated the effects of accumulating at least 30 minutes of self-selected lifestyle physical activity ( LPA ) on perceived physical function , pain , fatigue , body mass index , depression , tenderness , and the six-minute walk test in adults with FM . Methods Eighty-four minimally active adults with FM were r and omized to either LPA or a FM education control ( FME ) group . LPA participants worked toward accumulating 30 minutes of self-selected moderate-intensity LPA , five to seven days per week , while the FME participants received information and support . Results Seventy-three of the 84 participants ( 87 % ) completed the 12-week trial . The LPA group increased their average daily steps by 54 % . Compared to FME , the LPA group reported significantly less perceived functional deficits ( P = .032 ) and less pain ( P = .006 ) . There were no differences between the groups on the six-minute walk test ( P = .067 ) , fatigue , depression , body mass index , or tenderness . Conclusions Accumulating 30 minutes of LPA throughout the day produces clinical ly relevant changes in perceived physical function and pain in previously minimally active adults with FM.Trial Registration clinical trials.gov",
"UNLABELLED Altan L , Korkmaz N , Bingol U , Gunay B. Effect of Pilates training on people with fibromyalgia syndrome : a pilot study . OBJECTIVE To investigate the effects of Pilates on pain , functional status , and quality of life in fibromyalgia , which is known to be a chronic musculoskeletal disorder . DESIGN R and omized , prospect i ve , controlled , and single-blind trial . SETTING Physical medicine and rehabilitation department . PARTICIPANTS Women ( N=50 ) who had a diagnosis of fibromyalgia syndrome ( FMS ) according to the American College of Rheumatology criteria . INTERVENTION The participants were r and omly assigned into 2 groups . In group 1 , a Pilates exercise program of 1 hour was given by a certified trainer to 25 participants 3 times a week for 12 weeks . In group 2 , which was design ed as the control group , 25 participants were given a home exercise ( relaxation/stretching ) program . In both groups , pre- ( week 0 ) and posttreatment ( week 12 and week 24 ) evaluation was performed by one of the authors , who was blind to the group allocation . MAIN OUTCOME MEASURES Primary outcome measures were pain ( visual analog scale ) and Fibromyalgia Impact Question naire ( FIQ ) . Exploratory outcome measures were number of tender points , algometric score , chair test , and Nottingham Health Profile . RESULTS Twenty-five Pilates exercise and 24 relaxation/stretching exercise participants completed the study . In group 1 , significant improvement was observed in both pain and FIQ at week 12 but only in FIQ at 24 weeks . In group 2 , no significant improvement was obtained in pain and FIQ at week 12 and week 24 . Comparison of the 2 groups showed significantly superior improvement in pain and FIQ in group 1 at week 12 but no difference between the 2 groups at week 24 . CONCLUSIONS We suggest Pilates as an effective and safe method for people with FMS . Our study is the first clinical study design ed to investigate the role of the Pilates method in FMS treatment . We believe that further research with more participants and longer follow-up periods could help assess the therapeutic value of this popular physical exercise method",
"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",
"OBJECTIVE To compare 2 exercise modalities , aerobic fitness training and stretching exercises , in patients with fibromyalgia ( FM ) in relation to function , pain , quality of life , depression , and anxiety , and to correlate the cardiorespiratory fitness gain with symptom improvement . METHODS Seventy-six women with FM between 18 and 60 years old were r and omized to either an aerobic program or stretching program , for 20 weeks . They were evaluated at the beginning of the program and after 10 and 20 weeks in relation to the improvement of aerobic fitness , flexibility , function , Fibromyalgia Impact Question naire ( FIQ ) , Short-form Health Survey ( SF-36 ) , and depression and anxiety levels . Ventilatory anaerobic threshold ( VT ) and maximum oxygen uptake ( VO2max ) were determined by expired gas analyses . RESULTS Aerobic exercise was superior to stretching in relation to VO2 max , VT , function , depression , pain , and the emotional aspects and mental health domains of SF-36 . Patients in the stretching group showed no improvement in depression , \" role emotional , \" and \" mental health . \" No association was noted between improvement in aerobic fitness as measured by VT and the improvement of pain , function , or scores in FIQ and SF-36 . CONCLUSION Our results confirm that aerobic exercise is beneficial to patients with FM , but the cardiorespiratory fitness gain is not related to improvement of FM symptoms",
"OBJECTIVE To assess the utility of an exercise program , which included aerobic , flexibility and strengthening elements , in the treatment of fibromyalgia ( FM ) . FM is a chronic musculoskeletal condition characterized by diffuse musculoskeletal pain and aching . It has been suggested that aerobic exercise is helpful in its treatment . METHODS We studied 60 patients who met American College of Rheumatology criteria for FM and had no significant comorbidities . Measurements performed on each patient at the pre and post study assessment included the number of tender points ( TP ) , total myalgic scores ( TM ) , aerobic fitness ( AF ) , flexibility and isokinetic strength . After initial evaluation patients were r and omly assigned to either an exercise or a relaxation group . Each group met 3 times per week for 6 weeks for 1 h of supervised exercise or relaxation . All patients data were stored in a computerized data base and statistical analysis was performed on all pre and post study assessment s. RESULTS Thirty-eight patients ( 18 exercise and 20 relaxation ) completed the study . Analysis of our data showed no significant difference between the groups in their pre study assessment . Post study assessment s , however , showed a significant improvement between the exercise and relaxation groups in TP ( p TM ( p AF ( p Exercise is helpful in the management of FM in the short term . It also shows that FM patients can undertake an exercise program which includes aerobic , flexibility , and strength training exercises without adverse effects . The long term utility of this type of exercise requires further evaluation",
"Introduction The objective of this study was to investigate the effects of moderate-to-high intensity Nordic walking ( NW ) on functional capacity and pain in fibromyalgia ( FM ) . Methods A total of 67 women with FM were recruited to the study and r and omized either to moderate-to-high intensity Nordic Walking ( n = 34 , age 48 ± 7.8 years ) or to a control group engaging in supervised low-intensity walking ( LIW , n = 33 , age 50 ± 7.6 years ) . Primary outcomes were the six-minute walk test ( 6MWT ) and the Fibromyalgia Impact Question naire Pain scale ( FIQ Pain ) . Secondary outcomes were : exercise heart rate in a submaximal ergometer bicycle test , the FIQ Physical ( activity limitations ) and the FIQ total score . Results A total of 58 patients completed the post-test . Significantly greater improvement in the 6MWT was found in the NW group ( P = 0.009 ) , as compared with the LIW group . No between-group difference was found for the FIQ Pain ( P = 0.626 ) . A significantly larger decrease in exercise heart rate ( P = 0.020 ) and significantly improved scores on the FIQ Physical ( P = 0.027 ) were found in the NW group as compared with the LIW group . No between-group difference was found for the change in the FIQ total . The effect sizes were moderate for the above mentioned outcomes . Conclusions Moderate-to-high intensity aerobic exercise by means of Nordic walking twice a week for 15 weeks was found to be a feasible mode of exercise , result ing in improved functional capacity and a decreased level of activity limitations . Pain severity did not change over time during the exercise period . Trial registration Clinical trials.gov identifier NCT00643006",
"Previous research ers have found that 10-form Tai chi yields symptomatic benefit in patients with fibromyalgia ( FM ) . The purpose of this study was to further investigate earlier findings and add a focus on functional mobility . We conducted a parallel-group r and omized controlled trial FM-modified 8-form Yang-style Tai chi program compared to an education control . Participants met in small groups twice weekly for 90 min over 12 weeks . The primary endpoint was symptom reduction and improvement in self-report physical function , as measured by the Fibromyalgia Impact Question naire ( FIQ ) , from baseline to 12 weeks . Secondary endpoints included pain severity and interference ( Brief Pain Inventory ( BPI ) , sleep ( Pittsburg sleep Inventory ) , self-efficacy , and functional mobility . Of the 101 r and omly assigned subjects ( mean age 54 years , 93 % female ) , those in the Tai chi condition compared with the education condition demonstrated clinical ly and statistically significant improvements in FIQ scores ( 16.5 vs. 3.1 , p = 0.0002 ) , BPI pain severity ( 1.2 vs. 0.4 , p = 0.0008 ) , BPI pain interference ( 2.1 vs. 0.6 , p = 0.0000 ) , sleep ( 2.0 vs. −0.03 , p = 0.0003 ) , and self-efficacy for pain control ( 9.2 vs. −1.5 , p = 0.0001 ) . Functional mobility variables including timed get up and go ( −.9 vs. −.3 , p = 0.0001 ) , static balance ( 7.5 vs. −0.3 , p = 0.0001 ) , and dynamic balance ( 1.6 vs. 0.3 , p = 0.0001 ) were significantly improved with Tai chi compared with education control . No adverse events were noted . Twelve weeks of Tai chi , practice twice weekly , provided worthwhile improvement in common FM symptoms including pain and physical function including mobility . Tai chi appears to be a safe and an acceptable exercise modality that may be useful as adjunctive therapy in the management of FM patients . ( Clinical Trials.gov Identifier , NCT01311427",
"& NA ; Mindfulness‐based stress reduction ( MBSR ) is a structured 8‐week group program teaching mindfulness meditation and mindful yoga exercises . MBSR aims to help participants develop nonjudgmental awareness of moment‐to‐moment experience . Fibromyalgia is a clinical syndrome with chronic pain , fatigue , and insomnia as major symptoms . Efficacy of MBSR for enhanced well‐being of fibromyalgia patients was investigated in a 3‐armed trial , which was a follow‐up to an earlier quasi‐r and omized investigation . A total of 177 female patients were r and omized to one of the following : ( 1 ) MBSR , ( 2 ) an active control procedure controlling for nonspecific effects of MBSR , or ( 3 ) a wait list . The major outcome was health‐related quality of life ( HRQoL ) 2 months post‐treatment . Secondary outcomes were disorder‐specific quality of life , depression , pain , anxiety , somatic complaints , and a proposed index of mindfulness . Of the patients , 82 % completed the study . There were no significant differences between groups on primary outcome , but patients overall improved in HRQoL at short‐term follow‐up ( P = 0.004 ) . Post hoc analyses showed that only MBSR manifested a significant pre‐to‐post‐intervention improvement in HRQoL ( P = 0.02 ) . Furthermore , multivariate analysis of secondary measures indicated modest benefits for MBSR patients . MBSR yielded significant pre‐to‐post‐intervention improvements in 6 of 8 secondary outcome variables , the active control in 3 , and the wait list in 2 . In conclusion , primary outcome analyses did not support the efficacy of MBSR in fibromyalgia , although patients in the MBSR arm appeared to benefit most . Effect sizes were small compared to the earlier , quasi‐r and omized investigation . Several method ological aspects are discussed , e.g. , patient burden , treatment preference and motivation , that may provide explanations for differences . In a 3‐armed r and omized controlled trial in female patients suffering from fibromyalgia , patients benefited modestly from a mindfulness‐based stress reduction intervention",
"OBJECTIVES To evaluate the efficacy of a brief , intense treatment program for fibromyalgia and to determine which patient characteristics are associated with a better treatment response . PATIENTS AND METHODS Two self-report measures , the Fibromyalgia Impact Question naire ( FIQ ) and the Multidimensional Pain Inventory ( MPI ) , were administered before patients completed treatment and 1 month after participating in the program . The main outcome measure was the difference in FIQ score and MPI scale before and after program participation . RESULTS Of 139 patients who met the American College of Rheumatology criteria for fibromyalgia , 100 chose to participate in the 1 1/2-day Fibromyalgia Treatment Program at the Mayo Clinic , Rochester , Minn. Of these 100 patients , 74 completed the follow-up surveys . Patients were less affected by fibromyalgia after participation in the treatment program . This was demonstrated by a posttreatment improvement in the total FIQ score ( P MPI pain severity score ( P MPI interference score ( P=.01 ) . The 1 patient characteristic found to be significantly associated ( P pretreatment level of impairment from fibromyalgia , as measured by the pretreatment FIQ score . CONCLUSIONS A brief interdisciplinary program for treating fibromyalgia reduced some associated symptoms . Patients more severely affected by fibromyalgia may benefit most from this approach . Clinicians may apply these findings to develop beneficial and convenient treatment programs for patients with fibromyalgia",
"Objective : To evaluate the efficacy of a treatment programme for patients with fibromyalgia ( FM ) based on self management , using pool exercises and education . Methods : R and omised controlled trial with a 6 month follow up to evaluate an outpatient multidisciplinary programme ; 164 patients with FM were allocated to an immediate 6 week programme ( n = 84 ) or to a waiting list control group ( n = 80 ) . The main outcomes were changes in quality of life , functional consequences , patient satisfaction and pain , using a combination of patient question naires and clinical examinations . The question naires included the Fibromyalgia Impact Question naire ( FIQ ) , Psychological General Well-Being ( PGWB ) index , regional pain score diagrams , and patient satisfaction measures . Results : 61 participants in the treatment group and 68 controls completed the programme and 6 month follow up examinations . Six months after programme completion , significant improvements in quality of life and functional consequences of FM were seen in the treatment group as compared with the controls and as measured by scores on both the FIQ ( total score p = 0.025 ; fatigue p = 0.003 ; depression p = 0.031 ) and PGWB ( total score p = 0.032 ; anxiety p = 0.011 ; vitality p = 0.013 , ) . All four major areas of patient satisfaction showed greater improvement in the treatment than the control groups ; between-group differences were statistically significant for “ control of symptoms ” , “ psychosocial factors ” , and “ physical therapy ” No change in pain was seen . Conclusion : A 6 week self management based programme of pool exercises and education can improve the quality of life of patients with FM and their satisfaction with treatment . These improvements are sustained for at least 6 months after programme completion",
"Background The al- And alus physical activity intervention study is a r and omised control trial to investigate the effectiveness of a l and - and water-based exercise intervention for reducing the overall impact of fibromyalgia ( primary outcome ) , and for improving tenderness and pain-related measures , body composition , functional capacity , physical activity and sedentary behaviour , fatigue , sleep quality , health-related quality of life , and cognitive function ( secondary outcomes ) in women with fibromyalgia . Methods / Design One hundred eighty women with fibromyalgia ( age range : 35 - 65 years ) will be recruited from local associations of fibromyalgia patients in And alucía ( Southern Spain ) . Patients will be r and omly assigned to a usual care ( control ) group ( n = 60 ) , a water-based exercise intervention group ( n = 60 ) or a l and -based exercise intervention group ( n = 60 ) . Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions ( 60 min each ) per week during 24 weeks . Both exercise interventions will consist of aerobic , muscular strength and flexibility exercises . We will also study the effect of a detraining period ( i.e. , 12 weeks with no exercise intervention ) on the studied variables . Discussion Our study attempts to reduce the impact of fibromyalgia and improve patients ' health status by implementing two types of exercise interventions . Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia . If the interventions would be effective , this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia . Results from the al- And alus physical activity intervention will help to better underst and the potential of regular physical activity for improving the well-being of women with fibromyalgia . Trial registration Clinical Trials.gov ID :",
"BACKGROUND Previous research has suggested that tai chi offers a therapeutic benefit in patients with fibromyalgia . METHODS We conducted a single-blind , r and omized trial of classic Yang-style tai chi as compared with a control intervention consisting of wellness education and stretching for the treatment of fibromyalgia ( defined by American College of Rheumatology 1990 criteria ) . Sessions lasted 60 minutes each and took place twice a week for 12 weeks for each of the study groups . The primary end point was a change in the Fibromyalgia Impact Question naire ( FIQ ) score ( ranging from 0 to 100 , with higher scores indicating more severe symptoms ) at the end of 12 weeks . Secondary end points included summary scores on the physical and mental components of the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) . All assessment s were repeated at 24 weeks to test the durability of the response . RESULTS Of the 66 r and omly assigned patients , the 33 in the tai chi group had clinical ly important improvements in the FIQ total score and quality of life . Mean ( + /-SD ) baseline and 12-week FIQ scores for the tai chi group were 62.9+/-15.5 and 35.1+/-18.8 , respectively , versus 68.0+/-11 and 58.6+/-17.6 , respectively , for the control group ( change from baseline in the tai chi group vs. change from baseline in the control group , -18.4 points ; P SF-36 physical-component scores were 28.5+/-8.4 and 37.0+/-10.5 for the tai chi group versus 28.0+/-7.8 and 29.4+/-7.4 for the control group ( between-group difference , 7.1 points ; P=0.001 ) , and the mental-component scores were 42.6+/-12.2 and 50.3+/-10.2 for the tai chi group versus 37.8+/-10.5 and 39.4+/-11.9 for the control group ( between-group difference , 6.1 points ; P=0.03 ) . Improvements were maintained at 24 weeks ( between-group difference in the FIQ score , -18.3 points ; P adverse events were observed . CONCLUSIONS Tai chi may be a useful treatment for fibromyalgia and merits long-term study in larger study population s. ( Funded by the National Center for Complementary and Alternative Medicine and others ; Clinical Trials.gov number , NCT00515008 .",
"AIM Fibromyalgia ( FM ) is a chronic disorder characterized by widespread pain . Fibromyalgia is associated with balance problems and increased fall frequency . Whole-body vibration therapy had been used for improve balance in special population s but not in fibromyalgia . The main objective of this study was to analyze the effects of 12 weeks of tilting whole-body vibration therapy on static balance in fibromyalgia patients . METHODS Women with FM were r and omly and sequentially assigned to either the vibration group ( N.=21 ) or the control group ( N.=20 ) based on a r and omly generated number table , and a code number was assigned to each participant . All participants received st and ard care that included medical care through the public health system ( hospital and outpatient clinic , including primary care ) and social support through the local fibromyalgia association . Participants in the exercise group received whole-body vibration therapy ( 12 weeks , 12.5 Hz frequency and 3 mm amplitude ) . Outcome measure was determined using postural stability indices ( overall , anterior-posterior and medial-lateral ) assessed by the Biodex Balance System in a single dominant limb stance . RESULTS Treatment effect after 12-weeks of tilting whole body vibration therapy were 57.1 % on overall stability and 66.6 % on anterior-posterior stability . CONCLUSION Tilting whole-body vibration therapy effectively improves static balance in patients with FM",
"OBJECTIVE To investigate the effects of supervised aerobic exercise ( AE ) and a combined program of supervised aerobic , muscle strengthening , and flexibility exercises ( combined exercise [ CE ] ) on important health outcomes in women with fibromyalgia syndrome ( FMS ) . DESIGN R and omized controlled trial . SETTING Community-based supervised intervention . PARTICIPANTS Women ( N=64 ) with a diagnosis of FMS according to the American College of Rheumatology criteria . INTERVENTION Participants were r and omly allocated to 1 of 3 groups : supervised AE , supervised CE , or usual-care control . Exercise sessions were performed twice weekly ( 45 - 60min/session ) for 24 weeks . MAIN OUTCOME MEASURES The primary outcome measure was the Fibromyalgia Impact Question naire ( FIQ ) . Exploratory outcome measures were the 36-Item Short-Form Health Survey , Beck Depression Inventory ( BDI ) , aerobic capacity ( 6-minute walk test ) , h and -grip strength , and range of motion in the shoulders and hips . RESULTS Compliance with both interventions was excellent , with women in the exercise groups attending more than 85 % of sessions . A 14 % to 15 % improvement from baseline in total FIQ score was observed in the exercise groups ( P≤.02 ) and was accompanied by decreases in BDI scores of 8.5 ( P the SF-36 Physical Functioning ( P=.003 ) and Bodily Pain ( P=.003 ) domains and was more effective than AE for evoking improvements in the Vitality ( P=.002 ) and Mental Health ( P=.04 ) domains . Greater improvements also were observed in shoulder/hip range of motion and h and grip strength in the CE group . CONCLUSION Given the equivalent time commitment required for AE and CE , our results suggest that women with FMS can gain additional health benefits by engaging in a similar volume of CE",
"OBJECTIVE To evaluate the effectiveness and tolerability of two pool-based physical therapies , stretching and Ai Chi , in fibromyalgia symptomatology and sleep quality . METHODS Eighty-one patients , r and omly assigned to stretching ( n=39 ) or Ai Chi ( n=42 ) , received 18 physiotherapy sessions and were evaluated at baseline , at treatment termination , and after 4 and 12 weeks of follow-up . Main outcome measures were the Fibromyalgia Impact Question naire ( FIQ ) and the Pittsburgh Sleep Quality Index ( PSQI ) . Secondary outcome measures included the Beck Depression Inventory ( BDI ) , the State and Trait Anxiety Inventory ( STAI ) , and the SF-12 Health Survey ( SF-12 ) . Data analysis was done with repeated measures ANOVA and effect size estimation . RESULTS No differences were found between groups but significant reduction in the FIQ and the PSQI scores were observed in Ai Chi but not in stretching group , with larger effect sizes and longer effect duration on sleep measures . BDI scores decreased in stretching but not in Ai Chi group with small effect sizes . Trait-anxiety scores decreased in both groups also with small effect sizes . The mental component summary of the SF-12 increased only in stretching group with effect sizes moderate to large . CONCLUSIONS Although no global differences were found between groups , Ai Chi significantly improved fibromyalgia symptomatology and sleep quality , whereas stretching only improved subjects ' psychological well-being",
"OBJECTIVE The aim of this study was to investigate the effectiveness of a 6-week traditional exercise program with supplementary whole-body vibration ( WBV ) in improving health status , physical functioning , and main symptoms of fibromyalgia ( FM ) in women with FM . METHODS Thirty-six ( 36 ) women with FM ( mean + /- st and ard error of the mean age 55.97 + /- 1.55 ) were r and omized into 3 treatment groups : exercise and vibration ( EVG ) , exercise ( EG ) , and control ( CG ) . Exercise therapy , consisting of aerobic activities , stretching , and relaxation techniques , was performed twice a week ( 90 min/day ) . Following each exercise session , the EVG underwent a protocol with WBV , whereas the EG performed the same protocol without vibratory stimulus . The Fibromyalgia Impact Question naire ( FIQ ) was administered at baseline and 6 weeks following the initiation of the treatments . Estimates of pain , fatigue , stiffness , and depression were also reported using the visual analogue scale . RESULTS A significant 3 x 2 ( group x time)-repeated measures analysis of variance interaction was found for pain ( p = 0.018 ) and fatigue ( p = 0.002 ) but not for FIQ ( p = 0.069 ) , stiffness ( p = 0.142 ) , or depression ( p = 0.654 ) . Pain and fatigue scores were significantly reduced from baseline in the EVG , but not in the EG or CG . In addition , the EVG showed significantly lower pain and fatigue scores at week 6 compared to the CG , whereas no significant differences were found between the EG and CG ( p > 0.05 ) . CONCLUSION Results suggest that a 6-week traditional exercise program with supplementary WBV safely reduces pain and fatigue , whereas exercise alone fails to induce improvements",
"The Department of Veterans Affairs ( VA ) Cooperative Studies Program ( CSP ) Study # 470 is a 2 x 2 factorial trial design ed to evaluate the hypothesis that both cognitive behavioral therapy ( CBT ) and aerobic exercise will significantly improve physical function in participants with Gulf War veterans ' illnesses ( GWVI ) , and that adding CBT to aerobic exercise will provide further incremental benefit . One thous and three hundred fifty-six veterans will be r and omized to one of four treatment arms : CBT plus aerobic exercise plus usual and customary care , aerobic exercise plus usual and customary care , CBT plus usual and customary care , or usual and customary care alone . The study duration is 2.5 years with 1.5 years of intake and 1 year of follow-up . The primary outcome measure is the proportion of veterans improved more than seven units on the physical component summary ( PCS ) scale of the Short Form Health Survey for Veterans ( SF-36V ) measured 12 months after r and omization . This generic quality -of-life measure was chosen because there is no disease-specific measure for GWVI and the symptoms of GWVI span a wide range of physical manifestations that are related to the domains covered by the PCS scale . Sample size was determined to detect all six pairwise comparisons between the four treatment arms with 90 % power and a Bonferroni adjustment for an overall type I error of 0.05 or 0.05/6 = 0.0083 . CSP # 470 was initiated in May 1999 in 18 VA and two Department of Defense medical centers . To date this represents the largest r and omized trial design ed to evaluate treatments for individuals with unexplained physical symptoms . This paper will focus on the rationale and unique features of the study design . Control Clin Trials 2001;22:310 -",
"The aim of this study was to investigate the results of a supervised exercise with transcutaneous electrical nerve stimulation ( TENS ) in an exercise controlled study in women with fibromyalgia . Sixty-six women with fibromyalgia who admitted to the outpatient clinic of our hospital were r and omized into two treatment groups . The patients in both groups participated in a supervised combined exercise program for 12 weeks . The women in first group had additional TENS in the first 3 weeks of the study . All subjects were analyzed at the baseline , at the end of the 3rd and 12th weeks . Outcome measures were tender point count ( TPC ) , myalgic pain score ( MPS ) , Fibromyalgia Impact Question naire ( FIQ ) and Short Form-36 ( SF-36 ) Health Survey . Sixty women with fibromyalgia completed the study . The patients in both groups showed improvement in terms of TPC , MPS , FIQ , physical and mental summary scores and total scores of SF-36 at the end of the 3rd and 12th weeks . The improvement in MPS at the third week was higher in the first group ( p = 0.01 ) . But there was no difference in terms of the improvement in MPS between the groups at the end of the 12th week control ( p = 0.87 ) . There was no significant difference between the improvement in the other outcome parameters of the two groups . As a result , supervised exercise program was successful to improve the myalgic pain , functional status and quality of life in women with fibromyalgia . Exercises combined with TENS might be useful due to quick myalgic pain relief in the treatment of fibromyalgia in everyday practice",
"& NA ; Both pharmacological and non‐pharmacological interventions have demonstrated efficacy in the management of fibromyalgia ( FM ) . Non‐pharmacological interventions however are far less likely to be used in clinical setting s , in part due to limited access . This manuscript presents the findings of a r and omized controlled trail of an Internet‐based exercise and behavioral self‐management program for FM design ed for use in the context of a routine clinical care . 118 individuals with FM were r and omly assigned to either ( a ) st and ard care or ( b ) st and ard care plus access to a Web‐Enhanced Behavioral Self‐Management program ( WEB‐SM ) grounded in cognitive and behavioral pain management principles . Individuals were assessed at baseline and again at 6 months for primary endpoints : reduction of pain and an improvement in physical functioning . Secondary outcomes included fatigue , sleep , anxiety and depressive symptoms , and a patient global impression of improvement . Individuals assigned to the WEB‐SM condition reported significantly greater improvement in pain , physical functioning , and overall global improvement . Exercise and relaxation techniques were the most commonly used skills throughout the 6 month period . A no‐contact , Internet‐based , self‐management intervention demonstrated efficacy on key outcomes for FM . While not everyone is expected to benefit from this approach , this study demonstrated that non‐pharmacological interventions can be efficiently integrated into routine clinical practice with positive outcomes",
"OBJECTIVES The main objective was to assess the influence of resistance exercise on pain threshold and pain ratings . Secondary objectives included measuring state anxiety , body awareness , systolic blood pressure , diastolic blood pressure , and heart rate responses . METHODS Pressure ( 3 kg force ) was applied to the middle digit of the left h and for two minutes using a Forgione-Barber pain stimulator before and after ( five minute and 15 minutes ) resistance exercise and quiet rest . Resistance exercise consisted of 45 minutes of lifting three sets of 10 repetitions at 75 % of an individual 's one repetition maximum . Quiet rest consisted of sitting quietly in a room free from distractions . RESULTS Data were analysed by repeated measures analysis of variance for multifactor experiments . Pain threshold was significantly higher ( p pain ratings were significantly lower ( p resistance exercise . Changes in pain perception were accompanied by changes in heart rate , systolic blood pressure , and body awareness after exercise . CONCLUSION A single bout of resistance exercise is capable of modifying the sensation of experimentally induced pain",
"Introduction Fibromyalgia is difficult to treat and requires the use of multiple approaches . This study is a r and omized controlled trial of qigong compared with a wait-list control group in fibromyalgia . Methods One hundred participants were r and omly assigned to immediate or delayed practice groups , with the delayed group receiving training at the end of the control period . Qigong training ( level 1 Chaoyi Fanhuan Qigong , CFQ ) , given over three half-days , was followed by weekly review / practice sessions for eight weeks ; participants were also asked to practice at home for 45 to 60 minutes per day for this interval . Outcomes were pain , impact , sleep , physical function and mental function , and these were recorded at baseline , eight weeks , four months and six months . Immediate and delayed practice groups were analyzed individually compared to the control group , and as a combination group . Results In both the immediate and delayed treatment groups , CFQ demonstrated significant improvements in pain , impact , sleep , physical function and mental function when compared to the wait-list/usual care control group at eight weeks , with benefits extending beyond this time . Analysis of combined data indicated significant changes for all measures at all times for six months , with only one exception . Post-hoc analysis based on self-reported practice times indicated greater benefit with the per protocol group compared to minimal practice . Conclusions This study demonstrates that CFQ , a particular form of qigong , provides long-term benefits in several core domains in fibromyalgia . CFQ may be a useful adjuvant self-care treatment for fibromyalgia . Trial registration clinical trials.gov NCT00938834",
"To compare training programs for women with trapezius myalgia regarding physical performance and pain , 102 women were r and omized to strength , endurance , co-ordination and non-training groups . Before and after the intervention , static strength and dynamic muscular endurance in shoulder muscles were measured on a Cybex II dynamometer . Muscle activity in shoulder muscles was monitored via surface EMG . The signal amplitude ratio between the active and passive phase of repeated contractions indicated the ability to relax . Pain at present , pain in general and pain at worst were measured on visual analogue scales . After training , within group comparisons showed that the training groups rated less pain , and in the strength training group ratings of pain at worst differed from the non-training group . Using the non-training group as a reference , static strength increased in the strength and endurance training groups and muscular endurance in all training groups . The study indicates that regular exercises with strength , endurance or co-ordination training of neck/shoulder muscles might alleviate pain for women with work-related trapezius myalgia",
"OBJECTIVE To determine the efficacy of a 12-week individualized home-based exercise programme on physical functioning , pain severity and psychological distress for women with fibromyalgia ( FM ) . METHODS Seventy-nine women with a primary diagnosis of FM were r and omized to a 12-week individualized home-based moderate-intensity exercise programme or to a usual care control group . Outcomes were functional capacity ( Fibromyalgia Impact Question naire ) , pain severity and psychological distress . Outcomes were measured at study entry , at the end of the 12-week intervention , and at 3 and 9 months following completion of the intervention . RESULTS On the basis of intention-to-treat analyses , a significant improvement in functional capacity at 3 and 9 months following treatment for participants in the exercise group who were more functionally disabled at study entry was observed . At both 3 and 9 months post-treatment , the mean estimated benefit of the intervention was more than 10 points [ -12.3 ( 95 % CI , -21.9 to -2.8 ) ; -10.8 ( 95 % CI , -21.5 to -0.2 ) ] . Compared with the control group , statistically significant improvements in upper body pain were evident in the exercise group at post-treatment . These between-group differences in upper body pain were maintained at 3 and 9 months post-treatment . No statistically significant group differences on lower body pain and psychological distress were found . CONCLUSIONS Home-based exercise , a relatively low-cost treatment modality , has the potential to improve important health outcomes in FM",
"Introduction Physical therapy in warm water has been effective and highly recommended for persons with fibromyalgia , but its efficiency remains largely unknown . Should patients or health care managers invest in this therapy ? The aim of the current study was to assess the cost-utility of adding an aquatic exercise programme to the usual care of women with fibromyalgia . Methods Costs to the health care system and to society were considered in this study that included 33 participants , r and omly assigned to the experimental group ( n = 17 ) or a control group ( n = 16 ) . The intervention in the experimental group consisted of a 1-h , supervised , water-based exercise sessions , three times per week for 8 months . The main outcome measures were the health care costs and the number of quality -adjusted life-years ( QALYs ) using the time trade-off elicitation technique from the EuroQol EQ-5D instrument . Sensitivity analyses were performed for variations in staff salary , number of women attending sessions and time spent going to the pool . The cost effectiveness acceptability curves were created using a non-parametric bootstrap technique . Results The mean incremental treatment costs exceeded those for usual care per patient by € 517 for health care costs and € 1,032 for societal costs . The mean incremental QALY associated with the intervention was 0.131 ( 95 % CI : 0.011 to 0.290 ) . Each QALY gained in association with the exercise programme cost an additional € 3,947/QALY ( 95 % CI : 1,782 to 47,000 ) for a health care perspective and € 7,878/QALY ( 3,559 to 93,818 ) from a societal perspective . The curves showed a 95 % probability that the addition of the water-based programme is a cost-effective strategy if the ceiling of inversion is € 14,200/QALY from a health care perspective and € 28,300/QALY from a societal perspective . Conclusion The addition of an aquatic exercise programme to the usual care regime for fibromyalgia in women is cost effective in terms of both health care costs and societal costs . However , the characteristics of facilities ( distance from the patients ' homes and number of patients that can be accommo date d per session ) are major determinants to consider before investing in such a programme . Trial registration Current controlled trials IS RCT N53367487",
"Abstract Objectives : To evaluate cardiovascular fitness exercise in people with fibromyalgia Design : R and omised controlled trial Setting : Hospital rheumatology out patients . Group based classes took place at a “ healthy living centre . ” Participants : 132 patients with fibromyalgia . Interventions : Prescribed grade d aerobic exercise ( active treatment ) and relaxation and flexibility ( control treatment ) . Main outcome measures : Participants ' self assessment of improvement , tender point count , impact of condition measured by fibromyalgia impact question naire , and short form McGill pain question naire . Results : Compared with relaxation exercise led to significantly more participants rating themselves as much or very much better at three months : 24/69 ( 35 % ) v 12/67 ( 18 % ) , P=0.03 . Benefits were maintained or improved at one year follow up when fewer participants in the exercise group fulfilled the criteria for fibromyalgia ( 31/69 v 44/67 , P=0.01 ) . Peoplein the exercise group also had greater reductions in tender point counts ( 4.2 v 2.0 , P=0.02 ) and in scores on the fibromyalgia impact question naire ( 4.0 v 0.6 , P=0.07 ) . Conclusions : Prescribed grade d aerobic exercise is a simple , cheap , effective , and potentially widely available treatment for fibromyalgia",
"& NA ; A mounting body of literature recommends that treatment for fibromyalgia ( FM ) encompass medications , exercise and improvement of coping skills . However , there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping . The aim of this r and omized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping . A sample of 53 female FM patients were r and omized to the 8‐week Yoga of Awareness program ( gentle poses , meditation , breathing exercises , yoga‐based coping instructions , group discussion s ) or to wait‐listed st and ard care . Data were analyzed by intention to treat . At post‐treatment , women assigned to the yoga program showed significantly greater improvements on st and ardized measures of FM symptoms and functioning , including pain , fatigue , and mood , and in pain catastrophizing , acceptance , and other coping strategies . This pilot study provides promising support for the potential benefits of a yoga program for women with FM",
"OBJECTIVE To compare the effectiveness of biofeedback/relaxation , exercise , and a combined program for the treatment of fibromyalgia . METHODS Subjects ( n = 119 ) were r and omly assigned to one of 4 groups : 1 ) biofeedback/relaxation training , 2 ) exercise training , 3 ) a combination treatment , or 4 ) an educational/attention control program . RESULTS All 3 treatment groups produced improvements in self-efficacy for function relative to the control condition . In addition , all treatment groups were significantly different from the control group on tender point index scores , reflecting a modest deterioration by the attention control group rather than improvements by the treatment groups . The exercise and combination groups also result ed in modest improvements on a physical activity measure . The combination group best maintained benefits across the 2-year period . CONCLUSION This study demonstrates that these 3 treatment interventions result in improved self-efficacy for physical function which was best maintained by the combination group",
"OBJECTIVE To determine the effectiveness of a muscle strengthening program compared to a stretching program in women with fibromyalgia ( FM ) . METHODS Sixty-eight women with FM were r and omly assigned to a 12 week , twice weekly exercise program consisting of either muscle strengthening or stretching . Outcome measures included muscle strength ( main outcome variable ) , flexibility , weight , body fat , tender point count , and disease and symptom severity scales . RESULTS No statistically significant differences between groups were found on independent t tests . Paired t tests revealed twice the number of significant improvements in the strengthening group compared to the stretching group . Effect size scores indicated that the magnitude of change was generally greater in the strengthening group than the stretching group . CONCLUSION Patients with FM can engage in a specially tailored muscle strengthening program and experience an improvement in overall disease activity , without a significant exercise induced flare in pain . Flexibility training alone also results in overall improvements , albeit of a lesser degree",
"BACKGROUND AND PURPOSE The purpose s of this study were : ( 1 ) to assess the effectiveness of a 16-week progressive program of home-based , videotape-based , low-impact aerobic exercise on physical function and signs and symptoms of fibromyalgia in previously sedentary women aged 20 to 55 years and ( 2 ) to compare the effects of 1 long exercise bout versus 2 short exercise bouts per training day ( fractionation ) on physical function , signs and symptoms of fibromyalgia , and exercise adherence . SUBJECTS One hundred forty-three sedentary women were r and omly assigned to 1 of 3 groups : a group who trained using a long bout of exercise ( LBE group , n=51 ) , a group who trained using short bouts of exercise ( SBE group , n=56 ) , and a group who performed no exercise ( NE group , n=36 ) . METHODS The SBE group exercised twice daily , and the LBE group worked out once daily . Both groups progressed in total daily training duration from 10 to 30 minutes , 3 to 5 times a week , for 16 weeks . Physical and psychological well-being , symptoms , and self-efficacy were evaluated using a multivariate analysis of variance . RESULTS Dropout rates for the NE , SBE , and LBE groups were 14 % , 38 % , and 29 % , respectively . The NE group differed from the LBE group in disease severity , self-efficacy , and psychological well-being ( midtest , efficacy analysis ) and from the SBE group in disease severity and self-efficacy ( posttest , efficacy analysis ) . Exercise adherence was greater for the LBE group than for the SBE group between weeks 5 and 8 of the training program . No other differences between exercise groups were found . DISCUSSION AND CONCLUSION Progressive , home-based , low-impact aerobics improved physical function and fibromyalgia symptoms minimally in participants who completed at least two thirds of the recommended exercise . Fractionation of exercise training provided no advantage in terms of exercise adherence , improvements in fibromyalgia symptoms or physical function . High attrition rates and problems with exercise adherence were experienced in both exercise groups",
"BACKGROUND Self-management has increasingly been recommended as part of st and ard care for fibromyalgia , a common , poorly understood condition with limited treatment options . Data that assess popular self-management recommendations are scarce . We evaluated and compared the effectiveness of 4 common self-management treatments on function , symptoms , and self-efficacy in women with fibromyalgia . METHODS A total of 207 women with confirmed fibromyalgia were recruited from September 16 , 2002 , through November 30 , 2004 , and r and omly assigned to 16 weeks of ( 1 ) aerobic and flexibility exercise ( AE ) ; ( 2 ) strength training , aerobic , and flexibility exercise ( ST ) ; ( 3 ) the Fibromyalgia Self-Help Course ( FSHC ) ; or ( 4 ) a combination of ST and FSHC ( ST-FSHC ) . The primary outcome was change in physical function from baseline to completion of the intervention . Secondary outcomes included social and emotional function , symptoms , and self-efficacy . RESULTS Improvements in the mean Fibromyalgia Impact Question naire score in the 4 groups were -12.7 for the ST-FSHC group , -8.2 for the AE group , -6.6 for the ST group , and -0.3 for the FSHC group . The ST-FSHC group demonstrated greater improvement than the FSHC group ( mean difference , -12.4 ; 95 % confidence interval [ CI ] , -23.1 to -1.7 ) . The ST-FSHC ( mean difference , 13.6 ; 95 % CI , 2.3 to 24.9 ) and AE ( mean difference , 13.1 ; 95 % CI , 1.6 to 25.6 ) groups had similar improvements in physical function scores on the 36-Item Short-Form Health Survey . Bodily pain scores on the 36-Item Short-Form Health Survey improved in the ST-FSHC ( 14.8 ) , AE ( 13.2 ) , and ST ( 5.7 ) groups . Social function , mental health , fatigue , depression , and self-efficacy also improved . The beneficial effect on physical function of exercise alone and in combination with education persisted at 6 months . CONCLUSIONS Progressive walking , simple strength training movements , and stretching activities improve functional status , key symptoms , and self-efficacy in women with fibromyalgia actively being treated with medication . The benefits of exercise are enhanced when combined with targeted self-management education . Our findings suggest that appropriate exercise and patient education be included in the treatment of fibromyalgia",
"OBJECTIVE To evaluate the effects of 6 months of pool exercise combined with a 6 session education program for patients with fibromyalgia syndrome ( FM ) . METHODS The study population comprised 58 patients , r and omized to a treatment or a control group . Patients were instructed to match the pool exercises to their threshold of pain and fatigue . The education focused on strategies for coping with symptoms and encouragement of physical activity . The primary outcome measurements were the total score of the Fibromyalgia Impact Question naire ( FIQ ) and the 6 min walk test , recorded at study start and after 6 mo . Several other tests and instruments assessing functional limitations , severity of symptoms , disabilities , and quality of life were also applied . RESULTS Significant differences between the treatment group and the control group were found for the FIQ total score ( p = 0.017 ) and the 6 min walk test ( p physical function , grip strength , pain severity , social functioning , psychological distress , and quality of life . CONCLUSION The results suggest that a 6 month program of exercises in a temperate pool combined with education will improve the consequences of FM",
"The aim of this study was to evaluate the effectiveness of aerobic exercise in water pool compared with aerobic exercise performed in sea by women with fibromyalgia ( FM ) . A total of 46 patients were r and omly allocated into two groups : pool group ( 23 patients ) and sea group ( 23 patients ) that performed the same aerobic exercise program . Patients were evaluated baseline and after 12 weeks using : VAS , number of tender points , FIQ , SF-36 , PSQI , and BDI . Both groups improved significantly in post-treatment for all the evaluated variables . There were no significant differences between two groups , except for BDI ( F = 2.418 , P Aerobic exercise program performed in water ( pool or sea ) was effective for patients with FM . However , sea water exercises have been shown to bring more advantages related to emotional aspects . Then , exercise performed sea water ( thalassotherapy ) is an option for effective treatment with low cost for patients with FM",
"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",
"OBJECTIVES This study aim ed to verify whether techniques of yoga with and without the addition of Tui Na might improve pain and the negative impact of fibromyalgia ( FMS ) on patients ' daily life . DESIGN Forty ( 40 ) FMS women were r and omized into two groups , Relaxing Yoga ( RY ) and Relaxing Yoga plus Touch ( RYT ) , for eight weekly sessions of stretching , breathing , and relaxing yogic techniques . RYT patients were further su bmi tted to manipulative techniques of Tui Na . OUTCOME MEASURE Outcome measures comprised the Fibromyalgia Impact Question naire ( FIQ ) , pain threshold at the 18 FMS tender points , and a verbal graduation of pain assessed before treatment and on the followup . The visual analog scale ( VAS ) for pain was assessed before and after each session and on the follow-up . RESULTS Seventeen ( 17 ) RYT and 16 RY patients completed the study . Both RY and RYT groups showed improvement in the FIQ and VAS scores , which decreased on all sessions . The RYT group showed lower VAS and verbal scores for pain on the eighth session , but this difference was not maintained on the follow-up . Conversely , RY VAS and verbal scores were significantly lower just on the follow-up . CONCLUSIONS These study results showed that yogic techniques are valid therapeutic methods for FMS . Touch addition yielded greater improvement during the treatment . Over time , however , RY patients reported less pain than RYT . These results suggest that a passive therapy may possibly decrease control over FMS symptoms",
"OBJECTIVES To evaluate the effects of a 16-week exercise therapy in a chest-high pool of warm water through applicable tests in the clinical practice on the global symptomatology of women with fibromyalgia ( FM ) and to determine exercise adherence levels . DESIGN A r and omized controlled trial . SETTING Testing and training were completed at the university . PARTICIPANTS Middle-aged women with FM ( n=60 ) and healthy women ( n=25 ) . INTERVENTION A 16-week aquatic training program , including strength training , aerobic training , and relaxation exercises . MAIN OUTCOME MEASURES Tender point count ( syringe calibrated ) , health status ( Fibromyalgia Impact Question naire ) ; sleep quality ( Pittsburgh Sleep Quality Index ) ; physical ( endurance strength to low loads tests ) , psychologic ( State Anxiety Inventory ) , and cognitive function ( Paced Auditory Serial Addition Task ) ; and adherence 12 months after the completion of the study . RESULTS For all the measurements , the patients showed significant deficiencies compared with the healthy subjects . Efficacy analysis ( n=29 ) and intent-to-treat analysis ( n=34 ) of the exercise therapy was effective in decreasing the tender point count and improving sleep quality , cognitive function , and physical function . Anxiety remained unchanged during the follow-up . The exercise group had a significant improvement of health status , not associated exclusively with the exercise intervention . There were no changes in the control group . Twenty-three patients in the exercise group were exercising regularly 12 months after completing the program . CONCLUSIONS An exercise therapy 3 times a week for 16 weeks in a warm pool could improve most of the symptoms of FM and cause a high adherence to exercise in unfit women with heightened FM symptomatology . The therapeutic intervention 's effects can be assessed through applicable tests in the clinical practice",
"BACKGROUND This pilot study was design ed to test the efficacy of a physical activity program for improving psychological variables and fibromyalgia syndrome ( FMS ) symptoms and to provide preliminary evidence regarding the effects on perceived cognitive symptoms and objective ly measured cognitive performance by FMS patients . METHODS Sixteen women diagnosed with FMS were r and omly assigned to an 18-week physical activity program or to a control condition . Psychological measures , FMS symptoms , perceived cognitive function , objective measures of cognition , and walking capacity were assessed at baseline and posttest . RESULTS At posttest , there were significant differences in fatigue ( effect size , ES=1.86 ) , depression ( ES=1.27 ) , FMS symptoms ( ES=1.56 ) , self-reported cognitive symptoms ( ES=1.19 ) , and delayed recall performance ( ES=1.16 ) between the physically active group and the control group , indicating that the FMS patients benefited from physical activity . Beneficial effects were also observed for 6 of the 7 objective measures of cognition and ranged from small to large ( ESs=0.26 to 1.06 ) . CONCLUSIONS Given that all FMS patients do not respond well to conventional treatments , these beneficial effects of physical activity are important . Future studies with larger sample s are warranted to test the reliability of the findings for the objective measures of cognition",
"OBJECTIVE To evaluate the efficacy of a 6-week exercise and educational program for patients with fibromyalgia . METHODS Forty-one subjects were r and omly assigned to the program or served as waiting list controls . Program outcome was assessed with a 6-minute walk test , the Fibromyalgia Impact Question naire , a Self-Efficacy Scale , and a \" knowledge \" question naire ( based on information provided during the educational sessions ) . Waiting list control subjects subsequently completed the program . Program outcome was reassessed 3 or 6 months post-program . RESULTS The program produced significant improvements in 6-minute walk distance , well-being , fatigue , self-efficacy ( for controlling pain and other symptoms ) , and knowledge . At followup , immediate gains in walk distance , well-being , and self-efficacy were maintained , but gains in fatigue and knowledge were lost . CONCLUSION Short-term exercise and educational programs can produce immediate and sustained benefits for patients with fibromyalgia . The benefits of our program may be due to exercise or education since both interventions were given",
"OBJECTIVE To determine the level of improvement , as regards pain , impact on fibromyalgia and depression , achieved by patients with fibromyalgia by comparing aquatic biodanza and stretching exercises . DESIGN R and omised controlled trial with two intervention groups . LOCATION Five health centres ( Almeria ) . PATIENTS A total of 82 fibromyalgia patients between 18 and 65 years old , diagnosed by American College of Rheumatology criteria , were included , with 12 patients declining to take part in the study . The 70 remaining patients were r and omly assigned to two groups of 35 patients each : aquatic biodanza and stretching exercises . Those who did not attend in at least 14 sessions or changed their treatment during the studio were excluded . The final sample consisted of 19 patients in aquatic biodanza group and 20 in stretching group . The limitations of the study included , the open evaluation design and a sample size reduced by defaults . MAIN MEASURES The outcome measures were sociodemographic data , quality of life ( Fibromyalgia Impact Question naire ) , pain ( McGill-Melzack question naire ; and Visual Analogue Scale ) , pressure algometry ( Wagner FPI10 algometer ) and depression ( Beck Inventory ) . These were carried out before and after a 12-week therapy . RESULTS The mean age of the sample was 55.41 years . The mean period from diagnosis was 13.44 years . The sample consisted mainly of housewives . There were significant differences ( P pain ( P fibromyalgia impact ( P depression ( P biodanza aquatic exercises improve pain and quality of life in fibromyalgia patients",
"This study was aim ed to investigate the effects of an exercise trial on self-esteem , self-concept and quality of life in patients with fibromyalgia and to evaluate whether improvements in psychological distress were related to changes in physical functioning . Twenty-eight women with a primary diagnosis of fibromyalgia were r and omized to a usual care control group or to a 12-week supervised training programme consisting of 3 weekly sessions of aerobic , strengthening and flexibility exercises . Outcomes were physical functioning ( Fibromyalgia Impact Question naire ( FIQ ) , lower-body strength and flexibility ) and psychological functioning ( SF-36 , Rosenberg self-esteem scale and Erdmann self-concept scale ) . Outcomes were measured at study entry and at the end of the intervention . Compared to the control group , statistically significant improvements in self-esteem , self-concept , FIQ , physical functioning , role physical , bodily pain , vitality , role emotional , social functioning , mental health , isometric strength , muscular endurance and flexibility were evident in the exercise group at the end of treatment . Self-esteem and self-concept scores were correlated positively with role emotional , mental health and the mental component summary of SF-36 and were negatively correlated to FIQ scores . No significant correlation existed between self-esteem or self-concept and isometric strength , muscular endurance or flexibility . Our results highlight the need for a broader array of physical and mental outcomes and the importance of examining patient ’s perceptions in future research therapies",
"Forty-two patients with primary fibromyalgia were r and omized into a 20-week program consisting of either cardiovascular fitness ( CVR ) training or simple flexibility exercises ( FLEX ) that did not lead to enhanced cardiovascular fitness . Patients were supervised by the same medical fitness instructors . Patients in neither group had contact with members of the other group , and were blinded as to the exercise taught to the alternative group . Groups met for 60 minutes 3 times each week . The compliance rate was 90 % . Thirty-eight patients completed the study ( 18 with CVR training and 20 with FLEX ) . Blind assessment s ( st and ardized in preliminary trials to achieve acceptable inter-rater agreement ) were performed by the same 2 examiners . After 20 weeks , patients receiving CVR training showed significantly improved cardiovascular fitness scores compared with those receiving FLEX training ( t[35 ] = -4.22 , P less than 0.003 ) . Logistic regression analysis showed clinical ly and statistically significant improvements in pain threshold scores , which were measured directly over fibrositic tender points , in patients undergoing CVR ( t[35 ] = 2.21 , P less than 0.04 ) . There was also a trend toward improvement in pain scores ( visual analog scale ) in the CVR group , but this did not reach statistical significance . There was no improvement in the percentage of body area affected by fibrositic symptoms or the number of nights per week or hours per night of disturbed sleep ( self-report inventories ) . However , compared with the FLEX group , the CVR-trained patients improved significantly in both patient and physician global assessment scores . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE To analyze the long-term efficacy of 2 interventions for female fibromyalgia ( FM ) patients : 1 ) cognitive-behavioral therapy ( CBT ) , and 2 ) a physical exercise (PE)-based strategy . METHODS We conducted a prospect i ve , long-term , r and omized , parallel clinical trial . The outcome variables are physical activity , aerobic capacity , and results of the Fibromyalgia Impact Question naire ( FIQ ) , Short Form 36 , Beck Anxiety and Depression Inventory , Chronic Pain Self-Efficacy Scale , and Chronic Pain Coping Inventory . All were measured at baseline , posttreatment , 6 months , and 1 year . The duration of both treatments was 8 weeks . RESULTS Some items of the FIQ and some strategies to cope with pain improved significantly in both groups after treatment . All variables measuring functional capacity improved significantly in the PE group , whereas only physical activity of the vertebral column improved in the CBT group . There were no differences in anxiety , depression , and self efficacy after treatment in either group . After 1 year of followup , most of the parameters had returned to baseline values in both groups . However , in the PE group , functional capacity remained significantly better . CONCLUSIONS PE and CBT improve clinical manifestations in FM patients only for short periods of time . Improvement in self efficacy and physical fitness are not associated with improvement in clinical manifestations",
"OBJECTIVE To examine the effectiveness of concurrent strength and endurance training on muscle strength , aerobic and functional performance , and symptoms in postmenopausal women with fibromyalgia ( FM ) . DESIGN R and omized controlled trial . SETTING Local gym and university research laboratory . PARTICIPANTS Twenty-six women with FM . INTERVENTION Progressive and supervised 21-week concurrent strength and endurance training . MAIN OUTCOME MEASURES Muscle strength of leg extensors , upper extremities , and trunk ; peak oxygen uptake ( Vo(2)peak ) , maximal workload ( Wmax ) , and work time ; 10-m walking and 10-step stair-climbing time and self-reported functional capacity ( Health Assessment Question naire ) ; and symptoms of FM . RESULTS After concurrent strength and endurance training , the groups differed significantly in Wmax ( P=.001 ) , work time ( P=.001 ) , concentric leg extension force ( P=.043 ) , walking ( P=.001 ) and stair-climbing ( P time , and fatigue ( P=.038 ) . The training led to an increase of 10 % ( P=.004 ) in Wmax and 13 % ( P=.004 ) in work time on the bicycle but no change in Vo(2)peak . CONCLUSIONS Concurrent strength and endurance training in low to moderate volume improves the muscle strength of leg extensors , Wmax , work time , and functional performance as well as perceived symptoms , fatigue in particular . Concurrent strength and endurance training is beneficial to postmenopausal women with FM without adversities , but more extensive studies are needed to confirm the results",
"OBJECTIVE To determine whether abnormalities of peripheral and central nociceptive sensory input processing exist outside areas of spontaneous pain in patients with fibromyalgia ( FM ) as compared with controls , by using quantitative sensory testing ( QST ) and a neurophysiologic paradigm independent from subjective reports . METHODS A total of 164 out patients with FM who were attending a self-management program were invited to participate in the study . Data for 85 patients were available and were compared with those for 40 non-FM controls matched for age and sex . QST was performed using thermal , mechanical , and electrical stimuli at locations of nonspontaneous pain . Pain assessment was 2-fold and included use of subjective scales and the spinal nociceptive flexion reflex ( NFR ) , a specific physiologic correlate for the objective evaluation of central nociceptive pathways . Question naires regarding quality of life and the impact of FM were available . RESULTS Participants were mainly middle-aged women , with a mean disease duration of 8 years . Between-group differences were significant for neurophysiologic , clinical , and quality of life measures . In patients with FM , peripheral QST showed significantly altered cold and heat pain thresholds , and tolerance to cold pain was radically reduced . The median NFR threshold in patients with FM ( 22.7 mA [ range 17.5 - 31.7 ] ) was significantly decreased compared with that in controls ( 33 mA [ range 28.1 - 41 ] ) . A cutoff value of sensitivity of 73 % and specificity of 80 % for detecting central allodynia in the setting of FM . CONCLUSION Our results strongly , although indirectly , point to a state of central hyperexcitability of the nociceptive system in patients with FM . The NFR can be used to assess central allodynia in FM . It may also help discriminate patients who may benefit from use of central ly acting analgesics",
"The purpose of this study was to evaluate the efficacy of a multidisciplinary treatment program in patients severely affected by fibromyalgia . Thirty-four fibromyalgia patients were r and omly divided into two groups . The control group : 17 women who continued their medical treatment and participated in four educational sessions and the experimental group that included 17 patients who besides the former medical treatment also underwent a weekly 1-h session program for 8 weeks including massage therapy , ischemic pressure on the 18 tender points , aerobic exercise and thermal therapy . At the beginning of the program , there were no significant differences between the two groups in any of the parameters . At the end of treatment , there was a significant improvement in the experimental group in the following items : vitality , social functioning , grip strength and the 6-min walk test . At 1 month after the end of treatment , the experimental group showed significant differences in overall health perception , social functioning , grip strength and the 6-min walk test . At that time , considering the threshold for clinical efficacy set at an improvement of 30 % or above for the analyzed variables , 25 % of the patients met the requirement for improvement of the following : number of symptoms : Visual Analogic Scale for fatigue , Fibromyalgia Impact Question naire and Beck Anxiety Inventory . In conclusion , patients with severe manifestations of fibromyalgia can obtain improvement with a short-term , low-cost and simple-delivery multidisciplinary program . However , additional studies including higher numbers of patients are needed to confirm the beneficial effect of this treatment program",
"OBJECTIVES The aim of the present study was to assess the effectiveness of belly dance as a treatment option for patients with fibromyalgia . METHODS Eighty female patients with fibromyalgia between 18 to 65 years were r and omly allocated to a dance group ( n=40 ) and control group ( n=40 ) . Patients in the dance group underwent 16 weeks of belly dance twice a week , while the patients in the control group remained on a waiting list . The patients were evaluated with regard to pain ( VAS ) , function ( 6MWT ) , quality of life ( FIQ and SF-36 ) , depression ( Beck Inventory ) , anxiety ( STAI ) and self-image ( BDDE ) . Evaluations were carried out at baseline , 16 weeks and 32 weeks by a blinded assessor . RESULTS The dance group achieved significant improvements in VAS for pain ( p as well as the pain ( p ) , emotional aspects ( p ) and mental health ( p Belly dance can be used in the treatment of fibromyalgia to reduce pain and improve functional capacity , quality of life and self-image",
"OBJECTIVE To determine the efficacy of training in fibromyalgia ( FM ) , we compared the effects of high intensity fitness training ( HIF ) and low intensity fitness training ( LIF ) . METHODS Thirty-seven female patients with FM were r and omly allocated to either a HIF group ( n = 19 ) or a LIF group ( n = 18 ) . Four patients ( 1 HIF group , 3 LIF group ) refused to participate after r and omization but before the start of the intervention . They were excluded from the analysis . Assessment s were performed at baseline and after 20 weeks of HIF or LIF . The primary outcome was patient 's global assessment [ on 100 mm visual analog scale ( VAS ) ] . Secondary endpoints were pain , number of tender points , total myalgic score , physical fitness , health status , and psychological distress . RESULTS One patient in the HIF group ( n = 18 ) and 2 in the LIF group ( n = 15 ) stopped training sessions during the course of the study . Nine of 18 patients in the HIF group compared to 8 of 15 patients in the LIF group achieved a participation rate of 67 % or more . Most important reasons for nonadherence were postexercise pain and fatigue , time consumption , and stress . The VAS for global well being improved slightly from 64 to 56 mm in the HIF group , and did not change in the LIF group ( 58 to 61 mm ) ( p = 0.07 ) . The Wmax ( physical fitness ) changed modestly from 110 to 123 watt in the HIF group , and from 97 to 103 watt in the LIF group ( p = 0.3 ) . VAS for pain increased from 53 to 64 mm in the HIF group and from 52 to 54 mm in the LIF group . The large st and ard deviations around mean change in global assessment s , number of tender points , total myalgic score , and psychological distress ( by SCL-90 ) severely influenced the power to detect within- and between-group differences . Analysis limited to those patients who accomplished a high attendance rate ( > 67 % ) showed similar results . CONCLUSION High intensity physical fitness training compared to low intensity physical fitness training leads to only modest improvements in physical fitness and general well being in patients with FM , and does not positively affect psychological status and general health",
"OBJECTIVE To examine the effectiveness of a supervised aerobic exercise program , a self-management education program , and the combination of exercise and education for women with fibromyalgia ( FM ) . METHODS One hundred fifty-two women were r and omized into one of 4 groups : exercise-only , education-only , exercise and education , or control . The duration of the study was 12 weeks . All subjects were analyzed at 3 times : before study , immediately upon completion , and 3 months after completion of the intervention program on measures of disability , self-efficacy , fitness , tender point count , and tender point tenderness . Of the 152 women , complete data were available for 95 and 69 who complied with the protocol . In order to determine the group time interaction , a 2 way analysis of variance with repeated measures was used for each measure . RESULTS The only significant group time interaction was reported with the compliance analysis for the Self-Efficacy Coping with Other Symptoms subscale and the Six Minute Walk . If the program was followed , the combination of a supervised exercise program and group education provided persons with FM with a better sense of control over their symptoms . Fitness improved in the 2 groups undergoing supervised aerobic exercise programs . However , the improvement in fitness was maintained at followup in the exercise-only group and not the combined group . Conclusion . Subjects receiving the combination of exercise and education and who complied with the treatment protocol improved their perceived ability to cope with other symptoms . In addition , a supervised exercise program increased walking distance at post-test , an increase that was maintained at followup in the exercise-only group . Results demonstrate the challenges with conducting exercise and education studies in persons with FM",
"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",
"OBJECTIVE To determine the efficacy of an Internet-based Arthritis Self-Management Program ( ASMP ) as a re source for arthritis patients unable or unwilling to attend small-group ASMPs , which have proven effective in changing health-related behaviors and improving health status measures . METHODS R and omized intervention participants were compared with usual care controls at 6 months and 1 year using repeated- measures analyses of variance . Patients with rheumatoid arthritis , osteoarthritis , or fibromyalgia and Internet and e-mail access ( n = 855 ) were r and omized to an intervention ( n = 433 ) or usual care control ( n = 422 ) group . Measures included 6 health status variables ( pain , fatigue , activity limitation , health distress , disability , and self-reported global health ) , 4 health behaviors ( aerobic exercise , stretching and strengthening exercise , practice of stress management , and communication with physicians ) , 5 utilization variables ( physician visits , emergency room visits , chiropractic visits , physical therapist visits , and nights in hospital ) , and self-efficacy . RESULTS At 1 year , the intervention group significantly improved in 4 of 6 health status measures and self-efficacy . No significant differences in health behaviors or health care utilization were found . CONCLUSION The Internet-based ASMP proved effective in improving health status measures at 1 year and is a viable alternative to the small-group ASMP",
"To determine and compare short- and long-term effects of aerobic exercise ( AE ) , stress management treatment ( SMT ) , and treatment-as-usual ( TAU ) in fibromyalgia , 60 patients were r and omized to 14 weeks of treatment by either AE , SMT or TAU . Outcome measures at baseline , midway through treatment , at treatment completion , and at 4 year follow up included a patient made drawing of pain distribution , dolorimetry of tender points , ergometer cycle test , global subjective improvement , and VAS registration s of : pain , disturbed sleep , lack of energy , and depression . Both AE and SMT showed positive short-term effects . AE was the overall most effective treatment , despite being subject to the most sceptical patient attitude prior to the study . At follow up , there were no obvious group differences in symptom severity , which for AE seemed to be due to a considerable compliance problem",
"BACKGROUND The management of persistent , unexplained physical symptoms is challenging and often unsatisfactory for patients and doctors . Aerobic exercise training has benefited patients referred to secondary care with symptoms of chronic fatigue and fibromyalgia . It is not known if this approach is either possible or beneficial for patients with the broader range of persistent , unexplained symptoms found in primary care . OBJECTIVES To examine the feasibility and effects of aerobic exercise training in primary care patients with unexplained physical symptoms persisting more than 12 months . METHODS R and omized comparison ( n = 228 ) of aerobic exercise with stretching as control among patients recruited from primary care . Training comprised 20 , one-hour , sessions led by NHS physiotherapists . Adherence to training was recorded along with two groups of outcome measures : ( i ) documented symptoms and health care use , monitored from six months before to six months after training ; and ( ii ) self-reported measures including emotional state and perceived disability , assessed before , during and six months after training . RESULTS Exercise training proved feasible : more than 70 % of referred patients attended for assessment and were r and omized to aerobic or control exercise ; 78 % of eligible patients attended the first session ; and median attendance was 11 sessions for both programmes . Primary care consultations and prescriptions were significantly reduced in the 6 months after training ; extent of reduction was related to attendance at training sessions , irrespective of type . Whilst self-reported measures improved similarly during both training programmes , improvements were unrelated to level of attendance . CONCLUSION For primary care patients with persistent , unexplained physical symptoms willing to be involved in exercise training , aerobic exercise offers no benefits over non-aerobic exercise . Whilst the observed reduction in primary health care use following exercise training is potentially of practical importance in a group of patients characterized by high consultation rates , improvement in patients ' subjective state was not clearly attributable to exercise training",
"Objective The aim of this study was to compare pool-based exercise and balneotherapy in fibromyalgia syndrome ( FMS ) patients . Methods Fifty female patients diagnosed with FMS according to the American College of Rheumatism ( ACR ) criteria were r and omly assigned to two groups : group 1 ( n=25 ) with pool-based exercise , and in group 2 ( n=25 ) balneotherapy was applied in the same pool without any exercise for 35 min three times a week for 12 weeks . In both groups , pre- ( week 0 ) and post-treatment ( weeks 12 and 24 ) evaluation was performed by one of the authors , who was blind to the patient group . Evaluation parameters included pain , morning stiffness , sleep , tender points , global evaluation by the patient and the physician , fibromyalgia impact question naire , chair test , and Beck depression inventory . Statistical analysis was done on data collected from three evaluation stages . Results Twenty-four exercise and 22 balneotherapy patients completed the study . Pretreatment ( week 0 ) measurements did not show any difference between the groups . In group 1 , statistically significant improvement was observed in all parameters ( P chair test at both weeks 12 and 24 . In group 2 , week 12 measurements showed significant improvement in all parameters ( P chair test and Beck depression inventory . Week 24 evaluation results in group 2 showed significant improvements in pain and fatigue according to visual analogue scale ( VAS ) , 5-point scale , number of tender points , algometric and myalgic scores , and patient and physician global evaluation ( P morning stiffness , sleep , fibromyalgia impact question naire ( FIQ ) , chair test , and Beck depression inventory parameters in this group . Comparison of the two groups based on the post-treatment ( weeks 12 and 24 ) percent changes and difference scores relative to pretreatment ( week 0 ) values failed to show a significant difference between the groups for any parameter except Beck depression inventory ( P pool-based exercise had a longer-lasting effect on some of the FMS symptoms , but statistical analysis failed to show a significant superiority of pool-based exercise over balneotherapy without exercise . While we believe that exercise is a gold st and ard in FMS treatment , we also suggest in light of our results that balneotherapy is among the valid treatment options in FMS , and further research regarding the type and duration of the exercise programs is necessary",
"Objective : To examine the effects of strength training on maximal force , cross‐sectional area ( CSA ) , and electromyographic ( EMG ) activity of muscles and serum hormone concentrations in elderly females with fibromyalgia ( FM ) . Methods : Twenty‐six patients with FM were r and omly assigned to a training ( FMT ; n = 13 ; mean age 60 years ) or a control ( FMC ; n = 13 ; 59 years ) group . FMT performed progressive strength training twice a week for 21 weeks . The measurements included maximal isometric and concentric leg extension forces , EMG activity of the vastus lateralis and medialis , CSA of the quadriceps femoris , and serum concentrations of testosterone ( T ) , free testosterone ( FT ) , growth hormone ( GH ) , insulin‐like growth factor‐1 ( IGF‐1 ) , dehydroepi and rosterone sulfate ( DHEAS ) , and cortisol . Subjectively perceived symptoms of FM were also assessed . Results : All patients were able to complete the training . In FMT strength training led to increases of 36 % ( p in maximal isometric and concentric forces , respectively . The CSA increased by 5 % ( p and the EMG activity in isometric action by 47 % ( p ) . Basal serum hormone concentrations remained unaltered during strength training . The subjective perceived symptoms showed a minor decreasing tendency ( ns ) . No statistically significant changes occurred in any of these parameters in FMC . Conclusion : Progressive strength training increases strength , CSA , and voluntary activation of the trained muscles in elderly women with FM , while the measured basal serum hormone concentrations remain unaltered . Strength training benefits the overall physical fitness of the patients without adverse effects or any exacerbation of symptoms and should be included in the rehabilitation programmes of elderly patients with FM",
"OBJECTIVE To test the short and longterm benefits of an 8 week mind-body intervention that combined training in mindfulness meditation with Qigong movement therapy for individuals with fibromyalgia syndrome ( FM ) . METHODS A total of 128 individuals with FM were r and omly assigned to the mind-body training program or an education support group that served as the control . Outcome measures were pain , disability ( Fibromyalgia Impact Question naire ) , depression , myalgic score ( number and severity of tender points ) , 6 minute walk time , and coping strategies , which were assessed at baseline and at 8 , 16 , and 24 weeks . RESULTS Both groups registered statistically significant improvements across time for the Fibromyalgia Impact Question naire , Total Myalgic Score , Pain , and Depression , and no improvement in the number of feet traversed in the 6 minute walk . However , there was no difference in either the rate or magnitude of these changes between the mind-body training group and the education control group . Salutary changes occurring by the eighth week ( which corresponded to the end of the mind-body and education control group sessions ) were largely maintained by both groups throughout the 6 month followup period . CONCLUSION While both groups showed improvement on a number of outcome variables , there was no evidence that the multimodal mind-body intervention for FM was superior to education and support as a treatment option . Additional r and omized controlled trials are needed before interventions of this kind can be recommended for treatment of FM",
"OBJECTIVE To evaluate the efficacy of operant pain treatment for fibromyalgia syndrome ( FMS ) in an inpatient setting . METHODS Sixty-one patients who fulfilled the American College of Rheumatology criteria for FMS were r and omly assigned to the operant pain treatment group ( OTG ; n = 40 ) or a st and ardized medical program with an emphasis on physical therapy ( PTG ; n = 21 ) . Pain assessment s were performed before , immediately after , 6 months after , and 15 months after treatment . RESULTS The OTG patients reported a significant and stable reduction in pain intensity , interference , solicitous behavior of the spouse , medication , pain behaviors , number of doctor visits , and days at a hospital as well as an increase in sleeping time . Sixty-five percent of the OTG compared with none of the patients in the PTG showed clinical ly significant improvement . CONCLUSION These results suggest that operant pain treatment provided in an inpatient setting is an effective treatment for FMS , whereas a purely somatically oriented program may lead to a deterioration of the pain problem",
"OBJECTIVE To determine whether women with fibromyalgia benefit from strength training . DESIGN R and omized controlled trial . SETTING Testing was completed at the university and training was completed at a local community wellness facility . PARTICIPANTS Twenty-nine women ( age range , 18 - 54 y ) with fibromyalgia participated . Subjects were r and omly assigned to a control ( n=14 ; wait-listed for exercise ) or strength ( n=15 ) group . After the first 4 weeks , 7 ( 47 % ) women dropped from the strength group . INTERVENTION Subjects underwent 12 weeks of training on 11 exercises , 2 times a week , performing 1 set of 8 to 12 repetitions at 40 % to 60 % of their maximal lifts and were progressed to 60 % to 80 % . MAIN OUTCOME MEASURES Subjects were measured for strength , functionality , tender point sensitivity , and fibromyalgia impact . RESULTS The strength group significantly ( P upper- ( strength , 39+/-11 to 42+/-12 kg ; control , 38+/-13 to 38+/-12 kg ) and lower- ( strength , 68+/-28 to 82+/-25 kg ; control , 61+/-25 to 61+/-26 kg ) body strength . Upper-body functionality measured by the Continuous-Scale Physical Functional Performance test improved significantly ( strength , 44+/-11 to 50+/-16U ; control , 51+/-11 to 49+/-13U ) after training . Tender point sensitivity and fibromyalgia impact did not change . CONCLUSIONS Strength training improved strength and some functionality in women with fibromyalgia . Interventions with resistance have important implication s on independence and quality of life issues for women with fibromyalgia ",
"Cardiovascular fitness training has been suggested as a treatment for the fibrositis/fibromyalgia syndrome . Thirty-four patients with fibrositis/fibromyalgia who met Smythe 's original criteria were r and omly assigned to enter either a cardiovascular fitness training program or a program consisting only of flexibility exercises . Patients met in supervised groups three times weekly for a 20-week observation period . The cardiovascular fitness group underwent gradual heart rate-elevated training using a bicycle ergometer and achieved a 29.1 + /- 24.4 percent increase in peak work capacity at 170 beats per minute ( PWC-170 ) . Patients undergoing flexibility training had a net reduction in their PWC-170 scores of 4.3 + /- 9.4 percent . Patients in the cardiovascular fitness group had statistically significant improvements in the visual analogue pain scale of current pain intensity ; total myalgic scores in which pain thresholds at five fibrositic tender points selected for acceptable intra-rater and inter-rater reliability were measured using a dolorimeter ; percentage total body area affected as measured by self-administered pain diagrams ; and patients ' and physicians ' global assessment scores . Psychologic profiles as measured by Symptom Checklist-90R also improved in the cardiovascular fitness group compared with the flexibility training group . It is concluded that cardiovascular fitness training is feasible in patients with fibrositis/fibromyalgia and that such training improves subjective measurements of pain-reporting behavior . A theoretic basis for improvements in pain measurement scales and psychologic profiles is discussed in light of recent literature",
"OBJECTIVE People with fibromyalgia ( FM ) often have low insulin-like growth factor-I ( IGF-I ) levels and a suboptimal growth hormone ( GH ) response to acute exercise . As previous work had demonstrated a normalization of the acute GH response to exercise with the use of pyridostigmine ( PYD ) , we tested the hypothesis that 6 months of PYD therapy plus supervised exercise would increase IGF-I levels . METHODS Subjects with primary FM were r and omized into 4 groups : ( 1 ) PYD/exercise ; ( 2 ) PYD/diet recall ; ( 3 ) placebo/exercise ; and ( 4 ) placebo/diet recall . The dosing of PYD was 60 mg tid for 6 months . Resting IGF-I levels were measured at baseline and after 6 months of treatment . In addition the acute GH response to exercise at VO2 max was measured at baseline and after treatment . RESULTS A total of 165 FM subjects ( mean age 49.5 yrs , 5 male ) were entered and 154 ( 93.3 % ) completed the study . Six months of therapy ( PYD plus exercise or exercise alone ) failed to improve the IGF-I levels . The use of PYD 1 hour prior to exercise improved the acute GH response ( 4.54 ng/dl ) compared to placebo ( 1.74 ng/dl ) ( p = 0.001 ) at the end of the 6-month trial . The acute GH response to exercise at baseline did not correlate with IGF-I , age , depression , medications , estrogen status , or obesity . CONCLUSION A combination of triweekly supervised exercise plus the daily use of PYD for 6 months failed to increase IGF-I levels in patients with FM , despite the confirmation that PYD normalizes the acute GH response to strenuous aerobic exercise",
"OBJECTIVE To evaluate the short- and long-term efficacy of exercise therapy in a warm , waist-high pool in women with fibromyalgia . METHODS Thirty-four women ( mean + /- SD tender points 17 + /- 1 ) were r and omly assigned to either an exercise group ( n = 17 ) to perform 3 weekly sessions of training including aerobic , proprioceptive , and strengthening exercises during 12 weeks , or to a control group ( n = 17 ) . Maximal unilateral isokinetic strength was measured in the knee extensors and flexors in concentric and eccentric actions at 60 degrees /second and 210 degrees /second , and in the shoulder abductors and adductors in concentric contractions . Health-related quality of life ( HRQOL ) was assessed using the EQ-5D question naire ; pain was assessed on a visual analog scale . All were measured at baseline , posttreatment , and after 6 months . RESULTS The strength of the knee extensors in concentric actions increased by 20 % in both limbs after the training period , and these improvements were maintained after the de-training period in the exercise group . The strength of other muscle actions measured did not change . HRQOL improved by 93 % ( P = 0.007 ) and pain was reduced by 29 % ( P = 0.012 ) in the exercise group during the training , but pain returned close to the pretraining level during the subsequent de-training . However , there were no changes in the control group during the entire period . CONCLUSION The therapy relieved pain and improved HRQOL and muscle strength in the lower limbs at low velocity in patients with initial low muscle strength and high number of tender points . Most of these improvements were maintained long term",
"OBJECTIVE This r and omized controlled clinical trial evaluates the effectiveness of outpatient group cognitive/educational treatment for patients with the fibromyalgia ( FM ) syndrome . We hypothesized that the combination of group education with cognitive treatment aim ed at developing pain coping skills would be more effective than group education alone . METHODS 131 patients with FM were r and omly assigned to 3 conditions : an experimental condition , which was the combined cognitive/educational intervention ( ECO ) ; an attention control condition consisting of group education plus group discussion ( EDI ) ; and a waiting list control ( WLC ) . For the treatment conditions ECO and EDI , assessment s were made 2 weeks before treatment , at start of treatment , at post-treatment , and at 6 and 12 mo followup . WLC patients received only 3 assessment s. RESULTS There were no pretreatment differences between the groups , or between dropouts and patients who remained in the study . At post-treatment , and compared with the WLC , the ECO patients improved in knowledge about FM ( p = 0.007 ) and pain coping ( p pain coping ( p = 0.005 ) and pain control ( p = 0.002 ) . EDI patients reported significantly less fear than ECO patients ( p = 0.005 ) . There were no other differential effects between ECO and EDI at post-treatment or 6 mo or 12 mo followup . Based on the reliability of change index for clinical significance , the relative short term success rates are 6.4 and 18.4 % for ECO and EDI , respectively . CONCLUSION The surplus value of a highly structured , 12 session group cognitive treatment added to group education can not be supported by our study . In EDI , fear reduction might have enhanced pain coping and pain control , while poor compliance , the difficulty of homework assignments , and lack of individual support may have limited the effectiveness of ECO ",
"OBJECTIVES The aim of this study was to investigate the effectiveness of a 6-week traditional exercise programme with supplementary whole-body vibration ( WBV ) in improving strength and health status in women with fibromyalgia ( FM ) . METHODS Thirty postmenopausal women with FM ( mean ( SD ) age : 59 ( 7.90 ) years ) were r and omised into one of two groups , one intervention group ( GEV n=15 ) , which combined exercise training ( two days a week ) with three days of WBV ( 3 sets of 45 s at 20 Hz-3 mm and four sets of unilateral static squats at 20 Hz-2 mm ) and another control group ( n=15 ) , that performed the same physical activity programme but without vibration training ( GEnV ) . The Fibromyalgia Impact Question naire ( FIQ ) and the global score of the SF-36 were used to assess functional capacity and quality of life . Two additional tests were employed to assess muscle strength . Baseline data and pre-test and post-test data were collected before and after the six-week intervention period . RESULTS Significant improvements in all outcomes measured were found from baseline in both groups . A 5 % improvement from baseline in total FIQ score was observed in the exercise groups ( p≤0.05 ) , and was accompanied by reductions in SF36 scores of 9.8 % ( p muscle strength in both groups but greater in the GEV group . CONCLUSIONS The results suggest that women with FMS can gain additional health benefits by engaging in a 6-week traditional exercise programme with supplementary WBV",
"UNLABELLED Fibromyalgia ( FM ) , a rheumatological disorder of unknown origin , is characterized by both physical and psychological symptoms . Although inconclusive results have been reported for most treatment modalities , exercise appears to have universal support for decreasing the myriad of symptoms associated with FM . Weaknesses in the literature , however , prevent conclusive statements regarding exercise prescription and concomitant impact on FM symptomology . PURPOSE The current pilot study attempted to examine the effect of a 24-wk walking program at predetermined intensities on FM . METHODS Initial design was a r and omized control trial with high- and low-intensity exercise groups , and a control group . Subsequent nonr and omized control trials were based on actual exercise behavior . RESULTS No differences between initial groups were identified . By collapsing groups , heart rate ( HR ) decreased ( P Functional impairments were reduced 54 % weeks 0 - 24 , with exercise having a large impact ( omega2 = 0.30 ) on this decrease . By reassigning groups , impact of FM on current health status decreased in the low-intensity group ( P influence of exercise on pain ( omega2 = 0.51 ) , with greater pain in the high-intensity group . CONCLUSIONS A larger number of subjects and direct supervision of the training program to increase compliance is necessary to clarify the effects of a walking program on the manifestations of FM . Results indicate that intensity of the walking program is an important consideration . Individuals with FM can adhere to low-intensity walking programs two to three times per week , possibly reducing FM impact on daily activities",
"OBJECTIVE The aim of this study was to evaluate the cardiorespiratory fitness and perceived exertion of female patients with fibromyalgia syndrome ( FMS ) compared with that of healthy female subjects . DESIGN AND SUBJECTS This was design ed as a cross-sectional case-control study , with a consecutive sample of 30 female patients with FMS and an age-matched control group of 67 healthy female subjects . SETTING This study was conducted at the multidisciplinary pain center of a university hospital in a city of more than 1 million inhabitants . OUTCOME MEASURES A cardiorespiratory fitness index ( PWC65%/kg ) and an original perceived exertion index ( B65 % ) were obtained from the heart rates and perceived exertions scored on a 10-point Borg scale during a submaximal cycle ergometer test . Average indexes for the FMS patients and control subjects were compared . RESULTS The mean cardiorespiratory fitness index of the FMS patients was not significantly different from that of the controls . The mean perceived exertion index in the FMS patients was significantly greater than that of the controls , meaning that the FMS patients systematic ally reported higher ratings of perceived exertion during exercise . CONCLUSIONS Cardiorespiratory fitness , as expressed by a submaximal work capacity index , seems normal in female patients with FMS compared with age- and sex-matched healthy individuals . The fact that FMS patients overscore their perception of exertion may be due to a greater overlap of peripheral pain and perceived exertion perceptions during exercise . This observation should be noted when using perceived exertion scores to prescribe and monitor exercise in FMS patients",
"OBJECTIVE The purpose of this study was to investigate the effect of acute and chronic whole-body vibration exercise on serum insulin-like growth factor-1 ( IGF-1 ) levels in women with fibromyalgia . METHODS A r and omized controlled two-factor mixed experimental design was used . Twenty-four women with fibromyalgia ( age + /- st and ard error of the mean , 54.95 + /- 2.03 ) were r and omized into the vibration group or the control group . The vibration group underwent a protocol of static and dynamic tasks with whole-body vibration exercise twice a week for a total of six weeks , whereas the control group performed the same protocol without vibratory stimulus . Both groups continued their usual pharmacological treatment . Serum IGF-1 levels were determined using enzyme-linked immunosorbent assay ( ELISA ) . To test the effects of long-term whole-body vibration exercise , serum IGF-1 measurements were taken at baseline and at weeks 1 , 3 , and 6 of the intervention . To test the short-term effects , at week 1 , serum IGF-1 measurements were taken before and immediately following a session of whole-body vibration exercise . RESULTS Treatment adherence was 93 % in the vibration group and 92 % in the control group . None of the subjects dropped out of the study . There was an absence of change in IGF-1 at week 1 and week 6 of whole-body vibration exercise . CONCLUSION Results show no change in serum IGF-1 levels in women with fibromyalgia undergoing whole-body vibration exercise . Although high-intensity exercise and whole-body vibration exercise have been shown to increase serum IGF-1 in healthy individuals , the effectiveness of whole-body vibration exercise as a strategy to produce improvements in serum IGF-1 levels in women with fibromyalgia could not be demonstrated",
"OBJECTIVE To compare hydrotherapy ( HT ) and conventional physiotherapy ( CP ) in the treatment of fibromyalgia ( FM ) , regarding quality of life ( QOL ) , total sleep time ( TST ) , and total nap time ( TNT ) . METHODS Fifty out patients , all female , 30 - 60 years old , diagnosed with FM , were r and omly assigned to two groups to carry out 3 weeks of treatment with HT or CP . In the beginning and in the end of treatment , patients were evaluated with the SF-36 question naire to measure QOL and the sleep diary for TST and TNT . Data analyses were blind . RESULTS All 24 HT patients increased 1h in TST compared to 19 CP patients . TNT decreased in the HT group . QOL improved for the two groups in all domains when pre- and post-intervention were compared , but there was no difference between groups . CONCLUSION HT is more effective than CP to improve TST and to decrease TNT in FM patients",
"OBJECTIVE To compare an evidence -based clinical fibromyalgia program , referred to as Fibro-Fit , with results of controlled clinical trials . METHODS An interdisciplinary group education and exercise program with 36 sessions over 12 weeks was used . Demographic , clinical , and outcome variables were collected on 149 participants , of whom 71 % completed the program . Outcomes included measures of self-efficacy , pain , physical fitness , function , and coping skills . RESULTS Results of the prospect i ve before-after evaluation showed statistically significant ( P grip strength . These results were comparable with controlled clinical trials found in the literature . Data suggest that smoking , fibromyalgia support groups , and medications may be important modifiable factors . CONCLUSIONS Results suggest that Fibro-Fit was effective in improving physical impairments and function . Further investigation is required to refine the effective components of these programs and determine how modifiable factors can be used to improve outcomes",
"OBJECTIVE To compare in patients with fibromyalgia ( FM ) utilities derived by rating scale and st and ard gamble methods ; to gain insight into construct validity by relating utility values to other outcome measures ; to assess the sensitivity to change of utilities . METHODS A total of 73 patients with FM were r and omized into one of 3 groups : low impact fitness training , biofeedback , or controls . At baseline and after 6 mo the Maastricht Utility Measurement Question naire was applied . By means of both the rating scale and st and ard gamble method patients were asked to value their own health status . Construct validity of patient utility measurements was evaluated by Spearman correlation and multiple regression of baseline values with pain , stiffness , patient 's global assessment , Sickness Impact Profile ( SIP ) , modified Health Assessment Question naire and Arthritis Impact Measurement Scale ( AIMS ) . Sensitivity to change was assessed against changes in these outcomes . RESULTS Rating scale utilities correlated significantly ( p patient 's global assessment ( rs = 0.53 ) , pain ( rs = -0.47 ) , SIP ( rs = -0.43 ) , and with 9 of 11 dimensions of the AIMS ( rs ranging from 0.23 to 0.62 ) . St and ard gamble utilities correlated significantly with mobility , pain , and arthritis impact of the AIMS scale ( rs from 0.22 to 0.36 ) and with pain by visual analog scale ( rs = -0.24 ) and patient 's global assessment ( rs = 0.32 ) . Multiple regression analysis showed that patient 's global assessment explained 41 % ( rating scale ) and 10 % ( st and ard gamble ) of total variance in baseline utilities . Also , 16 % of the variance in change in rating scale utility values was explained by changes in patient 's global assessment . In contrast , variance of changes in st and ard gamble utility values was not explained significantly by changes in other disease outcomes . CONCLUSION Rating scale utilities correlated more strongly with disease outcome measures than st and ard gamble utilities . Also , construct validity for the rating scale was better than for the st and ard gamble . In FM , utility measurement is sensitive to the method chosen to elicit patient priorities",
"OBJECTIVE To determine the effectiveness of self-management education and physical training in decreasing fibromyalgia ( FMS ) symptoms and increasing physical and psychological well being . METHODS A pretest-posttest control group design was used . Ninety-nine women with FMS were r and omly assigned to 1 of 3 groups ; 86 completed the study . The education only group received a 6-week self-management course . The education plus physical training group received the course and 6 h of training design ed to assist them to exercise independently . The control group got treatment after 3 months . RESULTS The experimental programs had a significant positive impact on quality of life and self-efficacy . Helplessness , number of days feeling bad , physical dysfunction , and pain in the tender points decreased significantly in one or both of the treated groups when retested 6 weeks after the end of the program . Longterm followup of 67 treated subjects showed significant positive changes on the Fibromyalgia Impact Question naire primarily in the physical training group . Among all subjects , 87 % were exercising at least 3 times/week for 20 min or more ; 46 % said they had increased their exercise level since participating in the program ; 70 % were practicing relaxation strategies as needed ; 46 % were working at least half time as opposed to 37 % at pretest . CONCLUSION Self-efficacy of the treated groups was enhanced significantly by the program . Other changes were smaller and more delayed than had been expected . Recommendations for future trials include a longer education program , more vigorous physical training , and longterm followup",
"Objective . Increasing research interest and emerging new therapies for treatment of fibromyalgia ( FM ) have led to a need to develop a consensus on a core set of outcome measures that should be assessed and reported in all clinical trials , to facilitate interpretation of the data and underst and ing of the disease . This aligns with the key objective of the Outcome Measures in Rheumatology ( OMERACT ) initiative to improve outcome measurement through a data driven , interactive consensus process . Methods . Through patient focus groups and Delphi processes , working groups at previous OMERACT meetings identified potential domains to be included in the core data set . A systematic review has shown that instruments measuring these domains are available and are at least moderately sensitive to change . Most instruments have been vali date d in multiple language s. This pooled analysis study aims to develop the core data set by analyzing data from 10 r and omized controlled trials ( RCT ) in FM . Results . Results from this study provide support for the inclusion of the following in the core data set : pain , tenderness , fatigue , sleep , patient global assessment , and multidimensional function/health related quality of life . Construct validity was demonstrated with outcome instruments showing convergent and divergent validity . Content and criterion validity were confirmed by multivariate analysis showing R square values between 0.4 and 0.6 . Low R square value is associated with studies in which one or more domains were not assessed . Conclusion . The core data set was supported by high consensus among attendees at OMERACT 9 . Establishing an international st and ard for RCT in FM should facilitate future metaanalyses and indirect comparisons",
"OBJECTIVE To compare the therapeutic effects of physical fitness training or biofeedback training with the results of usual care in patients with fibromyalgia ( FM ) . METHODS One hundred forty-three female patients with FM ( American College of Rheumatology criteria ) were r and omized into 3 groups : a fitness program ( n = 58 ) , biofeedback training ( n = 56 ) , or controls ( n = 29 ) . Half the patients in the active treatment groups also received an educational program aim ed at improving compliance . Assessment s were done at baseline and after 24 weeks . The primary outcome was pain [ visual analog scale ( VAS ) ] . Other endpoints were the number of tender points , total myalgic score ( dolorimetry ) , physical fitness , functional ability ( Arthritis Impact Measurement Scale and Sickness Impact Profile ) , psychological distress ( Symptom Checklist-90-Revised ) , patient global assessment ( 5 point scale ) , and general fatigue ( VAS ) . RESULTS Baseline scores were similar in all 3 groups . Altogether 25 ( 17.5 % ) patients dropped out ; they were similarly distributed over all groups : 14 patients after r and omization and 11 ( 8 % ) during the study . A true high impact level for fitness training was not attained by any patient . After treatment , no significant differences in change scores of any outcome were found between the groups ( ANOVA , p > 0.05 ) . All outcome measures showed large variations intra- and interindividually . The educational program did not result in higher compliance with training sessions ( 62 % vs 71 % ) . Analysis of the subgroup of subjects with a high attendance rate ( > 67 % ) also showed no improvement . CONCLUSION In terms of training intensity and maximal heart rates , the high impact fitness intervention had a low impact benefit . Therefore effectiveness of high impact physical fitness training can not be demonstrated . Thus compared to usual care , the fitness training ( i.e. , low impact ) and biofeedback training had no clear beneficial effects on objective or subjective patient outcomes in patients with FM",
"OBJECTIVE To investigate the effects of 21 weeks ' progressive strength training on neuromuscular function and subjectively perceived symptoms in premenopausal women with fibromyalgia ( FM ) . METHODS Twenty one women with FM were r and omly assigned to experimental ( FMT ) or control ( FMC ) groups . Twelve healthy women served as training controls ( HT ) . The FMT and HT groups carried out progressive strength training twice a week for 21 weeks . The major outcome measures were muscle strength and electromyographic ( EMG ) recordings . Secondary outcome measures were pain , sleep , fatigue , physical function capacity ( Stanford Health Assessment Question naire ) , and mood ( short version of Beck 's depression index ) . RESULTS Female FMT subjects increased their maximal and explosive strength and EMG activity to the same extent as the HT group . Moreover , the progressive strength training showed immediate benefits on subjectively perceived fatigue , depression , and neck pain of training patients with FM . CONCLUSIONS The strength training data indicate comparable trainability of the neuromuscular system of women with FM and healthy women . Progressive strength training can safely be used in the treatment of FM to decrease the impact of the syndrome on the neuromuscular system , perceived symptoms , and functional capacity . These results confirm the opinion that FM syndrome has a central rather than a peripheral or muscular basis",
"OBJECTIVE To examine the effects of strength training on basal concentrations and acute responses of serum hormones , and their possible interrelationships with training induced muscle hypertrophy and strength gains of the knee extensor muscles in women with fibromyalgia ( FM ) and healthy controls . METHODS Twenty-one premenopausal women with FM were r and omized to 21 week strength training ( FMT ; n = 11 ) or control ( FMC ; n = 10 ) groups . Twelve premenopausal sedentary healthy women served as controls ( HC ) . Surface electromyographic ( EMG ) activity , maximal unilateral isometric force of the right knee extensors , and muscle cross-sectional area ( CSA ) of the quadriceps femoris throughout the lengths of 3/12 to 12/15 of the femur ( Lf ) were measured . Serum concentrations of total and free testosterone and growth hormone ( GH ) were analyzed at rest and in pre- and post-exercise conditions , while levels of insulin-like growth factor and dehydroepi and rosterone sulfate were measured at rest only . RESULTS Mean ( SD ) maximal force increased by 18 % ( 10 % ) ( p Maximum integrated EMG of the agonists ( VL + VM/2 ) increased in HC by 22 % ( p CSA of the QF were observed at 5 to 12/15 Lf in FMT ( p serum hormones examined . A significant acute increase took place in the mean concentration of GH at pre-training in HC ( p women with FM were completely comparable to those taking place in healthy women . Basal levels of the anabolic hormones seem to be similar in women with FM compared to age matched healthy women . Observations recorded during the acute loading conditions might be considered an indication of the training induced adaptation of the endocrine system , showing that the acute GH response may become systematic after strength training in both women with FM and controls ",
"OBJECTIVES To compare the cognitive function performance in patients with fibromyalgia ( FM ) with respect healthy controls and to evaluate the short-term efficacy of exercise therapy in a warm , chest-high pool on pain and cognitive function in women with FM . METHODS Sixty middle-aged women with FM were r and omly assigned to either an exercise training group ( n = 35 ) to perform 3 sessions per week of aquatic training ( 32 degrees C ) including mobility , aerobic , strengthening , and relaxation exercises for 16 weeks , or a control group ( n = 25 ) . Twenty-five healthy women matched for age , weight , body mass index , and educational and physical activity levels were recruited . Pain was assessed in patients using a syringe calibrated like a pressure dolorimeter , and a visual analog scale . The severity of FM was evaluated using the Fibromyalgia Impact Question naire . Cognitive function was measured in healthy individuals and patients using several st and ardized neuropsychological tests . All patients were measured at baseline and post-treatment . RESULTS At baseline , the healthy group evidence d cognitive performance that was significantly superior to the group of patients with FM in all of the neuropsychological tests . The exercise group significantly improved their pain threshold , tender point count , self-reported pain , severity of FM , and cognitive function , while in the control group the differences were not significant . CONCLUSION An exercise therapy three times per week for 16 weeks in a warm-water pool is an adequate treatment to decrease the pain and severity of FM well as to improve cognitive function in previously unfit women with FM and heightened painful symptomatology",
"OBJECTIVE To compare the clinical effectiveness of aerobic exercise in the water with walking/jogging for women with fibromyalgia ( FM ) . METHODS Sixty sedentary women with FM , ages 18 - 60 years , were r and omly assigned to either deep water running ( DWR ) or l and -based exercises ( LBE ) . Patients were trained for 15 weeks at their anaerobic threshold . Visual analog scale of pain , Fibromyalgia Impact Question naire ( FIQ ) , Beck Depression Inventory , Short Form 36 Health Survey ( SF-36 ) , and a patient 's global assessment of response to therapy ( PGART ) were measured at baseline , week 8 , and week 15 . Statistical analysis included all patients . RESULTS Four patients dropped out from each group . Both groups improved significantly at week 15 compared with baseline , with an average 36 % reduction in pain intensity . For PGART , 40 % of the DWR group and 30 % of the LBE group answered \" much better \" at posttreatment . FIQ total score and FIQ depression improvements in the DWR group were faster ( week 8) than the LBE group and kept improving ( week 15 ; P improvements in SF-36 role emotional ( P = 0.006 ) . No significant between-group differences were observed for peak oxygen uptake and other outcomes . CONCLUSION DWR is a safe exercise that has been shown to be as effective as LBE regarding pain . However , it has been shown to bring more advantages related to emotional aspects . Aerobic gain was similar for both groups , regardless of symptom improvement . Therefore , DWR could be studied as an exercise option for patients with FM who have problems adapting to LBE or lower limbs limitations",
"The purpose of this study was to evaluate and compare the effectiveness of muscle-strengthening exercises ( MS ) and a walking program ( WA ) in reducing pain in patients with fibromyalgia . Ninety women , 30–55 years of age , diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria , were r and omized into 3 groups : WA Group , MS Group , and control group . Pain ( visual analog scale ) was evaluated as the primary outcome . Physical functioning ( Fibromyalgia Impact Question naire , FIQ ) , health-related quality of life ( Short-Form 36 Health Survey , SF-36 ) , and use of medication were evaluated as secondary outcomes . Assessment s were performed at baseline , 8 , 16 , and 28 weeks . Intention-to-treat and efficacy analyses were conducted . Sixty-eight patients completed the treatment protocol . All 3 groups showed improvement after the 16-week treatment compared to baseline . At the 28-week follow-up , pain reduction was similar for the WA and MS groups ( P = 0.39 ) , but different from the control group ( P = 0.01 ) . At the end of the treatment , 80 % of subjects in the control group took pain medication , but only 46.7 % in the WA and 41.4 % in the MS groups . Mean FIQ total scores were lower for the WA and MS groups ( P = 0.96 ) compared with the control group ( P the WA and MS groups reported higher scores ( better health status ) than controls in almost all SF-36 subscales . MS was as effective as WA in reducing pain regarding all study variables ; however , symptoms management during the follow-up period was more efficient in the WA group",
"OBJECTIVE To determine the safety , feasibility and consequences of a program of progressive strength training and cardiovascular exercise in women with fibromyalgia syndrome ( FMS ) . METHODS Fifteen women with confirmed FMS were monitored for injury and exercise compliance , and assessed for muscle strength ( 1-repetition maximum technique ) , cardiovascular endurance ( 6-minute walk test ) , and functional status ( Fibromyalgia Impact Question naire [ FIQ ] ) before and after a 20-week exercise intervention . RESULTS Zero injuries and an 81 % compliance rate occurred during training . Improvement was seen in muscle strength of the lower ( 191 + /- 75 to 265 + /- 67 pounds ; P body , 6-minute walk distance ( 530 + /- 80 to 629 + /- 74 meters ; P FIQ score ( 44 + /- 9 to 32 + /- 14 ; P program of progressive strength training and cardiovascular exercise can be safe , well tolerated , and effective at improving muscle strength , cardiovascular endurance and functional status in women with FMS without exacerbating symptoms . This program may also contribute to a reduction in the severity of several symptoms",
"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 evaluate the effect of exercise on mood and physical function in individuals with fibromyalgia . METHODS Subjects were r and omly assigned to an exercise ( EX ) or control ( CTL ) group . EX subjects participated in 3 30-minute exercise classes per week for 23 weeks . Subjects were tested at entry and at 6 , 12 , and 23 weeks . Tests included the Beck Depression Inventory ( BDI ) , 6-minute walk , State-Trait Anxiety Inventory ( STAI ) , Mental Health Inventory ( MHI ) , Fibromyalgia Impact Question naire ( FIQ ) , Arthritis Self-Efficacy Scale ( ASES ) , and a measure of tender points and knee strength . RESULTS Fifty subjects ( 27 EX , 23 CTL ) completed the study , and 31 ( 15 EX , 16 CTL ) met criteria for efficacy analyses . In efficacy analyses , significant improvements were seen for EX subjects in 6-minute walk distances , BDI ( total , cognitive/ affective ) , STAI , FIQ , ASES , and MHI ( 3 of 5 subscales ) scores . These effects were reduced but remained during intent-to-treat analyses . CONCLUSION Exercise can improve the mood and physical function of individuals with fibromyalgia",
"PURPOSE To evaluate the effects of a 12-wk period of aquatic training and subsequent detraining on health-related quality of life ( HRQOL ) and physical fitness in females with fibromyalgia . METHODS Thirty-four females with fibromyalgia were r and omly assigned into two groups : an exercise group , who exercised for 60 min in warm water , three times a week ( N = 17 ) ; and a control group , who continued their habitual leisure-time activities ( N = 17 ) . HRQOL was assessed using the Short Form 36 question naire and the Fibromyalgia Impact Question naire . Physical fitness was measured using the following tests : Canadian Aerobic Fitness , h and grip dynamometry , 10-m walking , 10-step stair climbing , and blind one-leg stance . Outcomes were measured at baseline , after treatment , and after 3 months of detraining . RESULTS After 12 wk of aquatic exercise , significant positive effects of aquatic training were found in physical function , body pain , general health perception , vitality , social function , role emotional problems and mental health , balance , and stair climbing . After the detraining period , only the improvements in body pain and role emotional problems were maintained . CONCLUSION The present water exercise protocol improved some components of HRQOL , balance , and stair climbing in females with fibromyalgia , but regular exercise and higher intensities may be required to preserve most of these gains",
"OBJECTIVE To assess the impact of a long-term exercise programme vs usual care on perceived health status , functional capacity and depression in patients with fibromyalgia . DESIGN R and omized controlled trial . SUBJECTS Forty-two women with fibromyalgia were allocated r and omly to 1 of 2 groups : an experimental group that carried out aerobic , strength and flexibility exercises for 24 weeks and a usual care control group . METHODS Health status and functional capacity were evaluated using the Fibromyalgia Impact Question naire and the Short Form Health Survey 36 . Depression was evaluated with the Beck Depression Inventory . RESULTS Significant improvements were observed in health status and functional capacity for the exercise group over the control group . The magnitude of the effect size of these improvements , expressed as Cohen 's d , was medium . The effect size ( 95 % confidence interval ) for the Fibromyalgia Impact Question naire was 0.58 ( -14.12 , -2.35 ) , for the Short Form Health Survey 36 . global score 0.54 ( 1.28 , 14.52 ) , and in the mental health domain of the Short Form Health Survey 36 . 0.51 ( 1.20 , 16.26 ) . There was a large effect size in vitality . All the aforementioned improvements can be considered as clinical ly important changes . CONCLUSION Results confirm that a long-term combination of aerobic exercise , strengthening and flexibility improves psychological health status and health-related quality of life in patients with fibromyalgia",
"OBJECTIVE This study assessed the effect of 2 physiotherapy programs design ed to improve flexibility and to reduce the impact of the illness and pain perception in women with the fibromyalgia syndrome ( FMS ) , and compared the effects of the 2 programs in the short and intermediate term . METHODS Twenty FMS patients were r and omly assigned to 2 training groups , one following a program of kinesiotherapy and active muscular stretching and one using techniques of Global Myofascial Physiotherapy , according to the Mézières method . Both groups met twice a week for 12 weeks , for a total of 150 minutes each week . Flexibility and illness impact were measured by means of a st and ard test , whereas pain was assessed by means of thumb palpation . Measurements were taken at the beginning and end of the program and 24 weeks after its end . RESULTS Patients had achieved a statistically significant reduction in the severity of the disease and improved their flexibility level by the end of the program , but had returned to initial values after follow-up . Significant differences were not observed between the 2 treatment groups in the initial values or in the results at the end of the program or after the follow-up , so neither program proved better than the other . CONCLUSION The FMS patients in this study improved their flexibility level and general well-being using both kinesiotherapy and stretching exercises techniques",
"OBJECTIVE To compare a supervised 12-week aerobic exercise class with unsupervised home aerobic exercises in the treatment of patients with fibromyalgia . METHODS This was a 48-week r and omized single ( observer ) blind study in a teaching hospital rheumatology and physiotherapy department . The subjects were 74 patients who fulfilled the American College of Rheumatology criteria for fibromyalgia . Results and conclusions . A 12-week exercise class programme with home exercises demonstrated no benefit over a single physiotherapy session with home exercises in the treatment of pain in patients with fibromyalgia . Neither group ( nor the groups combined ) showed an improvement in pain compared with baseline . There was some significant benefit in psychological well-being in the exercise class group and perhaps a slowing of functional deterioration in this group",
"Summary Strengthening and aerobic exercise had equivalent effects on reducing pain severity in patients with fibromyalgia . Abstract Strength training and aerobic exercise have beneficial effects on pain in adults with fibromyalgia . However , the equivalence of strengthening and aerobic exercise has not been reported . The primary aim of this r and omized equivalence trial involving patients with fibromyalgia admitted to an interdisciplinary pain treatment program was to test the hypothesis that strengthening ( n = 36 ) and aerobic ( n = 36 ) exercise have equivalent effects ( 95 % confidence interval within an equivalence margin ±8 ) on pain , as measured by the pain severity subscale of the Multidimensional Pain Inventory . Secondary aims included determining the effects of strengthening and aerobic exercise on peak Vo2 uptake , leg strength , and pressure pain thresholds . In an intent‐to‐treat analysis , the mean ( ± st and ard deviation ) pain severity scores for the strength and aerobic groups at study completion were 34.4 ± 11.5 and 37.6 ± 11.9 , respectively . The group difference was −3.2 ( 95 % confidence interval , −8.7 to 2.3 ) , which was within the equivalence margin of Δ8 . Significant improvements in pain severity ( P ( P that strength and aerobic exercise had equivalent effects on reducing pain severity among patients with fibromyalgia",
"OBJECTIVE To investigate prognostic factors in the course of the fibromyalgia syndrome ( FM ) from baseline to post-treatment . METHODS Fifty-seven patients with FM were examined in a r and omized intervention study . Pre-treatment variables were entered into linear regression analyses : gender , age , duration of disease , allocation to treatment , pain distribution ( based on a patient-made drawing ) , fatigue , sleep disturbance , and depressed mood ( based on visual analog scores ) , with pain distribution at treatment completion as the dependent variable . RESULTS Depressed mood at baseline was a significant predictor of sustained widespread pain at treatment completion . CONCLUSION The findings indicate a role for depressed mood as a predictive factor for treatment response",
"Abstract : Fibromyalgia ( FM ) is a disorder characterised by diffuse widespread musculoskeletal aching and stiffness and multiple tender points [ 1 ] . Its pathophysiology is poorly understood . The influence of aerobic endurance exercise on pain in patients with FM was investigated . Twenty-seven patients ( 25 female , 2 male ) participated in a controlled clinical study and performed 12 weeks of jogging , walking , cycling or swimming following a given schedule . Twelve sedentary FM patients ( 11 female , 1 male ) served as controls . Before and after training both the study and the control groups were evaluated spiroergometrically . Tender point pain was quantified by dolorimetry . The painful body surface was estimated by a pain body diagram , and its intensity by a visual analogue scale and a ranking scale . Patients trained for an average of 25 min two to three times a week , with an average intensity of 50 % of maximal oxygen uptake ( VO2max ) . Unlike the control group , the training group exhibited a decrease in heart rate and VO2 and an increase in respiratory quotient during submaximal workload . Maximal performance capacity and VO2max remained unchanged , whereas the wattpulse ( watt/heart rate ) improved at maximal workload . Pain parameters remained unchanged in the control group , but in the training group the mean number of positive tender points ( 15.4/12.7 ) , the mean pain threshold of the gluteal tender point ( 2.89 kp/3.50 kp ) and the painful body surface ( 18%/15 % body surface ) decreased significantly . Subjective general pain condition deteriorated in two patients but improved in 17 . Our results suggest a positive effect of aerobic endurance exercise on fitness and well-being in patients with FM",
"BACKGROUND Hamstring strains are the most common soft-tissue injury observed in recreational and athletic activities , yet no consensus exists regarding appropriate primary and secondary strategies to prevent these strains . Eccentric exercise has been reported to reduce the incidence of ham-string strains but its role has not been clearly defined . OBJECTIVE The objective of this systematic review was to determine the effectiveness of eccentric exercise in preventing hamstring strains . DATA SOURCES Online data bases , including MED-LINE , PubMed , CINAHL , PEDro , SPORTD iscus , EMBASE , Cochrane Data base of Systematic Review s , Cochrane Central Register of Controlled Trials , and Web of Science were search ed for relevant articles . Each data base was search ed from the earliest date to July 2007 . STUDY SELECTION Selection criteria included diagnosis of hamstring strain , otherwise healthy individuals , and at least one group receiving an eccentric exercise intervention . Seven articles { three r and omized controlled trials ( RCTs ) and four cohort studies } met the inclusion criteria . DATA EXTRACTION Data were extracted using a customized form . Method ological rigor of included studies was assessed using the PEDro scale and Oxford Centre for Evidence -based Medicine Levels of Evidence . DATA SYNTHESIS STUDIES WERE GROUPED BY ECCENTRIC EXERCISE INTERVENTION PROTOCOL : hamstring lowers , isokinetic strengthening , and other strengthening . A best- evidence synthesis of pooled data was qualitatively summarized . CONCLUSIONS Findings suggest that eccentric training is effective in primary and secondary prevention of hamstring strains . Study heterogeneity and poor method ological rigor limit the ability to provide clinical recommendations . Further RCTs are needed to support the use of eccentric training protocol s in the prevention of hamstring strains",
"Fibromyalgia ( FM ) is characterized by generalized muscle pain , low muscle strength and autonomic dysfunction . Heart rate ( HR ) variability ( HRV ) is reduced in individuals with FM increasing their risk for cardiovascular morbidity and mortality . We tested the hypothesis that resistance exercise training ( RET ) improves HRV , baroreflex sensitivity ( BRS ) and muscle strength in women with FM . Women with FM ( n = 10 ) and healthy controls ( n = 9 ) , aged 27–60 years , were compared at baseline . Only women with FM underwent supervised RET 2 days per week for 16 weeks . Baseline and post‐training measurements included HRV and spontaneous baroreflex sensitivity ( BRS , alpha index ) from continuous electrocardiogram and blood pressure ( BP ) recorded with finger plethysmography during 5 min in the supine position . RR interval , total power , log transformed ( Ln ) squared root of the st and ard deviation of RR interval ( RMSSD ) , low‐frequency power and BRS were lower ( P and HR and pulse pressure were higher ( P , mean ( SEM ) total power increased ( 387 ± 170 ms2 , P ) , RMSSD increased ( 0·18 ± 0·08 Ln ms , P of high‐frequency power increased ( 0·54 ± 0·27 Ln ms2 , P = 0·08 ) in women with FM . Upper and lower body muscle strength increased by 63 % and 49 % ( P perception decreased by 39 % in women with FM . There were no changes in BRS , HR and BP after RET . Our study demonstrates that RET improves total power , cardiac parasympathetic tone , pain perception and muscle strength in women with FM who had autonomic dysfunction before the exercise programme",
"OBJECTIVES The aim of this study was to analyze the effect of 12-week tilting Whole Body Vibration therapy ( WBV ) on Health Related Quality of Life ( HRQoL ) in fibromylagia ( FM ) within the context of a r and omized control trial ( IS RCT N16950947 ) . SUBJECTS AND METHODS Thirty-six ( 36 ) women with FM were r and omly allocated to either an exercise or a control group . The women in the exercise group were assigned to a 12-week course of tilting WBV ( 12.5-Hz frequency ; 3-mm amplitude ) . HRQoL was assessed using the Fibromyalgia Impact Question naire ( FIQ ) and a 15D question naire . RESULTS A 12-week course of tilting WBV therapy was associated with improvements in FIQ scores ( 12 % ) but not in the 15D question naire . CONCLUSIONS Tilting WBV was a feasible intervention that prevented the loss of HRQoL in previously physically untrained women with FM",
"OBJECTIVE To compare in a pilot study the effect of two physical therapies , the Mensendieck system ( MS ) and body awareness therapy ( BAT ) according to Roxendal , in fibromyalgia patients and to investigate differences in effect between the two interventions . METHODS Twenty female patients were r and omized to either MS or BAT in a program lasting 20 weeks . Evaluations were tender point examination and question naires , including visual analog scales ( pain intensity at worst site , muscular stiffness , evening fatigue , and global health ) , Fibromyalgia Impact Question naire ( FIQ ) , Coping Strategies Question naire , Quality of Life Scales , Arthritis Self-Efficacy Scale ( ASES ) , and disability before , immediately after , and at 6 and 18 months follow-up . RESULTS The BAT group had improved global health at 18 months follow-up , but lower results than the MS group . The MS group had improved FIQ , ASES other symptoms , and pain at worst site at 18 months follow-up . CONCLUSION In the present pilot study , MS was associated with more positive changes than BAT",
"Background : In a 12-week r and omized controlled trial of the effects of lifestyle physical activity ( LPA ) on symptoms and function among adults with fibromyalgia , we found that LPA participants increased their average daily step count by 54 % , improved their self-reported functioning by 18 % , and reduced their pain by 35 % . Objectives : The objective of the study was to evaluate the intermediate ( 6 months ) and long-term ( 12 months ) effects of the LPA intervention on outcomes . Methods : Participants completed follow-up assessment s of physical activity , pain , fibromyalgia-related function , fatigue , depression , number of tender points , 6-minute walk test , and perceived improvement at 6 and 12 months after intervention . Results : Of the 73 participants who completed the 12-week trial , 53 ( 73 % ) completed both the 6- and 12-month follow-up . Although the LPA participants reported greater perceived improvement at each follow-up , they did not differ from controls on pain , physical activity , tenderness , fatigue , depression , or the 6-minute walk test . Self-reported functioning declined markedly at follow-up for the LPA participants . Conclusions : Although participants reported greater perceived improvement at each assessment , the beneficial effects of LPA on physical activity , function , and pain found after the 12-week intervention were not sustained over time . This recidivism is seen in studies of activity and exercise in nearly any condition , and innovative methods that may prevent this are a focus of future studies",
"Objective : To evaluate the effects of a community patient education -exercise programme , using a cognitive-behavioural approach , for people with fibromyalgia . Design : A r and omized , parallel group trial with assessment s at 0 , 4 and 8 months . Setting : Community leisure centres . Subjects : People with fibromyalgia ( n=183 ) attending a rheumatology outpatient department at a large district general hospital . Interventions : Participants were r and omized to a patient education-exercise group ( n=97 ) or relaxation ( attention control ) group ( n=86 ) . Main measures : The Fibromyalgia Impact Question naire ( 0 - 80 ; lower score means better health ) . Secondary outcomes included : the Arthritis Self-Efficacy Scale(pain and other symptoms subscales : 1 -10 scale ; higher scores mean greater self-efficacy ) and self-reported improvement . Results : Fifty participants withdrew or were unable to attend and 133 completed and returned baseline question naires : patient education group ( n=71 ) ; relaxation group ( n=62 ) ; 120/133 participants were women . Average age was 48 . 53 ( SD 10.89 ) years . Follow-up ranged between 73 and 82 % of question naires returned . At four months , there was a difference in average changes in total Fibromyalgia Impact Question naire scores between the two groups : patient education group -3.38 ( SD 9.35 ) ; relaxation group 0.3 ( SD 8.85 ) ; P=0.02 . Arthritis Self-Efficacy Scale scores were significantly higher in the patient education group : pain 0.59 ( SD 1.45)compared to the relaxation group ’s -0.12 ( SD 1.22 ) ; P=0.003 ; other symptoms ( patient education group 0.72 ( SD 1.33 ) ; relaxation group 0.03 ( SD 1.16 ) ; P=0.002 ) . At eight months these differences were no longer apparent . Forty-seven per cent in the patient education group self-reported improvement compared with 13 % in the relaxation group ( ϰ=13.65 ; P=0.0001 ) . Conclusion : Short-term improvements result ed from the education -exercise programme but were not sustained . Appropriate selection may improve efficacy",
"OBJECTIVES This study evaluated the effectiveness of a 6-week \" usual care \" exercise program supplemented with whole-body vibration ( WBV ) to improve balance and strength in women with fibromyalgia ( FM ) . DESIGN This was a r and omized controlled study . SETTING S The setting was a physical therapy department in an academic setting . SUBJECTS The subjects were 30 postmenopausal women with FM ( age : 59±7.90 years ) . INTERVENTIONS Subjects were r and omized into one of two groups : an experimental group ( EG : n=15 ) , which combined exercise training ( 2 days a week ) with 3 days of WBV , and a control group ( CG : n=15 ) , who performed the same exercise training program ( 2 days a week ) but without WBV . OUTCOME MEASURES Balance and muscle strength were measured at baseline and after the 6-week intervention . RESULTS Significant differences were found ( p for the Medio-Lateral Stability Index ( MLSI ) , when patients were assessed with their eyes open and closed . The effect size of the improvement was large with eyes closed ( R2=0.260 ) and moderate when the eyes were open ( R2=0.047 ) . However , no significant differences were found ( p>0.05 ) between the study groups for other outcomes . CONCLUSIONS Women with FM may increase their MLSI by engaging in a 6-week traditional exercise program with supplementary WBV . This may have implication s for falls prevention in this patient group"
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Objective To evaluate the effectiveness of exercise and physical activity ( PA ) promotion on cardiovascular fitness , muscle strength , flexibility , neuromotor performance ( eg , balance ) and daily PA in people with rheumatoid arthritis ( RA ) , spondyloarthritis ( SpA ) and hip/knee osteoarthritis ( HOA/KOA ) . Methods systematic review ( SR ) and meta- analysis ( MA ) were performed search ing the data bases PubMed / Medline , CENTRAL , Embase , Web of Science , Emcare and PsycInfo until April 2017 . We included r and omised controlled trials ( RCTs ) in adults ( ≥18 years ) with RA , SpA and HOA/KOA , investigating the effects of exercise or PA promotion according to the public health PA recommendations by the American College of Sports Medicine . The time point of interest was the first assessment after the intervention period . If suitable , data were pooled in a MA using a r and om-effects model presented as st and ardised mean difference ( SMD ) . Results The SR included 63 RCTs , of which 49 ( 3909 people with RA/SpA/HOA/KOA ) were included in the MA . Moderate effects were found of aerobic exercises and resistance training on cardiovascular fitness ( SMD 0.56 ( 95 % CI 0.38 to 0.75 ) ) and muscle strength ( SMD 0.54 ( 95 % CI 0.35 to 0.72 ) ) , respectively , but no effect of combined strength/aerobic/flexibility exercises on flexibility ( SMD 0.12 ( 95 % CI -0.16 to 0.41 ) ) . PA promotion interventions produced a small increase in PA behaviour ( SMD 0.21 ( 95 % CI 0.03 to 0.38 ) ) . Conclusion Exercises and PA promotion according to public health recommendations for PA improved cardiovascular fitness , muscle strength and PA behaviour , with moderate effect sizes in people with SpA , RA and HOA/KOA . Trial registration number CRD42017082131
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"OBJECTIVES This study aims to assess the impact of a structured education and home exercise programme in daily practice patients with ankylosing spondylitis . METHODS A total of 756 patients with ankylosing spondylitis ( 72 % males , mean age 45 years ) participated in a 6-month prospect i ve multicentre controlled study , 381 of whom were r and omised to an education intervention ( a 2-hour informative session about the disease and the implementation of a non-supervised physical activity programme at home ) and 375 to st and ard care ( controls ) . Main outcome measures included Bath Ankylosing Spondylitis Disease Activity and Functional Index ( BASDAI , BASFI ) . Secondary outcome measures were 0 - 10 cm visual analog scale ( VAS ) for total pain , nocturnal pain and global disease activity and quality of life ( ASQoL ) , knowledge of disease ( self-evaluation ordinal scale ) and daily exercise ( diary card ) . RESULTS At 6 months , the adjusted mean difference between control and educational groups for BASDAI was 0.32 , 95 % confidence interval ( CI ) 0.10 - 0.54 , p=0.005 , and for BASFI 0.31 , 95%CI 0.12 - 0.51 , p=0.002 . Significant differences were found also in VAS for total pain , patient´s global assessment and in ASQoL. Patients in the education group increased their knowledge about the disease and its treatments significantly ( p CONCLUSIONS A structured education and home exercise programme for patients with ankylosing spondylitis in daily practice was feasible and helped to increase knowledge and exercise . Although statistically significant , the magnitudes of the clinical benefits in terms of disease activity and physical function were poor",
"Background The effect of exercise on specific impairments and activity limitations in people with hip osteoarthritis ( OA ) is limited . Objective The study objective was to evaluate the long-term effect of exercise therapy and patient education on range of motion ( ROM ) , muscle strength , physical fitness , walking capacity , and pain during walking in people with hip OA . Design This was a secondary outcome analysis of a r and omized clinical trial . Setting The setting was a university hospital . Participants One hundred nine people with clinical ly and radiographically evident hip OA were r and omly allocated to receive both exercise therapy and patient education ( exercise group ) or patient education only ( control group ) . Intervention All participants attended a patient education program consisting of 3 group meetings led by 2 physical therapists . Two other physical therapists were responsible for providing the exercise therapy program , consisting of 2 or 3 weekly sessions of strengthening , functional , and stretching exercises over 12 weeks . Both interventions were conducted at a sports medicine clinic . Measurements Outcome measures included ROM , isokinetic muscle strength , predicted maximal oxygen consumption determined with the Astr and bicycle ergometer test , and distance and pain during the Six-Minute Walk Test ( 6MWT ) . Follow-up assessment s were conducted 4 , 10 , and 29 months after enrollment by 5 physical therapists who were unaware of group allocations . Results No significant group differences were found for ROM , muscle strength , predicted maximal oxygen consumption , or distance during the 6MWT over the follow-up period , but the exercise group had less pain during the 6MWT than the control group at 10 months ( mean difference=−8.5 mm ; 95 % confidence interval=−16.1 , −0.9 ) and 29 months ( mean difference=−9.3 mm ; 95 % confidence interval=−18.1 , −0.6 ) . Limitations Limitations of the study were reduced statistical power and 53 % rate of adherence to the exercise therapy program . Conclusions The previously described effect of exercise on self-reported function was not reflected by beneficial results for ROM , muscle strength , physical fitness , and walking capacity , but exercise in addition to patient education result ed in less pain during walking in the long term",
"We recruited 132 subjects with bilateral knee osteoarthritis ( Altman Grade II ) to compare the effects of different stretching techniques on the outcomes of isokinetic muscle strengthening exercises . Patients were r and omly divided into four groups ( I-IV ) . The patients in Group I received isokinetic muscular strengthening exercises , Group II received bilateral knee static stretching and isokinetic exercises , Group III received proprioceptive neuromuscular facilitation ( PNF ) stretching and isokinetic exercises , and Group IV acted as controls . Outcomes were measured by changes in Lequesne 's index , range of knee motion , visual analog pain scale , and peak muscle torques during knee flexion and extension . Patients in all the treated groups experienced significant reductions in knee pain and disability , and increased peak muscle torques after treatment and at follow-up . However , only patients in Groups II and III had significant improvements in range of motion and muscle strength gain during 60 degrees/second angular velocity peak torques . Group III demonstrated the greatest increase in muscle strength gain during 180 degrees/second angular velocity peak torques . In conclusion , stretching therapy could increase the effectiveness of isokinetic exercise in terms of functional improvement in patients with knee osteoarthritis . PNF techniques were more effective than static stretching",
"The objective of this study was to evaluate the effectiveness of a sensorimotor training in patients with rheumatoid arthritis on the improvement of functional skills and quality of life , a double-blinded , prospect i ve , r and omized controlled trial . One hundred two participants with rheumatoid arthritis were selected . After the baseline evaluation , the participants were r and omized to two different groups : sensorimotor group ( 2 sessions per week , 30–50 min each session , besides continuing taking the same drugs as the control group ) and control group ( control group was only su bmi tted to the clinical drug treatment with Methotrexate , Leflunomide and /or Prednisone ( 5 mg ) , being then evaluated 4 months later ) . Functional capacity [ Health Assessment Question naire ( HAQ ) and Timed Up & Go Test ( TU > ) ] , Balance and Gait ( Berg Balance Scale ( BBS ) and Tinetti Test ) and Quality of Life ( Short Form Health Survey — SF-36 ) . The study had been concluded with ninety-one participants , and a statistically significant improvement was found in all variables assessed : HAQ ( P TU > ( P ) , BBS ( P Tinetti Test ( P ) and improvement in the subscales of SF-36 ( P the sensorimotor training is effective in the improvement of the functional capacity and quality of life of patients with rheumatoid arthritis",
"The effect of 8 wk of progressive bicycle training on the immune system was evaluated in a controlled study on 18 patients with rheumatoid arthritis and moderate disease activity . Maximal O2 uptake increased significantly , whereas heart rate at stage 2 and rate of perceived exertion decreased significantly , in the training group compared with the controls . Resting levels of a number of immune parameters were measured before and after 4 and 8 wk of training . Training did not induce changes in blood mononuclear cell sub population s , proliferative response , or natural killer cell activity . Furthermore the plasma concentrations of interleukin-1 alpha , interleukin-1 beta , and interleukin-6 did not change in response to training . It is concluded that 8 wk of bicycle training does not influence the immune system of patients with rheumatoid arthritis",
"Patients with rheumatoid arthritis ( RA ) suffer from muscle loss , causing reduced muscle strength and endurance . The current study aim ed to : ( 1 ) evaluate the effects of combined strength and endurance training ( CT ) on disease activity and functional ability in patients with RA and ( 2 ) investigate the benefits of a 6-month supervised CT program on muscle strength , cardio-respiratory fitness , and body composition of RA patients . Forty patients with RA , aged 41–73 years , were recruited for the current study . Twenty of these patients ( 19 females , one male ) were r and omly assigned to a 6-month supervised CT program ; 20 patients ( 17 females , three males ) served as controls . Within the CT program , strength training consisted of sets of weight bearing exercises for all major muscle groups . In addition to strength training , systematic endurance training was performed on a cycle ergometer two times per week . For RA patients involved in CT , disease activity ( p = 0.06 ) and pain ( p = 0.05 ) were reduced after the 6-month training period while general health ( p = 0.04 ) and functional ability ( p = 0.06 ) improved . Cardio-respiratory endurance was found to have improved significantly ( by 10 % ) after 6 months of CT ( p The overall strength of patients undertaking CT increased by an average of 14 % . Lean body mass increased , and the percentage of body fat was found to decrease significantly ( p improvements in RA patients ’ muscle strength and cardio-respiratory endurance , accompanied by positive changes in body composition and functional ability . Long-term training appears to be effective in reducing disease activity and associated pain and was found to have no deleterious effects ",
"Background Hip osteoarthritis ( OA ) is a common condition leading to pain , disability and reduced quality of life . There is currently limited evidence to support the use of conservative , non-pharmacological treatments for hip OA . Exercise and manual therapy have both shown promise and are typically used together by physiotherapists to manage painful hip OA . The aim of this r and omised controlled trial is to compare the efficacy of a physiotherapy treatment program with placebo treatment in reducing pain and improving physical function . Methods The trial will be conducted at the University of Melbourne Centre for Health , Exercise and Sports Medicine . 128 participants with hip pain greater or equal to 40/100 on visual analogue scale ( VAS ) and evidence of OA on x-ray will be recruited . Treatment will be provided by eight community physiotherapists in the Melbourne metropolitan region . The active physiotherapy treatment will comprise a semi-structured program of manual therapy and exercise plus education and advice . The placebo treatment will consist of sham ultrasound and the application of non-therapeutic gel . The participants and the study assessor will be blinded to the treatment allocation . Primary outcomes will be pain measured by VAS and physical function recorded on the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) immediately after the 12 week intervention . Participants will also be followed up at 36 weeks post baseline . Conclusions The trial design has important strengths of reproducibility and reflecting contemporary physiotherapy practice . The findings from this r and omised trial will provide evidence for the efficacy of a physiotherapy program for painful hip OA.Trial Registration Australian New Zeal and Clinical Trials Registry reference :",
"Background Physical activity can improve health outcomes in people with knee osteoarthritis ( OA ) ; however , participation in physical activity is very low in this population . Objective The objective of our study was to assess the feasibility and preliminary efficacy of the use of wearables ( Fitbit Flex ) and telephone counselling by a physical therapist ( PT ) for improving physical activity in people with a physician-confirmed diagnosis of knee OA , or who have passed 2 vali date d criteria for early OA . Methods We conducted a community-based feasibility r and omized controlled trial . The immediate group ( n=17 ) received a brief education session by a physical therapist , a Fitbit Flex activity tracker , and a weekly telephone call for activity counselling with the physical therapist . The delayed group ( n=17 ) received the same intervention 1 month later . All participants were assessed at baseline ( T0 ) , and the end of 1 month ( T1 ) and 2 months ( T2 ) . Outcomes were ( 1 ) mean moderate to vigorous physical activity time , ( 2 ) mean time spent on sedentary behavior , ( 3 ) Knee Injury and Osteoarthritis Outcome Score ( KOOS ) , and ( 4 ) Partners in Health Scale . Feasibility data were summarized with descriptive statistics . We used analysis of covariance to evaluate the effect of the group type on the outcome measures at T1 and T2 , after adjusting for blocking and T0 . We assessed planned contrasts of changes in outcome measures over measurement periods . Results We identified 46 eligible individuals ; of those , 34 ( 74 % ) enrolled and no one dropped out . All but 1 participant adhered to the intervention protocol . We found a significant effect , with the immediate intervention group having improved in the moderate to vigorous physical activity time and in the Partners in Health Scale at T0 to T1 compared with the delayed intervention group . The planned contrast of the immediate intervention group at T0 to T1 versus the delayed group at T1 to T2 showed a significant effect in the sedentary time and the KOOS symptoms subscale , favoring the delayed group . Conclusions This study demonstrated the feasibility of a behavioral intervention , supported by the use of a wearable device , to promote physical activity among people with knee OA . Trial Registration Clinical Trials.gov NCT02313506 ; https:// clinical trials.gov/ct2/show/NCT02313506 ( Archived by WebCite at http://www.webcitation.org/6r4P3Bub0",
"OBJECTIVE To compare the effectiveness and safety of supervised aerobic exercise and home aerobic exercise in female Chinese patients with rheumatoid arthritis . DESIGN Single-blind r and omized controlled trial . SUBJECTS Thirty female Chinese patients with rheumatoid arthritis were assigned to either supervised aerobic exercise or home aerobic exercise groups . METHODS The supervised aerobic exercise programme was supervised by a physical therapist , while the home aerobic exercise programme was performed at home after one session of exercise instruction . Each programme consisted of 1 h of aerobic exercise conducted 3 times per week for 8 weeks . Aerobic capacity and disease-related variables , including pain intensity , functional ability , psychological status and joint function , were measured . RESULTS Significant difference in changed score between pre- and post-exercise data was observed between the supervised aerobic exercise and home aerobic exercise groups regarding aerobic capacity ( p aerobic capacity only in the supervised aerobic exercise group . Pre- and post-exercise within-group comparison showed significant improvement in 5 and 3 items of disease-related variables in supervised aerobic exercise and home aerobic exercise groups , respectively . CONCLUSION An 8-week supervised aerobic exercise programme induced significant improvement in the aerobic capacity of female Chinese patients with rheumatoid arthritis , and was superior to a home aerobic exercise programme . Both programmes of aerobic exercise were safe for female Chinese patients with rheumatoid arthritis",
"The aims of this study were to describe rheumatoid arthritis patients ’ compliance with continued exercise after participation in a 2-year supervised high-intensity exercise program and to investigate if the initially achieved effectiveness and safety were sustained . Data were gathered by follow-up of the participants who completed the 2-year high-intensity intervention in a r and omized controlled trial ( Rheumatoid Arthritis Patient In Training study ) . Eighteen months thereafter , measurements of compliance , aerobic capacity , muscle strength , functional ability , disease activity , and radiological damage of the large joints were performed . Seventy-one patients were available for follow-up at 18 months , of whom 60 ( 84 % ) were still exercising ( exercise group : EG ) , with average similar intensity but at a lower frequency as the initial intervention . Eleven patients ( 16 % ) reported low intensity or no exercises ( no-exercise group : no-EG ) . Patients in the EG had better aerobic fitness and functional ability , lower disease activity , and higher attendance rate after the initial 2-year intervention . At follow-up , both groups showed a deterioration of aerobic fitness and only patients in the EG were able to behold their muscle strength gains . Functional ability , gained during the previous participation in high-intensity exercises , remained stable in both groups . Importantly , no detrimental effects on disease activity or radiological damage of the large joints were found in either group . In conclusion , the majority of the patients who participated in the 24-month high-intensity exercise program continued exercising in the ensuing 18 months . In contrast to those who did not continue exercising , they were able to preserve their gains in muscle strength without increased disease activity or progression of radiological damage",
"OBJECTIVE To evaluate the effects of a 12 month , weight bearing , aerobic exercise program on disease activity , physical function , and bone mineral density ( BMD ) in women with rheumatoid arthritis ( RA ) taking low dose prednisone . METHODS A group of women with RA ( n = 23 ) not receiving steroid therapy and in American College of Rheumatology functional class I or II was compared to 30 steroid treated patients with similar demographics . The latter group was r and omized to usual care ( n = 16 ) or an aerobic , weight bearing exercise program ( n = 14 ) 3 times a week for 12 months . All subjects were recruited from an outpatient rheumatology clinic or physical therapy department and met the study inclusion criteria . Outcome measures included disease activity ( erythrocyte sedimentation rate , active joint count ) , physical function ( Health Assessment Question naire disability index , activity level ) and BMD of the spine and femoral neck ( by dual energy projection radiology ) . RESULTS Subjects in the exercise group had a small but nonsignificant decrease in disease activity and statistically significant improvements in function ( p = 0.05 ) and activity levels ( p = 0.05 ) . BMD remained unchanged in the exercise group , decreased significantly ( p = 0.004 ) in the nonsteroid comparison group ( hip ) , and changed nonsignificantly in the control group . However , between-group changes in spinal BMD of the steroid treated groups was not significant ( p = 0.09 ) . CONCLUSION Women with RA taking low dose steroid therapy can safely participate in a dynamic , weight bearing exercise program with positive effects on their physical function , activity and fitness levels , and BMD with no exacerbation of disease activity ",
"AIM The aim of the study was to compare the effects of conventional exercise ( CE ) , swimming and walking on the pulmonary functions , aerobic capacity , quality of life , Bath indexes and psychological symptoms in patients with ankylosing spondylitis ( AS ) . METHODS Forty-five patients were r and omised into either swimming ( group 1 ) , walking ( group 2 ) , CE group ( group 3 ) . Patients in Group 1 performed CE and swimming , patients in Group 2 performed CE and walking and patients in Group 3 performed CE only . Exercise sessions were performed three times a week for a period of six weeks . Patients were assessed before and after the rehabilitation program , with respect to , pulmonary function test ( forced vital capacity [ FVC , mL ] , forced expiration volume in one second [ FEV1 , mL ] , FEV1/FVC ( % ) and vital capacity [ VC , mL ] ) , maximal oxygen uptake ( pV.O2 ) , 6-minute walking test ( 6MWT ) , Bath Ankylosing Spondylitis Functional Index , Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Metrology Index , Nottingham Health Profile and Beck Depression Inventory . RESULTS There were significant increases in pVO2 and 6MWT after treatment in Groups 1 and 2 ( P FeV1 , FVC and VC improved significantly with treatment in all three groups ( P energy , emotional reaction and physical mobility sub-scores of NHP in three exercise groups after completion of the exercise program ( P , walking and CE had beneficial effects on the quality of life and pulmonary functions . Aerobic exercises such as swimming and walking in addition to CE increased functional capacities of patients",
"OBJECTIVE To test the effects of a high intensity home-based progressive strength training program on the clinical signs and symptoms of osteoarthritis ( OA ) of the knee . METHODS Forty-six community dwelling patients , aged 55 years or older with knee pain and radiographic evidence of knee OA , were r and omized to a 4 month home based progressive strength training program or a nutrition education program ( attention control ) . Thirty-eight patients completed the trial with an adherence of 84 % to the intervention and 65 % to the attention control . The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index pain and physical function subscales . Secondary outcomes included clinical knee examination , muscle strength , physical performance measures , and question naires to measure quality of life variables . RESULTS Patients in the strength training group who completed the trial had a 71 % improvement in knee extension strength in the leg reported as most painful versus a 3 % improvement in the control group ( p self-reported pain improved by 36 % and physical function by 38 % in the strength training group versus 11 and 21 % , respectively , in the control group ( p = 0.01 for between group comparison ) . In addition , those patients in the strength training group who completed the trial had a 43 % mean reduction in pain ( p = 0.01 vs controls ) , a 44 % mean improvement in self-reported physical function ( p physical performance , quality of life , and self-efficacy when compared to the control group . CONCLUSION High intensity , home based strength training can produce substantial improvements in strength , pain , physical function and quality of life in patients with knee OA",
"Background Physical therapy is recommended for the management of axial spondyloarthritis ( axSpA ) and flexibility exercises have traditionally been the main focus . Cardiovascular ( CV ) diseases are considered as a major health concern in axSpA and there is strong evidence that endurance and strength exercise protects against CV diseases . Therefore , the aim of this study was to investigate the efficacy of high intensity endurance and strength exercise on disease activity and CV health in patients with active axSpA. Methods In a single blinded r and omized controlled pilot study the exercise group ( EG ) performed 12 weeks of endurance and strength exercise while the control group ( CG ) received treatment as usual . The primary outcome was the Ankylosing Spondylitis ( AS ) Disease Activity Score ( ASDAS ) . Secondary outcomes included patient reported disease activity ( Bath AS Disease Activity Index [ BASDAI ] ) , physical function ( Bath AS Functional Index [ BASFI ] ) , and CV risk factors measured by arterial stiffness ( Augmentation Index [ Alx ] ) and Pulse Wave Velocity [ PWV ] ) , cardiorespiratory fitness ( VO2 peak ) and body composition . ANCOVA on the post intervention values with baseline values as covariates was used to assess group differences , and Mann Whitney U-test was used for outcomes with skewed residuals . Results Twenty-eight patients were included and 24 ( EG , n = 10 , CG , n = 14 ) completed the study . A mean treatment effect of −0.7 ( 95%CI : −1.4 , 0.1 ) was seen in ASDAS score . Treatment effects were also observed in secondary outcomes ( mean group difference [ 95%CI ] ) : BASDAI : −2.0 ( −3.6 , −0.4 ) , BASFI : −1.4 ( −2.6 , −0.3 ) , arterial stiffness ( estimated median group differences [ 95 % CI ] ) : AIx ( % ) : −5.3 ( −11.0 , −0.5 ) , and for PVW ( m/s ) : −0.3 ( −0.7 , 0.0 ) , VO2 peak ( ml/kg/min ) ( mean group difference [ 95%CI ] : 3.7 ( 2.1 , 5.2 ) and trunk fat ( % ) : −1.8 ( −3.0 , −0.6 ) . No adverse events occurred . Conclusion High intensity exercise improved disease activity and reduced CV risk factors in patients with active axSpA. These effects will be further explored in a larger trial . Trial Registration Clinical Trials.gov",
"Abstract Patients in r and omized clinical trials have to adapt themselves to a restricted language to capture the necessary information to determine the safety and efficacy of a new treatment . The aim of this study was to explore the experience of patients with rheumatoid arthritis after completing their participation in a biologic therapy r and omized clinical trial for a period of 3 years . A qualitative approach was used . The information was collected using 15 semi-structured interviews of patients with rheumatoid arthritis . Data collection was guided by the emergent analysis until no more relevant variations in the categories were found . The data were analysed using the grounded theory method . The objective of the patients when entering the study was to improve their quality of life by initiating the treatment . However , the experience changed the significance of the illness as they acquired skills and practical knowledge related to the management of their disease . The category “ Interactional Empowerment ” emerged as core category , as it represented the participative experience in a clinical trial . The process integrates the follow categories : “ weight of systematisation ” , “ working together ” , and the significance of the experience : “ the duties ” . Simultaneously these categories evolved . The clinical trial monitoring activities enabled patients to engage in a reflexive – interpretative mechanism that transformed the emotional and symbolic significance of their disease and improved the empowerment of the patient . A better communicative strategy with the health professionals , the relatives of the patients , and the community was also achieved",
"Patients with knee osteoarthrosis are often referred for physiotherapy and many different types of treatment are given . The value of many of these treatments has been question ed . This study was intended to evaluate the effect of commonly used physiotherapy treatments in a training programme on patients with medial knee osteoarthrosis , scheduled for surgery . The results from this study also provide useful data for further evaluation of different physiotherapy treatments to this patient group . Thirty-four patients were r and omised to physiotherapy three times a week for 5 weeks and the other 34 received no treatment . The training programme is described in detail . The patients were evaluated by clinical examination , step test , gait analysis and isokinetic measurements of thigh muscle strength before and after treatment . The patients in the treatment group experienced a feeling of overall improvement in the knee and the ability to descend steps improved when compared to the control group . There were no significant differences in gait , range of motion or isokinetic measurements of muscle strength between the groups . We conclude that physiotherapy as given here made our patients feel better and their ability to descend stairs improved . These improvements are beneficial to the patients and support the positive effects of exercises and activity . Whilst the objective improvements were small , suggesting that this treatment may not be justified , patients in the treatment group believed that they were improved",
"OBJECTIVES To investigate the maintenance of physical activity 12 months after two 1-year Internet-based physical activity interventions in patients with RA . METHODS This follow-up study was a r and omized comparison of an Internet-based individualized training ( IT ) and a general training ( GT ) programme in sedentary RA patients . Outcome measures included physical activity ( meeting public health recommendations for moderate physical activity , i.e. 30 min for at least 5 days/week ; or vigorous physical activity , i.e. 20 min for at least 3 days/week ) , functional ability and quality of life ( QoL ) . RESULTS Of the 152 RA patients who completed the initial study , 110 ( 72 % ) were available at follow-up . At 24 months , the proportions of patients meeting public health recommendations for moderate intensity physical activity were significantly higher compared with baseline in both the IT and GT groups ( 19 and 24 % , respectively , P meeting the recommendation for vigorous activity was only significantly higher compared with baseline in the IT group ( P proportions of patients meeting moderate or vigorous physical activity recommendations at 24 months . Apart from a significantly higher RAQoL score in the IT group at 24 months compared with baseline , there were no significant differences within or between the programmes regarding functional ability or QoL. CONCLUSION In RA patients , the effectiveness of both an individualized and a general 1-year Internet-based physical activity programme is sustained with respect to moderate intensity physical activity up to 12 months after the interventions",
"Background Quadriceps femoris muscle ( QFM ) weakness is a feature of knee osteoarthritis ( OA ) and exercise programs that strengthen this muscle group can improve function , disability and pain . Traditional supervised resistance exercise is however re source intensive and dependent on good adherence which can be challenging to achieve in patients with significant knee OA . Because of the limitations of traditional exercise programs , interest has been shown in the use of neuromuscular electrical stimulation ( NMES ) to strengthen the QFM . We conducted a single-blind , prospect i ve r and omized controlled study to compare the effects of home-based resistance training ( RT ) and NMES on patients with moderate to severe knee OA . Methods 41 patients aged 55 to 75 years were r and omised to 6 week programs of RT , NMES or a control group receiving st and ard care . The primary outcome was functional capacity measured using a walk test , stair climb test and chair rise test . Additional outcomes were self-reported disability , quadriceps strength and cross-sectional area . Outcomes were assessed pre- and post-intervention and at 6 weeks post-intervention ( weeks 1 , 8 and 14 respectively ) . Results There were similar , significant improvements in functional capacity for the RT and NMES groups at week 8 compared to week 1 ( p≤0.001 ) and compared to the control group ( p . Cross sectional area of the QFM increased in both training groups ( NMES : + 5.4 % ; RT : + 4.3 % ; p = 0.404 ) . Adherence was 91 % and 83 % in the NMES and RT groups respectively ( p = 0.324 ) . Conclusions Home-based NMES is an acceptable alternative to exercise therapy in the management of knee OA , producing similar improvements in functional capacity . Trial registration : Current Controlled Trials IS RCT",
"OBJECTIVE To assess the engagement in and satisfaction with an Internet-mediated physical activity intervention with individual supervision in patients with rheumatoid arthritis ( RA ) . METHODS The intervention studied was one of the two strategies aim ed at enhancing physical activity in RA patients that were being compared in a r and omized controlled trial . A total of 82 patients , all experienced in using Internet and e-mail and registered at three different rheumatology out-patient clinics , were r and omly allocated to the Internet-mediated individualized intervention ( 52 weeks ) . They had access to personal physical activity schedules and received individual supervision by a physical therapist by means of weekly e-mail feedback . In addition , telephone contacts , an online discussion forum , six face-to-face group meetings and electronic newsletters were offered . Besides registration of returned physical activity schedules , engagement and satisfaction were measured through question naires . RESULTS The median physical activity schedule return rate of the 82 participants was 55 % . The mean number of patients logging into the website at least once a week was 53 ( 70 % ) over 12 months . Of all patients , 69 returned the question naires ( response 84 % ) . Telephone contacts were used by 38/67 patients ( 57 % ) , the mean ( SD ) number of attended group meetings was 3.1 ( 1.5 ) and the discussion forum comprised 15 posted messages . Overall , the proportions of patients being ( very ) satisfied with the amount of e-mail contacts , telephone contacts , usefulness of website information , physical activity schedules , group meetings and website layout were > /=85 % . A smaller proportion of patients were satisfied with the links to other websites ( 68 % ) , the newsletters ( 55 % ) and the online discussion forum ( 32 % ) . CONCLUSION Physical activity schedules with weekly feedback by e-mail , telephone contacts and a limited number of group meetings were frequently used website tools and modes of communication of an Internet-based physical activity intervention , with high-satisfaction rates from RA patients . Discussion forum and newsletters were less used and appreciated . Caution should be taken when extrapolating the results found to groups of patients who are not experienced Internet and e-mail users or patients with more severe physical disabilities",
"Background Osteoarthritis ( OA ) is the most common joint disorder in the world , as it is appears to be prevalent among 80 % of individuals over the age of 75 . Although physical activities such as walking have been scientifically proven to improve physical function and arthritic symptoms , individuals with OA tend to adopt a sedentary lifestyle . There is therefore a need to improve knowledge translation in order to influence individuals to adopt effective self-management interventions , such as an adapted walking program . Methods A single-blind , r and omized control trial was conducted . Subjects ( n = 222 ) were r and omized to one of three knowledge translation groups : 1 ) Walking and Behavioural intervention ( WB ) ( 18 males , 57 females ) which included the supervised community-based aerobic walking program combined with a behavioural intervention and an educational pamphlet on the benefits of walking ; 2 ) Walking intervention ( W ) ( 24 males , 57 females ) wherein participants only received the supervised community-based aerobic walking program intervention and the educational pamphlet ; 3 ) Self-directed control ( C ) ( 32 males , 52 females ) wherein participants only received the educational pamphlet . One-way analyses of variance were used to test for differences in quality of life , adherence , confidence , and clinical outcomes among the study groups at each 3 month assessment during the 12-month intervention period and 6-month follow-up period . Results The clinical and quality of life outcomes improved among participants in each of the three comparative groups . However , there were few statistically significant differences observed for quality of life and clinical outcomes at long-term measurements at 12-months end of intervention and at 6- months post intervention ( 18-month follow-up ) . Outcome results varied among the three groups . Conclusion The three groups were equivalent when determining the effectiveness of knowledge uptake and improvements in quality of life and other clinical outcomes . OA can be managed through the implementation of a proven effective walking program in existing community-based walking clubs . Trial registration Current Controlled Trials",
"Objective : To investigate whether a four-week walking exercise programme in patients with knee osteoarthritis improves the ability of dual-task performance in older adults with knee osteoarthritis . Design : A r and omized controlled trial with two groups : a walking group and a control group . Subjects : Forty older adults with knee osteoarthritis , 20 participants in each group . Intervention : The walking intervention was design ed to increase the number of steps walked daily . The walking group was instructed to increase their number of steps to 3000 steps more than before the intervention . Main outcome measures : Dual-task performance was computed by an automaticity index : the walking velocity under single-task condition/under dual-task conditions × 100 ( % ) , defined as automaticity . The nearer to 100 % automaticity , the better the dual-task performance . Decrease of the Trail Making Test ( TMT ) performance was defined as ΔTMT . ΔTMT was calculated as the difference between times ( part B – part A ) as a measure of executive function . In addition , functional ability was measured by the Japanese Knee Osteoarthritis Measure . Results : The walking group improved significantly in automaticity ( P ( 10.4 ) , ΔTMT ( P ) and Japanese Knee Osteoarthritis Measure score ( P found that walking exercise improves executive function and dual-task performance ",
"The objective was to study the long-term effect ( 2 years ) of different training programs in patients with rheumatoid arthritis . The method was a r and omized trial with 75 patients participating . The measured variables included morning stiffness , a pain score , number of swollen joints , a health assessment score , a functional score , ESR , Hb , the cost of medicine , and progression using X-rays of h and s and feet . The results showed no effect of training on the disease activity or on the progression of the disease . The conclusion is that although most patients are in favour of training , the present study does not support that training lessons per se affect the disease activity or the progression of the disease",
"OBJECTIVE To determine whether hip abductor and adductor muscle strengthening reduces medial compartment knee load and improves symptoms in people with medial tibiofemoral OA and varus malalignment . METHODS In a r and omised controlled trial , 89 participants were r and omly allocated to a hip strengthening group or to a control group with no intervention . The strengthening group performed a physiotherapist-supervised home exercise program targeting the hip abductor and adductor muscles for 12 weeks . The primary outcome was the peak external knee adduction moment measured using three-dimensional gait analysis by a blinded assessor . Secondary outcomes included a pain numeric rating scale , Western Ontario and McMaster Universities Osteoarthritis Index , step test , stair climb test , maximum isometric strength of hip and quadriceps muscles and participant-perceived rating of overall change . Intention-to-treat analyses were performed using linear regression modelling adjusting for baseline outcomes and other characteristics . RESULTS The trial was completed by 76/89 participants ( 85 % ) . There was no significant between-group difference in change in the knee adduction moment [ mean difference ( 95 % confidence interval ( CI ) ) 0.134 ( -0.069 to 0.337 ) Nm/BW x HT% ] . All pain , physical function and muscle strength measures showed significantly greater improvement in the strengthening group ( all P<0.05 ) . The relative risk ( 95 % CI ) of participant-perceived overall improvement in the strengthening group compared to the control group was 20.02 ( 6.21 - 64.47 ) . CONCLUSIONS Although strengthening the hip muscles improved symptoms and function in this patient group , it did not affect medial knee load as measured by the knee adduction moment . Thus it is unlikely that hip muscle strengthening influences structural disease progression . TRIAL REGISTRATION ACTR12607000001493",
"INTRODUCTION There is a need to establish a framework and exercise level for patients with early rheumatoid arthritis ( RA ) . The aim of this study was to compare the effect of a partly supervised and a self-administered exercise programme for patients with early RA . METHODS A total of 51 patients with early ( ≤ 5 years ) RA were r and omised to either a six-week supervised , progressive , high-intensity exercise programme followed by a six-week self-administered exercise programme or a 12-week self-administered exercise programme . RESULTS A total of 36 patients completed the study . Following the 12 weeks of exercises , patients in the two groups had improved both their muscle strength and their physical fitness . There was a significant difference in Disease Activity Score in 28 joints calculated with C-reactive protein between the two exercise groups , but no significant differences in physical fitness , pain perception , Health Assessment Question naire , Short Form 36 health survey question naire , Fear-Avoidance Beliefs Question naire , or in muscle strength , except from a significant difference in trunk extensors . The dropout was 40 % in the supervised group versus 20 % in the self-administered group . CONCLUSION A progressive , high-intensity exercise programme is feasible for patients with early RA , although we observed an elevated number of dropouts for reasons not related to the intervention . The partly supervised exercise programme with follow-up after 12 weeks does not seem to be more effective than the self-administered exercise programme . FUNDING none . TRIAL REGISTRATION The trial was registered with www . clinical trials.gov ( NCT01553305 )",
"Thirty-nine consecutive patients with recent-onset rheumatoid or psoriatic arthritis were r and omly allotted for six months period either to the experimental progressive dynamic strength training group ( EG , 10 women and 11 men ; 41 + /- 10 yrs ) , or to the control group ( CG , 10 women and 8 men ; 45 + /- 11 yrs ) who just maintained their habitual physical activities . All patients received antirheumatic medication throughout the experimental period . During the study period significant improvements took place in the EG in maximal muscle strength of all examined muscle groups ( 31.5 % for the knee extensors , p erytrocyte sedimentation rate ( p Ritchie 's articular index ( RI ) ( p HAQ ( p RI was statistically significant ( p Erosive changes in joints increased only slightly and less in the EG than in the CG . The present results suggest that dynamic strength training in early arthritis increases the neuromuscular performance without detrimental effects on disease activity or joint damage",
"Background and Purpose : Muscle strength training is important for people with knee osteoarthritis ( OA ) . High-resistance exercise has been demonstrated to be more beneficial than low-resistance exercise for young subjects . The purpose of this study was to compare the effects of high- and low-resistance strength training in elderly subjects with knee OA . Subjects and Methods : One hundred two subjects were r and omly assigned to groups that received 8 weeks of high-resistance exercise ( HR group ) , 8 weeks of low-resistance exercise ( LR group ) , or no exercise ( control group ) . Pain , function , walking time , and muscle torque were examined before and after intervention . Results : Significant improvement for all measures was observed in both exercise groups . There was no significant difference in any measures between HR and LR groups . However , based on effect size between exercise and control groups , the HR group improved more than the LR group . Discussion and Conclusion : Both high- and low-resistance strength training significantly improved clinical effects in this study . The effects of high-resistance strength training appear to be larger than those of low-resistance strength training for people with mild to moderate knee OA , although the differences between the HR and LR groups were not statistically significant",
"OBJECTIVE To determine the effects of structured exercise programs on self-reported disability in older adults with knee osteoarthritis . SETTING AND DESIGN A r and omized , single-blind clinical trial lasting 18 months conducted at 2 academic medical centers . PARTICIPANTS A total of 439 community-dwelling adults , aged 60 years or older , with radiographically evident knee osteoarthritis , pain , and self-reported physical disability . INTERVENTIONS An aerobic exercise program , a resistance exercise program , and a health education program . MAIN OUTCOME MEASURES The primary outcome was self-reported disability score ( range , 1 - 5 ) . The secondary outcomes were knee pain score ( range , 1 - 6 ) , performance measures of physical function , x-ray score , aerobic capacity , and knee muscle strength . RESULTS A total of 365 ( 83 % ) participants completed the trial . Overall compliance with the exercise prescription was 68 % in the aerobic training group and 70 % in the resistance training group . Postr and omization , participants in the aerobic exercise group had a 10 % lower adjusted mean ( + /- SE ) score on the physical disability question naire ( 1.71 + /- 0.03 vs 1.90 + /- 0.04 units ; P knee pain question naire ( 2.1 + /- 0.05 vs 2.4 + /- 0.05 units ; P=.001 ) , and performed better ( mean [ + /- SE ] ) on the 6-minute walk test ( 1507 + /- 16 vs 1349 + /- 16 ft ; P time to climb and descend stairs ( 12.7 + /- 0.4 vs 13.9 + /- 0.4 seconds ; P=.05 ) , time to lift and carry 10 pounds ( 9.1 + /- 0.2 vs 10.0 + /- 0.1 seconds ; P time to get in and out of a car ( 8.7 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P resistance exercise group had an 8 % lower score on the physical disability question naire ( 1.74 + /- 0.04 vs 1.90 + /- 0.03 units ; P=.003 ) , 8 % lower pain score ( 2.2 + /- 0.06 vs 2.4 + /- 0.05 units ; P=.02 ) , greater distance on the 6-minute walk ( 1406 + /- 17 vs 1349 + /- 16 ft ; P=.02 ) , faster times on the lifting and carrying task ( 9.3 + /- 0.1 vs 10.0 + /- 0.16 seconds ; P=.001 ) , and the car task ( 9.0 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P=.003 ) than the health education group . There were no differences in x-ray scores between either exercise group and the health education group . CONCLUSIONS Older disabled persons with osteoarthritis of the knee had modest improvements in measures of disability , physical performance , and pain from participating in either an aerobic or a resistance exercise program . These data suggest that exercise should be prescribed as part of the treatment for knee osteoarthritis",
"The objective of this study was to investigate the effects of Pilates on pain , functional status , and quality of life in patients with ankylosing spondylitis . The study was performed as a r and omized , prospect i ve , controlled , and single-blind trial . Fifty-five participants ( 30 men , 25 women ) who were under a regular follow-up protocol in our Rheumatology Clinic with the diagnosis of AS according to the modified New York criteria were included in the study . The participants were r and omly assigned into two groups : in group I , Pilates exercise program of 1 h was given by a certified trainer to 30 participants 3 times a week for 12 weeks , and in group II , design ed as the control group , 25 participants continued previous st and ard treatment programs . In groups , pre-(week 0 ) and post treatment ( week 12 and week 24 ) evaluation was performed by one of the authors who was blind to the group allocation . Primary outcome measure was functional capacity . Evaluation was done using the Bath Ankylosing Spondylitis Functional Index ( BASFI ) . Exploratory outcome measures were Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , Bath Ankylosing Spondylitis Metrology Index ( BASMI ) , Chest expansion , and ankylosing spondylitis quality of life ( ASQOL ) question naire . In group I , BASFI showed significant improvement at week 12 ( P = 0.031 ) and week 24 ( P = 0.007 ) . In group II , this parameter was not found to have significantly changed at week 12 and week 24 . Comparison of the groups showed significantly superior results for group I at week 24 ( P = 0.023 ) . We suggest Pilates exercises as an effective and safe method to improve physical capacity in AS patients . Our study is the first clinical study design ed to investigate the role of Pilates method in AS treatment . We believe that further research with more participants and longer follow-up periods could help assess the therapeutic value of this popular physical exercise method in AS",
"The purpose of this study is to evaluate the effects of targeting both the motivation and action phases of behaviour change in a 5-week intervention to increase physical activity ( PA ) among patients with rheumatoid arthritis ( RA ) not meeting current PA recommendations . In a r and omised controlled trial , a control group — which received a group-based patient education session led by a physical therapist — was compared to a treatment group which received the education session plus a motivational interview from a physical therapist and two self-regulation coaching sessions from a rheumatology nurse . Outcomes included leisure-time PA , days per week with at least 30 min of moderate-intensity PA , self-efficacy and autonomous motivation ( cognitions which predict PA initiation and maintenance ) , disease activity , functional status , depressive symptoms and fatigue . Effects were assessed using mixed models repeated measures . Of the 78 patients r and omised , 76 and 67 completed the post-treatment and follow-up assessment s , respectively . Significant treatment effects were found for leisure-time PA ( p = 0.022 ) , active days/week ( p = 0.016 ) , self-efficacy ( p = 0.008 ) and autonomous motivation ( p = 0.001 ) . At post-treatment and 6-months follow-up , significantly more treated patients than controls met current PA recommendations . No significant effects were found for disease activity , functional status , depressive symptoms or fatigue . Combining motivation- and action-focused intervention approaches improved PA-related cognitions and led to improved uptake and maintenance of leisure-time PA . However , further research is necessary to identify ways of helping patients with RA transition to— and maintain — more intensive forms of PA which are more likely to improve disease activity and functional status",
"Background : To investigate the effects of moderate aerobic exercise on the hemoglobin , hematocrit , and red blood cell ( RBC ) mass of women with rheumatoid arthritis ( RA ) . Material s and Methods : This r and omized clinical trial was conducted at the Specialized Clinic of Physical Medicine and Rehabilitation , Al-Zahra Hospital of Isfahan , during a 4-month period in 2014 . We included patients with RA who did not have any malignancy and hematologic disorder . Two groups — one group receiving aerobic therapy along with medical therapy ( N = 16 ) and the other group receiving medical therapy alone ( N = 17 ) both for a period of 8 weeks . The levels of RBC mass , Hb , and HCT were measured before and after the intervention . The changes in these parameters were compared between the two study groups . Results : There was no significant difference between the two study groups regarding the baseline characteristics . The aerobic exercise result ed in increased RBC mass ( P Hb ( P and HCT ( P medical therapy alone did not experience any significant changes in these parameters . We found that the RBC mass ( P = 0.581 ) , Hb ( P = 0.882 ) , and HCT ( P = 0.471 ) were comparable between the two study groups after 8 weeks of intervention . Conclusion : Although the aerobic exercise results in increased Hb , HCT , and RBC mass in patients with RA , the increase was not significant when compared to that in controls . Thus , the increase in the HB , HCT , and RBC could not be attributable to aerobic exercise",
"STUDY DESIGN R and omized clinical trial . OBJECTIVE To investigate the clinical and functional efficacy of 2 different non-weight-bearing exercise regimens , proprioceptive training ( PrT ) versus strength training ( ST ) , for patients with knee osteoarthritis ( OA ) . BACKGROUND Both strength and proprioceptive training are important interventions for individuals with knee OA . The benefits of weight-bearing exercises are generally recognized in the clinical setting . However , exercising in a st and ing or weight-bearing position may aggravate symptoms in patients with knee OA . METHODS AND MEASURES One hundred eight patients were r and omly assigned to the PrT , ST , or no exercise ( control ) group for an 8-week intervention . Both the PrT and ST interventions consisted of non-weight-bearing exercises . Western Ontario and McMaster Universities Osteoarthritis Index-pain ( WOMAC-pain ) and -function scores , walking time on 3 different terrains , knee strength , and absolute knee reposition error were assessed before and after intervention . Data were analyzed using mixed-model ANOVAs . RESULTS Both PrT and ST significantly improved WOMAC-pain and -function score after intervention ( P WOMAC-function scores ( 17.2 points ) and for knee extension strength ( 10.3 - 14.9 Nm ) was greater than the minimally clinical ly important difference for these measurements . The PrT group demonstrated greater improvement in walking time on a spongy surface and knee reposition error than the other 2 groups . No improvements were apparent in the control group . CONCLUSION Both types of non-weight-bearing exercises ( PrT and ST ) significantly improved outcomes in this study . PrT led to greater improvements in proprioceptive function , while ST result ed in a greater increase in knee extensor muscle strength",
"QUESTIONS Does a 3-month behaviour change intervention targeting physical activity ( PA ) increase habitual physical activity in adults with ankylosing spondylitis ( AS ) ? Does the intervention improve health-related physical fitness , AS-related features , and attitude to exercise ? Are any gains maintained over a 3-month follow-up ? DESIGN Parallel-group , r and omised , controlled trial with concealed allocation , assessor blinding and intention-to-treat analysis . PARTICIPANTS Forty adults with a diagnosis of AS , on stable medication , and without PA-limiting comorbidities . INTERVENTION Over a 3-month period , the experimental group engaged in individually-tailored , semi-structured consultations aim ing to motivate and support individuals in participating in PA . The control group continued with usual care . OUTCOME MEASURES The primary outcome was PA measured by accelerometry over 1 week . Secondary outcomes included clinical question naires and measures of health-related physical fitness . Measures were taken at baseline , post-intervention , and after a 3-month follow-up period . RESULTS Baseline characteristics were similar across groups , except age and body composition . There were statistically significant , moderate-to-large time-by-group effects in health-enhancing PA ( mixed- design ANOVA for overall effect F(2 , 76)=14.826 , p ) , spinal mobility ( F(2 , 76)=5.691 , p ) and quality of life ( χ2(2)=8.400 , p other physical fitness outcomes or on clinical question naires . No adverse effects were reported during the study . CONCLUSION Health-enhancing PA , spinal mobility and quality of life were significantly improved after the intervention , and improvements were maintained at 3-month follow-up . TRIAL REGISTRATION NCT02374502 . [ O'Dwyer T , Monaghan A , Moran J , O'Shea F , Wilson F ( 2016 ) Behaviour change intervention increases physical activity , spinal mobility and quality of life in adults with ankylosing spondylitis : a r and omised trial . Journal of PhysiotherapyXX : XX-XX ]",
"BACKGROUND AND PURPOSE Few r and omized controlled studies have examined the effects of exercise in patients with ankylosing spondylitis ( AS ) . This study investigated the effects of a 12-week , multimodal exercise program in patients with AS . SUBJECTS A convenience sample of 30 patients with AS ( 18 male , 12 female ) , with a mean age of 34.9 years ( SD=6.28 ) , participated in the study . Twenty-six subjects were classified as having stage I AS and 4 subjects were classified as having stage II AS according to the modified New York Criteria . METHODS This study was a r and omized controlled trial . Subjects were assigned to either a group that received an exercise program or to a control group . The exercise program consisted of 50 minutes of multimodal exercise , including aerobic , stretching , and pulmonary exercises , 3 times a week for 3 months . Subjects in both groups received medical treatment for AS , but the exercise group received the exercise program in addition to the medical treatment . All subjects received a physical examination at baseline and at 12 weeks . The examinations were conducted under the supervision of a physician who specialized in physical medicine and rehabilitation and included the assessment of spinal mobility using 2 methods : clinical measurements ( chin-to-chest distance , Modified Schober Flexion Test , occiput-to-wall distance , finger-to-floor distance , and chest expansion ) and inclinometer measurements ( gross hip flexion , gross lumbar flexion , and gross thoracic flexion ) . In addition , vital capacity was measured by a physiologist , and physical work capacity was evaluated by a doctorally prepared exercise instructor . RESULTS The measurements of the exercise group for chest expansion , chin-to-chest distance , Modified Schober Flexion Test , and occiput-to-wall distance were significantly better than those of the control group after the 3-month exercise period . The spinal movements of the exercise group improved significantly at the end of exercise program , but those of the control group showed no significant change . In addition , the results showed that the posttraining value of gross thoracic flexion of the exercise group was significantly higher than that of the control group . Physical work capacity and vital capacity values improved in the exercise group but decreased in the control group . DISCUSSION AND CONCLUSION In this study , a multimodal exercise program including aerobic , stretching , and pulmonary exercises provided in conjunction with routine medical management yielded greater improvements in spinal mobility , work capacity , and chest expansion",
"OBJECTIVE Quadriceps weakness is a risk factor for incident knee osteoarthritis ( OA ) . We describe a r and omized controlled trial of effects of lower-extremity strength training on incidence and progression of knee OA . METHODS A total of 221 older adults ( mean age 69 years ) were stratified by sex , presence of radiographic knee OA , and severity of knee pain , and were r and omized to strength training ( ST ) or range-of-motion ( ROM ) exercises . Subjects exercised 3 times per week ( twice at a fitness facility , once at home ) for 12 weeks , followed by transition to home-based exercise after 12 months . Assessment s of isokinetic lower-extremity strength and highly st and ardized knee radiographs were obtained at baseline and 30 months . RESULTS Subjects in both groups lost lower-extremity strength over 30 months ; however , the rate of loss was slower with ST than with ROM . Compared with ROM , ST decreased the mean rate of joint space narrowing ( JSN ) in osteoarthritic knees by 26 % ( P = not significant ) . However , the difference between ST and ROM groups with respect to frequency of knee OA progression in JSN consensus ratings was marginally significant ( 18 % versus 28 % ; P = 0.094 ) . In knees that were radiographically normal at baseline , JSN > 0.50 mm was more common in ST than in ROM ( 34 % versus 19 % ; P = 0.038 ) . Incident JSN was unrelated to exercise adherence or changes in quadriceps strength or knee pain . CONCLUSION The ST group retained more strength and exhibited less frequent progressive JSN over 30 months than the ROM group . The increase in incident JSN > 0.50 mm in ST is unexplained and requires confirmation",
"OBJECTIVE To determine the effect of a low load resistance exercise training program on muscle strength , functional outcome , and cardiovascular endurance . METHODS Forty-nine patients , 37 women and 12 men between the ages of 35 - 76 yrs ( mean 60.5 yrs ) , with definite rheumatoid arthritis ( RA ) functional class II and III ( mean disease duration of 10.5 yrs ) were r and omly assigned to exercise and control groups for a 12 wk resistive muscle training program . A circuit weight bearing form of training was incorporated using light loads with high repetitions . A video tape demonstrating the exercises was given to all exercising participants to enable them to continue the program at home at least 3 times per wk with a biweekly self-report evaluation . Baseline and post-intervention evaluations included joint activity , muscle strength , endurance , functional outcome , and self-report . Cardiovascular fitness measured by treadmill time , anaerobic threshold and peak oxygen consumption ( VO2 ) in this group were assessed at baseline and 12 wks . RESULTS A significant improvement at 12 wks was noted in the exercise group for self-reported joint count ( p = 0.02 ) , number of painful joints ( p = 0.004 ) , HAQ ( p = 0.012 ) , sit-to-st and time ( p = 0.02 ) , grip strength ( p = 0.05 ) knee extension 60 degrees ( p = 0.03 ) , Arthritis Impact Measurement Scales dexterity ( p = 0.02 ) , and time to anaerobic threshold ( p = 0.03 ) . Significant improvement in the exercise group compared to the control group was noted for self-reported joint count ( p = 0.02 ) , night time pain ( p = 0.05 ) , and sit-to-st and time ( p = 0.02 ) . Increase in treadmill time was not statistically significant nor was a change in peak oxygen consumption ( VO2 ) noted . Abnormalities on initial treadmill screening were detected in 2 of 49 asymptomatic patients . They were excluded from the study and subsequent workup revealed significant coronary artery disease . CONCLUSION Low load resistive muscle training increased functional capacity as reported by patients and is a clinical ly safe form of exercise in functional class II and III RA . Screening this population for dormant coronary artery disease is recommended",
"OBJECTIVE To determine the effects of participation in a low-impact aerobic exercise program on fatigue , pain , and depression ; to examine whether intervention groups compared with a control group differed on functional ( grip strength and walk time ) and disease activity ( total joint count , erythrocyte sedimentation rate , and C-reactive protein ) measures and aerobic fitness at the end of the intervention ; and to test which factors predicted exercise participation . METHODS A convenience sample of 220 adults with rheumatoid arthritis ( RA ) , ages 40 - 70 , was r and omized to 1 of 3 groups : class exercise , home exercise using a videotape , and control group . Measures were obtained at baseline ( T1 ) , after 6 weeks of exercise ( T2 ) , and after 12 weeks of exercise ( T3 ) . RESULTS Using structural equation modeling , overall symptoms ( latent variable for pain , fatigue , and depression ) decreased significantly at T3 ( P exercise group compared with the control group . There were significant interaction effects of time and group for the functional measures of walk time and grip strength : the treatment groups improved more than the control group ( P measures of disease activity . Fatigue and perceptions of benefits and barriers to exercise affected participants ' amount of exercise , supporting previous research . CONCLUSION This study supported the positive effects of exercise on walk time and grip strength , and demonstrated that fatigue and perceived benefits /barriers to exercise influenced exercise participation . Furthermore , overall symptoms of fatigue , pain , and depression were positively influenced in this selective group of patients with RA ages 40 - 70 years",
"AIM This paper reports a study of the effects of aquatic exercise on physical fitness ( flexibility , strength and aerobic fitness ) , self-reported physical functioning and pain in adults with osteoarthritis of the hip or knee . BACKGROUND Osteoarthritis is a common cause of disability and a primary reason for hip and knee joint replacement . Exercise is important for preventing and /or managing the functional limitations associated with joint disease . Aquatic exercise is thought to be beneficial and is often recommended for people with osteoarthritis ; however , few studies have examined the effects on people with osteoarthritis , and these have yielded inconsistent results . METHODS A two-group r and omized controlled trial with a convenience sample was used . Participants were recruited from community sources and r and omly assigned to a 12-week aquatic programme or a non-exercise control condition . Data for 38 participants were collected at baseline , week 6 , and week 12 during 2003 and 2004 . Instruments were a st and ard plastic goniometer , a h and held dynamometer , the 6-minute walk test , the multidimensional Health Assessment Question naire , and a visual analogue scale for pain . RESULTS Repeated measures analysis of variance showed that aquatic exercise statistically significantly improved knee and hip flexibility , strength and aerobic fitness , but had no effect on self-reported physical functioning and pain . The exercise adherence rate was 81.7 % , and no exercise-related adverse effect was observed or reported . CONCLUSIONS Beneficial short-term effects of aquatic exercise were found in adults with osteoarthritis of the hip or knee . Although the programme may not offer pain relief or self-reported improvements in physical functioning , results suggest that aquatic exercise does not worsen the joint condition or result in injury . Nurses engaging in disease management and health promotion for these patients should consider recommending or implementing aquatic classes for patients",
"BACKGROUND Osteoarthritis is a common musculo-skeletal problem accompanied with muscle weakness . Muscle weakness may be readily improved by resistance training . Greater muscle strength has been associated with a lower knee joint loading rate . METHODS We conducted a single-blind r and omized controlled trial of 54 female patients with osteoarthritis in at least one knee , according to the American College of Rheumatology clinical criteria . Patients were r and omized into a 6-month high intensity progressive resistance training or a sham-exercise program . The primary outcomes were first peak knee and hip adduction moment measured using three-dimensional gait analysis at self-selected habitual and maximal speeds . Secondary outcomes were sagittal plane knee and hip moments , peak muscle strength , gait speed , and self-reported knee osteoarthritis symptoms measured by the Western Ontario and McMaster Osteoarthritis Index ( WOMAC ) . FINDINGS Six months of high intensity resistance training did not change the first peak knee or hip adduction moment at either habitual or maximum walking speeds ( P>0.413 ) compared to the sham-exercise . However , the second peak hip adduction moment ( P=0.025 ) and WOMAC pain score ( P second peak hip adduction moment were inversely related to the changes in the WOMAC pain score ( r=-0.394 , P=0.009 ) . INTERPRETATIONS Muscle strength training in women with osteoarthritis , while effective for reducing osteoarthritis symptoms , appeared to operate through mechanisms other than improved knee or hip joint loading , as paradoxically , improved symptoms were related to decreases of hip adduction moment in late stance",
"OBJECTIVE To evaluate the mean overall effects over a 1-year period of a multidisciplinary in-patient rehabilitation programme for patients with ankylosing spondylitis . DESIGN Observer-blinded , r and omized controlled trial , with assessment s made after 4 and 12 months . PATIENTS Forty-six patients received a 3-week in-patient rehabilitation programme and 49 patients received treatment as usual . METHODS Primary outcomes were disease activity measured with the Bath Ankylosing Spondylitis Disease Activity Scale ( BASDAI ) , and function measured with the Bath Ankylosing Spondylitis Functional Index ( BASFI ) . Secondary outcomes included well-being , spinal and hip mobility , and health-related quality of life measured with the Medical Outcome Study Short Form-36 . Overall treatment effects were estimated with Mixed models repeated measures analyses . RESULTS Significant overall treatment effects in favour of the rehabilitation group were found in the BASDAI score ( mean difference over the 1-year period -10.0 , 95 % confidence interval : -3.7 to -16.3 ) , in well-being ( -7.3 , 95 % confidence interval : -1.0 to -14.7 ) , and in the Medical Outcome Study Short Form-36 variables social functioning , role physical , role mental and bodily pain ( mean differences ranging from 5.8 ( pain ) to 10.7 ( role physical ) ) . CONCLUSION A 3-week in-patient rehabilitation programme had positive overall effects on disease activity , pain , function and well-being , and should be considered an important complement to medical disease management in persons with ankylosing spondylitis",
"OBJECTIVE To investigate the effect of a 1-year coaching program for healthy physical activity on perceived health status , body function , and activity limitation in patients with early rheumatoid arthritis . METHODS A total of 228 patients ( 169 women , 59 men , mean age 55 years , mean time since diagnosis 21 months ) were r and omized to 2 groups after assessment s with the EuroQol visual analog scale ( VAS ) , Grippit , Timed-St and s Test , Escola Paulista de Medicina Range of Motion scale , walking in a figure-of-8 , a visual analog scale for pain , the Health Assessment Question naire disability index , a self-reported physical activity question naire , and the Disease Activity Score in 28 joints . All patients were regularly seen by rheumatologists and underwent rehabilitation as prescribed . Those in the intervention group were further individually coached by a physical therapist to reach or maintain healthy physical activity ( > or = 30 minutes , moderately intensive activity , most days of the week ) . RESULTS The retention rates after 1 year were 82 % in the intervention group and 85 % in the control group . The percentages of individuals in the intervention and control groups fulfilling the requirements for healthy physical activity were similar before ( 47 % versus 51 % ; P > 0.05 ) and after ( 54 % versus 44 % ; P > 0.05 ) the intervention . Analyses of outcome variables indicated improvements in the intervention group over the control group in the EuroQol VAS ( P = 0.025 ) and muscle strength ( Timed-St and s Test ; P = 0.000 ) ( Grippit ; P = 0.003 ) , but not in any other variables assessed . CONCLUSION A 1-year coaching program for healthy physical activity result ed in improved perceived health status and muscle strength , but the mechanisms remain unclear , as self-reported physical activity at healthy level did not change",
"OBJECTIVE : To investigate the benefit of intensive dynamic exercises in comparison to range of motion ( ROM ) and isometric exercises in rheumatoid arthritis . METHODS : 100 consecutive rheumatoid arthritis patients on stable medication were r and omly assigned to ( 1 ) intensive dynamic group exercises which included full weight bearing exercises and conditioning exercises on a stationary bicycle while the heart rate was maintained at 70 - 85 % of the age predicted maximum heart rate , ( 2 ) range of motion ( ROM ) exercises and isometric exercises in a group , ( 3 ) individual isometric and ROM exercises , and ( 4 ) home instructions for isometric and ROM exercises . Variables of physical condition , muscle strength , joint mobility , daily functioning ( HAQ ) , and disease activity were assessed before and after the 12 week exercise course , and 12 weeks thereafter . An intention to treat analysis was performed . RESULTS : Increases in aerobic capacity ( n = 77 ) , muscle strength , and joint mobility in the high intensity exercise programme were respectively 17 % , 17 % and 16 % and differed significantly from the changes in aerobic capacity , muscle strength , and joint mobility in the other exercise groups . No deterioration of disease activity was observed . Twelve weeks after discontinuation of the exercise course the gain in physical capacity had disappeared . CONCLUSIONS : Intensive dynamic training is more effective in increasing aerobic capacity , joint mobility , and muscle strength than ROM exercises and isometric training in rheumatoid arthritis patients with well controlled disease",
"A group of 120 patients with rheumatoid arthritis or osteoarthritis volunteered to be subjects for this study of aerobic versus nonaerobic exercise . Patients were stratified by diagnosis and r and omized into an exercise program of aerobic walking , aerobic aquatics , or nonaerobic range of motion ( controls ) . The retention rate for the 12-week program was 83 % . Exercise tolerance , disease-related measures , and self-reported health status were assessed . The aquatics and walking exercise groups showed significant improvement over the control group in aerobic capacity , 50-foot walking time , depression , anxiety , and physical activity after the 12-week exercise program . There were no significant between-group group differences in the change scores for flexibility , number of clinical ly active joints , duration of morning stiffness , or grip strength . Our findings document the feasibility and efficacy of conditioning exercise for people who have rheumatoid arthritis or osteoarthritis",
"OBJECTIVES To investigate the long-term effects on perceived general health , disease activity , pain , activity limitation and cognitive behavioural factors of a one-year coaching programme performed in ordinary physical therapy practice to promote the adoption of health-enhancing physical activity in patients with early rheumatoid arthritis ( RA ) . METHODS A total of 228 patients with early RA , from 10 rheumatology clinics in Sweden , were r and omly assigned to an intervention group ( IG ; n = 94 ) or a control group ( CG ; n = 134 ) . The IG was coached by physical therapists during the first year to adopt health-enhancing levels of physical activity ( 30 minutes/day , moderately intensive , ≥ 4 days/week ) . No coaching was given during the subsequent year between post-intervention and follow-up . Follow-up assessment consisted of a postal question naire on physical activity and of visual analogue scales for ratings of general health perception and pain . The Health Assessment Question naire Disability Index ( HAQ ) and the Disease Activity Score in 28 joints ( DAS 28 ) were collected at regular medical check-ups . RESULTS Sixty-five ( 69 % ) participants in the IG and 92 ( 69 % ) in the CG completed the entire study period by filling in the follow-up question naire on physical activity two years after baseline . The intervention seemed to lack any significant influence on long-term outcome . However , different patterns of change in physical activity behaviour were observed in the two groups . CONCLUSIONS No long-term improvement in perceived general health or other outcomes were found in the follow-up . This may partly be because the intervention lacked several important behavioural elements for physical activity maintenance",
"OBJECTIVE To confirm , in a r and omized controlled trial ( RCT ) , the efficacy of high-intensity progressive resistance training ( PRT ) in restoring muscle mass and function in patients with rheumatoid arthritis ( RA ) . Additionally , to investigate the role of the insulin-like growth factor ( IGF ) system in exercise-induced muscle hypertrophy in the context of RA . METHODS Twenty-eight patients with established , controlled RA were r and omized to either 24 weeks of twice-weekly PRT ( n = 13 ) or a range of movement home exercise control group ( n = 15 ) . Dual x-ray absorptiometry-assessed body composition ( including lean body mass [ LBM ] , appendicular lean mass [ ALM ] , and fat mass ) ; objective physical function ; disease activity ; and muscle IGFs were assessed at weeks 0 and 24 . RESULTS Analyses of variance revealed that PRT increased LBM and ALM ( P reduced trunk fat mass by 2.5 kg ( not significant ) ; and improved training-specific strength by 119 % , chair st and s by 30 % , knee extensor strength by 25 % , arm curls by 23 % , and walk time by 17 % ( for objective function tests , P values ranged from 0.027 to 0.001 versus controls ) . In contrast , body composition and physical function remained unchanged in control patients . Changes in LBM and regional lean mass were associated with changes in objective function ( P values ranged from 0.126 to diminished muscle levels of IGF-1 and IGF binding protein 3 both increased following PRT ( P lean mass and function in patients with RA . Muscle hypertrophy coincided with significant elevations of attenuated muscle IGF levels , revealing a possible contributory mechanism for rheumatoid cachexia . PRT should feature in disease management",
"Abstract Purpose : To evaluate the effect of an exercise therapy concept ( the Tübingen exercise therapy approach THüKo ) for increasing hip muscle strength ( HMS ) in patients with hip osteoarthritis ( OA ) , and to investigate whether patients do adhere to the intervention and if there are any adverse events related to the intervention . Methods : A total of 210 hip OA patients ( 89 females , 121 males ) were r and omized into a 12-week exercise intervention ( THüKo ) including group sessions ( 1/week ) and home exercising ( 2/week ) , a placebo ultrasound group ( 1/week ) or a control group ( no treatment ) . HMS was measured as isometric peak torque of hip abduction , adduction , flexion , and extension . Adherence to exercise and safety aspects were monitored as additional outcomes . Results : Baseline adjusted post intervention HMS of the THüKo group were higher compared to the control group ( differences of 0.11–0.27 Nm/kg , p 0.01 ) . Adherence to exercise was high ( about 90 % ) . No subject had to refuse from training because of an exercise related adverse event and exercise related pain was only of intermittent nature without sustainable adverse effects . Conclusions : The Tübingen exercise therapy approach has shown to have a significant positive effect on HMS . Its implementation has shown to be feasible and safe according to the percentage of exercise participation and the absence of sustainable adverse events",
"OBJECTIVE To investigate the efficacy and feasibility of progressive explosive-type resistance training ( RT ) in patients with osteoarthritis ( OA ) of the hip scheduled for total hip arthroplasty ( THA ) . METHOD R and omized controlled trial ( 1:1 ) in patients diagnosed with hip OA and scheduled for THA . The intervention group ( IG ) performed supervised preoperative progressive explosive-type RT twice a week for 10 weeks ; four exercises ( hip/thigh ) performed in three series each ( 8 - 12 repetition maximum ) . The control group ( CG ) received ' care as usual ' . Efficacy was reported as the between-group difference in the Hip Osteoarthritis Outcome Score ( HOOS ) ( primary endpoint ; ADL function ) , and leg muscle power at post intervention follow-up immediate before surgery . Intention-to-treat analyses were performed in a multilevel regression model adjusting for baseline , sex , age and weight . Feasibility was reported as adherence , exercise related pain and adverse effects . Post-surgical follow up will be reported separately . Clinical Trials.gov registration : NCT01164111 . RESULTS Eighty patients ( age 70.4 ± 7.6 years , BMI 27.8 ± 4.6 , 52 females ( 65 % ) were included . Adherence was high ( 93 % ) with acceptable exercise related pain ( VAS score ≤ 5 ) reported in 83 % of sessions and no adverse events . Changes in HOOS ' function ' was 10.0 points 95%CI [ 4.7 ; 15.3 ] higher in IG compared to CG ( P had higher leg extension muscle power ( P CONCLUSION Progressive explosive-type RT was feasible in the included group of hip OA patients scheduled for THA and result ed in significant improvement in self-reported outcomes and increased leg muscle power ",
"UNLABELLED Knee pain is a common health problem in the elderly population , for which non-invasive treatments are recommended as a first line treatment in the management of knee pain . A r and omized controlled trial was conducted to determine the effects of exercise with or without thermal therapy in community-dwelling elderly women with chronic knee pain . Women over 75 years of age with knee pain ( n=150 ) were r and omly assigned into four groups ; exercise ( Ex ) and heat/steam generating sheet ( HSGS ) ( n=38 ) , Ex ( n=37 ) , HSGS ( n=38 ) , or health education ( HE ) ( n=37 ) . The Ex group attended a 60-min comprehensive training program twice a week for 3-months . The HSGS group placed two sheets on the knee for five hours per day . Functional fitness , visual analog scale ( VAS ) , and Japanese knee osteoarthritis measure ( JKOM ) were assessed at baseline and post-intervention . The results showed VAS improvements in the Ex+HSGS and HSGS groups . Total JKOM score , muscle strength , and functional mobility significantly improved in the Ex+HSGS group compared with the HE group . The odds ratio ( OR ) for VAS and functional mobility improvement was more than eight times as great in the Ex+HSGS group ( OR=8.60 , 95 % confidence interval (CI)=2.82 - 32.73 ) compared with the education group . Ex or HSGS alone were insufficient in enhancing functional fitness or improving pain and quality of life . The combined effects of both Ex and heat therapy seems to have an added benefit of decreasing pain , improving physical function and increasing quality of life . TRIAL REGISTRATION NUMBER JMA-IIA00110",
"Objective . To evaluate the effects of aerobic exercise in patients with ankylosing spondylitis ( AS ) . Methods . Seventy patients classified with AS by the modified New York criteria were included . The patients were r and omly assigned into 2 groups . The intervention group ( IG ) performed 50 min of walking followed by stretching exercises 3 times a week for 12 weeks . The control group ( CG ) performed only stretching exercises . The outcome measurements were the Bath indexes [ Bath AS Functional Index ( BASFI ) , Bath AS Disease Activity Index ( BASDAI ) , and Bath AS Metrology Index ( BASMI ) ] , Health Assessment Question naire for the Spondyloarthropathies ( HAQ-S ) , AS Disease Activity Score ( ASDAS ) , the 6-min walk test ( 6MWT ) , chest expansion , and the Medical Outcomes Study Short Form-36 . Aerobic capacity was assessed by ergospirometry on a treadmill . Routine laboratory techniques were used in determining lipid levels . Assessment s were performed immediately before r and omization and after 6 , 12 , and 24 weeks . Results . Thirty-five patients were r and omized to the IG and 35 to the CG . There was significant improvement in the BASFI , HAQ-S , BASMI , BASDAI , and ASDAS in both groups ( p walking distance in the 6MWT in the IG compared with CG ( p cardiopulmonary capacity compared with CG . Cholesterol and triglyceride levels did not change in either group . Conclusion . In patients with AS , aerobic training improved walking distance and aerobic capacity . Aerobic training did not provide additional benefits in functional capacity , mobility , disease activity , quality of life , and lipid levels when compared with stretching exercises alone",
"OBJECTIVE To investigate physical function in patients with severe osteoarthritis ( OA ) of the knees during and after a general physical training program . DESIGN R and omized control trial , blinded observer , follow-up at 3 months and 1 year . SETTING Outpatient clinic . PATIENTS Consecutive sample of 25 patients ( 3 men , 22 women ) with OA of the knees according to the criteria of the American College of Rheumatology ( ACR ) . Two patients ( 8 % ) failed to complete the study . There were no withdrawals for adverse effects . INTERVENTION Twelve patients received training in groups of 6 , twice a week for 3 months . Training focused on general fitness , balance , coordination , stretching , and lower extremity muscle strength , and included a daily home exercise program . MAIN OUTCOME MEASURES Muscle strength across the knee ( extension and flexion ) , Algofunctional Index ( AFI ) , pain ( 0 to 10 point scale ) , walking speed , clinical findings . RESULTS Patients participated in 96 of 96 assessment s ( 100 % ) and in 218 of 280 training sessions ( 77.9 % ) . From baseline to 3 months , isokinetic quadriceps strength ( 30 degrees/sec ) improved 20 % ( confidence interval [ CI ] 2alpha = .05 , 8 % to 50 % ) in the least affected leg ; isometric strength improved 21 % . By 1 year , AFI had decreased 3.8 points ( CI2alpha = .05 , 1.0 to 7.0 ) , pain had decreased 2.0 points ( CI2alpha = 05 , 0.0 to 4.0 ) , and walking speed had increased 13 % ( CI2alpha = .05 , 4 % to 23 % ) . There was an increase in the frequency of palpable joint effusions ( p Frequency of crepitus decreased on the least affected side ( p General physical training appears to be beneficial to patients with OA of the knee . As shown by the high compliance and low dropout frequency , such a program is feasible even in patients with severe OA of the knee",
"Objective : To assess the effects of a 16-week progressive , individualized , high-intensity strength training program on muscle strength , pain , and function in patients with rheumatoid arthritis ( RA ) . Methods : Twenty-four RA patients ( men , n = 5 ; women , n = 19 ) receiving infliximab participated in a r and omized controlled trial . The strength training ( ST ) group ( n = 16 ) participated in a supervised program 3 times per week , and the control ( C ) group ( n = 8) continued with st and ard of care as overseen by their rheumatologist . Assessment s were completed at baseline and at weeks 8 and 16 . Strength was measured by 3 repetition maximum ( 3RM ) , isometric h and dynamometer , and isokinetic dynamometer . A 100-mm visual analogue scale was used to assess pain . Functional performance was derived from a timed 50-foot walk and the Health Assessment Question naire Disability Index . Results : The mean percent increase in strength ( 3RM ) for the ST group from baseline to week 16 was 46.1 % ± 31.6 % ( P mean gains in strength up to 4 times that of baseline values reported in all strength training exercises ( upper and lower body ) performed during exercise sessions . On average , right-h and grip strength increased by 2.9 ± 4.0 kg in the ST group , in comparison with a loss of 1.2 ± 3.0 kg in the C group over 16 weeks . The ST group had a 53 % reduction in pain , in comparison with almost no change in the C group . The ST group had a significant improvement in 50-foot walk time , with a mean reduction of −1.2 ± 1.6 seconds , in comparison with the C group ( mean increase of 0.8 ± 1.0 seconds ; P = 0.01 ) over the 16 weeks . There was a clinical ly important difference ( predefined as mean change ±0.25 ) in the Health Assessment Question naire Disability Index in the ST group ( −0.4 ± 0.4 ) but not in the C group ( −0.1 ± 0.4 ) . Conclusion : High-intensity strength training in RA patients with varying levels of disease activity and joint damage had a large , significant effect on strength , and led to improvements in pain and function , with additive patient benefits beyond the effect of their infliximab use",
"OBJECTIVE There are insufficient data on the effects of long-term intensive exercise in patients with rheumatoid arthritis ( RA ) . We undertook this r and omized , controlled , multicenter trial to compare the effectiveness and safety of a 2-year intensive exercise program ( Rheumatoid Arthritis Patients In Training [ RAPIT ] ) with those of physical therapy ( termed usual care [ UC ] ) . METHODS Three hundred nine RA patients were assigned to either the RAPIT program or UC . The primary end points were functional ability ( assessed by the McMaster Toronto Arthritis [ MACTAR ] Patient Preference Disability Question naire and the Health Assessment Question naire [ HAQ ] ) and the effects on radiographic progression in large joints . Secondary end points concerned emotional status and disease activity . RESULTS After 2 years , participants in the RAPIT program showed greater improvement in functional ability than participants in UC . The mean difference in change of the MACTAR Question naire score was 2.6 ( 95 % confidence interval [ 95 % CI ] 0.1 , 5.2 ) over the first year and 3.1 ( 95 % CI 0.7 , 5.5 ) over the second year . After 2 years , the mean difference in change of the HAQ score was -0.09 ( 95 % CI -0.18 , -0.01 ) . The median radiographic damage of the large joints did not increase in either group . In both groups , participants with considerable baseline damage showed slightly more progression in damage , and this was more obvious in the RAPIT group . The RAPIT program proved to be effective in improving emotional status . No detrimental effects on disease activity were found . CONCLUSION A long-term high-intensity exercise program is more effective than UC in improving functional ability of RA patients . Intensive exercise does not increase radiographic damage of the large joints , except possibly in patients with considerable baseline damage of the large joints",
"Objective The purpose of this study was to compare the effectiveness of l and -based ( LB ) and water-based ( WB ) aerobic exercises in women with rheumatoid arthritis ( RA ) . Design A total of 133 women with RA were included in this r and omized , blinded , prospect i ve , 16-week controlled trial . The subjects were r and omized into 3 groups : WB ( n = 33 ) , LB ( n = 33 ) , and control ( n = 34 ) . Muscle strength ( MS ) was measured using an isokinetic dynamometer . Disease activity ( DAS-28 ) and functional ability ( health assessment question naire ) were measured by an expert rheumatologist . Total body densitometry was used to assess body composition . The intervention was performed 3 times per week , and all groups were evaluated at baseline and after 8 and 16 weeks . Compliance , concomitant medications , and adverse events were recorded . The data were analyzed by intention to treat . P 133 patients recruited , 100 were r and omized and 82 completed the study . In the first evaluation , the 3 groups were matched to age , body composition , functional capacity , MS , and concomitant medications . After 16 weeks , there were no significant changes of knee MS neither body composition among the groups . However , there was a significant improvement in disease activity and functional ability in the WB after 8 and 16 weeks . Conclusion Aquatic exercises provided significant improvement in disease activity , pain , and functional capacity",
"The effects of physical training on elderly , fragile patients with rheumatoid arthritis ( RA ) who are on low-dose steroids were investigated . The controlled study included 24 patients who had been treated with low-dose steroids for 2 years . Each patient was assigned either to a treatment group receiving training or to an untrained control group . The training took place over a 3-month period and was based on a protocol using progressive interval training consisting of bicycle exercises , heel lifts , and step-climbing . The exercises were performed twice weekly for 45 minutes . Comparison of the two groups showed that disease activity did not increase in the trained group and that fewer , but not significantly fewer , swollen joints were observed in this group ( p = 0.06 ) . No significant changes were noticed in erythrocyte sedimentation rate , tender joints , or morning stiffness . The work capacity of the trained patients were doubled and the numbers of repetitions increased 76 % . Individually adapted exercise programs can therefore be recommended for elderly rheumatoid arthritis patients on steroid treatment",
"Background : Osteoarthritis ( OA ) is a degenerative joint disease affecting the knee joint of many middle-aged and older adults . As OA symptoms typically involve knee pain and stiffness , individuals with knee OA are often insufficiently physically active , have low levels of physical function , and are at increased risk of other comorbidities and reduced quality of life . While moderate-intensity continuous training ( MICT ) cycling is often recommended , little is known about the feasibility , safety , and benefits of high-intensity interval training ( HIIT ) cycling for this population , even though the feasibility , safety , and benefits of HIIT have been demonstrated in other chronic disease groups . Purpose : The primary objective of this pilot study was to examine the feasibility and safety of home-based HIIT and MICT cycling in middle-aged and older adults with knee OA . A secondary objective was to gain some insight into the relative efficacy of HIIT and MICT for improving health status ( pain , stiffness , and disability ) , muscle function , and body composition in this population . This study protocol is being published separately to allow a detailed description of the research methods , explain the rationale for choosing the method ological details , and to stimulate consideration of the best means to simulate a research protocol that is relevant to a real-life treatment environment . Study Design : R and omized pilot study protocol . Methods : This trial sought to recruit 40 middle-aged and older adults with knee OA . Participants were r and omly allocated to either continuous ( MICT ) or HIIT home-based cycle training programs , with both programs requiring the performance of 4 cycling sessions ( approximately 25 minutes per session ) each week . Participants were measured at baseline and postintervention ( 8 weeks ) . Feasibility and safety were assessed by adherence rate , dropout rate , and number of adverse events . The relative efficacy of the cycling programs was investigated by 2 knee OA health status question naires ( Western Ontario and McMaster Universities Osteoarthritis Index scale[WOMAC ] and the Lequesne Index ) as well as the timed up and go , sit to st and , preferred gait speed , and body composition . Discussion : This pilot study appears to be the first study assessing the feasibility and safety of a home-based HIIT training program for middle-aged and older adults with knee OA . As HIIT has been demonstrated to be more effective than MICT for improving aspects of health status , body composition , and /or muscular function in other chronic disease groups , the current study has the potential to improve patient outcomes and inform the design of future r and omized controlled trials ",
"OBJECTIVE To evaluate the functional , clinical , radiological and quality of life outcomes of a 4-week dynamic exercise programme ( DEP ) in RA . METHODS Patients matched on the principal medico-social parameters were r and omly assigned to either the DEP or the conventional joint rehabilitation group . Primary end point for judging effectiveness was functional status assessed by HAQ . Secondary outcomes included Nottingham Health Profile ( NHP ) , Arthritis Impact Measurement Scale 2-Short Form ( AIMS 2-SF ) and radiological worsening measured by Simple Narrowing Erosion Score ( SENS ) . Clinical evaluation consisted of disease activity score ( DAS 28 ) , cycling aerobic fitness and dexterity . Dexterity was measured using Sequential Occupational Dexterity Assessment ( SODA ) and Duruoz H and Index ( DHI ) . Data were collected at baseline 1 , 6 and 12 months . RESULTS Fifty patients were enrolled . HAQ improved throughout the length of the trial in the DEP group . This improvement was greater in DEP than in the st and ard joint rehabilitation group at 1 month ( -0.2 vs no variation from baseline , P = 0.04 ) , but not at 6 months ( -0.2 vs -0.1 in control group , P = 0.25 ) or 12 months ( -0.1 vs no variation in control group , P = 0.51 ) . DEP improved NHP ( -23 vs + 7 % in control group , P = 0.01 ) and aerobic fitness ( + 0.3 vs + 0.1 km per 5 min in control group , P = 0.02 ) at 1 month but the progress was not statistically significant thereafter . DEP also improved DHI , SODA , DAS 28 and AIMS 2-SF , although not significantly . CONCLUSION DEP was effective on functional status assessed by HAQ , quality of life and aerobic fitness at 1 month",
"OBJECTIVE To investigate whether weight-bearing ( WB ) exercise enhances functional capacity to a greater extent than nonweight-bearing ( NWB ) exercise in participants with knee osteoarthritis . DESIGN R and omized controlled trial . SETTING Kinesiology laboratory . PARTICIPANTS Participants ( N=106 ) were r and omly assigned to WB exercise , NWB exercise , or a control group ( no exercise ) . INTERVENTION WB exercise and NWB exercise groups underwent an 8-week knee extension-flexion exercise program . MAIN OUTCOME MEASURES Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) function scale , walking speed , muscle torque , and knee reposition error were assessed before and after intervention . RESULTS Equally significant improvements were apparent for all outcomes after WB exercise and NWB exercise , except for reposition error , for which improvement was greater in the WB exercise group . In contrast , there were no improvements in the control group . CONCLUSIONS Simple knee flexion and extension exercises ( WB and NWB ) performed over 8 weeks result ed in significant improvement in the WOMAC function scale and knee strength compared with the control group . NWB exercise alone may be sufficient enough to improve function and muscle strength . The additional benefit of WB exercise was improved position sense , which may enhance complex walking tasks ( walking on figure of 8 route and spongy surface )",
"Objective : To evaluate the short- and long-term effectiveness of exercise training in relation to pain , function and direct costs to health care systems attributable to hip osteoarthritis . Design : Prospect i ve , two-year r and omized controlled trial . Setting : An outpatient primary health care setting . Subjects : One hundred and twenty men and women aged from 55 to 80 , with radiologically diagnosed hip osteoarthritis with associated clinical symptoms . Interventions : The combined exercise and general practitioner ( GP ) care group received 12 supervised ( once per week ) exercise sessions at the baseline and four additional booster sessions one year later . Both groups received st and ard GP care . Main measures : The WOMAC Osteoarthritis Index , physical functioning score of R AND -36 ( SF-36 ) , the use and health care system costs of doctor visits and physiotherapy associated with hip osteoarthritis , number of total hip replacements , the use of analgesic and non-steroidal anti-inflammatory drugs ( NSAIDs ) , performance-based outcome scores and body mass index ( BMI ) . Results : There were no differences between the groups with respect to WOMAC hip pain , physical functioning score of R AND -36 , performance-based outcome scores or BMI . The effect of the exercise intervention on WOMAC function was statistically significant at 6 months ( mean = −7.5 ; 95 % confidence interval ( CI ) −13.9 to −1.0 ; P = 0.02 ) and 18 months ( mean = −7.9 ; 95 % CI −15.3 to −0.4 ; P = 0.04 ) . There were no statistically significant differences in the total health care system costs between the groups . Conclusion : The mostly home-based exercise training programme provided in this study did not result in reduced hip pain over the two-year follow-up period",
"OBJECTIVE To design an aquatic exercise ( AQE ) and l and -based exercise ( LBE ) program to enhance knee function and reduce body fat in patients with obesity and knee osteoarthritis and to investigate the effectiveness of AQE and LBE on body fat , functional fitness , and functional status . SETTING Outpatient clinic at a Seoul National University Bundang Hospital . PARTICIPANTS Obese patients with knee osteoarthritis were recruited from patients who visited the rehabilitation , orthopedic surgery , and geriatric outpatient clinics at the hospital . Study participants were limited to those who met the following criteria : body mass index more than 25 kg/m(2 ) , abdominal circumference more than 90 cm ( men ) or 85 cm ( women ) , clinical ly diagnosed osteoarthritis with Kellgren-Lawrence scale 2 or higher on radiographic studies , and independent ambulation state . METHODS Participants were r and omly allocated into 3 groups : AQE ( n = 26 ) , LBE ( n = 25 ) , and the control group ( n = 24 ) . Exercise interventions were conducted 3 times a week for 8 weeks . OUTCOME MEASURES Body fat analysis , brief pain inventory , Western Ontario and McMaster Universities ' osteoarthritis index , Short Form-36 question naire , and knee isokinetic tests were evaluated to assess changes in body fat composition , pain , physical function , and quality of life before and after the exercise program . RESULTS Although no significant difference was found in general characteristics among the 3 groups before exercise , body fat proportion in the AQE group decreased significantly ( mean + /- SD , from 34.4 + /- 4.7 to 33.3 + /- 4.7 ; P = .031 ) after intervention . The body mass index was slightly reduced after intervention , but it was not statistically significant . The AQE group showed significant improvements in pain , disability , and quality of life . Notably , the change in pain interference in the AQE group ( mean + /- SD , from 25.8 + /- 15.1 to 18.8 + /- 13.1 ; P = .009 ) was greater than that of the LBE group . Both exercise groups showed significant improvements in Western Ontario and McMaster Universities ' osteoarthritis index disability compared with the control group . CONCLUSIONS AQE had an advantage in controlling the interference with activity because of pain . AQE may be an effective tool for patients with obesity who have difficulties with active exercise due to knee osteoarthritis"
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Hypertensive emergencies occur when high blood pressure is associated with the presence of acute end-organ damage , such as hypertensive encephalopathy . There is controversy as to when and which antihypertensive drugs to use in these situations . Using a comprehensive search strategy in electronic sources , MEDLINE , EMBASE and Cochrane clinical trial register , we conducted a systematic review to look all r and omized control trials ( RCTs ) that compare an antihypertensive drug versus placebo , no treatment or another antihypertensive drug . Fifteen RCTs ( representing 869 patients ) met the inclusion criteria . Two trials included a placebo arm . All studies ( except one ) were open-label trials . Seven drug classes were evaluated in those trials : nitrates ( nine trials ) , angiotensin-converting enzyme inhibitors ( seven ) , diuretics ( three ) , calcium channel blockers ( six ) , α-1 adrenergic antagonists ( four ) , direct vasodilators ( two ) and dopamine agonists ( one ) . Mortality event data were reported in seven trials . Due to insufficient data , no meta- analysis was performed for clinical outcomes . Differences in blood pressure changes between antihypertensives were minor . There is no RCT evidence demonstrating that antihypertensive drugs reduce mortality or morbidity in patients with hypertensive emergencies . Furthermore , there is insufficient RCT evidence to determine which drug or drug class is most effective in reducing mortality and morbidity . There were some minor differences in the degree of blood pressure lowering when one class of antihypertensive drug is compared to another . However , the clinical significance is unknown . RCTs are needed to assess different drug classes to determine initial and longer-term mortality and morbidity outcomes
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"Abstract Objective : A clinical definition of a hypertensive emergency is excessively high blood pressure in the presence of symptoms indicating end organ damage . Equally high blood pressure without symptoms is called a hypertensive crisis . Patients with hypertensive crisis or emergency need prompt , effective , and specific therapy and a controlled reduction of blood pressure . Methods : We performed a r and omized , double-blind multi-centre study , to compare the safety , efficacy and tolerability of an intravenous ( IV ) infusion of two dihydropyridine calcium channel blockers ( either nifedipine or felodipine ) in 122 patients , of whom 63 were diagnosed as hypertensive emergencies and 59 as hypertensive crisis , who had not reacted adequately ( diastolic blood pressure nifedipine PO . Results : Both drugs lowered blood pressure adequately in more than 90 % of the patients and were well tolerated . Only one patient had to be withdrawn , because of an excessive decrease in blood pressure . Conclusion : Patients with excessively high blood pressure who do not react to oral nifedipine can be treated equally effectively with felodipine and nifedipine IV . Felodipine is easier to h and le because of its lack of light sensitivity",
"Sublingual captopril ( 25 mg ) was compared with sublingual nifedipine ( 10 mg ) to determine their effectiveness and safety in the treatment of hypertensive emergencies . In nine of 10 patients who received sublingual captopril , mean ( + /- SD ) systolic blood pressure and diastolic blood pressure dropped from 245 + /- 39 to 190 + /- 25 mm Hg ( P less than .0025 ) and from 144 + /- 8 to 115 + /- 8 mm Hg ( P less than .001 ) at 50 minutes , respectively . The hypotensive effect of the drug was maintained for a mean of 4 hours . In six of nine responders to sublingual captopril , blood pressure-lowering effect was associated with a clear improvement of end-organ failure within 60 minutes . There were no side effects , including a dangerous fall in blood pressure or reflex tachycardia . Sublingual nifedipine lowered diastolic blood pressure and systolic blood pressure in eight of 10 patients . The hypotensive effect of nifedipine was more rapid than that of captopril ( 10 vs 20 minutes for diastolic blood pressure and 20 vs 30 minutes for systolic blood pressure , respectively ) , but no difference was observed in the time or in the magnitude of peak hypotensive effect between the two treatments , nor was a difference observed in the duration of hypotensive effect . In six of eight responders to nifedipine therapy , a clear improvement of symptoms and signs of end-organ failure was observed within 60 minutes . In three patients , minor side effects were observed . We conclude that sublingual captopril effectively and safely lowers arterial blood pressure in patients with hypertensive emergencies",
"BACKGROUND Converting enzyme inhibitors meet most of the criteria required to be used in acute pulmonary edema . However , they could also induce deleterious effects on renal function and electrolytes . The purpose of this study was to evaluate the efficacy and safety of a single intravenous 2-hour infusion of enalaprilat ( 1 mg ) after an acute pulmonary edema . METHODS AND RESULTS This was a placebo-controlled , r and omized , double-blind study performed in 20 congestive heart failure patients ( New York Heart Association class III or IV ) . Systemic and regional hemodynamic parameters , biological parameters , and blood gases were measured before and repeatedly after the onset of infusion . Compared with placebo , enalaprilat decreased pulmonary capillary wedge pressure ( -37 % versus -10 % , P = .001 ) , diastolic and mean systemic blood pressures ( -21 % versus 0 % , P = .009 , and -18 % versus -1 % , P = .026 , respectively ) , diastolic and mean pulmonary blood pressures ( -21 % versus -8 % , P = .040 ; -18 % versus -9 % , P = .046 ) , and brachial and renal resistances ( -44 % versus -14 % , P = .017 , and -22 % versus -2 % , P = .014 , respectively ) ; increased brachial and renal blood flows ( + 77 % versus + 8 % , P = .036 , and + 12 % versus 0 % , P = .043 , respectively ) , arterial oxygen tension ( + 2 % versus -16 % , P = .041 ) , and arterial oxygen saturation ( + 1 % versus -2 % , P = .045 ) ; and tended to decrease rate-pressure product ( -19 % versus -7 % , P = .076 ) , increase brachial artery diameter ( + 13 % versus 0 % , P = .081 ) , and improve intrapulmonary shunt ( -18 % versus + 16 % , P = .080 ) . Enalaprilat did not affect cardiac output or carotid or hepatosplanchnic hemodynamics . CONCLUSIONS Early administration of enalaprilat is effective and well tolerated in acute pulmonary edema",
"OBJECTIVE To determine if previously hypertensive patients with acute ischemic stroke should be treated with antihypertensive medication in the immediate poststroke period . DESIGN R and omized double-blind , placebo-controlled trial . SETTING Sixteen consecutive hypertensive patients ( four men and 12 women ; mean age , 66 years [ age range , 46 to 83 years ] ) with middle cerebral artery infa rct ion within 72 hours of onset and blood pressure between 170 and 220 mm Hg(systolic ) and 95 and 120 mm Hg ( diastolic ) . INTERVENTION Placebo ( n = 6 ) , nicardipine hydrochloride ( 20 mg [ n = 5 ] ) , captopril ( 12.5 mg [ n = 3 ] ) , or clonidine hydrochloride ( 0.1 mg [ n = 2 ] ) given every 8 hours for 3 days . MAIN OUTCOME MEASURES Decline in blood pressure , change in cerebral blood flow as measured by single photon emission computed tomography , and clinical change as determined by the National Institutes of Health Stroke Scale . RESULTS Blood pressure fell significantly in both the drug-treated group as a whole and in those patients receiving placebo ( P blood pressure levels between these two groups throughout the study period . Patients receiving nicardipine had a consistently lower pressure than the other groups . A significant negative relationship was noted between the maximum blood pressure fall and improvement in cerebral blood flow . There were four patients whose blood pressure dropped by more than 16 % of the baseline value on any 24 hours in the first 3 days . All either failed to increase or actually decreased their cerebral blood flow to the affected area . Three of these patients were treated with nicardipine . There was no significant difference in clinical course between the placebo- and drug-treated groups as a whole . CONCLUSIONS Hypertensive ischemic stroke patients with a moderate elevation of blood pressure in the first few days may not require antihypertensive therapy . Nicardipine and possibly other calcium channel blockers may cause an excessive fall in blood pressure and impair cerebral blood flow in these patients and should therefore be used with caution",
"This prospect i ve study compared the efficacy of nicardipine and nitroprusside for treating hypertensive emergencies by measuring haemodynamic indices and serum catecholamine levels . Patients admitted to the emergency department with a hypertensive crisis and acute pulmonary oedema received intravenous infusions of nitroprusside ( starting dose 1 μg/kg per min , n = 20 ) or nicardipine ( starting dose 3 μg/kg per min , n = 20 ) . Both groups experienced significant declines in systolic and diastolic blood pressure after treatment , but there were no significant time-dependent differences between the groups . Heart rate decreased in the nicardipine group and increased in the nitroprusside group , but neither change was significant . Respiration rate decreased and capillary oxygen saturation rate increased after treatment in both groups . Adrenaline and noradrenaline levels decreased significantly after treatment in both groups ; noradrenaline levels were significantly decreased in the nicardipine-treated group compared with the nitroprusside-treated group . Injectable nicardipine is easy to use and as effective as nitroprusside for treating hypertensive crisis with acute pulmonary oedema",
"Objective To present the efficacy and tolerability of a new oral dosage form of the calcium antagonist nitrendipine compared to nifedipine capsules in patients with hypertensive emergency . Design Multicenter r and omized double blind clinical study . Setting 23 study centres ( hospitals ) in Germany . Patients 161 patients between 20 and 70 years with acutely elevated blood pressure ( systolic 200–250 mmHg , diastolic between 110–140 mmHg ) with and without concomitant clinical symptoms . Interventions Double blind treatment with 10 mg nifedipine or 5 mg nitrendipine . Nifedipine was administered as capsules , nitrendipine was given from a small plastic tube ( vial ) , containing 1 ml alcoholic solution . Every patient received in addition to the test medication a placebo corresponding to the other product . Patients with insufficient treatment after 45 min were given either an additional capsule of 10 mg nifedipine or a further vial containing 5 mg nitrendipine according to their group and maintaining the double dummy procedure . Measurements and results Blood pressure and heart rate were measured repeatedly during 4 h , before and 90 min after beginning of the treatment a 12 channel resting ECG was recorded . At 45 min after administration the blood pressure had fallen significantly from 216.0/117.4 mmHg to 170.0/93.3 mmHg under nifedipine and from 216.9/117.3 mmHg to 177.4/94.4 mmHg under nitrendipine . 61.6 % of the nifedipine patients and 58.8 % of the nitrendipine patients had already reached blood pressure values h. Tolerability was very good in both groups . Conclusion The new dosage form of nitrendipine ( vial with 1 ml of alcoholic solution ) represents an alternative in the treatment of hypertensive emergency",
"In an open-label study , we compared the efficacy and safety of intravenous infusion of fenoldopam mesylate with that of sodium nitroprusside in patients with severe hypertension or in hypertensive crisis . Both antihypertensive medications were infused at a maximal dose increment of 0.2 /ig/kg/min ( fenoldopam ) and 1 jtg/kg/min ( nitroprusside ) , with a maximal infusion rate of 1.5 /ig/kg/min fenoldopam mesylate or 8 //.g/kg/min sodium nitroprusside . Once the desired reduction in diastolic blood pressure was achieved ( less than 110 mm Hg if initial diastolic blood pressure was 120–149 mm Hg , or by at least 40 mm Hg if initial diastolic blood pressure was 150–190 mm Hg ) , the maximal infusion rate used was maintained for at least 1 hour , and then , the infusion was slowed gradually over 2 hours . After the infusion treatment , patients remained in the hospital for 2 days of follow-up . Both antihypertensive agents successfully controlled the blood pressure in all the patients by the end of the maintenance periods . Between the baseline and the end of the maintenance period , analysis of variance showed that the changes in the variables induced by fenoldopam mesylate did not differ significantly from those induced by sodium nitroprusside . The incidence of side effects listed were similar in both groups of patients . The detection of toxic levels of thiocyanate in two patients treated with nitroprusside , however , shows that fenoldopam might be preferable for the control of a hypertensive crisis or severe hypertension in patients with decreased renal function",
"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",
"Emergency treatment of acute , severe hypertension defined as diastolic blood pressure ( DBP ) greater than or equal to 135 mmHg combined with cerebral symptoms was prospect ively monitored in a r and omized multicenter study including 64 patients . Treatment was divided into two periods . In the first hour the patients were observed in the supine position after being given 40 mg furosemide intravenously . If DBP remained greater than 125 mmHg ( n = 52 ) , the patients were put on fractionated diazoxide administered intravenously ( n = 28 ) or dihydralazine administered intramuscularly ( n = 24 ) . Blood pressure ( BP ) decreased with diazoxide from an average of 241/149 mmHg to 180/111 mmHg after 5 hours and with dihydralazine from 237/149 to 161/101 mmHg . The inter-individual BP response varied considerably . A clear and identical regression in neurological symptoms was observed on both drug regimens . No new neurological symptoms were seen to develop . It is concluded that a gradual fall in BP can be obtained after fractionated dosage of diazoxide ( i.v . ) as well as after dihydralazine ( i.m . ) . The indication of acute parenteral therapy compared to less aggressive oral treatment is discussed",
"Aim of the study was to assess the effectiveness and tolerability of sublingual captopril ( SLC ) versus sublingual nifedipine ( SLN ) in treating hypertensive emergencies . During hypertensive crises ( systolic blood pressure exceeding 200 mmHg and diastolic blood pressure exceeding 115 mmHg ) forty hypertensive patients received either 25 mg of SLC or 10 mg of SLN in a r and omized single blind fashion . Blood pressure and heart rate were then controlled after 5 , 10 , 15 , 20 , 30 , 45 , 60 , 120 min . and , in 18 cases , up to the 8th hour from the administration . Our results showed : 1 ) a satisfactory control of the hypertensive crises in 80 % of patients treated with SLC with a significant blood pressure reduction after 10 min . ( 13/8 mmHg , p less than 0.02 ) , while the maximum hypotensive effect was achieved after 30 min . ( 52/36 mmHg , p less than 0.001 ) ; SLN was able to reduce blood pressure in 90 % of all the cases , with a significant reduction after 5 min . ( 15/11 mmHg , p less than 0.02 ) and hypotensive peak after 20 min ( 57/38 mmHg , p greater than 0.001 ) ; 2 ) no significant differences for hypotensive effectiveness between the two groups , but with SLC having a mildly delayed onset of action when compared to SLN ; 3 ) antihypertensive effect lasting for about 6 hours in patients treated with SLC and blood pressure progressively raising after 4 hours in patients who received SLN ; 4 ) a significant correlation between blood pressure reduction and blood pressure before drug administration in both groups ; a significant correlation between pretreatment PRA and antihypertensive effect in the SLC group . We conclude that both drugs are effective and useful in treating hypertensive emergencies . Anyway we think that in severe forms SLN should be preferred for the shorter time preceding onset of action",
"& 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",
"The aim of our studies was to evaluate the effect of acute treatment in hypertensive emergencies and of chronic and acute treatment in uncomplicated hypertensives with calcium antagonists on blood pressure ( BP ) and cerebral blood flow ( CBF ) . Ten patients with high blood pressure requiring emergency reduction were r and omized to treatment with oral nifedipine or intravenous clonidine . The effect on CBF was investigated using xenon-133 . Twenty-one patients with mild to moderate hypertension were r and omly assigned to nitrendipine ( n = 10 ) and to verapamil treatment for 4 weeks . After 14 days of washout , all patients received chlorthalidone for 4 weeks . CBF was measured before calcium antagonists , after 4 weeks , after washout , and after 4 weeks of chlorthalidone . Until now , five patients with mild to moderate hypertension entered in an ongoing study . After 14 days of placebo , CBF and BP reduction were measured 2 h and 6 weeks after nitrendipine . In hypertensive emergencies , nifedipine and clonidine lowered BP significantly , whereas CBF increased after nifedipine and decreased after clonidine . After chronic treatment with nitrendipine and verapamil and after chlorthalidone , the BP-lowering effect was significant whereas CBF remained unchanged . Two hours after nitrendipine , BP decreased and CBF remained unchanged . The reason for increasing CBF in hypertensive emergencies after nifedipine is due to its spasmolytic effect on cerebral vessels . The unchanged CBF after short- and long-term treatment with nitrendipine is due to the fact that in these patients the autoregulatory mechanism is intact",
"The effects and safety of using oral nifedipine 10 - 20 mg as acute antihypertensive treatment were studied in a single-blind placebo-controlled study of 25 consecutive patients with very high blood pressure requiring emergency reduction . In addition the effect of this treatment on cerebral blood flow was investigated using xenon-133 in 10 patients r and omly allocated to receive oral nifedipine or intravenous clonidine . Whereas placebo did not alter the blood pressure , oral nifedipine significantly reduced the systolic and diastolic blood pressures in all 25 patients ( from 221 + /- 22/126 + /- 14 mm Hg to 152 + /- 20/89 + /- 12 mm Hg after 30 minutes , p less than 0.001 ) . Heart rate increased from 74 + /- 11 to 84 + /- 11 beats/minute ( p less than 0.01 ) ; this effect was inversely related to age ( r = -0.65 , p less than 0.01 ) . The falls in systolic and diastolic blood pressures were closely related to the blood pressures before treatment ) r = 0.67 , p less than 0.001 for systolic , and r = -0.58 , p less than 0.01 for diastolic values ) . No serious unwanted effects were observed . Measurement of cerebral blood flow after nifedipine showed an increase in flow in four out of five patients . Clonidine , by contrast , reduced cerebral blood flow in all patients by up to 28 % . Nifedipine is a simple , effective , and safe alternative drug for managing hypertensive emergencies , especially when continuous monitoring of the patient can not be guaranteed",
"Background : Nitric oxide donors have been used in the management of hypertensive emergencies ( HE ) . Isosorbide dinitrate aerosol ( ISA ) is a nitric oxide fast-acting donor . The aim of this study is to compare the efficacy of ISA and nifedipine in the treatment of HE . Methods : Sixty adult patients with an HE were r and omised to receive either ISA ( 2.5 mg ) or nifedipine ( 10 mg ) . Patients were given an electrocardiogram ( ECG ) immediately prior , and 30 min after administering the medication . Blood pressure ( BP ) was measured every 5 min for the first 30 min , and then every 30 min for a period of 6 h. Results : Blood pressure values for all patients in the ISA group decreased significantly ( 187 ± 13/121 ± 6 to 153 ± 15/92.3 ± 7.6 mm Hg , P angor pectoris with evidence of subepicardial ischaemia as seen in the first ecg , both of which disappeared with the drug . heart rate decreased by 14 % similarly , all patients in the nifedipine group had significant decreases in bp ( 190 ± 23/115 ± 7 to 153 ± 26/86 ± 6 mm hg , P first ecg was normal . two patients suffered angor pectoris after nifedipine , with subepicardial ischaemia registering in the second ecg . heart rate increased 11.9 % in this group . during the follow-up period , no clinical ly significant side effects or cases of rebound hypertension were observed in the isa group , whereas in the nifedipine group , eight patients reported having headaches and four others rebound hypertension . Conclusion : Our results show a favourable effect of ISA in the treatment of HE",
"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",
"Objective : To assess the safety and efficacy of urapidil compared to sodium nitroprusside in the treatment of hypertensive emergencies . Design : r and omized , prospect i ve clinical study . Setting : Emergency department in a 2000-bed inner city hospital . Patients : Eighty-one patients with hypertensive emergencies defined as elevation of systolic blood pressure above 200 mmHg and /or diastolic blood pressure above 110 mmHg plus evidence of end-organ damage were included in the study protocol . The efficacy of therapy was defined as 1 ) blood pressure reduction below 180/95 mmHg within 90 min and 2 ) no re-elevation of blood pressure during a 4-h follow-up period in primary responders . The safety of both drugs was defined as the number of minor and major side effects during treatment . Interventions : Patients received either sodium nitroprusside ( n = 35 ; continuous intravenous administration with a starting dose of 0.5 μg/kg per min ; increase in increments of 0.5 μg/kg per min every 15 min until response to treatment or a maximum of 3 μg/kg per min ) or urapidil ( n = 46 ; intravenous bolus ; starting dose : 12.5 mg ; repetitive administration of 12.5 mg every 15 min until response or a maximum dose of 75 mg ) . Measurements and results : Blood pressure was measured every 2.5 min by using a non-invasive oscillometric blood pressure measurement unit . Response to treatment within 90 min was observed in 75 ( 93 % ) patients ( urapidil : n = 41 [ 89 % ] ; nitroprusside : n = 34 [ 97 % ] ; p = 0.18 ) . During the follow-up period 8/34 ( 24 % ) patients in the nitroprusside group and 1/41 ( 2 % ) patients in the urapidil group exhibited blood pressure re-elevation . Major side effects were observed in seven patients receiving nitroprusside and two patients in the urapidil group ( p = 0.04 ) . Conclusion : Urapidil is equally effective , compared to sodium nitroprusside , in the treatment of hypertensive emergencies . Due to a smaller number of adverse events , urapidil is a reasonable alternative to nitroprusside in the treatment of hypertensive emergencies",
"OBJECTIVE To test the hypothesis that sublingual captopril produces a more rapid improvement of acute pulmonary edema ( APE ) than does placebo , when added to a st and ard regimen of O2 , nitrates , morphine , and furosemide . METHODS Prospect i ve , r and omized , double-blind , placebo-controlled clinical trial in an urban teaching hospital ED . Adults brought to the ED with APE were given captopril or placebo sublingually . Every 5 minutes a clinical APE distress score ( APEX ) was obtained . RESULTS Over the first 40 minutes of treatment , the mean APEXs were significantly better for the patients given captopril [ p captopril had a mean APEX improvement of 43 % ( i.e. , to 57 % of initial distress ) ; the group given the current st and ard regimen plus placebo improved only 25 % ( i.e. , to 75 % of initial distress ; p = 0.03 , multiway ANOVA ) . In addition , there was less respiratory failure necessitating mechanical ventilation in the captopril patients ( 9 % ) vs the placebo patients ( 20 % ) , which did not achieve significance ( p = 0.10 , Fisher 's exact test ) . CONCLUSION In APE , the addition of sublingual captopril to the st and ard regimen of O2 , nitrates , morphine , and furosemide produces more rapid clinical improvement than does the st and ard regimen alone",
"In a prospect ively design ed r and omized study , we compared the efficacy of sublingual nitroglycerine and intravenous enalaprilat in the out-of-hospital treatment of 46 hypertensive patients with pulmonary edema ( defined as rales over both lungs and systolic blood pressure > 200 mm Hg and diastolic blood pressure > 100 mg ) . The out-of-hospital treatment consists of oxygen ( 6 Ll/min ) via a face mask , furosemide 80 mg i.v . , opioids 10 mg s.c . , and either sublingual nitroglycerine ( n = 23 ; initial dose : 0.8 mg ; repetitive application of 0.8 mg every 10 min until a cumulative dose of 3.2 mg ) or intravenous enalaprilat ( initial dose : 2.5 mg ; repetitive application of 2.5 mg every 30 min until a cumulative dose of 10 mg ) . The aim of the antihypertensive treatment was a reduction of systolic blood pressure below 160 mm Hg and diastolic blood pressure below 90 mm Hg until admission to the emergency department . In the emergency room , an arterial and venous blood sample was taken to determine the respiratory ( pO2 , pCO2 ) and metabolic status ( pH value ; base-excess ; serum lactate ) of the patient . Successful antihypertensive treatment was observed in 13/23 ( 57 % ) patients of the enalaprilat group and 15/23 ( 65 % ) patients of the nitroglycerine group ( p = 0.54 ) . Systolic and diastolic blood pressure on admission were similar in both treatment groups ( systolic RR : enalaprilat : 179 [ 31 ] mm Hg ; nitroglycerine : 184 [ 38 ] mm Hg ; p = 0.59 ; diastolic RR : enalaprilat : 96 [ 14 ] mm Hg ; nitroglycerine : 101 [ 14 ] mm Hg ; p = 0.12 ) . No significant differences were observed between the enalaprilat and the nitroglycerine groups concerning respiratory and metabolic parameters on admission ( pO2 : 67 [ 15 ] vs. 64 [ 17 ] mm Hg ; p = 0.50 ; pCO2 : 46 [ 9 ] vs. 47 [ 13 ] ; p = 0.75 ; pH value : 7.27 [ 0.12 ] vs. 7.27 [ 0.09 ] ; p = 0.98 ; BE : -4.2 [ 3.7 ] vs. -5.7 [ 4.1 ] ; p = 0.23 ; lactate : 4.2 [ 3.3 ] vs. 4.2 [ 2.7 ] ; p = 0.98 ) . Intravenous enalaprilat did not exhibit any advantage compared to nitroglycerine in terms of blood pressure reduction or respiratory and metabolic parameters on admission to the emergency room . We conclude that enalaprilat is no substitute for nitroglycerine in the out-of-hospital treatment of hypertensive patients with pulmonary edema",
"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",
"The immediate haemodynamic effects of intravenous frusemide ( 1 mg/kg ) and intravenous isosorbide dinitrate ( 50 - 200 micrograms/kg/h ) were compared in a prospect i ve , r and omised , between-group study in 28 men with radiographic and haemodynamic evidence of left ventricular failure following acute myocardial infa rct ion . The diuresis induced by frusemide reduced the left heart filling pressure and cardiac output and transiently raised systemic blood-pressure . In contrast , isosorbide dinitrate was accompanied by a reduction in systemic blood-pressure and peripheral resistance with the result that the cardiac output was not decreased despite a large fall in the pulmonary vascular and left heart filling pressures . These results indicate that reduction of excessive preload by venodilatation may be haemodynamically superior to that induced by diuresis in terms of both reducing myocardial oxygen consumption and maintaining peripheral perfusion . The influence of these contrasting treatments on the prognosis of these high-risk patients warrants further study",
"BACKGROUND Nitrates are superior to furosemide in the management of acute pulmonary edema associated with myocardial infa rct ion ; however , their role in the absence of infa rct ion is unclear . METHODS AND RESULTS A r and omized comparison was undertaken of the relative effectiveness of primary therapy with either intravenous morphine/furosemide ( men/women ; n = 32 ) or nitroglycerin/N-acetylcysteine ( NTG/NAC ; n = 37 ) in consecutive patients with acute pulmonary edema . The primary end point was change in PaO2/FIO2 over the first 60 minutes of therapy . Secondary end points were needed for mechanical respiratory assistance ( ie , continuous positive airway pressure via mask or intubation and ventilation ) and changes in other gas exchange parameters . Both treatment groups showed improvement in oxygenation after 60 minutes of therapy ; however , this reached statistical significance only with NTG/NAC therapy . There was no significant difference between groups in the assessed parameters ( 95 % CI for differences in Pao2/FIO2 : furosemide/morphine -12 to 23 and NTG/NAC 4 to 44 ) , a finding also confirmed in 32 patients presenting with respiratory failure . Only 11 % of the study group required mechanical ventilatory assistance ( continuous positive airway pressure in 4 patients and intubation and ventilation in 3 patients ) . CONCLUSIONS NTG/NAC therapy is as effective as furosemide/morphine in the initial management of acute pulmonary edema , regardless of the presence or absence of respiratory failure . The necessity for mechanical ventilatory assistance is infrequent in these patients , regardless of the initial medical treatment regimen",
"A prospect i ve r and omised trial compared the immediate haemodynamic effects of intravenous diuretic ( frusemide ) , venodilator ( isosorbide dinitrate ) . arteriolar dilator ( hydralazine ) , and positive inotropie stimulation ( prenalterol ) as first-line therapy for acute left ventricular ( LV ) failure following myocardial infa rct ion . Forty-eight patients with transmural myocardial infa rct ion and a pulmonary artery occluded pressure ( PAOP ) of > 20 mm Hg were studied within 18 h of admission to a coronary care unit . Both frusemide ( -4 mm Hg : p isosorbide dinitrate ( -6 mm Hg : p reduced LV filling pressure without change in cardiac index and heart rate . Although both hydralazine and prenalterol increased cardiac index ( p in LV filling pressure ( -2 mm Hg : p with frusemide and isosorbide dinitrate . and was associated with an increased heart rate ( + 8 and + 13 beats min−1 : p ( isosorbide dinitrate ) — decrease of LV pressure/work : ( b ) diuretic therapy (frusemide)— decrease of LV pressure/work offset by a transient pressor effect : ( c ) arteriolar dilatation ( hydralazine ) —decrease of LV pressure/work and of PAOP . but offset by tachycardia : and ( d ) positive inotropic therapy ( β1-agonist prenalterol ) — tachycardia and augmented LV afterload . Combination of the former and latter agents , because of their differing modes of action , should offer haemodynamic advantages over monotherapy and deserves further evaluation",
"Thirty-three patients with severe systemic hypertension defined as a diastolic blood pressure ( DBP ) > or = 120 mm Hg were r and omized in a single-blind fashion to be treated with either intravenous fenoldopam mesylate ( FNP ) or sodium nitroprusside ( NTP ) . Fenoldopam mesylate and NTP infusion rates began at 0.1 microgram/kg/minute and 0.5 microgram/kg/minute , respectively and were titrated to achieve a goal DBP of between 95 and 110 mm Hg ; or a reduction of at least 40 mm Hg if the baseline DBP was > 150 mm Hg . Fenoldopam mesylate ( n = 15 ) reduced blood pressure from 217/145 + /- 6/5 to 187/112 + /- 6/3 mm Hg ( P goal DBP with FNP was 1.5 + /- 1.4 hours . Nitroprusside ( n = 18 ) reduced blood pressure from 210/136 + /- 5/2 to 172/103 + /- 6/2 mm Hg ( P Nitroprusside response time averaged 2 + /- 2.5 hours . There was no significant difference between the magnitude of effect seen with either FNP or NTP ; nor was there any difference observed in the adverse effect rates of the two agents . Fenoldopam mesylate and NTP demonstrate similar overall efficacy in the treatment of severe systemic hypertension",
". Emergency treatment of acute , severe hypertension was monitored prospect ively during a period of nine months in a Danish multicenter trial . A total of 101 patients with supine diastolic blood pressures ( DBP ) , phase V , ≥135 mmHg in three measurements at 5 min intervals entered the study . The emergency treatment was divided into three periods . In period I , lasting for the first hour , the patient was placed in the supine position and no drug treatment was given . If DBP did not fall below 135 mmHg , the patient entered period II , during which furosemide , 80 mg i.v . , was given and observation continued for another hour . Patients with pronounced hypertensive encephalopathy ( n = 15 ) and left venticular heart failure ( n = 2 ) started directly at period II . Provided DBP thereafter was still 135 mmHg or higher , the patients were r and omized in period III ( 2nd-5th hour ) to treatment with either chlorpromazine or dihydralazine in small refractory i.v . doses or diazoxide , 5 mg/kg b.wt . i.v . , as a bolus injection . In period I , DBP fell below our “ emergency limit ” of 135 mmHg in 23 ( 27 % ) of 84 patients whose mean arterial BP fell from 171 to 140 mmHg during the study . In period II , DBP fell below 135 mmHg in 23 ( 30 % ) of 78 patients and their mean arterial BP decreased from 174 to 135 mmHg during the study . In period III , 24 patients were treated with chlorpromazine , 16 with dihydralazine and 15 with diazoxide . In patients treated with chlorpromazine or dihydralazine , BP decreased gradually during the first hour , on average from 211/146 to 155/103 and from 219/147 to 162/89 mmHg , respectively . After diazoxide BP decreased abruptly in the first two minutes , on average from 211/144 to 166/100 mmHg . The complication rate was generally low and only a few patients were resistant to any of the treatments given . The study was not able to demonstrate that diazoxide is preferable to the other two drugs in emergency treatment",
"BACKGROUND Corticosteroids have been used to treat head injuries for more than 30 years . In 1997 , findings of a systematic review suggested that these drugs reduce risk of death by 1 - 2 % . The CRASH trial -- a multicentre international collaboration-- aim ed to confirm or refute such an effect by recruiting 20000 patients . In May , 2004 , the data monitoring committee disclosed the unmasked results to the steering committee , which stopped recruitment . METHODS 10008 adults with head injury and a Glasgow coma score ( GCS ) of 14 or less within 8 h of injury were r and omly allocated 48 h infusion of corticosteroids ( methylprednisolone ) or placebo . Primary outcomes were death within 2 weeks of injury and death or disability at 6 months . Prespecified subgroup analyses were based on injury severity ( GCS ) at r and omisation and on time from injury to r and omisation . Analysis was by intention to treat . Effects on outcomes within 2 weeks of r and omisation are presented in this report . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N74459797 . FINDINGS Compared with placebo , the risk of death from all causes within 2 weeks was higher in the group allocated corticosteroids ( 1052 [ 21.1 % ] vs 893 [ 17.9 % ] deaths ; relative risk 1.18 [ 95 % CI 1.09 - 1.27 ] ; p=0.0001 ) . The relative increase in deaths due to corticosteroids did not differ by injury severity ( p=0.22 ) or time since injury ( p=0.05 ) . INTERPRETATION Our results show there is no reduction in mortality with methylprednisolone in the 2 weeks after head injury . The cause of the rise in risk of death within 2 weeks is unclear",
"Hypertensive emergencies , and to a certain extent their treatment , contribute to morbidity and mortality in elderly patients . We studied 22 hospitalized patients , aged 70 - 90 years , all of whom had moderate essential hypertensive . During acute hypertension , mean systolic and diastolic blood pressure rose to 230 + /- 24 and 120 + /- 22 mmHg , respectively . Symptoms of reduced tissue perfusion/oxygenation and /or organ failure occurred , forcing us to begin antihypertensive therapy . We administered 50 mg of the angiotensin converting enzyme ( ACE ) inhibitor captopril sublingually , and within 15 min , systolic blood pressure decreased by an average 60 + /- 16 mmHg and diastolic blood pressure by an average 25 + /- 14 mmHg . There was no significant change in the heart rate . In addition , we treated 22 comparable patients with 10 mg nifedipine sublingually and observed , in four cases , a greater fall in blood pressure ( up to 90 mmHg ) together with tachycardia . These results show the beneficial effects of captopril in the treatment of hypertensive emergencies in elderly patients . The absence of dangerous side effects indicates that ACE inhibitors can be used as first-choice drugs for the treatment of acute hypertensive crises , even in old age",
"BACKGROUND Nitrates and furosemide , commonly administered in the treatment of pulmonary oedema , have not been compared in a prospect i ve clinical trial . We compared the efficacy and safety of these drugs in a r and omised trial of patients with severe pulmonary oedema and oxygen saturation below 90 % . METHODS Patients presenting to mobile emergency units with signs of congestive heart failure were treated with oxygen 10 L/min , intravenous furosemide 40 mg , and morphine 3 mg bolus . 110 patients were r and omly assigned either to group A , who received isosorbide dinitrate ( 3 mg bolus administered intravenously every 5 min ; n=56 ) or to group B , who received furosemide ( 80 mg bolus administered intravenously every 15 min , as well as isosorbide dinitrate 1 mg/h , increased every 10 min by 1 mg/h ; n=54 ) . Six patients were withdrawn on the basis of chest radiography results . Treatment was continued until oxygen saturation was above 96 % or mean arterial blood pressure had decreased by 30 % or to below 90 mm Hg . The main endpoints were death , need for mechanical ventilation , and myocardial infa rct ion . The analyses were by intention to treat . FINDINGS Mechanical ventilation was required in seven ( 13 % ) of 52 group-A patients and 21 ( 40 % ) of 52 group-B patients ( p=0.0041 ) . Myocardial infa rct ion occurred in nine ( 17 % ) and 19 ( 37 % ) patients , respectively ( p=0.047 ) . One patient in group A and three in group B died ( p=0.61 ) . One or more of these endpoints occurred in 13 ( 25 % ) and 24 ( 46 % ) patients , respectively ( p=0.041 ) . INTERPRETATION High-dose isosorbide dinitrate , given as repeated intravenous boluses after low-dose intravenous furosemide , is safe and effective in controlling severe pulmonary oedema . This treatment regimen is more effective than high-dose furosemide with low-dose isosorbide nitrate in terms of need for mechanical ventilation and frequency of myocardial infa rct ion",
" Forty patients with hypertensive crises , whose pressure levels had not satisfactorily decreased after intravenous furosemide 20 mg , were selected in the Emergency Ward . These patients were divided in two groups . The ones in group A received sublingual nifedipine 10 mg and the others in group B received oral captopril 50 mg . These drugs were repeated after 30 minutes to the maximum of three doses or until obtaining diastolic blood pressure less than 115 mmHg . Most patients ( 77.5 % ) had their blood pressure reduced to the proposed values after the first dose , and the remaining ones ( 22.5 % ) reacted to the therapy only after the administration of the subsequent doses . No side effects were observed . All patients were discharged from the emergency unit and were sent for follow-up in the outpatient service . The use of nifedipine and captopril has proved to be an effective treatment for hypertensive crises",
"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",
"Cerebral symptoms were registered in a multicenter study including 64 patients with severe hypertension , diastolic blood pressure ( DBP ) greater than or equal to 135 mmHg , and more or less pronounced hypertensive encephalopathy . The symptoms were : headache ( 70 % ) , dizziness ( 35 % ) , consciousness disturbances ( 28 % ) , nausea ( 27 % ) , paresis ( 23 % ) , blurred vision ( 22 % ) , paraesthesia ( 21 % ) and vomiting ( 14 % ) . None had convulsions or coma . Initial treatment was furosemide i.v . , and if DBP was greater than or equal to 125 mmHg after one hour , patients were r and omized to treatment with either i.v . diazoxide ( bolus injections of 75 - 150 mg ) or i.m . dihydralazine ( bolus injections of 6 - 12.5 mg ) . A gradual fall in blood pressure ( BP ) was obtained in all three groups . Along with BP reduction a substantial regression of neurological symptoms was registered . After 5 hours only minor cerebral symptoms were present without significant difference between diazoxide and dihydralazine . None developed cerebral complications . The study failed to show a significant correlation between BP reduction and regression of neurological symptoms grade d semiquantitatively . Reduction of BP by titration using small repeated bolus injections is recommended , but oral treatment should be considered in the patients who are able to ingest peroral medication in spite of neurological symptoms",
"OBJECTIVE To compare the safeties and efficacies of IV fenoldopam ( FNP ) vs sodium nitroprusside ( NTP ) in severe acute hypertension . METHODS A prospect i ve , r and omized , open-label , multicenter international trial , at 24 academic medical centers , was conducted . The participants were adult patients ( 21 - 80 years of age ) who had supine diastolic blood pressures ( DBPs ) > or = 120 mm Hg , were capable of written informed consent , and did not have selected exclusion criteria . The subjects were r and omized to either FNP or NTP therapy ; DBP was titrated to 95 - 110 mm Hg , or a maximum reduction of 40 mm Hg for very high pressures . Infusions were maintained for at least six hours , then the patients were weaned off the IV therapy and oral medication was started . Measurements included BP , heart rate , and duration of study drug infusion and frequency of side effects or complications . RESULTS A total of 183 patients ( 90 FNP , 93 NTP ) were enrolled . Fifteen patients from each arm were excluded from efficacy analysis due to protocol violation . There was no significant difference in baseline characteristics . The two antihypertensive agents were equivalent in controlling and maintaining DBP . Systolic blood pressure ( SBP ) was reduced to a slightly greater degree for the NTP-treated patients during the initial ( 0.5 - 1-hr ) study period , and both SBP and DBP were reduced more for the FNP-treated patients in the subset receiving infusions during the 12 - 24-hour period . The adverse effect profiles of the drugs were similar , as were the times to achieve target pressure , with no clinical ly relevant difference . CONCLUSIONS For patients who had acute severe hypertension , FNP and NTP were equivalent in terms of efficacy and acute adverse events . Because of a unique mechanism of action , FNP may have advantages in selected subsets of patients . Further studies may be indicated in patient population s with pure \" hypertensive emergencies . ",
"A positive history of arterial hypertension ( HBP ) is present in as many as 30 % of patients with acute myocardial infa rct ion ( AMI ) and their clinical outcome could be greatly improved by drugs enhancing blood pressure control and preserving ventricular function . The aim of the present study was to evaluate the importance of a history of HBP on the clinical efficacy of early treatment with the angiotensin-converting enzyme ( ACE ) inhibitor zofenopril in patients with anterior AMI . We summarize the results of a post-hoc analysis of data from the Survival of Myocardial Infa rct ion Long-term Evaluation ( SMILE ) study , which r and omly evaluated the efficacy of zofenopril given within 24 h of symptom onset to patients with anterior AMI not undergoing thrombolysis . Of 1441 patients who entered the study , 565 ( 39.2 % ) had a history of HBP . The mean follow-up time was 12 months and the main outcome measures were 6-week combined occurrence of death and severe congestive heart failure ( CHF ) and 1-year mortality . After 6-week of treatment with zofenopril the relative risk of death or severe CHF was 0.60 ( 95 % confidence interval [ CI ] : 0.45 - 0.81 ; 2P 1-year risk of death was 0.61 ( 95 % CI : 0.23,0.89 ; 2P mild-to-moderate CHF was also significantly reduced by zofenopril in the hypertensive population ( 14.1 % v 9.4 % ; 2P zofenopril started within 24 h of the onset of anterior AMI could be highly beneficial in patients with a history of HBP",
"Hypertensive emergencies in hemodialysis require immediate therapy , usually by parenteral drug administration ; however , sublingual medications may have potential in this special condition . Sublingual captopril ( 25 mg ) , nifedipine ( 10 mg ) and prazosin ( 2 mg ) were prescribed to determine the effectiveness and safety of each medication in the treatment of hypertensive emergencies during hemodialysis . Blood pressure and heart rate were measured continuously up to 120 min postdose . The response rates were 83 % for captopril , 90 % for nifedipine and 11 % for prazosin . The significant hypotensive effects of both sublingual captopril and nifedipine occurred at 10 min and continued up to 120 min . The reduction of systolic blood pressure occurred earlier in nifedipine than captopril ( 10 vs. 15 min ) . No significant difference in heart rate between them was noted . There were no side effects in the captopril group but flushing , tachycardia and headache were observed in 4 patients of the nifedipine group . We concluded that sublingual captopril and nifedipine were effective but captopril seemed to have less side effects than nifedipine and may be an excellent alternative to sublingual nifedipine in the urgent treatment of hypertensive emergencies in hemodialysis . Prazosin was not recommended because of its low response rate",
"The primary objective of this study was to compare the antihypertensive efficacy and safety of intravenously administered nicardipine with that of intravenous nitroprusside ( SNP ) in patients with severe hypertension . The study was conducted in 121 patients with severe hypertension ( diastolic blood pressure [ BP ] > 120 mm Hg , or systolic BP > 200 mm Hg ) . Patients were r and omized to receive intravenous nicardipine or SNP . Drugs were administered according to a predetermined dosing schedule for a 10 to 12 h period . Sixty-one patients were r and omized to intravenous nicardipine and 60 to SNP . Pretreatment BP values for the nicardipine and SNP groups were 217/128 mm Hg and 219/128 mm Hg , respectively . Therapeutic response ( diastolic BP 15 mm Hg ; systolic BP 20 mm Hg ) was achieved in 98 % ( 60/61 ) of patients treated with nicardipine and 93 % ( 56/60 ) of patients treated with SNP . The mean decreases in systolic and diastolic BP were 61 mm Hg and 40 mm Hg after 4 h of nicardipine , and 59 mm Hg and 38 mm Hg after 4 h of SNP . The mean increases in heart rate also were similar in both groups ( nicardipine , 12 beats/min ; SNP 10 beats/min ) . The mean numbers of dose adjustments per hour required to maintain the BP reductions were lower ( P nicardipine-treated patients ( 0.5 + /- 0.1 times per hour ) than in the SNP-treated patients ( 1.5 + /- 0.2 times per hour ) . ( ABSTRACT TRUNCATED AT 250 WORDS"
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4117e10a-06ff-11f0-808a-c43d1ab1c353
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We conducted a systematic review and meta- analysis of twenty-eight US-based studies applying the findings of the Diabetes Prevention Program , a clinical trial that tested the effects of a lifestyle intervention for people at high risk for diabetes , in real-world setting s. The average weight change at twelve months after the intervention was a loss of about 4 percent from participants ' baseline weight . Change in weight was similar regardless of whether the intervention was delivered by clinical ly trained professionals or lay educators . Additional analyses limited to seventeen studies with a nine-month or greater follow-up assessment showed similar weight change . With every additional lifestyle session attended , weight loss increased by 0.26 percentage point . We conclude that costs associated with diabetes prevention can be lowered without sacrificing effectiveness , using nonmedical personnel and motivating higher attendance at program sessions
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"Weight losses and psychological well-being were examined at 30 months in 69 men and 61 women initially treated with behavior therapy as a function of ( a ) initial weight loss and ( b ) weight-loss goals . Initial weight losses were positively , not negatively , related to weight loss at 30 months . Weight loss goals did not predict short-term or long-term weight loss . People who reached weight goals had better long-term weight losses than those who did not , but this finding was largely due to differences in initial weight loss . Psychological well-being at 30 months was not related to initial weight losses or goals . Although correlational rather than experimental , these results do not support the hypothesis that obese patients should be encouraged to set lower weight-loss goals",
"Purpose The purpose of this article is to describe efforts to develop and administer a formal curriculum to train community workers to deliver a group-based adaptation of the Diabetes Prevention Program ( DPP ) lifestyle intervention in YMCA setting s. The DPP demonstrated that a structured diet and physical activity intervention that achieves and maintains modest weight loss for overweight adults with impaired glucose tolerance can significantly reduce the development of diabetes . Although tens of millions of American adults could benefit from access to the DPP lifestyle intervention , there currently is no available model for nationwide dissemination of this highly beneficial and cost-effective approach to diabetes prevention . A description of 2 ongoing r and omized pilot studies provides information about the feasibility and effectiveness of future efforts to apply this new training curriculum on a national scale . Conclusions Diabetes educators are challenged to partner with community organizations and other health care workers for extensive distribution of the DPP lifestyle intervention messages",
"Prevention of type 2 diabetes by intensive lifestyle intervention design ed to achieve and maintain ideal body weight was assessed in subjects with impaired glucose tolerance ( IGT ) . Male subjects with IGT recruited from health-screening examinees were r and omly assigned in a 4:1 ratio to a st and ard intervention group ( control group ) and intensive intervention group ( intervention group ) . The final numbers of subjects were 356 and 102 , respectively . The subjects in the control group and in the intervention group were advised to maintain body mass index ( BMI ) of 24.0 kg/m2 and of , respectively , by diet and exercise . In the intervention group , detailed instructions on lifestyle were repeated every 3 - 4 months during hospital visits . Diabetes was judged to have developed when two or more consecutive fasting plasma glucose ( FPG ) values exceeded 140 mg/dl . A 100 g oral glucose tolerance test was performed every 6 months to detect improvement of glucose tolerance . The subjects were seen in an ordinary outpatient clinic . The cumulative 4-year incidence of diabetes was 9.3 % in the control group , versus 3.0 % in the intervention group , and the reduction in risk of diabetes was 67.4 % ( P Body weight decreased by 0.39 kg in the control group and by 2.18 kg in the intervention group ( P decrease in body weight . The incidence of diabetes was positively correlated with the changes in body weight , and the improvement in glucose tolerance was negatively correlated . Subjects with higher FPG at baseline developed diabetes at a higher rate than those with lower FPG . Higher 2h plasma glucose values and higher BMI values at baseline were also associated with a higher incidence of diabetes , but the differences were not significant . Subjects with a low insulinogenic index ( DeltaIRI/DeltaPG 30 min after an oral glucose load ) developed diabetes at a significantly higher rate than those with a normal insulinogenic index . Comparison of the BMI data and incidence of diabetes in five diabetes prevention studies by lifestyle intervention revealed a linear correlation between the incidence of diabetes and the BMI values , with the exception of the DaQing Study . However , the slope of the reduction in incidence of diabetes in the intensive intervention groups was steeper than expected simply on the basis of the reduction of BMI , suggesting that the effect of lifestyle intervention can not be solely ascribed to the body weight reduction . We conclude that lifestyle intervention aim ed at achieving ideal body weight in men with IGT is effective and can be conducted in an outpatient clinic setting",
"The diabetes and obesity epidemics are closely intertwined . International r and omized controlled trials demonstrate that , in high-risk individuals , type 2 diabetes can be prevented or at least delayed through lifestyle modification and , to a lesser degree , medication . We explored the relative roles of science , surgery , service delivery , and social policy in preventing diabetes . Although it is clear that there is a role for all , diabetes is a complex problem that dem and s commitment across a range of government and nongovernment agencies to be effectively controlled . Accordingly , we argue that social policy is the key to achieving and sustaining social and physical environments required to achieve widespread reductions in both the incidence and prevalence of diabetes",
"Introduction Although lifestyle interventions are effective in delaying the onset of diabetes , translating these lessons to routine health care setting s remains a challenge . We investigated the effectiveness of a theory-based , brief , small-group weight loss intervention for diabetes prevention . A secondary purpose was to determine the potential reach of the intervention . Methods A total of 14,379 members of an integrated health care organization newly diagnosed with prediabetes were potentially eligible to participate in this matched cohort longitudinal study . Of this group , 1,030 attended a 90-minute , small-group session that targeted personal action planning for healthful eating , physical activity , and weight management . We accessed electronic medical records to select 1 to 2 controls ( matched on impaired fasting glucose measurement , sex , age , and body mass index ) for each member who attended the small-group session ( n = 760 ) . Weight change , as recorded in the medical record , was the primary outcome . Mixed models analyses were used to adjust for matching variables and covariates and to account for individual r and om effects over time . Results Small-group participants lost significantly more weight than did their matched controls . A significantly higher proportion of small-group participants lost at least 5 % of their body weight compared with controls . Conclusion A brief , small-group weight loss intervention was effective . However , it did not reach broadly into the population that was at risk for diabetes",
"CONTEXT Weight loss programs on the Internet appear promising for short-term weight loss but have not been studied for weight loss in individuals at risk of type 2 diabetes ; thus , the longer-term efficacy is unknown . OBJECTIVE To compare the effects of an Internet weight loss program alone vs with the addition of behavioral counseling via e-mail provided for 1 year to individuals at risk of type 2 diabetes . DESIGN , SETTING , AND PARTICIPANTS A single-center r and omized controlled trial conducted from September 2001 to September 2002 in Providence , RI , of 92 overweight adults whose mean ( SD ) age was 48.5 ( 9.4 ) years and body mass index , 33.1 ( 3.8 ) . INTERVENTIONS Participants were r and omized to a basic Internet ( n = 46 ) or to an Internet plus behavioral e-counseling program ( n = 46 ) . Both groups received 1 face-to-face counseling session and the same core Internet programs and were instructed to su bmi t weekly weights . Participants in e-counseling su bmi tted calorie and exercise information and received weekly e-mail behavioral counseling and feedback from a counselor . MAIN OUTCOME MEASURES Measured weight and waist circumference at 0 and 12 months . RESULTS Intent-to-treat analyses showed the behavioral e-counseling group lost more mean ( SD ) weight at 12 months than the basic Internet group ( -4.4 [ 6.2 ] vs -2.0 [ 5.7 ] kg ; P = .04 ) , and had greater decreases in percentage of initial body weight ( 4.8 % vs 2.2 % ; P = .03 ) , body mass index ( -1.6 [ 2.2 ] vs -0.8 [ 2.1 ] ; P = .03 ) , and waist circumference ( -7.2 [ 7.5 ] vs -4.4 [ 5.7 ] cm ; P = .05 ) . CONCLUSION Adding e-mail counseling to a basic Internet weight loss intervention program significantly improved weight loss in adults at risk of diabetes",
"OBJECTIVES Our community-academic partnership employed community-based participatory research to develop and pilot a simple , peer-led intervention to promote weight loss , which can prevent diabetes and eliminate racial/ethnic disparities in incident diabetes among overweight adults with prediabetes . METHODS We recruited overweight adults at community sites , performed oral glucose tolerance testing to identify persons with blood glucose levels in the prediabetes range , and r and omized eligible people to a peer-led lifestyle intervention group or delayed intervention in 1 year . Outcomes , including weight , blood pressure , and health behaviors , were measured at baseline and 3 , 6 , and 12 months . RESULTS More than half of those tested ( 56 % , or 99 of 178 ) had prediabetes and enrolled in the study . Participants were predominantly Spanish-speaking , low-income , undereducated women . The intervention group lost significantly more weight than the control group and maintained weight loss at 12 months ( 7.2 versus 2.4 pounds ; P to diabetes . CONCLUSIONS In underserved minority communities , prediabetes prevalence may be higher than previously reported . Low-cost , community-based interventions can succeed in encouraging weight loss to prevent diabetes",
"OBJECTIVE To pilot test the feasibility and effectiveness of interactive voice response ( IVR ) calls targeting physical activity and healthful eating as strategies for weight loss for patients with pre-diabetes . METHODS Participants ( N=77 ) who engaged in a 90-min diabetes prevention class were r and omly assigned to receive IVR support targeting physical activity and nutrition weight loss strategies or to a no-contact control . Physical activity , dietary intake , and body weight were assessed prior to and following the 3-month intervention . RESULTS Eighty-five percent of the intervention participants completed at least half of the intervention . Participants assigned to receive the intervention lost an average of 2.6 % of body weight during the 3 months while control participants lost an average of 1.6 % . To determine the effect of the calls when used we found that those who used the system lost approximately 3 % of body weight which approached significance when compared to controls ( p IVR holds promise for follow-up encounters with patients with pre-diabetes . PRACTICE IMPLICATION S IVR can be used to provide physical activity and nutrition counseling that can enhance the potential reach and effectiveness of health professionals working with patients who have diabetes while placing a minimal burden on financial re sources and staff time",
"OBJECTIVE To describe the costs of the Diabetes Prevention Program ( DPP ) interventions to prevent or delay type 2 diabetes . RESEARCH DESIGN AND METHODS We describe the direct medical costs , direct nonmedical costs , and indirect costs of the placebo , metformin , and intensive lifestyle interventions over the 3-year study period of the DPP . Re source use and cost are summarized from the perspective of a large health system and society . Research costs are excluded . RESULTS The direct medical cost of laboratory tests to identify one subject with impaired glucose tolerance ( IGT ) was $ 139 . Over 3 years , the direct medical costs of the interventions were $ 79 per participant in the placebo group , $ 2,542 in the metformin group , and $ 2,780 in the lifestyle group . The direct medical costs of care outside the DPP were $ 272 less per participant in the metformin group and $ 432 less in the lifestyle group compared with the placebo group . Direct nonmedical costs were $ 9 less per participant in the metformin group and $ 1,445 greater in the lifestyle group compared with the placebo group . Indirect costs were $ 230 greater per participant in the metformin group and $ 174 less in the lifestyle group compared with the placebo group . From the perspective of a health system , the cost of the metformin intervention relative to the placebo intervention was $ 2,191 per participant and the cost of the lifestyle intervention was $ 2,269 per participant over 3 years . From the perspective of society , the cost of the metformin intervention relative to the placebo intervention was $ 2,412 per participant and the cost of the lifestyle intervention was $ 3,540 per participant over 3 years . CONCLUSIONS The metformin and lifestyle interventions are associated with modest incremental costs compared with the placebo intervention . The evaluation of costs relative to health benefits will determine the value of these interventions to health systems and society",
"OBJECTIVES The purpose of this study was to determine the feasibility of implementing a diabetes prevention program ( DPP ) in a rural African-American church . METHODS A six-session DPP , modeled after the successful National Institutes of Health ( NIH ) DPP , was implemented in a rural African-American church . Adult members of the church identified as high risk for diabetes , based on results of a risk question naire , were screened with a fasting glucose . Persons with prediabetes , a fasting glucose of 100 - 125 mg/dL , participated in the six-session , Lifestyle Balance Church DPP . The primary outcomes were attendance rates and changes in fasting glucose , weight and body mass index measured at baseline , six- and 12-month follow-up . RESULTS Ninety-nine adult church members were screened for diabetes risk . Eleven had impaired fasting glucose . Ten of 11 participated in the six-session intervention , for an attendance rate of 78 % . After the intervention and 12-month follow-up , there was a mean weight loss of 7.9 lbs and 10.6 lbs , respectively . CONCLUSIONS This pilot project suggests that a modified six-session DPP can be translated to a group format and successfully implemented in a church setting . Further r and omized studies are needed to determine the effectiveness of such an intervention"
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4117e146-06ff-11f0-808a-c43d1ab1c353
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Our systematic review in BMC Psychiatry concluded that selective serotonin reuptake inhibitors ( SSRIs ) compared with placebo significantly increase the risk of serious adverse events ( SAEs ) in patients with major depression and the potential beneficial effects of SSRIs seem to be outweighed by the harms . Hieronymus et al. accused us of method ological inaccuracies and blatant errors . In their post-hoc analysis of our data , they reported that SSRIs only increase the risk of SAEs in elderly and seems safe for non-elderly patients . They also found our review misleading because our efficacy analyses were based on the 17-item Hamilton Depression Rating Scale ; we included suboptimal SSRI doses ; and we missed some ' pivotal trials ' . We do not agree with Hieronymus et al. regarding several of the ' errors ' they cl aim that we have made . However , we acknowledge that they have identified minor errors and that we missed some trials . After rectifying the errors and inclusion of the missed trials by us and Hieronymus et al. , we re-analysed the data . The up date d analyses are even more robust and confirm our earlier conclusions . SSRIs significantly increase the risk of an SAE both in non-elderly ( p=0.045 ) and elderly ( p=0.01 ) patients [ overall odds ratio 1.39 ; 95 % confidence interval ( CI ) 1.13 to 1.73 ; p=0.002 ; I2=0 % ] . Moreover , SSRIs did not change noticeably the 17-item Hamilton Depression Rating Scale , the internationally accepted scale ( mean difference -2.02 points ; 95 % CI -2.38 to -1.66 ; p<0.00001 ) . We found no differential effect of dose ( p=0.20 )
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"CONTEXT Extracts of Hypericum perforatum ( St John 's wort ) are widely used for the treatment of depression of varying severity . Their efficacy in major depressive disorder , however , has not been conclusively demonstrated . OBJECTIVE To test the efficacy and safety of a well-characterized H perforatum extract ( LI-160 ) in major depressive disorder . DESIGN AND SETTING Double-blind , r and omized , placebo-controlled trial conducted in 12 academic and community psychiatric research clinics in the United States . PARTICIPANTS Adult out patients ( n = 340 ) recruited between December 1998 and June 2000 with major depression and a baseline total score on the Hamilton Depression Scale ( HAM-D ) of at least 20 . INTERVENTIONS Patients were r and omly assigned to receive H perforatum , placebo , or sertraline ( as an active comparator ) for 8 weeks . Based on clinical response , the daily dose of H perforatum could range from 900 to 1500 mg and that of sertraline from 50 to 100 mg . Responders at week 8 could continue blinded treatment for another 18 weeks . MAIN OUTCOME MEASURES Change in the HAM-D total score from baseline to 8 weeks ; rates of full response , determined by the HAM-D and Clinical Global Impressions ( CGI ) scores . RESULTS On the 2 primary outcome measures , neither sertraline nor H perforatum was significantly different from placebo . The r and om regression parameter estimate for mean ( SE ) change in HAM-D total score from baseline to week 8 ( with a greater decline indicating more improvement ) was -9.20 ( 0.67 ) ( 95 % confidence interval [ CI ] , -10.51 to -7.89 ) for placebo vs -8.68 ( 0.68 ) ( 95 % CI , -10.01 to -7.35 ) for H perforatum ( P = .59 ) and -10.53 ( 0.72 ) ( 95 % CI , -11.94 to -9.12 ) for sertraline ( P = .18 ) . Full response occurred in 31.9 % of the placebo-treated patients vs 23.9 % of the H perforatum-treated patients ( P = .21 ) and 24.8 % of sertraline-treated patients ( P = .26 ) . Sertraline was better than placebo on the CGI improvement scale ( P = .02 ) , which was a secondary measure in this study . Adverse-effect profiles for H perforatum and sertraline differed relative to placebo . CONCLUSION This study fails to support the efficacy of H perforatum in moderately severe major depression . The result may be due to low assay sensitivity of the trial , but the complete absence of trends suggestive of efficacy for H perforatum is noteworthy",
"Background : Major depressive disorder occurs commonly in association with alcohol dependence , both in clinical sample s and in the community . Efforts to treat major depressive disorder in alcoholics with antidepressants have yielded mixed results . This multicenter , double-blind , placebo-controlled trial of sertraline was design ed to address many of the potential method ological shortcomings of studies of co-occurring disorders . Method : Following a 1-week , single-blind , placebo lead-in period , 328 patients with co-occurring major depressive disorder and alcohol dependence were r and omly assigned to receive 10 weeks of treatment with sertraline ( at a maximum dose of 200 mg/d ) or matching placebo . R and omization was stratified , based on whether initially elevated scores on the 17-item Hamilton Depression Rating Scale declined with cessation of heavy drinking , result ing in a sample of 189 patients with Hamilton Depression Rating Scale scores ≥17 ( group A ) and 139 patients with Hamilton Depression Rating Scale scores ≤16 ( group B ) . Results : Both depressive symptoms and alcohol consumption decreased substantially over time in both groups . There were no reliable medication group differences on depressive symptoms or drinking behavior in either group A or B patients . Conclusion : Despite careful attention to method ological considerations , this study does not provide consistent support for the use of sertraline to treat co-occurring major depressive disorder and alcohol dependence . The high rate of response among placebo-treated patients may help to explain these findings . Further research is needed to identify efficacious treatments for patients with these commonly co-occurring disorders",
"AIM The main purpose of this study was to evaluate the efficacy of paroxetine controlled-release ( CR ) formulation compared to placebo . A secondary objective was to test the hypothesis that the CR decreases selective-serotonin-reuptake-inhibitors-induced nausea as its formulation allows more distal gastrointestinal absorption than the paroxetine immediate-release ( IR ) formulation . METHODS We conducted this study in Japanese and Korean patients with major depressive disorder ( MDD ) in order to demonstrate the efficacy and safety of paroxetine CR compared with placebo . The primary efficacy end-point was the adjusted mean change from baseline in the 17-item Hamilton Rating Scale for Depression total score at Week 8 . RESULTS A total of 416 patients with MDD were r and omly assigned to the CR , IR and placebo groups . The mean change from baseline in the 17-item Hamilton Rating Scale for Depression was -12.8 in the CR group , -12.5 in the IR group , and -10.4 in the placebo group , which showed a statistically significant difference compared to placebo in CR ( P incidence of adverse events was 65 % in CR , 69 % in IR and 55 % in placebo . The adverse events were mostly mild or moderate in severity . In the early treatment period , when initiated from 12.5 mg , the incidence of nausea in the CR group was 6 % , which was comparable with that of placebo ( 5 % ) . CONCLUSION Paroxetine CR is efficacious in the acute treatment of MDD and may have the potential benefit of decreasing the incidence of nausea in the early treatment period",
"The efficacy and safety of fluvoxamine maleate , a selective serotonin reuptake inhibitor , was compared with placebo and imipramine in patients with major depressive disorder . Previous literature has cited a dose range of 100 to 300 mg/day of fluvoxamine maleate for the treatment of major depression ; however , this study demonstrates that a dose range of 50 to 150 mg/day is as effective as imipramine ( 80 - 240 mg/day ) . After a 1- to 2-week , single-blind , placebo washout phase , 150 depressed out patients were r and omized to double-blind treatment with fluvoxamine maleate ( 50 - 150 mg/day ) , imipramine ( 80 - 240 mg/day ) , or placebo for 6 weeks . Fluvoxamine produced a significant therapeutic benefit over placebo ( p Hamilton Rating Scale for Depression ; imipramine ( 80 - 240 mg/day ) produced similar results . The secondary outcome variables ( i.e. , Clinical Global Impression severity of illness item and 56-Item Hopkins Symptom Checklist depression factor ) also showed significant differences between fluvoxamine maleate and placebo during three of the four final weeks of the study . Both fluvoxamine maleate and imipramine appeared to be safe and well tolerated by the majority of patients . As expected from the pharmacology of these agents , the imipramine groups reported more anticholinergic effects ( dry mouth , dizziness , and urinary retention ) and electrocardiographic effects , whereas the fluvoxamine group reported more nausea , somnolence , and abnormal ejaculation . The majority of these adverse events were mild to moderate and , with the exception of dry mouth ( imipramine ) and abnormal ejaculation ( fluvoxamine ) , were transient . The data clearly demonstrate the antidepressant activity and tolerability of fluvoxamine maleate ( 50 - 150 mg/day ) as compared with placebo ; it is also as effective as the tricyclic antidepressant imipramine ( 80 - 240 mg/day ) in patients with major depressive disorder",
"OBJECTIVE Empirical evidence has only weakly supported antidepressant treatment for patients with co-occurring depression and alcohol dependence . While some studies have demonstrated that antidepressants reduce depressive symptoms in individuals with depression and alcohol dependence , most studies have not found antidepressant treatment helpful in reducing excessive drinking in these patients . The authors provide results from a double-blind , placebo-controlled trial that evaluated the efficacy of combining approved medications for depression ( sertraline ) and alcohol dependence ( naltrexone ) in treating patients with both disorders . METHOD A total of 170 depressed alcohol-dependent patients were r and omly assigned to receive 14 weeks of treatment with sertraline ( 200 mg/day [ N=40 ] ) , naltrexone ( 100 mg/day [ N=49 ] ) , the combination of sertraline plus naltrexone ( N=42 ) , or double placebo ( N=39 ) while receiving weekly cognitive-behavioral therapy . RESULTS The sertraline plus naltrexone combination produced a higher alcohol abstinence rate ( 53.7 % ) and demonstrated a longer delay before relapse to heavy drinking ( median delay=98 days ) than the naltrexone ( abstinence rate : 21.3 % ; delay=29 days ) , sertraline ( abstinence rate : 27.5 % ; delay=23 days ) , and placebo ( abstinence rate : 23.1 % ; delay=26 days ) groups . The number of patients in the medication combination group not depressed by the end of treatment ( 83.3 % ) approached significance when compared with patients in the other treatment groups . The serious adverse event rate was 25.9 % , with fewer reported with the medication combination ( 11.9 % ) than the other treatments . CONCLUSIONS More depressed alcohol-dependent patients receiving the sertraline plus naltrexone combination achieved abstinence from alcohol , had delayed relapse to heavy drinking , reported fewer serious adverse events , and tended to not be depressed by the end of treatment",
"BACKGROUND Depression is the second most common neuropsychiatric disorder in older Americans , with significant clinical and public health costs . Despite advances in treatment , late-life depression remains a clinical challenge . Although the selective serotonin reuptake inhibitors ( SSRIs ) are the most common pharmacologic intervention for late-life depression , few placebo-controlled trials have assessed the efficacy of SSRIs for this condition . METHOD In this 12-week , multicenter , placebo-controlled , flexible-dose , double-blind , r and omized trial , 319 elderly patients ( mean age = 70 years ) were treated with controlled-release paroxetine ( paroxetine CR ) up to 50 mg/day ( N = 104 ) , immediate-release paroxetine ( paroxetine IR ) up to 40 mg/day ( N = 106 ) , or placebo ( N = 109 ) . Patients met DSM-IV criteria for major depressive disorder and had a total score of 18 or more on the 17-item Hamilton Rating Scale for Depression ( HAM-D ) . The primary efficacy measure was change from baseline to endpoint in HAM-D total score . RESULTS The primary efficacy analysis showed an adjusted difference between change from baseline in HAM-D score for paroxetine CR and placebo of -2.6 ( 95 % confidence interval [ CI ] = -4.47 to -0.73 , p = .007 ) at the week 12 last-observation-carried-forward ( LOCF ) endpoint . The adjusted difference between paroxetine IR and placebo was -2.8 ( 95 % CI = -4.65 to -0.99 , p = .003 ) at week 12 . Paroxetine CR and IR were more effective than placebo , with mean + /- SD endpoint HAM-D total scores of 10.0 + /- 7.41 and 10.0 + /- 7.10 , respectively , for the active treatments compared with 12.6 + /- 7.34 for placebo . Response , defined as a score of 1 or 2 on the Clinical Global Impressions-global improvement scale , was achieved by 72 % of paroxetine CR patients ( LOCF ; p Remission , defined as a HAM-D total score paroxetine CR patients ( LOCF ; p = .009 vs. placebo ) , 44 % of paroxetine IR patients ( p = .01 vs. placebo ) , and 26 % of placebo patients . In a post hoc analysis , mean HAM-D improvement for paroxetine CR and paroxetine IR was greater than for placebo in both chronically depressed patients ( duration > 2 years ) and those with short-term ( or = 2 years ) depression . Dropout rates due to adverse events were 12.5 % for paroxetine CR , 16.0 % for paroxetine IR , and 8.3 % for placebo . CONCLUSION Paroxetine CR and paroxetine IR are effective and well tolerated treatments for major depressive disorder in elderly patients , including those with chronic depression",
"OBJECTIVE To evaluate the efficacy and tolerability of low daily doses of controlled-release ( CR ) paroxetine in patients with late-life depression . METHOD This was a 10-week , multicenter , placebo-controlled , double-blind , fixed-dose trial r and omly assigning patients > or= 60 years old to daily doses of paroxetine CR 12.5 mg ( N = 168 ) , paroxetine CR 25 mg ( N = 177 ) , or placebo ( N = 180 ) . Patients had major depressive disorder ( DSM-IV criteria ) and 17-item Hamilton Rating Scale for Depression ( HAM-D ) total scores of > or= 18 . The primary efficacy variable was the change from baseline to study endpoint in total HAM-D scores . The study was conducted from June 2003 to October 2004 . RESULTS The drug/placebo difference in HAM-D change from baseline at study endpoint was -1.8 ( 95 % CI = -3.41 to -0.19 , p = .029 ) for paroxetine CR 12.5 mg , and -3.3 ( 95 % CI = -4.84 to -1.68 , p paroxetine CR 25 mg . A significantly larger percentage of patients achieved remission ( HAM-D total score paroxetine CR 25 mg ( 41 % ) , but not with 12.5 mg ( 31 % ) , as compared with placebo ( 28 % ) ( p = .008 ) . Both doses of paroxetine CR also achieved statistical significance compared to placebo for the Clinical Global Impressions-Severity of Illness scale ( p patient-rated measures of depression severity ( p quality of life ( p tolerated , with adverse event withdrawal rates of 6 % , 8 % , and 7 % for paroxetine CR 12.5 mg , paroxetine CR 25 mg , and placebo , respectively . CONCLUSION These data demonstrate that paroxetine CR 12.5 mg and 25 mg daily are efficacious and well tolerated in the treatment of major depressive disorder in patients > or= 60 years of age , although effect sizes are relatively smaller with the 12.5 mg/day dose",
"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",
"OBJECTIVE There have been few placebo-controlled trials of selective serotonin reuptake inhibitors for depressed elderly patients . This placebo-controlled study of sertraline was design ed to confirm the results of non-placebo-controlled trials . METHOD The subjects were out patients age 60 years or older who had a DSM-IV diagnosis of major depressive disorder and a total score on the 17-item Hamilton Depression Rating Scale of 18 or higher . The patients were r and omly assigned to 8 weeks of double-blind treatment with placebo or a flexible daily dose of 50 or 100 mg of sertraline . The primary outcome variables were the Hamilton scale and Clinical Global Impression ( CGI ) scales for severity and improvement . RESULTS A total of 371 patients assigned to sertraline and 376 assigned to placebo took at least one dose . At endpoint , the patients receiving sertraline evidence d significantly greater improvements than those receiving placebo on the Hamilton depression scale and CGI severity and improvement scales . The mean changes from baseline to endpoint in Hamilton score were -7.4 points ( SD=6.3 ) for sertraline and -6.6 points ( SD=6.4 ) for placebo . The rate of CGI-defined response at endpoint was significantly higher for sertraline ( 45 % ) than for placebo ( 35 % ) , and the time to sustained response was significantly shorter for sertraline ( median , 57 versus 61 days ) . There were few discontinuations due to treatment-related adverse events , 8 % for sertraline and 2 % for placebo . CONCLUSIONS Sertraline was effective and well tolerated by older adults with major depression , although the drug-placebo difference was not large in this 8-week trial",
"1 A double-blind placebo-controlled study of fluvoxamine and imipramine was performed in a group of depressed patients . Twenty-two patients received fluvoxamine ( mean dose 101 mg/day ) , 25 received imipramine ( mean dose 127 mg/day ) and 22 received placebo . 2 Apart from an increase in the SGOT and SGPT values of four imipramine patients , no statistically significant changes in haematology or urinalysis were judged to be medically relevant . Fluvoxamine exhibited fewer anticholinergic side effects than imipramine . 3 Both fluvoxamine treated patients and imipramine-treated patients exhibited a statistically significant improvement at the end of the 28-day treatment period with respect to the placebo patients , as measured using the Hamilton Rating Scale for Depression , and the Clinical Global Impression Scale . Evaluations of the results of the Beck Depression Inventory and the Profile of Mood States revealed a statistically significant improvement for imipramine patients with respect to placebo at week 4 , but not for fluvoxamine patients . It is postulated on the basis of quantitative pharmaco-EEG findings , that the slight superiority of imipramine over fluvoxamine was due to underdosing of the latter",
"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",
"Agomelatine ( S 20098 ) has a unique and new pharmacological profile . It is a melatoninergic agonist and selective antagonist of 5-HT2C receptors , and has been shown to be active in several animal models of depression . The aim of this study was to determine the active dose of agomelatine in the treatment of major depressive disorder ( DSM-IV criteria ) . The methodology used was a conventional double-blind design comparing three different doses of agomelatine ( 1 , 5 and 25 mg once a day ) with placebo over an 8-week treatment period . Paroxetine was used as the study validator . Seven hundred and eleven patients with a baseline mean score of 27.4 on the 17-item Hamilton Rating Scale for Depression ( HAM-D ) were included . On the pivotal analysis , the mean final HAM-D total score ( Full Analysis Set LOCF ) demonstrated agomelatine 25 mg to be statistically more effective than placebo . This was confirmed by other analyses and criteria ( responders , remission , sub population of severely depressed patients , Montgomery – Åsberg Depression Rating Scale , Clinical Global Impression-Severity of Illness ) . Agomelatine 25 mg alleviated the anxiety associated with depression , as measured on Hamilton Anxiety Scale . Paroxetine was found to be effective on pivotal analysis and most of the secondary criteria used to vali date the study methodology and population . Agomelatine , whatever the dose , showed good acceptability with a side-effects profile close to that of placebo . In conclusion , this study demonstrates that agomelatine is efficient in the treatment of major depressive disorder and that 25 mg is the target dose",
"& NA ; Escitalopram was compared to placebo in moderately to severely depressed patients in primary care with citalopram as the active reference . Patients were r and omized to receive flexible doses of 10–20 mg/day escitalopram ( n=155 ) , 20–40 mg/day citalopram ( n=160 ) , or placebo ( n=154 ) over an 8‐week double‐blind period . The primary efficacy parameter was the change from baseline to last assessment in the Montgomery – Asberg Depression Rating Scale total score . Escitalopram produced a statistically significant therapeutic difference of 2.9 points ( P=0.002 ) compared to placebo , and escitalopram was consistently and statistically significantly more efficacious than placebo from week 1 onwards . Analysis of Clinical Global Impression – Severity and Clinical Global Impression – Improvement confirmed the primary efficacy results . By week 8 , significantly more patients had responded to treatment with escitalopram than with citalopram ( P=0.021 ) or placebo ( P=0.009 ) . Escitalopram was as well tolerated as citalopram and had a similar adverse event profile . Both escitalopram‐ and citalopram‐treated patients had placebo‐level adverse event withdrawal rates ( 3 % and 4 % , respectively ) . This study demonstrates the consistent antidepressant efficacy and excellent tolerability of escitalopram 10–20 mg/day in primary care patients with major depressive disorder",
"OBJECTIVE Management of depression in elderly patients presents a significant medical challenge , and there is a need for further clinical trials . The authors examined the efficacy and tolerability of escitalopram and fluoxetine versus placebo in the treatment of elderly patients with major depressive disorder ( MDD ) . METHODS This was an 8-week , r and omized , double-blind comparison of the efficacy and tolerability of escitalopram ( 10 mg/day ) and fluoxetine ( 20 mg/day ) , to placebo in elderly patients with MDD . The prospect ively defined primary efficacy parameter was the change from baseline in mean Montgomery-Asberg Depression Rating Scale ( MADRS ) total score at endpoint , using last observation carried forward . RESULTS The intent-to-treat set comprised 517 patients ; the escitalopram group included 173 patients ; fluoxetine , 164 patients ; and placebo , 180 patients . Mean age was 75 years , with a range of 65 to 93 . Formally , this was a \" failed study \" ( i.e. , neither active treatment was superior to placebo ) , and the efficacy results should , therefore , be interpreted with caution . On the basis of the primary efficacy parameter , fluoxetine showed significantly lower efficacy than both escitalopram and placebo , which were not significantly different from each other . Rates of withdrawal because of adverse events/lack of efficacy were : placebo ( 2.8%/4.4 % , respectively ) , escitalopram ( 9.8%/1.7 % , respectively ) , and fluoxetine ( 12.2%/1.8 % , respectively ) . No single adverse event occurred at an incidence > or = 10 % in escitalopram-treated patients . CONCLUSIONS Both escitalopram and fluoxetine were well tolerated by elderly patients with MDD . Neither demonstrated superior efficacy on primary endpoint versus placebo",
"Paroxetine is a novel antidepressant that selectively inhibits neuronal reuptake of serotonin . Results are reported from a 6-week , double-blind trial of paroxetine , imipramine , and placebo in 120 out patients with DSM-III major depression . Paroxetine was significantly superior to placebo on almost all measures . This included the main outcome variable , the Hamilton Rating Scale for Depression ( HAM-D ) , and its factor scores , anxiety-somatization , cognitive disturbance , psychomotor retardation , and sleep disturbance . There were no significant differences between paroxetine and imipramine on the same scales . Imipramine-treated patients were significantly more likely than those taking placebo to report one or more adverse effects , which were predominantly anticholinergic in nature . There was no significant difference in the number of paroxetine and placebo patients who reported one or more adverse effects . The results of this and similar studies indicate that paroxetine is an effective treatment in major depression and has a favorable side effect profile",
"CONTEXT Major depressive disorder causes significant morbidity and mortality . Current therapies fail to fully treat both emotional and physical symptoms of major depressive disorder . OBJECTIVE To evaluate duloxetine , a dual reuptake inhibitor of serotonin and norepinephrine , on improvement of emotional and painful physical symptoms . DESIGN R and omized , double-blind , evaluation of duloxetine at 40 mg/d ( 20 mg twice daily ) and 80 mg/d ( 40 mg twice daily ) versus placebo and paroxetine 20 mg/d in depressed out patients . MAIN OUTCOME MEASURES The primary efficacy measure was the 17-item Hamilton Depression Rating Scale . Visual Analog Scales for pain , Clinical Global Impression of Severity , Patient 's Global Impression of Improvement , and Quality of Life in Depression Scale were also used . Safety was evaluated by assessing discontinuation rates , adverse event rates , vital signs , and laboratory tests . RESULTS Duloxetine 80 mg/d was superior to placebo on mean 17-item Hamilton Depression Rating Scale total change by 3.62 points ( 95 % CI 1.38 , 5.86 ; P = 0.002 ) . Duloxetine at 40 mg/d was also significantly superior to placebo by 2.43 points ( 95 % CI 0.19 , 4.66 ; P = 0.034 ) , while paroxetine was not ( 1.51 points ; 95 % CI -0.55 , 3.56 ; P = 0.150 ) . Duloxetine 80 mg/d was superior to placebo for most other measures , including overall pain severity , and was superior to paroxetine on 17-item Hamilton Depression Rating Scale improvement ( by 2.39 points ; 95 % CI 0.14 , 4.65 ; P = 0.037 ) and estimated probability of remission ( 57 % for duloxetine 80 mg/d , 34 % for paroxetine ; P = 0.022 ) . The only adverse event reported significantly more frequently for duloxetine 80 mg/d than for paroxetine was insomnia ( 19.8 % for duloxetine 80 mg/d , 8.0 % for paroxetine ; P = 0.031 ) . Hypertension incidence was not affected by any treatment . CONCLUSION Duloxetine therapy was efficacious for emotional and physical symptoms of depression , with a selective serotonin reuptake inhibitor-like profile of side effects",
"OBJECTIVES To compare the sensitivity of the 6-item Hamilton Rating Scale for Depression ( HRSD6 ) with the more widely used 17-item Hamilton Rating Scale for Depression ( HRSD17 ) in patients suffering from major depressive disorder , with or without melancholia and /or dysthymic disorder . A secondary objective was to compare the sensitivity of the HRSD6 to the Montgomery-Asberg Depression Rating Scale ( MADRS ) . DESIGN Retrospective analysis of 4 clinical trials that tested antidepressant therapies . SETTING Outpatient treatment in a major psychiatric hospital . PARTICIPANTS One hundred and forty-three male and female out patients meeting the criteria of the DSM-III-R or DSM-IV for major depressive disorder . OUTCOME MEASURES HRSD17 , HRSD6 and MADRS . RESULTS The HRSD6 correlated strongly with the HRSD17 , both at baseline and termination of treatment , and for the subgroups of double depression and melancholia . The HRSD6 was also correlated significantly with the MADRS at both measurement times , and for the subgroups . Paired t-tests with the HRSD6 , HRSD17 and MADRS demonstrated equal sensitivity to change over the course of treatment , both in the full sample and in the dysthymic and melancholic subgroups . CONCLUSIONS The HRSD6 appears to be as sensitive to change over treatment as the HRSD17 and the MADRS . A shorter , less time-consuming measure of depression may have utility in clinical practice and research",
"Paroxetine is a selective serotonin reuptake inhibitor with significant antidepressant properties . This was a 6-week placebo- and imipramine-controlled study of 120 out patients with major depression . Paroxetine was statistically significantly superior to placebo on almost all outcome measures . This was apparent as early as 1 week . Paroxetine was also significantly superior to imipramine on the Hamilton Rating Scale for Depression total score . Paroxetine was generally better tolerated than imipramine . These results strongly support paroxetine 's effectiveness in the treatment of major depression and suggest that paroxetine will be a valuable addition to the options in treating depressive illness",
" A total of 149 patients in 7 centers in Denmark , Norway and Sweden entered a 6‐week double‐blind trial intended to assess the antidepressant effect and safety of citalopram vs placebo in depressed elderly patients ( 65 years of age or older ) who might also suffer from somatic disorders and /or senile dementia . Results of ratings on the Hamilton Rating Scale for Depression , the Montgomery‐Åsberg Depression Rating Scale and the Clinical Global Impression Scale provided consistent evidence that the citalopram‐treated patients improved more than the placebo‐treated patients . Results of ratings on the Gottfries‐Bråne‐Steen dementia rating scale indicated that both cognitive and emotional functioning improved significantly more in the citalopram‐treated subgroup of patients with dementia than in the placebo‐treated subgroup",
"Paroxetine , a phenylpiperidine derivative , is an antidepressant that selectively inhibits serotonin reuptake . In this study 111 out patients with major depression diagnosed by DSM-III criteria were treated with either paroxetine or placebo in a 6-week , r and omized , double-blind study . Paroxetine was significantly superior to placebo on six of the seven major efficacy variables . Significant differences in favor of paroxetine were apparent by Week 2 . Paroxetine was also well tolerated . These results support the efficacy and safety of paroxetine as a treatment for patients with major depression",
" Aprepitant is a neurokinin 1 receptor antagonist approved for prevention of chemotherapy‐induced and post‐operative nausea and vomiting . Early studies demonstrated promising antidepressant activity as monotherapy , although this was unsupported by subsequent phase 3 trials . This phase 2 study evaluated whether aprepitant potentiated the antidepressant effects of paroxetine"
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BACKGROUND There has an increasing number of published trials on psychosocial intervention programmes for pre-school children with autism spectrum disorder ( ASD ) . To achieve better quality of unbiased evidence for the effectiveness of ASD interventions , it is necessary to conduct a comprehensive review that covers studies with adequate quality st and ards , such as r and omised controlled trials ( RCTs ) , and different types of intervention In this study , we categorize interventions for ASD as behavioural , social-communication focused , and multimodal developmental based on Howlin 's classification of early interventions for children with ASD . The aim of this study was to compare these three models and investigate the strengths and weaknesses of each type of intervention and to identify the approaches that contribute to a successful outcome for children with autism . METHODS We performed a systematic review and meta- analysis . We included RCTs targeting children with ASD 6 years old or younger . A r and om effects model was used to present the effect estimate for the outcomes . This study also performed combined meta-analyses of all the three models to investigate the overall effectiveness of the intervention programmes . RESULTS 32 r and omized controlled studies were found to be eligible for inclusion . The synthesized data included 594 children from 14 RCTs . There was no statistically significant difference in the effects on autism general symptoms between the social-communication-focused model and the multimodal developmental model ( p = 0.83 ) . The results suggest that there is evidence of an effect on ' reciprocity of social interaction towards others ' ( st and ard mean difference [ 95 % confidential interval ] = 0.53[0.29,0.78 ] , p ' parental synchrony ' ( SMD = 0.99[0.70,1.29 ] , p ' reciprocity of social interaction towards others ' could be a dependent variable that might be context -bound to interactions with the child 's parent , we can not conclude the interventions for pre-school children with ASD have significant effects on a generalized skill to engage in reciprocal interactions with others . However , the outcomes of ' reciprocity of social interaction towards others ' and ' parental synchrony ' may be promising targets for interventions involving pre-school children with ASD . TRIAL REGISTRATION Prospero CRD42011001349
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"BACKGROUND Delays and deficits in joint attention and symbolic play constitute two important developmental problems in young children with autism . These areas of deficit have been well studied in autism but have rarely been the focus of treatment efforts ( see Kasari , Freeman , & Paparella , 2001 ) . In this study , we examine the efficacy of targeted interventions of joint attention and symbolic play . METHODS Participants were 58 children with autism aged 3 and 4 years ( 46 boys ) . Children were r and omized to a joint attention intervention , a symbolic play intervention , or control group . Interventions were conducted 30 minutes daily for 5 - 6 weeks . Both structured assessment s of joint attention and play skills and mother-child interactions were collected pre and post intervention by independent assessors . RESULTS Results indicate that both intervention groups improved significantly over the control group on certain behaviors . Children in the joint attention intervention initiated significantly more showing and responsiveness to joint attention on the structured joint attention assessment and more child-initiated joint attention in the mother-child interaction . The children in the play group showed more diverse types of symbolic play in interaction with their mothers and higher play levels on both the play assessment and in interaction with their mothers . CONCLUSIONS This r and omized controlled trial provides promising data on the specificity and generalizability of joint attention and play interventions for young children with autism . Future studies need to examine the long-term effects of these early interventions on children 's development",
"Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement",
"OBJECTIVE This study reports 12-month follow-up data from a r and omized controlled trial of preschool-based social communication treatment for young children with autism . METHOD A total of 61 children ( 48 males ) with autism , 29 to 60 months of age , had earlier been r and omized either to 8 weeks of preschool-based social communication treatment in addition to st and ard preschool program ( n = 34 ) or to st and ard preschool program only ( n = 27 ) . Significant short-term effects on targeted social communication skills have previously been published . Long-term gains in social communication , language and global social functioning and communication were assessed from video-taped preschool teacher-child and mother-child interactions , Early Social Communication Scales , Reynell Developmental Language Scale , and Social Communication Question naire . RESULTS Compared with those in the control group , the treated children achieved significantly larger improvements in joint attention and joint engagement from baseline to 12-month follow-up . However , no effects were detected on language and global ratings of social functioning and communication . The treatment effect on child initiation of joint attention increased with increasing level of sociability at baseline , whereas nonverbal IQ and expressive language had no moderating effect . CONCLUSIONS This study is the first to show that , similar to specialist-delivered treatment , preschool-based treatment may produce small but possibly clinical ly important long-term changes in social communication in young children with autism . The treatment did not affect language and global ratings of social functioning and communication . More studies are needed to better underst and whether treatment effects may be improved by increasing the intensity and duration of the treatment . Clinical trial registration information -- Joint Attention Intervention and Young Children With Autism ; http:// clinical trials.gov/ ; NCT00378157",
"This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer",
"The current study is a r and omized clinical trial evaluating the efficacy of Focused Playtime Intervention ( FPI ) in a sample of 70 children with Autism Spectrum Disorder . This parent-mediated intervention has previously been shown to significantly increase responsive parental communication ( Siller et al. in J Autism Dev Disord 43:540–555 , 2013a ) . The current analyses focus on children ’s attachment related outcomes . Results revealed that children who were r and omly assigned to FPI showed bigger increases in attachment-related behaviors , compared to children assigned to the control condition . Significant treatment effects of FPI were found for both an observational measure of attachment-related behaviors elicited during a brief separation-reunion episode and a question naire measure evaluating parental perceptions of child attachment . The theoretical and clinical implication s of these findings are discussed",
"Background Although social skills training programs for people with high-functioning autism ( HFA ) are widely practice d , the st and ardization of curricula , the examination of clinical effectiveness , and the evaluation of the feasibility of future trials have yet to be done in Asian countries . To compensate for this problem , a Japanese pilot r and omized controlled trial ( RCT ) of the Treatment and Education of Autistic and Related Communication H and icapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted . Methods Eleven children with HFA , aged 5–6 years , and their mothers were r and omly assigned to the TEACCH program ( n=5 ) or a waiting-list control group ( n=6 ) . The program involved comprehensive group intervention and featured weekly 2-hour sessions , totaling 20 sessions over six months . The adaptive behaviors and social reciprocity of the children , parenting stress , and parent – child interactions were assessed using the Strengths and Difficulties Question naire ( SDQ ) , Parenting Stress Index ( PSI ) , Beck depression inventory-II ( BDI-II ) , and Interaction Rating Scale ( IRS ) . Results Through this pilot trial , the intervention and evaluation of the program has been shaped . There were no dropouts from the program and the mothers ’ satisfaction was high . The outcome measurements improved more in the program group than in the control group , with moderate effect sizes ( SDQ , 0.71 ; PSI , 0.58 ; BDI-II , 0.40 ; and IRS , 0.69 ) . This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not . Conclusion We have st and ardized the TEACCH program , confirmed the feasibility of a future trial , and successfully estimated the positive effect size . These findings will contribute to a larger trial in the future and to forthcoming systematic review s with meta-analyses . Trial registration",
"We piloted a 2-week “ Autism-1 - 2 - 3 ” early intervention for children with autism and their parents immediately after diagnosis that targeted at ( 1 ) eye contact , ( 2 ) gesture and ( 3 ) vocalization/words . Seventeen children were r and omized into the Intervention ( n = 9 ) and Control ( n = 8) groups . Outcome measures included the Autism Diagnostic Observation Schedule , Ritvo-Freeman Real Life Rating Scale , Symbolic Play Test , and Parenting Stress Index . Children with autism improved in language /communication , reciprocal social interaction , and symbolic play . Parents perceived significant improvement in their children ’s language , social interaction , and their own stress level . This intervention can serve as short-term training on communication and social interaction for children with autism , and reduce the stress of their parents during the long waiting time for public health services",
"OBJECTIVE : To conduct a r and omized , controlled trial to evaluate the efficacy of the Early Start Denver Model ( ESDM ) , a comprehensive developmental behavioral intervention , for improving outcomes of toddlers diagnosed with autism spectrum disorder ( ASD ) . METHODS : Forty-eight children diagnosed with ASD between 18 and 30 months of age were r and omly assigned to 1 of 2 groups : ( 1 ) ESDM intervention , which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years ; or ( 2 ) referral to community providers for intervention commonly available in the community . RESULTS : Compared with children who received community-intervention , children who received ESDM showed significant improvements in IQ , adaptive behavior , and autism diagnosis . Two years after entering intervention , the ESDM group on average improved 17.6 st and ard score points ( 1 SD : 15 points ) compared with 7.0 points in the comparison group relative to baseline scores . The ESDM group maintained its rate of growth in adaptive behavior compared with a normative sample of typically developing children . In contrast , over the 2-year span , the comparison group showed greater delays in adaptive behavior . Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder , not otherwise specified , than the comparison group . CONCLUSIONS : This is the first r and omized , controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis . Results of this study underscore the importance of early detection of and intervention in autism",
"Children with autism exhibit significant deficits in imitation skills . Reciprocal Imitation Training ( RIT ) , a naturalistic imitation intervention , was developed to teach young children with autism to imitate during play . This study used a r and omized controlled trial to evaluate the efficacy of RIT on elicited and spontaneous imitation skills in 21 young children with autism . Results found that children in the treatment group made significantly more gains in elicited and spontaneous imitation , replicating previous single-subject design studies . Number of spontaneous play acts at pre-treatment was related to improvements in imitation during the intervention , suggesting that children with a greater play repertoire make greater gains during RIT",
"This study aim ed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism . The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later . Compared to caregivers and toddlers r and omized to the waitlist control group the immediate treatment ( IT ) group made significant improvements in targeted areas of joint engagement . The IT group demonstrated significant improvements with medium to large effect sizes in their responsiveness to joint attention and their diversity of functional play acts after the intervention with maintenance of these skills 1 year post-intervention . These are among the first r and omized controlled data to suggest that short-term parent-mediated interventions can have important effects on core impairments in toddlers with autism . Clinical Trials # : NCT00065910",
"Abstract Camarata 's ( 2014 ) review summarizes the progress that has been made in the field of early identification and early intervention in autism spectrum disorders ( ASD ) over the past few decades , but also provides a salutary reminder that much still needs to be done . Whilst it is possible to prospect ively identify cases of ASD using screening instruments ; it is critical that those using such screens in clinical practice underst and how to interpret data from published studies and consider how screening information is communicated to parents . After several decades when few r and omized controlled trials of early intervention in ASD were conducted , the last decade has seen an explosion of new studies . Despite initial optimism , as more trials are published they have highlighted the limits of , and challenges to , early intervention in ASD . Given the complex nature of ASD these sobering lessons are perhaps not surprising . Rather than promote despondency , they need to inspire and inform the next decade of clinical research to move the field forward to the benefit of young children with ASD and those who care for them",
"Summary Background Results of small trials suggest that early interventions for social communication are effective for the treatment of autism in children . We therefore investigated the efficacy of such an intervention in a larger trial . Methods Children with core autism ( aged 2 years to 4 years and 11 months ) were r and omly assigned in a one-to-one ratio to a parent-mediated communication-focused ( Preschool Autism Communication Trial [ PACT ] ) intervention or treatment as usual at three specialist centres in the UK . Those assigned to PACT were also given treatment as usual . R and omisation was by use of minimisation of probability in the marginal distribution of treatment centre , age ( ≤42 months or > 42 months ) , and autism severity ( Autism Diagnostic Observation Schedule-Generic [ ADOS-G ] algorithm score 12–17 or 18–24 ) . Primary outcome was severity of autism symptoms ( a total score of social communication algorithm items from ADOS-G , higher score indicating greater severity ) at 13 months . Complementary secondary outcomes were measures of parent-child interaction , child language , and adaptive functioning in school . Analysis was by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N58133827 . Results 152 children were recruited . 77 were assigned to PACT ( London [ n=26 ] , Manchester [ n=26 ] , and Newcastle [ n=25 ] ) ; and 75 to treatment as usual ( London [ n=26 ] , Manchester [ n=26 ] , and Newcastle [ n=23 ] ) . At the 13-month endpoint , the severity of symptoms was reduced by 3·9 points ( SD 4·7 ) on the ADOS-G algorithm in the group assigned to PACT , and 2·9 ( 3·9 ) in the group assigned to treatment as usual , representing a between-group effect size of −0·24 ( 95 % CI −0·59 to 0·11 ) , after adjustment for centre , sex , socioeconomic status , age , and verbal and non-verbal abilities . Treatment effect was positive for parental synchronous response to child ( 1·22 , 0·85 to 1·59 ) , child initiations with parent ( 0·41 , 0·08 to 0·74 ) , and for parent-child shared attention ( 0·33 , −0·02 to 0·68 ) . Effects on directly assessed language and adaptive functioning in school were small . Interpretation On the basis of our findings , we can not recommend the addition of the PACT intervention to treatment as usual for the reduction of autism symptoms ; however , a clear benefit was noted for parent-child dyadic social communication . Funding UK Medical Research Council , and UK Department for Children , Schools and Families",
"Children with autism exhibit deficits in their quantity and quality of joint attention . Early autism intervention studies rarely document improvement in joint attention quality . The purpose of this study was to determine whether there was a change in joint attention quality for preschoolers with autism who were r and omized to a joint attention intervention , symbolic play intervention , or a control group . Quality was defined as shared positive affect during joint attention as well as shared positive affect and utterances during joint attention . Interactions of group and time were found for both types of joint attention quality . During the follow up visits , the joint attention and symbolic play intervention groups produced more of these two types of joint attention quality than the control group",
"OBJECTIVE This study was carried out to examine the efficacy of a 12-week , low-intensity ( 1-hour/wk of therapist contact ) , parent-delivered intervention for toddlers at risk for autism spectrum disorders ( ASD ) aged 14 to 24 months and their families . METHOD A r and omized controlled trial involving 98 children and families was carried out in three different sites investigating the efficacy of a parent delivery of the Early Start Denver model ( P-ESDM ) , which fosters parental use of a child-centered responsive interaction style that embeds many teaching opportunities into play , compared to community treatment as usual . Assessment s were completed at baseline and 12 weeks later , immediately after the end of parent coaching sessions . RESULTS There was no effect of group assignment on parent-child interaction characteristics or on any child outcomes . Both groups of parents improved interaction skills , and both groups of children demonstrated progress . Parents receiving P-ESDM demonstrated significantly stronger working alliances with their therapists than did the community group . Children in the community group received significantly more intervention hours than those in the P-ESDM group . For the group as a whole , both younger child age at the start of intervention and a greater number of intervention hours were positively related to the degree of improvement in children 's behavior for most variables . CONCLUSIONS Parent-implemented intervention studies for early ASD thus far have not demonstrated the large effects seen in intensive-treatment studies . Evidence that both younger age and more intervention hours positively affect developmental rates has implication s for clinical practice , service delivery , and public policy",
"Imitation is an early skill thought to play a role in social development , leading some to suggest that teaching imitation to children with autism should lead to improvements in social functioning . This study used a r and omized controlled trial to evaluate the effect of a focused imitation intervention on initiation of joint attention and social-emotional functioning in 27 young children with autism . Results indicated the treatment group made significantly more gains in joint attention initiations at post-treatment and follow-up and social-emotional functioning at follow-up than the control group . Although gains in social functioning were associated with treatment , a mediation analysis did not support imitation as the mechanism of action . These findings suggest the intervention improves social functioning in children with ASD",
"BACKGROUND This r and omized controlled trial compared Hanen 's ' More than Words ' ( HMTW ) , a parent-implemented intervention , to a ' business as usual ' control group . METHODS Sixty-two children ( 51 boys and 11 girls ; M age = 20 months ; SD = 2.6 ) who met criteria for autism spectrum disorders ( ASD ) and their parents participated in the study . The HMTW intervention was provided over 3.5 months . There were three measurement periods : prior to r and omization ( Time 1 ) and at 5 and 9 months post enrollment ( Times 2 and 3 ) . Children 's communication and parental responsivity were measured at each time point . Children 's object interest , a putative moderator , was measured at Time 1 . RESULTS There were no main effects of the HMTW intervention on either parental responsivity or children 's communication . However , the effects on residualized gains in parental responsivity from Time 1 to both Times 2 and 3 yielded noteworthy effect sizes ( Glass 's Δ = .71 , .50 respectively ) . In contrast , there were treatment effects on child communication gains to Time 3 that were moderated by children 's Time 1 object interest . Children with lower levels of Time 1 object interest exhibited facilitated growth in communication ; children with higher levels of object interest exhibited growth attenuation . CONCLUSIONS The HMTW intervention showed differential effects on child communication depending on a baseline child factor . HMTW facilitated communication in children with lower levels of Time 1 object interest . Parents of children who evidence higher object interest may require greater support to implement the HMTW strategies , or may require different strategies than those provided by the HMTW curriculum",
"The purpose of this study was to investigate the effects of improvisational music therapy on joint attention behaviors in pre-school children with autism . It was a r and omized controlled study employing a single subject comparison design in two different conditions , improvisational music therapy and play sessions with toys , and using st and ardized tools and DVD analysis of sessions to evaluate behavioral changes in children with autism . The overall results indicated that improvisational music therapy was more effective at facilitating joint attention behaviors and non-verbal social communication skills in children than play . Session analysis showed significantly more and lengthier events of eye contact and turn-taking in improvisational music therapy than play sessions . The implication s of these findings are discussed further",
"This r and omized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone . The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. ( Eur Child Adolesc Psychiatr 11:266–272 , 2002 ) . Seventy-five toddlers with autism spectrum disorder ( 65 autism , 10 PDD-NOS , mean age = 34.4 months , SD = 6.2 ) were enrolled . Analyses were conducted on a final sample of 67 children ( lost to follow-up = 8) . No significant intervention effects were found for any of the primary ( language ) , secondary ( global clinical improvement ) , or mediating ( child engagement , early precursors of social communication , or parental skills ) outcome variables , suggesting that the ‘ Focus parent training ’ was not of additional value to the more general care-as-usual",
"OBJECTIVE The vast majority of children with an autism spectrum disorder ( ASD ) attend public preschools at some point in their childhood . Community preschool practice s often are not evidence based , and almost none target the prelinguistic core deficits of ASD . This study investigated the effectiveness of public preschool teachers implementing a vali date d intervention ( the Joint Attention and Symbolic Play/Engagement and Regulation intervention ; JASP/ER ) on a core deficit of autism , initiating joint attention . METHOD Sixteen dyads ( preschoolers with ASD and the public school teachers who worked in the child 's classroom ) were r and omly assigned to the 6-week JASP/ER intervention or a control group . RESULTS At the end of the intervention , JASP/ER teachers used more JASP/ER strategies than the control teachers , and JASP/ER preschoolers used more joint attention in their classroom than control children . Additionally , JASP/ER children spent more time in supported engagement and less time in object engagement than control preschoolers on a taped play interaction . CONCLUSIONS Findings suggest that teachers were able to improve a core deficit of children with ASD in a public preschool context ",
"& NA ; This study reports on the results of a r and omized controlled trial that evaluated a caregiverbased intervention program for children with autism in community day‐care centers . Thirty‐five preschool children with a DSM III‐R diagnosis of autism or pervasive developmental disorder were r and omized to an experimental or control group . Children in the experimental group were enrolled in day care and their parents and child care workers received a 12‐week intervention consisting of lectures and on‐site consultations to day‐care centers . In addition , supportive work was undertaken with families . Control subjects received day care alone . In the experimental group , there were greater gains in language abilities , significant increases in caregivers ' knowledge about autism , greater perception of control on the part of mothers , and greater parent satisfaction . We conclude that this research design demonstrated that the intervention was significantly superior to day care alone",
"Young children with pervasive developmental disorder were r and omly assigned to intensive treatment or parent training . The intensive treatment group ( 7 with autism , 8 with pervasive developmental disorder not otherwise specified -- NOS ) averaged 24.52 hours per week of individual treatment for one year , gradually reducing hours over the next 1 to 2 years . The parent training group ( 7 with autism , 6 with pervasive developmental disorder NOS ) received 3 to 9 months of parent training . The groups appeared similar at intake on all measures ; however , at follow-up the intensive treatment group outperformed the parent training group on measures of intelligence , visual-spatial skills , language , and academics , though not adaptive functioning or behavior problems . Children with pervasive developmental disorder NOS may have gained more than those with autism",
"Tests of mediation in treatment trials can illuminate processes of change and suggest causal influences in development . We conducted a mediation analysis of a previously published r and omised controlled trial of parent-mediated communication-focused treatment for autism against ordinary care , with 28 children aged 2–5 years ( Aldred et al. in J Child Psychol Psychiatr 45:1–11 , 2004 ) . The hypothesised mediating process , targeted by the intervention , was an increase in parental synchronous response within parent – child interaction . The results showed partial mediation , with change in synchrony accounting for 34 % of the positive intervention effect on autism symptomatology ( Autism Diagnostic Observation Schedule communication and social domain algorithm ) ; the result was confirmed by bootstrap estimation . Improved parental synchronous response to child communication can alter short-term autism symptom outcome with targeted therapy",
"The study compared the effect of music training , speech training and no-training on the verbal production of children with Autism Spectrum Disorders ( ASD ) . Participants were 50 children with ASD , age range 3 to 5 years , who had previously been evaluated on st and ard tests of language and level of functioning . They were r and omly assigned to one of three 3-day conditions . Participants in music training ( n = 18 ) watched a music video containing 6 songs and pictures of the 36 target words ; those in speech training ( n = 18 ) watched a speech video containing 6 stories and pictures , and those in the control condition ( n = 14 ) received no treatment . Participants ' verbal production including semantics , phonology , pragmatics , and prosody was measured by an experimenter design ed verbal production evaluation scale . Results showed that participants in both music and speech training significantly increased their pre to posttest verbal production . Results also indicated that both high and low functioning participants improved their speech production after receiving either music or speech training ; however , low functioning participants showed a greater improvement after the music training than the speech training . Children with ASD perceive important linguistic information embedded in music stimuli organized by principles of pattern perception , and produce the functional speech",
"BACKGROUND Psychosocial treatments are the mainstay of management of autism in the UK but there is a notable lack of a systematic evidence base for their effectiveness . R and omised controlled trial ( RCT ) studies in this area have been rare but are essential because of the developmental heterogeneity of the disorder . We aim ed to test a new theoretically based social communication intervention targeting parental communication in a r and omised design against routine care alone . METHODS The intervention was given in addition to existing care and involved regular monthly therapist contact for 6 months with a further 6 months of 2-monthly consolidation sessions . It aim ed to educate parents and train them in adapted communication tailored to their child 's individual competencies . Twenty-eight children with autism were r and omised between this treatment and routine care alone , stratified for age and baseline severity . Outcome was measured at 12 months from commencement of intervention , using st and ardised instruments . RESULTS All cases studied met full Autism Diagnostic Interview ( ADI ) criteria for classical autism . Treatment and controls had similar routine care during the study period and there were no study dropouts after treatment had started . The active treatment group showed significant improvement compared with controls on the primary outcome measure -- Autism Diagnostic Observation Schedule ( ADOS ) total score , particularly in reciprocal social interaction-- and on secondary measures of expressive language , communicative initiation and parent-child interaction . Suggestive but non-significant results were found in Vinel and Adaptive Behaviour Scales ( Communication Sub-domain ) and ADOS stereotyped and restricted behaviour domain . CONCLUSIONS A R and omised Treatment Trial design of this kind in classical autism is feasible and acceptable to patients . This pilot study suggests significant additional treatment benefits following a targeted ( but relatively non-intensive ) dyadic social communication treatment , when compared with routine care . The study needs replication on larger and independent sample s. It should encourage further RCT design s in this area",
"Aim : To determine the effect of parent education on adaptive behaviour , autism symptoms and cognitive/ language skills of young children with autistic disorder . Method : A r and omised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent skills training and a control sample . Two rural and two metropolitan regions were r and omly allocated to intervention groups ( n = 70 ) or control ( n = 35 ) . Parents from autism assessment services in the intervention regions were r and omly allocated to parent education and behaviour management ( n = 35 ) or parent education and counselling ( n = 35 ) . Results : Parent education and behaviour management result ed in significant improvement in adaptive behaviour and autism symptoms at 6 months follow-up for children with greater delays in adaptive behaviour . Parent education and behaviour management was superior to parent education and counselling . We conclude that a 20-week parent education programme including skills training for parents of young children with autistic disorder provides significant improvements in child adaptive behaviour and symptoms of autism for low-functioning children",
"BACKGROUND Social and communication impairments are core deficits and prognostic indicators of autism . We evaluated the impact of supplementing a comprehensive intervention with a curriculum targeting socially synchronous behavior on social outcomes of toddlers with autism spectrum disorders ( ASD ) . METHODS Fifty toddlers with ASD , ages 21 to 33 months , were r and omized to one of two six-month interventions : Interpersonal Synchrony or Non-Interpersonal Synchrony . The interventions provided identical intensity ( 10 hours per week in classroom ) , student-to-teacher ratio , schedule , home-based parent training ( 1.5 hours per month ) , parent education ( 38 hours ) , and instructional strategies , except the Interpersonal Synchrony condition provided a supplementary curriculum targeting socially engaged imitation , joint attention , and affect sharing ; measures of these were primary outcomes . Assessment s were conducted pre-intervention , immediately post-intervention , and , to assess maintenance , at six-month follow-up . R and om effects models were used to examine differences between groups over time . Secondary analyses examined gains in expressive language and nonverbal cognition , and time effects during the intervention and follow-up periods . RESULTS A significant treatment effect was found for socially engaged imitation ( p = .02 ) , with more than doubling ( 17 % to 42 % ) of imitated acts paired with eye contact in the Interpersonal Synchrony group after the intervention . This skill was generalized to unfamiliar context s and maintained through follow-up . Similar gains were observed for initiation of joint attention and shared positive affect , but between-group differences did not reach statistical significance . A significant time effect was found for all outcomes ( p toddlers to identify an active ingredient for enhancing socially engaged imitation . Adding social engagement targets to intervention improves short-term outcome at no additional cost to the intervention . The social , language , and cognitive gains in our participants provide evidence for plasticity of these developmental systems in toddlers with ASD . http://www . clinical trials.gov/ct2/show/NCT00106210?term = l and a&rank = 3",
"In this pilot study , we tested the effects of a novel intervention ( JASPER , Joint Attention Symbolic Play Engagement and Regulation ) on 3 to 5 year old , minimally verbal children with autism who were attending a non-public preschool . Participants were r and omized to a control group ( treatment as usual , 30 h of ABA-based therapy per week ) or a treatment group ( substitution of 30 min of JASPER treatment , twice weekly during their regular program ) . A baseline of 12 weeks in which no changes were noted in core deficits was followed by 12 weeks of intervention for children r and omized to the JASPER treatment . Participants in the treatment group demonstrated greater play diversity on a st and ardized assessment . Effects also generalized to the classroom , where participants in the treatment group initiated more gestures and spent less time unengaged . These results provide further support that even brief , targeted interventions on joint attention and play can improve core deficits in minimally verbal children with ASD",
"Through behavioural analysis , this study investigated the social-motivational aspects of musical interaction between the child and the therapist in improvisational music therapy by measuring emotional , motivational and interpersonal responsiveness in children with autism during joint engagement episodes . The r and omized controlled study ( n = 10 ) employed a single subject comparison design in two different conditions , improvisational music therapy and toy play sessions , and DVD analysis of sessions . Improvisational music therapy produced markedly more and longer events of ` joy ' , ` emotional synchronicity ' and ` initiation of engagement ' behaviours in the children than toy play sessions . In response to the therapist 's interpersonal dem and s , ` compliant ( positive ) responses ' were observed more in music therapy than in toy play sessions , and ` no responses ' were twice as frequent in toy play sessions as in music therapy . The results of this exploratory study found significant evidence supporting the value of music therapy in promoting social , emotional and motivational development in children with autism",
"Longitudinal research has demonstrated that responsive parental behaviors reliably predict subsequent language gains in children with autism spectrum disorder . To investigate the underlying causal mechanisms , we conducted a r and omized clinical trial of an experimental intervention ( Focused Playtime Intervention , FPI ) that aims to enhance responsive parental communication ( N = 70 ) . Results showed a significant treatment effect of FPI on responsive parental behaviors . Findings also revealed a conditional effect of FPI on children ’s expressive language outcomes at 12-month follow up , suggesting that children with baseline language skills below 12 months ( n = 24 ) are most likely to benefit from FPI . Parents of children with more advanced language skills may require intervention strategies that go beyond FPI ’s focus on responsive communication",
"The study evaluates a social-communication-based approach to autism intervention aim ed at improving the social interaction skills of children with autism spectrum disorder . We report preliminary results from an ongoing r and omized controlled trial of 51 children aged 2 years 0 months to 4 years 11 months . Participants were assigned to either a target treatment or community treatment group . Families in the target treatment group were given 2 hours of therapy and coaching each week in an intervention emphasizing social-interaction and the parent-child relationship . Children in the community treatment group received a variety of services averaging 3.9 hours per week . After 12 months , outcomes were measured to determine changes in the groups in social interaction and communication . In addition , a regression analysis was conducted to determine whether changes in social interaction skills were associated with language development . Results suggest that children in the treatment group made significantly greater gains in social interaction skills in comparison to the community treatment group , but no between-group differences were found for st and ard language assessment s. Initiation of joint attention , involvement , and severity of language delay were found to be significantly associated with improvement of language skills in children with autism . Finally caregiver skills targeted by the intervention were found to be significantly associated with changes in children ’s interaction skills",
"INTRODUCTION There is debate about the type and intensity of early childhood intervention that is most helpful for children with developmental problems . The aim of the study was to determine whether a home-based programme provided over 12 months result ed in sustained improvement in development and behaviour 12 months after the intervention ceased . The characteristics of the children and families who benefited most from the intervention were also studied . METHOD R and omized controlled trial . Participants A total of 59 children , aged 3 - 5 years , attending two early childhood intervention centres in Melbourne , Australia . Intervention Half of the subjects received an additional home-based programme consisting of 40 weekly visits . MAIN OUTCOME MEASURES Bayley Scales of Infant Development and Wechsler Preschool and Primary Scale of Intelligence Revised , Preschool Behaviour Checklist , Bayley Behaviour Rating Scale and Behaviour Screening Question naire . All tests administered pre-intervention , following the intervention and 12 months later . Secondary outcome measures Family stress , support and empowerment . RESULTS Fifty-four children completed the assessment s 12 months after conclusion of the intervention . Compared with the control group , improvement in aspects of cognitive development in the children who received the extra intervention was sustained 1 year later ( P= 0.007 ) while significant behavioural differences post intervention were not . Analyses of the data by the Reliable Change Index indicated improvement of clinical significance occurred in non-verbal areas . In contrast to the control group who deteriorated , language skills in the intervention group remained stable . Improvements were significantly associated with higher stress in the families . CONCLUSION Improvements following the provision of a home-based programme to preschool children with developmental disabilities were sustained 1 year later . Children from highly stressed families appeared to benefit most , reinforcing the importance of involving families in early childhood intervention programmes",
"BACKGROUND Deficits in joint attention ( JA ) and joint engagement ( JE ) represent a core problem in young children with autism as these affect language and social development . Studies of parent-mediated and specialist-mediated JA-intervention suggest that such intervention may be effective . However , there is little knowledge about the success of the intervention when done in preschools . AIM Assess the effects of a preschool-based JA-intervention . METHODS 61 children ( 48 males ) with autistic disorder ( 29 - 60 months ) were r and omized to either 8 weeks of JA-intervention , in addition to their preschool programs ( n = 34 ) , or to preschool programs only ( n = 27 ) . The intervention was done by preschool teachers with weekly supervision by trained counselors from Child and Adolescent Mental Health Clinics ( CAMHC ) . Changes in JA and JE were measured by blinded independent testers using Early Social Communication Scale ( ESCS ) and video taped preschool teacher-child and mother-child play at baseline and post-intervention . CLINICAL TRIALS REGISTRATION Clinical trials.gov : NCT00378157 . RESULTS Intention-to-treat analysis showed significant difference between the intervention and the control group , with the intervention group yielding more JA initiation during interaction with the preschool teachers . The effect generalized to significantly longer duration of JE with the mothers . CONCLUSIONS This is the first r and omized study to show positive and generalized effects of preschool-based JA-intervention",
"The study evaluated the efficacy a parent training intervention for children with autism based on the TEACCH model . Twenty families were r and omly assigned to the treatment or waitlist group . All families were compared at pre- and post-treatment on formal dependent measures . Direct measures of behavior were compared across six matched pairs using a multiple baseline probe design . The results of the multiple baseline design showed robust support for improvement in child and parent behavior . Due to the sample size and short time frame , results of a repeated measures analysis of variance did not reach significance",
"The effects of a teacher consultation intervention were examined — namely , the collaborative model for promoting competence and success ( COMPASS ) , which was design ed to improve objectives of individualized education programs for children with autism . The intervention consists of an initial parent — teacher consultation , followed by four teacher consultations across the school year . Thirty-five teachers and a r and omly selected child with autism ( M age = 6.1 years ) from each classroom participated . Compared to the nonintervention teacher — child dyads , the intervention teacher — child dyads showed improvements in individualized education program objectives , with a large effect size ( d = 1.51 )",
"The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms . Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers ( n = 14 ) . The 14 preschool special education teachers were r and omly assigned to one of three groups : ( 1 ) symbolic play then joint attention intervention , ( 2 ) joint attention then symbolic intervention , and ( 3 ) wait-list control period then further r and omized to either group 1 or group 2 . In the intervention , teachers participated in eight weekly individualized 1-h sessions with a research er that emphasized embedding strategies targeting symbolic play and joint attention into their everyday classroom routines and activities . The main child outcome variables of interest were collected through direct classroom observations . Findings indicate that teachers can implement an intervention to significantly improve joint engagement of young children with autism in their classrooms . Furthermore , multilevel analyses showed significant increases in joint attention and symbolic play skills . Thus , these pilot data emphasize the need for further research and implementation of classroom-based interventions targeting play and joint attention skills for young children with autism",
"Abstract . Few attempts have been made to conduct r and omised control trials ( RCTs ) of interventions for pre-school children with autism . We report findings of a pilot RCT for a parent training intervention with a focus on the development of joint attention skills and joint action routines . Twenty-four children meeting ICD-10 criteria for childhood autism ( mean age = 23 months ) were identified using the CHAT screen and r and omised to the parent training group or to local services only . A follow-up was conducted 12 months later ( mean age = 35 months ) . There was some evidence that the parent training group made more progress in language development than the local services group . However , the present pilot study was compromised by several factors : a reliance on parental report to measure language , non-matching of the groups on initial IQ , and a lack of systematic checking regarding the implementation of the parent training intervention . Furthermore , three parents in the local services group commenced intensive , home-based behavioural intervention during the course of the study . The difficulties encountered in the conduct of RCTs for pre-school children with autism are discussed . Method ological challenges and strategies for future well- design ed RCTs for autism interventions are highlighted"
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BACKGROUND The management of depressive and mixed symptoms in children and adolescents with bipolar disorder ( BD ) remains a matter of debate . The goal of this review is , thus , to systematic ally examine the impact of atypical antipsychotics ( AAPs ) and mood stabilisers in the treatment of bipolar depression and /or mixed states . METHODS A literature search was conducted for studies assessing the efficacy of pharmacological treatments for bipolar disorder type I , type II and not otherwise specified with a recent depressive , mixed or manic episode ( with depressive symptoms ) following DSM-IV criteria in children and adolescents as either acute or maintenance treatment . The data bases search ed were PubMed / Medline , Google Scholar and Trip data base , as well as Clinical Trials.gov . The search was limited to clinical trials , systematic review s , meta-analyses and open-label trials published in the English language between the years 2000 and 2015 . Sixty clinical studies were found assessing the efficacy of mood stabilisers and AAPs in paediatric BD . Fifteen studies were not included in the primary analysis because they did not assess depressive symptomology/include scores on rating scales of depressive symptoms ( Online Supplementary Material ) . RESULTS There is sufficient evidence for a Grade A recommendation of the use of olanzapine plus fluoxetine at reducing depressive symptoms in bipolar depression and of quetiapine at high doses for depressive symptoms occurring during mixed episodes . Importantly , even though monotherapy with aripiprazole , risperidone , valproate and lithium was effective at controlling mania , these drugs were not effective at reducing depressive symptoms ( level A evidence for non recommendation ) . CONCLUSIONS These results mostly overlap with the approved treatments for bipolar depression in adults
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"OBJECTIVE The treatment of pediatric bipolar depression has not been well studied . The authors wished to prospect ively study the efficacy of lamotrigine as adjunctive or monotherapy in adolescents with bipolar disorder who were experiencing a depressive episode . METHOD This was an 8-week open-label trial of lamotrigine with 20 adolescents ages 12 - 17 years ( mean age 15.8 ; 7 boys , 13 girls ) with diagnoses of bipolar disorder I , II , or not otherwise specified , who were experiencing a depressive episode . Lamotrigine was begun at 12.5 to 25 mg/day . Primary response criteria was a 1 or a 2 on the Clinical Global Impression-Improvement at week 8 . A secondary criterion was at least a 50 % decrease in Children 's Depression Rating Scale-Revised scores . RESULTS Nineteen subjects completed the trial . The mean final dose was 131.6 mg/day . Seven subjects were taking other psychotropic medications . Sixteen subjects ( 84 % ) responded by primary criteria , and 12 ( 63 % ) responded to our secondary criteria . Eleven subjects ( 58 % ) were considered in remission at week 8 . Young Mania Rating Scale and Overt Aggression Scale-Modified scores also decreased significantly during the trial . There was no significant weight change , rash , or other adverse effects during the trial . CONCLUSIONS Adolescents with bipolar depression appeared to respond to lamotrigine treatment , whether as adjunctive therapy or monotherapy , with decreases in depression , mania , and aggression . Larger , placebo-controlled studies of lamotrigine are needed in this population",
"BACKGROUND Antidepressant-induced mania ( AIM ) has been described in bipolar disorder ( BD ) and has been associated with the short-allele of the serotonin transporter gene ( 5-HTT ) . We wished to investigate the frequency of and risk factors for AIM in pediatric patients with or at high risk for BD . METHODS Fifty-two children and adolescents ( 30 with BD and 22 with subthreshold manic symptoms , 15.1 + /- 3.4 years old ) , all with a parent with BD , were interviewed with their parents for manic/depressive symptoms occurring before and after past antidepressant treatment . The 47 subjects with serotonin reuptake inhibitor ( SSRI ) exposure were genotyped for the 5-HTT polymorphism . RESULTS Fifty percent of subjects were AIM + and 25.5 % had new onset of suicidal ideation . The AIM + and AIM - groups did not differ significantly in relation to allele ( p = .36 ) or genotype ( p = .53 ) frequencies of the 5-HTT polymorphism . The AIM + subjects were more likely to have more comorbidities ( 3.2 vs. 2.4 ; p = .02 ) and be BD type I ( p = .04 ) than AIM - subjects . CONCLUSIONS Youth with or at high risk for BD may be particularly vulnerable to SSRI AIM and thus should be monitored if given SSRIs . In this preliminary study , we did not find that the 5-HTT polymorphism significantly influenced vulnerability to AIM",
"OBJECTIVE To assess the effectiveness and tolerability of ziprasidone for treating pediatric mania . METHODS This was an eight-week , open-label , prospect i ve study of ziprasidone monotherapy ( 57.3 + /- 33.9 mg/day ) in 21 bipolar youth [ manic , mixed , or bipolar not otherwise specified ( NOS ) ; 6 - 17 years old ] . Assessment s included the Young Mania Rating Scale ( YMRS ) , Clinical Global Impressions-Improvement scale ( CGI-I ) , and Brief Psychiatric Rating Scale ( BPRS ) . Adverse events were assessed through spontaneous self-reports , vital signs , weight monitoring , and laboratory analysis . RESULTS Fourteen of the 21 youth ( 67 % ) completed the study . Ziprasidone treatment was associated with clinical ly and statistically significant improvement in mean YMRS scores ( -10.8 + /- 8.4 , p CGI-I body weight ( 0.6 + /- 0.4 kg , p = 0.2 ) or QTc interval ( -3.7 + /- 4.7 , p = 0.5 ) . CONCLUSIONS Open-label ziprasidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder . Future placebo-controlled , double-blind studies are warranted",
"The British Association for Psychopharmacology guidelines specify the scope and targets of treatment for bipolar disorder . The third version is based explicitly on the available evidence and presented , like previous Clinical Practice Guidelines , as recommendations to aid clinical decision making for practitioners : it may also serve as a source of information for patients and carers , and assist audit . The recommendations are presented together with a more detailed review of the corresponding evidence . A consensus meeting , involving experts in bipolar disorder and its treatment , review ed key areas and considered the strength of evidence and clinical implication s. The guidelines were drawn up after extensive feedback from these participants . The best evidence from r and omized controlled trials and , where available , observational studies employing quasi-experimental design s was used to evaluate treatment options . The strength of recommendations has been described using the GRADE approach . The guidelines cover the diagnosis of bipolar disorder , clinical management , and strategies for the use of medicines in short-term treatment of episodes , relapse prevention and stopping treatment . The use of medication is integrated with a coherent approach to psychoeducation and behaviour change",
"BACKGROUND This study evaluates the long-term efficacy of aripiprazole compared to placebo in children with bipolar disorders . METHOD Out patients aged 4 to 9 years meeting DSM-IV criteria for a bipolar disorder ( I , II , not otherwise specified , cyclothymia ) were eligible to receive up to 16 weeks of open-label treatment with aripiprazole ( phase 1 ) . Patients were r and omized into the 72-week double-blind phase of the study once they met a priori response criteria for stabilization ( phase 2 ) . During phase 2 , patients either remained on their current aripiprazole regimen or began a double-blind taper with aripiprazole discontinued and switched to placebo . The primary outcome measure for phase 2 was time to discontinuation due to a mood event . RESULTS Patients were recruited between May 2004 and November 2008 . Following phase 1 , in which 96 patients received aripiprazole , 30 patients ( mean age = 7.1 years ) were r and omly assigned to continue aripiprazole and 30 patients ( mean age = 6.7 years ) were r and omly assigned to placebo . The mean ( SD ) dose of aripiprazole prior to r and omization for these patients was 6.4 ( 2.1 ) mg/d . Patients r and omly assigned to aripiprazole were enrolled significantly longer until time to study discontinuation due to a mood event ( 6.14 median weeks , SE ± 11.88 weeks ; P = .005 ) and discontinuation for any reason ( including mood events ) ( 4.00 median weeks , SE ± 3.91 weeks ; P = .003 ) than those r and omly assigned to placebo ( mood event , 2.29 median weeks , SE ± 0.38 weeks ; any reason , 2.00 median weeks , SE ± 0.31 weeks ) . Regardless of r and om assignment , both the aripiprazole and placebo groups showed substantial rates of withdrawal from maintenance treatment over the initial 4 weeks ( 15/30 [ 50 % ] for aripiprazole ; 27/30 [ 90 % ] for placebo ) , suggesting a possible nocebo effect ( ie , knowledge of possibly switching from active medication to placebo increasing concern about relapse ) . The most frequently reported adverse events during double-blind aripiprazole therapy included stomach pain ( n = 10 , 33 % ) , increased appetite ( n = 9 , 30 % ) , and headaches ( n = 9 , 30 % ) . CONCLUSIONS Despite the possibility of a nocebo effect , these results suggest that aripiprazole may be superior to placebo in the long-term treatment of pediatric patients following stabilization with open-label aripiprazole . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00194077",
"BACKGROUND Evidence is accumulating to support the use of atypical neuroleptics as adjunctive treatment for refractory mood disorders , although there are currently no published data on the efficacy of an atypical neuroleptic in treatment-resistant depression when a previous trial of drug from the same class has failed . The authors hypothesized that aripiprazole would be efficacious in augmenting antidepressant treatment in resistant patients with non-psychotic unipolar depression who had previously failed a trial of another atypical neuroleptic . METHODS This study was a retrospective chart review of the efficacy of aripiprazole augmentation in 30 treatment-resistant unipolar depression patients who had failed multiple previous antidepressant trials and had also failed augmentation with at least one other atypical neuroleptic . Prospect i ve Global Assessment of Functioning and Clinical Global Impressions-Improvement scores were completed on each patient throughout treatment . RESULTS Utilizing an intent-to-treat analysis ( including 9 patients who dropped out prior to completion of 6 weeks ) , 46.7 % ( 14/30 ) patients were rated much improved or very much improved with treatment . This improvement negatively correlated with Thase-Rush staging of treatment resistance . GAF scores also showed a significant improvement . Six of the 14 patients who initially improved subsequently relapsed ( yielding a long-term net response rate of 26.7 % ) . CONCLUSION Aripiprazole may be effective as an antidepressant augmentation agent in highly treatment resistant patients who had failed a prior trial of another atypical neuroleptic",
"OBJECTIVE This study examined the long-term effectiveness of lithium for the treatment of pediatric bipolar disorder within the context of combination mood stabilizer therapy for refractory mania and pharmacological treatment of comorbid psychiatric conditions . METHODS Out patients , ages 7 - 17 years , meeting American Psychiatric Association , diagnostic and statistical manual of mental disorders , 4th ed . ( DSM-IV ) diagnostic criteria for bipolar disorder I ( BP-I ) ( manic or mixed ) who demonstrated at least a partial response to 8 weeks of open-label treatment with lithium ( phase I ) were eligible to receive open-label lithium for an additional 16 weeks ( phase II ) . Up to two adjunctive medications could be prescribed to patients experiencing residual symptoms of mania or comorbid psychiatric conditions , following a st and ardized algorithm . RESULTS Forty-one patients received continued open-label long-term treatment with lithium for a mean of 14.9 ( 3.0 ) weeks during phase II . The mean weight-adjusted total daily dose at end of phase II was 27.8 ( 6.7 ) mg/kg/day , with an average lithium concentration of 1.0 ( 0.3 ) mEq/L. Twenty-five of the 41 patients ( 60.9 % ) were prescribed adjunctive psychotropic medications for residual symptoms . The most frequent indications for adjunctive medications were refractory mania ( n=13 ; 31.7 % ) and attention-deficit/hyperactivity disorder ( ADHD ) ( n=15 ; 36.6 % ) . At the end of this phase 28 ( 68.3 % ) patients met a priori criteria for response ( ≥50 % reduction from phase I baseline in young mania rating scale [ YMRS ] summary score and a clinical global impressions-improvement [ CGI-I ] score of 1 or 2 ) , with 22 ( 53.7 % ) considered to be in remission ( YMRS summary score≤12 and CGI-severity score of 1 or 2 ) . These data suggest that patients who initially responded to lithium maintained mood stabilization during continuation treatment , but partial responders did not experience further improvement during Phase II , despite the opportunity to receive adjunctive medications . The most commonly reported ( ≥20 % ) adverse events associated with lithium treatment were vomiting , headache , abdominal pain , and tremor . CONCLUSIONS Lithium may be a safe and effective longer-term treatment for patients with pediatric bipolar disorder who respond to acute treatment with lithium . Partial responders to acute lithium did not appear to experience substantial symptom improvement during the continuation phase , despite the possibility that adjunctive medications could be prescribed",
"OBJECTIVES To evaluate the efficacy , safety , and tolerability of risperidone monotherapy for the treatment of an acute mixed or manic episode in children and adolescents with bipolar I disorder . METHODS This r and omized , placebo-controlled , double-blind , 3-arm study ( N = 169 ) included children and adolescents ( ages 10 - 17 years ) with a DSM-IV diagnosis of bipolar I disorder , experiencing a manic or mixed episode . Study participants were r and omized to placebo ( n = 58 ) , risperidone 0.5 - 2.5 mg/day ( n = 50 ) , or risperidone 3 - 6 mg/day ( n = 61 ) for 3 weeks . The primary efficacy measure was change in Young Mania Rating Scale ( YMRS ) total score from baseline to end point . Safety assessment s included adverse event ( AE ) monitoring and scores on extrapyramidal symptom rating scales . RESULTS Improvement in mean YMRS total score was significantly greater in risperidone-treated subjects than in placebo-treated subjects [ mean change ( SD ) -9.1 ( 11.0 ) for placebo ; -18.5 ( 9.7 ) for risperidone 0.5 - 2.5 mg ( p risperidone 3 - 6 mg ( p risperidone-associated AEs were somnolence , headache , and fatigue . Mean ( SD ) weight gain was 0.7 ( 1.9 ) kg , 1.9 ( 1.7 ) kg , and 1.4 ( 2.4 ) kg in the placebo , risperidone 0.5 - 2.5 mg , and risperidone 3 - 6 mg groups , respectively , during this 3-week study . CONCLUSIONS At daily doses of 0.5 - 2.5 mg and 3 - 6 mg , risperidone was effective and well tolerated in children and adolescents experiencing acute manic or mixed episodes of bipolar I disorder . Results indicate that risperidone 0.5 - 2.5 mg has a better benefit-risk profile than risperidone 3 - 6 mg",
"OBJECTIVE To compare the efficacy and safety of divalproex extended-release ( ER ) to placebo in a 28-day double-blind study of bipolar disorder in children and adolescents and evaluate the safety of divalproex ER in a 6-month open-label extension study . METHOD In the double-blind study , 150 patients ( manic or mixed episode , aged 10 - 17 years ) with baseline Young Mania Rating Scale ( YMRS ) score of 20 or higher were r and omized to once-daily placebo or divalproex ER , which was titrated to clinical response or serum valproate concentration of 80 to 125 microg/mL. Sixty-six patients enrolled in the extension study . RESULTS In the double-blind study , a treatment effect was not observed with divalproex ER based on change in mean YMRS score ( divalproex ER -8.8 [ n = 74 ] ; placebo -7.9 [ n = 70 ] ) or secondary measures . Divalproex was similar to placebo based on incidence of adverse events . Four subjects treated with divalproex ER and three treated with placebo discontinued because of adverse events . Mean ammonia levels increased in the divalproex ER group , but only one patient was symptomatic . In the long-term study , YMRS scores decreased modestly ( 2.2 points from baseline ) . The most common adverse events were headache and vomiting . CONCLUSIONS The results of the study do not provide support for the use of divalproex ER in the treatment of youths with bipolar I disorder , mixed or manic state . Further controlled trials are required to confirm or refute the findings from this study",
"OBJECTIVE To determine whether divalproex sodium ( DVPX ) was superior to lithium carbonate ( Li+ ) in the maintenance monotherapy treatment of youths diagnosed with bipolar disorder who had been previously stabilized on combination Li+ and DVPX ( Li+/DVPX ) pharmacotherapy . METHOD Youths ages 5 - 17 years with bipolar I or II disorder were initially treated with Li /DVPX . Patients meeting remission criteria for four consecutive weeks were then r and omized in a double-blind fashion to treatment with either Li+ or DVPX for up to 76 weeks . Study participation ended if the subject required additional clinical intervention or if the subject did not adhere to study procedures . RESULTS Patients were recruited between July 1998 and May 2002 . One hundred thirty-nine youths with a mean ( SD ) age of 10.8 ( 3.5 ) years were initially treated with Li+/DVPX for a mean ( SD ) duration of 10.7 ( 5.4 ) weeks . Sixty youths were then r and omized to receive monotherapy with Li+ ( n = 30 ) or DVPX ( n = 30 ) . The Li+ and DVPX treatment groups did not differ in survival time until emerging symptoms of relapse ( p = .55 ) or survival time until discontinuation for any reason ( p = .72 ) . CONCLUSIONS DVPX was not found to be superior to Li+ as maintenance treatment in youths who stabilized on combination Li+/DVPX pharmacotherapy",
"OBJECTIVE Quetiapine is an atypical antipsychotic with demonstrated efficacy in the treatment of adolescent schizophrenia and pediatric bipolar mania . Large , placebo-controlled studies of interventions in pediatric bipolar depression are lacking . The current study investigated the efficacy and safety of quetiapine extended-release ( XR ) in patients 10 - 17 years of age , with acute bipolar depression . METHODS This multicenter , double-blind , r and omized , placebo-controlled study investigated quetiapine XR ( dose range , 150 - 300 mg/day ) in pediatric out patients with an American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed . , Text Revision ( DSM-IV-TR ) diagnosis of bipolar I or bipolar II disorder ( current or most recent episode depressed ) treated for up to 8 weeks ( Clinical Trials.gov identifier : NCT00811473 ) . The primary study outcome was mean change in Children 's Depression Rating Scale-Revised ( CDRS-R ) total score . Secondary efficacy outcomes included CDRS-R-based response and remission rates . RESULTS Of 193 patients r and omized to treatment , 144 patients completed the study ( 75.3 % of quetiapine XR group [ n=70 ] ; 74.0 % of placebo group [ n=74 ] ) . Least squares mean changes in CDRS-R total score at week 8 were : -29.6 ( SE , 1.65 ) with quetiapine XR and -27.3 ( SE , 1.60 ) with placebo , a between-treatment group difference of -2.29 ( SE , 1.99 ; 95 % CI , -6.22 , 1.65 ; p=0.25 ; mixed-model for repeated measures analysis ) . Rates of response and remission did not differ significantly between treatment groups . The safety profile of quetiapine XR was broadly consistent with the profile reported previously in adult studies of quetiapine XR and pediatric studies of quetiapine immediate-release ( IR ) . Potentially clinical ly significant elevations in clinical chemistry values included triglycerides ( 9.3 % , quetiapine XR ; 1.4 % , placebo group ) and thyroid stimulating hormone ( 4.7 % , quetiapine XR ; 0 % , placebo group ) . An adverse event potentially related to diabetes mellitus occurred in 3.3 % of the quetiapine XR versus no adverse events in the placebo group . CONCLUSIONS Quetiapine XR did not demonstrate efficacy relative to placebo in this 8 week study of pediatric bipolar depression . Quetiapine XR was generally safe and well tolerated",
"Aim : To evaluate the safety and efficacy of lamotrigine monotherapy as an acute treatment of bipolar mood elevation in children with bipolar spectrum disorders . Method : This was a 12‐week , open‐label , prospect i ve trial of lamotrigine monotherapy to assess the effectiveness and tolerability of this compound in treating pediatric bipolar disorder . Assessment s included the Young Mania Rating Scale ( YMRS ) , Clinical Global Impressions‐Improvement scale ( CGI‐I ) , Children 's Depression Rating Scale ( CDRS ) , and Brief Psychiatric Rating Scale ( BPRS ) . Adverse events were assessed through spontaneous self‐reports , vital signs weight monitoring , and laboratory analysis . Results : Thirty‐nine children with bipolar disorder ( YMRS at entry : 31.6 ± 5.5 ) were enrolled in the study and 22 ( 56 % ) completed the 12‐week trial . Lamotrigine was slowly titrated to an average endpoint dose of 160.7 ± 128.3 in subjects age ( N = 22 ) and 219.1 ± 172.2 mg/day in children 12–17 years of age ( N = 17 ) . Treatment with lamotrigine was associated with statistically significant levels of improvement in mean YMRS scores ( −14.9 ± 9.7 , P . Lamotrigine treatment also result ed in significant improvement in the severity of depressive , attention‐deficit/hyperactivity disorder ( ADHD ) , and psychotic symptoms . Lamotrigine was generally well tolerated with marginal increase in body weight ( 47.0 ± 18.0 kg vs. 47.2 ± 17.9 kg , P= 0.6 ) and was not associated with abnormal changes in laboratory parameters . Several participants were discontinued due to skin rash ; in all cases , the rash resolved shortly after discontinuation of treatment . No patient developed Steven Johnson syndrome . Conclusions : Open‐label lamotrigine treatment appears to be beneficial in the treatment of bipolar disorder and associated conditions in children . Future placebo‐controlled , double‐blind studies are warranted to confirm these findings",
"OBJECTIVE The aim of this study was to evaluate the potential of risperidone as a treatment of pediatric bipolar disorder . METHODS This was an 8-week , open-label , prospect i ve study of risperidone monotherapy ( 1.25 + /- 1.5 mg/d ) for 30 bipolar youths ( manic , mixed , or hypomanic ; 6 - 17 years of age ) . RESULTS Twenty-two of the 30 youths ( 73 % ) completed the study . Using predefined criteria for improvement ( a Clinical Global Impressions Improvement in Mania score of manic symptoms was 70 % . The significant reduction in symptoms of mania result ed in a mean Young Mania Rating Scale ( YMRS ) score 13.5 at endpoint , indicating mild residual symptoms . Weight increased significantly from baseline ( 2.1 + /- 2.0 kg ; p increase in prolactin levels from baseline ( p risperidone treatment was associated with a significant shortterm improvement of symptoms of pediatric bipolar disorder . Future placebo-controlled , double-blind studies are needed to confirm these preliminary results",
"Background The purpose of the study was to determine the effectiveness and tolerability of quetiapine as a maintenance treatment preventing against relapse or recurrence of acute mood episodes in adolescent patients diagnosed with bipolar disorder . Methods Consenting patients meeting DSM-IV lifetime criteria for a bipolar disorder and clinical ly appropriate for maintenance treatment were enrolled in a 48-week open prospect i ve study . After being acutely stabilized ( CGI-S ≤ 3 for 4 consecutive weeks ) , patients were started or continued on quetiapine and other medications were weaned off over an 8-week period . Quetiapine monotherapy was continued for 40-weeks and other mood stabilizers or antidepressants were added if clinical ly indicated . A neurocognitive test battery assessing the most reliable findings in adult patients was administered at fixed time points throughout the study to patients and matched controls . Results Of the 21 enrolled patients , 18 completed the 48-week study . Thirteen patients were able to be maintained without relapse or recurrence in good quality remission on quetiapine monotherapy , while 5 patients required additional medication to treat impairing residual depressive and /or anxiety symptoms . According to symptom ratings and global functioning scores , the quality of remission for all patients was very good . Neurocognitive test performance over treatment was equivalent to that of a matched control group of never ill adolescents . Quetiapine was generally well tolerated with no serious adverse effects . Conclusion This study suggests that a proportion of adolescent patients diagnosed with bipolar disorder can be successfully maintained on quetiapine monotherapy . The good quality of clinical remission and preserved neurocognitive functioning underscores the importance of early diagnosis and effective stabilization . Clinical Trials",
"OBJECTIVE To assess the efficacy and safety of olanzapine/fluoxetine combination ( OFC ) for the acute treatment of bipolar depression in children and adolescents . METHOD Patients 10 to 17 years of age with bipolar I disorder ( BP-I ) , depressed episode , baseline Children 's Depression Rating Scale-Revised ( CDRS-R ) total score ≥40 , Young Mania Rating Scale ( YMRS ) total score ≤15 , and YMRS-item 1 ≤2 were r and omized to OFC ( 6/25 - 12/50 mg/day olanzapine/fluoxetine ; n = 170 ) or placebo ( n = 85 ) for up to 8 weeks of double-blind treatment . The primary efficacy measure was mean change in CDRS-R using mixed-model repeated- measures methodology . RESULTS Baseline-to-week-8 least-squares mean change in CDRS-R total score was greater for OFC-treated patients than for placebo-treated patients ( -28.4 versus -23.4 , p = .003 ; effect size = .46 ) , with between-group differences statistically significant at week 1 ( p = .02 ) and all subsequent visits ( all p remission were statistically significantly greater for OFC- than for placebo-treated patients . The most frequent treatment-emergent adverse events in the OFC group were weight gain , increased appetite , and somnolence . Mean weight gain at patient 's endpoint was significantly greater for OFC- than for placebo-treated patients ( 4.4 kg versus 0.5 kg , p .001 ) . Treatment-emergent hyperlipidemia was very common among OFC-treated patients . Abnormal increases in hepatic analytes , prolactin , and corrected QT interval ( QTc ) were also common or very common but generally not clinical ly significant . CONCLUSION In this study , OFC was superior to placebo , and has been approved by the US Food and Drug Administration ( FDA ) for the acute treatment of bipolar I depression in patients 10 to 17 years of age . Benefits should be weighed against the risk of adverse events , particularly weight gain and hyperlipidemia . Clinical trial registration information-A Study for Assessing Treatment of Patients Ages 10 - 17 with Bipolar Depression ; http:// clinical trials.gov ; NCT00844857",
"OBJECTIVE The purpose of this study was to evaluate the short- and long-term efficacy and safety of ziprasidone in children and adolescents with bipolar I disorder . METHODS Subjects 10 - 17 years of age with a manic or mixed episode associated with bipolar I disorder participated in a 4 week , r and omized , double-blind , placebo-controlled multicenter trial ( RCT ) followed by a 26 week open-label extension study ( OLE ) . Subjects were r and omized 2:1 to initially receive flexible-dose ziprasidone ( 40 - 160 mg/day , based on weight ) or placebo . Primary outcome was the change in Young Mania Rating Scale ( YMRS ) scores from baseline . Safety assessment s included weight and body mass index ( BMI ) , adverse events ( AEs ) , vital signs , laboratory measures , electrocardiograms , and movement disorder ratings . RESULTS In the RCT , 237 subjects were treated with ziprasidone ( n=149 ; mean age , 13.6 years ) or placebo ( n=88 ; mean age , 13.7 years ) . The estimated least squares mean changes in YMRS total ( intent-to-treat population ) were -13.83 ( ziprasidone ) and -8.61 ( placebo ; p=0.0005 ) at RCT endpoint . The most common AEs in the ziprasidone group were sedation ( 32.9 % ) , somnolence ( 24.8 % ) , headache ( 22.1 % ) , fatigue ( 15.4 % ) , and nausea ( 14.1 % ) . In the OLE , 162 subjects were enrolled , and the median duration of treatment was 98 days . The mean change in YMRS score from the end of the RCT to the end of the OLE ( last observation carried forward ) was -3.3 ( 95 % confidence interval , -5.0 to -1.6 ) . The most common AEs were sedation ( 26.5 % ) , somnolence ( 23.5 % ) , headache ( 22.2 % ) , and insomnia ( 13.6 % ) . For both the RCT and the OLE , no clinical ly significant mean changes in movement disorder scales , BMI z-scores , liver enzymes , or fasting lipids and glucose were observed . One subject on ziprasidone in the RCT and none during the OLE had Fridericia-corrected QT interval ( QTcF ) ≥ 460 ms . CONCLUSION These results demonstrate that ziprasidone is efficacious for treating children and adolescents with bipolar disorder . Ziprasidone was generally well tolerated with a neutral metabolic profile . CLINICAL TRIALS REGISTRY NCT00257166 and NCT00265330 at Clinical Trials.gov",
"OBJECTIVE To evaluate the efficacy and safety of quetiapine monotherapy in children and adolescents with mania associated with bipolar I disorder . METHOD Patients aged 10 to 17 years , with a DSM-IV-TR diagnosis of a manic episode associated with bipolar I disorder and Young Mania Rating Scale ( YMRS ) total score ≥ 20 were r and omized to 3 weeks of quetiapine ( 400 or 600 mg/d ) or placebo . The primary efficacy measure was change in YMRS total score . The study was conducted at 34 centers in the United States between August 2004 and July 2006 . RESULTS The intent-to-treat population included 277 patients . Least squares mean change in YMRS score from baseline to end point by mixed-model , repeated- measures analysis was -14.25 , -15.60 , and -9.04 for quetiapine 400 mg/d , quetiapine 600 mg/d , and placebo , respectively ( P YMRS score versus placebo was first observed at day 4 ( P = .015 ) with quetiapine 400 mg/d and day 7 ( P with quetiapine 600 mg/d . Mean changes in body weight at day 21 ( observed cases ) were 1.7 kg for both quetiapine doses and 0.4 kg for placebo . Numerically larger mean increases in total cholesterol , low-density lipoprotein cholesterol , and triglycerides were observed with quetiapine than placebo . Adverse events associated with quetiapine were mostly mild to moderate in intensity . CONCLUSIONS In this 3-week study , quetiapine was significantly more effective than placebo in improving manic symptoms in youth with mania associated with bipolar disorder . Treatment was generally well tolerated and adverse events were broadly consistent with the known profile of quetiapine in adults with bipolar disorder . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00090311",
"OBJECTIVE Co-morbid diagnoses , such as disruptive behavior disorders ( DBDs ) and high levels of aggression , are extremely common among youth with pediatric bipolar disorder ( PBD ) and may interfere with treatment response ; however , they have rarely been examined as predictors of response to pharmacotherapy . The current study examines co-morbid DBD and aggression prospect ively as predictors of pharmacotherapy outcome , as well as potential moderators of response to a specific medication ( risperidone vs. divalproex ) , among children with PBD . METHODS Data are from a prospect i ve 6-week double-blind , placebo-controlled , r and omized outpatient medication treatment trial of risperidone versus divalproex for manic episodes in 65 children 8 - 18 with PBD . Outcome measures were administered at pretest , post-test , and weekly during the 6 weeks of treatment . Mixed-effects regression models were used to examine pharmacotherapy response . RESULTS Results indicated that youth with co-morbid DBD experienced greater improvement in manic symptoms in response to risperidone versus divalproex , whereas youth with non-co-morbid DBD experienced similar trajectories of symptom improvement in both medication groups . In addition , the non-DBD group experienced greater improvement in global functioning over time as compared with youth with co-morbid-DBD , and this gap increased over the course of treatment . Results also indicated that high-aggression youth experienced worse global functioning by end treatment versus low-aggression youth . CONCLUSIONS In conclusion , a co-morbid diagnosis of DBD and /or high levels of aggressive symptoms in youth with PBD may be important clinical predictors of variation in treatment response to pharmacotherapy . These findings may help research ers and clinicians develop tailored treatment approaches that optimize symptom and functional outcomes",
"OBJECTIVE Lithium carbonate ( Li ) or divalproex sodium ( DVPX ) may be effective for some juveniles with bipolar disorder . Many youths with bipolar disorder do not respond to DVPX or Li monotherapy . An open-label study was conducted to examine the effectiveness of combination DVPX and Li therapy with youths diagnosed with bipolar disorder . METHOD Patients meeting DSM-IV criteria for bipolar I or bipolar II disorder , ages 5 to 17 years , were treated prospect ively for up to 20 weeks with DVPX + Li . Assessment s included the Young Mania Rating Scale ( YMRS ) , Children 's Depression Rating Scale-Revised ( CDRS-R ) , and the Children 's Global Assessment Scale ( CGAS ) . The a priori definition of clinical remission utilized included four contiguous weekly ratings of YMRS /=51 , clinical stability , and no evidence of mood cycling . RESULTS Ninety patients ( 66 males , 24 females ) were treated . Significant improvement ( p juvenile bipolar disorder may be safely and effectively treated acutely with DVPX + Li",
"OBJECTIVE It has been reported that bipolar disorder may become less responsive to previously effective treatment with each symptomatic relapse . The primary goal of this study was to assess the rate of re-stabilization after the resumption of lithium ( Li ) plus divalproex ( DVPX ) following relapse on either agent as monotherapy . METHOD This is a prospect i ve , 8-week , open-label outpatient Li/DVPX combination therapy trial . Patients ages 5 to 17 years with bipolar disorder type I or II , who had achieved symptom remission with Li/DVPX combination therapy and subsequently relapsed during treatment with Li or DVPX monotherapy were enrolled between January 1999 and January 2003 . RESULTS Thirty-eight patients with a mean age of 10.5 years entered the study . Thirty-four ( 89.5 % ) patients responded to treatment with Li/DVPX mood stabilizer therapy alone , but four patients required adjunctive antipsychotic treatment to address residual symptomatology . Overall , reinitiation of Li/DVPX combination therapy was well tolerated with no subjects discontinuing because of a medication-related adverse event . CONCLUSIONS It appears that most youths with bipolar disorder who stabilize on combination Li/DVPX therapy and subsequently relapse during monotherapy can safely and effectively be re-stabilized with the reinitiation of Li/DVPX combination treatment",
"OBJECTIVE To assess the efficacy of topiramate monotherapy for acute mania in children and adolescents with bipolar disorder type I. METHOD This double-blind , placebo-controlled study was discontinued early when adult mania trials with topiramate failed to show efficacy . Efficacy end points included the Young Mania Rating Scale ( YMRS ) , Brief Psychiatric Rating Scale for Children , Children 's Depression Rating Scale , Children 's Global Assessment Scale , and Clinical Global Impressions-Improvement . RESULTS Fifty-six children and adolescents ( 6 - 17 years ) with a diagnosis of bipolar disorder type I received topiramate ( n=29 , 52 % ) or placebo ( n=27 , 48 % ) . The only statistically significant differences in efficacy measures between treatment groups were the difference between slopes of the linear mean profiles of the YMRS ( p=.003 ) using a post hoc repeated measures regression and the change in Brief Psychiatric Rating Scale for Children at day 28 ( -14.9 versus-5.9 , p=.048 ) using observed data . Adverse events with topiramate included decreased appetite , nausea , diarrhea , and paresthesia . CONCLUSIONS Topiramate was well tolerated ; however , the results are inconclusive because of premature termination result ing in a limited sample size . Adequately powered controlled trials are necessary to determine whether topiramate has efficacy in reducing symptoms of acute mania in children and adolescents",
"We have studied striatal D2 dopamine binding in schizophrenic patients treated with the novel atypical antipsychotic drug , olanzapine.123I iodobenzamide ( IBZM ) single photon emission tomography ( SPET ) was used to estimate striatal dopamine D2 receptor binding in vivo . Patients were recruited from a prospect i ve , double blind controlled trial of olanzapine versus haloperidol treatment . In vivo striatal D2 binding data from olanzapine treated patients ( n=6 ) were compared with previously reported data from typical antipsychotic responsive ( n=10 ) ; clozapine ( n=10 ) ; and risperidone ( n=6 ) treated patient groups . Mean % Brief Psychiatric Rating Scale score ( BPRS ) improvement following olanzapine treatment was 49 % ( SD 44 ) . The hypothesis that clinical improvement in olanzapine treated patients would be associated with higher mean striatal D2 binding of123I IBZM ( reflecting lower levels of D2 occupancy ) than typical antipsychotic ( 1.25±0.05 ) or risperidone ( 1.24±0.04 ) treatment was confirmed . Olanzapine treated patients had similar levels of striatal D2 binding in vivo ( 1.41±0.06 ) as those treated with clozapine ( 1.49±0.04 ) . This preliminary evidence suggests olanzapine is another atypical antipsychotic drug in which therapeutic response is not associated with a high degree of striatal D2 receptor occupancy in vivo",
"OBJECTIVE To evaluate the efficacy and tolerability of ziprasidone in children and adolescents with Tourette 's syndrome and chronic tic disorders . METHOD Twenty-eight patients aged 7 to 17 years were r and omly assigned to ziprasidone or placebo for 56 days . Ziprasidone was initiated at a dose of 5 mg/day and flexibly titrated to a maximum of 40 mg/day . RESULTS Ziprasidone was significantly more effective than placebo in reducing the Global Severity ( p = .016 ) and Total Tic ( p = .008 ) scores on the Yale Global Tic Severity Scale . Compared with placebo , ziprasidone significantly reduced tic frequencies as determined by blind videotape tic counts ( p = .039 ) . The mean ( + /- SD ) daily dose of ziprasidone during the last 4 weeks of the trial was 28.2 + /- 9.6 mg . Mild transient somnolence was the most common adverse event . No clinical ly significant effects were observed on specific ratings of extrapyramidal symptoms , akathisia , or tardive dyskinesia . CONCLUSIONS In this limited sample , ziprasidone ( 5 - 40 mg/day ) appears to be effective and well tolerated in the treatment of Tourette 's syndrome . Ziprasidone may be associated with a lower risk of extrapyramidal side effects in children . However , additional studies are necessary to evaluate more fully its safety and efficacy in children with tic disorders",
"OBJECTIVE This prospect i ve 6-month open trial examined the effectiveness and safety of divalproex sodium ( DVPX ) in pediatric mixed mania . METHOD Thirty-four subjects with a mean age of 12.3 ( SD = 3.7 ) years , DSM-IV diagnosis of a current mixed episode and a baseline Young Mania Rating Scale ( YMRS ) score > 20 were treated with DVPX monotherapy . The primary outcome measures were the YMRS and the Child Depression Rating Scale-Revised . Secondary measures were the Clinical Global Impression Scale for Bipolar Disorder ( CGI-BP ) and the Children 's Global Assessment of Functioning Scale ( C-GAS ) . Measures of safety and tolerability were also administered . RESULTS Effect size ( Cohen 's d ) based on change scores from baseline was 2.9 for the YMRS and 1.23 for the CDRS-R. Response rate ( > or = 50 % change from baseline YMRS score and remission rate ( > or = 50 % change from baseline on YMRS , CDRS-R , CGI-BP-Improvement subscale of or = 51 CGAS score ) was 52.9 % . Significant improvements ( p outcome measures ( i.e. , YMRS , CGI-BP , CDRS-R , and C-GAS ) . DVPX was safe and well tolerated with no serious adverse events during the 6-month trial . CONCLUSION This study provides evidence for the effectiveness and safety of DVPX in the treatment of pediatric mixed mania over a 6-month period . Placebo-controlled , r and omized trials involving larger sample s will ultimately shed light on the efficacy of this agent",
"BACKGROUND : Lithium is a benchmark treatment for bipolar disorder in adults . Definitive studies of lithium in pediatric bipolar I disorder ( BP-I ) are lacking . METHODS : This multicenter , r and omized , double-blind , placebo-controlled study of pediatric participants ( ages 7–17 years ) with BP-I/manic or mixed episodes compared lithium ( n = 53 ) versus placebo ( n = 28 ) for up to 8 weeks . The a priori primary efficacy measure was change from baseline to the end of study ( week 8/ET ) in the Young Mania Rating Scale ( YMRS ) score , based on last-observation-carried-forward analysis . RESULTS : The change in YMRS score was significantly larger in lithium-treated participants ( 5.51 [ 95 % confidence interval : 0.51 to 10.50 ] ) after adjustment for baseline YMRS score , age group , weight group , gender , and study site ( P = .03 ) . Overall Clinical Global Impression – Improvement scores favored lithium ( n = 25 ; 47 % very much/much improved ) compared with placebo ( n = 6 ; 21 % very much/much improved ) at week 8/ET ( P = .03 ) . A statistically significant increase in thyrotropin concentration was seen with lithium ( 3.0 ± 3.1 mIU/L ) compared with placebo ( –0.1 ± 0.9 mIU/L ; P with respect to weight gain . CONCLUSIONS : Lithium was superior to placebo in reducing manic symptoms in pediatric patients treated for BP-I in this clinical trial . Lithium was generally well tolerated in this patient population and was not associated with weight gain , distinguishing it from other agents commonly used to treat youth with bipolar disorder",
"OBJECTIVE To determine the comparative efficacy of quetiapine and divalproex for the treatment of adolescent mania . METHOD Fifty adolescents ( ages 12 - 18 years ) with bipolar I disorder , manic or mixed episode , were r and omized to quetiapine ( 400 - 600 mg/day ) or divalproex ( serum level 80 - 120 microg/mL ) for 28 days for this double-blind study , which was conducted from July 2002 through January 2004 . The primary efficacy measure was change in Young Mania Rating Scale ( YMRS ) score across the study period . RESULTS Repeated measures analysis of variance using the last-observation carried forward data indicated no statistically significant group difference in YMRS scores across the 28 days of the study ( p = 0.3 ) . Mixed regression analyses ( comparison of slopes ) revealed that improvement in YMRS scores occurred more rapidly in the quetiapine than in the divalproex group for both the last-observation carried forward ( p = 0.01 ) and observed data ( p = 0.03 ) . Response and remission rates were significantly greater in the quetiapine than in the divalproex group ( p Rates of adverse events did not differ significantly between groups . CONCLUSIONS The results suggest that quetiapine is at least as effective as divalproex in the treatment of acute manic symptoms associated with adolescent bipolar disorder ; however , a quicker reduction of manic symptoms may occur with quetiapine as compared with divalproex . Quetiapine may be useful as monotherapy for the treatment of adolescents with manic or mixed episodes , although placebo-controlled studies are necessary",
"OBJECTIVE This prospect i ve 6-month open trial examined the safety and efficacy of two combination therapies for manic or mixed episodes of pediatric bipolar disorder : ( 1 ) divalproex sodium plus risperidone ( DVPX+Risp ) , or ( 2 ) lithium plus risperidone ( Li+Risp ) . METHODS Thirty-seven ( 37 ) subjects aged 5 and 18 ( age=12.1+/-3.5 years ) with DSM IV current mixed or manic episode and Young Mania Rating Scale ( YMRS ) score > 20 were sequentially assigned to either DVPX+Risp or Li+Risp in a 6-month , prospect i ve open-label trial . Outcome measures included the YMRS , Clinical Global Impression Scale for Bipolar Disorder ( CGI-BP ) , Child Depression Rating Scale-Revised ( CDRS-R ) as well as measures of safety and tolerability . RESULTS Effect sizes ( Cohen 's d ) based on change of YMRS scores from baseline were 4.36 for DVPX+Risp and 2.82 for Li+Risp . Response rates ( > or=50 % change from baseline YMRS score at the end of study ) were 80 % for DVPX+Risp and 82.4 % for Li+Risp . Both combination treatments were well tolerated . Significant improvements ( p efficacy measures , i.e. , YMRS , CGI-BP , and CDRS-R. There were no significant group differences in safety or tolerability , and no serious adverse events during the 6-month trial . CONCLUSION Both DVPX+Risp and Li+Risp show strong effects coupled with safety and tolerability in treating children and adolescents with manic or mixed episodes associated with type I bipolar disorder",
"OBJECTIVE The aim of this study was to evaluate the safety and efficacy of extended release carbamazepine ( CBZ-ER ) monotherapy in the treatment of pediatric bipolar disorder ( BD ) . METHOD This was an 8-week , open-label , prospect i ve trial of CBZ-ER monotherapy ( 788 + /- 252 mg/day ) to assess the effectiveness and tolerability of this compound in treating pediatric bipolar spectrum disorders . Assessment s included the Young Mania Rating Scale ( YMRS ) , Clinical Global Impressions-Improvement scale , Children 's Depression Rating Scale , and Brief Psychiatric Rating Scale . Adverse events were assessed through spontaneous self-reports , vital signs weight monitoring , and laboratory analysis . RESULTS Of the 27 participating children with BD , 16 ( 59.% ) completed the study . CBZ-ER treatment was associated with statistically significant , but modest , levels of improvement in mean YMRS scores ( -10.1 + /- 10.2 , p end-point mean YMRS score ( 21.8 + /- 12.2 ) suggesting a lack of complete resolution of mania . CBZ-ER treatment also result ed in significant improvement in the severity of depressive , attention-deficit/hyperactivity disorder , and psychotic symptoms . With the exception of 2 participants who discontinued due to skin rash , CBZ-ER was well tolerated with marginal increase in body weight ( 0.8 + /- 2.5 kg , p = 0.04 ) and was not associated with any abnormal changes in laboratory parameters . CONCLUSIONS Open-label CBZ-ER treatment was beneficial for the treatment of BD in children . Future controlled trials are warranted",
"OBJECTIVE The purpose of this study was to evaluate the efficacy and safety of olanzapine for the treatment of acute manic or mixed episodes associated with bipolar disorder in adolescents . METHOD A 3-week multicenter , parallel , double-blind , r and omized placebo-controlled trial was conducted at 24 sites in the United States and two sites in Puerto Rico . The participants were outpatient and inpatient male and female adolescents 13 - 17 years of age with an acute manic or mixed episode . Subjects received either olanzapine ( 2.5 - 20 mg/day [ N=107 ] ) or placebo ( N=54 ) . The mean change from baseline to endpoint in the Young Mania Rating Scale total score was the primary outcome measure . RESULTS The mean baseline-to-endpoint change in the Young Mania Rating Scale total score was significantly greater for patients receiving olanzapine relative to patients receiving placebo , and a greater proportion of olanzapine-treated patients met response and remission criteria ( 44.8 % versus 18.5 % and 35.2 % versus 11.1 % , respectively ) . The mean baseline-to-endpoint weight change was significantly greater for patients receiving olanzapine relative to patients receiving placebo ( 3.7 kg versus 0.3 kg ) , and the incidence of treatment-emergent weight gain > or = 7 % of baseline was higher for olanzapine-treated patients ( 41.9 % versus 1.9 % ) . The mean baseline-to-endpoint changes in prolactin , fasting glucose , fasting total cholesterol , uric acid , and the hepatic enzymes aspartate transaminase and alanine transaminase were significantly greater in patients treated with olanzapine relative to patients receiving placebo . CONCLUSIONS Olanzapine was effective in the treatment of bipolar mania in adolescent patients . Patients treated with olanzapine , however , had significantly greater weight gain and increases in the levels of hepatic enzymes , prolactin , fasting glucose , fasting total cholesterol , and uric acid",
"OBJECTIVE The aim of this study was to assess the safety and efficacy of risperidone augmentation of lithium in preschool-onset bipolar disorder ( BD ) among youth who insufficiently respond to lithium monotherapy . METHOD Thirty-eight subjects between the ages of 4 and 17 years ( mean age = 11.37 + /- 3.8 years ) with onset of BD in preschool years ( manic or mixed episode ) entered this 12-month trial . All subjects received lithium monotherapy . Patients who failed to adequately respond to lithium monotherapy after 8 weeks and those who relapsed after an initial response were given risperidone augmentation for up to 11 months . The Young Mania Rating Scale ( YMRS ) was the primary outcome measure . Response was defined as a > or = 50 % decrease from baseline . Additional data were collected on diagnostic comorbidity , family history , number of hospitalizations , perinatal risk factors , history of physical or sexual abuse , Child Depression Rating Scale-Revised ( CDRS-R ) , Clinical Global Impression ( CGI ) scale for BD ( CGI-BP ) , Children 's Global Assessment Scale ( C-GAS ) , and adverse medication effects . RESULTS Of the 38 subjects treated with lithium monotherapy , 17 responded , whereas 21 required augmentation with risperidone . Response rate in the youths treated with lithium + risperidone was 85.7 % ( n = 18/21 ) . Significant predictors of inadequate response to lithium monotherapy requiring augmentation were : ( 1 ) attention-deficit/hyperactivity disorder ( ADHD ) , ( 2 ) severity at baseline , ( 3 ) history of sexual or physical abuse , and ( 4 ) preschool age . Combination treatment of lithium and risperidone was found to be safe and well tolerated . CONCLUSIONS A substantial proportion of youth with a history of preschool-onset BD treated with lithium were either nonresponders or partial responders . Subsequent augmentation of lithium with risperidone in these cases was well tolerated and efficacious . Potential predictors of lithium nonresponse identified in this study may guide the choice of medications earlier in the treatment process",
"OBJECTIVE There are no published placebo-controlled studies of any agent in the treatment of acute mania in children or adolescents . This is the first placebo-controlled study of lithium 's efficacy in the treatment of acute mania in adolescents . METHOD In this discontinuation study , participants received open treatment with lithium at therapeutic serum levels ( mean 0.99 mEq/L ) for at least 4 weeks . Responders were r and omly assigned to continue or discontinue lithium during a 2-week double-blind , placebo-controlled phase . This study had 80 % power to detect a 40 % difference in exacerbation rates between groups ( 10 % on lithium versus 50 % on placebo ) . RESULTS Twenty-three of 40 protocol participants ( 57.5 % ) experienced a clinical ly significant symptom exacerbation during the 2-week double-blind phase . However , the slightly lower exacerbation rate in the group maintained on lithium ( 10/19 or 52.6 % ) versus the group switched to placebo ( 13/21 or 61.9 % ) did not reach statistical significance . CONCLUSIONS This study does not support a large effect for lithium continuation treatment of adolescents with acute mania , mostly due to the unexpectedly high rate of exacerbations in the group that continued on lithium . Further studies are warranted to clarify whether acute mania in adolescents is lithium responsive",
"In clinical sample s , juvenile bipolar disorder ( JBPD ) is frequently accompanied by co-morbid attention-deficit/hyperactivity disorder ( ADHD ) . Clinical trials assessing combined psychopharmacological interventions in this population are scarce , and methylpheni date ( MPH ) may worsen manic symptoms . We conducted a r and omized crossover trial with MPH and placebo ( 2 weeks each ) combined with aripiprazole in children and adolescents ( n = 16 ; 8 - 17 years old ) with JBPD and ADHD who had a significant response in manic symptoms with aripiprazole but still presented clinical ly significant symptoms of ADHD . ADHD , manic , and depressive symptoms were assessed by means of st and ard scales . Fourteen out of the 16 subjects completed the trial . No significant differences between the effects of methylpheni date and placebo were detected in ADHD ( F(1 , 43.22 ) = 0.00 ; p = 0.97 ) or manic ( F(1 , 40.19 ) = 0.93 ; p = 0.34 ) symptoms . Significant improvement in depressive symptoms was observed in the MPH group ( F(1,19.03 ) = 7.75 ; p = 0.01 ) according to a secondary self-reported outcome measure . One patient using aripiprazole and MPH discontinued the trial due to the onset of a severe mixed episode . No other significant adverse events were observed . Although MPH did not worsen manic symptoms , it was not more effective than placebo in improving ADHD symptoms in children and adolescents with JBPD co-morbid with ADHD stabilized with aripiprazole . Further investigations are warranted . This study is registered at www . clinical trials.gov under the identifier NCT00305370",
"OBJECTIVE To conduct a pilot study comparing the effects of quetiapine and placebo for the treatment of depressive episodes in adolescents with bipolar I disorder . METHOD Thirty-two adolescents ( ages 12 - 18 years ) with a depressive episode associated with bipolar I disorder were r and omized to eight weeks of double-blind treatment with quetiapine , 300 - 600 mg/day , or placebo . This two-site study was conducted from March 2006 through August 2007 . The primary efficacy measure was change in Children 's Depression Rating Scale-Revised Version ( CDRS-R ) scores from baseline to endpoint . Secondary efficacy measures included change in CDRS-R scores over the eight-week study period ( PROC MIXED ) , changes from baseline to endpoint in Hamilton Anxiety Rating Scale ( HAM-A ) , Young Mania Rating Scale ( YMRS ) , and Clinical Global Impression-Bipolar Version Severity ( CGI-BP-S ) scores , as well as response and remission rates . Safety and tolerability were assessed weekly . RESULTS There was no statistically significant treatment group difference in change in CDRS-R scores from baseline to endpoint ( p = 0.89 , effect size = -0.05 , 95 % confidence interval : -0.77 - 0.68 ) , nor in the average rate of change over the eight weeks of the study ( p = 0.95 ) . Additionally , there were no statistically significant differences in response ( placebo = 67 % versus quetiapine = 71 % ) or remission ( placebo = 40 % versus quetiapine = 35 % ) rates , or change in HAM-A , YMRS , or CGI-BP-S scores ( all p > 0.7 ) between treatment groups . Dizziness was more commonly reported in the quetiapine ( 41 % ) than in the placebo ( 7 % ) group ( Fisher 's exact test , p = 0.04 ) . CONCLUSIONS The results suggest that quetiapine monotherapy is no more effective than placebo for the treatment of depression in adolescents with bipolar disorder . However , limitations of the study , including the high placebo response rate , may have contributed to our findings and should be considered in the design of future investigations of pharmacological interventions for this population",
"OBJECTIVES This r and omized , double-blind , placebo-controlled study examined the efficacy and tolerability of quetiapine in combination with divalproex ( DVP ) for acute mania in adolescents with bipolar disorder . It was hypothesized that DVP in combination with quetiapine would be more effective than DVP alone for treating mania associated with adolescent bipolar disorder . Furthermore , it was hypothesized that quetiapine would be well tolerated . METHOD Thirty manic or mixed bipolar I adolescents ( 12 - 18 years ) received an initial DVP dose of 20 mg/kg and were r and omly assigned to 6 weeks of combination therapy with quetiapine , which was titrated to 450 mg/day ( n = 15 ) or placebo ( n = 15 ) . Primary efficacy measures were change from baseline to endpoint in Young Mania Rating Scale ( YMRS ) score and YMRS response rate . Safety and tolerability were assessed weekly . RESULTS The DVP + quetiapine group demonstrated a statistically significantly greater reduction in YMRS scores from baseline to endpoint than the DVP + placebo group ( F(1,27 ) = 5.04 , p = .03 ) . Moreover , YMRS response rate was significantly greater in the DVP + quetiapine group than in the DVP + placebo group ( 87 % versus 53 % ; Fisher exact test , p = .05 ) . No significant group differences from baseline to endpoint in safety measures were noted . Sedation , rated as mild or moderate , was significantly more common in the DVP + quetiapine group than in the DVP + placebo group . CONCLUSIONS The findings of this study indicate that quetiapine in combination with DVP is more effective for the treatment of adolescent bipolar mania than DVP alone . In addition , the results suggest that quetiapine is well tolerated when used in combination with DVP for the treatment of mania",
"There is growing evidence that atypical antipsychotics may be effective in the treatment of acute bipolar depression . Results from r and omized , placebo-controlled trials support the use of quetiapine monotherapy and a combination of olanzapine-fluoxetine in the depressed phase of bipolar disorder , while only limited data exists regarding the use of aripiprazole in this population . To assess the potential effectiveness of aripiprazole in treating acute bipolar depression , a chart review was conducted on 12 patients with treatment-resistant bipolar disorder ( I , II , and not otherwise specified [ NOS ] ) who received aripiprazole augmentation for the relief of an acute major depressive episode . After 8 weeks of treatment , 4 of 12 ( 33 % ) patients demonstrated a response , defined as a 50 % reduction in the Montgomery-Asberg Depression Rating Scale ( MADRS ) score . In addition , 5 of 12 ( 42 % ) patients newly developed akathisia . This report , though limited by its small sample size and naturalistic design , suggests that the usefulness of aripiprazole in the treatment of bipolar depression may be limited by akathisia",
"BACKGROUND Although bipolar disorder frequently onsets in the preschool years , treatment studies to guide management of these highly dysfunctional children are limited . This study evaluates the response to quetiapine monotherapy in preschool and school age children with bipolar spectrum disorder ( BSD ) . METHOD Two eight-week , prospect i ve , open-label trials utilizing identical methodology to assess the effectiveness and tolerability of quetiapine monotherapy in the treatment of BSD in preschool ( age 4 - 6 years ) and school age children ( age 6 - 15 years ) . RESULTS Forty-nine children ( 30 preschool and 19 school age ) with BSD ( Young Mania Rating Scale [ YMRS ] at entry : 34.5±5.5 and 30±6.5 respectively ) were enrolled and 34 ( 20 preschool and 14 school age ) completed the trial . Quetiapine was titrated to a mean endpoint dose of 175.8±63.8 mg/day in preschool and 248.7±153.1 mg/day in school age children . At endpoint , treatment with quetiapine was associated with similar and statistically significant improvement in mean YMRS scores in preschool ( -14.5±11.5 , p ) children . Quetiapine was generally well tolerated with treatment limiting adverse-events observed in 3/30 preschool and 1/19 school age children . Quetiapine monotherapy in preschool and school age children was associated with significant weight gain ( + 3.1±1.8 and + 7.4±7.7 lb respectively , p in vital signs . LIMITATIONS As an uncontrolled study , the assessment s were not blind to treatment and the effects of treatment can not be separated from time . CONCLUSIONS Open-label quetiapine treatment was beneficial for the treatment of BSD in preschool and school age children . Further controlled trials are warranted",
"Abstract : Topiramate is an antiepileptic drug , recently also used in the treatment of psychiatric diseases . Inasmuch as topiramate and valproate , which are currently used for aggressive behavior , share several pharmacological mechanisms ( positive modulatory effect on the GABA activity and negative modulatory effect on glutamatergic neurotransmission ) , the objective of the present study was to compare the pharmacological effects of topiramate with those of valproate and their combination in patients with psychiatric disorders showing marked aggression and agitation . A retrospective , case-controlled , mirror-image study was carried out in a sample of 45 in patients affected by schizophrenia , schizoaffective and bipolar disorder , and hospitalized in a maximum-security Canadian psychiatry hospital . Overt Aggression Scale , Agitation-Calmness Evaluation Scale , number and intensity of psychotic episodes , number of episodes of withdrawal from group activities per week , and number of therapeutic isolation per week and of strict surveillance intervention per week were evaluated before and after the treatments . Results indicate that patients treated with topiramate show a decrease in the average score of the Overt Aggression Scale , a decrease of episodes of agitation and of strict surveillance interventions . This effect was similar to the group treated with valproate or with the combination of valproate-topiramate . However , valproate therapy , but not topiramate therapy , decreased the intensity of agitation episodes measured by the Agitation-Calmness Evaluation Scale ; valproate and the combination topiramate-valproate decreased the number of psychotic disorganization episodes as well . These results suggest that topiramate could be a valid medicine in the control of aggression in psychosis . Double-blind , r and omized , placebo-controlled studies need to further assess this pharmacological indication",
"OBJECTIVE The purpose of this open-label study was to describe the effectiveness of aripiprazole ( APZ ) in the treatment of children with bipolar disorders suffering from manic symptomatology . METHOD Symptomatic out patients ( Young Mania Rating Scale [ YMRS ] score ≥15 ) meeting strict , unmodified , Diagnostic and Statistical Manual of Mental Disorders , 4th edition , diagnostic symptom criteria for a bipolar disorder , ages 4 - 9 years , were eligible . Subjects were treated prospect ively with flexible doses of APZ ( maximum daily dose of 15 mg/day ) , for up to 16 weeks or until a priori response criteria were met . Outcome measures included the YMRS , Clinical Global Impressions Scale-Severity , Children 's Global Assessment Scale ( CGAS ) , and the Children 's Depression Rating Scale-Revised ( CDRS-R ) . A priori response criteria consisted of 3 of 4 consecutive weeks with ( 1 ) CDRS-R 50 . RESULTS Ninety-six children ( 62 males ; mean age of 6.9 ( SD = 1.7 ) , received APZ for an average length of treatment of 12.5 ( SD = 3.9 ) weeks . Significant improvements in YMRS , CDRS-R , CGAS , and Clinical Global Impressions Scale-Severity scores ( p were stomachache , increased appetite , and headache . Two subjects were removed from the study due to side effects [ epistaxis ( n = 1 ) ; akathisia ( n = 1 ) ] . Subjects experienced an average weight gain of 2.4 ( SD = 1.9 ) kg . CONCLUSION APZ may be effective in the acute treatment of symptoms of children with bipolar illnesses",
"BACKGROUND To evaluate short-term safety and efficacy of atypical antipsychotics in a single-site , prospect i ve , open-label , 8-week study of risperidone and olanzapine monotherapy in preschoolers with bipolar disorder ( BPD ) . METHODS Risperidone was initiated at an open-label dose of .25 mg/day , increased weekly according to response and tolerability to a maximum does of 2.0 mg/day . Olanzapine was initiated at 1.25 mg/day and increased to no more than 10 mg/day . RESULTS Thirty-one children aged 4 - 6 years were treated with olanzapine ( n = 15 , 6.3 + /- 2.3 mg/day ) or risperidone ( n = 16 , 1.4 + /- .5 mg/day ) . At study end point ( week 8 or last observation carried forward ) , there was a 18.3 + /- 11.9 point ( t = -5.6 , p Young Mania Rating Scale ( YMRS ) scores in olanzapine-treated subjects that did not differ between groups ( t = 1.4 , p = .2 ) . Response criteria ( Clinical Global Impression improvement of \" Much \" or \" Very Much \" improved or a YMRS change of > or= 30 % or more ) indicated no difference in rate of response with risperidone and olanzapine ( 69 % vs. 53 % , chi(2)((1 ) ) = .8 , p = .4 ) . CONCLUSIONS This prospect i ve open study suggests that treatment with risperidone or olanzapine may result in a rapid reduction of symptoms of mania in preschool children with BPD . Because of substantial residual symptomatology and adverse effects , however , a pressing need exists to identify additional safe and effective treatments for the management of BPD in this high-risk population",
"OBJECTIVE To examine initial response to treatment in a large sample of acutely manic bipolar I adolescents and to examine potential predictors of nonresponse , such as the presence of prominent depressive features , psychosis , or psychiatric comorbidity . METHOD Adolescents , 12 to 18 years of age , with an acute manic episode were treated with open lithium . Response was defined as a decline in Young Mania Rating Scale total score of > or=33 % and a rating of \" much improved \" or \" very much improved \" on the Clinical Global Impressions Improvement item at week 4 . Remission of mania was defined as a Young Mania Rating Scale score of 100 subjects , 63 met response criteria and 26 achieved remission of manic symptoms at the week 4 assessment . Prominent depressive features , age at first mood episode , severity of mania , and comorbidity with attention-deficit/hyperactivity disorder did not distinguish responders from nonresponders . When treated with adjunctive antipsychotic medication , subjects with psychotic features at baseline responded as well as subjects without psychosis . CONCLUSIONS In this largest systematic treatment trial of acutely manic adolescents to date , lithium appears effective for acute stabilization of symptoms . Controlled treatment studies in adolescents with acute mania are needed",
"OBJECTIVE To assess response to treatment with aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder ( ADHD ) . METHOD Children and adolescents were extensively assessed according to DSM-IV criteria for bipolar disorder comorbid with ADHD ( n = 710 ) . Those with this comorbidity who were acutely manic or in mixed states were r and omly assigned in a 6-week double-blind , placebo-controlled trial to aripiprazole ( n = 18 ) or placebo ( n = 25 ) . Primary outcome measures were assessed weekly and included the Young Mania Rating Scale ; the Swanson , Nolan , and Pelham Scale-Version IV ; and weight . Secondary outcome measures were the Clinical Global Impressions-Severity of Illness scale , the Child Mania Rating Scale-Parental Version ( CMRS-P ) , the Children 's Depression Rating Scale-Revised , the Kutcher Adolescent Depression Scale , and adverse events . The trial was conducted at the Hospital de Clínicas de Porto Alegre , Rio Gr and e do Sul , Brazil , from January 2005 to November 2007 . RESULTS The group receiving aripiprazole showed a significantly greater reduction in YMRS scores ( P = .02 , effect size [ ES ] = 0.80 ) , CMRS-P scores ( P = .02 ; ES = 0.54 ) , and CGI-S scores ( P = .04 ; ES = 0.28 ) from baseline to endpoint than the placebo group . In addition , higher rates of response ( P = .02 ) and remission ( P = .01 ) were found for the aripiprazole group . No significant between-group differences were found in weight , ADHD symptoms , and depressive symptoms . Adverse events significantly more frequent in the aripiprazole group were somnolence and sialorrhea . CONCLUSION Aripiprazole was effective in reducing manic symptoms and improving global functioning without promoting severe adverse events or weight gain . No significant treatment effect in ADHD symptoms was observed . Studies are needed to assess psychopharmacologic interventions for improving ADHD symptoms in juvenile bipolar disorder comorbid with ADHD . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00116259",
"OBJECTIVE To investigate the effectiveness and tolerability of quetiapine for the treatment of adolescents at high risk for developing bipolar I disorder . METHOD Twenty adolescents ( aged 12 - 18 years ) with mood symptoms that did not meet DSM-IV-TR criteria for bipolar I disorder and who had at least one first-degree relative with bipolar I disorder were recruited from August 2003 to June 2005 to participate in a single-blind , 12-week prospect i ve study of quetiapine . Subjects were diagnosed using the Washington University in St. Louis Kiddie Schedule of Affective Disorders and Schizophrenia and were symptomatic , defined by a Young Mania Rating Scale ( YMRS ) score > or = 12 or a Childhood Depression Rating Scale-Revised Version ( CDRS-R ) score > or = 28 at baseline . The primary effectiveness measure was an endpoint Clinical Global Impressions-Improvement scale ( CGI-I ) score change from baseline to endpoint in YMRS and CDRS-R scores . RESULTS Mood disorder diagnoses in the adolescents consisted of bipolar disorder not otherwise specified ( N = 11 ) , dysthymia ( N = 3 ) , bipolar II disorder ( N = 3 ) , cyclothymia ( N = 2 ) , and major depressive disorder ( N = 1 ) . The majority of patients ( N = 12 , 60 % ) were non-responders to previous trials of psychotropic agents . Fifteen subjects ( 75 % ) completed all study visits . Eighty-seven percent of patients were responders ( CGI-I quetiapine at week 12 ( mean + /- SD endpoint dose = 460 + /- 88 mg/day ) . YMRS scores decreased from 18.1 + /- 5.5 at baseline to 8.7 + /- 7.9 at endpoint ( p CDRS-R scores decreased from 38.2 + /- 9.8 to 27.7 + /- 9.3 , ( p = .0003 ) . The most frequently reported adverse events were somnolence , headache , musculoskeletal pain , and dyspepsia . No subjects discontinued study participation due to adverse events . CONCLUSION Although these findings are limited by the small sample size and open-label treatment , the results suggest that quetiapine may be an effective treatment for mood symptoms in adolescents with a familial risk for developing bipolar I disorder",
"OBJECTIVES To determine the efficacy and safety of aripiprazole for the treatment of pediatric bipolar I disorder , manic or mixed episode , with or without psychotic features . METHOD Subjects were enrolled between March 2005 and February 2007 in a r and omized , multicenter , double-blind 4-week study of aripiprazole 10 mg/d , aripiprazole 30 mg/d , and placebo . Subjects ( n = 296 ) were 10 to 17 years old with a DSM-IV diagnosis of bipolar I disorder with current manic or mixed episodes , with or without psychotic features , and a Young Mania Rating Scale ( YMRS ) score > or = 20 . The primary efficacy variable was change from baseline in the YMRS total score . RESULTS Both doses of aripiprazole were superior to placebo on the YMRS total score beginning at week 1 and continuing through week 4 . Aripiprazole 10 mg and 30 mg were more effective than placebo on global improvement , mania , and overall bipolar illness outcome measures . Response ( > or = 50 % reduction in YMRS total score ) at week 4 was achieved by 44.8 % , 63.6 % , and 26.1 % of subjects in the aripiprazole 10 mg , aripiprazole 30 mg , and placebo groups , respectively ( P tolerated . The most common adverse events were extrapyramidal disorder and somnolence ; rates were higher for aripiprazole 30 mg compared with aripiprazole 10 mg . Average weight gain was not significantly different between the aripiprazole 10 mg ( + 0.82 kg ) or 30 mg ( + 1.08 kg ) groups compared with the placebo group ( + 0.56 kg ) ( P = .35 and P = .13 , respectively ) . CONCLUSIONS Aripiprazole in daily doses of 10 mg or 30 mg is an effective and generally well-tolerated acute treatment for pediatric subjects with bipolar I mania or mixed episodes . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00110461",
"INTRODUCTION Aripiprazole is a novel second-generation antipsychotic approved for the treatment of bipolar disorder in adults but there is no systematic data available in pediatric bipolar disorder . METHODS This was an 8-week , open-label , prospect i ve study of aripiprazole 9.4+/-4.2 mg/day monotherapy to assess the efficacy and tolerability of this compound in treating pediatric bipolar disorder . Assessment s included the Young Mania Rating Scale , Clinical Global Impressions-Improvement scale , and Brief Psychiatric Rating Scale . Adverse events were assessed through spontaneous self-reports , vital signs weight monitoring , and laboratory analysis . RESULTS Fifteen of the 19 bipolar youth ( 79 % ) completed the study . Aripiprazole treatment was associated with clinical ly and statistically significant improvement in mean Young Mania Rating Scale scores ( -18.0+/-6.9 , P body weight ( 1.8+/-1.7 kg , P=.2 ) . CONCLUSION Open-label aripiprazole treatment was beneficial in the treatment of mania in youth with bipolar disorder . Future placebo-controlled , double-blind studies are warranted",
"OBJECTIVE To determine the relative effects of risperidone and divalproex in pediatric mania . METHODS This is a double-blind , r and omized , outpatient clinical trial with 66 children and adolescents ( mean age= 10.9 ± 3.3 years ; age range= 8 - 18 years ) with mania who were r and omly assigned to either risperidone ( 0.5 - 2 mg/day , n= 33 ) or divalproex ( 60 - 120 μg/mL , n= 33 ) for a six-week period . Measures included the Young Mania Rating Scale ( YMRS ) and Child Depression Rating Scale-Revised ( CDRS-R ) . RESULTS Mixed-effects regression models , with interaction between time and the active drug as predictors , found that the risperidone group had more rapid improvement than the divalproex group ( p The response rate on YMRS was 78.1 % for risperidone and 45.5 % for divalproex ( p . The remission rate for risperidone was 62.5 % , compared with 33.3 % for divalproex ( p 0.05 ) . Improvement on the CDRS-R was significantly higher for the risperidone group relative to the divalproex group ( p in safety , but subject retention was significantly higher at study endpoint in the risperidone group ( p 0.01 ) . Dropout rate was 24 % in the risperidone group and 48 % in the divalproex group , with increased irritability being the most common reason for dropout in the latter . There was no significant weight gain in either group . CONCLUSION Results suggest that risperidone was associated with more rapid improvement and greater reduction in manic symptoms compared to divalproex . Although the results suggest that both drugs are safe , risperidone 's lower attrition rate and lower rate of adverse events may suggest better toleration . Clinical trials with larger sample s are required to confirm these preliminary findings",
"The Brief Psychiatric Rating Scale for Children ( BPRS-C ) is increasingly used as an outcome measure in research , managed care , and public sector child/adolescent clinical setting s. The BPRS-C was developed to provide a descriptive profile of symptoms applicable to a broad range of child and adolescent psychiatric disorders . Its use frequently includes trained and untrained clinician raters with differing degrees of experience and training in child and adolescent disorders . Unfortunately , this latter approach leads to a large amount of variability in scores and consequently reduces its overall reliability . This study reports on a revised BPRS-C with the addition of clinical descriptive anchors design ed to improve reliability and validity for both trained and untrained raters . A sample of 4,733 children and adolescents seen in 10 public sector facilities was administered the BPRS-C along with other st and ard clinical measures ( Child Behavior Checklist and Global Assessment of Functioning ) . Additional reliability data were gathered in a University Medical Center child and adolescent research site with both trained and untrained raters . The data indicated improvement in overall reliability and validity scores , good internal consistency , and improved factor scores . The addition of an overall total severity score may prove to be a useful outcome measure for assessment of treatment response",
"BACKGROUND Offspring of parents with bipolar disorder , by virtue of their high-risk status for developing bipolar disorder , merit an investigation of the efficacy of treatment with mood stabilizers . Behavioral and mood difficulties in this population may represent prodromal forms of bipolar disorder . We studied the efficacy of divalproex in treating child and adolescent bipolar offspring with mood or behavioral disorders who did not yet meet criteria for bipolar I or II disorder . METHOD We studied 24 children aged 6 - 18 years ( mean = 11.3 years ; 17 boys/7 girls ) with at least 1 biological parent with bipolar disorder . Participants were diagnosed by the Washington University in St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia with at least 1 of the following DSM-IV disorders : major depressive disorder , dysthymic disorder , cyclothymic disorder , or attention-deficit/hyperactivity disorder . Subjects all had at least moderate affective symptoms ( 28-item Hamilton Rating Scale for Depression or Young Mania Rating Scale score > 12 ) . After a 2-week washout period , subjects were treated with divalproex for 12 weeks , titrated to achieve serum levels of 50 - 120 micro g/mL ( mean final dose = 821 mg/day ; mean final serum level = 79.0 micro g/mL ) . RESULTS One subject discontinued after 2 weeks due to continuation of symptoms . Of the remaining 23 subjects , 18 ( 78 % ) were considered responders by primary outcome criteria ( \" very much improved \" or \" much improved \" on the Clinical Global Impressions-Improvement scale ) . Divalproex was well tolerated with no discontinuations due to adverse effects . CONCLUSION Bipolar offspring with mood or behavioral disorders and at least mild affective symptoms may respond to divalproex treatment . Our study was limited by the open treatment , lack of a placebo group , and the heterogeneous nature of the sample . Controlled studies are warranted in the use of divalproex in symptomatic bipolar offspring",
"OBJECTIVE This study evaluated the safety and effectiveness of divalproex sodium ( Depakote ) in the treatment of youths with bipolar disorder . METHOD Forty bipolar disorder patients aged 7 to 19 years , with a manic , hypomanic , or mixed episode , enrolled in an open-label study of divalproex ( 2 - 8 weeks ) , followed by a double-blind , placebo-controlled period ( 8 weeks ) . RESULTS Twenty-two subjects ( 61 % ) showed > or = 50 % improvement in Mania Rating Scale ( MRS ) scores during the open-label period . Significant ( all efficacy measures , including the MRS , Manic Syndrome Scale , Behavior and Ideation Scale , Brief Psychiatric Rating Scale , Clinical Global Impressions Severity scale , and Hamilton Rating Scale for Depression . Of the 23 subjects who discontinued the study during the open-label period , 6 ( 15 % ) discontinued for ineffectiveness , 6 ( 15 % ) for intolerance , 6 ( 15 % ) for noncompliance , and 6 ( 15 % ) for other reasons . Adverse events were generally mild or moderate in severity , with the most common being headache , nausea , vomiting , diarrhea , and somnolence . Laboratory data results were unremarkable . Too few subjects participated in the double-blind period for statistical analysis . CONCLUSION This study provides preliminary support for the safety and effectiveness of divalproex in the treatment of bipolar disorder in youths",
"CONTEXT There was a paucity of comparative pharmacological research for initial treatment of bipolar I disorder , manic or mixed phase , in children and adolescents . OBJECTIVE To investigate which medication to administer first to antimanic medication-naive subjects . DESIGN , SETTING , AND PARTICIPANTS The Treatment of Early Age Mania ( TEAM ) study recruited 6- to 15-year-old children and adolescents with DSM-IV bipolar I disorder ( manic or mixed phase ) at 5 US sites from 2003 to 2008 into a controlled , r and omized , no-patient-choice , 8-week protocol . Blinded , independent evaluators conducted all baseline and end-point assessment s. INTERVENTIONS Subjects received a titrated schedule of lithium , divalproex sodium , or risperidone . Medications were increased weekly only if there was inadequate response , and no dose-limiting adverse effects , to maximum doses of lithium carbonate ( 1.1 - 1.3 mEq/L ) , divalproex sodium ( 111 - 125 μg/mL ) , and risperidone ( 4 - 6 mg ) . MAIN OUTCOME MEASURES Primary outcome measures were the Clinical Global Impressions for Bipolar Illness Improvement-Mania and the Modified Side Effects Form for Children and Adolescents . RESULTS There were 279 antimanic medication-naive subjects ( mean [ SD ] age , 10.1 [ 2.8 ] years ; 50.2 % female ) who had the following characteristics : 100 % elated mood and /or gr and iosity , 77.1 % psychosis , 97.5 % mixed mania , 99.3 % daily rapid cycling , and mean ( SD ) mania duration of 4.9 ( 2.5 ) years . The mean ( SD ) titrated lithium level was 1.09 ( 0.34 ) mEq/L , and the mean ( SD ) divalproex sodium level was 113.6 ( 23.0 ) μg/mL. The mean ( SD ) titrated risperidone dose was 2.57 ( 1.21 ) mg . Higher response rates occurred with risperidone vs lithium ( 68.5 % vs 35.6 % ; χ(2)(1 ) = 16.9 , P vs divalproex sodium ( 68.5 % vs 24.0 % ; χ(2)(1 ) = 28.3 , P to lithium vs divalproex sodium did not differ . The discontinuation rate was higher for lithium than for risperidone ( χ(2)(1 ) = 6.4 , P = .011 ) . Increased weight gain , body mass index , and prolactin level occurred with risperidone vs lithium ( F(1,212 ) = 45.5 , P vs divalproex sodium ( F(1,212 ) = 34.7 , P .001 , respectively ) . The thyrotropin level increased in subjects taking lithium ( t(62 ) = 11.3 , P CONCLUSIONS Risperidone was more efficacious than lithium or divalproex sodium for the initial treatment of childhood mania but had potentially serious metabolic effects . TRIAL REGISTRATION clinical trials.gov Identifier :"
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Background : The increasing incidence of people affected by overweight or obesity is a significant health problem . The knowledge of the factors which influences the inappropriate eating behaviors causing excessive body fat is an essential goal for the research . Overweight and obesity are significant risk factors for many health diseases , such as cardiovascular problems , diabetes . Recently , many studies have focused on the relationship between body weight and cognitive processes . Objectives : This systematic review is aim ed to investigate the existence and the nature of the relationship between excessive body weight ( overweight/obesity ) and executive functions , analyzing cross-sectional , and longitudinal studies in order to verify the evidence of a possible causality between these variables . Methods : The review was carried out according to the PRISMA -Statement , through systematic search es in the scientific data bases PubMed , Medline , PsychInfo , and PsycArticles . The studies selected examined performance on executive tasks by participants with overweight or obesity , aged between 5 and 70 years . Studies examining eating disorders or obesity result ing from other medical problems were excluded . Furthermore , the results of studies using a cross-sectional design and those using a longitudinal one were separately investigated . Results : Sixty-three cross-sectional studies and twenty-eight longitudinal studies that met our inclusion and exclusion criteria were analyzed . The results confirmed the presence of a relation between executive functions and overweight/obesity , although the directionality of this relation was not clear ; nor did any single executive function emerge as being more involved than others in this relation . Despite this , there was evidence of a reciprocal influence between executive functions and overweight/obesity . Conclusions : This systematic review underlines the presence of a relationship between executive functions and overweight/obesity . Moreover , it seems to suggest a bidirectional trend in this relationship that could be the cause of the failure of interventions for weight reduction . The results of this review highlight the importance of a theoretical model able to consider all the main variables of interest , with the aim to structuring integrated approaches to solve the overweight/obesity problems
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"BACKGROUND Dietary intake of fish and the omega-3 fatty acids have been associated with lower risk of Alzheimer disease and stroke . OBJECTIVE To examine whether intakes of fish and the omega-3 fatty acids protect against age-related cognitive decline . DESIGN Prospect i ve cohort study . SETTING Geographically defined Chicago , Ill , community . PARTICIPANTS Residents , 65 years and older , who participated in the Chicago Health and Aging Project . MAIN OUTCOME MEASURE Change in a global cognitive score estimated from mixed models . The global score was computed by summing scores of 4 st and ardized tests . In-home cognitive assessment s were performed 3 times over 6 years of follow-up . RESULTS Cognitive scores declined on average at a rate of 0.04 st and ardized units per year ( SU/y ) . Fish intake was associated with a slower rate of cognitive decline in mixed models adjusted for age , sex , race , education , cognitive activity , physical activity , alcohol consumption , and total energy intake . Compared with a decline rate in score of -0.100 SU/y among persons who consumed fish less than weekly , the rate was 10 % slower ( -0.090 SU/y ) among persons who consumed 1 fish meal per week and 13 % slower ( -0.088 SU/y ) among persons who consumed 2 or more fish meals per week . The fish association was not accounted for by cardiovascular-related conditions or fruit and vegetable consumption but was modified after adjustment for intakes of saturated , polyunsaturated , and trans fats . There was little evidence that the omega-3 polyunsaturated fatty acids were associated with cognitive change . CONCLUSIONS Fish consumption may be associated with slower cognitive decline with age . Further study is needed to determine whether fat composition is the relevant dietary constituent",
"OBJECTIVE Cognitive dysfunction and structural brain abnormalities have been observed in obese versus lean individuals , but with variability across age and weight groups . The current study was design ed to clarify the cognitive profile of obesity by examining performance across multiple cognitive domains in adults with wide-ranging age and weight status . METHOD Participants ( N = 732 ; 61 % women ; ages 18 - 88 ; BMI range 19 - 75 ) underwent assessment of cognitive functioning and relevant medical/demographic covariates . Neuropsychological tests were grouped by cognitive domain ( via confirmatory factor analysis ) , and st and ardized scores were averaged into composite variables . RESULTS Hierarchical linear regression analyses revealed main effects for BMI on motor ( ΔR2 = .02 , β = -.15 ) and attention/processing speed ( ΔR2 = .01 , β = -.07 ) , whereas a significant interaction between BMI and age was observed ( ΔR2 = .01 , β = -.08 ) for predicting executive functioning ( p with memory or language functioning and no interaction effects were observed for these variables . Although BMI was not independently related to executive dysfunction , a significant age × BMI interaction suggests that obesity-related executive deficits may increase with age . CONCLUSIONS Overall , these findings may support an independent association between obesity and a frontal-subcortical pathology , though prospect i ve studies are needed to further clarify this possibility",
"Background Previous research has found associations between parental feeding practice s and children 's eating behaviour and weight status . Prospect i ve research is needed to eluci date these relationships . Methods One hundred and fifty-six mothers of 2- to 4-year-old children completed question naires including measures of maternal feeding practice s ( pressure to eat , restriction , monitoring and modelling of healthy eating ) , child eating behaviour ( food responsiveness , food fussiness and interest in food ) , and mother reported child height and weight . The question naire was repeated 12 months later . Regression analyses were used to find longitudinal associations between maternal feeding practice s , child eating behaviour and child body mass index ( BMI ) . Results Modelling of healthy eating predicted lower child food fussiness and higher interest in food one year later , and pressure to eat predicted lower child interest in food . Restriction did not predict changes in child eating behaviour . Maternal feeding practice s did not prospect ively predict child food responsiveness or child BMI . Conclusion Maternal feeding practice s appear to influence young children 's eating behaviour but not weight status in the short term",
"OBJECTIVE Research has indicated that individuals with obesity have neurocognitive deficits , especially in cognitive flexibility that may in turn impact on their weight loss and maintenance . Consequently , we examined the efficacy of a manualised face-to-face cognitive remediation therapy for obesity ( CRT-O ) within a r and omised controlled trial , in terms of improving cognitive flexibility , reducing binge eating behaviour , improving quality of life and helping with weight loss . METHODS 80 adults with obesity ( body mass index > 30 kg/m2 ) , 70 % binge eaters , received three weekly sessions of group Behavioural Weight Loss ( BWL ) and then were r and omised to 8 sessions of individual CRT-O or to a no-treatment control group . RESULTS Mixed-effects model analyses revealed that the CRT-O group had a significant improvement in their cognitive flexibility at post-treatment and 3-month follow-up compared to the control group ( Cohen 's d = 0.96 to 2.1 ) . 68 % of those in the CRT-O group achieved a weight loss of 5 % or more at follow-up compared to only 15 % of the controls ( Cohen 's d = 1.3 ) . Changes in set-shifting predicted changes in weight ( p Binge eating reduced in the CRT-O group compared to the control ( Cohen 's d = 0.80 ) . DISCUSSION This is the first study showing the efficacy of CRT-O for obesity . Future CRT-O studies with longer follow-ups and pairing it with longer BWL programs are needed . TRIALS REGISTRY ( ANZCTR ) 12613000537752 . DATE OF ANZCTR REGISTRATION 14 May 2013",
"Background Two primary factors that contribute to obesity are unhealthy eating and sedentary behavior . These behaviors are particularly difficult to change in the long-term because they are often enacted habitually . Cognitive Remediation Therapy has been modified and applied to the treatment of obesity ( CRT-O ) with preliminary results of a r and omized controlled trial demonstrating significant weight loss and improvements in executive function . The objective of this study was to conduct a secondary data analysis of the CRT-O trial to evaluate whether CRT-O reduces unhealthy habits that contribute to obesity via improvements in executive function . Method Eighty participants with obesity were r and omized to CRT-O or control . Measures of executive function ( Wisconsin Card Sort Task and Trail Making Task ) and unhealthy eating and sedentary behavior habits were administered at baseline , post-intervention and at 3 month follow-up . Results Participants receiving CRT-O demonstrated improvements in both measures of executive function and reductions in both unhealthy habit outcomes compared to control . Mediation analyses revealed that change in one element of executive function performance ( Wisconsin Card Sort Task perseverance errors ) mediated the effect of CRT-O on changes in both habit outcomes . Conclusion These results suggest that the effectiveness of CRT-O may result from the disruption of unhealthy habits made possible by improvements in executive function . In particular , it appears that cognitive flexibility , as measured by the Wisconsin Card Sort task , is a key mechanism in this process . Improving cognitive flexibility may enable individuals to capitalise on interruptions in unhealthy habits by adjusting their behavior in line with their weight loss goals rather than persisting with an unhealthy choice . Trial registration The RCT was registered with the Australian New Zeal and Registry of Clinical Trials ( trial i d : ACTRN12613000537752 )",
"Little is known about the acute effects of drugs of abuse on impulsivity and self-control . In this study , impulsivity was assessed in humans using a computer task that measured delay and probability discounting . Discounting describes how much the value of a reward ( or punisher ) is decreased when its occurrence is either delayed or uncertain . Twenty-four healthy adult volunteers ingested a moderate dose of ethanol ( 0.5 or 0.8 g/kg ethanol : n = 12 at each dose ) or placebo before completing the discounting task . In the task the participants were given a series of choices between a small , immediate , certain amount of money and $ 10 that was either delayed ( 0 , 2 , 30 , 180 , or 365 days ) or probabilistic ( i.e. , certainty of receipt was 1.0 , .9 , .75 , .5 , or .25 ) . The point at which each individual was indifferent between the smaller immediate or certain reward and the $ 10 delayed or probabilistic reward was identified using an adjusting-amount procedure . The results indicated that ( a ) delay and probability discounting were well described by a hyperbolic function ; ( b ) delay and probability discounting were positively correlated within subjects ; ( c ) delay and probability discounting were moderately correlated with personality measures of impulsivity ; and ( d ) alcohol had no effect on discounting",
"This individual differences study examined the separability of three often postulated executive functions-mental set shifting ( \" Shifting \" ) , information updating and monitoring ( \" Updating \" ) , and inhibition of prepotent responses (\"Inhibition\")- and their roles in complex \" frontal lobe \" or \" executive \" tasks . One hundred thirty-seven college students performed a set of relatively simple experimental tasks that are considered to predominantly tap each target executive function as well as a set of frequently used executive tasks : the Wisconsin Card Sorting Test ( WCST ) , Tower of Hanoi ( TOH ) , r and om number generation ( RNG ) , operation span , and dual tasking . Confirmatory factor analysis indicated that the three target executive functions are moderately correlated with one another , but are clearly separable . Moreover , structural equation modeling suggested that the three functions contribute differentially to performance on complex executive tasks . Specifically , WCST performance was related most strongly to Shifting , TOH to Inhibition , RNG to Inhibition and Updating , and operation span to Updating . Dual task performance was not related to any of the three target functions . These results suggest that it is important to recognize both the unity and diversity of executive functions and that latent variable analysis is a useful approach to study ing the organization and roles of executive functions",
"OBJECTIVE Obesity is as an independent risk factor for poor neurocognitive outcomes , including Alzheimer 's disease . Bariatric surgery has recently been shown to result in improved memory at 12-weeks postoperatively . However , the long-term effects of bariatric surgery on cognitive function remain unclear . DESIGN AND METHODS Eighty-six individuals ( 63 bariatric surgery patients , 23 obese controls ) were recruited from a prospect i ve study examining the neurocognitive effects of bariatric surgery . All participants completed self-report measurements and a computerized cognitive test battery prior to surgery and at 12-week and 24-month follow-up ; obese controls completed measures at equivalent time points . RESULTS Bariatric surgery patients exhibited high rates of pre-operative cognitive impairments in attention , executive function , memory , and language . Relative to obese controls , repeated measures ANOVA showed improvements in memory from baseline to 12-weeks and 24-months postoperatively ( P improved memory ( β = -.30 , P = 0.075 ) . CONCLUSION These findings suggest that cognitive benefits of bariatric surgery may extend to 24-months postoperatively . Larger prospect i ve studies with extended follow-up periods are needed to eluci date whether bariatric surgery decreases risk for cognitive decline and possibly the development of dementia ",
"OBJECTIVE This experiment tested the hypothesis that exercise would improve executive function . DESIGN Sedentary , overweight 7- to 11-year-old children ( N = 171 , 56 % girls , 61 % Black , M ± SD age = 9.3 ± 1.0 years , body mass index [ BMI ] = 26 ± 4.6 kg/m² , BMI z-score = 2.1 ± 0.4 ) were r and omized to 13 ± 1.6 weeks of an exercise program ( 20 or 40 min/day ) , or a control condition . MAIN OUTCOME MEASURES Blinded , st and ardized psychological evaluations ( Cognitive Assessment System and Woodcock-Johnson Tests of Achievement III ) assessed cognition and academic achievement . Functional MRI measured brain activity during executive function tasks . RESULTS Intent to treat analysis revealed dose-response benefits of exercise on executive function and mathematics achievement . Preliminary evidence of increased bilateral prefrontal cortex activity and reduced bilateral posterior parietal cortex activity attributable to exercise was also observed . CONCLUSION Consistent with results obtained in older adults , a specific improvement on executive function and brain activation changes attributable to exercise were observed . The cognitive and achievement results add evidence of dose-response and extend experimental evidence into childhood . This study provides information on an educational outcome . Besides its importance for maintaining weight and reducing health risks during a childhood obesity epidemic , physical activity may prove to be a simple , important method of enhancing aspects of children 's mental functioning that are central to cognitive development . This information may persuade educators to implement vigorous physical activity ",
"BACKGROUND Bariatric surgery is associated with improved cognition , and it is possible that such improvements are found at extended follow-ups . We hypothesized that cognitive improvement would be maintained 3 years after bariatric surgery . METHODS Fifty bariatric patients were recruited from the Longitudinal Assessment of Bariatric Surgery parent project . Participants completed a computerized cognitive test battery to assess cognitive function at 12 weeks , 12 months , 24 months , and 36 months after surgery . RESULTS Repeated measures revealed main effects for attention , executive function , and memory . Attention improved up to 24 months and then slightly declined although it still fell within the average range at 36 months . Improvements in executive function reached their peak at 36 months after surgery . Short-term improvements in memory were maintained at 36 months . No main effect emerged for language . CONCLUSIONS Bariatric surgery may lead to lasting improvements in cognition . Prospect i ve studies with extended follow-ups ( eg , 10 years ) should examine whether bariatric surgery can attenuate cognitive decline in severely obese patients",
"For obese children behavioral treatment results in only small changes in relative weight and frequent relapse . The current study investigated the effects of an Executive Functioning ( EF ) training with game-elements on weight loss maintenance in obese children , over and above the care as usual in an inpatient treatment program . Forty-four children ( aged 8 - 14 years ) who were in the final months of a 10-months inpatient treatment program in a medical paediatric centre were r and omized to either the 6 week EF-training condition or to a care as usual only control group . The EF-training consisted of a 25-session training of inhibition and working memory . Treatment outcomes were child performances on cognitive tasks of inhibition and working memory and childcare worker ratings on EF-symptoms as well as weight loss maintenance after leaving the clinic . Children in the EF-training condition showed significantly more improvement than the children in the care as usual only group on the working memory task as well as on the childcare worker reports of working memory and meta-cognition . They were also more capable to maintain their weight loss until 8 weeks post-training . This study shows promising evidence for the efficacy of an EF-training as weight stabilization intervention in obese children",
"The overall objective of this study was to examine the relationship between executive function , specifically decision-making , and weight loss . We used the Iowa Gambling Task ( IGT ) to characterize decision-making and compared performance on this task to weight loss in obese women ( n=29 ) participating in a 12-week controlled , calorie-reduced intervention . We hypothesized that a greater amount of weight loss over the course of the intervention would be associated with better performance on the IGT , assessed at the end of the intervention . The intervention led to significant weight loss of 5.8±3.1 kg ( p and fat loss of 5.1±3.0 kg ( p over the 12-week intervention varied widely , ranging from -12.5 kg to 0.0 kg for body weight and -10.4 kg to + 0.8 kg for fat mass . A greater amount of body weight loss was correlated ( r=0.425 ; p reduction in body fat mass was also correlated with the IGT score ( r=0.408 ; p other physiological ( salivary cortisol ) , metabolic ( resting energy expenditure ) , and behavioral ( food intake ; dietary restraint ) factors that might be related to differences in the magnitude of weight loss . Of these variables , ad libitum consumption of energy , fat and protein during a buffet meal was inversely related to weight loss ( r=-0.428 ; p between diet-induced weight loss and performance on the IGT , and this association was specific to the loss of body fat . Our results suggest that differences in weight loss may be linked to executive function that involves decision-making about events that have emotionally or socially salient ramifications . These findings underscore the need to further investigate higher cognitive and neuroendocrine pathways that may influence or be altered by the process of dieting and weight loss",
"HighlightsWe present associations of executive function with weight loss among overweight and obese adolescents and young adults . We performed a prospect i ve weight loss study with combination of exercise training and food restriction . Greater executive function correlated with better weight loss . ABSTRACT People with cognitive deficits or executive dysfunction are often overweight or obese . Several human neuroimaging studies have found that executive function ( EF ) predicts food intake and weight gain ; however , fewer studies have investigated the relationship between EF and weight loss . The Stroop task is a classic measure of EF that is used in many neuroimaging studies . In the present work , functional near infrared spectroscopy ( fNIRS ) data were collected during performance of the Stroop task from a sample of overweight or obese adolescents and young adults ( n = 31 ) who participated in a summer fitness and weight loss camp . We assessed the Stroop effect by interference in the reaction time ( RT ) to visual challenges , and by alterations in levels of oxygenated hemoglobin , as detected by fNIRS . In line with previous studies , we found that the Stroop effect was successfully induced by different visual task conditions among obese/overweight individuals . Moreover , our results reveal that better Stroop task performance is correlated with greater weight loss over a4‐weekfitness intervention . Indeed , behavioral data demonstrated that reduced RT interference predicted a greater percentage of weight loss . Moreover , overweight/obese individuals with a greater hemodynamic response in the left ventrolateral and bilateral dorsolateral prefrontal cortex due to the Stroop effect lost more weight during the short‐term fitness intervention than participants with lower levels of activation of these neural regions . Overall , our results support a role for prefrontal cortex‐mediated EF in influencing food intake and weight loss outcomes in a population of a previously unstudied age",
"Cognitive decline is an increasingly important public health problem , with more than 100 million adults worldwide projected to develop dementia by 2050 . Accordingly , there has been an increased interest in preventive strategies that diminish this risk . It has been recognized that lifestyle factors including dietary patterns , may be important in the prevention of cognitive decline and dementia in later life . Several dietary components have been examined , including antioxidants , fatty acids , and B vitamins . In addition , whole dietary eating plans , including the Mediterranean diet ( MeDi ) , and the Dietary Approaches to Stop Hypertension ( DASH ) diet , with and without weight loss , have become areas of increasing interest . Although prospect i ve epidemiological studies have observed that antioxidants , fatty acids , and B vitamins are associated with better cognitive functioning , r and omized clinical trials have generally failed to confirm the value of any specific dietary component in improving neurocognition . Several r and omized trials have examined the impact of changing ' whole ' diets on cognitive outcomes . The MeDi and DASH diets offer promising preliminary results , but data are limited and more research in this area is needed",
"The study tested the effect of aerobic exercise training on executive function in overweight children . Ninety-four sedentary , overweight but otherwise healthy children ( mean age = 9.2 years , body mass index 85th percentile ) were r and omized to a low-dose ( 20 min/day exercise ) , high-dose ( 40 min/day exercise ) , or control condition . Exercise sessions met 5 days/week for 15 weeks . The Cognitive Assessment System ( CAS ) , a st and ardized test of cognitive processes , was administered individually before and following intervention . Analysis of covariance on posttest scores revealed effects on executive function . Group differences emerged for the CAS Planning scale ( p = .03 ) . Planning scores for the high-dose group were significantly greater than those of the control group . Exercise may prove to be a simple , yet important , method of enhancing aspects of children 's mental functioning that are central to cognitive and social development",
"OBJECTIVE Executive function impairments and depression are associated with obesity but whether they predict weight gain is unclear . METHODS Forty-six individuals ( 35 m , 37±10y ) completed the Stroop Task , Iowa Gambling Task ( IGT ) , Wisconsin Card Sorting Task ( WCST ) , Inventory for Depressive Symptomatology ( IDS-SR ) , Physical Anhedonia Scale ( PAS ) , and Perceived Stress Scale ( PSS ) . Body composition ( DXA ) and fasting glucose were also measured . Data from return visits were used to assess changes in weight . RESULTS Poorer Stroop and WCST performance associated with higher BMI whereas poorer IGT and WCST performance associated with higher body fat ( % ; all p's≤0.05 ) . Stroop interference ( p=0.04 ; p=0.05 ) and IDS-SR ( p=0.06 ; p=0.02 ) associated with increased BMI and weight gain ( % /yr ) . In a multivariate linear model Stroop interference ( β=0.40 , p increased BMI and weight gain ( % /yr ) even after controlling for baseline weight and glucose levels . CONCLUSIONS Poorer response inhibition and depressive symptoms , but not glucose levels , predicted weight gain . Evaluating neurocognitive and mood deficits could improve current treatment strategies for weight loss . Clinical Trial Registration Numbers NCT00523627 , NCT00342732 , NCT01224704 . clinical trials.gov",
"BACKGROUND Discerning the determinants of weight loss maintenance is important in the planning of future interventions and policies regarding overweight and obesity . We have therefore systematic ally synthesized recent literature on determinants of weight loss maintenance for individuals with overweight and obesity . METHODS With the use of the Preferred Reporting Items for Systematic Review s and Meta-Analyses statement , prospect i ve studies were identified from search es in PubMed and PsycINFO from 2006 to 2016 . We included articles investigating adults with overweight and obesity undergoing weight loss without surgery or medication . Included articles were scored on their method ological quality , and a best- evidence synthesis was applied to summarize the results . RESULTS Our search result ed in 8,222 articles of which 67 articles were selected . In total , 124 determinants were identified of which 5 were demographic , 59 were behavioural , 51 were psychological/cognitive and 9 were social and physical environmental determinants . We found consistent evidence that demographic determinants were not predictive of weight loss maintenance . Behavioural and cognitive determinants that promote a reduction in energy intake , an increase in energy expenditure and monitoring of this balance are predictive determinants . CONCLUSION This review identifies key determinants in weight loss maintenance . However , more research regarding cognitive and environmental determinants of weight loss maintenance is needed to advance our knowledge on determinants of weight loss maintenance",
"BACKGROUND Clinical ly significant cognitive impairment is found in a subset of patients undergoing bariatric surgery . These difficulties could contribute to a reduced adherence to postoperative lifestyle changes and decreased weight loss . The present study is the first to prospect ively examine the independent contribution of cognitive function to weight loss after bariatric surgery . Executive function/attention and verbal memory at baseline were expected to negatively predict the percentage of excess weight loss ( % EWL ) and body mass index ( BMI ) at follow-up . Three sites of the Longitudinal Assessment of Bariatric Surgery parent project were used : Columbia ( New York , NY ) , Cornell ( Princeton , NJ ) , and the Neuropsychiatric Research Institute ( Fargo , ND ) . METHODS A total of 84 individuals enrolled in the Longitudinal Assessment of Bariatric Surgery project undergoing bariatric surgery completed a cognitive evaluation at baseline . The BMI and % EWL were calculated at the 12-week and 12-month postoperative follow-up visits . RESULTS Clinical impairment in task performance was most prominent in tasks associated with verbal recall and recognition ( 14.3 - 15.5 % of the sample ) and perseverative errors ( 15.5 % ) . After accounting for demographic and medical variables , the baseline test results of attention/executive function and memory predicted the BMI and % EWL at 12 months but not at 12 weeks . CONCLUSIONS These results have demonstrated that baseline cognition predicts for greater % EWL and lower BMI 12 months after bariatric surgery . Additional work is needed to clarify the degree to which cognition contributes to adherence and the potential mediation of cognition on the relationship between adherence and weight loss in this group",
"Nutritional state ( e.g. fasted vs. fed ) and different food stimuli ( e.g. high-calorie vs. low-calorie , or appetizing vs. bl and foods ) are both recognized to change activity in brain reward systems . Using functional magnetic resonance imaging , we have studied the interaction between nutritional state and different food stimuli on brain food reward systems . We examined how blood oxygen level-dependent activity within a priori regions of interest varied while viewing pictures of high-calorie and low-calorie foods . Pictures of non-food household objects were included as control stimuli . During scanning , subjects rated the appeal of each picture . Twenty non-obese healthy adults [ body mass index 22.1 + /- 0.5 kg/m(2 ) ( mean + /- SEM ) , age range 19 - 35 years , 10 male ] were scanned on two separate mornings between 11:00 and 12:00 h , once after eating a filling breakfast ( ' fed ' : 1.6 + /- 0.1 h since breakfast ) , and once after an overnight fast but skipping breakfast ( ' fasted ' : 15.9 + /- 0.3 h since supper ) in a r and omized cross-over design . Fasting selectively increased activation to pictures of high-calorie over low-calorie foods in the ventral striatum , amygdala , anterior insula , and medial and lateral orbitofrontal cortex ( OFC ) . Furthermore , fasting enhanced the subjective appeal of high-calorie more than low-calorie foods , and the change in appeal bias towards high-calorie foods was positively correlated with medial and lateral OFC activation . These results demonstrate an interaction between homeostatic and hedonic aspects of feeding behaviour , with fasting biasing brain reward systems towards high-calorie foods",
"The practice of combining forward and backward memory span , as represented so prominently on the various Wechsler Scales , to arrive at a composite score for clinical interpretation is examined historically and actuarially using a large ( N = 1,342 ) nationally stratified r and om sample of children from ages 5 years through 19 years . Past literature does not support the additive nature of forward and backward memory span as elements of a common process . Factor analyses of forward and backward recall using both digits and letters indicate that the two memory processes are distinct as well and should not be combined for clinical interpretation"
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4117e240-06ff-11f0-808a-c43d1ab1c353
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Background To develop a synthesis within a Bayesian probability framework of previously established evidence , in order to derive an overall conclusion about the hypothesis ( H1 ) : ‘ High-viscosity glass-ionomer cements ( HVGIC ) are inferior to silver amalgam as ( load bearing ) restorative material s for permanent posterior teeth ’ . Methods Following Bayesian method , the prior Odds that H1 is true ( established from past uncontrolled clinical longitudinal and laboratory trials ) , the Likelihood Ratio incorporating new evidence ( established from recent meta-epidemiological studies and systematic review s of controlled clinical trials ) , as well as the posterior hypothesis Odds in view of the new evidence , were calculated . Results The prior Odds that HVGICs are clinical ly inferior to amalgam as restorative material s in posterior permanent teeth in relation to the hypothesis that this is not so was 1.12 to 1 . The Likelihood Ratio based on new evidence in favor the hypothesis was zero and the subsequent posterior Odds 0 to 1 . Therefore , based on the new evidence , the Odds that HVGICs are clinical ly inferior to amalgam as restorative material s in posterior permanent teeth degreased from 1.12 to zero . Conclusion The current evidence suggests lack of support for the hypothesis that high-viscosity glass-ionomer cements are inferior to silver amalgam as restorative material s for permanent posterior teeth . Should future research to this topic uphold the current findings , a wider range of clinical benefits for both patient and care provider , beyond appropriate restoration longevity for placing HVGIC based restorations may apply
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"Background To report the results of an audit concerning research gaps in clinical trials that were accepted for appraisal in authored and published systematic review s regarding the application of glass-ionomer cements ( GIC ) in dental practice Methods Information concerning research gaps in trial precision was extracted , following a framework that included classification of the research gap reasons : ‘ imprecision of information ( results ) ’ , ‘ biased information ’ , ‘ inconsistency or unknown consistency ’ and ‘ not the right information ’ , as well as research gap characterization using PICOS elements : population ( P ) , intervention ( I ) , comparison ( C ) , outcomes ( O ) and setting ( S ) . Internal trial validity assessment was based on the underst and ing that successful control for systematic error can not be assured on the basis of inclusion of adequate methods alone , but also requires empirical evidence about whether such attempt was successful . Results A comprehensive and interconnected coverage of GIC-related clinical topics was established . The most common reasons found for gaps in trial precision were lack of sufficient trials and lack of sufficient large sample size . Only a few research gaps were ascribed to ‘ Lack of information ’ caused by focus on mainly surrogate trial outcomes . According to the chosen assessment criteria , a lack of adequate r and omisation , allocation concealment and blinding/masking in trials covering all review ed GIC topics was noted ( selection - and detection/performance bias risk ) . Trial results appear to be less affected by loss-to-follow-up ( attrition bias risk ) . Conclusion This audit represents an adjunct of the systematic review articles it has covered . Its results do not change the systematic review ’s conclusions but highlight existing research gaps concerning the precision and internal validity of review ed trials in detail . These gaps should be addressed in future GIC-related clinical research",
"Background Naïve-indirect comparisons are comparisons between competing clinical interventions ’ evidence from separate ( uncontrolled ) trials . Direct comparisons are comparisons within r and omised control trials ( RCTs ) . The objective of this empirical study is to test the None-hypothesis that trends and performance differences inferred from naïve-indirect comparisons and from direct comparisons/ RCTs regarding the failure rates of amalgam and direct high-viscosity glass-ionomer cement ( HVGIC ) restorations in permanent posterior teeth have similar direction and magnitude . Methods A total of 896 citations were identified through systematic literature search . From these , ten and two uncontrolled clinical longitudinal studies for HVGIC and amalgam , respectively , were included for naïve-indirect comparison and could be matched with three out twenty RCTs . Summary effects sizes were computed as Odds ratios ( OR ; 95 % Confidence intervals ) and compared with those from RCTs . Trend directions were inferred from 95 % Confidence interval overlaps and direction of point estimates ; magnitudes of performance differences were inferred from the median point estimates ( OR ) with 25 % and 75 % percentile range , for both types of comparison . Mann-Whitney U test was applied to test for statistically significant differences between point estimates of both comparison types . Results Trends and performance differences inferred from naïve-indirect comparison based on evidence from uncontrolled clinical longitudinal studies and from direct comparisons based on RCT evidence are not the same . The distributions of the point estimates differed significantly for both comparison types ( Mann – Whitney U = 25 , nindirect = 26 ; ndirect = 8 ; p = 0.0013 , two-tailed ) . Conclusion The None-hypothesis was rejected . Trends and performance differences inferred from either comparison between HVGIC and amalgam restorations failure rates in permanent posterior teeth are not the same . It is recommended that clinical practice guidance regarding HVGICs should rest on direct comparisons via RCTs and not on naïve-indirect comparisons based on uncontrolled longitudinal studies in order to avoid inflation of effect estimates",
"Pain during invasive treatment of dental caries is a common phenomenon , if no local analgesia has been used before cavity preparation . Atraumatic restorative technique ( ART ) is a suggested procedure which is at least less traumatic for the patient . Although the ART approach has been received well by both children and adults who belong to population groups hardly ever exposed to regular oral health care , it has not yet been proven that this particular procedure really causes less pain , compared to more conventional techniques with rotating instruments . In the present study , pain was reported in connection with tooth restoration in 19.3 percent of the cases , when the ART technique was used , which is significantly less than with a conventional restorative technique ( 35.7 percent ) . Finally the results show a clear relationship in the pain reports between the first and the following treatments in both ART and the conventional technique groups",
"The atraumatic restorative treatment technique ( ART ) is based on removing infected tooth material using only h and instruments and filling the subsequently cleaned cavity with adhesive material such as glass ionomer . As its name suggests , the ART technique should be atraumatic during treatment , as well as for the tooth itself as for the patient . It was primarily developed for treating people living in underserved areas of the world where re sources and facilities such as electricity and trained manpower are limited . Many studies have evaluated the ART technique and the results have supported its application . However , a very limited number of studies have compared ART with more conventional techniques . For that reason , a study was conducted in Pakistan , to compare the ART technique with another more conventional treatment technique . The results of this study show that the preparations with h and instruments result ed in smaller sized cavities and therefore may be less traumatic to the tooth . It was also associated with less pain reactions compared to the more conventional technique . Although preparations with h and instruments required more time , this did not seem to affect the survival of restorations . The survival of glass ionomer cement restorations made with h and instruments was comparable with single surface amalgam restorations made with a more conventional technique . Recurrent caries was not associated with any glass ionomer cement restorations made with h and instruments . The retention rate of glass ionomer sealants was low , however one dentist had a sealant retention rate of 81.5 percent that suggests that this procedure can be performed satisfactorily in conjunction with a glass ionomer cement restoration . Operator variances did seem to affect the restorations . Survival of glass ionomer restorations made with both h and and rotary instruments varied for different operators . Similarly , the retention of fissure sealant also varied amongst operators . Operator differences also influenced the extent of tooth substance lost due to cavity preparation . The ART technique is a feasible approach towards the treatment of dental caries especially of one-surface lesions for underserved population"
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4117e27c-06ff-11f0-808a-c43d1ab1c353
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Greater fish oil consumption has been associated with reduced CVD risk , although the mechanisms are unclear . Plant- source oil omega-3 fatty acids ( ALA ) have also been studied regarding their cardiovascular effect . We conducted a systematic review of r and omized controlled trials that evaluated the effect of consumption of fish oil and ALA on commonly measured serum CVD risk factors , performing meta-analyses when appropriate . Combining 21 trials evaluating lipid outcomes , fish oil consumption result ed in a summary net change in triglycerides of -27 ( 95 % CI -33 , -20)mg/dL , in HDL cholesterol of + 1.6 ( 95 % CI + 0.8 , + 2.3)mg/dL , and in LDL cholesterol of + 6 ( 95 % CI + 3 , + 8)mg/dL. There was no effect of fish oil on total cholesterol . Across studies , higher fish oil dose and higher baseline levels were associated with greater reductions in serum triglycerides . Overall , the 27 fish oil trials evaluating Hgb A(1c ) or FBS found small non-significant net increases compared to control oils . Five studies of ALA were inconsistent in their effects on lipids , Hgb A(1c ) or FBS . Four studies investigating the effects of omega-3 fatty acids on hs-CRP were also inconsistent and non-significant . The evidence supports a dose-dependent beneficial effect of fish oil on serum triglycerides , particularly among people with more elevated levels . Fish oil consumption also modestly improves HDL cholesterol , increases LDL cholesterol levels , but does not appear to adversely affect glucose homeostasis . The evidence regarding the effects of omega-3 fatty acids on hs-CRP is inconclusive , as are data on ALA
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"Objective : Fish oil supplement has been proposed as a non-pharmacological strategy to correct the atherogenic lipid profile associated with type 2 diabetes mellitus . However , fish oil may have deleterious effects on lipid peroxidation and glycemic control . Design : In this study , 44 type 2 diabetic patients were r and omized to vitamin E st and ardized ( 53.6 mg/day ) supplementation ( capsules ) with 4 g daily of either fish oil ( n=23 ) or corn oil ( n=21 ) for 8 weeks preceded by a 4 week run-in period of corn oil supplementation . LDL was isolated by density gradient ultracentrifugation and oxidized in vitro with Cu2 + . As a marker of in vivo oxidation malondialdehyde concentration in LDL ( LDL-MDA ) was measured . Results : Fish oil reduced both mean lag time ( before , 57.8 ; after , 48.8 min , P and mean propagation rate ( before , 0.018 ΔOD/min ; after , 0.015 ΔOD/min , P whereas corn oil had no influence on lag time and propagation rate . The changes in lag time and propagation rate differed significantly between fish oil and corn oil treatment . LDL-MDA changes differed borderline significantly between groups ( FO , 110.4 pmol/mg protein ; CO , 6.7 pmol/mg protein ; P=0.057 ) . Fish oil supplementation had no influence on glycemic control as assessed from HbA1c and fasting blood glucose . Conclusion : According to our findings , fish oil supplementation leads to increased in vivo oxidation and increased in vitro oxidation susceptibility of LDL particles . More studies are needed to clarify the clinical importance of this finding . Sponsorship : Financially supported by The Danish Heart Association and Dansk Droge A/S. Dansk Droge A/S generously provided the fish oil and corn oil capsules",
"Restenosis after successful coronary angioplasty ( PTCA ) occurs in 25 - 35 % of all procedures . To date , most pharmacologic strategies have failed to reduce the restenosis rate significantly . However , recent studies have suggested a potential benefit of dietary supplementation with omega-3 fatty acids ( fish oil ) on restenosis following PTCA . The benefit of omega-3 polyunsaturated fatty acids on the incidence of coronary artery restenosis following elective PTCA was assessed in 212 consecutive patients ( 41 female , 171 male ) . Following a successful angioplasty , 204 patients received a dietary supplementation with either nine capsules containing fish oil ( 3.15 g omega-3 fatty acids ) or nine placebo capsules containing olive oil . Treatment was started immediately after PTCA and maintained over 4 mon . Compliance was assessed by analysis of lipid fatty acids prior to angioplasty and at 4 mon follow-up . The angiographically determined incidence of restenosis ( stenosis diameter > 50 % ) was 31.2 % per lesion in patients receiving fish oil and 33.7 % in patients receiving olive oil . Gross progression of coronary artery disease in vessels not subjected to angioplasty was 17 % and 16 % , respectively . In conclusion , low dose fish oil supplementation begun on the day of a successful coronary angioplasty failed to demonstrate any effect on coronary artery restenosis",
"The extent to which women of reproductive age are able to convert the n-3 fatty acid alpha-linolenic acid ( ALNA ) to eicosapentaenoic acid ( EPA ) , docosapentaenoic acid ( DPA ) and docosahexaenoic acid ( DHA ) was investigated in vivo by measuring the concentrations of labelled fatty acids in plasma for 21 d following the ingestion of [U-13C]ALNA ( 700 mg ) . [13C]ALNA excursion was greatest in cholesteryl ester ( CE ) ( 224 ( sem 70 ) micromol/l over 21 d ) compared with triacylglycerol ( 9-fold ) , non-esterified fatty acids ( 37-fold ) and phosphatidylcholine ( PC , 7-fold ) . EPA excursion was similar in both PC ( 42 ( sem 8) micromol/l ) and CE ( 42 ( sem 9 ) micromol/l ) over 21 d. In contrast both [13C]DPA and [13C]DHA were detected predominately in PC ( 18 ( sem 4 ) and 27 ( sem 7 ) micromol/l over 21 d , respectively ) . Estimated net fractional ALNA inter-conversion was EPA 21 % , DPA 6 % and DHA 9 % . Approximately 22 % of administered [13C]ALNA was recovered as 13CO2 on breath over the first 24 h of the study . These results suggest differential partitioning of ALNA , EPA and DHA between plasma lipid classes , which may facilitate targeting of individual n-3 fatty acids to specific tissues . Comparison with previous studies suggests that women may possess a greater capacity for ALNA conversion than men . Such metabolic capacity may be important for meeting the dem and s of the fetus and neonate for DHA during pregnancy and lactation . Differences in DHA status between women both in the non-pregnant state and in pregnancy may reflect variations in metabolic capacity for DHA synthesis ",
" In this long-term study , we wanted to explore the effect of dietary supplementation of seal oil ( SO ) as compared cod-liver oil ( CLO ) on subjects with moderate hypercholesterolemia . The test parameters included fatty acid composition in serum , blood lipids , platelet aggregation , and the activity of blood monocytes . After a run-in period of 6 mon , 120 clinical ly healthy hypercholesterolemic ( 7.0–9.5 mmol/L ; 270–366 mg/dL ) subjects were r and omly selected to consume either 15 mL of SO or CLO daily for 14 mon followed by a 4-mon wash-out period . A third group was not given any dietary supplement ( control ) . Consumption of marine oils ( SO and CLO ) changed the fatty acid composition of serum significantly . Maximal levels were achieved after 10 mon . No further changes were seen after 14 mon . A wash-out period of 4 mon hardly altered the level of n−3 fatty acids in serum . Addition of SO gave 30 % higher level of eicosapentaenoic acid , as compared to CLO . Subjects taking SO or CLO had lower whole-blood platelet aggregation than the control group . Neither SO nor CLO had any effects on the levels of serum total cholesterol , high-density lipoprotein cholesterol , postpr and ial triacylglycerol , apolipoproteins A1 and B100 , lipoprotein ( a ) , monocyte function expressed as monocyte-derived tissue factor expression , and tumor necrosis factor",
"A study was performed to explore the effects of supplemental intake of various marine oils known to be part of the Eskimo diet . Healthy men and women ( 134 ) were r and omly selected to consume 15 mL/d of oil from blubber of seal , cod liver , seal/cod liver , blubber of Minke whale , or no oil for ten weeks . Total cholesterol was unchanged in the oil groups , whereas high density lipoprotein cholesterol increased 7 % in the seal/cod liver oil ( CLO ) group ( P whale oil group ( P Triacylglycerol was significantly reduced in the CLO group only . The concentration of prothrombin fragment 1 + 2 was reduced 25 % ( P fibrinogen or factor VIIc was detected . Tumor necrosis factor generation in lipopolysaccharide (LPS)-stimulated blood was 30 % reduced after whale oil ( P LPS-induced tissue factor activity in monocytes was reduced to a significant degree only in the seal/CLO group ( 34 % ) and whale oil group ( 35 % ) ( P thromboxane B2 in LPS-stimulated blood was seen after whale oil intake with 44 % reduction ( P seal oil and CLO and especially with whale oil seems to have beneficial effects on several products thought to be associated with cardiovascular and thrombotic diseases",
"To compare the effects of highly purified ethyl ester concentrates of eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) on serum lipids , apolipoproteins , and serum phospholipid fatty acids in humans , we conducted a double-blind , placebo-controlled , parallel design intervention study . Healthy nonsmoking men ( n = 234 ) aged 36 - 56 y were r and omly assigned to dietary supplementation with 3.8 g EPA/d , 3.6 g DHA/d , or 4.0 g corn oil/d ( placebo ) for 7 wk . Serum triacylglycerols decreased 26 % ( P DHA group and 21 % ( P = 0.0001 ) in the EPA group compared with the corn oil group . Although not significant , net decreases in serum triacylglycerols were consistently greater in the DHA group across all quartiles of baseline triacylglycerol concentrations . Serum high-density-lipoprotein cholesterol increased 0.06 mmol/L ( P = 0.0002 ) in the DHA group . In the EPA group , serum total cholesterol decreased 0.15 mmol/L ( P = 0.02 ) and apolipoprotein A-I decreased 0.04 g/L ( P = 0.0003 ) . In the DHA group , serum phospholipid DHA increased by 69 % and EPA increased by 29 % , indicating retroconversion of DHA to EPA . In the EPA group , serum phospholipid EPA increased by 297 % whereas DHA decreased by 15 % , suggesting that EPA is not elongated to DHA in humans . The serum phospholipid ratio of n-3 to n-6 fatty acids increased in both groups , whereas the relative changes in n-6 fatty acids suggested possible alterations in liver desaturation activity in the DHA group . We conclude that both DHA and EPA decrease serum triacylglycerols , but have differential effects on lipoprotein and fatty acid metabolism in humans",
"BACKGROUND Results of epidemiologic studies and clinical trials indicate that moderate doses of n-3 fatty acids reduce the risk of cardiovascular disease and may improve prognosis . OBJECTIVE The objective was to evaluate the effect of a high-dose ethylester concentrate of n-3 fatty acids administered early after an acute myocardial infa rct ion ( MI ) on subsequent cardiac events and serum lipids . DESIGN Three hundred patients with acute MI were r and omly assigned to a daily dose of either 4 g highly concentrated n-3 fatty acids or corn oil , administered in a double-blind manner over 12 - 24 mo . Median follow-up time was 1.5 y. Clinical follow-up , including the drawing of blood sample s , was performed after 6 wk of treatment and later at 0.5-year intervals . RESULTS Forty-two ( 28 % ) patients in the n-3 group and 36 ( 24 % ) in the corn oil group experienced at least one cardiac event ( cardiac death , resuscitation , recurrent MI , or unstable angina ) . No significant difference in prognosis was observed between groups for single or combined cardiac events . Total cholesterol concentrations decreased in both groups , with no significant intergroup differences . On average , the monthly increase in HDL cholesterol was 1.11 % in the n-3 group and 0.55 % in the corn oil group ( P = 0.0016 ) . Triacylglycerol concentrations decreased by 1.30%/mo in the n-3 group , whereas they increased by 0.35%/mo in the corn oil group ( P n-3 fatty acids compared with corn oil was found despite a favorable effect on serum lipids",
"BACKGROUND Flaxseed oil is a rich source of 18:3n-3 ( alpha-linolenic acid , or ALA ) , which is ultimately converted to 22:6n-3 ( docosahexaenoic acid , or DHA ) , a fatty acid important for the development of the infant brain and retina . OBJECTIVE The objective of this study was to determine the effect of flaxseed oil supplementation on the breast-milk , plasma , and erythrocyte contents of DHA and other n-3 fatty acids in lactating women . DESIGN Seven women took 20 g flaxseed oil ( 10.7 g ALA ) daily for 4 wk . Breast-milk and blood sample s were collected weekly before , during , and after supplementation and were analyzed for fatty acid composition . RESULTS Breast milk , plasma , and erythrocyte ALA increased significantly over time ( P 20:5n-3 ( eicosapentaenoic acid , or EPA ) increased significantly in breast milk ( P = 0.004 ) and in plasma ( P plasma EPA increased significantly ( P breast-milk 22:5n-3 ( docosapentaenoic acid , or DPA ) ( P plasma DPA ( P erythrocyte DPA ( P breast-milk , plasma , or erythrocyte DHA contents after flaxseed oil supplementation . CONCLUSIONS Dietary flaxseed oil increased the breast-milk , plasma , and erythrocyte contents of the n-3 fatty acids ALA , EPA , and DPA but had no effect on breast-milk , plasma , or erythrocyte DHA contents",
"BACKGROUND Regular consumption of n-3 fatty acids of marine origin can improve serum lipids and reduce cardiovascular risk . OBJECTIVE This study aim ed to determine whether eicosapentaenoic ( EPA ) and docosahexaenoic ( DHA ) acids have differential effects on serum lipids and lipoproteins , glucose , and insulin in humans . DESIGN In a double-blind , placebo-controlled trial of parallel design , 59 overweight , nonsmoking , mildly hyperlipidemic men were r and omly assigned to receive 4 g purified EPA , DHA , or olive oil ( placebo ) daily while continuing their usual diets for 6 wk . RESULTS Fifty-six men aged 48.8 + /- 1.1 y completed the study . Relative to those in the olive oil group , triacylglycerols fell by 0.45 + /- 0.15 mmol/L ( approximately 20 % ; P = 0.003 ) in the DHA group and by 0.37 + /- 0.14 mmol/L ( approximately 18 % ; P = 0.012 ) in the EPA group . Neither EPA nor DHA had any effect on total cholesterol . LDL , HDL , and HDL(2 ) cholesterol were not affected significantly by EPA , but HDL(3 ) cholesterol decreased significantly ( 6.7 % ; P = 0.032 ) . Although HDL cholesterol was not significantly increased by DHA ( 3 . 1 % ) , HDL(2 ) cholesterol increased by approximately 29 % ( P = 0.004 ) . DHA increased LDL cholesterol by 8 % ( P = 0.019 ) . Adjusted LDL particle size increased by 0.25 + /- 0.08 nm ( P = 0.002 ) with DHA but not with EPA . EPA supplementation increased plasma and platelet phospholipid EPA but reduced DHA . DHA supplementation increased DHA and EPA in plasma and platelet phospholipids . Both EPA and DHA increased fasting insulin significantly . EPA , but not DHA , tended to increase fasting glucose , but not significantly so . CONCLUSIONS EPA and DHA had differential effects on lipids , fatty acids , and glucose metabolism in overweight men with mild hyperlipidemia",
"BACKGROUND n-3 Fatty acids lower blood pressure , improve lipids , and benefit other cardiovascular disease risk factors . Effects on glycemia in patients with type 2 diabetes are uncertain . OBJECTIVE We determined whether purified eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) have differential effects on glycemic control , including insulin sensitivity and stimulated insulin secretion ; 24-h ambulatory blood pressure ; and serum lipids in type 2 diabetic patients with treated hypertension . DESIGN In a double-blind , placebo-controlled trial of parallel design , 59 subjects were r and omly assigned to consume 4 g EPA , DHA , or olive oil/d for 6 wk while continuing to consume their usual diet . RESULTS Thirty-nine men and 12 postmenopausal women with a mean ( + /- SE ) age of 61.2 + /- 1.2 y completed the study . In comparison with the change from baseline in fasting glucose in the olive oil group , fasting glucose in the EPA and DHA groups increased 1.40 + /- 0.29 mmol/L ( P = 0.002 ) and 0.98 + /- 0.29 mmol/L ( P = 0.002 ) , respectively . Neither EPA nor DHA had significant effects on glycated hemoglobin , fasting insulin or C-peptide , insulin sensitivity or secretion , or blood pressure . Serum triacylglycerols in the EPA and DHA groups decreased 19 % ( P = 0.022 ) and 15 % ( P = 0.022 ) , respectively . There were no significant changes in serum total , LDL , or HDL cholesterol , although HDL(2 ) cholesterol in the EPA and DHA groups increased 16 % ( P = 0.026 ) and 12 % ( P = 0.05 ) , respectively . HDL(3 ) cholesterol decreased 11 % ( P = 0.026 ) with EPA supplementation . CONCLUSIONS EPA and DHA had similar benefits on lipids but adverse effects on short-term glycemic control in hypertensive diabetic patients . The overall implication s for cardiovascular disease require long-term evaluation",
"C-reactive protein ( CRP ) is a sensitive marker for low- grade inflammation . Long-chain n-3 polyunsaturated fatty acids ( PUFA ) have anti-inflammatory effects . The objective of the present study was to investigate the effect on serum levels of CRP of n-3 PUFA at two different doses . We also investigated correlations between CRP and the cellular contents of PUFA . Sixty healthy volunteers ( twenty-five women and thirty-five men ) were r and omly assigned to three treatment groups in a double-blind design . The subjects received a supplement of either 6.6 g n-3 PUFA/d , 2.0 g n-3 PUFA/d or placebo ( olive oil ) for 12 weeks . CRP was measured using a highly sensitive assay . The median serum CRP concentration was 0.78 mg/l . No significant correlations were found between CRP and the content of n-3 PUFA in granulocytes or platelets . Subjects receiving n-3 PUFA had a significant ( P cellular contents of 20 : 5n-3 , 22 : 5n-3 and 22 : 6n-3 , with the largest increase occurring in the group receiving 6.6 g PUFA/d . A significant ( P cellular content of 18 : 2n-6 and 20 : 4n-6 was observed simultaneously . Serum CRP concentrations , however , were unaffected by the PUFA-containing supplements . The present study shows that dietary supplementation with PUFA-containing supplements has no effect on serum concentrations of CRP , measured with a highly sensitive assay , in healthy subjects",
"The effect of fish oil rich in eicosapentaenoic ( EPA ) and docosahexaenoic ( DHA ) acids on serum lipoprotein concentrations is not clear , and it is not known whether EPA and DHA are similarly related to serum lipid or lipoprotein levels . We conducted a r and omized , 10-week , dietary supplementation trial in which the effects of 6 g per day of 85 % EPA and DHA were compared with 6 g per day of corn oil in 156 men and women . Multivariate analyses were used to assess independent relations between plasma phospholipid EPA and DHA and serum lipoprotein levels . In the fish oil group triglycerides fell 21 % ( p less than 0.001 ) and high density lipoprotein cholesterol ( HDL-C ) rose 3.8 % ( p less than 0.05 ) . In the corn oil group triglycerides did not change , but HDL-C rose 6.1 % ( p less than 0.01 ) . Compared with fish oil , apolipoprotein A-I ( apo A-I ) rose 5.1 % after corn oil intake ( p less than 0.05 ) . Plasma EPA and DHA levels rose after fish oil intake and fell after corn oil intake ( all p less than 0.001 ) . The change ( delta ) in EPA was inversely correlated with delta triglycerides ( p = 0.035 ) and positively correlated with delta HDL-C and delta apo A-I ( both p less than 0.001 ) in the multivariate analyses . In contrast , delta DHA was not correlated with delta triglycerides but was inversely correlated with delta HDL-C and delta apo A-I ( both p less than 0.001 ) . St and ardizing for DHA removed the difference in apo A-I levels between groups . This study suggests that EPA and DHA are divergently associated with HDL , possibly through different mechanisms",
"Omega-3 fatty acids ( FAs ) reduce postpr and ial triacylglycerol ( TG ) concentrations . This study was undertaken to determine whether this effect was due to reduced production or increased clearance of chylomicrons . Healthy subjects ( n = 33 ) began with a 4-week , olive oil placebo ( 4 g/d ) run-in period . After a 4-week wash-out period , subjects were r and omized to supplementation with 4 g/d of ethyl esters of either safflower oil ( SAF ) , eicosapentaenoic acid ( EPA ) , or docosahexaenoic acid ( DHA ) for 4 weeks . Results for EPA and DHA were similar , and therefore the data were combined into one ω-3 FA group . Omega-3 FA supplementation reduced the postpr and ial TG and apolipoprotein B ( apo B)-48 and apoB-100 concentrations by 16 % ( P = 0.08 ) , 28 % ( P respectively . Chylomicron TG half-lives in the fed state were reduced after ω-3 FA treatment ( 6.0 ± 0.5 vs. 5.1 ± 0.4 min ; P after SAF ( 6.9 ± 0.7 vs. 7.1 ± 0.7 min ) . Omega-3 FA supplementation decreased chylomicron particle sizes ( mean diameter ; 293 ± 44 vs. 175 ± 25 nm ; P and increased preheparin lipoprotein lipase ( LPL ; 0.6 ± 0.1 vs. 0.9 ± 0.1 μmol/h/ml ; P on postheparin LPL or hepatic lipase activities . The results suggest that ω-3 FA supplementation accelerates chylomicron TG clearance by increasing LPL activity , and that EPA and DHA are equally effective",
"Objective : To assess the effects of omega-3 ( n-3 ) fatty acid supplementation on blood pressure and plasma lipids in hypertensives treated with diuretics or beta-blockers . Design : Double-blind placebo-controlled cross-over trial consisting of a 4-week run-in phase and two 6-week intervention phases . Patients : A total of 43 patients of either sex taking a beta-blocker only ( n = 29 ) , a diuretic only ( n = 3 ) or a beta-blocker plus diuretic ( n=11 ) for hypertension were recruited from general practice . One patient from the latter group was withdrawn . Methods : Seated blood pressure was measured every 2 weeks in the clinic with a Dinamap . After the run-in phase , participants were r and omly assigned to take a supplement of either Omacor ( 85 % n-3 fatty acid concentrate ) or corn oil ( four 1-g capsules/day ) for 6 weeks , after which they crossed over to the other supplement . Fasted blood sample s were taken at the end of each phase for lipid analysis . Main outcome measures : The within-individual differences in systolic and diastolic pressure and plasma lipids between Omacor and corn oil treatment . Results : Systolic/diastolic blood pressures measured during the run-in phase were normal ( 132±2/76±1 mmHg , n = 42 ) but decreased further with n-3 fatty acid supplementation . The mean within-individual difference in blood pressure compared with corn oil supplementation was 3.1 ± 1.0/1.8±0.6 mmHg ( P reduction in plasma triglycerides ( P increase in high-density lipoprotein-2 cholesterol ( P differences in total or low-density lipoprotein cholesterol . Conclusion : The antihypertensive and hypotriglyceridaemic effects of n-3 fatty acid supplementation seen in the present study suggest that it may be a useful adjunct to antihypertensive therapy with beta-blockers or diuretics ",
"Fish-oil supplementation can reduce circulating triacylglycerol ( TG ) levels and cardiovascular risk . This study aim ed to assess independent associations between changes in platelet eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) and fasting and postpr and ial ( PP ) lipoprotein concentrations and LDL oxidation status , following fish-oil intervention . Fifty-five mildly hypertriacylglycerolaemic ( TG 1.5 - 4.0 mmol/l ) men completed a double-blind placebo controlled cross over study , where individuals consumed 6 g fish oil ( 3 g EPA+DHA ) or 6 g olive oil (placebo)/d for two 6-week intervention periods , with a 12-week wash-out period in between . Fish-oil intervention result ed in a significant increase in the platelet phospholipid EPA ( + 491 % , P DHA ( + 44 % , P arachidonic acid ( -10 % , P gamma-linolenic acid ( -24 % , P ex vivo LDL oxidation ( P fish oil result ed in a significant decrease in fasting and PP TG levels ( P PP non-esterified fatty acid ( NEFA ) levels , and in the percentage LDL as LDL-3 ( P=0.040 ) , and an increase in LDL-cholesterol ( P=0.027 ) . In multivariate analysis , changes in platelet phospholipid DHA emerged as being independently associated with the rise in LDL-cholesterol , accounting for 16 % of the variability in this outcome measure ( P=0.030 ) . In contrast , increases in platelet EPA were independently associated with the reductions in fasting ( P=0.046 ) and PP TG ( P=0.023 ) , and PP NEFA ( P=0.015 ) , explaining 15 - 20 % and 25 % of the variability in response respectively . Increases in platelet EPA+DHA were independently and positively associated with the increase in LDL oxidation ( P=0.011 ) . EPA and DHA may have differential effects on plasma lipids in mildly hypertriacylglycerolaemic men",
"BACKGROUND Chronic low- grade inflammation may contribute to the increased risk of atherosclerosis in visceral obesity . Statin and fish oil have been reported to have antiinflammatory effects . We studied whether dyslipidemic , obese individuals have increased plasma high-sensitivity C-reactive protein ( hs-CRP ) concentrations and whether treatment with atorvastatin and fish oil lowered plasma hs-CRP concentrations . METHODS We compared plasma hs-CRP , interleukin-6 ( IL-6 ) , and tumor necrosis factor-alpha ( TNF-alpha ) concentrations in 48 obese individuals with the concentrations in 10 lean normolipidemic men . The obese individuals were then r and omized to treatment with atorvastatin ( 40 mg/day ) , fish oil ( 4 g/day ) , atorvastatin plus fish oil , or matching placebo for 6 weeks . RESULTS Compared with controls , obese individuals had increased hs-CRP [ geometric mean , 2.19 mg/L ( 95 % confidence interval , 2.15 - 3.15 mg/L ) vs 0.49 mg/L ( 0.30- 0.93 mg/L ) ; P IL-6 [ 351 pg/L ( 318 - 449 pg/L ) vs 251 pg/L ( 211 - 305 pg/L ) ; P Atorvastatin treatment had a significant main effect of decreasing plasma hs-CRP ( -0.87 mg/L ; 95 % confidence interval , -0.10 to -1.60 mg/L ; P IL-6 ( -70 pg/L ; 10 to -140 pg/L ; P hs-CRP with atorvastatin were not significantly correlated to changes in plasma lipids , IL-6 , insulin resistance , or cholesterogenesis . Plasma TNF-alpha concentrations in obese individuals , however , were neither statistically different from concentrations in the lean controls nor altered with atorvastatin or fish oil treatment . CONCLUSIONS This study shows that visceral obesity is associated with increased plasma hs-CRP and IL-6 and , hence , a low- grade chronic inflammatory state and that treatment with atorvastatin or atorvastatin with fish oil , but not fish oil alone , reverses this abnormality",
"Dietary n-3 fatty acids ( FAs ) found in fish oils markedly lower plasma triglyceride ( TG ) and very low density lipoprotein ( VLDL ) levels in both normal and hypertriglyceridemic subjects . The present study examined the mechanism of this effect . Ten subjects with widely different plasma triglyceride levels ( 82 to 1002 mg/dl ) were fed metabolically controlled diets containing 20 % fat . The control diet contained a blend of cocoa butter and peanut oil ( P/S = 0.8 ) . The test diet contained fish oil ( P/S = 1.1 ) and provided 10 - 17 g of n-3 FAs per day ( depending on calorie intake ) . After 3 to 5 weeks of each diet , the kinetics of VLDL-TG were determined over a 48-h period after the injection of [3H]glycerol . The fish oil diet reduced the VLDL-TG synthetic rate from 23 + /- 14.3 ( mean + /- SD ) to 12.6 + /- 7.5 mg/h per kg ideal weight ( P less than 0.005 ) and increased the fractional catabolic rate ( FCR ) for VLDL-TG from 0.23 + /- 0.12 to 0.38 + /- 0.16 h -1 ( P less than 0.005 ) . At the same time , there was a 66 % reduction of plasma triglyceride levels , result ing largely from a 78 % decrease in VLDL-TG levels ( 398 + /- 317 to 87 + /- 77 mg/dl ; P less than 0.005 ) . There was a strong correlation ( r = 0.83 ; P less than 0.01 ) between the change in synthetic rates and pool sizes , but there was no correlation ( r = 0.24 ; NS ) between changes in FCRs and pool sizes . The VLDL cholesterol : triglyceride ratio increased during the n-3 diet suggesting that smaller VLDL particles were present . These particles would be expected to leave the VLDL fraction more rapidly than larger particles producing a higher FCR . We conclude that the hypotriglyceridemic effect of fish oil appears to be caused primarily by an inhibition of very low density lipoprotein-triglyceride synthesis , but an additional , independent effect upon VLDL catabolism can not be ruled out",
"Non-insulin-dependent diabetes mellitus ( NIDDM ) is associated with elevated very-low-density lipoprotein ( VLDL ) triglyceride concentrations and abnormalities of low-density lipoprotein ( LDL ) composition . Because fish oil supplementation may favorably affect lipid and lipoprotein concentrations in nondiabetic subjects , we determined the effect of fish oil concentrate on plasma lipids and lipoprotein composition in patients with NIDDM . Dietary-supplementation 1-mo periods of 4.0 and 7.5 g of omega-3 fatty acids in fish oil were compared with a placebo of 12 g safflower oil by use of a single-blind crossover design . Medications , including antidiabetic therapy , were continued through the study . Compared with safflower oil treatment , fish oil supplementation result ed in a significant reduction of total plasma triglycerides of 24 % at the 4-g dose and a larger reduction of 39 % at the 7.5-g dose . These decreases were due to similar reductions in VLDL triglycerides . LDL cholesterol levels were mildly elevated , but a larger 20 % increase in LDL apolipoprotein B ( apoB ) concentration was observed . During supplementation with the fish oil concentrate , the LDL cholesterol-to-apoB ratio was significantly reduced when compared with pretreatment values , but not when compared with safflower oil treatment . Highdensity lipoprotein ( HDL ) cholesterol and plasma apoA1 levels were not significantly changed during fish oil treatment . At the 7.5-g dose , fasting glucose and glycohemoglobin levels increased by 20 and 12 % , respectively , but were unchanged at the lower level of supplementation . Thus , in NIDDM patients , dietary supplementation with omega-3 fatty acids induces a reduction in total plasma and VLDL triglyceride levels . However , the observed increase in LDL apoB levels , and the deterioration in glycemic control , indicate thatfurther study will be required to establish whether fish oil has a role in the treatment of NIDDM",
"OBJECTIVES To investigate the effect of an omega-3 fatty acid concentrate K85 on serum lipids , lipoproteins , insulin metabolism and blood pressure in subjects with combined hyperlipidaemia . DESIGN After a run-in dietary period of 10 weeks , subjects were r and omly allocated to receive either encapsulated K85 ( n = 28 ) or corn oil ( n = 29 ) . The intervention was double-blind . SETTING An outpatient centre in Stavanger , Norway . SUBJECTS Fifty-seven of 141 individuals , who , after the run-in period continued to meet the inclusion criteria : serum triglycerides of > or = 2.0 mmol L-1 and total serum cholesterol of > or = 6.0 mmol L-1 . INTERVENTION Encapsulated K85 , containing 85 % eicosapentaenoic acid (EPA)/docosahexaenoic acid ( DHA ) , or corn oil , both administered in a daily dose of 4 g for 12 weeks . MAIN OUTCOME MEASURES Change in metabolic and haemodynamic parameters related to intervention . RESULTS Serum EPA and DHA increased significantly in the K85 group during the treatment period . The body-mass index remained unchanged . A 28 % reduction in serum triglycerides was noted in the K85 group from the first 4 weeks . Total serum cholesterol was significantly reduced with both regimens . Serum high-density lipoprotein cholesterol increased significantly during the first 8 weeks in the K85 group . Significant reductions in systolic and diastolic blood pressures were noted in subjects on K85 . The treatment did not affect serum glucose , plasma insulin and proinsulin levels . Insulin : glucose and proinsulin : glucose ratios remained unchanged . CONCLUSIONS The atherogenic risk profile was improved with K85 in subjects with combined hyperlipidaemia , but n-3 fatty acids supplementation did not affect glucose/insulin homeostasis",
"OBJECTIVE The triglyceride-lowering effects of ω-3 fats and HDL cholesterol-raising effects of exercise may be appropriate management for dyslipidemia in NIDDM . However , fish oil may impair glycemic control in NIDDM . The present study examined the effects of moderate aerobic exercise and the incorporation of fish into a low-fat ( 30 % total energy ) diet on serum lipids and glycemic control in dyslipidemic NIDDM patients . RESEARCH DESIGN AND METHODS In a controlled , 8-week intervention , 55 sedentary NIDDM subjects with serum triglycerides > 1.8 mmol/l and /or HDL cholesterol were r and omly assigned to a low-fat diet ( 30 % daily energy intake ) with or without one fish meal daily ( 3.6 g ω-3/day ) and further r and omized to a moderate ( 55–65 % VO2max ) or light ( heart rate An oral glucose tolerance test ( 75 g ) , fasting serum glucose , insulin , lipids , and GHb were measured before and after intervention . Self-monitoring of blood glucose was performed throughout . RESULTS In the 49 subjects who completed the study , moderate exercise improved aerobic fitness ( VO2max ) by 12 % ( from 1.87 to 2.07 l/min , P = 0.0001 ) . Fish consumption reduced triglycerides ( 0.80 mmol/l , P = 0.03 ) and HDL3 cholesterol ( 0.05 mmol/l , P = 0.02 ) and increased HDL2 cholesterol ( 0.06 mmol/l , P = 0.01 ) . After adjustment for age , sex , and changes in body weight , fish diets were associated with increases in GHb ( 0.50 % , P = 0.05 ) and self-monitored glucose ( 0.57 mmol/l , P = 0.0002 ) , which were prevented by moderate exercise . CONCLUSIONS A reduced fat diet incorporating one daily fish meal reduces serum triglycerides and increases HDL2 cholesterol in dyslipidemic NIDDM patients . Associated deterioration in glycemic control can be prevented by a concomitant program of moderate exercise",
"Summary Decreased release of nitric oxide from damaged endothelium is responsible for the impaired endothelium-dependent vasodilator responses found in animal models of vascular disease . Dietary supplementation with fish oils has been shown to augment endothelium-dependent relaxations , principally by improving the release of nitric oxide from injured endothelium . Using forearm venous occlusion plethysmography we studied vascular responses to 60 , 120 , 180 and 240 nmol/min of acetylcholine ( an endothelium-dependent vasodilator ) and 3 , 6 and 9 nmol/min of glyceryl trinitrate ( an endothelium-independent vasodilator ) infused into the brachial artery in 23 patients with Type 2 ( non-insulin-dependent ) diabetes mellitus . NG monomethyl-l-arginine was employed to inhibit stimulated and basal release of nitric oxide from the endothelium . On completion of the baseline studies patients r and omly received either fish oil or matching olive oil capsules in a double-blind crossover fashion for 6 weeks followed by a 6-week washout period and a final 6-week treatment phase . Studies , identical to the initial baseline studies , were performed at the end of the active treatment periods at 6 and 18 weeks . Fish oil supplementation significantly improved forearm blood flow responses to each dose of acetylcholine when compared to the vasodilator responses recorded at baseline and after olive oil administration ( p oil nor olive oil supplementation produced any significant changes in forearm blood flow to the incremental infusions of glyceryl trinitrate when compared with responses recorded during the baseline studies . NG monomethyl-l-arginine significantly reduced forearm blood flow from maximal stimulated values to acetylcholine when compared to the uninhibited decline in flow to acetylcholine infusions at comparable time points ( p fish oils improved endothelium-dependent responses to acetylcholine without altering endothelium-independent responses to glyceryl trinitrate . By increasing stimulated nitric oxide release from the endothelium fish oils may afford protection against vasospasm and thrombosis in patients with diabetes mellitus",
"BACKGROUND Inflammation plays an important role in the pathogenesis of coronary artery disease . We examined whether dietary supplementation with alpha-linolenic acid ( ALA , 18:3n-3 ) affects the levels of inflammatory markers in dyslipidaemic patients . METHODS We recruited 76 male dyslipidaemic patients ( mean age=51+/-8 years ) following a typical Greek diet . They were r and omly assigned either to 15 ml of linseed oil ( rich in ALA ) per day ( n=50 ) or to 15 ml of safflower oil ( rich in linoleic acid ( LA , 18:2n-6 ) ) per day ( n=26 ) . The ratio of n-6:n-3 in linseed oil supplemented group was 1.3:1 and in safflower oil supplemented group 13.2:1 . Dietary intervention lasted for 3 months . Blood lipids and C-reactive protein ( CRP ) , serum amyloid A ( SAA ) , and interleukin-6 ( IL-6 ) levels were determined prior and after intervention . CRP and SAA were measured by nephelometry and IL-6 by immunoassay . RESULTS Dietary supplementation with ALA decreased significantly CRP , SAA and IL-6 levels . The median decrease of CRP was 38 % ( 1.24 vs. 0.93 mg/l , P=0.0008 ) , of SAA 23.1 % ( 3.24 vs. 2.39 mg/l , P=0.0001 ) and of IL-6 10.5 % ( 2.18 vs. 1.7 pg/ml , P=0.01 ) . The decrease of inflammatory markers was independent of lipid changes . Dietary supplementation with LA did not affect significantly CRP , SAA and IL-6 concentrations but decreased cholesterol levels . CONCLUSIONS Dietary supplementation with ALA for 3 months decreases significantly CRP , SAA and IL-6 levels in dyslipidaemic patients . This anti-inflammatory effect may provide a possible additional mechanism for the beneficial effect of plant n-3 polyunsaturated fatty acids in primary and secondary prevention of coronary artery disease",
"Objective : To investigate the effects of increased alpha-linolenic acid (ALA)-intake on intima – media thickness ( IMT ) , oxidized low-density lipoprotein ( LDL ) antibodies , soluble intercellular adhesion molecule-1 ( sICAM-1 ) , C-reactive protein ( CRP ) , and interleukins 6 and 10 . Design : R and omized double-blind placebo-controlled trial . Subjects : Moderately hypercholesterolaemic men and women ( 55±10 y ) with two other cardiovascular risk factors (n=103).Intervention : Participants were assigned to a margarine enriched with ALA ( fatty acid composition 46 % LA , 15 % ALA ) or linoleic acid ( LA ) ( 58 % LA , 0.3 % ALA ) for 2 y. Results : Dietary ALA intake was 2.3 en% among ALA users , and 0.4 en% among LA users . The 2-y progression rate of the mean carotid IMT ( ALA and LA : + 0.05 mm ) and femoral IMT ( ALA:+0.05 mm ; LA:+0.04 mm ) was similar , when adjusted for confounding variables . After 1 and 2 y , ALA users had a lower CRP level than LA users ( net differences −0.53 and −0.56 mg/l , respectively , P in oxidized LDL antibodies , and levels of sICAM-1 , interleukins 6 and 10 . Conclusions : A six-fold increased ALA intake lowers CRP , when compared to a control diet high in LA . The present study found no effects on markers for atherosclerosis . Sponsorship : The Dutch ‘ Praeventiefonds ’",
"Objectives : To compare the effect of alcohol-free Mediterranean-type diet ( MD ) and high-fat diet ( HFD ) on plasma concentration of emergent haemostatic cardiovascular risk factors ( HCVRF ) . Also , to test if red wine supplementation modifies HCVRF , independent of diet . Design , subjects and intervention : Controlled prospect i ve intervention study . Two groups , each of 21 healthy male university students ( 22±3.4 y ) , received either MD or HFD for 90 days . Between days 30 and 60 , both diets were supplemented with 240 ml/day of red wine . Baseline and T30 , T60 and T90-day sample s were drawn . No drop out from the study was observed . Setting : University campus and outpatient nutrition clinic . Results : Volunteers on HFD at T30 had increases in pro-coagulants fibrinogen ( 22 % ) , factor VIIc ( 9 % ) , and factor VIIIc ( 4 % ) , and decreases in natural anticoagulants antithrombin III ( 3 % ) , protein C ( 11 % ) and protein S ( 6 % ) and of 20 % in plasminogen activator inhibitor-1 . At the same time , individuals on MD had increases in fibrinogen ( 4 % ) , antithrombin III ( 5 % ) , protein C ( 3 % ) , protein S ( 2.7 % ) , and decreases in factor VIIIc ( 9 % ) , and plasminogen activator inhibitor-1 ( 21 % ) . After adjusting by baseline values , MD was associated with lower plasma fibrinogen ( P=0.03 ) , factor VIIc ( P=0.034 ) and factor VIIIc ( P=0.0057 ) and with higher levels of protein S ( P=0.013 ) . Red wine supplementation , in both diets , result ed in decreased plasma fibrinogen ( P=0.001 ) and factor VIIc ( P=0.05 ) , and increased tissue plasminogen activator antigen ( P=0.01 ) and plasminogen activator inhibitor-1 antigen ( P=0.0003 ) . Wine consumption was also associated with significantly ( P=0.01 ) divergent effects on antithrombin III : it decreased by 10 % in individuals on HFD but increased slightly in those on MD . No effects of diet or wine were detected in plasma protein C and C-reactive protein . Conclusion : MD and moderate consumption of red wine have complementary , mostly beneficial effects on HCVRF.Sponsorship : P Catholic University of Chile . Descriptors : diet ; wine ; haemostasis ; cardiovascular risk factorsEuropean Journal of Clinical Nutrition ( 2001 ) 55 ,",
"Objective : High-sensitivity C-reactive protein ( CRP ) , a marker of systemic inflammation , is a powerful predictor of cardiovascular risk . We hypothesised that n-3 fatty acids reduce underlying inflammatory processes and consequently CRP concentrations in healthy middle-aged subjects . Design : Placebo-controlled , double-blind study .Subjects : A total of 43 men and 41 postmenopausal women aged 50–70 y. Before and after intervention , we measured serum CRP concentrations with an enzyme immunoassay . Interventions : Capsules with either 3.5 g/day fish oil ( 1.5 g/day n-3 fatty acids ) or placebo for 12 weeks . Results : The median CRP change in the fish oil group did not significantly differ from that in the placebo group ( 0.01 vs −0.17 mg/l , P = 0.057 ) . Conclusion : The currently available data —including ours— do not support that beneficial effects on CRP are involved in a mechanism explaining the protective effect on heart disease risk of n-3 fatty acids as present in fish . Sponsorship : Wageningen Centre for Food Sciences",
"Objective To study the effects of moderate doses of fish oil on blood pressure and high-density lipoprotein (HDL)-cholesterol . Methods The participants were 350 normotensive men and women aged 30–54 years who were enrolled from seven academic medical centers in phase I of the Trials of Hypertension Prevention . They were r and omly assigned to receive placebo or 6 g purified fish oil once a day , which supplied 3 g n-3 polyunsaturated fatty acids for 6 months . Results Baseline blood pressure was ( mean ± SD ) 123±9/81 ±5mmHg . The mean differences in the blood pressure changes between the fish oil and placebo groups were not statistically significant . There was no tendency for fish oil to reduce blood pressure more in subjects with baseline blood pressures in the upper versus the lower quartile ( 132/87 versus 114/75 mmHg ) , low habitual fish consumption ( 0.4 versus 2.9 times a week ) or low baseline plasma levels of n-3 fatty acids . Fish oil increased HDL2-cholesterol significantly compared with the placebo group . Subgroup analysis showed this effect to be significant in the women but not in the men . Increases in serum phospholipid n-3 fatty acids were significantly correlated with increases in HDL2-cholesterol and decreases in systolic blood pressure . Conclusion Moderate amounts of fish oil ( 6g/day ) are unlikely to lower blood pressure in normotensive persons , but may increase HDL2-cholesterol , particularly in women",
"n-3 Fatty acids in the form of ethyl esters ( EE ) allow lower daily doses and improved compliance . Administration of n-3 fatty acids to patients with glucose intolerance has led to controversial findings , some studies indicating worsening of the disorder , others no effect , or an improvement . A total of 935 patients with hypertriglyceridemia , associated with additional cardiovascular risk factors , i.e. glucose intolerance , NIDDM and /or arterial hypertension were entered a double blind ( DB ) protocol lasting 6 months with n-3 EE versus placebo , followed by a further 6 months of open study ( n = 868 ) on 2 g a day of n-3 EE . At the end of the DB period , triglyceridemia in the total group was reduced significantly more by n-3 EE , without alterations in glycemic parameters . In the 6 months open follow up , patients on n-3 EE with type IIB hyperlipoproteinemia showed a significant reduction of total cholesterol , both in cases with ( -4.15 % vs. the 6 month levels ) and without NIDDM ( -3.8 % ) . HDL-cholesterol had an overall mean rise of 7.4 % , maximal in type IV patients with ( + 9.1 % ) and without ( + 10.1 % ) NIDDM . No alterations in glycemic parameters were detected in treated patients . Administration of n-3 EE to patients with hypertriglyceridemia associated with NIDDM or impaired glucose tolerance appears safe and effective",
"Recent epidemiological studies have shown some beneficial health effects of the long chain ( n-3 ) polyunsaturated fatty acids found in fatty fish . Although the results of these studies are often ambiguous and inconclusive , they have prompted many intervention trials to study the effects of n-3 fatty acids ( FA ) on the cardiovascular risk profile . However screening of the literature revealed that many of the beneficial effects of fish ( oil ) were obtained in intervention studies which had several serious shortcomings in their design . Therefore we started a placebo controlled r and omised trial with increasing doses of n-3FA ( respectively 0 ; 1.12 ; 2.24 and 3.37 g n-3 FA/day ) and in order to have a maximum compliance this study was done in healthy monks . Fifty eight subjects took the fish oil capsules during 12 months and were thereafter followed for another 6 months . We could n't detect any effect of n-3 FA supplementation on total cholesterol , HDL cholesterol , LDL cholesterol , apo A1 , Lp(a ) , HbA1C , glucose , fibrinogen , factor VIII , antithrombin III , plasminogen activator inhibitor , tissue plasminogen activator and von Willebr and factor concentration , on bleeding time or on systolic or diastolic blood pressure . A pronounced significant dose dependent decrease of triglyceride levels was seen , while a slight but statistical significant decrease of apo B levels was observed in the highest fish oil dose . As the importance of triglycerides in the pathogenesis of atherosclerosis is still under discussion , the clinical relevance of these finding is not clear at the moment . It seems therefore improbable that the anti-atherosclerotic action of n-3 FA is due to an effect on the lipid , apoprotein , coagulation or fibrinolysis parameters as measured in our study . Hence further research must be focused on other parameters ( prostagl and ins ) which can be influenced by n-3 FA and which probably play an equally important role in the atherosclerotic process",
"There is growing evidence supporting the importance of inflammation in all stages of atherosclerosis . While both omega-3 polyunsaturated fatty acids ( n3PUFA ) and the lipid-soluble antioxidant alpha-tocopherol ( AT ) have been shown to independently have significant anti-inflammatory effects , there is paucity of data examining the effect of n3PUFA alone and in combination with AT on markers of inflammation and monocyte function . Therefore , we tested the effect of n3PUFA alone , all-rac ( synthetic ) AT alone , and the combination on markers of inflammation and monocyte function . Healthy nonsmoking volunteers were r and omly assigned to 1 of 4 groups ( n = 20 per group ) : 1.5 g/d n3PUFA , 800 IU/d AT , 1.5 g n3PUFA + 800 IU/d AT , or placebo in a parallel double-blinded study . Compared to baseline , 12 weeks of supplementation result ed in no changes in plasma lipids regardless of treatment . Plasma AT was significantly increased only in those groups that received AT ( P n3PUFA showed a significant increase in plasma docosahexaenoic acid ( P plasma levels of high-sensitivity C-reactive protein ( hsCRP ) . Furthermore , there were no differences in monocyte proinflammatory cytokine release ( interleukin [IL]-1beta , tumor necrosis factor [TNF]-alpha and IL-6 ) after activation with monocyte chemotactic protein-1 ( MCP-1 ) . In conclusion , supplementation with n3PUFA and all-rac AT at these doses is not anti-inflammatory",
"OBJECTIVES The effect of a fish oil preparation , K-85 , in which the omega-3 fatty acid content was concentrated to 92 % of total fat , on serum lipid and lipoprotein concentrations was investigated in patients with primary hypertriglyceridaemia . DESIGN The study was a r and omized , double-blind , placebo-controlled study . SETTING Seven centres participated in the study , five secondary referral centres and two general practice s. SUBJECTS Men and women aged 18 - 70 years with fasting serum triglyceride concentrations between 2 and 10 mmol/l and fasting serum cholesterol concentrations > 5.2 mmol/l were studied . Patients with diabetes mellitus , hypothyroidism , serious illness in the previous 3 months or severe concurrent illness were excluded from the study , as were drug or alcohol abusers and pregnant and lactating women . Ninety-five subjects entered the study , 79 completed the study . INTERVENTIONS Patients were r and omized to receive K-85 2 g twice daily or corn oil 2 g twice daily for 14 weeks . MAIN OUTCOME MEASUREMENTS The serum concentrations of triglycerides and cholesterol , very low-density lipoprotein ( VLDL ) , low-density lipoprotein ( LDL ) , high-density lipoprotein ( HDL ) and lipoprotein ( a ) . Fasting blood glucose and blood pressure . RESULTS Serum triglycerides and VLDL-cholesterol were significantly lower in the group treated with K-85 than in the placebo group after 6 , 10 and 14 weeks ( all P serum triglyceride concentration from 3.99 ( 2.94 - 9.47 ) to 2.87 ( 1.2 - 9.93 ) mmol/l ( P VLDL-cholesterol from 1.47 ( 0.77 - 3.63 ) to 1.12 ( 0.21 - 3.67 ) mmol/l ( P K-85 . Serum HDL-cholesterol increased from 0.98 ( 0.95 - 1.01 ) to 1.11 ( 1.07 - 1.15 ) mmol/l ( P Serum LDL-cholesterol , lipoprotein ( a ) and fasting blood glucose were unaffected by K-85 . Diastolic blood pressure decreased from 86 + /- 11 to 80 + /- 12 mmHg ( P K-85 is effective in lowering serum triglycerides and VLDL in patients with primary hypertriglyceridaemia and may have utility as a triglyceride-lowering agent",
"OBJECTIVE The purpose of this study was to evaluate the effects of a concentrate of fish oil on blood pressure and serum lipids in patients treated for coronary artery disease . DESIGN One hundred and twenty-five patients were r and omly assigned to receive 15 g/day MaxEPA ( 4.5 g eicosapentaenoic and docosahexaenoic acids ) or olive oil . Blood pressure and serum lipids were measured at enrollment and six months thereafter . MAIN RESULTS As an important proportion of antihypertensive or antianginal drug users stopped their usual medication during the trial , blood pressure increased in both groups . The increase in systolic blood pressure was less in the fish oil group than in the control group ( P = 0.002 ) . Serum triglyceride levels decreased markedly in the fish oil group while they remained constant in the control group ( P = 0.0001 ) . Fish oil supplementation had no effect on total cholesterol and only marginal independent influence on high density lipoprotein and low density lipoprotein cholesterol levels . CONCLUSIONS In conclusion , fish oil supplementation has a beneficial effect on blood pressure and serum triglycerides in patients treated for coronary artery disease",
"Various studies have already shown that the fatty acid composition of dietary fat has different effects on hemostasis and platelet function . However , knowledge on this topic is incomplete . In the present study , fifty-eight healthy students received either a 4-week rapeseed oil [ high content of monounsaturated fatty acids ( MUFA ) and high n-3/n-6 PUFA ratio ] , an olive oil ( high content of MUFA , low n-3/n-6 PUFA ratio ) or a sunflower oil ( low content of MUFA , low n-3/n-6 PUFA ratio ) diet . In each group , effects on hemostatic parameters were compared with a wash-in diet rich in saturated fatty acids with respect to intermediate-time effects on the hemostatic system and platelet function . With the olive oil diet , a reduction of coagulation factors VIIc , XIIc , XIIa , and Xc was found , whereas sunflower oil led to lower values of coagulation factors XIIc , XIIa , and IXc . In all study groups levels of plasmin-alpha2-antiplasmin were lower in week 4 than at baseline . Lower fibrinogen binding on platelets was found after the sunflower oil diet , whereas expression of CD62 and spontaneous platelet aggregation were slightly higher after the olive oil diet . However , given the major differences in the fatty acid compositions of the diets , the differences between the groups with respect to hemostasis tended to be small . Therefore , the clinical significance of the present findings remains to be evaluated",
"BACKGROUND Percutaneous transluminal coronary angioplasty ( PTCA ) is complicated by restenosis within 6 months in > 40 % of patients . Theoretical , animal experimental , and human epidemiological and clinical trial findings have suggested that fish oils ( n-3 ) might reduce restenosis . Low-molecular-weight heparin ( LMWH ) has reduced cellular proliferation and restenosis in several experimental systems . METHODS AND RESULTS We r and omized 814 patients to fish oils ( 5.4 g n-3 fatty acids ) or placebo a median of 6 days before PTCA and continued for 18 weeks . At the time of sheath removal , 653 patients with at least one successfully dilated lesion were r and omized to LMWH ( 30 mg SC BID ) or control for 6 weeks in a 2 x 2 factorial design . Follow-up with quantitative coronary angiography ( QCA ; target , 18 weeks ) was interpretable on 96 % of these patients . Restenosis rates per patient were for n-3 , 46.5 % ; placebo , 44.7 % ; LMWH , 45.8 % ; and control , 45.4 % . Restenosis rates per lesion were for n-3 , 39.7 % ; placebo , 38.7 % ; LMWH , 38 % ; and control , 40.4 % . At follow-up QCA , mean minimal lumen diameters were ( mm ) for n-3 , 1.12 ; placebo , 1.10 ; LMWH , 1.12 ; and control , 1.10 . Fifteen percent of patients permanently discontinued n-3/placebo before study completion , and 21 % of patients discontinued LMWH early . There were no significant differences in the occurrences of ischemic events . Bleeding was more common with LMWH , usually was mild , and led to early discontinuation of study medication in only 0.9 % of patients . Gastrointestinal side effects were more common in patients receiving n-3 than placebo . CONCLUSIONS There is no evidence for a clinical ly important reduction of PTCA restenosis in this trial by either n-3 or LMWH . Evaluation of the results for n-3 in the context of previously published data on the reduction of PTCA restenosis indicates that n-3 is not efficacious and that further trials are unwarranted",
"In a prospect i ve , r and omised single-blinded secondary prevention trial we compared the effect of a Mediterranean alpha-linolenic acid-rich diet to the usual post-infa rct prudent diet . After a first myocardial infa rct ion , patients were r and omly assigned to the experimental ( n = 302 ) or control group ( n = 303 ) . Patients were seen again 8 weeks after r and omisation , and each year for 5 years . The experimental group consumed significantly less lipids , saturated fat , cholesterol , and linoleic acid but more oleic and alpha-linolenic acids confirmed by measurements in plasma . Serum lipids , blood pressure , and body mass index remained similar in the 2 groups . In the experimental group , plasma levels of albumin , vitamin E , and vitamin C were increased , and granulocyte count decreased . After a mean follow up of 27 months , there were 16 cardiac deaths in the control and 3 in the experimental group ; 17 non-fatal myocardial infa rct ion in the control and 5 in the experimental groups : a risk ratio for these two main endpoints combined of 0.27 ( 95 % CI 0.12 - 0.59 , p = 0.001 ) after adjustment for prognostic variables . Overall mortality was 20 in the control , 8 in the experimental group , an adjusted risk ratio of 0.30 ( 95 % CI 0.11 - 0.82 , p = 0.02 ) . An alpha-linolenic acid-rich Mediterranean diet seems to be more efficient than presently used diets in the secondary prevention of coronary events and death",
"Background Severe hypertriglyceridemia is a risk factor for acute pancreatitis , therefore decreasing serum triglyceride concentrations is an important component of risk management . Omega-3 fatty acids are well known hypotriglyceridemic agents , but their efficacy in severe forms of the disorder is not well documented . Our objective was to examine the effects of Omacor , a drug composed of 85 % omega-3 fatty acid ethyl esters . Methods Forty-two patients with triglyceride concentrations between 5.65 and 22.60 mmol/l ( 500 and 2000 mg/dl ) were studied in a prospect i ve , double-blind , placebo-controlled trial of Omacor ( 4 g/day for 4 months ) . Results Compared with baseline values , Omacor significantly reduced mean triglyceride concentrations by 45 % ( P cholesterol by 15 % ( P very-low-density lipoprotein cholesterol by 32 % ( P cholesterol : High density lipoprotein ( HDL ) cholesterol ratio by 20 % ( P = 0.0013 ) , and increased HDL cholesterol by 13 % ( P = 0.014 ) and low-density lipoprotein cholesterol by 31 % ( P = 0.0014 ) . The placebo had no effect on these parameters . Omacor was well tolerated and no patient discontinued medication because of side effects . Conclusions Four capsules of Omacor per day markedly decreased triglyceride concentrations in patients with severe hypertriglyceridemia . The availability of a potent and safe omega-3 fatty acid preparation for this patient population should diminish the risk for acute pancreatitis , and may also reduce the long-term risk for cardiovascular disease",
"BACKGROUND A state of increased oxidative stress has been recognised in type 2 diabetes mellitus ( DM ) . The present study was done to assess the effects of low dose omega-3 fatty acids substitution in patients with type 2 DM with special reference to oxidative stress . METHOD Sixty-five patients with type 2 DM of body mass index ( BMI ) were evaluated for blood glucose , blood pressure and lipid profile and oxidative stress was assessed in them by measuring lipid peroxides ( LP ) , diene conjugates ( DC ) and reduced glutathione ( RG ) in the serum . Of the 65 , 40 motivated patients were r and omly divided into two groups -- group 1 comprising of fifteen patients prescribed a diabetic diet along with a placebo and group 2 consisting of twenty-five patients on the same diet with the addition of 0.6 g omega-3 fatty acids as one capsule Maxigard ( containing 180 mg eicosapentaenoic acid and 120 mg docosahexaenoic acid ) twice daily . All parameters were reassessed after six weeks . RESULTS The levels of lipid peroxides ( micromol/L ) , diene conjugates ( OD units ) and reduced glutathione ( mmol GSH/L ) were significantly altered indicating increased oxidative stress in the diabetics compared to the healthy controls : 4.106 + /- 0.889 , 2.751 + /- 0.424 , 1.344 + /- 0.316 and 1.91 + /- 0.541 , 1.735 + /- 0.315 , 1.919 + /- 0.310 , respectively ( p oxidative stress at the start of therapy . After six weeks , on comparing the mean % changes in the three parameters of oxidative stress between the two groups , it was seen that the % change was significantly higher in group 2 ( Maxigard group ) compared to group 1 ( Placebo ; 5.22 + /- 1.056 ( p = 0.05 ) , 3.28 + /- 0.608 ( p = 0.01 ) , 5.27 + /- 0.585 ( p glycemic status , blood pressure and lipid profiles . CONCLUSIONS The present study documented the existence of a state of increased oxidative stress in type 2 diabetics . Significant beneficial effects of low dose omega-3 fatty acids substitution for PUFA-6 were observed not only on oxidative stress parameters but also on blood pressure and metabolic profile",
"The aim of this study was to evaluate the effects of a fish oil preparation ( MaxEPA ) on hemostatic function and fasting lipid and glucose levels in non-insulin-dependent diabetic ( NIDDM ) subjects . Eighty NIDDM out patients aged 55.9 yr ( mean SD 11.5 yr ) participated in a prospect i ve double-blind placebo-controlled study of MaxEPA capsules ( 10 g/day ) or olive oil ( control ) treatment over 6 wk . Patients received either MaxEPA or olive oil in addition to preexisting therapy . Metabolic and hemostatic variables were measured before treatment and after 3 and 6 wk . Platelet membrane eicosapentaenoic acid ( EPA ) content increased in the treatment group ( P total triglycerides ( P total cholesterol ( P = 0.7 ) compared with control treatment . Fasting plasma glucose increased after 3 wk ( P = 0.01 ) but not after 6 wk ( P = 0.17 ) treatment with MaxEPA . Spontaneous platelet aggregation in whole blood fell in the MaxEPA group ( P agonist-induced platelet aggregation , thromboxane generation in platelet-rich plasma , or plasma P-thromboglobulin and platelet factor IV levels . An increase in clotting factor VII ( P = 0.02 ) , without changes in fibrinogen or factor X levels , occurred in the MaxEPA group . Similar reductions in blood pressure were observed in both groups . Dietary supplementation with MaxEPA capsules ( 10 g/day ) in NIDDM subjects is associated with improvement in hypertriglyceridemia but with deleterious effects in factor VII and blood glucose levels . Most indices of platelet function are unaffected by this therapy",
"Since the first AHA Science Advisory “ Fish Consumption , Fish Oil , Lipids , and Coronary Heart Disease,”1 important new findings , including evidence from r and omized controlled trials ( RCTs ) , have been reported about the beneficial effects of omega-3 ( or n-3 ) fatty acids on cardiovascular disease ( CVD ) in patients with preexisting CVD as well as in healthy individuals.2 New information about how omega-3 fatty acids affect cardiac function ( including antiarrhythmic effects ) , hemodynamics ( cardiac mechanics ) , and arterial endothelial function have helped clarify potential mechanisms of action . The present Statement will address distinctions between plant-derived ( α-linolenic acid , C18:3n-3 ) and marine-derived ( eicosapentaenoic acid , C20:5n-3 [ EPA ] and docosahexaenoic acid , C22:6n-3 [ DHA ] ) omega-3 fatty acids . ( Unless otherwise noted , the term omega-3 fatty acids will refer to the latter . ) Evidence from epidemiological studies and RCTs will be review ed , and recommendations reflecting the current state of knowledge will be made with regard to both fish consumption and omega-3 fatty acid ( plant- and marine-derived ) supplementation . This will be done in the context of recent guidance issued by the US Environmental Protection Agency and the Food and Drug Administration ( FDA ) about the presence of environmental contaminants in certain species of fish . # # # Coronary Heart Disease As review ed by Stone,1 three prospect i ve epidemiological studies within population s reported that men who ate at least some fish weekly had a lower coronary heart disease ( CHD ) mortality rate than that of men who ate none.3–6 ⇓ ⇓ ⇓ More recent evidence that fish consumption favorably affects CHD mortality , especially nonsudden death from myocardial infa rct ion ( MI ) , has been reported in a 30-year follow-up of the Chicago Western Electric Study .7 Men who consumed 35 g or more of fish daily compared with those who consumed none had a relative risk of death from CHD of 0.62 and a relative risk of nonsudden death from MI of 0.33 . In an"
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BACKGROUND Generally , before being operated on , patients will be given informal information by the healthcare providers involved in the care of the patients ( doctors , nurses , ward clerks , or healthcare assistants ) . This information can also be provided formally in different formats including written information , formal lectures , or audio-visual recorded information . OBJECTIVES To compare the benefits and harms of formal preoperative patient education for patients undergoing laparoscopic cholecystectomy . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) ( Issue 2 , 2013 ) , MEDLINE , EMBASE , and Science Citation Index Exp and ed to March 2013 . SELECTION CRITERIA We included only r and omised clinical trials irrespective of language and publication status . DATA COLLECTION AND ANALYSIS Two review authors independently extracted the data . We planned to calculate the risk ratio with 95 % confidence intervals ( CI ) for dichotomous outcomes , and mean difference ( MD ) or st and ardised mean difference ( SMD ) with 95 % CI for continuous outcomes based on intention-to-treat analyses when data were available . MAIN RESULTS A total of 431 participants undergoing elective laparoscopic cholecystectomy were r and omised to formal patient education ( 215 participants ) versus st and ard care ( 216 participants ) in four trials . The patient education included verbal education , multimedia DVD programme , computer-based multimedia programme , and Power Point presentation in the four trials . All the trials were of high risk of bias . One trial including 212 patients reported mortality . There was no mortality in either group in this trial . None of the trials reported surgery-related morbidity , quality of life , proportion of patients discharged as day-procedure laparoscopic cholecystectomy , the length of hospital stay , return to work , or the number of unplanned visits to the doctor . There were insufficient details to calculate the mean difference and 95 % CI for the difference in pain scores at 9 to 24 hours ( 1 trial ; 93 patients ) ; and we did not identify clear evidence of an effect on patient knowledge ( 3 trials ; 338 participants ; SMD 0.19 ; 95 % CI -0.02 to 0.41 ; very low quality evidence ) , patient satisfaction ( 2 trials ; 305 patients ; SMD 0.48 ; 95 % CI -0.42 to 1.37 ; very low quality evidence ) , or patient anxiety ( 1 trial ; 76 participants ; SMD -0.37 ; 95 % CI -0.82 to 0.09 ; very low quality evidence ) between the two groups . A total of 173 participants undergoing elective laparoscopic cholecystectomy were r and omised to electronic consent with repeat-back ( patients repeating back the information provided ) ( 92 participants ) versus electronic consent without repeat-back ( 81 participants ) in one trial of high risk of bias . The only outcome reported in this trial was patient knowledge . The effect on patient knowledge between the patient education with repeat-back versus patient education without repeat-back groups was imprecise and based on 1 trial of 173 participants ; SMD 0.07 ; 95 % CI -0.22 to 0.37 ; very low quality evidence ) . AUTHORS ' CONCLUSIONS Due to the very low quality of the current evidence , the effects of formal patient education provided in addition to the st and ard information provided by doctors to patients compared with st and ard care remain uncertain . Further well- design ed r and omised clinical trials of low risk of bias are necessary
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"AIMS To investigate the incidence , risk factors and natural history of gallstone disease , a r and om sample of females belonging to a rural population was enrolled in a ten-year longitudinal study . METHODS The study has been performed in a small town on the hills south of Rome . In 1985 , a r and om sample of 426 females , aged 20 - 69 years , was screened by real-time ultrasonography for gallstones and previous cholecystectomy . Screening methods included anthropometry , collection of a blood sample and a question naire on the occurrence of abdominal symptoms . During 1995 , all these subjects were invited for a 10-year follow-up examination . RESULTS The overall 10-year incidence of gallstone disease was 6.3 % ( 5.5 % of new gallstones and 0.8 % of cholecystectomies ) . Only 23.1 % of the women with gallstones were aware of their condition . More than three quarters ( 76.9 % ) had not suffered biliary pain . Univariate and multivariate analyses demonstrated a positive independent association of new gallstone disease with body mass index and parity . Out of the initially asymptomatic gallstone women , 15.4 % experienced at least one episode of biliary pain , 23.1 % were su bmi tted to elective cholecystectomy and 61.5 % remained asymptomatic . CONCLUSIONS The study demonstrates a high incidence of gallstone disease in women belonging to a rural free-living population in Italy and suggests body mass index and parity as possible true risk factors . Moreover , it confirms that a remarkable proportion of asymptomatic patients become symptomatic and eventually undergo cholecystectomy",
"Aim of this study is the evaluation of the impact of preoperative informative session using a Multimedia Health Educational Program ( MHEP ) on patients undergoing elective Laparoscopic Cholecystectomy ( LC ) for cholelithiasis , preoperative anxiety and postoperative pain and nausea . Sixty consecutive patients scheduled for elective LC were considered for enrollment in the trial . Patients were assigned r and omly to four groups : Group A included 15 patients , preoperatively informed regarding LC through the MHEP presented by a Registered Nurse ( RN ) . Group B included 15 patients preoperatively informed through a leaflet ( design ed and developed using the exact contents of the MHEP ) . In Group C , there were 15 patients who were being informed verbally from the RN . Finally , the control Group D included 15 patients , who had the conventional preoperative information about the operation and postoperative course by the attending surgeon and anesthesiologist , as every other patient included in groups A , B , C. Preoperative assessment of patient 's knowledge about cholelithiasis and LC was performed after informative session , and was based on a specifically developed \" closed , true-false \" question naire . Preliminary results suggest that conventional information provided by the attending surgeon ( Group D ) is inadequate . Specifically developed informative sessions with the contribution of MHEP seems to be effective on reducing preoperative anxiety and postoperative pain , in patients undergoing elective LC",
"OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials",
" A r and om sample of 4,807 men and women , aged 30 , 40 , 50 , and 60 years , who lived in the western part of Copenhagen County , was drawn from the National Central Person Registry . A total of 226 subjects who were not of Danish origin were omitted . The response rate was 78.8 % ( 3,608/4,581 ) . Each person had his or her gallbladder examined by ultrasonography . The examinations took place between November 1982 and February 1984 . The overall prevalence of gallstone disease ( cases with stones and cholecystectomized cases ) in males aged 30 , 40 , 50 , and 60 years was 1.8 % , 1.5 % , 6.7 % , and 12.9 % , respectively . The corresponding prevalence in females was 4.8 % , 6.1 % , 14.4 % , and 22.4 % , respectively . Differences according to sex were significant in all age groups . Differences between the 40- and 50-year and 50- and 60-year age groups were significant in both sexes . Among subjects with gallstone disease , the disease was unknown to the prob and in the majority of males and in the 30-year-old females , but only in half of the women aged 40 , 50 , and 60 years . The prevalence of clinical ly diagnosed gallstones was not significantly different between respondents and nonrespondents",
"A prospect i ve study of the prevalence of gall stone disease at necropsy in a stable population has been undertaken over a 10 year period up to June 1988 . In women , the prevalence of gall stone disease remained static but in men aged 50 - 59 years it rose from 7 % ( n = 148 ) in the first three years to 18 % ( n = 138 ) in the last three years ( p less than 0.01 ) and in men aged 60 - 69 it rose from 12 % ( n = 370 ) to 20 % ( n = 366 , p less than 0.01 ) . In the latter age group the female : male ratio fell from 2:1 to 0.8:1 . The proportion of deaths from coronary heart disease in men fell slightly in those over 70 during the study period . There was a fall in deaths from coronary heart disease in all age groups in women . Men with gall stones were less likely to have had a cholecystectomy than women , and overall 88 % of gall stones remained in situ . In a parallel clinical study , the number of cholecystectomies carried out in the same district fell by 18 % over the 10 years without any apparent change in the provision of re sources . Cholecystectomy remained almost three times more frequent in women . National data indicate that there have been major changes in the average diet before and during the period of study in favour of reducing coronary heart disease . There has been no change in mortality from coronary heart disease in young men but if the observed increase in the prevalence of gall stones in men and the decrease in deaths from coronary heart disease in women are real phenomena , it seems likely that they are diet related",
"OBJECTIVE Occupational violence as experienced by professional nurses has been extensively research ed . However , the majority of studies have focused primarily on psychological and emotional outcomes and have not identified any interventions that may reduce the impact of aggressive behaviour on professional competence . The purpose of this study was to investigate the relationship between organisational support , occupational violence and perceived professional competence of professional nurses in Australia . DESIGN A model testing research design was used to test the hypothesis that organisational support , as experienced by nurses , would moderate the relationship between occupational violence and perceived professional competence . SETTING Nurses registered in Division 1 of the Nurses Board ( Victoria , Australia ) . PARTICIPANTS A systematic r and om sample of 380 registered nurses from the target population of nurses in Victoria was identified . MAIN OUTCOME MEASURE The relationship between organisational support , occupational violence and perceived professional competence of professional nurses in Australia . RESULTS The result showed that there was a significant effect of occupational violence on perceived competence . Analysis of the moderating effect of organisational support on the relationship between occupational violence and professional competence showed there was significant organisational support and occupational violence interaction . Overall , the data analysis demonstrated the hypothesis was upheld that the negative effects of occupational violence on perceived professional competence will be moderated by perceived organisational support . CONCLUSIONS The failure to receive appropriate organisational support may result in lowering professional nurses ' competence levels , causing a significant problem for the profession in that a reduction in professional competence has significant implication s for patient care . The findings heighten the responsibility of the nursing profession to become more aware of the needs of professional nurses",
"OBJECTIVES The objectives of this r and omised controlled study were to determine if pre-admission patient education affects post-operative pain levels , domiciliary self-care capacity and patient recall following a laparoscopic cholecystectomy ( LC ) . Participants were r and omised to receive the st and ard preadmission program ( SP ) or an individualised , education intervention ( El ) . DESIGN A pre-operative question naire was administered in the pre-admission clinic to determine participants ' knowledge of LC and post-operative management . Telephone follow-up and post-operative question naire were conducted approximately 14 days post discharge . SETTING Preadmission clinic of a Sydney , Australia , tertiary referral hospital . SAMPLE Ninety-three elective LC patients . RESULTS EI participants experienced lower pain levels and had significantly greater recall of provided information . However , no significant differences were found between the control and intervention groups for domiciliary self-care . CONCLUSION Pre-admission education intervention helps reduce post-operative pain levels following LC and significantly increases patients ' knowledge of self-care and complication management",
"Purpose The informed consent is a legal requirement prior to surgery and should be based on an extensive preoperative interview . Multimedia productions can therefore be utilised as supporting tool . In a prospect i ve r and omised trial , we evaluated the impact of an extended education on patients undergoing cholecystectomy . Material s and methods For extended patient information , a professionally built DVD was used . After r and omisation to either the DVD or the control group , patients were informed with or without additional presentation of the DVD . The quality of education was evaluated using a purpose -built question naire . Results One hundred fourteen patients were included in the DVD and 98 in the control group . Patient characteristics did not differ significantly despite a higher educational level in the DVD group . The score of correctly answered questions was higher in the DVD group ( 19.88 vs. 17.58 points , p Multimedia productions therefore offer a suitable instrument . In the presented study , we could prove the positive impact of an information DVD on patients knowledge . Nevertheless , multimedia tools can not replace personal interaction and should only be used to support daily work",
"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 .",
"Psychological stress has been shown to impair wound healing , but experimental research in surgical patients is lacking . This study investigated whether a brief psychological intervention could reduce stress and improve wound healing in surgical patients . This r and omised controlled trial was conducted at a surgical centre . Inclusion criteria were English-speaking patients over 18 years booked to undergo elective laparoscopic cholecystectomy ; exclusion criteria were cancellation of surgery , medical complications , and refusal of consent . Seventy five patients were r and omised and 15 patients were excluded ; 60 patients completed the study ( 15 male , 45 female ) . Participants were r and omised to receive st and ard care or st and ard care plus a 45-min psychological intervention that included relaxation and guided imagery with take-home relaxation CDs for listening to for 3 days before and 7 days after surgery . In both groups ePTFE tubes were inserted during surgery and removed at 7 days after surgery and analysed for hydroxyproline as a measure of collagen deposition and wound healing . Change in perceived stress from before surgery to 7-day follow-up was assessed using question naires . Intervention group patients showed a reduction in perceived stress compared with the control group , controlling for age . Patients in the intervention group had higher hydroxyproline deposition in the wound than did control group patients ( difference in means 0.35 , 95 % CI 0.66 - 0.03 ; t(43)=2.23 , p=0.03 ) . Changes in perceived stress were not associated with hydroxyproline deposition . A brief relaxation intervention prior to surgery can reduce stress and improve the wound healing response in surgical patients . The intervention may have particular clinical application for those at risk of poor healing following surgery",
"Objective : In this r and omized , controlled , unblinded trial , we sought to test Repeat Back 's ( RB ) effect on comprehension following informed consent discussion s. Summary Background Data : RB has been suggested as a method to improve patient comprehension when obtaining informed consent . In this technique , patients are asked to recount what they have been told in the informed consent discussion . Despite preliminary data , this practice has not been evaluated in any large scale study . Methods : This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent , the VA 's computer based platform . Patients scheduled for elective surgeries were r and omized to RB ( a module added to the iMedConsent package ) or st and ard iMedConsent ( no RB ) . Comprehension was tested after the informed consent using procedure-specific question naires . Time stamps in the iMedConsent program estimated the time spent completing the informed consent process . Provider and patient satisfaction were measured using 5-point Likert scales . Statistical comparisons of groups were performed using t-tests and & khgr;2 tests . Results : A total of 575 patients were enrolled . In the RB group , providers spent 2.6 minutes longer ( P obtaining informed consent . The mean comprehension score was significantly higher in the RB group ( 71.4 % ) versus the no RB group ( 68.2 % , P = 0.03 ) ; the effect was greatest in carotid endarterectomy patients ( RB = 73.4 % vs. no RB = 67.7 % , P = 0.02 ) . Quality of decision making was rated similarly . Providers were neutral to slightly favorable regarding RB . Conclusions : RB implemented within an electronic informed consent system improved patient comprehension . The additional time required was acceptable to providers . RB should be considered as an enhancement to surgical informed consent . This clinical trial was registered at http://www . clinical trials.gov ( Identifier NCT00288899 )",
"Background Laparoscopic cholecystectomy is the st and ard treatment for symptomatic gallstones . The quality of the procedure frequently is included in quality improvement programs , but outcome values have not been described to define the st and ard of care for a general population . This study included 20,307 cholecystectomies from a national prospect i ve data base that combines administrative data with clinical data . This report states the quality of cholecystectomy in Denmark , establishes benchmarks , and identifies significant risk factors . Methods The Danish Cholecystectomy Data base was queried for data from 2006 to 2009 . The outcome measures included conversion rate , hospital length of stay ( LOS ) , readmission , additional procedures , and 30-day mortality . Patient characteristics and operative findings were analyzed as risk factors using stepwise backward logistic regression . Results The study included 20,307 patients ( 82 % of all cholecystectomies ) . The conversion rate was 7.6 % . Male sex , acute cholecystitis , and previous upper abdominal surgery were risk factors for conversion , with respective odds ratios of 1.50 , 4.61 , and 3.54 . The mean LOS was 1.5 days , and 37.3 % of the patients had same-day surgery . The readmission rate was 9.6 % . Nearly 70 % had a LOS of 1 day or less and no readmission ; 17.3 % had a LOS longer than 3 days and /or readmission ; 5.6 % had an additional procedure within 30 days ; and 0.2 % had a bile duct injury requiring reconstructive surgery . The 30-day mortality rate was 0.27 % . Age older than 60 years , American Society of Anesthesiology ( ASA ) score exceeding 1 , and open procedure were significant risk factors for all the outcomes . Body mass index ( BMI ) was not a risk factor for any of the outcomes . Conclusion The quality of cholecystectomy is high in Denmark , with a low conversion rate and a high frequency of short admissions without readmission . Acute cholecystitis and open procedure are important risk factors for poorer outcomes .The results of this study analyzing a large , unbiased population can be used to benchmark outcomes of cholecystectomy",
"BACKGROUND Patient comprehension during surgical informed consent remains problematic . Using data from our r and omized trial of methods to improve informed consent comprehension , we performed an additional analysis to define independent factors associated with improved patient underst and ing . STUDY DESIGN Patients scheduled for 1 of 4 elective operations ( total hip arthroplasty [ n = 137 ] , carotid endarterectomy [ n = 178 ] , laparoscopic cholecystectomy [ n = 179 ] , or radical prostatectomy [ n = 81 ] ) at 7 Department of Veterans Affairs ( VA ) medical centers were enrolled . All informed consent discussion s were performed using iMedConsent ( Dialog Medical ) , the VA 's computerized informed consent platform . Using a unique module within iMedConsent , we r and omized patients to repeat back ( RB ) , requiring correct reiteration of procedure-specific facts , or st and ard ( STD ) iMedConsent . Patient comprehension was tested after the informed consent discussion using procedure-specific question naires . Time spent completing the informed consent process was measured using time stamps within iMedConsent . Multiple linear regression identified factors independently associated with improved comprehension . RESULTS We enrolled 575 patients ( 276 RB , 299 st and ard ) ; 93 % were male , 74 % were Caucasian , and 89 % had at least a high school education . Independent factors associated with improved comprehension included race ( p total consent time ( p Patient comprehension was maximized when informed consent took between 15 and 30 minutes . RB 's positive impact on patient comprehension was weaker in the analysis including consent time . CONCLUSIONS Comprehension during informed consent discussion s may be limited in individuals with potential language difficulty due to ethnicity or education . Total consent time was the strongest predictor of patient comprehension . Affording adequate time for informed consent discussion s and using informed consent adjuncts such as RB may enhance comprehension in such individuals",
"BACKGROUND Obtaining informed consent before performing invasive procedures and operations has become a st and ard practice at all medical institutions in the United States . All agree that patients should be both conscious of and in agreement with their medical care . Though patients routinely sign consent forms with numerous risks and complications detailed , there are only a limited amount of reports that study if these patients have a thorough underst and ing of those risks and complications . Confounding the issue of the efficacy of informed consents is the growing population of patients who do not speak English . To obtain objective data on the efficacy of informed consents and the role of language barriers we looked at how well patients who consented to have a laparoscopic cholecystectomy understood the complications associated with this procedure . METHODS We conducted a r and omized prospect i ve study of all patients seen in the General Surgery Resident Outpatient Clinic who presented for an elective cholecystectomy . Fifty patients agreed to participate in our study . Participants were split into two groups . In the first group ( the control group ) surgical benefits , risks and complications were explained in the usual fashion . In the second group , after hearing the st and ard explanation of surgical risks , complications and benefits , patients watched a PowerPoint presentation with illustrations on laparoscopic cholecystectomy . Patients from both groups then took a ten question assessment based on the presentations that they encountered . Spanish speaking patients were addressed with an interpreter and given a Spanish PowerPoint presentation with a Spanish assessment . The patients ' age , education level , income , and birth country were also studied . RESULTS Fifty-two percent of the patients in the study were born outside of the United States . All of the non-US born patients were Hispanic and their primary language was Spanish . The average age of the studied patients was 38 . Sixty-eight percent of the patients reported an education level no higher than high school . The majority of the studied patients noted an income of less than $ 40,000 . Differences were seen between patient native to the US and those born outside the United States . US born patients had an 80 % correct response rate versus non-US born patients who had only a 63 % correct response . Differences were seen between US born patient and non-US born patients concerning the topics of the severity of a common bile duct injury , gastrointestinal changes after cholecystectomy and the safety concerning conversion from laparoscopic to open cholecystectomy . No difference was appreciated in the PowerPoint group versus the non-PowerPoint group . CONCLUSION The addition of a PowerPoint presentation did not increase underst and ing of the risks and benefits associated with a laparoscopic cholecystectomy . This study did however highlight the problem of obtaining consent from foreign born patients . Patients who were not US natives showed a decreased underst and ing of the surgical procedure and the severity of the complications in both the control group and the PowerPoint group . Better methods of educating foreign patients should be investigated to truly obtain informed consents from this patient population",
"UNLABELLED In this study , we evaluated the effects of viewing an educational videotape about pediatric anesthesia on measures of parental knowledge of anesthesia and preoperative anxiety using a r and omized , controlled design . During their routine preoperative visit , 85 parents of children scheduled to undergo ambulatory surgical procedures under general anesthesia were r and omized to view either the experimental videotape about pediatric anesthesia or a control videotape with no medical content . Before and immediately after viewing the assigned videotape , parents completed measures of situational anxiety ( State-Trait Anxiety Inventory-State ) , preoperative anxiety and need for information ( Amsterdam Preoperative Anxiety and Information Scale ) , and anesthesia knowledge ( St and ard Anesthesia Learning Test ) . Repeated- measures analyses of variance showed that parents who viewed the experimental videotape showed a significant increase in anesthesia knowledge ( P state of anxiety ( P anesthesia-specific anxiety , and need for information ( P educational videotape about pediatric anesthesia can provide immediate educational and anxiolytic benefits for parents of children undergoing ambulatory surgery . The duration of these benefits remains to be determined . IMPLICATION S In this study , we demonstrated the benefits of viewing an educational videotape about pediatric anesthesia on measures of parental knowledge of anesthesia and preoperative anxiety using a r and omized , controlled design . We found that videotape viewing facilitated preoperative preparation and lessened preoperative anxiety",
"OBJECTIVES Aim of this study is the evaluation of the impact of a multimedia CD ( MCD ) on preoperative anxiety and postoperative recovery of patients undergoing elective laparoscopic cholecystectomy ( LC ) . METHODS Sixty consecutive c and i date s for elective LC were r and omly assigned to four groups . Group A included 15 patients preoperatively informed regarding LC through the MCD presented by Registered Nurse ( RN ) . Patients in group B ( n = 15 ) were informed through a leaflet . Patients in group C ( n = 15 ) were informed verbally from a RN . Finally , the control Group D included 15 patients informed conventionally by the attending surgeon and anesthesiologist , as every other patient included in groups A , B , and C. Preoperative assessment of knowledge about LC was performed after each informative session through a question naire . Evaluation of preoperative anxiety was conducted using APAIS scale . Postoperative pain and nausea scores were measured using an NRS scale , 16 hours after the patient had returned to the ward . RESULTS Statistical processing of the results ( single linear regression ) showed that patients in groups A , B , and C achieved a higher knowledge score , less preoperative anxiety score and less postoperative pain and nausea , compared to Group D. In multiple regression analysis , group A had a higher knowledge score compared to the four groups ( p knowledge , especially in day-surgery cases , like LC",
"Objective : The term “ informed consent ” explains the process by which a patient , before treatment , is provided comprehensive and impartial information regarding a planned operative procedure so that he/she underst and s the implication s of the procedure before consenting . The goal of the current study was to investigate whether st and ard methods of consenting can be improved using a multimedia-based information program ( MM-IP ) . Patients and Methods : In a prospect i ve multicenter study , 80 patients undergoing laparoscopic cholecystectomy went through the st and ard informed consent process . One group of patients was also given access to a MM-IP . Question naires were completed before surgery . These evaluated how patients perceived their own underst and ing of important aspects of their illness ( ie , disease , therapeutic alternatives , operation , risks ) and satisfaction with the consenting process . Patients ’ anxiety levels were also assessed . These question naires were used to evaluate the effectiveness of the MM-IP for improving the consent process . Results : Seventy-six patients ( 47 women , 29 men , median age 54 years ) were included . There was no significant age or gender variation between the groups ( st and ard n = 41 and MM-IP n = 35 ) . Eighty-two percent of all respondents were satisfied with the st and ard informed consent process . However , perceived underst and ing of the material was significantly improved in the MM-IP group ( P MM-IP . Preoperative anxiety did not vary between the groups . Conclusion : Use of the multimedia-based program was positively evaluated by patients , and significantly improved patients ’ perceived underst and ing of their disease and its treatment . It is , therefore , valuable in the informed consent process",
"Published evidence suggests that aspects of trial design lead to biased intervention effect estimates , but findings from different studies are inconsistent . This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials . Outcome measures were classified as \" mortality , \" \" other objective , \" \" or subjective , \" and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity . Intervention effect estimates seemed to be exaggerated in trials with inadequate or unclear ( vs. adequate ) r and om-sequence generation ( ratio of odds ratios , 0.89 [ 95 % credible interval { CrI } , 0.82 to 0.96 ] ) and with inadequate or unclear ( vs. adequate ) allocation concealment ( ratio of odds ratios , 0.93 [ CrI , 0.87 to 0.99 ] ) . Lack of or unclear double-blinding ( vs. double-blinding ) was associated with an average of 13 % exaggeration of intervention effects ( ratio of odds ratios , 0.87 [ CrI , 0.79 to 0.96 ] ) , and between-trial heterogeneity was increased for such studies ( SD increase in heterogeneity , 0.14 [ CrI , 0.02 to 0.30 ] ) . For each characteristic , average bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes , with little evidence of bias in trials with objective and mortality outcomes . This study is limited by incomplete trial reporting , and findings may be confounded by other study design characteristics . Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes"
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Background Tiredness is one of the most frequent complaints in primary care . Although often self-limiting and frequently associated with psychosocial stress , patients but also their physicians are often uncertain regarding a serious cause and appropriate diagnostic work-up . We conducted a systematic review and meta- analysis of studies reporting on differential diagnosis of fatigue in primary care . Methods MEDLINE , EMBASE and conference abstract s were search ed for primary care based studies of patients presenting with tiredness . Twenty-six studies were included . We report on anaemia , malignancy , serious organic disease , depression and the chronic fatigue syndrome ( CFS ) as causes of tiredness as presenting complaint . Results We found considerable heterogeneity of estimates which was reduced by limiting our analysis to high quality studies . Prevalences were as follows-anaemia : 2.8 % ( CI ( confidence interval ) 1.6–4.8 % ) ; malignancy : 0.6 % ( CI 0.3–1.3 % ) ; serious somatic disease : 4.3 % ( CI 2.7–6.7 % ) ; depression 18.5 % ( CI 16.2–21.0 % ) . Pooling was not appropriate for CFS.In studies with control groups of patients without the symptom of tiredness , prevalence of somatic disease was identical to those complaining of tiredness . Depression , however , was more frequent among those with tiredness . Conclusions Serious somatic disease is rare in patients complaining of tiredness . Since prevalence is similar in patients without tiredness , the association may not be causal . Extensive investigations are only warranted in case of specific findings from the history or clinical examination . Instead , attention should focus on depression and psychosocial problems
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"OBJECTIVE To examine self-reported health care use and health care-seeking behaviour of patients meeting DSM-IV 's diagnostic criteria for generalized anxiety disorder ( GAD ) . DESIGN Survey of out patients recruited at three different times of the day using question naires on worry and anxiety ( a six-item screening question naire based on DSM-IV criteria for GAD ) , on perceived health problems , and on health care use and health care-seeking behaviour . The assessment package also included well vali date d assessment instruments for insomnia and depression symptoms . All patients seeking health care were invited to participate . Participants completed the survey as they waited in the reception area . SETTING Four r and omly selected community-based medical clinics of Quebec city 's metropolitan area . PARTICIPANTS A final sample of 1110 patients among 1878 out patients invited to participate included 219 ( 19.7 % ) who tested positive for GAD . MAIN OUTCOME MEASURES Self-reported worry and anxiety ( based on DSM-IV criteria for GAD ) , self-perceived health problems , health care use and health care-seeking behaviour , insomnia , and symptoms of depression . RESULTS Participants who tested positive on a screening test for GAD reported more annual medical visits ( 5.3 versus 3.4 ) than other patients . Those who reported at least five annual medical visits were nearly four times more likely to have positive results for GAD . Women were 1.6 times more likely to have positive results than men were . Patients who tested positive reported insomnia-type sleep disturbances , depressive symptoms , fatigue , and gastric problems significantly more often than others . Forty-two percent had consulted a family physician in the past year with a complaint of anxiety . Eighty percent of patients who tested positive reported they believed they had an anxiety problem , and this belief predicted positive test results ( odds ratio = 20.3 ) . Yet most reported not having sought other types of medical or psychological care specifically for anxiety in the past year . CONCLUSION Some patients in this sample with symptoms of GAD mainly seek primary care for their symptoms . Questions about excessive worrying and anxiety , as part of routine examination , can increase recognition of GAD",
"INTRODUCTION Tiredness is a common presentation in general practice for which pathology tests are commonly ordered . Our aim was to study their utilisation for tiredness . METHODS We examined an integrated data base which contains the medical records for 58,139 patients and their 696,518 associated general practitioner encounters . Three hundred and forty-two patients and their 1652 associated encounters were r and omly selected out of 12,291 patients and their 26,748 associated encounters that had mentioned tiredness ( or a synonym ) . RESULTS One hundred and eighty-one patients ( 53 % ) had at least one pathology test ordered at any time in their episode of care . Patients over 60 years of age , patients who consulted their GP more than once and patients without comorbidity were more likely to have a pathology test ordered . Only 12 patients ( 3 % ) had a significant clinical diagnosis based on an abnormal pathology test . CONCLUSION Pathology testing for patients presenting with tiredness is high . Most tests do not yield a significant clinical diagnosis ",
"OBJECTIVE --To describe the characteristics of patients attending their general practitioners and complaining of fatigue or being \" tired all the time . \" DESIGN -- Prospect i ve study of cohort aged 16 years and older with follow up at two weeks and by question naires at two and six months . SUBJECTS--220 patients ( 164 women ) with mean age 43 years and an age-sex matched comparison group . SETTING S -- Doctors and patients in four practice s in Lancashire , Mid Glamorgan , Suffolk , and Surrey . MAIN OUTCOME MEASURES --General clinical data , results from st and ard group of laboratory tests , fatigue question naire , and 12 item general health question naire . RESULTS --Over twice as many patients with fatigue had high scores on the health question naire compared with the comparison group ( 156 ( 75 % ) v 69 ( 34 % ) ) . Results of laboratory tests were abnormal and contributed to the diagnosis in 19 patients . 59 out of 102 patients who responded had high fatigue scores six months later . Patients with persistent fatigue were more likely to have a history of anxiety or depression and to have had fatigue for more than three months on entry to the study . CONCLUSIONS --Women are particularly at risk of fatigue . The outcome is better if patients have had symptoms for three months or less or there is no history of emotional illness",
"BACKGROUND Unexplained fatigue is frequently encountered in general practice . Because of the low prior probability of underlying somatic pathology , the positive predictive value of abnormal ( blood ) test results is limited in such patients . AIM The study objectives were to investigate the relationship between established diagnoses and the occurrence of abnormal blood test results among patients with unexplained fatigue ; to survey the effects of the postponement of test ordering on this relationship ; and to explore consultation-related determinants of abnormal test results . DESIGN OF STUDY Cluster r and omised trial . SETTING General practice s of 91 GPs in the Netherl and s. METHOD GPs were r and omised to immediate or postponed blood-test ordering . Patients with new unexplained fatigue were included . Limited and exp and ed sets of blood tests were ordered either immediately or after 4 weeks . Diagnoses during the 1-year follow-up period were extracted from medical records . Two-by-two tables were generated . To establish independent determinants of abnormal test results , a multivariate logistic regression model was used . RESULTS Data of 325 patients were analysed ( 71 % women ; mean age 41 years ) . Eight per cent of patients had a somatic illness that was detectable by blood-test ordering . The number of false-positive test results increased in particular in the exp and ed test set . Patients rarely re-consulted after 4 weeks . Test postponement did not affect the distribution of patients over the two-by-two tables . No independent consultation-related determinants of abnormal test results were found . CONCLUSION Results support restricting the number of tests ordered because of the increased risk of false-positive test results from exp and ed test sets . Although the number of re-consulting patients was small , the data do not refute the advice to postpone blood-test ordering for medical reasons in patients with unexplained fatigue in general practice",
"To determine the psychiatric morbidity of patients complaining of chronic fatigue , we undertook a prospect i ve evaluation of 100 adults ( 65 women and 35 men ; mean age , 41 years ; and mean duration of chronic fatigue , 13 years ) . The study was conducted in an internal medicine outpatient clinic . In addition to a comprehensive medical evaluation , the patients were administered the 260-item Diagnostic Interview Schedule , a highly structured instrument that enabled the physician-interviewer to make accurate psychiatric diagnoses . A thorough follow-up examination was given an average of 8.4 months later . Sixty-six patients had one or more psychiatric disorders that were considered a major cause of their chronic fatigue ( mood disorder , 47 patients ; somatization disorder , 15 patients ; and anxiety disorder , nine patients ) . Five patients had medical conditions that were considered a major cause of their fatigue . The complaint of chronic fatigue remained unexplained in 31 patients . In this prospect i ve study , two thirds of cases of chronic fatigue appeared to be caused by psychiatric disorders . A thorough evaluation of the mental health of patients complaining of chronic fatigue could therefore provide pharmacologic and psychotherapeutic approaches and avoid unnecessary and costly medical investigations and therapies",
"BACKGROUND Early diagnosis of cancer is an important challenge in general practice . Symptoms are the most common starting points . OBJECTIVE To assess the association between symptoms presented and subsequent cancer . DESIGN A cohort study of all patients seen consecutively by GPs . Prospect i ve recording of cancer diagnosis , new cancer or new recurrence . SETTING Two hundred and eighty-three general practice surgeries and 10 working days . METHOD During patient consultations , GPs registered seven focal symptoms and three general symptoms , commonly considered as warning signs of cancer ( WSC ) . Follow-up 6 - 11 months later with registration of any subsequent diagnosis of cancer was done . RESULTS Of 51 073 patients , 6321 ( 12.4 % ) had recordings of 7704 WSC . During a median follow-up period of 8 months , 263 patients were diagnosed with cancer and 59 of them with recurrence of a previously diagnosed cancer . Of the cancer patients , 106 ( 40 % ) had presented one or more WSC during a preceding consultation . Examined symptoms had likelihood ratios for cancer from 1.5 to 8.2 and positive predictive values ( PPVs ) from 0.8 % to 3.8 % . Limited to older age groups , PPVs were a little higher . General symptoms were rarely associated with cancer unless a focal symptom had been recorded as well . Multiple symptoms increased the probability of cancer . CONCLUSION 12.4 % of GP patients presented with WSC . A general symptom may have cancer diagnostic value , but usually , only when it occurs along with a focal symptom . PPV of any single symptom is low , and decisions about referral require additional information",
"Background : Little is known about the distribution of diagnoses that account for fatigue in patients in primary care . We evaluated the diagnoses established within 1 year after presentation with fatigue in primary care that were possibly associated with the fatigue . Methods : We conducted a prospect i ve observational cohort study with 1-year follow-up . We included adult patients who presented with a new episode of fatigue between June 2004 and January 2006 . We extracted data on diagnoses during the follow-up period from the patients ’ medical records as well as data on pre-existing chronic diseases . Results : Of the 571 patients for whom diagnostic data were available , 268 ( 46.9 % ) had received one or more diagnoses that could be associated with fatigue . The diagnoses were diverse and mostly included symptom diagnoses , with main categories being musculoskeletal ( 19.4 % ) and psychological problems ( 16.5 % ) . Clear somatic pathology was diagnosed in 47 ( 8.2 % ) of the patients . Most diagnoses were not made during the consultation when fatigue was presented . Interpretation : Only a minority of patients were diagnosed with serious pathology . Half of the patients did not receive any diagnosis that could explain their fatigue . Nevertheless , because of the wide range of conditions and symptoms that may explain or co-occur with the fatigue , fatigue is a complex problem that deserves attention not only as a symptom of underlying specific disease",
"BACKGROUND Chronic fatigue syndrome ( CFS ) has been defined , but many more patients consult in primary care with chronic fatigue that does not meet the criteria for CFS . General practitioners ( GPs ) do not generally use the CFS diagnosis , and have some doubt about the validity of CFS as an illness . AIM To describe the proportion of patients consulting their GP for fatigue that met the criteria for CFS , and to describe the social , psychological , and physical differences between patients with CFS and those with non-CFS chronic fatigue in primary care . DESIGN OF STUDY Baseline data from a trial of complex interventions for fatigue in primary care . SETTING Twenty-two general practice s located in London and the South Thames region of the United Kingdom recruited patients to the study between 1999 and 2001 . METHOD One hundred and forty-one patients who presented to their GP with unexplained fatigue lasting six months or more as a main symptom were recruited , and the Centers for Disease Control ( CDC ) case definition was applied to classify CFS . RESULTS Approximately two-thirds ( 69 % ) of patients had chronic fatigue and not CFS . The duration of fatigue ( 32 months ) and perceived control over fatigue were similar between groups ; however , fatigue , functioning , associated symptoms , and psychological distress were more severe in the patients in the CFS group , who also consulted their GP significantly more frequently , were twice as likely to be depressed , and more than twice as likely to be unemployed . About half ( CFS = 50 % ; chronic fatigue = 55 % ) in each group attributed their fatigue to mainly psychological causes . CONCLUSIONS In primary care , CFS is a more severe illness than chronic fatigue , but non-CFS chronic fatigue is associated with significant fatigue and is reported at least twice as often . That half of patients , irrespective of CFS status , attribute their fatigue to psychological causes , more than is observed in secondary care , indicates an openness to the psychological therapies provided in that setting . More evidence on the natural history of chronic fatigue and CFS in primary care is required , as are trials of complex interventions . The results may help determine the usefulness of differentiating between chronic fatigue and CFS",
"BACKGROUND The symptom iceberg describes the phenomenon that most symptoms are managed in the community without people seeking professional health care . The size of the iceberg for many symptoms is unknown , as is their association with personal characteristics , including history of a chronic disease . AIM To ascertain the size of the symptom iceberg in the UK . DESIGN OF STUDY A UK-wide community-based postal survey . SETTING Urban and rural communities across the UK . METHOD A postal survey was sent to an age- and sex-stratified r and om sample of 2474 adults , aged 18 - 60 years , drawn from 20 practice s around the UK . Questions were aim ed at investigating adults ' experiences of 25 different symptoms in the previous 2 weeks . RESULTS The number of symptoms experienced by one individual in the previous 2 weeks ranged from 0 to 22 ( mean 3.66 ) . Of the symptoms examined , the three most common were : feeling tired/run down ; headaches ; and joint pain . Univariate analysis found symptom prevalence to be significantly associated with a wide range of participant characteristics . However , after adjustment , many of these associations no longer remained significant for a number of the symptoms . Presence of a chronic condition , age , and employment status were the three factors most commonly associated with the 2-week prevalence of symptoms . Reported symptom characteristics ( severity , duration , interference , and time off work ) varied little by sex or age . CONCLUSION Symptoms in the UK community are common . Symptom prevalence was associated with a number of participant characteristics , although the extent of this association was less than has been reported in previous research . This study provides an important current baseline prevalence of 25 symptoms in the community for those who do , and do not , have a chronic condition",
"Fatigue is one of the 10 most common reasons for visiting a physician . Yet little is known about its course or impact , from the patient 's perspective , on quality of life or utilization of medical care . The Dartmouth COOP Project , a primary care research network , conducted a one-year prospect i ve study comparing chief complaint fatigue ( CCF ) patients with two age/sex matched comparison groups ( N = 243 ) . Results show that almost 67 % of the CCF patients improved over one year ; however , they had much higher utilization rates and substantial limitations in physical and emotional function . Fatigue was associated with physical symptoms and interference with many aspects of daily life . We conclude that fatigue has a powerful , adverse effect on quality of life . We hope the findings may help physicians to better underst and and treat patients who seek care for fatigue",
"PURPOSE This case series describes associated diagnoses and prognoses of persistent fatigue in a community-based , primary care population . PATIENTS AND METHODS All patients presenting to a private practice internist with a chief complaint of fatigue of more than 1 month 's duration were prospect ively evaluated with clinical ly directed examination and diagnostic testing . Patients were excluded if they had a previously diagnosed illness associated with fatigue . Fatigue was attributed to newly established diagnoses or medication use based on explicit criteria . Change in the state of each patient 's fatigue was measured 6 months after entry . RESULTS Fifty-two consecutive patients entered the study . The diagnoses associated with fatigue were a medical disorder in 25 patients , depression in 10 patients , and no definitive diagnosis in 18 patients . The mean cost of diagnostic testing was $ 131 . At 6 months , 37 of 52 patients ( 72 % ) reported improvement in or resolution of their fatigue . CONCLUSION In a primary care setting , many patients presenting with persistent fatigue have an associated , treatable disease that can be determined using a cost-effective , clinical ly directed approach . Most will experience an improvement in their fatigue",
"The Dartmouth COOP Project , a primary care research network , conducted a prospect i ve study of patients presenting to 28 primary care practice s with a chief complaint of fatigue . Data were gathered on fatigue status , associated systems , health status , and origin of fatigue . Fatigue patients were demographically similar to nonfatigue patients but had significantly worse physical and mental health at study intake . Sixty-three percent of physicians and 52 % of patients rated fatigue origin as primarily physical ( gamma = 0.48 , P less than .05 ) , but in 41 % of cases , physicians indicated there was substantial interaction between physical and psychological factors . Only two factors -- depression and anxiety -- separated fatigue of physical origin from fatigue of psychological origin . Clinicians must thoughtfully evaluate fatigue 's often multiple causes and communicate their underst and ing of those causes to the patient to gain support for a reasonable treatment regimen"
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BACKGROUND Evolvements in the design , fixation methods , size , and bearing surface of implants for total hip replacement ( THR ) have led to a variety of options for healthcare professionals to consider . The need to determine the most optimal combinations of THR implant is warranted . This systematic review evaluated the clinical effectiveness of different types of THR used for the treatment of end stage arthritis of the hip . METHODS A comprehensive literature search was undertaken in major health data bases . R and omised controlled trials ( RCTs ) and systematic review s published from 2008 onwards comparing different types of primary THR in patients with end stage arthritis of the hip were included . RESULTS Fourteen RCTs and five systematic review s were included . Patients experienced significant post-THR improvements in Harris Hip scores , but this did not differ between impact types . There was a reduced risk of implant dislocation after receiving a larger femoral head size ( 36 mm vs. 28 mm ; RR = 0.17 , 95 % CI : 0.04 , 0.78 ) or cemented cup ( vs. cementless cup ; pooled odds ratio : 0.34 , 95 % CI : 0.13 , 0.89 ) . Recipients of cross-linked vs. conventional polyethylene cup liners experienced reduced femoral head penetration and revision . There was no impact of femoral stem fixation and cup shell design on implant survival rates . Evidence on mortality and complications ( aseptic loosening , femoral fracture ) was inconclusive . CONCLUSIONS The majority of evidence was inconclusive due to poor reporting , missing data , or uncertainty in treatment estimates . The findings warrant cautious interpretation given the risk of bias ( blinding , attrition ) , method ological limitations ( small sample size , low event counts , short follow-up ) , and poor reporting . Long-term pragmatic RCTs are needed to allow for more definitive conclusions . Authors are encouraged to specify the minimal clinical ly important difference and power calculation for their primary outcome ( s ) as well CONSORT , PRISMA and STROBE guidelines to ensure better reporting and more reliable production and assessment of evidence
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"The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care",
"CONTEXT R and omized controlled trials have been developed essentially in the context of pharmacological treatments ( ie , oral drugs ; intra-articular injection ; and topical , intramuscular , and intravenous treatments ) , but assessment of the effectiveness of nonpharmacological treatments ( ie , surgery , arthroscopy , joint lavage , rehabilitation , acupuncture , and education ) presents specific issues . OBJECTIVES To compare the quality of articles of nonpharmacological and pharmacological treatments of hip and knee osteoarthritis and to identify specific method ological issues related to assessment of nonpharmacological treatments . DESIGN AND SETTING We search ed MEDLINE and the Cochrane Central Register of Controlled Trials for articles of r and omized controlled trials published between January 1 , 1992 , and February 28 , 2002 , in 28 general medical and specialty journals with high impact factors and assessing nonpharmacological and pharmacological treatments in patients with hip or knee osteoarthritis . MAIN OUTCOME MEASURES The quality of the methods reported in the selected articles was assessed by 2 independent review ers using the Jadad scale , the Delphi list , and guidelines found in the Users ' Guides to the Medical Literature . Investigators also used a checklist of items developed by the authors to analyze study characteristics . RESULTS A total of 110 articles were included in the analysis ; 50 ( 45.5 % ) assessed nonpharmacological treatments and 60 ( 54.5 % ) assessed pharmacological treatments . Reports of nonpharmacological treatments had a lower global quality score than did reports of pharmacological treatments as measured by the Jadad scale ( mean [ SD ] score , 1.4 [ 1.3 ] vs 3.0 [ 1.3 ] ) and the Delphi list ( mean [ SD ] score , 5.2 [ 1.5 ] vs 7.5 [ 1.1 ] ) . Lack of reporting adequate r and om sequence generation and intention-to-treat analyses were found in both nonpharmacological and pharmacological articles . Nonpharmacological treatments were less often compared with a placebo than were pharmacological treatments ( 28.0 % of articles vs 71.7 % ) . Compared with pharmacological articles , nonpharmacological articles less often described blinding of patients ( 26.0 % vs 96.7 % ) , care providers ( 6.0 % vs 81.7 % ) , and outcome assessors ( 68.0 % vs 98.3 % ) . Care providers ' skill levels could influence treatment effect in 84.0 % of nonpharmacological articles vs 23.3 % of pharmacological articles . CONCLUSIONS In this analysis of reports of hip and knee osteoarthritis therapy , nonpharmacological articles scored lower than pharmacological articles in terms of quality . Assessment s of nonpharmacological treatments must take into consideration additional method ological issues",
"BACKGROUND The conduct of r and omized , controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports . OBJECTIVE To develop an extension of the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement for trials of nonpharmacologic treatments . DESIGN A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses r and omized trials of nonpharmacologic treatments . To prepare for the meeting , a survey was conducted to identify the specific issues for discussion . SETTING Consensus meeting in Paris , France . PARTICIPANTS A total of 33 experts attended the meeting . The experts were method ologists ( n = 17 ) ; surgeons ( n = 6 ) ; editors ( n = 5 ) ; and clinicians involved in rehabilitation ( n = 1 ) , psychotherapy ( n = 2 ) , education ( n = 1 ) , and implantable devices ( n = 1 ) . MEASUREMENTS Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments . During a 3-day consensus meeting , all items were discussed and additional method ological issues related to nonpharmacologic research were identified . RESULTS The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials : item 1 ( title and abstract ) , item 3 ( participants ) , item 4 ( interventions ) , item 7 ( sample size ) , item 8 ( r and omization ) , item 11 ( blinding ) , item 12 ( statistical methods ) , item 13 ( participant flow ) , item 15 ( baseline data ) , item 20 ( discussion : interpretation ) , and item 21 ( generalizability ) . In addition , the meeting participants added 1 item related to implementation of the intervention . LIMITATION Evidence was not always available to support the inclusion of each checklist item . CONCLUSION The methods and processes used to develop this extension could be used for other reporting guidelines . The use of this extension to the CONSORT Statement should improve the quality of reporting r and omized , controlled trials assessing nonpharmacologic treatments",
"Background Hip replacement ( arthroplasty ) surgery is a highly successful treatment for patients with severe symptomatic arthritis of the hip joint . For older patients , several design s of Total Hip Arthroplasty have shown excellent results in terms of both function and value for money . However , in younger more active patients , there is approximately a 50 % failure rate at 25 years for traditional implants . Hip resurfacing is a relatively new arthroplasty technique . In a recent review of the literature on resurfacing arthroplasty it was concluded that the short-term functional results appear promising but some potential early disadvantages were identified , including the risk of femoral neck fracture and collapse of the head of the femur . The aim of the current study is to assess whether there is a difference in functional hip scores at one year post-operation between Total Hip Arthroplasty and Resurfacing Arthroplasty . Secondary aims include assessment of complication rates for both procedures as well cost effectiveness . Methods / design All patients medically fit for surgery and deemed suitable for a resurfacing arthroplasty are eligible to take part in this study . A r and omisation sequence will be produced and administered independently . After consenting , all patients will be clinical ly review ed and hip function , quality of life and physical activity level will be assessed through question naires . The allocated surgery will then be performed with the preferred technique of the surgeon . Six weeks post-operation hip function will be assessed and complications recorded . Three , six and 12 months post-operation hip function , quality of life and physical activity level will be assessed . Additional information about patients ' out-of-pocket expenses will also be collected . Trial registration Current Controlled Trials IS RCT N33354155UKCLRN portfolio ID",
"BACKGROUND The use of larger femoral heads has been proposed to reduce the risk of dislocation after total hip arthroplasty , but there is a lack of evidence to support this proposal . The aim of this multicenter r and omized controlled trial was to determine whether the incidence of dislocation one year after total hip arthroplasty is significantly lower in association with the use of a 36-mm femoral head articulation as compared with a 28-mm articulation . METHODS Six hundred and forty-four middle-aged and elderly patients undergoing primary or revision arthroplasty were r and omized intraoperatively to receive either a 36 or 28-mm metal femoral head on highly cross-linked polyethylene . Patients who were at high risk of dislocation ( including those with dementia and neuromuscular disease ) and those undergoing revision for the treatment of recurrent hip dislocation or infection were excluded . Patients were stratified according to other potential risk factors for dislocation , including diagnosis and age . Diagnosis of hip dislocation required confirmation by a physician and radiographic evidence of a dislocation . RESULTS Overall , at one year of follow-up , hips with a 36-mm femoral head articulation had a significantly lower incidence of dislocation than did those with a 28-mm articulation ( 1.3 % [ four of 299 ] compared with 5.4 % [ seventeen of 316 ] ; difference , 4.1 % [ 95 % confidence interval , 1.2 % to 7.2 % ] ) when controlling for the type of procedure ( primary or revision ) ( p = 0.012 ) . The incidence of dislocation following primary arthroplasty was also significantly lower for hips with a 36-mm femoral head articulation than for those with a 28-mm articulation ( 0.8 % [ two of 258 ] compared with 4.4 % [ twelve of 275 ] ; difference , 3.6 % [ 95 % confidence interval , 0.9 % to 6.8 % ] ) ( p = 0.024 ) . The incidence of dislocation following revision arthroplasty was 4.9 % ( two of forty-one ) for hips with a 36-mm articulation and 12.2 % ( five of forty-one ) for hips with a 28-mm articulation ; this difference was not significant with the relatively small sample size of the revision group ( difference , 7.3 % [ 95 % confidence interval , -5.9 % to 21.1 % ] ) ( p = 0.273 ) . CONCLUSIONS Compared with a 28-mm femoral head articulation , a larger 36-mm articulation result ed in a significantly decreased incidence of dislocation in the first year following primary total hip arthroplasty . However , before a 36-mm metal-on-highly cross-linked polyethylene articulation is widely recommended , the incidence of late dislocation , wear , periprosthetic osteolysis , and liner fracture should be established",
"This prospect i ve , r and omized , multicenter study of alumina ceramic-on-alumina ceramic bearing couples includes 452 patients ( 475 hips ) . Their average age was 53 years with approximately two thirds men and 82 % with osteoarthritis . At an average 8-year follow-up , clinical results were excellent and cortical erosions significantly less than in the conventional polyethylene-on-metal bearing group . Nine hips have undergone revision of one or both components for any reason . Of the 380 ceramic liners , 2 ( 0.5 % ) have fractured requiring reoperation , and 3 ( 0.8 % ) ceramic patients reported a transient squeaking sound , one of which had a head and liner change due to groin pain secondary to psoas tendinitis at 5 years . With no revisions for aseptic loosening and minimal cortical erosions , alumina-ceramic bearing couples are performing in a manner superior to the polyethylene-on-metal bearing in this young , active patient population",
"BACKGROUND Highly cross-linked polyethylene was introduced for clinical use in total hip arthroplasty with the expectation that it would exhibit less wear when compared with conventional polyethylene . The purpose of this study was to report the clinical and radiographic results , after a minimum of five years of follow-up , of a r and omized , blinded , controlled trial comparing a conventional polyethylene with a first-generation highly cross-linked polyethylene . METHODS One hundred patients were enrolled in a prospect i ve , r and omized controlled study comparing highly cross-linked and conventional polyethylene acetabular liners in total hip arthroplasty . Fifty patients were in each group . At the time of follow-up , clinical outcomes were assessed and steady-state femoral head penetration rates ( after bedding-in ) for each patient were calculated with use of a vali date d radiographic technique . In addition , a statistical comparison of polyethylene wear between groups was performed with use of generalized estimating equations . RESULTS At a mean of 6.8 years postoperatively , there were no differences between the two polyethylene groups with regard to the Harris hip score , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , or Short Form-12 ( SF-12 ) score . The mean femoral head penetration rate in the first through fifth years was found to be significantly lower in the group treated with the highly cross-linked polyethylene ( 0.003 mm/yr [ 95 % confidence interval , + /-0.027 ] ) than it was in the group treated with conventional polyethylene ( 0.051 mm/yr [ 95 % confidence interval , + /-0.022 ] ) ( p=0.006 ) . Men treated with a conventional polyethylene liner had a significantly higher ( p femoral head penetration rate ( 0.081 mm/yr [ 95 % confidence interval , + /-0.065 ] ) than both men and women with a highly cross-linked liner ( -0.013 mm/yr [ 95 % confidence interval , + /-0.074 ] and 0.009 mm/yr [ 95 % confidence interval , + /-0.028 ] , respectively ) . The general estimating equations demonstrated that the group with a highly cross-linked polyethylene liner had a significantly lower femoral head penetration rate than the group with a conventional polyethylene liner ( p=0.025 ) , and a significantly higher femoral head penetration rate was demonstrated in men with a conventional polyethylene liner when compared with both men and women with a highly cross-linked liner ( p=0.003 ) . CONCLUSIONS At a minimum of five years postoperatively , the steady-state femoral head penetration rate associated with this first-generation highly cross-linked polyethylene liner was significantly lower than that associated with a conventional polyethylene liner . Long-term follow-up is required to demonstrate the clinical benefit of this new material",
"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",
"In 1999 , our institution initiated a prospect i ve study to compare the outcome of total hip arthroplasty patients r and omized to either non-cross-linked liners or polyethylene liners that were cross-linked with 5.0 Mrad of gamma-irradiation and heat treated to eliminate free radicals . Among 230 r and omized THAs , 13 have had reoperations , and 31 patients with 32 THAs died with less than 9-year follow-up . Follow-up for the remaining 185 THAs averaged 10.0 ± 1.8 years . There have been 9 wear-related liner exchanges among the non-cross-linked group and none among the cross-linked group . Using revision for wear-related complications as an endpoint , survivorship at 10-years was 94.7 ± 4.6 % for non-cross-linked and 100 % for cross-linked ( P = .003 ) . Among unrevised hips , the mean linear wear rate was 0.22 mm/yr for non-cross-linked and 0.04 mm/yr for cross-linked ( P incidence of clinical ly important osteolysis with an area of at least 1.5 square centimeters among unrevised hips was 22 % for non-cross-linked and 0 % for cross-linked ( P < .001 )",
"The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . 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 .",
"OBJECTIVES The McMaster Toronto Arthritis patient preference question naire ( MACTAR ) is a functional index that measures change in impaired activities selected by each patient in a baseline interview , and change in rheumatoid arthritis ( RA ) disease activity . In addition , it contains questions on the state of physical , social and emotional function and overall health , and their relation to RA . We evaluated MACTAR 's feasibility and validity ( content validity , construct validity , and responsiveness ) . METHODS A r and omized trial of combined treatment in 155 patients with early RA ; patients ' mean age at baseline was 50 years and median disease duration since diagnosis was 4 months . RESULTS Feasibility : MACTAR requires trained interviewers . In the trial , interviews took about 15 min . In longer term followup , activities selected at baseline may become less relevant as the pattern of disability changes . Followup from 153 patients ( 99 % ) was available . At least 5 impaired activities were identified and ranked by 147 patients ( 95 % ) ; interviewers could follow 99 % of these . The scoring system proved complex and required amendments . Content validity : Although its main focus is physical function , the MACTAR also contains generic questions ; 75 % of the patients named at least one impaired activity from the category \" mobility . \" Only 48 % were covered by Health Assessment Question naire ( HAQ ) items . Construct validity : MACTAR scores correlate highly with other functional indices and with measures of disease activity . Responsiveness : At 16 weeks the st and ardized response mean for the total MACTAR score in the combined-treatment group was excellent , at 2.2 . Items that directly address change were even more responsive . CONCLUSION The MACTAR interview is a valid and highly responsive instrument to assess change in functional ability of patients with early RA with active disease . It provides insight into problems -- mainly of physical function -- that really matter to patients . For st and ard clinical trials and clinical care , feasibility of the MACTAR is limited and the simpler HAQ remains the instrument of choice",
"Background Even though there are multiple studies documenting the outcome of the Charnley low-friction arthroplasty as well as abundant studies on uncemented arthroplasties , there is a dearth of comparative studies of the uncemented acetabular component and a cemented component . In this study we aim ed to document the long-term clinical and radiographic outcome as well as component survival in a r and omized controlled trial . Material s and methods Two hundred fifteen patients ( 240 hips ) were r and omly allocated to receive a cemented Charnley cup or uncemented Duraloc 1200 cup . All patients received cemented Charnley stems and were evaluated clinical ly and radiographically after 6 months , and 2 , 5 , and 10 years . Results Harris Hip Scores improved from 48.3 [ 95 % confidence interval ( CI ) 45.0–51.6 ] to 90.2 [ 95 % CI 87.9–92.6 ] in the Charnley group and from 49.3 [ 95 % CI 86.9–91.3 ] in the Duraloc group at 6 months . After 10 years , the Charnley group ’s Harris Hip Score was 89.8 [ 95 % confidence interval ( CI ) 87.0–92.6 ] , and the Duraloc group ’s score was 87.3 ( 95 % CI 84.1–90.6 ) . In the radiographic analysis after 10 years , there was no statistical difference in the prevalence of radiographic signs of loosening . Nine cups were revised in the Charnley group , and five cups were removed in the Duraloc group . The difference was not statistically significant . There was no statistical difference between the cups when aseptic loosening was the end-point , nor in survival analyses . Conclusions There is no statistically significant difference in clinical or radiological outcome between the Charnley cup and the Duraloc after 10 years , and no difference in implant survival after 12–14 years . The uncemented Duraloc cup is as good as the cemented Charnley cup after 10 years",
"The purpose of this r and omized clinical trial was to compare the > 20-year outcomes of cemented ( n=124 ) versus cementless ( n=126 ) total hip replacements ( THRs ) in patients with end-stage , unilateral hip osteoarthritis . At 20 years , 168 patients ( 67 % ) were available for follow-up , 78 ( 31 % ) had died , and 4 ( 2 % ) were lost . A power analysis was performed to determine the number of patients needed in each study cohort . Patients were assessed pre- and postoperatively by vali date d disease-specific Western Ontario McMaster Osteoarthritis Score , patient-specific McMaster Arthritis Score , global health ( sickness impact profile ) , functional capacity ( 6-minute walk ) , and cost utility ( cost-to- quality adjusted life years ) . Patients were followed every 2 years clinical ly and radiographically . The cementless THR outperformed its cemented counterpart in terms of overall ( P=.01 ) , socket ( P=.009 ) , and stem ( P Patients younger than 65 years had significantly poorer cemented and cementless socket survivorships , and male sex adversely affected cementless socket survivorship . The cementless tapered stem had 100 % survivorship with aseptic loosening as the endpoint at 20 years . Although this study has demonstrated the superiority of the cementless THR over its cemented counterpart , care must be taken in generalizing these results to other cemented and cementless THRs",
"Special problems may arise when the principles of the r and omized trial are used to compare operative methods . In the trial design that is used at present , each surgeon performs the operatons to be compared in a r and om order . A prerequisite for a trial so design ed to result in a fair comparison is that the participating surgeons are equally conversant with both techniques . If they are not , the design may imply systematic bias in favor of operations that are in wide use and bias in favor of technically simple procedures . An alternative to this design is given . Reports on trials should contain information about pretrial routine and level of training of participants",
"The purpose of this article was to demonstrate the efficacy of a cementless , flat , tapered wedge femoral stem and compare cobalt-chrome and titanium femoral stems with this design . Three hundred ninety femoral stems observed for a mean of 4.7 years ( 2.0 - 8.9 years ) were prospect ively evaluated with clinical and radiographic follow-up . Hips were stratified by Dorr classification , bone stock ( femoral index ) , size of implant used , and material of femoral implant . Survivorship of the femoral stem at 8.9 years was 99.8 % with no significant difference between cohorts . Thigh pain ( 4.9 % ) was more common with cobalt-chrome femoral stems ( 6.5 % ) than titanium femoral stems ( 3.1 % ) . The flat , tapered wedge femoral stem design provides excellent femoral reconstruction in total hip arthroplasty . On the basis of this study , we use titanium femoral stems",
"The results of a prospect i ve multicenter trial comparing 357 hips r and omized to total hip arthroplasty with either ceramic-ceramic or ceramic-polyethylene couplings are presented . No statistically significant difference in clinical outcomes scores between the ceramic-ceramic and ceramic-polyethylene groups was observed at any time interval . The mean linear rate was statistically lower ( P ceramic-ceramic group ( 30.5 μm/year ) when compared with the ceramic-polyethylene group ( 218.2 μm/year ) . The rates of ceramic implant fracture ( 2.6 % ) and audible component-related noise ( 3.1 % ) were statistically higher in the ceramic-ceramic group when compared with the ceramic-polyethylene group ( P in the dislocation or revision rate between the groups at the time of last clinical follow-up",
"This article presents an experience with alumina ceramic bearings involving the use of improved ceramic material s as well as new design considerations . The alumina-alumina ceramic hard bearing is a safe option for the younger , more active patient",
"BACKGROUND The Charnley stem provides good outcome for 10 years , but several studies find deteriorating results thereafter . However , study population s , techniques and data analysis vary widely . We have studied 240 Charnley stems in a homogeneous group of patients providing clinical , radiological and survival data after 11 - 14 years . HYPOTHESIS The clinical and radiological outcome of the Charnley stem is not as good than previously thought . PATIENTS AND METHODS Five surgeons implanted 240 femoral stems in a community hospital in Norway using antibiotic impregnated cement and third generation cementing techniques . The Charnley stems were implanted with a Charnley cup in 120 cases and an uncemented hemispherical cup ( Duraloc ) in 120 cases . The mean age of the patients was 65.5 years and the mean Body Mass Index ( BMI ) was 26.8 . All patients received low molecular weight heparin and antibiotic prophylaxis . Patients were assessed after 10 years by means of Harris Hip Score ( HHS ) and radiographic evaluation . Implant survival studies were performed after 11 - 14 years . RESULTS One hundred and fifty-eight patients were available for clinical and radiographic evaluation after 10 years . HHS improved from 48.4 ( 95 % CI : 46.6 - 50,2 ) preoperatively to 87.9 ( 95%CI : 86.6 - 89.3 ) after 6 months and 87.6 ( 95 % CI : 85.3 - 89.8 ) at 10 years . Thirty-one stems had been revised , the reasons for revision were loosening ( 21 ) , infection ( five ) , instability ( four ) and late perisprosthetic fracture ( one ) . Forty-one stems had one or more signs of loosening . Stem survival was 83.6 % using any revisions as end point , and mean estimated stem survival was 12.7 years ( 12.2 - 13.3 years ) . DISCUSSION Other studies report survival at mid-term from 83 - 96 % . Our results are in the low-end . Even though our rate of infection was high ( 2 % ) , the main cause of the poor results is aseptic loosening . We do not know the reason for this high-rate of loosening . As we believe that our technique is adequate and patient population average , we suspect that this rate of loosening is a characteristic of the implant . Results from this prospect i ve cohort study add to the evidence that the Charnley stem should not be used hip arthroplasty unless patient life expectancy is less than 10 years",
"This r and omized study was performed to compare wear and migration of five different cemented total hip joint articulations in 150 patients . The patients received either a Charnley femoral stem with a 22.2 mm head or a Spectron EF femoral stem with a 28 mm head . The Charnley articulated with a γ-sterilized Charnley Ogee acetabular cup . The Spectron EF was used with either EtO-sterilized non-cross-linked polyethylene ( Reflection All-Poly ) or highly cross-linked ( Reflection All-Poly XLPE ) cups , combined with either cobalt chrome ( CoCr ) or Oxinium femoral heads . The patients were followed with repeated RSA measurements for 2 years . After 2 years , the EtO-sterilized non-cross-linked Reflection All-Poly cups had more than four times higher proximal penetration than its highly cross-linked counterpart . Use of Oxinium femoral heads did not affect penetration at 2 years compared to heads made of CoCr . Further follow-up is needed to evaluate the benefits , if any , of Oxinium femoral heads in the clinical setting . The Charnley Ogee was not outperformed by the more recently introduced implants in our study . We conclude that this prostheses still represents a st and ard against which new implants can be measured",
"Three hundred twenty-eight ceramic bearings were implanted by six surgeons in 316 patients as a part of a prospect i ve r and omized US Investigational Device Exemption study comparing alumina ceramic bearings with cobalt chrome-on-polyethylene bearings . There was no difference between the control metal-on-polyethylene and the alumina bearing couple patient cohorts regarding demographics or clinical scores through 7 years . Revision for any reason occurred in 2.7 % of the patients with alumina bearings and 7.5 % of the control patients with polyethylene bearings . Osteolysis was found in 1.4 % of the patients with alumina bearings and in 14.0 % of the control patients . At an average followup of 5.0 years ( range , 1 - 86 months ) no ceramic fractures or ceramic bearing failures have occurred . Results of this study suggest that alumina ceramics perform as well as the metal-on-polyethylene in clinical scores , but the patients with ceramic bearings had fewer revisions and less osteolysis . These results lead us to think that this new alumina ceramic bearing provides a safe option for younger and more active patients . Level of Evidence : Therapeutic study , Level I-1b ( r and omized controlled trial , no significant difference , but narrow confidence intervals ) . See the Guidelines for Authors for a complete description of levels of evidence",
"There have been comparatively few studies of the incidence of osteolysis and the survival of hybrid and cementless total hip replacements ( THRs ) in patients younger than 50 years of age . We prospect ively review ed 78 patients ( 109 hips ) with a hybrid THR having a mean age of 43.4 years ( 21 to 50 ) and 79 patients ( 110 hips ) with a cementless THR with a mean age of 46.8 years ( 21 to 49 ) . The patients were evaluated clinical ly using the Harris hip score , the Western Ontario and McMaster Universities ( WOMAC ) osteoarthritis score and the University of California , Los Angeles ( UCLA ) activity score . Radiographs and CT scans were assessed for loosening and osteolysis . The mean follow-up was for 18.4 years ( 16 to 19 ) in both groups . The mean post-operative Harris hip scores ( 91 points versus 90 points ) , the mean WOMAC scores ( 11 points versus 13 points ) and UCLA activity scores ( 6.9 points versus 7.1 points ) were similar in both groups . The revision rates of the acetabular component ( 13 % versus 16 % ) and the femoral component ( 3 % versus 4 % ) , and the survival of the acetabular component ( 87 % versus 84 % ) and the femoral component ( 97 % versus 96 % ) were similar in both groups . Although the long-term fixation of the acetabular metallic shell and the cemented and cementless femoral components was outst and ing , wear and peri-acetabular osteolysis constitute the major challenges of THR in young patients",
"Background Total hip arthroplasty ( THA ) has been associated with high survival rates , but debate remains concerning the best fixation mode of THA . Questions / purpose sWe conducted a r and omized controlled trial ( RCT ) with 250 patients with a mean age of 64 years between October 1987 and January 1992 to compare the results of cementless and cemented fixation . Patients and Methods Patients were evaluated for revision of either of the components . One hundred twenty-seven patients had died ( 51 % ) and 12 ( 4.8 % ) were lost to followup . The minimum 17-year followup data ( mean , 20 years ; range , 17–21 years ) for 52 patients of the cementless group and 41 patients of the cemented group were available for evaluation . Results Kaplan-Meier survivorship analysis at 20 years revealed lower survival rates of cemented compared with cementless THA . The cementless tapered stem was associated with a survivorship of 99 % . Age younger than 65 years and male gender were predictors of revision surgery . Conclusions The efficacy of future RCTs can be enhanced by r and omizing patients in specific patient cohorts stratified to age and gender in multicenter RCTs . Including only younger patients might improve the efficacy of a future RCT with smaller sample sizes being required . A minimum 10-year followup should be anticipated , but this can be expected to be longer if the difference in level of quality between the compared implants is smaller . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"OBJECTIVES To evaluate the validity , reliability , responsiveness , and mode preference of electronic data capture ( EDC ) using the Western Ontario and McMaster ( WOMAC ) numerical rating scale ( NRS ) 3.1 Osteoarthritis ( OA ) Index on Motorola V3 mobile phones . STUDY DESIGN AND SETTING Patients with OA undergoing hip or knee joint replacement were assessed preoperatively and 3 - 4 months postoperatively , completing the WOMAC Index in paper ( p-WOMAC ) and electronic ( m-WOMAC ) format in r and om order . RESULTS Data were successfully and securely transmitted from patients in Australia to a server in the United States . Pearson correlations between the summated total index scores ( TISs ) for the p-WOMAC and m-WOMAC pre- and postsurgery were 0.98 and 0.99 ( P total summated scores , pre- and postsurgery ( adjusted mean differences=4.44 , P=0.474 and 1.73 , P=0.781 , respectively ) . Internal consistency estimates of m-WOMAC reliability were 0.87 - 0.98 . The m-WOMAC detected clinical ly important , statistically significant ( P improvements in pain , stiffness , function , and TIS . No statistically significant differences in mode preference were detected . CONCLUSIONS There was close agreement and no significant differences between m-WOMAC and p-WOMAC scores . This study confirms the validity , reliability , and responsiveness of the Exco InTouch-engineered , Java-based m-WOMAC Index application . EDC with the m-WOMAC Index provides unique opportunities for using quantitative measurement in clinical research and practice",
"Total hip arthroplasty has been associated with excellent implant survival rates , but debate remains concerning the best fixation method for the components . A r and omized controlled trial , which included 250 patients ( mean age , sixty-four years ) with osteoarthritis who were managed with total hip arthroplasty between October 1987 and January 1992 , was conducted to compare the results of fixation with and without cement . Patients were followed for a mean of twenty years ( range , seventeen to twenty-one years ) . Kaplan-Meier survivorship analysis at twenty years revealed significantly lower survival rates for cemented implants as compared with cementless implants . The cementless tapered stem had an extremely good survival rate of 99 % . Radiographs showed evidence of mild stress-shielding around 95 % of the cemented stems and 88 % of the cementless stems ; stress-shielding of grade 3 or greater was seen around the remaining 12 % of the cementless stems",
"Cross-linked liners were introduced with the promise that they would substantially reduce polyethylene wear . In 1999 , our institution initiated a prospect i ve study to compare the outcome of total hip arthroplasty patients who were r and omized to non-cross-linked Enduron liners with that of total hip arthroplasty patients who were r and omized to Marathon polyethylene liners that had been cross-linked with 5 Mrad ( 50 kGy ) of gamma-irradiation and heat-treated to eliminate free radicals . At a mean follow-up of 5.7 years , the clinical outcomes among the Marathon and Enduron liners were similar . However , the mean wear rate was 0.01 + /- 0.07 mm/y for the Marathon group , which represents a 95 % reduction compared with the mean wear rate of 0.19 + /- 0.12 mm/y for the Enduron group . In addition , the incidence of osteolysis was lower in the Marathon group",
"BACKGROUND In clinical trials , at the group level , results are usually reported as mean and st and ard deviation of the change in score , which is not meaningful for most readers . OBJECTIVE To determine the minimal clinical ly important improvement ( MCII ) of pain , patient 's global assessment of disease activity , and functional impairment in patients with knee and hip osteoarthritis ( OA ) . METHODS A prospect i ve multicentre 4 week cohort study involving 1362 out patients with knee or hip OA was carried out . Data on assessment of pain and patient 's global assessment , measured on visual analogue scales , and functional impairment , measured on the Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) function subscale , were collected at baseline and final visits . Patients assessed their response to treatment on a five point Likert scale at the final visit . An anchoring method based on the patient 's opinion was used . The MCII was estimated in a subgroup of 814 patients ( 603 with knee OA , 211 with hip OA ) . RESULTS For knee and hip OA , MCII for absolute ( and relative ) changes were , respectively , ( a ) -19.9 mm ( -40.8 % ) and -15.3 mm ( -32.0 % ) for pain ; ( b ) -18.3 mm ( -39.0 % ) and -15.2 mm ( -32.6 % ) for patient 's global assessment ; ( c ) -9.1 ( -26.0 % ) and -7.9 ( -21.1 % ) for WOMAC function subscale score . The MCII is affected by the initial degree of severity of the symptoms but not by age , disease duration , or sex . CONCLUSION Using criteria such as MCII in clinical trials would provide meaningful information which would help in interpreting the results by expressing them as a proportion of improved patients",
"Background : This study was design ed to compare the fixation of a Mallory-Head total hip prosthesis with and without cement . Methods : Two hundred and fifty patients with osteoarthritis of the hip were r and omized to receive a Mallory-Head total hip prosthesis design ed for insertion with cement or the same prosthesis design ed for insertion without cement . Neither the patient nor the outcomes assessor was aware of the type of prosthesis . Outcomes were assessed with respect to mortality , revision arthroplasty , health-related quality of life ( evaluated with the Harris hip score , Merle d'Aubigné and Postel hip score , McMaster-Toronto Arthritis Patient Preference Disability Question naire ( MACTAR ) , Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) , and the time trade-off technique ) , and the six-minute-walk test . Patients were seen at three , six , and twelve months and yearly thereafter . Results : The prosthesis was inserted with cement in 124 patients and without cement in 126 patients . The mean age of the patients was sixty-four years , 48 % were female , and the mean duration of follow-up was 6.3 years . There were thirteen revisions in the group that had fixation with cement and six in the group that had fixation without cement ( p = 0.11 ) , and more femoral components were revised in the group that had fixation with cement ( twelve versus one ; p = 0.002 ) . All health-related quality -of-life measures improved postoperatively in both groups . Conclusions : In this r and omized trial , the group that had the cemented Mallory-Head hip prostheses required more revisions of the femoral component than did the group with the cementless Mallory-Head prostheses , which was perhaps related to the titanium-alloy femoral stem . Our findings are specific to the implants evaluated in this study",
"We developed a 12-item question naire for completion by patients having total hip replacement ( THR ) . A prospect i ve study of 220 patients was undertaken before operation and at follow-up six months later . Each completed the new question naire as well as the SF36 , and some the Arthritis Impact Measurement Scales ( AIMS ) . An orthopaedic surgeon assessed the Charnley hip score . The single score derived from the question naire had a high internal consistency . Reproducibility was examined by test-retest reliability and was found to be satisfactory . The validity of the question naire was established by obtaining significant correlation in the expected direction with the Charnley scores and relevant scales of the SF36 and the AIMS . Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at the follow-up . The st and ardised effect size for the new question naire compared favourably with that for the SF36 and the AIMS . The new question naire provides a measure of outcome for THR which is short , practical , reliable , valid and sensitive to clinical ly important changes",
"The purpose of this investigation was to assess the midterm clinical outcomes after implantation of Oxinium ( OX ) vs cobalt-chrome ( CC ) femoral heads . Primary total hip arthroplasty ( THA ) procedures were performed in 100 patients . After r and omization , half of the patients received OX femoral heads and half received CC femoral heads . At a minimum follow-up of 2-years , stem survival was 98 % for both groups . The mean Harris Hip score was 92 for OX and 92.5 for CC , with mean WOMAC scores of 84.9 and 87 , respectively . For SF-12 , the OX group had mean physical and mental component scores of 45.2 and 53.8 and the CC group 49.2 and 52.6 , respectively . At a minimum follow-up of 2 years , clinical outcomes for THA procedures using OX and CC femoral heads appear equivalent",
"Research on surgical interventions is associated with several method ological and practical challenges of which few , if any , apply only to surgery . However , surgical evaluation is especially dem and ing because many of these challenges coincide . In this report , the second of three on surgical innovation and evaluation , we discuss obstacles related to the study design of r and omised controlled trials and non-r and omised studies assessing surgical interventions . We also describe the issues related to the nature of surgical procedures -for example , their complexity , surgeon-related factors , and the range of outcomes . Although difficult , surgical evaluation is achievable and necessary . Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential",
"The aim of this prospect i ve r and omised study was to compare the clinical and radiological results of a cemented all-polyethylene Ultima acetabular component with those of a cementless porous-coated acetabular component ( PFC ) following total hip replacement ( THR ) . A total of 287 patients received either a polyethylene acetabular component ( group A ) or a cobalt-chromium porous-coated component ( group B ) with an identical cemented femoral component and 28 mm cobalt-chromium head , thus making it the largest study of its type . Patients were evaluated radiologically and clinical ly using the Harris hip score ( HHS ) . Group A comprised 183 patients ( 73 male , 110 female ) with a mean age of 71.3 years ( 55 to 89 ) . Group B comprised 104 patients ( 48 male , 56 female ) with a mean age of 69.8 years ( 56 to 89 ) . A total of 16 patients ( 13 in Group A , three in Group B ) did not have post-operative data for analysis . The mean follow-up in group A was 7.52 years ( 0.4 to 15.0 ) and in Group B 7.87 years ( 0.5 to 14.0 ) . At final follow-up the mean HHS was similar between groups A and B ( 74.5 ( 25 to 100 ) and 78.0 ( 37 to 100 ) , respectively ; p = 0.068 ) . The total number of revisions for any cause was 28 , 17 of which were in group A and 11 in group B. The ten-year survivorship was 86.8 % ( 95 % confidence interval ( CI ) 78.4 to 92.1 ) and 89.2 % ( 95 % CI 78.3 to 94.8 ) for groups A and B , respectively ( log-rank p-value = 0.938 ) . A total of 20 cemented and two cementless acetabular components had evidence of acetabular radiolucencies or acetabular component migration at last follow-up ( p = 0.001 ) . These results indicate that patients with a cemented all-polyethylene and cementless porous-coated polyethylene lined acetabular component have similar long-term clinical outcomes"
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[ Author Affiliation]Tom Baranowski . USDA/ARS Children 's Nutrition Research Center , Department of Pediatrics , Baylor College of Medicine , Houston , TX.Address correspondence to : Tom Baranowski , PhD , Professor of Pediatrics ( Behavioral Nutrition and Physical Activity ) Children 's Nutrition Research Center , Department of Pediatrics , Baylor College of Medicine , 1100 Bates Street , Houston , TX 77030 , E-mail : [email protected] readers of this journal know all too well , obesity is the most prevalent health problem among children in the United States1 and globally,2 leading to diverse health problems3 and staggering costs.4 Most child obesity prevention interventions are not working well , or not at all.5 Part of the problem is that the causes of child obesity are not clearly known6 ; nor are the influences on weight control.7 Further , our common measures of diet and physical activity ( PA ) are fraught with error,8 thereby minimizing our ability to detect true relationships between lifestyle behavior and adiposity or the outcomes of our interventions .9 What a mess!Within this conundrum , new ideas and approaches are needed . Video games , the most commonly enjoyed medium by this generation of children , generates more money than Hollywood productions . Whereas some believe that games are anathema to childhood obesity prevention or treatment because most games involve sedentariness , the literature on media exposure and childhood obesity indicates that time watching television ( TV ) , and not time playing video games , is the major offending screen medium10 and the pathway of TV exposure to obesity is primarily through diet , not physical inactivity.11Games for health ( G4H ) is a new arena of research and practice that uses entertainment game technology to attain health goals . Diverse G4H have been design ed and tested for childhood obesity prevention and treatment.12 A scoping and systematic review of these articles identified 28 studies involving video games , mostly for childhood obesity prevention . Forty percent of these studies influenced obesity or obesogenic behavior in the desired directions.12 A roundtable discussion of investigators of G4H and obesity indicated substantial potential for video games to reduce child obesity , but emphasized the need for games to be fun , not just health promoting.13 Some of the obesity-related studies used games specially design ed to target diet and /or PA change outside the games.14 - 17 " Squire 's Quest ! , " targeted at dietary change alone , result ed in an increase of one serving of fruit and vegetables among fourth- grade students after only 5 weeks of game play.15 " Creature 101 , " a comprehensive behavior management software system , including video games , enabled middle school students to decrease sweetened beverage and processed snack intake.16 " Fitter Critters " enhanced attitudes and self-efficacy toward healthy eating among elementary school students.17 " Escape from Diab " and " Nanoswarm : Invasion from Inner Space " targeted diet and PA among 10- to 12-year-olds and achieved diet , but not PA , change.14Most research on games targeted at PA used commercially available active video games , also called exergames . Exergames were design ed by corporations as a new profit-making strategy to incorporate PA into game play ( e.g. , fancy footwork was needed for the game to progress ) . Reflecting public health interest in the potential of exergames to encourage PA , many review s of this literature have appeared.18 - 20 Some review s have been sympathetic,21,22 whereas others have been critical.23,24 A reasonably balanced assessment revealed that , in research laboratories , exergames could provide an intense workout that included moderate-to-vigorous PA , but under less-supervised circumstances , children tended not to get much activity18 and their interest in the activity waned over 1 week or less .
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"BACKGROUND Sedentary activities such as video gaming are independently associated with obesity . Active video games , in which players physically interact with images on screen , may help increase physical activity and improve body composition . OBJECTIVE The aim of this study was to evaluate the effect of active video games over a 6-mo period on weight , body composition , physical activity , and physical fitness . DESIGN We conducted a 2-arm , parallel , r and omized controlled trial in Auckl and , New Zeal and . A total of 322 overweight and obese children aged 10 - 14 y , who were current users of sedentary video games , were r and omly assigned at a 1:1 ratio to receive either an active video game up grade package ( intervention , n = 160 ) or to have no change ( control group , n = 162 ) . The primary outcome was the change from baseline in body mass index ( BMI ; in kg/m(2 ) ) . Secondary outcomes were changes in percentage body fat , physical activity , cardiorespiratory fitness , video game play , and food snacking . RESULTS At 24 wk , the treatment effect on BMI ( -0.24 ; 95 % CI : -0.44 , -0.05 ; P = 0.02 ) favored the intervention group . The change ( ±SE ) in BMI from baseline increased in the control group ( 0.34 ± 0.08 ) but remained the same in the intervention group ( 0.09 ± 0.08 ) . There was also evidence of a reduction in body fat in the intervention group ( -0.83 % ; 95 % CI : -1.54 % , -0.12 % ; P = 0.02 ) . The change in daily time spent playing active video games at 24 wk increased ( 10.03 min ; 95 % CI : 6.26 , 13.81 min ; P change in daily time spent playing nonactive video games ( -9.39 min ; 95 % CI : -19.38 , 0.59 min ; P = 0.06 ) . CONCLUSION An active video game intervention has a small but definite effect on BMI and body composition in overweight and obese children . This trial was registered in the Australian New Zeal and Clinical Trials Registry at http://www.anzctr.org.au/ as ACTRN12607000632493",
"IMPORTANCE Active video games may offer an effective strategy to increase physical activity in overweight and obese children . However , the specific effects of active gaming when delivered within the context of a pediatric weight management program are unknown . OBJECTIVE To evaluate the effects of active video gaming on physical activity and weight loss in children participating in an evidence -based weight management program delivered in the community . DESIGN , SETTING , AND PARTICIPANTS Group-r and omized clinical trial conducted during a 16-week period in YMCAs and schools located in Massachusetts , Rhode Isl and , and Texas . Seventy-five overweight or obese children ( 41 girls [ 55 % ] , 34 whites [ 45 % ] , 20 Hispanics [ 27 % ] , and 17 blacks [ 23 % ] ) enrolled in a community-based pediatric weight management program . Mean ( SD ) age of the participants was 10.0 ( 1.7 ) years ; body mass index ( BMI ) z score , 2.15 ( 0.40 ) ; and percentage overweight from the median BMI for age and sex , 64.3 % ( 19.9 % ) . INTERVENTIONS All participants received a comprehensive family-based pediatric weight management program ( JOIN for ME ) . Participants in the program and active gaming group received hardware consisting of a game console and motion capture device and 1 active game at their second treatment session and a second game in week 9 of the program . Participants in the program-only group were given the hardware and 2 games at the completion of the 16-week program . MAIN OUTCOMES AND MEASURES Objective ly measured daily moderate-to-vigorous and vigorous physical activity , percentage overweight , and BMI z score . RESULTS Participants in the program and active gaming group exhibited significant increases in moderate-to-vigorous ( mean [ SD ] , 7.4 [ 2.7 ] min/d ) and vigorous ( 2.8 [ 0.9 ] min/d ) physical activity at week 16 ( P moderate-to-vigorous ( mean [ SD ] net difference , 8.0 [ 3.8 ] min/d ; P = .04 ) and vigorous ( 3.1 [ 1.3 ] min/d ; P = .02 ) physical activity . Participants in both groups exhibited significant reductions in percentage overweight and BMI z scores at week 16 . However , the program and active gaming group exhibited significantly greater reductions in percentage overweight ( mean [ SD ] , -10.9%[1.6 % ] vs -5.5%[1.5 % ] ; P = .02 ) and BMI z score ( -0.25 [ 0.03 ] vs -0.11 [ 0.03 ] ; P Incorporating active video gaming into an evidence -based pediatric weight management program has positive effects on physical activity and relative weight . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01757925",
"Exergames are videogames that require gross motor activity , thereby combining gaming with physical activity . This study examined the role of competitive versus cooperative exergame play on short-term changes in executive function skills , following a 10-week exergame training intervention . Fifty-four low-income overweight and obese African American adolescents were r and omly assigned to a competitive exergame condition , a cooperative exergame condition , or a no-play control group . Youths in the competitive exergame condition improved in executive function skills more than did those in the cooperative exergame condition and the no-play control group . Weight loss during the intervention was also significantly positively correlated with improved executive function skills . The findings link competitive exergame play to beneficial cognitive outcomes for at-risk ethnic minority adolescents",
"Background Child fruit and vegetable intake is below recommended levels , increasing risk for chronic disease . Interventions to influence fruit and vegetable intake among youth have had mixed effects . Innovative , theory-driven interventions are needed . Goal setting , enhanced by implementation intentions ( i.e. , plans tightly connected to a behavioral goal ) , may offer a solution . Action plans state “ how ” a goal will be achieved , while coping plans identify a potential barrier and corresponding solution . The research reported here evaluated the short- and long-term effects of goal setting enhanced with implementation intentions on child fruit and vegetable intake in a 10-episode , theoretically-grounded serious videogame promoting fruit and vegetables . This is one of the first studies to test the efficacy of implementation intentions on the dietary intake of healthy children . Methods A four-group r and omized design with three data collection periods ( baseline , immediate post-intervention , 3 months post-intervention ) was employed . Groups varied on whether children created an implementation intention ( none , action , coping , both ) as part of goal setting . Participants were 4th and 5th grade children ( ~9 - 11 years old ) and one parent . An a priori power analysis indicated this would provide > 80 % power to detect a small effect ( Cohen ’s d = 0.17 ) . Children played a 10-episode online videogame ; parents received 10 electronic newsletters and access to a parent-only website . The primary outcome was child fruit and vegetable intake , assessed via three , dietitian-assisted telephone recalls at each data collection period . The primary analysis was conducted using a repeated measures analysis of covariance with a mixed model procedure . Secondary analyses examined intervention effects on fruit and vegetables separately . Results Four hundred parent/child dyads were recruited . A significant group-by-time interaction for fruit and vegetable intake ( p increases in fruit and vegetable intake at post 1 ( p effects for fruit ( p maintain fruit and vegetable intake in pre-adolescent children . Videogames promoting healthy diets offer an effective vehicle for delivering behavior change interventions to children . Trial registration Clinical Trials.gov NCT01004094",
"Physical inactivity among children is a serious public health problem . It has been suggested that high levels of screen time are contributory factors that encourage sedentary lifestyles in young people . As physical inactivity and obesity levels continue to rise in young people , it has been proposed that new-generation active computer- and video-console games ( otherwise known as “ exergaming ” ) may offer the opportunity to contribute to young people 's energy expenditure during their free time . Although studies have produced some encouraging results regarding the energy costs involved in playing active video-console games , the energy costs of playing the authentic versions of activity-based video games are substantially larger , highlighting that active gaming is no substitute for real sports and activities . A small number of exergaming activities engage children in moderate-intensity activity , but most do not . Only 3 very small trials have considered the effects of exergaming on physical activity levels and /or other health outcomes in children . Evidence from these trials has been mixed ; positive trends for improvements in some health outcomes in the intervention groups were noted in 2 trials . No adequately powered r and omized , controlled trial has been published to date , and no trial has assessed the long-term impact of exergaming on children 's health . We now need high- quality r and omized , controlled trials to evaluate the effectiveness and sustainability of exergaming , as well as its clinical relevance ; until such studies take place , we should remain cautious about its ability to positively affect children 's health",
"Objective . To evaluate the efficacy and feasibility of a multifaceted , community-based weight intervention program for children using exergaming technology ( activity-promoting video gaming ) . Design and Methods . This is a prospect i ve observational pilot study . Forty-eight children , between the ages of 8 and 16 years , who are overweight or obese , enrolled in Exergaming for Health , a multidisciplinary weight management program , which used active video gaming . Primary outcome measures were change in body mass index ( BMI ) z scores . Results . Most children ( n = 40 , 83 % ) completed the program and participated in outcome evaluations . The average BMI change was −0.48 kg/m2 ( SD = 0.93 ) , P 0.14 , P reduced , and exercise hours per week increased . Conclusions . The Exergaming for Health program may be an effective weight management intervention that is feasible with high participation rates . A larger r and omized controlled trial is needed to confirm these results",
"OBJECTIVE This study evaluated the effect of four active videogames ( AVGs ) varying in behavioral contingencies ( behavior-consequence relations ) on adolescent AVG play and overall activity levels over 4 weeks . MATERIAL S AND METHODS Each AVG , manufactured by SSD/Xavix ( ® ) ( Shiseido Co. of Japan , Tokyo , Japan ) , was coded and scored for the number of positive and aversive behavioral contingencies within the games . \" Bowling \" and \" Tennis \" were classified as having \" higher contingency scores , \" and \" Boxing \" and aerobic fitness training were classified as having \" lower contingency scores . \" Adolescents ( n=63 ; 11 - 15 years old ; 62 % male ; 38 % Hispanic ; 44 % overweight or obese ) were r and omized to play one of the four AVGs at home and recorded game play sessions in a paper log . Baseline and week 4 assessment s were completed at home ; week 1 , 2 , and 3 assessment s were completed by telephone . Accelerometers were worn during baseline and weeks 1 and 4 . RESULTS Accelerometer-measured sedentary and light activity hours/day were stable over time , whereas moderate-vigorous physical activity minutes/day increased in the higher contingency group and decreased in the lower contingency group ( interaction effect , 6.43 , P=0.024 ) . Reported game play minutes decreased in both groups from week 1 to week 4 ( -29.42 minutes , P=0.001 ) . DISCUSSION There was some support for the hypothesis that AVGs with more behavioral contingencies , compared with AVGs with fewer behavioral contingencies , result in more physical activity . However , overall AVG play decreased substantially after the first week . Further study is needed to better underst and how behavioral contingencies can be used in AVGs to enhance their potential to provide health benefits to game players",
"BACKGROUND Fruit , juice , and vegetable ( FJV ) consumption among children is low . Innovative programs are needed to enable children to increase FJV intake . Psychoeducational multimedia permits the delivery of interventions as design ed and capitalizes on known behavior change principles . DESIGN Elementary school was the unit of recruitment , assignment , and analysis . Twenty-six elementary schools were pair matched on size and percentage of free or reduced-price lunch , and r and omly assigned to treatment or control groups . Data were collected just before and just after the program . SETTING / PARTICIPANTS All fourth- grade students in participating elementary schools were invited to participate . Data were collected on 1578 students . MAIN OUTCOME Servings of fruit , 100 % juice , and vegetables consumed . INTERVENTION Squire 's Quest ! is a ten-session , psychoeducational , multimedia game delivered over 5 weeks , with each session lasting about 25 minutes . Based on social cognitive theory , educational activities attempted to increase preferences for FJV through multiple exposures and associating fun with their consumption , increase asking behaviors for FJV at home and while eating out , and increase skills in FJV preparation through making virtual recipes . MEASURES Four days of dietary intake were assessed before and after the intervention . Assessment was made by the Food Intake Recording Software System ( FIRSSt ) , which conducts a multiple pass , 24-hour dietary intake interview directly with the children . RESULTS Children participating in Squire 's Quest ! increased their FJV consumption by 1.0 servings more than the children not receiving the program . CONCLUSIONS Psychoeducational multimedia games have the potential to substantially change dietary behavior . More research is warranted",
"BACKGROUND Active video games ( AVGs ) have been shown to acutely increase energy expenditure when compared with seated video games ; however , the influence of AVGs on compensatory adjustments in energy intake and expenditure is largely unknown . OBJECTIVE The aim was to examine the acute effects of AVGs on energy intake and expenditure . DESIGN With the use of a r and omized crossover design , 26 male adolescents ( mean ± SD age : 14.5 ± 1.4 y ) completed three 1-h experimental conditions : resting control , seated video game play ( Xbox 360 ; Microsoft ) , and AVG play ( Kinect Adventures on Xbox 360 ) followed by an ad libitum lunch . A vali date d food menu was used to assess food intake immediately after the conditions and for the remainder of the day , and a dietary record was used for the subsequent 3-d period . Energy expenditure was measured by using portable indirect calorimetry throughout each experimental condition , and an accelerometer was used to assess the subsequent 3-d period . Appetite sensations were assessed by using visual analog scales at different time points during the testing day . The primary outcomes were acute ( immediately after the conditions and 24-h ) and short-term ( 3-d ) energy intake and expenditure . RESULTS Energy expenditure was significantly higher ( ~145 % ; P the AVG condition than during the resting control and seated video game conditions ; however , no significant differences in energy expenditure were observed 24 h ( ~6 % ; P > 0.49 ) and 3 d after the experimental conditions ( ~3 % ; P > 0.82 ) . No significant differences were observed in absolute energy intake immediately after the conditions ( ~2 % ; P > 0.94 ) or in absolute energy intake 24 h ( ~5 % ; P > 0.63 ) and 3 d ( ~9 % ; P > 0.53 ) after the experimental conditions . Finally , appetite sensations were similar between conditions at all time points ( P > 0.05 ) . CONCLUSIONS The increase in energy expenditure promoted by a single session of Kinect AVG play is not associated with increased food intake but is compensated for after the intervention , result ing in no measurable change in energy balance after 24 h. These results suggest that the potential of Kinect to reduce the energy gap underlying weight gain is offset within 24 h in male adolescents . This trial was registered at clinical trials.gov as NCT01655901"
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Introduction : Kinesiology is a diagnostic , therapeutic complementary therapy utilising subtle change in manual muscle testing results to evaluate the body ’s energetic balance and select healing modalities . Anecdotal evidence suggests kinesiology is helpful , therefore we wished to critically review the literature . Aims : ( 1 ) To ascertain if diagnostic accuracy including inter-examiner reliability has been established . ( 2 ) To review whether there is evidence for its therapeutic effectiveness . ( 3 ) To critically assess the quality of relevant studies . Methods : Electronic data bases were search ed . Diagnostic accuracy studies were analysed and scored for method ological quality and quality of reporting using the quality assessment tool for studies of diagnostic accuracy included in systematic review s ( QUADAS ) and the St and ards for Reporting of Diagnostic Studies ( STARD ) . Clinical studies were analysed for method ological quality using the JADAD scale and for quality of reporting using the Consoli date d St and ards of Reporting Trials ( CONSORT ) . Results : 22 original relevant studies were identified . Their methodology was poor . Items reported on QUADAS scored 1 - 11 out of a possible 14 , STARD scores were between 6 - 13 out of 25 , JADAD scores were all 0 out of 5 and CONSORT 4 - 6 out of 22 . Consequently , we were unable to answer any of our research questions . Conclusion : There is insufficient evidence for diagnostic accuracy within kinesiology , the validity of muscle response and the effectiveness of kinesiology for any condition . The st and ards of reporting were low . We recommend a pragmatic study of the effectiveness of kinesiology as the most appropriate initial step to determine whether kinesiology has any clinical value
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"To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results",
"INTRODUCTION A body of basic science and clinical research has been generated on the manual muscle test ( MMT ) since its first peer- review ed publication in 1915 . The aim of this report is to provide an historical overview , literature review , description , synthesis and critique of the reliability and validity of MMT in the evaluation of the musculoskeletal and nervous systems . METHODS Online re sources were search ed including Pubmed and CINAHL ( each from inception to June 2006 ) . The search terms manual muscle testing or manual muscle test were used . Relevant peer- review ed studies , commentaries , and review s were selected . The two review ers assessed data quality independently , with selection st and ards based on predefined method ologic criteria . Studies of MMT were categorized by research content type : inter- and intraexaminer reliability studies , and construct , content , concurrent and predictive validity studies . Each study was review ed in terms of its quality and contribution to knowledge regarding MMT , and its findings presented . RESULTS More than 100 studies related to MMT and the applied kinesiology chiropractic technique ( AK ) that employs MMT in its methodology were review ed , including studies on the clinical efficacy of MMT in the diagnosis of patients with symptomatology . With regard to analysis there is evidence for good reliability and validity in the use of MMT for patients with neuromusculoskeletal dysfunction . The observational cohort studies demonstrated good external and internal validity , and the 12 r and omized controlled trials ( RCTs ) that were review ed show that MMT findings were not dependent upon examiner bias . CONCLUSION The MMT employed by chiropractors , physical therapists , and neurologists was shown to be a clinical ly useful tool , but its ultimate scientific validation and application requires testing that employs sophisticated research models in the areas of neurophysiology , biomechanics , RCTs , and statistical analysis",
"Applied Kinesiology ( AK ) is a scientifically unproven method used in complementary medicine to recognize the (in)tolerance of dental material s. Test-retest reliability of AK was examined . The working hypothesis was the assumption that the reliability of AK would not exceed r and om chance . Two dentists qualified in AK examined 112 volunteers to determine individual (in)tolerance toward two dental composite material s. After the first examination , 31 subjects were excluded from further testing . At the end of the open test phase , 34 of 81 participants had been classified as “ tolerant ” , and seven as “ intolerant ” to both material s. The remaining 40 individuals showed a combination of either tolerant ( to material I)/intolerant ( to material II ) , or the reverse ( n = 20 each ) . Retrieval rate was tested under blind conditions . In 14 cases , the results of the open and blinded tests matched , whereas in 26 cases they did not ( 95 % confidence interval , 21%-52 % ; p = 0.98 ) . This outcome confirmed our working hypothesis",
"OBJECTIVE To determine phobic and nonphobic subject response to a provocative threat stimulus and to determine variables that confound the response . DESIGN R and omized blind examiner test-retest of r and omized phobic and control subjects with qualitative , semistructured , informal postint-ervention interview . SETTING Private chiropractic clinic . SUBJECTS Thirteen phobic individuals , as determined by the Diagnostic and Statistical Manual of Mental Disorders , Third Edition-Revised ( DSM-III-R ) , and 14 control volunteer subjects . INTERVENTION Manual muscle testing was performed while each subject viewed a threat stimulus ( i.e. , a cue word on a printed card ) . The results were recorded as \" weak \" or \" strong . \" RESULTS The analysis of data demonstrates poor inter- ( K = -0.19 ) and intraexaminer reliability ( K = -0.14(- ) + 0.29 ) the test for independence for valid muscle testing was strong for both examiners ( p = .462 , p = 1.00 ) . When confounding variables were corrected for , the validity of muscle testing increased to 91 % . CONCLUSION This preliminary inquiry demonstrates the need for musculoskeletal , attentional and presensitized subject variables to be controlled to ascertain if muscle testing can be reliably used as a tool to identify emotional arousal",
"OBJECTIVES To investigate pathogenetic mechanisms related to the lacrimal and lymphatic gl and s in patients with thyroid-associated orbitopathy ( TAO ) , and the potential of applied kinesiology diagnosis and homeopathic therapeutic measures . DESIGN Prospect i ve . SETTING S/LOCATION Thyroid outpatient unit and a specialized center for complementary medicine ( WOMED , Innsbruck ; R.M. and H.M. ) . SUBJECTS Thirty-two ( 32 ) patients with TAO , 23 with a long-st and ing disease , and 9 showing discrete initial changes . All patients were euthyroid at the time of the investigation . INTERVENTIONS Clinical investigation was done , using applied kinesiology methods . Departing from normal reacting muscles , both target organs as well as therapeutic measures were tested . Affected organs will produce a therapy localization ( TL ) that turns a normal muscle tone weak . Using the same approach , specific counteracting therapies ( i.e. , tonsillitis nosode and lymph mobilizing agents ) were tested . OUTCOME MEASURES Change of lid swelling , of ocular movement discomfort , ocular lock , tonsil reactivity and Traditional Chinese Medicine criteria including tenderness of San Yin Jiao ( SP6 ) and tongue diagnosis were recorded in a grade d fashion . RESULTS Positive TL reactions were found in the subm and ibular tonsillar structures , the pharyngeal tonsils , the San Yin Jiao point , the lacrimal gl and , and with the functional ocular lock test . Both Lymphdiaral ( Pascoe , Giessen , Germany ) and the homeopathic preparation chronic tonsillitis nosode at a C3 potency ( Spagyra , Grödig , Austria ) counteracted these changes . Both agents were used therapeutically over 3 - 6 months , after which all relevant parameters showed improvement . CONCLUSIONS Our study demonstrates the involvement of lymphatic structures and flow in the pathogenesis of TAO . The tenderness of the San Yin Jiao point correlates to the above mentioned changes and should be included in the clinical evaluation of these patients",
"The study investigated the effects of fatigue and task repetition on the relationship between integrated electromyogram and force output during subjective clinical testing of upper extremity muscles . Muscles were studied under two conditions differing in the nature and duration of constant force production ( SHORT-F ) and ( LONG-F ) . The findings included a significant relationship between force output and integrated EMG , a significant increase in efficiency of muscle activity with task repetition , and significant difference between Force/integrated EMG ratios for muscles labeled “ Strong ” and “ Weak ” in the LONG-F condition . This supports Smith 's 1974 notion that practice results in increased muscular efficiency . With fatigue , integrated EMG activity increased strongly and functional ( force ) output of the muscle remained stable or decreased . Fatigue results in a less efficient muscle process . Muscles subjectively testing “ Weak ” or “ Strong ” yield effects significantly different from fatigue",
"The effect of either the muscle spindle cell receptor technique of applied kinesiology or a placebo technique on isometric strength of the right quadriceps femoris muscle group was studied among 20 normal human subjects . Peak , perpendicular maximal values of isometric quadriceps femoris muscle force was measured by a force transducer . Three training sessions consisting of three trials of peak maximal contractions of the isometric quadriceps femoris muscle were performed by all subjects . After the three training sessions , matched pairs of subjects were formed from a r and order list of each subject 's mean values of isometric quadriceps femoris muscle strength on the third session . One subject of a matched pair was then r and omly assigned to either an experimental ( applied kinesiology ) or control ( placebo ) group for the testing session . No significant differences in mean values of isometric quadriceps femoris muscle strength between the matched pairs for control and experimental subjects were noted . Within the context of a normal population , the applied kinesiology technique does not appear to augment isometric quadriceps femoris muscle strength",
"The pilot study attempted to determine whether subjective muscle testing employed by Applied Kinesiology practitioners , prospect ively determine those individuals with specific hyperallergenic responses . Seventeen subjects were found positive on Applied Kinesiology ( A.K. ) muscle testing screening procedures indicating food hypersensitivity ( allergy ) reactions . Each subject showed muscle weakening ( inhibition ) reactions to oral provocative testing of one or two foods for a total of 21 positive food reactions . Tests for a hypersensitivity reaction of the serum were performed using both a radio-allergosorbent test ( RAST ) and immune complex test for IgE and IgG against all 21 of the foods that tested positive with A.K. muscle screening procedures . These serum tests confirmed 19 of the 21 food allergies ( 90.5 % ) suspected based on the applied kinesiology screening procedures . This pilot study offers a basis to examine further a means by which to predict the clinical utility of a given substance for a given patient , based on the patterns of neuromuscular response elicited from the patient , representing a conceptual expansion of the st and ard neurological examination process",
"The purpose of this study was to determine whether Educational Kinesiology ® integration movements or repatterning in conjunction with the integration movements affect the response times of college students to a visual stimulus . Ten men and ten women were r and omly assigned to each of the three conditions : control , Edu-K movement , or repatterned Edu-K movements . Each subject was pretested on simple and choice response-time tasks . Following the pretest , subjects in the control group sat quietly for 10 minutes . The movement group utilized seven Brain Gym ® activities . Subjects in the repatterned group experienced Dennison 's Laterality Repatterning prior to doing the same Brain Gym activities . All subjects were then retested to assess changes in performance using 30 trials of each task . Statistical analyses indicated significant differences in improvement between the groups on the 4-choice task , with the repatterned group showing greater change than the Edu-K movement-only group , who in turn showed greater improvement than the control group . The groups improved by 6 % , 31/2 % , and 1 % , respectively . No group differences were significant on the simple task , although a similar trend was indicated . Men responded faster than women on both tasks ; however , the amount of improvement was similar for both",
"Applied kinesiology is a technique used to assess nutritional status on the basis of the response of muscles to mechanical stress . In this study , 11 subjects were evaluated independently by three experienced applied kinesiologists for four nutrients ( thiamin , zinc , vitamin A , and ascorbic acid ) . The results obtained by those applied kinesiologists were compared with ( a ) one another , ( b ) st and ard laboratory tests for nutrient status , and ( c ) computerized isometric muscle testing . Statistical analysis yielded no significant interjudge reliability , no significant correlation between the testers and st and ard biochemical tests for nutrient status , and no significant correlation between mechanical and manual determinations of relative muscle strength . In addition , the subjects were exposed in a double-blind fashion to supplements of thiamin , zinc , vitamin A , and ascorbic acid and two placebos ( pectin and sucrose ) and then re-tested . According to applied kinesiology theory , \" weak \" ( indicating deficiency ) muscles are strengthened when the subject is exposed to an appropriate nutritional supplement . Statistical analysis revealed no significant differences in the response to placebo , nutrients previously determined ( by muscle testing ) to be deficient , and nutrients previously determined ( by muscle testing ) to be adequate . Even though the number of subjects ( 11 ) and nutrients ( 4 ) tested was limited , the results of this study indicated that the use of applied kinesiology to evaluate nutrient status is no more useful than r and om guessing",
"OBJECTIVES To assess the test-retest-reliability and validity of the Health Kinesiology muscle test . PATIENTS Seven patients with clinical ly and allergologically confirmed wasp venom allergy . DESIGN Four Health Kinesiology-examiners tested each patient in a r and om order for 10 verum and 10 placebo bottles . All examiners used the anterior deltoid as indicator muscle . Patients and examiners were completely blinded . OUTCOME MEASURES Weak muscle holds were rated as ' sensitivity ' towards the test substance , stable holding as normal ( not sensitive ) . RESULTS An overall kappa of 0.03 ( 95%-CI : -0.02 - 0.07 ) indicates the test is not reliable . Individual kappas do not substantially vary from examiner to examiner . Sensitivity and specificity were estimated at 40 % and 60 % . CONCLUSIONS The results suggest that the use of Health Kinesiology as a diagnostic tool is not more useful than r and om guessing . This should at least be true in patients with insect venom allergy that are tested by examiners with average skills"
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Background The prevalence of overweight/obesity in adults is raised to 39 % , which is nearly tripled more than 1975 . The alteration of the gut microbiome has been widely accepted as one of the main causal factors . To find an effective strategy for the prevention and treatment of overweight/obesity , a systematic review and meta- analysis were design ed . Methods In this study , we systematic ally review ed the article published from January 2008 to July 2018 and conducted a meta- analysis to examine the effects of probiotics on body weight control , lipid profile , and glycemic control in healthy adults with overweight or obesity . The primary outcomes were body weight , body mass index ( BMI ) , waist circumference , fat mass , fat percentages , plasma lipid profiles , and glucose metabolic parameters . Results We systematic ally search ed PubMed , Embase , and the Web of Science and identified 1248 articles , and 7 articles which were manually search ed by the references of included studies and previously systematic review s. Twelve r and omized controlled trials ( RCTs ) , including 821 participants , were included in the meta- analysis via full-text screening . Probiotics supplementation result ed in a statistical reduction in body weight ( WMD [ 95 % CI ] ; -0.55 [ -0.91 , -0.19 ] kg ) , BMI ( WMD [ 95 % CI ] ; -0.30 [ -0.43 , -0.18 ] kg m−2 ) , waist circumference ( WMD [ 95 % CI ] ; -1.20 [ -2.21 , -0.19 ] cm ) , fat mass ( WMD [ 95 % CI ] ; -0.91 [ -1.19 , -0.63 ] kg ) , and fat percentage ( WMD [ 95 % CI ] ; -0.92 [ -1.27 , -0.56 ] % ) compared with control groups . As expected , the metabolic parameters were improved significantly , with a pooled st and ardized mean difference in TC ( SMD [ 95 % CI ] ; -0.43 [ -0.80 , -0.07 ] ) , LDL-C ( SMD [ 95 % CI ] ; -0.41 [ -0.77 , -0.04 ] ) , FPG ( SMD [ 95 % CI ] ; -0.35 [ -0.67 , -0.02 ] ) , insulin ( SMD [ 95 % CI ] ; -0.44 [ -0.84 , -0.03 ] ) , and HOMA-IR ( SMD [ 95 % CI ] ; -0.51 [ -0.96 , -0.05 ] ) , respectively . The changes in TG ( SMD [ 95 % CI ] ; 0.14 [ -0.23 , 0.50 ] ) , HDL-C ( SMD [ 95 % CI ] ; -0.31 [ -0.70 , 0.07 ] ) , and HbA1c ( SMD [ 95 % CI ] ; -0.23 [ -0.46 , 0.01 ] ) were not significant . Conclusion This study suggests that the probiotics supplementation could potentially reduce the weight gain and improve some of the associated metabolic parameters , which may become an effective strategy for the prevention and treatment of obesity in adult individuals
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"Background The gut microbiota is interlinked with obesity , but direct evidence of effects of its modulation on body fat mass is still scarce . We investigated the possible effects of Bifidobacterium animalisssp . lactis 420 ( B420 ) and the dietary fiber Litesse ® Ultra polydextrose ( LU ) on body fat mass and other obesity-related parameters . Methods 225 healthy volunteers ( healthy , BMI 28–34.9 ) were r and omized into four groups ( 1:1:1:1 ) , using a computer-generated sequence , for 6 months of double-blind , parallel treatment : 1 ) Placebo , microcrystalline cellulose , 12 g/d ; 2 ) LU , 12 g/d ; 3 ) B420 , 1010 CFU/d in microcrystalline cellulose , 12 g/d ; 4 ) LU + B420 , 12 g + 1010 CFU/d . Body composition was monitored with dual-energy X-ray absorptiometry , and the primary outcome was relative change in body fat mass , comparing treatment groups to Placebo . Other outcomes included anthropometric measurements , food intake and blood and fecal biomarkers . The study was registered in Clinical trials.gov ( NCT01978691 ) . Findings There were marked differences in the results of the Intention-To-Treat ( ITT ; n = 209 ) and Per Protocol ( PP ; n = 134 ) study population s. The PP analysis included only those participants who completed the intervention with > 80 % product compliance and no antibiotic use . In addition , three participants were excluded from DXA analyses for PP due to a long delay between the end of intervention and the last DXA measurement . There were no significant differences between groups in body fat mass in the ITT population . However , LU + B420 and B420 seemed to improve weight management in the PP population . For relative change in body fat mass , LU + B420 showed a − 4.5 % ( − 1.4 kg , P = 0.02 , N = 37 ) difference to the Placebo group , whereas LU ( + 0.3 % , P = 1.00 , N = 35 ) and B420 ( − 3.0 % , P = 0.28 , N = 24 ) alone had no effect ( overall ANOVA P = 0.095 , Placebo N = 35 ) . A post-hoc factorial analysis was significant for B420 ( − 4.0 % , P = 0.002 vs. Placebo ) . Changes in fat mass were most pronounced in the abdominal region , and were reflected by similar changes in waist circumference . B420 and LU + B420 also significantly reduced energy intake compared to Placebo . Changes in blood zonulin levels and hsCRP were associated with corresponding changes in trunk fat mass in the LU + B420 group and in the overall population . There were no differences between groups in the incidence of adverse events . Discussion This clinical trial demonstrates that a probiotic product with or without dietary fiber controls body fat mass . B420 and LU + B420 also reduced waist circumference and food intake , whereas LU alone had no effect on the measured outcomes",
"Background / Objectives : The population of the obese is increasing worldwide . Prevention and improvement of obesity are indispensable for decreasing the risk of metabolic disorders . We have recently shown that obesity and fatty liver are reduced by a plant-derived lactic acid bacterium , Pediococcus pentosaceus LP28 ( LP28 ) , in high-fat diet-induced obese mice . The aim of the present clinical study is to prove that LP28 is effective for reducing body fat and body weight , as shown in the experiment using mice . Subjects/ Methods : The clinical trial was carried out as a double-blind , r and omized , placebo-controlled study comprising 62 subjects ( 20–70 years of age , BMI 25–30 kg/m2 ) . These subjects were r and omly assigned to three groups that received living LP28 , heat-killed LP28 or a placebo powder , administered orally once a day for 12 weeks . Results : Heat-killed LP28 reduced BMI ( 0.45 kg/m2 , 95 % CI ( 0.04 , 0.86 ) , P=0.035 ) , body fat percentage ( 1.11 % , ( 0.39 , 1.82 ) , P=0.002 ) , body fat mass ( 1.17 kg ( 0.43 , 1.92 ) , P=0.004 ) and waist circumference ( 2.84 cm ( 0.74 , 4.93 ) , P=0.009 ) when compared with a placebo group . Fasting plasma glucose , HbA1c , fasting insulin , HOMA-IR and serum lipids levels did not change by either living LP28 or heat-killed LP28 intake . Conclusions : Heat-killed LP28 displays an antiobesity effect that reduces BMI , body fat and waist circumference , suggesting that the plant-derived lactic acid bacterium LP28 would be a promising preventive of metabolic syndrome",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Objectives : The purpose of this study was to investigate whether probiotics had an effect on proinflammatory markers and cytokines in overweight and obese individuals and whether they could have synergistic effects with weight-loss diets . Methods : A total of 75 healthy overweight and obese individuals completed this r and omized doubled-blind controlled clinical trial . Participants were r and omly assigned to groups consuming regular yogurt with a low-calorie diet ( LCD , RLCD ; n = 25 ) or receiving probiotic yogurt with LCD ( PLCD ; n = 25 ) or consuming probiotic yogurt without LCD ( PWLCD ; n = 25 ) for 8 weeks . The pribiotic regimen contained 200 g/day yogurt , enriched by Lactobacillus acidophilus La5 , Bifidobacterium BB12 , and Lactobacillus casei DN001 108 colony-forming units/g . Body fat percentage , high-sensitive C-reactive protein ( hs-CRP ) , tumor necrosis factor-alpha ( TNF-α ) , leptin , and mRNA levels of inflammation-related genes ( TNF-α and RAR-related orphan receptor gamma [ ROR-γt ] ) in peripheral blood mononuclear cells ( P BMC s ) were measured . Results : A reduction in body mass index ( BMI ) , fat percentage , and leptin level was observed that was more obvious in groups who received the weight-loss diet with probiotic yogurt . Reduction in the gene expression of ROR-γt was significant in the PLCD group ( p The expression of TNF-α did not change among all groups after intervention . The mean concentration of leptin was significantly decreased in all groups after the dietary intervention , but the mean changes in leptin level in the PLCD group was more prominent compared to the other two groups ( −2.38 , p The reduction in serum levels of hs-CRP was more evident in the PWLCD group compared to the PLCD and RLCD groups after the 8-week intervention ( −3.4 , p = 0.03 vs −1.76 , p the weight-loss diet and probiotic yogurt had synergistic effects on T-cells subset specific gene expression in P BMC s , fat percentage , and body weight among overweight and obese individuals",
"Lactobacillus gasseri BNR17 is a probiotic strain isolated from human breast milk . Animal studies reported that BNR17 inhibited increases in body weight and adipose tissue weights . The purpose of this study was to evaluate the antiobesity effects of BNR17 in humans . In a r and omized , double-blind , placebo-controlled trial , 90 volunteers aged 20 - 75 years with body mass index ( BMI ) from 25 to 35 kg/m2 were r and omized to receive a placebo , low-dose BNR ( BNR-L , 109 CFU/day ) , or high-dose BNR ( BNR-H , 1010 CFU/day ) for 12 weeks . Body weight , BMI , waist and hip circumferences , waist-to-hip ratio , abdominal adipose tissue areas , body fat mass , lean body mass , and biochemical parameters were assessed at the beginning and end of the trial . Visceral adipose tissue ( VAT ) was significantly decreased in the BNR-H group compared with the placebo group ( P = .038 ) . Difference of VAT areas of the BNR-H group compared with the placebo group after 12-week consumption of BNR17 was significant ( -21.6 cm2 , P = .012 ) . Waist circumferences were significantly decreased in both the BNR-L and BNL-H groups ( P = .045 and .012 , respectively ) compared with the baseline values , but not in the placebo group . Biochemical parameters were not significantly different among the groups . These findings suggest that daily consumption of BNR17 may contribute to reduced visceral fat mass in obese adults",
"OBJECTIVE To investigate whether a probiotic mix has additional effects when compared with an isolated dietary intervention on the body composition , lipid profile , endotoxemia , inflammation , and antioxidant profile . METHODS Women who had excess weight or obesity were recruited to a r and omized , double-blind trial and received a probiotic mix ( Lactobacillus acidophilus and casei ; Lactococcus lactis ; Bifidobacterium bifidum and lactis ; 2 × 1010 colony-forming units/day ) ( n = 21 ) or placebo ( n = 22 ) for 8 weeks . Both groups received a dietary prescription . Body composition was assessed by anthropometry and dual-energy X-ray absorptiometry . The lipid profile , lipid accumulation product , plasma fatty acids , lipopolysaccharide , interleukin-6 , interleukin-10 , tumor necrosis factor-α , adiponectin , and the antioxidant enzymes activities were analyzed . RESULTS In comparison with the dietary intervention group , the dietary intervention + probiotic mix group showed a greater reduction in the waist circumference ( -3.40 % vs. -5.48 % , P = 0.03 ) , waist-height ratio ( -3.27 % vs. -5.00 % , P = 0.02 ) , conicity index ( -2.43 % vs. -4.09 % P = 0.03 ) , and plasma polyunsaturated fatty acids ( 5.65 % vs. -18.63 % , P = 0.04 ) and an increase in the activity of glutathione peroxidase ( -16.67 % vs. 15.62 % , P of a probiotic mix reduced abdominal adiposity and increased antioxidant enzyme activity in a more effective way than an isolated dietary intervention",
"Recent findings on the association of gut microbiota with various diseases , including obesity , prompted us to investigate the possibility of using a certain type of gut bacteria as a safe therapeutic for obesity . Lactobacillus mutants with enhanced capacity in absorption of free fatty acids ( FFAs ) were isolated to show reduced absorption of FFAs by the administered host , attributing to inhibition of body weight gain and body fat accumulation as well as amelioration of blood profiles . Consequently , high throughput screening of natural FFAs‐absorbing intestinal microbes led to the isolation of Lactobacillus reuteri JBD30 l. The administration of Lactobacillus JBD30l lowered the concentration of FFAs in the gut fluid content of small intestine , thus reducing intestinal absorption of FFAs whereas promoting fecal excretion of FFAs . Animal data also confirmed that the efficacy of Lactobacillus JBD30l on body weight similar to that of orlistat , an FDA ‐approved pharmaceutical for long‐term use to treat obesity . In a subsequent r and om , double‐blind , placebo‐controlled clinical trial ( KCT0000452 at Clinical Research Information Service of Korea ) , there was a statistically significant difference in the percentage change in body weight between the Lactobacillus JBD301 and the placebo group ( P = 0.026 ) as well as in the BMI ( P = 0.036 ) from the 0‐week assessment to the 12‐week assessment . Our results show that FFA‐absorbing Lactobacillus JBD301 effectively reduces dietary fat absorption , providing an ideal treatment for obesity with inherent safety",
"Purpose Controversy exists regarding whether increasing dairy intake without energy restriction would lead to weight loss . We aim ed to compare the potential weight-reducing effects of kefir drink ( a probiotic dairy product ) and milk in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women . Methods One hundred and forty-four subjects were assessed for eligibility in this single-center , multi-arm , parallel-group , r and omized controlled trial . Of these , seventy-five eligible women aged 25–45 years were r and omly assigned to three groups , labeled as control , milk , and kefir , to receive an outpatient dietary regimen for 8 weeks . Subjects in the control group received a diet providing a maintenance level of energy intake , containing 2 servings/day of low-fat dairy products , while those in the milk and kefir groups received a weight maintenance diet , containing 2 additional servings/day ( a total of 4 servings/day ) of dairy products from low-fat milk or commercial kefir drink , respectively . Anthropometric outcomes including weight , body mass index ( BMI ) , and waist circumference ( WC ) were measured every 2 weeks . Results Fifty-eight subjects completed the study . Using analysis of covariance models in the intention-to-treat population ( n = 75 ) , we found that at 8 weeks , subjects in the kefir and milk groups had significantly greater reductions in weight , BMI , and WC compared to those in the control group ( all p Conclusions Kefir drink leads to a similar weight loss , compared with milk , in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women . However , further studies are warranted",
"Our previous study showed that supplementation with a combination of Lactobacillus curvatus ( L. curvatus ) HY7601 and Lactobacillus plantarum ( L. plantarum ) KY1032 reduced the body weight , body fat percentage , body fat mass and L1 subcutaneous fat area in overweight subjects . We aim ed to evaluate whether the changes in adiposity after supplementation with Lactobacillus strains were associated with metabolic intermediates . A r and omized , double-blind , placebo-controlled study was conducted on 66 non-diabetic and overweight individuals . Over a 12-week period , the probiotic group consumed 2 g of probiotic powder , whereas the placebo group consumed the same product without the probiotics . To investigate metabolic alterations , we performed plasma metabolomics using ultra-performance liquid chromatography and mass spectrometry ( UPLC-LTQ/Orbitrap MS ) . Probiotic supplementation significantly increased the levels of octenoylcarnitine ( C8:1 ) , tetradecenoylcarnitine ( C14:1 ) , decanoylcarnitine ( C10 ) and dodecenoylcarnitine ( C12:1 ) compared with the levels from placebo supplementation . In the probiotic group , the changes in the body weight , body fat percentage , body fat mass and L1 subcutaneous fat area were negatively associated with changes in the levels of C8:1 , C14:1 , C10 and C12:1 acylcarnitines . In overweight individuals , probiotic-induced weight loss and adiposity reduction from the probiotic supplementation were associated with an increase in medium-chain acylcarnitines",
"BACKGROUND Despite evidence for the beneficial effects of probiotics and low-fat dairy products , to our knowledge , no study has compared the beneficial effect on weight loss of consuming a probiotic yogurt ( PY ) compared with a st and ard low-fat yogurt ( LF ) during a hypoenergetic program . OBJECTIVE We compared the effect of the PY with LF yogurt consumption on body weight and cardiometabolic risk factors in women during a weight-loss program . DESIGN Overweight and obese women [ body mass index ( in kg/m(2 ) ) : 27 - 40 ; age : 18 - 50 y ) who usually consumed st and ard LFs were asked to consume either PY or LF every day with their main meals for 12 wk while following a weight-loss program . RESULTS A total of 89 participants were r and omly assigned to one of the 2 intervention groups . Baseline variables were not significantly different between groups . A statistically significant reduction in anthropometric measurements and significant improvements in cardiometabolic risk characteristics were observed over the 12 wk in both groups . However , no significant differences in weight loss and anthropometric measurements were seen between groups after the intervention . Compared with the LF group , the PY group had a greater ( mean ± SD ) decrease in total cholesterol ( PY = -0.36 ± 0.10 mmol/L , LF = -0.31 ± 0.10 mmol/L ; P = 0.024 ) , low-density lipoprotein cholesterol ( PY = -0.35 ± 0.10 mmol/L , LF = -0.31 ± 0.11 mmol/L ; P = 0.018 ) , homeostasis model assessment of insulin resistance ( PY = -0.55 ± 0.32 , LF = -0.42 ± 0.20 ; P = 0.002 ) , 2-h postpr and ial glucose ( PY = -0.61 ± 0.24 mmol/L , LF = -0.44 ± 0.19 mmol/L ; P ( PY = -1.76 ± 1.01 mU/mL , LF = -1.32 ± 0.62 mU/mL ; P = 0.002 ) , as secondary endpoints after the study . No significant differences were found for fasting plasma glucose , high-density lipoprotein cholesterol , or triglycerides within both groups after the 12 wk . CONCLUSION Consumption of PY compared with LF with main meals showed no significant effects on weight loss . However , it may have positive effects on lipid profiles and insulin sensitivity during a weight-loss program . This trial was registered at http://www.i rct .ir/ as I RCT 201402177754N8",
"Gut microbiota-related metabolites are potential clinical biomarkers for cardiovascular disease ( CVD ) . Circulating succinate , a metabolite produced by both microbiota and the host , is increased in hypertension , ischemic heart disease , and type 2 diabetes . We aim ed to analyze systemic levels of succinate in obesity , a major risk factor for CVD , and its relationship with gut microbiome . We explored the association of circulating succinate with specific metagenomic signatures in cross-sectional and prospect i ve cohorts of Caucasian Spanish subjects . Obesity was associated with elevated levels of circulating succinate concomitant with impaired glucose metabolism . This increase was associated with specific changes in gut microbiota related to succinate metabolism : a higher relative abundance of succinate-producing Prevotellaceae ( P ) and Veillonellaceae ( V ) , and a lower relative abundance of succinate-consuming Odoribacteraceae ( O ) and Clostridaceae ( C ) in obese individuals , with the ( P + V/O + C ) ratio being a main determinant of plasma succinate . Weight loss intervention decreased ( P + V/O + C ) ratio coincident with the reduction in circulating succinate . In the spontaneous evolution after good dietary advice , alterations in circulating succinate levels were linked to specific metagenomic signatures associated with carbohydrate metabolism and energy production with independence of body weight change . Our data support the importance of microbe – microbe interactions for the metabolite signature of gut microbiome and uncover succinate as a potential microbiota-derived metabolite related to CVD risk",
"Consumption of fermented milk ( FM ) containing a probiotic , Lactobacillus gasseri SBT2055 ( LG2055 ) , previously showed a reduction in abdominal adiposity in a r and omised controlled trial ( RCT ) using FM with 10(8 ) colony-forming units ( cfu ) of LG2055/g . However , whether the effectiveness is observed at lower concentrations , the recommended minimum or intermediate levels of probiotics ( 10(6 ) or 10(7 ) cfu/g , respectively ) , remains to be examined . A multi-centre , double-blind , parallel-group RCT was conducted using 210 healthy Japanese adults with large visceral fat areas ( 80·2 - 187·8 cm(2 ) ) . They were balanced for their baseline characteristics and r and omly assigned to three groups receiving FM containing 10(7 ) , 10(6 ) or 0 ( control ) cfu LG2055/g of FM , and were asked to consume 200 g FM/d for 12 weeks . Abdominal visceral fat areas , which were determined by computed tomography , at week 12 , changed from baseline by an average of -8·5 % ( 95 % CI -11·9 , -5·1 ; P measures including BMI , waist and hip circumferences , and body fat mass were also significantly decreased from baseline at week 12 in both groups ; interestingly , the cessation of taking FM for 4 weeks attenuated these effects . In the control group , none of these parameters significantly decreased from baseline . These findings demonstrate that consumption of LG2055 at doses as low as the order of 10(8 ) cfu/d exhibited a significant lowering effect on abdominal adiposity , and suggest that constant consumption might be needed to maintain the effect"
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We conducted a meta- analysis , including r and omised controlled trials ( RCTs ) and cohort studies , to examine the effect of patient-specific instruments ( PSI ) on radiological outcomes after total knee replacement ( TKR ) including : mechanical axis alignment and malalignment of the femoral and tibial components in the coronal , sagittal and axial planes , at a threshold of > 3º from neutral . Relative risks ( RR ) for malalignment were determined for all studies and for RCTs and cohort studies separately . Of 325 studies initially identified , 16 met the eligibility criteria , including eight RCTs and eight cohort studies . There was no significant difference in the likelihood of mechanical axis malalignment with PSI versus conventional TKR across all studies ( RR = 0.84 , p = 0.304 ) , in the RCTs ( RR = 1.14 , p = 0.445 ) or in the cohort studies ( RR = 0.70 , p = 0.289 ) . The results for the alignment of the tibial component were significantly worse using PSI TKR than conventional TKR in the coronal and sagittal planes ( RR = 1.75 , p = 0.028 ; and RR = 1.34 , p = 0.019 , respectively , on pooled analysis ) . PSI TKR showed a significant advantage over conventional TKR for alignment of the femoral component in the coronal plane ( RR = 0.65 , p = 0.028 on pooled analysis ) , but not in the sagittal plane ( RR = 1.12 , p = 0.437 ) . Axial alignment of the tibial ( p = 0.460 ) and femoral components ( p = 0.127 ) was not significantly different . We conclude that PSI does not improve the accuracy of alignment of the components in TKR compared with conventional instrumentation
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"Purpose Restoration of correct alignment is one of the main objectives of total knee arthroplasty ( TKA ) . However , the influence of residual malalignment on clinical and functional outcomes is currently uncertain . This study was therefore undertaken to ascertain its influence in patients undergoing TKA for varus osteoarthritis of the knee . Methods A cohort of 132 consecutive patients ( 143 knees ) with pre-operative varus alignment was evaluated with a mean follow-up period of 7.2 years . Based upon the post-operative alignment , patients were stratified into three groups : neutral , mild varus , and severe varus . These groups were compared with respect to clinical and functional outcomes . Results All patients had post-operative improvements in Knee Society Score ( KSS ) . Knees that were left in mild varus scored significantly better for the KSS and the Western Ontario and McMaster Universities Arthritis Index , compared with knees that were corrected to neutral and knees that were left in severe varus exceeding 6 ° . No revisions occurred in any of the groups at midterm follow-up . Conclusion The results of this study contradict the conventional assumption that correction to neutral mechanical alignment leads to the best outcome following TKA . Patients with pre-operative varus had better clinical and functional outcome scores if the alignment was left in mild varus , as compared with patients with an alignment correction to neutral . Level of evidence Therapeutic study , Level III",
"Background Kinematically aligned TKA restores function by aligning the femoral and tibial components to the normal or prearthritic joint lines of the knee . However , aligning the components to the joint lines of the normal knee also aligns the tibial component in varus , creating concern that varus alignment might result in poor function and early catastrophic failure . Questions / Purpose sWe therefore determined whether function and the incidence of catastrophic failure were different when the tibial component , knee , and limb alignment were in a specified normal range , varus outlier , or valgus outlier . Methods We prospect ively followed all 198 patients ( 214 knees ) who underwent TKAs between February and October 2008 . We treated each knee in this cohort of patients with a kinematically aligned , cruciate-retaining prosthesis implanted using patient-specific guides . From a long-leg scanogram , we measured and categorized alignment of the tibial component as in range ( ≤ 0 ° ) or a varus outlier ( > 0 ° ) , alignment of the knee as in range ( between −2.5 ° to −7.4 ° valgus ) or a varus ( > −2.5 ° ) or valgus ( 3 ° ) or valgus ( Oxford Knee Score and WOMAC ™ score , and reported catastrophic failure as the incidence of revision attributable to loosening , wear , and instability of the femoral or tibial components . The minimum followup was 31 months ( mean , 38 months ; range , 31–43 months ) . Results The mean Oxford Knee Score of 43 and WOMAC ™ score of 92 were similar between the three alignment categories . The incidence of catastrophic failure in each alignment category was zero . Conclusions Kinematically aligned TKA restores function without catastrophic failure regardless of the alignment category . Because 75 % of patients had their tibial component categorized as a varus outlier and also had high function and a zero incidence of catastrophic failure , the concern that kinematic alignment compromises function and places the components at a high risk for catastrophic failure is unfounded and should be of interest to surgeons committed to cutting the tibia perpendicular to the mechanical axis of the tibia . Level of Evidence Level IV , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"Purpose To compare the femoral and tibial components rotational alignment in total knee arthroplasty ( TKA ) performed either with conventional or with patient-specific instrumentation . Methods Forty-five patients underwent primary TKA and were prospect ively r and omized into two groups : 22 patients into the conventional instrumentation group ( group A ) and 23 patients into the Signature ™ patient-specific instrumentation group ( group B ) . All patients underwent computed tomography of the operated knee in the first week after surgery to measure the components rotation . Results The femoral component rotation was 0.0 ° ( −0.25 , 1.0 ) in group A , and 0.0 ° ( 0.0 , 1.0 ) in group B. The tibial component rotation was −16.0 ° ( −18.5 , 11.8 ) in group A , and −16.0 ° ( −19.0 , −14.0 ) in group B. There were no significant differences between the two groups in tibial and femoral components rotation . The difference between the tibial component rotation and the neutral tibial rotation was similar in both groups [ 2.0 ° ( −0.5 , 6.3 ) in group A and 2.0 ° ( −1.0 , 4.0 ) in group B ] , but the dispersion around the median was different between the two groups . The amplitude of the difference between tibial rotation and neutral position was 27 ° ( −13 , 14 ) in group A and 9 ° ( −3 , 6 ) in group B. Conclusions There is a smaller chance of internal malrotation of the tibial component with the Signature ™ patient-specific instrumentation system , with less dispersion and amplitude of the tibial component rotation around the neutral position . Level of evidence II",
"Abstract Purpose It was our hypothesis that patient-specific instrumentation ( PSI ) can improve the accuracy of the rotational alignment in TKA based on the concept of the system and on the potential to clearly identify pre-operatively during planning the classical anatomical l and marks that serve as references to set-up the rotation both for the femur and tibia . Material s and methods In this prospect i ve comparative r and omized study , 40 patients ( 20 in each group ) operated in our institution between September 2012 and January 2013 by the 2 senior authors were included . R and omization of patients into one of the two groups was done by the Hospital Informatics Department with the use of a systematic sampling method . All patients received the same cemented high-flex mobile bearing TKA . In the PSI group , implant position was compared to the planed position using previously vali date d dedicated software . The position of the implants ( frontal and sagittal ) was compared in the 2 groups on st and ard X-rays , and the rotational position was analysed on post-operative CT-scan . Results 90 % of the patients add tibial rotation where the variations were much higher . Mean HKA was 179 ° ( 171–185 ) in the PSI group with 4 outliers ( 2 varus : 171 ° and 172 ° :184 ° and 185 ° ) and 178.3 ° with 2 outliers ( 171 ° and 176 ° ) in the control group . No difference was observed between the two groups concerning the frontal and sagittal position of the implants on the ML and AP X-rays . No significant difference of femoral rotation was observed between the two groups with a mean of 0.4 ° in the PSI group and 0.2 ° in the control group ( p : n.s ) . Mean tibial rotation was 8 ° of internal rotation in the PSI group and 15 ° of internal rotation in the st and ard group ( p : n.s ) . Conclusion Based on our results , we were unable to confirm our hypothesis as PSI can not improve rotation in TKA . More work needs to be done to more clearly define the place of PSI in TKA , to keep on improving the accuracy of the system and to better define the individual targets in TKA in terms of frontal , sagittal and rotational positioning of the implant for each patient . Level of evidence Prospect i ve comparative r and omized study , Level II",
"Background Recently , patient-specific guides ( PSGs ) have been introduced , cl aim ing a significant improvement in accuracy and reproducibility of component positioning in TKA . Despite intensive marketing by the manufacturers , this cl aim has not yet been confirmed in a controlled prospect i ve trial . Questions / purpose sWe ( 1 ) compared three-planar component alignment and overall coronal mechanical alignment between PSG and conventional instrumentation and ( 2 ) logged the need for applying changes in the suggested position of the PSG . Methods In this r and omized controlled trial , we enrolled 128 patients . In the PSG cohort , surgical navigation was used as an intraoperative control . When the suggested cut deviated more than 3 ° from target , the use of PSG was ab and oned and marked as an outlier . When cranial-caudal position or size was adapted , the PSG was marked as modified . All patients underwent long-leg st and ing radiography and CT scan . Deviation of more than 3 ° from the target in any plane was defined as an outlier . Results The PSG and conventional cohorts showed similar numbers of outliers in overall coronal alignment ( 25 % versus 28 % ; p = 0.69 ) , femoral coronal alignment ( 7 % versus 14 % ) ( p = 0.24 ) , and femoral axial alignment ( 23 % versus 17 % ; p = 0.50 ) . There were more outliers in tibial coronal ( 15 % versus 3 % ; p = 0.03 ) and sagittal 21 % versus 3 % ; p = 0.002 ) alignment in the PSG group than in the conventional group . PSGs were ab and oned in 14 patients ( 22 % ) and modified in 18 ( 28 % ) . Conclusions PSGs do not improve accuracy in TKA and , in our experience , were somewhat impractical in that the procedure needed to be either modified or ab and oned with some frequency . Level of Evidence Level I , therapeutic study . See instructions for authors for a complete description of levels of evidence",
"Background : The purpose of this study was threefold : ( 1 ) to determine the scientific quality of published r and omized trials in the American Volume of The Journal of Bone and Joint Surgery from 1988 through 2000 , ( 2 ) to identify predictors of study quality , and ( 3 ) to evaluate inter-rater agreement in the scoring of study quality with use of a simple scale . Methods : H and search es of The Journal of Bone and Joint Surgery were conducted in duplicate to identify r and omized clinical trials . Of 2468 studies identified , seventy-two ( 2.9 % ) met all eligibility criteria . Two investigators each assessed the quality of the study under blinded conditions and abstract ed relevant data . Results : The mean score ( and st and ard error ) for the quality of the seventy-two r and omized trials was 68.1 % ± 1.6 % ; 60 % ( forty-three ) scored higher mean quality score than did surgical trials ( 72.8 % compared with 63.9 % , p higher quality scores . Failure to conceal r and omization , to blind outcome assessors , and to describe why patients were excluded result ed in significantly lower quality scores ( p The Detsky quality scale met accepted st and ards of interobserver reliability ( kappa , 0.87 ; 95 % confidence interval , 0.70 to 0.95 ) . Conclusions : Few studies published in The Journal of Bone and Joint Surgery were r and omized trials . More than half of the trials were limited by a lack of concealed r and omization , lack of blinding of outcome assessors , or failure to report reasons for excluding patients . Application of st and ardized guidelines for the reporting of clinical trials in orthopaedics should improve quality",
"Purpose This prospect i ve , double-blind , r and omised controlled trial was design ed to address the following research questions : firstly , is there a significant difference in outliers in alignment in the frontal and sagittal plane between PSG TKA and conventional TKA . Secondly , is there a significant difference in operation time , blood loss and length of hospital stay between the two techniques . We hypothesise that there will be fewer outliers with PSG TKA and that operation time , blood loss and length of hospital stay can be significantly reduced with PSG . Methods A total of 180 patients were r and omised for PSG TKA ( group 1 ) or conventional TKA ( group 2 ) in two centres . Patients were stratified per hospital . Alignment of the mechanical axis of the leg and flexion/extension and varus/valgus of the individual prosthesis components were measured on digital , st and ing , long-leg and st and ard lateral radiographs by two independent outcome assessors in both centres . Percentages of outliers ( > 3 ° ) were determined . We compared blood loss , operation time and length of hospital stay . Results There was no statistically significant difference in mean mechanical axis or outliers in mechanical axis between groups . No statistically significant difference was found for the alignment of the individual components in the frontal plane nor for the percentages of outliers . There was a statistically significant difference in outliers for the femoral component in the sagittal plane , with a higher percentage of outliers in the group 1 ( p = 0.017 ) . No such significant result was found for the tibial component in that plane . All interclass correlation coefficients were good . Blood loss was 100 mL less in group 1 ( p ) . Operation time was 5 min shorter in group 1 ( p 0.001 ) . Length of hospital stay was identical with a mean of 3.6 days ( p = 0.657 ) . Conclusions The results in terms of obtaining a neutral mechanical axis and a correct position of the prosthesis components did not differ between groups . A small reduction in operation time and blood loss was found with the PSG system . Future research should especially focus on cost-effectiveness analysis and functional outcome of PSG TKA.Level of evidence",
"The primary purpose of this prospect i ve , r and omized study was to determine if patient-specific instrumentation ( PSI ) for total knee arthroplasty ( TKA ) shortened surgical time . Secondarily the number of instrument trays and alignment were also compared to cases performed with traditional instrumentation ( TI ) . Fifty-two cases ( 26 per group ) were r and omized and videotaped to measure the length of surgery , as well as each individual surgical step . Component alignment and mechanical axis was measured radiographically for each patient . Total surgical time was over 4 minutes shorter for patients in the TI group ( 57.4 minutes vs. 61.8 minutes ; P instrument trays were used in the TI group ( 7.3 vs. 2.5 ; P difference in mechanical alignment between groups on postoperative long alignment radiographs ( P=0.77 ) . In conclusion , PSI did not shorten surgical time or improve alignment compared with TI in this prospect i ve , r and omized trial , but did reduce the required number of trays",
"Patient specific instrumentation ( PSI ) was developed to increase total knee arthroplasty ( TKA ) accuracy and efficiency . The study purpose was to compare immediate post-operative mechanical alignment , achieved using PSI , with conventional and computer assisted surgery ( CAS ) instruments in high volume TKA practice s. This prospect i ve , multicenter , non-r and omized study accrued 66 TKA patients using PSI . A computed tomography ( CT ) based algorithm was used to develop the surgical plan . Sixty-two percent were females , 99 % were diagnosed with osteoarthritis , average age at surgery was 66 years , and 33 was the average body mass index . A historical control group was utilized that underwent TKA using conventional instruments ( n=86 ) or CAS ( n=81 ) , by the same set of surgeons . Postoperative mechanical alignment was comparable across the groups . Operative time mean and variance were significant",
"Abstract Purpose The aim of this study was to investigate the post-operative radiological outcomes of patient-specific instrumentation ( PSI ) surgery versus conventional total knee arthroplasty ( TKA ) . Methods Sixty patients scheduled for a primary TKA were prospect ively divided into PSI or conventional technique . Coronal and sagittal radiographic long limb films were taken post-operatively . The accepted values for normal alignment were 180 ° ± 3 ° for hip-knee-ankle angle ; 90 ° ± 3 ° for coronal femoral component angle or coronal tibia component angle ; 0 ° to 3 ° flexion for sagittal femoral component angle and 0 ° to 7 ° posterior slope for sagittal tibia component angle . Results For hip-knee-ankle angle , there were 21 % more outliers in the PSI group compared to the conventional group ( p = 0.045 ) . Most of these outliers had valgus deformity in the PSI group and varus deformity in the conventional group ( p = 0.045 ) . For implant placement , there was no difference in the proportion of outliers between the two groups . There was also no difference in the duration of surgery . Conclusions This study showed that PSI surgery is associated with a larger proportion of outliers for lower limb alignment . PSI surgery as an alternative to conventional TKA is not advisable . Level of evidence II",
"Abstract Purpose The purpose of the study was to evaluate the accuracy of the planning of the patient-specific pin guides in total knee arthroplasty ( TKA ) . This planning was performed primarily by a technician of the company and offered to the surgeon . All parameters of the implantation can either be modified or accepted by the surgeon . The hypothesis was that the plan needs preoperative intervention by the surgeon . Methods A prospect i ve study in 50 patients was carried out . All patients received the same posterior-stabilised implant with patient-specific instrumentation . All surgical parameters ( coronal , sagittal , rotational alignment , femoral and tibial resection levels and implant sizes ) were checked by the orthopaedic surgeon and changed if necessary . Results Preoperatively , the femoral size was changed in 8 patients ( 16 % ) , the femoral flexion in 23 patients ( 46 % ) , the femoral shift in 34 patients ( 68 % ) , the tibial size in 24 patients ( 48 % ) and the tibial rotation in all patients . The epicondylar axis was accepted in 47 patients ( 94 % ) in the technician plan . Mean planning time was 8 ± 4 min . Intraoperatively , the femoral anterior – posterior size was in 50 patients ( 100 % ) the same as in the surgeon and in 42 patients ( 84 % ) the same as in the technician plan ( p = 0.003 ) . The tibial component implanted was in 42 patients ( 84 % ) the same as in the surgeon and in 19 patients ( 38 % ) the same as in the technician plan ( p A femoral distal recut was necessary in 31 patients ( 62 % ) and a change of the tibial proximal cut in 17 patients ( 34 % ) during surgery . Intraoperatively , no changes of the femoral and tibial alignment , the femoral anterior – posterior size , the femoral flexion , the femoral shift , the femoral and tibial rotation were necessary . Postoperatively , the coronal mechanical overall axis was within ±3 ° in 47 patients ( 94 % ) with a maximum deviation of 5.6 ° . Conclusions Significant changes of the technician plan were necessary to get an accurate preoperative plan . Intraoperative changes were significant less compared to the surgeon than to the technician plan . No major changes ( alignment , femoral anterior – posterior size and rotation ) of the surgeon plan were necessary . Surgeons using patient-specific pin guides in TKA may verify the default plan provided by the technician . A blind reply on the technician plan may be not recommended . Level of evidence Therapeutic study , Level III",
"Patient specific cutting guides generated by preoperative Magnetic Resonance Imaging ( MRI ) of the patient 's extremity have been proposed as a method of improving the consistency of Total Knee Arthroplasty ( TKA ) alignment and adding efficiency to the operative procedure . The cost of this option was evaluated by quantifying the savings from decreased operative time and instrument processing costs compared to the additional cost of the MRI and the guide . Coronal plane alignment was measured in an unselected consecutive series of 200 TKAs , 100 with st and ard instrumentation and 100 with custom cutting guides . While the cutting guides had significantly lower total operative time and instrument processing time , the estimated $ 322 savings was overwhelmed by the $ 1,500 additional cost of the MRI and the cutting guide . All measures of coronal plane alignment were equivalent between the two groups . The data does not currently support the proposition that patient specific guides add value to TKA",
"BACKGROUND The purpose of this study was to assess whether custom cutting blocks improve accuracy of component alignment compared to conventional TKA instrumentation . METHODS Eighty primary TKA patients were enrolled in an open-label r and omized prospect i ve clinical trial and were divided into two groups , 40 custom cutting blocks and 40 conventional TKA instrumentations . The primary outcome was prosthetic alignment with respect to mechanical axis and epicondylar axis . Secondary outcomes included operative time , 24-hour postoperative blood loss and hemoglobin at discharged . RESULTS There were no statistical significant differences in the postoperative mechanical axis between the custom cutting blocks group and conventional TKA group , ( 95 % vs. 87.5 % within 3 ° of neutral mechanical alignment , p=0.192 ) . The average rotational alignment was statistically significantly different in the custom cutting blocks group ( 1.0 ° ±0.6 ° vs. 1.6 ° ±1.8 ° external rotation from epicondylar axis , p in operation time between custom cutting blocks group and conventional group , skin to skin [ 57.5±2.3 min vs. 62.1±1.5 , p proportion of patients with postoperative blood loss within 24 h. CONCLUSIONS Custom cutting blocks technique was a surgical procedure which provided better accuracy in rotational alignment but no statistical differences in mechanical axis , less operative time and reduced blood loss than the conventional TKA instrumentation in the majority of patients",
"Patient-specific cutting guides ( PSCGs ) are design ed to improve the accuracy of alignment of total knee replacement ( TKR ) . We compared the accuracy of limb alignment and component positioning after TKR performed using PSCGs or conventional instrumentation . A total of 80 patients were r and omised to undergo TKR with either of the different forms of instrumentation , and radiological outcomes and peri-operative factors such as operating time were assessed . No significant difference was observed between the groups in terms of tibiofemoral angle or femoral component alignment . Although the tibial component in the PSCGs group was measurably closer to neutral alignment than in the conventional group , the size of the difference was very small ( 89.8 ° ( sd 1.2 ) vs 90.5 ° ( sd 1.6 ) ; p = 0.030 ) . This new technology slightly shortened the bone-cutting time by a mean of 3.6 minutes ( p and the operating time by a mean 5.1 minutes ( p = 0.019 ) , without tangible differences in post-operative blood loss ( p = 0.528 ) or need for blood transfusion ( p = 0.789 ) . This study demonstrated that both PSCGs and conventional instrumentation restore limb alignment and place the components with the similar accuracy . The minimal advantages of PSCGs in terms of consistency of alignment or operative time are unlikely to be clinical ly relevant",
"Background Patient-specific CT-based instrumentation may reduce implant malpositioning and improve alignment in TKA . However , it is not known whether this innovation is an advance that benefits patients . Questions / purpose sWe evaluated ( 1 ) the precision of patient-specific TKA by comparing the incidence of outliers in postoperative alignment between TKAs using patient-specific instruments and TKAs using conventional instruments , and ( 2 ) the reliability of patient-specific instruments by intraoperatively investigating whether the surgery could be completed with patient-specific instruments alone . Methods In this r and omized controlled trial , we compared patient-specific TKA instruments from one manufacturer ( n = 50 ) with conventional TKA instruments ( n = 50 ) . Postoperative hip-knee-ankle angles , femoral component rotation , and coronal and sagittal alignments of each component were measured . The validity of the patient-specific instrument was examined using cross-checking procedures with conventional instruments during the surgeries . When the procedure could not be completed accurately with patient-specific instruments , the procedure was converted to TKA using conventional instruments , and the frequency of this occurrence was tallied . Results Outliers in the hip-knee-ankle angle were comparable between groups ( 12 % in the patient-specific instrument group and 10 % in the conventional instrument group ) . Other parameters such as sagittal alignment and femoral component rotation did not differ in terms of outliers . Patient-specific guides were ab and oned in eight knees ( 16 % ) during the surgery because of malrotation of the femoral components and decreased slope of the tibia . Conclusions Accuracy was comparable between TKAs done with patient-specific instruments and those done with conventional instruments . However , the patient-specific instrument procedures had to be aborted frequently , incurring expenses that did not benefit patients .Level of Evidence Level II , therapeutic study . See Instructions for Authors for a complete description of levels of evidence"
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4117e466-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE This article review ed the literature to clarify the physiological effects and benefits of , and misconceptions about , stretches used to reduce musculoskeletal disorders . METHODS Nine data bases were review ed to identify studies exploring the effectiveness of stretching to prevent work-related musculoskeletal disorders . Included studies were review ed and their method ological quality was assessed using the PEDro scale . RESULTS The physiological effects of stretches may contribute to reducing discomfort and pain . However , if other measures are not in place to remediate their causes , stretches may suppress awareness of risks , result ing in more debilitating injuries . If inadequately performed , stretches may also cause or aggravate injuries . Careful analysis and stretching program design are required before implementing stretches . Seven studies evaluating the effectiveness of stretching to prevent musculoskeletal disorders in different occupations were identified and review ed . CONCLUSION The studies provided mixed findings , but demonstrated some beneficial effect of stretching in preventing work-related musculoskeletal disorders . However , due to the relatively low method ological quality of the studies available in the literature , future studies are necessary for a definite response . Future studies should minimize threats to internal and external validity , have control groups , use appropriate follow-up periods , and present a more detailed description of the interventions and worker population
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"BACKGROUND AND PURPOSE Frequency and duration of static stretching have not been extensively examined . Additionally , the effect of multiple stretches per day has not been evaluated . The purpose of this study was to determine the optimal time and frequency of static stretching to increase flexibility of the hamstring muscles , as measured by knee extension range of motion ( ROM ) . SUBJECTS Ninety-three subjects ( 61 men , 32 women ) ranging in age from 21 to 39 years and who had limited hamstring muscle flexibility were r and omly assigned to one of five groups . The four stretching groups stretched 5 days per week for 6 weeks . The fifth group , which served as a control , did not stretch . METHODS Data were analyzed with a 5 x 2 ( group x test ) two-way analysis of variance for repeated measures on one variable ( test ) . RESULTS The change in flexibility appeared to be dependent on the duration and frequency of stretching . Further statistical analysis of the data indicated that the groups that stretched had more ROM than did the control group , but no differences were found among the stretching groups . CONCLUSION AND DISCUSSION The results of this study suggest that a 30-second duration is an effective amount of time to sustain a hamstring muscle stretch in order to increase ROM . No increase in flexibility occurred when the duration of stretching was increased from 30 to 60 seconds or when the frequency of stretching was increased from one to three times per day",
"BACKGROUND AND PURPOSE Little research has been done regarding the attitudes and behaviors of physical therapists relative to the use of evidence in practice . The purpose s of this study were to describe the beliefs , attitudes , knowledge , and behaviors of physical therapist members of the American Physical Therapy Association ( APTA ) as they relate to evidence -based practice ( EBP ) and to generate hypotheses about the relationship between these attributes and personal and practice characteristics of the respondents . METHODS A survey of a r and om sample of physical therapist members of APTA result ed in a 48.8 % return rate and a sample of 488 that was fairly representative of the national membership . Participants completed a question naire design ed to determine beliefs , attitudes , knowledge , and behaviors regarding EBP , as well as demographic information about themselves and their practice setting s. Responses were summarized for each item , and logistic regression analyses were used to examine relationships among variables . RESULTS Respondents agreed that the use of evidence in practice was necessary , that the literature was helpful in their practice s , and that quality of patient care was better when evidence was used . Training , familiarity with and confidence in search strategies , use of data bases , and critical appraisal tended to be associated with younger therapists with fewer years since they were licensed . Seventeen percent of the respondents stated they read fewer than 2 articles in a typical month , and one quarter of the respondents stated they used literature in their clinical decision making less than twice per month . The majority of the respondents had access to online information , although more had access at home than at work . According to the respondents , the primary barrier to implementing EBP was lack of time . DISCUSSION AND CONCLUSION Physical therapists stated they had a positive attitude about EBP and were interested in learning or improving the skills necessary to implement EBP . They noted that they needed to increase the use of evidence in their daily practice",
"Computer operators at two work sites ( n = 73 , n = 19 ) were prompted to take three 30-s and one 3-min break from computer work each hour in addition to conventional rest breaks . Some operators were asked to perform stretching exercises during the short breaks . Mood state and musculoskeletal discomfort were assessed at each work site over a 2- or 3-week baseline period and a 4- or 6-week treatment period , respectively . Operator productivity measures were obtained from company records . Operators complied with about half of the added breaks but favoured 3-min breaks over 30-s breaks . No improvement in productivity or well-being was found at the larger work site . At the smaller work site , productivity , eye , leg and foot comfort all improved when the short breaks included stretching exercises . These results provide evidence that frequent short breaks from continuous computer-mediated work can benefit worker productivity and well-being when the breaks integrate with task dem and",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"The purpose of this intervention study was to prove that increasing flexibility of the hamstring musculotendinous unit would decrease the number of lower extremity overuse injuries that occur in military infantry basic trainees . Two different companies going through basic training at the same time were used . Hamstring flexibility was checked at the beginning and at the end of the 13-week infantry basic training course . The control company ( N 148 ) proceeded through normal basic training . The intervention company ( N 150 ) followed the same program but added three hamstring stretching sessions to their already scheduled fitness program . All subsequent lower extremity overuse injuries were recorded through the troop medical clinic . Hamstring flexibility increased significantly in the intervention group compared with the control group . The number of injuries was also significantly lower in the intervention group . Forty-three injuries occurred in the control group for an incidence rate of 29.1 % , compared with 25 injuries in the intervention group for an incidence rate of 16.7 % . Thus , in this study , the number of lower extremity overuse injuries was significantly lower in infantry basic trainees with increased hamstring flexibility",
"This prospect i ve study was design ed to evaluate whether static stretching can prevent training-related injuries in Japan Ground Self-Defense Force military recruits . A total of 901 recruits between 1996 and 1998 were divided into two groups . Of which , 518 recruits were assigned to the stretching group and practice d static stretching before and after each physical training session . The control subjects ( 383 recruits in the nonstretching group ) did not stretch statically prior to exercise . The static stretching consisted of 18 exercises . We collected injury data from medical records and assessed the incidence and the location of injury . The total injury rate was almost the same between two groups ; however , the incidences of muscle/tendon injury and low back pain were significantly lower in the stretching group ( p Static stretching decreased the incidence of muscle-related injuries but did not prevent bone or joint injuries",
"OBJECTIVE To examine electromyography ( EMG ) activity , passive torque , and stretch perception during static stretch and contract-relax stretch . DESIGN Two separate r and omized crossover protocol s : ( 1 ) a constant angle protocol on the right side , and ( 2 ) a variable angle protocol on the left side . SUBJECTS 10 male volunteers . INTERVENTION Stretch-induced mechanical response in the hamstring muscles during passive knee extension was measured as knee flexion torque ( Nm ) while hamstring surface EMG was measured . Final position was determined by extending the knee to an angle that provoked a sensation similar to a stretch maneuver . Constant angle stretch : The knee was extended to 10 degree below final position , held 10sec , then extended to the final position and held for 80 sec. Variable angle stretch : The knee was extended from the starting position to 10 degrees below the final position , held 10sec , then extended to the onset of pain . Subjects produced a 6-sec isometric contraction with the hamstring muscles 10 degrees below the final position in the contract-relax stretch , but not in the static stretch . MAIN OUTCOME MEASURES Passive torque , joint range of motion , velocity , and hamstring EMG were continuously recorded . RESULTS Constant angle contract-relax and static stretch did not differ in passive torque or EMG response . In the final position , passive torque declined 18 % to 21 % in both contract-relax and static stretch ( p EMG activity was unchanged . In the variable angle protocol , maximal joint angle and corresponding passive torque were significantly greater in contract-relax compared with static stretch(p EMG did not differ . CONCLUSION At a constant angle the viscoelastic and EMG response was unaffected by the isometric contraction . The variable angle protocol demonstrated that PNF stretching altered stretch perception"
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4117e4a2-06ff-11f0-808a-c43d1ab1c353
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CONTEXT : Numerous faces scales have been developed for the measurement of pain intensity in children . It remains unclear whether any one of the faces scales is better for a particular purpose with regard to validity , reliability , feasibility , and preference . OBJECTIVES : To summarize and systematic ally review faces pain scales most commonly used to obtain self-report of pain intensity in children for evaluation of reliability and validity and to compare the scales for preference and utility . METHODS : Five major electronic data bases were systematic ally search ed for studies that used a faces scale for the self-report measurement of pain intensity in children . Fourteen faces pain scales were identified , of which 4 have undergone extensive psychometric testing : Faces Pain Scale ( FPS ) ( scored 0–6 ) ; Faces Pain Scale – Revised ( FPS-R ) ( 0–10 ) ; Oucher pain scale ( 0–10 ) ; and Wong-Baker Faces Pain Rating Scale ( WBFPRS ) ( 0–10 ) . These 4 scales were included in the review . Studies were classified by using psychometric criteria , including construct validity , reliability , and responsiveness , that were established a priori . RESULTS : From a total of 276 articles retrieved , 182 were screened for psychometric evaluation , and 127 were included . All 4 faces pain scales were found to be adequately supported by psychometric data . When given a choice between faces scales , children preferred the WBFPRS . Confounding of pain intensity with affect caused by use of smiling and crying anchor faces is a disadvantage of the WBFPRS . CONCLUSIONS : For clinical use , we found no grounds to switch from 1 faces scale to another when 1 of the scales is in use . For research use , the FPS-R has been recommended on the basis of utility and psychometric features . Data are sparse for children below the age of 5 years , and future research should focus on simplified measures , instructions , and anchors for these younger children
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"PURPOSE We determined if a difference in pain management occurred when topical anesthetics LMX ( formerly ELA-Max , lidocaine 4 % ) and EMLA ( lidocaine 2.5 % and prilocaine 2.5 % ) were compared in boys undergoing office meatotomy for symptomatic meatal stenosis . MATERIAL S AND METHODS A prospect i ve r and omized study was performed on 52 boys who underwent office meatotomy by a single pediatric urologist . Of the boys 26 , 2 to 9 years old ( mean age 4.4 ) underwent meatotomy 45 minutes after topical anesthetic application ( LMX 13 , EMLA 13 ) between February and December 2001 , 26 , ages 1 to 10 years old ( 4.6 ) underwent meatotomy 30 minutes after topical anesthetic application ( LMX 13 , EMLA 13 ) between April 2002 and January 2003 . A single pediatric urological nurse performed pain assessment using the Wong-Baker Faces scale before applying the anesthetic ointment and immediately following the procedure . Each child had either LMX or EMLA applied and covered with an occlusive dressing for either 45 or 30 minutes before the procedure . Oral acetaminophen ( 10 mg/kg ) was given at the time of anesthetic application . A meatotomy was then performed using a straight crushing hemostat for 1 to 2 minutes followed by incision . Mann-Whitney rank sum test was implemented to determine statistical significance . RESULTS Excellent procedure outcomes were experienced by all patients without recurrent meatal stenosis . CONCLUSIONS There was no significant difference between LMX and EMLA when applied 45 minutes before meatotomy . When applied 30 minutes before meatotomy LMX provided significantly superior pain management than EMLA",
"Objective : To examine if observational pain assessment can be used for purpose s of triage in children aged > 3 years . Methods : A prospect i ve , single blind , controlled trial was undertaken in children who presented to the emergency department ( ED ) with pain . Pain was assessed in the waiting room and again at triage before any treatment was administered using the Alder Hey Triage Pain Score ( AHTPS ) , an observational tool design ed for triage , and a self-report tool , either the Wong-Baker Faces Pain Rating Scale ( WBS ) for 3–7-year-old children or a visual analogue scale ( VAS ) for 8–15-year-old children . Scores were compared by instrument ( observational and self-report ) and ED location ( waiting room and triage room ) . Results : 75 children ( 29 aged 3–7 years and 46 aged 8–15 years ) were enrolled in the study . The AHTPS scores were significantly lower than the scores measured by the WBS/VAS ( p The level of pain measured by both methods ( self-report , observational ) was lower in the triage room . Compared with the AHTPS , the WBS and VAS scored significantly lower in the triage room than in the waiting room ( p Observational pain assessment underestimates children ’s perception of pain and should not be recommended in children aged > 3 years . Triage has a calming effect on children",
"Background To determine whether healthcare professionals perceive the pain of infants differently due to their underst and ing of that infant 's level of risk for neurological impairment . Method Neonatal Intensive Care Units ( NICU 's ) at two tertiary pediatric centers . Ninety-five healthcare professionals who practice in the NICU ( 50 nurses , 19 physicians , 17 respiratory therapists , 9 other ) participated . They rated the pain ( 0–10 scale and 0–6 Faces Pain Scale ) , distress ( 0–10 ) , effectiveness of cuddling to relieve pain ( 0–10 ) and time to calm without intervention ( seconds ) for nine video clips of neonates receiving a heel stick . Prior to each rating , they were provided with descriptions that suggested the infant had mild , moderate or severe risk for neurological impairment . Ratings were examined as a function of the level of risk described . Results Professionals ' ratings of pain , distress , and time to calm did not vary significantly with level of risk , but ratings of the effectiveness of cuddling were significantly lower as risk increased [ F ( 2,93 ) = 4.4 , p = .02 ] . No differences in ratings were found due to participants ' age , gender or site of study . Physicians ' ratings were significantly lower than nurses ' across ratings . Conclusion Professionals provided with visual information regarding an infants ' pain during a procedure did not display the belief that infants ' level of risk for neurological impairment affected their pain experience . Professionals ' estimates of the effectiveness of a nonpharmacological intervention did differ due to level of risk",
"Conclusion . Mepivacaine applied in the epipharyngeal space as an adjuvant local anaesthetic does not reduce postoperative pain after adenoidectomy in children given high-dose paracetamol preoperatively . Objective . To evaluate the pain-reducing effect of an adjuvant local anaesthetic ( mepivacaine ) applied in the epipharyngeal space after outpatient adenoidectomy . Material and methods . This was a prospect i ve , r and omized , double-blind , placebo-controlled trial . Postoperative pain was assessed in 98 children aged 3–10 years using a visual analogue scale ( VAS ) and the Wong – Baker FACES pain rating scale . The time between the end of surgery and discharge from hospital was recorded , as well as the need for extra pain medication in addition to the high-dose paracetamol ( acetaminophen ) that had been given preoperatively . Serum levels of mepivacaine were analysed in 10 consecutive patients . Results . No difference was seen between the mepivacaine and control groups regarding postoperative pain as estimated using either the VAS or the Wong – Baker FACES pain rating scale . There were also no differences between the groups concerning the time to discharge from hospital and the need for extra pain medication before discharge . No mepivacaine could be detected in the patients ’ sera",
"Background : Nausea , vomiting and pain are common complications after strabismus surgery in children . Diclofenac , a non‐steroid anti‐inflammatory drug , is widely used to treat acute and chronic pain but there are few reports of its use given rectally in children undergoing strabismus surgery . This open r and omised study was design ed to investigate the analgesic and anti‐emetic properties of rectally administered diclofenac compared with opioid ( morphine ) given i.v . in connection with strabismus surgery in children",
"BACKGROUND AND AIMS The multiplicity of vaccine injections during childhood leads to iterative painful and stressful experiences which may lead in turn to anticipated pain and then possibly to a true needle phobia . We aim ed at evaluating a multifactorial strategy of pain management combining pharmacological and non-pharmacological approaches during vaccination , as compared to usual care , in 4- to 12-year-old children . METHODS In all , 239 children were enrolled by 25 family practitioners in an open-label study . After a pseudo-r and omization , usual pain management ( n = 132 ) was compared to a multifactorial strategy ( n = 107 ) associating preliminary application of an anesthesic patch , preferential use of specified vaccines , child education by the parents and the doctor , parental accompaniment and child distraction with soap bubbles during the procedure . The primary outcome ( i.e. child pain ) was assessed with a self-report scale named visual analog scale ( VAS ) of pain . RESULTS A significant decrease in pain was obtained using the multifactorial strategy , as assessed by self-reported VAS ( P facial pain scale revised : P = 0.005 ) , as well as with hetero-evaluations by GPs and parents [ Children 's Hospital of Eastern Ontario Pain Scale : P = 0.0007 ; GPs VAS ( P parents VAS ( P pain in 4- to 12-year-old children . This strategy could make vaccines more acceptable to children and may improve child-doctor relationships and contribute to a decrease in child fear about health care",
"Background . Lidocaine – prilocaine cream ( EMLA ) is currently st and ard therapy to alleviate procedural pain in children . One of the disadvantages of lidocaine – prilocaine is the need to wait for 60 minutes for adequate skin anesthesia . Amethocaine gel ( Ametop ) is a new topical anesthetic that requires a shorter application time for skin anesthesia . Objectives . To compare the relative efficacy and safety of amethocaine gel and lidocaine – prilocaine cream in children with cancer undergoing Port-a-Cath puncture and to determine which patient factors influence judgments about pain . Methods . R and omized , blinded , crossover study . Each child received either 1 g of amethocaine gel for 30 minutes , preceded by a placebo gel for 30 minutes , or 1 g of lidocaine – prilocaine cream for 60 minutes . Children rated the pain using the faces scale , for which scores ranged from 0 to 5 . Parents and attending nurse operators rated pain on a 10-cm visual analog scale . Results . Thirty-nine children participated . The mean age was 10.2 years ( range : 5–16 years ) , and 69 % were male . There were no differences in mean pain assessment s between amethocaine and lidocaine – prilocaine as rated by the children ( 2.0 vs 0.5 ) , parents ( 2.6 vs 6.4 ) , or nurse operators ( 2.0 vs 0.9 ) . No serious adverse effects were detected with either preparation . Pain scores assigned by parents and children were not influenced by age , gender , duration of diagnosis , or anesthetic regimen ( amethocaine versus lidocaine – prilocaine ) in the child . Nurses , however , rated pain higher for younger children , and in males during pretreatment with lidocaine – prilocaine . Conclusion . Amethocaine achieves similar anesthesia to lidocaine – prilocaine during Port-a-Cath administration in children , with an application time that is half of lidocaine – prilocaine . Pain assessment s were not influenced by age , gender , or duration of diagnosis of the child . Nurses may perceive that pain is greater for younger children and in males . lidocaine – prilocaine , amethocaine , pain , children , Port-a-Cath puncture",
"Objective : Acute otitis media ( AOM ) is common in children , yet the optimal management of ear pain associated with AOM has not been well studied . We set out to determine the efficacy of topical aqueous 2 % lignocaine eardrops compared with a placebo ( saline ) for pain relief of AOM in children . Design : Double-blind , r and omised , placebo-controlled trial . Setting : Tertiary children ’s hospital emergency department . Patients and interventions : Children aged between 3 and 17 years with earache and AOM without evidence of perforation were eligible . Patients were r and omised to receive either 2 % lignocaine or saline eardrops ( placebo ) . Main outcome measures : Pain scores were measured before and after ear-drop administration . Patient and physician-interpreted pain scores were measured by using the Bieri faces pain scale and visual analogue scale at 10 , 20 and 30 minutes . The primary outcome measure was reduction in patient-measured pain scores by 50 % from the baseline . Secondary outcome measures were reduction in patient- measured pain scores by 25 % or by at least two points . Telephone follow-up occurred after 1 day and 1 week . Analysis was by intention to treat . Results : 63 children ( 31 were treated with lignocaine , 32 with placebo ) aged 3 to 12 years were enrolled . The groups were demographically and clinical ly similar , with similar proportions having received analgesia in the preceding 4 hours . Children receiving lignocaine showed significantly lower patient-measured pain scores with a reduction by 50 % from baseline at 10 minutes ( RR 2.06 , 95 % CI 1.03–4.11 , p = 0.03 ) and 30 minutes ( RR 1.44 , 95 % CI 1.07–1.93 , p = 0.009 ) but not at 20 minutes ( RR 1.35 95 % CI 0.88–2.06 ) . The response to lignocaine treatment showed significantly lower patient-measured pain scores for 25 % reduction at all time points and for two-point reduction at 10 minutes and favoured lignocaine at 20 minutes and 30 minutes without reaching statistical significance . There were no serious adverse events during the 30 minute follow-up period . Conclusion : This study suggests that topical aqueous 2 % lignocaine eardrops provide rapid relief for many young children presenting with ear pain attributed to AOM . The concurrent use of simple oral analgesia is a likely contributor to effective management of this painful childhood condition",
"OBJECTIVE To determine the construct , content , and convergent validity of 2 self-report pain scales for use in the untrained child in the emergency department ( ED ) . METHODS A prospect i ve study was conducted of all children who presented to an urban ED between 5 and 16 years of age inclusive after written informed consent was obtained . Children were excluded if they were intoxicated , had altered sensorium , were clinical ly unstable , did not speak English , or had developmental delays . Children marked their current pain severity on a st and ardized Color Analog Scale ( CAS ) and a 7-point Faces Pain Scale ( FPS ) . They were then asked whether their pain was mild , moderate , or severe . Children were then administered an analgesic at the discretion of the attending physician and asked to repeat these measurements . For assessing content validity , the scales were also administered to age- and gender-matched children in the ED for nonpainful conditions . Convergent validity was assessed by determining the Spearman correlation coefficient between the 2 pain scales . RESULTS A total of 60 children were enrolled , 30 with pain and 30 without , with a mean age of 9.3 + /- 3.3 years . Boys accounted for 38 of the enrollees ( 63.3 % ) . The median score before analgesic administration was 6.0 cm ( interquartile range [ IQR ] : 4.0 - 8.0 ) on the CAS and 3.0 faces ( IQR : 2.0 - 5.0 ) on the FPS ; after analgesic administration , the median scores decreased to 3.1 cm ( IQR : 1.1 - 4.3 ) and 2.0 faces ( IQR : 1.0 - 3.0 ) , respectively . As the reported pain intensity increased , so did the scores on the 2 pain scales . The 30 children with no pain had a median score on the CAS of 0.0 ( IQR : 0.0 - 1.0 ) and on the FPS of 0.0 ( IQR : 0.0 - 1.0 ) , whereas the 13 children with severe pain had a median CAS of 7.0 ( IQR : 6.0 - 8.0 ) and a median FPS of 5.0 ( IQR : 4.0 - 6.0 ) . The Spearman correlation coefficient between the CAS and the FPS was positive and strong ( r = 0.894 ) . CONCLUSION The CAS and the FPS exhibit construct , content , and convergent validity in the measurement of acute pain in children in the ED",
"OBJECTIVES Children view needle sticks as the worst source of pain and fear in the hospital setting . In an effort to minimize the pain of needle sticks , the use of eutectic mixture of lidocaine and prilocaine ( EMLA ) has become st and ard practice in many children 's hospitals . Unfortunately , EMLA requires at least 60 minutes to be fully effective and reportedly may cause vasoconstriction , leading to difficult vein cannulation . A newly available local anesthetic ( ELA-Max ) may require less time and cause less vasoconstriction . The purpose of this r and omized crossover study was to investigate the anesthetic equivalence of EMLA and ELA-Max . METHODS Thirty well children ( 14 girls and 16 boys ) who were between the ages of 7 and 13 years volunteered to have EMLA applied to the dorsal aspect of 1 h and for 60 minutes and ELA-Max applied to the other h and for 30 minutes . Right and left h and s were r and omized to treatment type and order of intravenous ( IV ) insertion . Clinical Research Center nurses , blind to the anesthetic r and omization , attempted to insert a 22-gauge Teflon IV catheter into a vein in each h and . The children rated pain during IV insertion on the Oucher scale , and the nurse rated the difficulty of the insertion . RESULTS There was no significant difference in pain ratings for h and s that were treated with EMLA ( mean : 20.5 ) or with ELA-Max ( mean : 24 ) , and there was no difference for the difficulty of vein cannulation . Children 's preprocedure state anxiety was positively associated with pain ratings . CONCLUSIONS ELA-Max , applied for 30 minutes before IV cannulation , has an anesthetic effectiveness similar to EMLA applied for 60 minutes . Some children rated IV insertion pain fairly high for both h and s ( eg , 60 on a 0- to 100-point scale ) despite anesthetic treatment . Preprocedural anxiety may affect the perception and /or rating of pain . There were no differences between h and s that were treated with EMLA or with ELA-Max for success of IV insertion",
"& NA ; The efficacy of ketorolac , a non‐steroidal anti‐inflammatory drug , in the management of moderate to severe pain in adults , has led us to conduct a trial of this analgesic in children following tonsillectomy . Children were r and omized to receive intramuscular ( i.m . ) ketorolac ( 1 mg/kg , EXP group , n = 45 ) or saline ( CTL group , n = 42 ) at the completion of surgery . Intravenous ( i.v . ) fentanyl ( 0.5 & mgr;g/kg/dose ) was administered in repeated doses postoperatively . Pain intensity was measured using both the Oucher and the Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) to allow for comparison between self‐report and behavioral measures of pain intensity . Severity of postoperative bleeding was measured using a 4‐point rating scale . The EXP group had a significant reduction in total fentanyl dose ( mean : 35.9 & mgr;g ) compared to the CTL group ( mean : 48.3 & mgr;g , t = −2.21 , P in pre‐fentanyl CHEOPS scores in the Post‐Anesthesia Care Unit ( PACU ) in the ketorolac group ( F ( 2,30 ) = 5.34 , P 0.05 ) . In the first hour postoperatively , the CHEOPS demonstrated significant decreases in pain intensity scores in response to opioids , in both groups . In the PACU , children were unable to provide a self‐report of pain intensity potentially due to a variety of factors ( e.g. , emergence delirium , agitation , excitement , sedation , and /or pain ) . However , during the remainder of the postoperative stay , the photographic scale of the Oucher was a more valid measure of pain intensity than the CHEOPS . There were no differences between the 2 groups in the severity of postoperative bleeding . Children in the EXP group were discharged significantly earlier ( i.e. , 30 min , t = −2.22 , P of ketorolac , at the end of surgery , significantly reduces opioid requirements and shortens length of stay without any evidence of increased bleeding . In addition , our data suggest that the patient 's altered level of consciousness and attention span may diminish the utility of self‐report measures of pain intensity in the immediate postoperative period",
"The objective of this study was to test the efficacy and suitability of virtual reality ( VR ) as a pain distraction for pediatric intravenous ( i.v . ) placement . Twenty children ( 12 boys , 8 girls ) requiring i.v . placement for a magnetic resonance imaging/computed tomography ( MRI/CT ) scan were r and omly assigned to two conditions : ( 1 ) VR distraction using Street Luge ( 5DT ) , presented via a head-mounted display , or ( 2 ) st and ard of care ( topical anesthetic ) with no distraction . Children , their parents , and nurses completed self-report question naires that assessed numerous health-related outcomes . Responses from the Faces Pain Scale-Revised indicated a fourfold increase in affective pain within the control condition ; by contrast , no significant differences were detected within the VR condition . Significant associations between multiple measures of anticipatory anxiety , affective pain , i.v . pain intensity , and measures of past procedural pain provided support for the complex interplay of a multimodal assessment of pain perception . There was also a sufficient amount of evidence supporting the efficacy of Street Luge as a pediatric pain distraction tool during i.v . placement : an adequate level of presence , no simulator sickness , and significantly more child- , parent- , and nurse-reported satisfaction with pain management . VR pain distraction was positively endorsed by all reporters and is a promising tool for decreasing pain , and anxiety in children undergoing acute medical interventions . However , further research with larger sample sizes and other routine medical procedures is warranted",
"STUDY OBJECTIVE To investigate the time of administration and concentration of inhaled nitrous oxide ( N(2)O ) needed to reduce the pain associated with intravenous ( i.v . ) cannulation in children . DESIGN Prospect i ve , r and omized study . SETTING Operating room of a children 's hospital . PATIENTS 73 ASA physical status I and II children , aged 6 - 15 years , scheduled for elective day or non-day surgery . INTERVENTIONS Children were r and omly allocated to one of 4 groups prior to i.v . insertion of a 24-gauge catheter in the dorsum of the h and : Group 1 ( n = 18 ) : 50 % N(2)O in O(2 ) for three minutes ; Group 2 ( n = 18 ) : 50 % N(2)O in O(2 ) for 5 minutes ; Group 3 ( n = 18 ) : 70 % N(2)O in O(2 ) for three minutes ; or Group 4 ( n = 19 ) : 70 % N(2)O in O(2 ) for 5 minutes . MEASUREMENTS Just after the venous cannulation , degree of pain was assessed by examining the faces of the patient by the parent and an operating room nurse . MAIN RESULTS Pain scores obtained from parents of children in Groups 3 and 4 were significantly lower than from those in Groups 1 and 2 . Pain scores from the nurse in Group 3 was significantly lower than those in Group 1 . However , there was no significant difference in pain score between Group 3 and Group 4 . Frequency of side effects was similar among the 4 groups . CONCLUSIONS Seventy percent N(2)O in O(2 ) given for three minutes was effective for reducing venipuncture pain in children",
"Local anesthesia by injection in pediatric patients undergoing dermatologic procedures is not well received because of the pain of injection and the fear of needles . Lidocaine iontophoresis is a method of topical anesthesia where lidocaine is driven into the skin under the influence of electric current . We performed a prospect i ve double-blind , placebo-controlled evaluation of iontophoresis of 2 % lidocaine with 1:100,000 epinephrine . Sixty children requiring dermatologic procedures were enrolled ( 50 shave biopsy , 7 curettage , 2 injection , 1 punch biopsy ) . Twenty-nine of 31 patients in the lidocaine group versus 2 of 29 placebo patients required no supplemental anesthesia ( p pain reported by the patients on the Oucher pain scale subsequent to the procedure was significantly lower in the lidocaine group ( p pain lower in the lidocaine group ( p Blanching and /or erythema occurred in 58 of 60 patients , but resolved within 1 hour in all patients . There were no other adverse events . Lidocaine iontophoresis is a safe and effective method of topical anesthesia prior to dermatologic procedures in children",
"INTRODUCTION The purpose of this study was to compare the efficacy of two methods of topical anesthesia before venipuncture or intravenous cannulation of pediatric patients to assess which type of topical anesthetic would better alleviate pain in the least amount of time with the greatest success rate of cannulation . METHODS This study was a r and omly controlled trial of 100 preoperative pediatric patients aged 5 to 21 years . The following methods of topical anesthesia were compared : ( a ) iontophoresis of a topical solution of 2 % lidocaine with epinephrine 1:100,000 using a Phoresor Dose Controller ( PDC ) with Numby Stuff electrodes and a eutectic mixture of local anesthetic and ( b ) 2.5 % lidocaine and 2.5 % prilocaine ( eutectic mixture of local anesthetics [ EMLA ] cream ) . RESULTS Children reported less pain with iontophoresis ( M = 0.08 ) compared with EMLA cream ( M = 1.88 , P Time to accomplish topical anesthesia was shorter with iontophoresis ( 13 minutes ) compared with EMLA cream ( 60 minutes , P Failure to accomplish venipuncture occurred 5 times with the iontophoresis method and 8 times with the EMLA method ( not significant ) . No dermal burns result ed from use of iontophoresis . DISCUSSION We conclude that use of iontophoresis in pediatric patients is safe , rapid , and significantly more effective than is EMLA cream in reducing pain associated with venipuncture or intravenous cannulation",
"This analysis of retrospective and prospect i ve data quantified children ( age range 0 - 18 years , total n = 132 ) during their stay in a cardiothoracic intensive care unit and examined pain management and sedation practice s. Data on both factors that could potentially affect pain and its management , and analgesics/sedatives ordered for and administered to subjects were collected from chart review . In the prospect i ve group , pain intensity was measured twice daily using the Wong-Baker FACES Pain Rating Scale . Repeat cardiac surgical procedure subjects reported significantly more pain than nonrepeat subjects on the first postoperative night . Subjects with sternal incisions reported significantly more pain than subjects with submammary incisions . Not all subjects were premedicated with analgesia for invasive procedures . Significantly greater amounts of analgesia were received by the 0 - 3 year-old subjects . Large amounts of sedation were used , especially in children under 3 years of age . The results prompted development of a nursing st and ard to assess and manage pain and sedation in this population",
"BACKGROUND Intraosseous ( IO ) anaesthesia has been shown to be effective in children . However , the pain associated with anaesthetic injections , and its acceptance by children , have never been studied . AIM The aim of this study was to assess the pain associated with the IO injection of 4 % articaine with 1 : 200 000 epinephrine using the computerized QuickSleeper ' system in a population of children and adolescents . DESIGN IO anaesthesia was performed on patients aged 10.4 + /- 2.6 years of age . The patients assessed their pain on a faces pain scale ( FPS ) and on a visual analogue scale ( VAS ) . The operators were also asked to assess signs of patient pain/discomfort . RESULTS No pain or mild discomfort was reported by , respectively , 81.8 % ( FPS ) and 83.9 % ( VAS ) of the patients . Some 58.9 % of children with previous experience of dental anaesthesia reported that computerized IO anaesthesia was more comfortable than traditional infiltration methods . Operators noted signs of discomfort during penetration and injection in 18.3 % and 25.3 % of the patients , respectively . CONCLUSIONS This study showed that the majority of children reported no pain or mild pain when anaesthetic was administered by computerized needle rotation and solution deposition . This technique holds promise for use by trained paediatric dentists ",
"This study was part of a project to improve pain assessment and management for a multiethnic group of children . Based on its visual appeal for the clinical team , the Oucher was selected for trial . A reduced size and shortened screening technique were introduced . Children ( N = 79 ) aged 3 to 12 years were r and omly assigned to use the original or a reduced-size Oucher first . Scale scores were highly correlated regardless of size or presentation order . There were no differences attributable to age , gender , or ethnicity ( Black , White , Hispanic ) . There is preliminary support for using the more convenient size and screening process",
"A prospect i ve controlled trial was conducted to compare the efficacy of an analgesic cream ( eutectic mixture of local anesthetics , or EMLA ) with a combination of EMLA with hypnosis in the relief of lumbar puncture-induced pain and anxiety in 45 pediatric cancer patients ( age 6 - 16 years ) . The study also explored whether young patients can be taught and can use hypnosis independently as well as whether the therapeutic benefit depends on hypnotizability . Patients were r and omized to 1 of 3 groups : local anesthetic , local anesthetic plus hypnosis , and local anesthetic plus attention . Results confirmed that patients in the local anesthetic plus hypnosis group reported less anticipatory anxiety and less procedure-related pain and anxiety and that they were rated as demonstrating less behavioral distress during the procedure . The level of hypnotizability was significantly associated with the magnitude of treatment benefit , and this benefit was maintained when patients used hypnosis independently",
"OBJECTIVE Pain is major problem regarding quality of life in children undergoing tonsillectomy . Preemptive analgesia by medicine given before commencement of surgery is a new way recommended for relief of pain during and after operation . The purpose in this study to evaluate preemptive efficacy and safety of lower dose of tramadol , which was recently introduced in children undergoing tonsillectomy . METHODS This study was performed on 45 children undergoing tonsillectomy with or without adenoidectomy as a double-blinded trial , by using tramadol in two dosages ( 1 and 0.5 mg kg(-1 ) ) and placebo . Pain assessment was done by facial pain score ( FPS ) , visual analog scale ( VAS ) and postoperative analgesic requirement ; further , duration of anesthesia and duration of awakening time , heart rate ( HR ) and mean arterial pressure ( MAP ) during and after anesthesia , postoperative nausea and vomiting ( PONV ) and recall of intraoperative events were recorded . RESULTS It was found that 73 % children in placebo group needed analgesic medicine at the end of the first hour after operation , although no analgesic medicine was needed in tramadol groups ( chi(2 ) test , P FPS and VAS in tramadol groups were only found up to 15th and 30th min after operation , respectively ( Kruskall-Wallis test , P intraoperative HR ( 10th , 20th and 30th min ) and MAP ( 10th and 20th min ) were found to be higher in placebo groups ( ANOVA variance analysis , Tukey-Kramer test adjusted paired t-test , P No significant difference was found in the other parameters , and no surgical complication and adverse side effect were occurred in this number of study sample . CONCLUSION Tramadol in lower doses ( 0.5 - 1 mg kg(-1 ) ) was an efficient preemptive analgesic that could be used at induction of anesthesia in adenotonsillectomies of children for providing both good analgesia during operation as supplementation to propofol anesthesia and postoperative analgesia in only early period",
"AIM Initial validation of ethyl chloride spray in minimising pain for children experiencing venepuncture in comparison to Ametop cream . DESIGN A r and omised non-inferiority cross-over trial comparing ethyl chloride with Ametop in 77 children aged five to 13 years undergoing measurement of glomerular filtration rate . Additional data were gathered on the child 's preferred choice for the third venepuncture . RESULTS Ethyl chloride spray is of equal preference to Ametop in children experiencing venepuncture , with lower self-reported pain score . It should be considered as an added alternative option to topical anaesthetic but further work is needed to clarify application technique",
"OBJECTIVES The Wong-Baker FACES Pain Rating Scale ( WBS ) , used in children to rate pain severity , has been vali date d outside the emergency department ( ED ) , mostly for chronic pain . The authors vali date d the WBS in children presenting to the ED with pain by identifying a corresponding mean value of the visual analog scale ( VAS ) for each face of the WBS and determined the relationship between the WBS and VAS . The hypothesis was that the pain severity ratings on the WBS would be highly correlated ( Spearman 's rho > 0.80 ) with those on a VAS . METHODS This was a prospect i ve , observational study of children ages 8 - 17 years with pain presenting to a suburban , academic pediatric ED . Children rated their pain severity on a six-item ordinal faces scale ( WBS ) from none to worst and a 100-mm VAS from least to most . Analysis of variance ( ANOVA ) was used to compare mean VAS scores across the six ordinal categories . Spearman 's correlation ( rho ) was used to measure agreement between the continuous and ordinal scales . RESULTS A total of 120 patients were assessed : the median age was 13 years ( interquartile range [ IQR ] = 10 - 15 years ) , 50 % were female , 78 % were white , and six patients ( 5 % ) used a language other than English at home . The most commonly specified locations of pain were extremity ( 37 % ) , abdomen ( 19 % ) , and back/neck ( 11 % ) . The mean VAS increased uniformly across WBS categories in increments of about 17 mm . ANOVA demonstrated significant differences in mean VAS across face groups . Post hoc testing demonstrated that each mean VAS was significantly different from every other mean VAS . Agreement between the WBS and VAS was excellent ( rho = 0.90 ; 95 % confidence interval [ CI ] = 0.86 to 0.93 ) . There was no association between age , sex , or pain location with either pain score . CONCLUSIONS The VAS was found to have an excellent correlation in older children with acute pain in the ED and had a uniformly increasing relationship with WBS . This finding has implication s for research on pain management using the WBS as an assessment tool",
"Objective : The experience of venipuncture is seen by children as one of the most fearful experiences during hospitalization . Children experience anxiety both before and during the procedure . Therefore , any intervention aim ing to prevent or reduce distress should focus on the entire experience of the procedure , including waiting , actual preparation , and conclusion . This study was design ed to determine whether the presence of musicians , who had attended specific training to work in medical setting s , could reduce distress and pain in children undergoing blood tests . Methods : Our sample population was composed of 108 unpremedicated children ( 4–13 years of age ) undergoing blood tests . They were r and omly assigned to a music group ( n = 54 ) , in which the child underwent the procedure while interacting with the musicians in the presence of a parent or to a control group ( n = 54 ) , in which only the parent provided support to the child during the procedure . The distress experienced by the child before , during and after the blood test was assessed with the Amended Form of the Observation Scale of Behavioral Distress , and pain experience with FACES scale ( Wong Baker Scale ) only after the venipuncture . Results : Our results show that distress and pain intensity was significantly lower ( p pain due to needle insertion",
"Objective The objective of this study was to explore the relation between the application of a mixture of lidocaine/prilocaine cream ( eutectic mixture of local anesthetics [ EMLA ] ) before intravenous cannula insertion and perceived pain in the pediatric patient . Design Double-blind placebo-controlled trial . Setting A general inpatient pediatric ward . Patients We examined 26 male and 31 female patients between the ages of 4 and 12 years who required intravenous cannula insertion . Intravenous insertion was performed on 57 patients , with 29 patients in the placebo group ( mean age , 8.1 years ) and 28 in the EMLA group ( mean age , 8.0 years ) . Interventions Application of either EMLA cream or placebo 45 minutes before intravenous cannulation . Outcome Measures Pain was scored by the patients using a 0-to 10-cm visual analogue scale combined with a Faces pain scale as well as visual observation by a nurse . Adverse side effects were recorded in a separate table . Results Data collected and the differences between the placebo and treated groups were tested using a Mann-Whitney U test . Those children in the EMLA group ( mean pain score , 1.25 ) experienced less pain than those in the placebo group ( mean , 8.39 ) . There was no statistical significance between age , sex , and race . Conclusions The authors conclude that a topical preparation of lidocaine/prilocaine significantly reduces children 's pain during intravenous cannula insertion when applied to an intact dermal layer of the skin and that this effect occurs within 45 minutes",
"This paper reports on the results of two studies conducted to further vali date the Abu-Saad Paediatric Pain Assessment Tool , a Dutch- language question naire developed to assess pain in school-age children . Children of 5 to 15 years of age reported in the first study their post-operative pain before and after the administration of analgesic medication using word descriptors of pain , the 10-cm scale , the Oucher , and a visual analogue scale ( VAS ) . Lower mean pain scores at 4-hourly intervals post-analgesia supported the construct validity of the tool . Convergent validity was supported in both studies when scores on all concurrently administered measures positively correlated with the pain tool . In the second study , the correlations between pain and fear , a concurrently used measure with the pain instruments , were low , substantiating the discriminant validity of the pain tool . The significance of the results in relation to instrument development and multidimensional pain assessment in children are further discussed and elaborated",
"Abstract Objective : To compare the effectiveness of nasal diamorphine spray with intramuscular morphine for analgesia in children and teenagers with acute pain due to a clinical fracture , and to describe the safety profile of the spray . Design : Multicentre r and omised controlled trial . Setting : Emergency departments in eight UK hospitals . Participants : Patients aged between 3 and 16 years presenting with a clinical fracture of an upper or lower limb . Main outcome measures : Patients ' reported pain using the Wong Baker face pain scale , ratings of reaction to treatment of the patients and acceptability of treatment by staff and parents , and adverse events . Results : 404 eligible patients completed the trial ( 204 patients given nasal diamorphine spray and 200 given intramuscular morphine ) . Onset of pain relief was faster in the spray group than in the intramuscular group , with lower pain scores in the spray group at 5 , 10 , and 20 minutes after treatment but no difference between the groups after 30 minutes . 80 % of patients given the spray showed no obvious discomfort compared with 9 % given intramuscular morphine ( difference 71 % , 95 % confidence interval 65 % to 78 % ) . Treatment administration was judged acceptable by staff and parents , respectively , for 98 % ( 199 of 203 ) and 97 % ( 186 of 192 ) of patients in the spray group compared with 32 % ( 64 of 199 ) and 72 % ( 142 of 197 ) in the intramuscular group . No serious adverse events occurred in the spray group , and the frequencies of all adverse events were similar in both groups ( spray 24.1 % v intramuscular morphine 18.5 % ; difference 5.6 % , -2.3 % to 13.6 % ) . Conclusion : Nasal diamorphine spray should be the preferred method of pain relief in children and teenagers presenting to emergency departments in acute pain with clinical fractures . The diamorphine spray should be used in place of intramuscular morphine",
"PURPOSE Pain is a frequent symptom of oral disease . It is difficult to measure , however , due to its subjectivity , especially among children . The purpose of this study was to verify the utility and applicability of a visual analogue scale of faces ( VASOF ) , adapted for 8- to 9-year-olds , to measure the severity of toothaches . METHODS A cross-sectional study was undertaken , which included 601 boys and girls r and omly selected from state and private schools in the city of Belo Horizonte , Minas Gerais , Brazil . They were interviewed and clinical ly examined , and a VASOF was applied . RESULTS The VASOF 's application revealed a high percentage of intense/very intense pain in the sample ( 39 % ) . The presence of this pain intensity was accompanied by a high incidence of children who cried , were awakened by the pain , and were unable to carry out habitual tasks . Furthermore , this severe pain was strongly associated with less-privileged economic groups and the presence of oral pathology ( P toothache severity experienced by school-age children",
"Various clinical protocol s are used to manage early postoperative tonsillectomy and /or adenoidectomy ( T&A ) pain in children . Although believed to be effective , these protocol s are not evidence d-based . Therefore , a double-blind , r and omized , placebo controlled ( 2 x 2 ) factorial design was used ( 1 ) to evaluate the effectiveness of 2 pain protocol s used interchangeably to manage early postoperative T&A pain and ( 2 ) to investigate whether nurses ' systematic pain assessment s improve pain management . In the first protocol children receive a loading dose ( 30 to 50 mg/kg ) of paracetamol ( acetaminophen ) Formularium der Nederl and se Apothekers ( Formulary of the Dutch Royal Society for the Advancement of Pharmacy ) intraoperatively , followed by regular doses ( 70 to 100 mg/kg/24 hours ) of paracetamol . In the second protocol children receive the first protocol , plus intramuscular fentanyl citrate ( 1 microgram/kg ) intraoperatively . Subjects were 83 healthy children between the ages of 3 and 12 years , admitted for T&A as an outpatient procedure . The child 's pain was measured using observation scales ( Children 's Hospital of Eastern Ontario Pain Scale and Face Legs Activity Cry Consolability Scale ) , a visual analogue scale , and self-report measures ( Faces Pain Scale and Oucher ) . Neither pain protocol sufficiently relieved early postoperative T&A pain , and systemic pain assessment s did not improve the effectiveness of analgesics . Further research evaluating the effectiveness of pain management protocol s is needed",
"Introduction : Ethyl chloride can be used as a cryoanalgesic , but with the availability of alternative and relatively safer topical analgesics , its use has decreased . However , it still has the advantage of being quicker to apply compared with other topical analgesics , making it ideal for use in the outpatient departments . We wanted to compare the effectiveness of ethyl chloride as an analgesic during venipuncture in children . Methods : Venipuncture was carried out using either no analgesia ( NO ) , ethyl chloride spray ( EC ) , or application of the topical anesthetic Ametop ( TA ) on children attending the phlebotomy outpatient service by experienced pediatric phlebotomists . A pain score was recorded using either the Faces scoring system or the Faces , Legs , Activity , Cry Consolability scoring system . Results : A total of 55 patients were included in the study , 18 from group EC , 18 from group TA , and 19 from group NO . Thirteen patients from both groups EC and TA and 17 from group NO scored 2 or less on the pain scores . Discussion : The use of ethyl chloride was as effective as topical anesthetics in preventing distress to children in venipuncture . However , in the appropriate situations , the use of NO could also be comfortable to the child if venipuncture was done by specialist pediatric phlebotomists",
"OBJECTIVE The main objective was to compare the utility of the Faces Pain Scale ( Bieri et al. , 1990 ) with three alternative self-report measures of pain intensity in children , as well as with pain ratings based on observations of the child 's behavior . DESIGN Fifty children used 4 self-report scales to rate the severity of needle pain from routine immunization . Using videotapes , the child 's pain-related behavior was coded in detailed fashion , and a subset of the sample were also rated globally by 60 registered pediatric nurses . MAIN OUTCOME MEASURES Faces Pain Scale ; Poker Chip Tool ; Visual Analogue Toy ; Verbal Rating Scale ; behavioral checklist ( scoring observable facial , motor , verbal and vocal reactions ) . RESULTS AND CONCLUSIONS The Faces Pain Scale was simple to use , readily understood by the children , and showed a realistic distribution of scores with respect to the type of pain being measured . With the exception of verbal reactions ( which were not meaningfully related to self-report ) , observer ratings based on detailed coding of the child 's behavior correlated only poorly to moderately well with self-report scores ( r = .39 to r = .58 ) . Similarly , although confident in their judgments , the nurses ' ratings showed only moderate agreement with those of the children . In estimating the child 's pain , all observers appeared to appropriately weigh changes in the child 's facial behavior , which showed evidence of being the most sensitive behavioral index to the intensity of short sharp ( needle ) pain in 4 to 6 years olds",
"In this double-blinded , r and omized , multicenter study , we examined analgesic efficacy and tolerability of tramadol in postoperative pediatric patients . Eighty-one postsurgical ASA physical status I and II patients ages 7–16 yr received oral tramadol ( approximately 1 or 2 mg/kg ) for postoperative analgesia when they were ready to transition from morphine patient-controlled analgesia to oral analgesics . Rescue analgesia consisted of morphine patient-controlled analgesia or an oral equivalent dose of oxycodone . Patients rated their pain just before the administration of tramadol and at regular intervals for 8 h afterwards using the Wong-Baker Faces Pain Rating Scale . The 2-mg/kg group required approximately half as much rescue analgesia as the 1-mg/kg group ( P = 0.006 ) . Parents rated the larger dose more favorably . Adverse events were generally mild to moderate in severity ( vomiting [ 10 % ] , nausea [ 9 % ] , pruritus [ 7 % ] , rash [ 4 % ] ) and similar between the two treatment groups . There were no significant changes in hemodynamic variables , respiratory rate , or Spo2 percentages between the two treatment groups or in all patients compared with pretreatment values",
"The purpose of this study was to determine if providing a sticker after a finger stick for hemoglobin check reduced pain perception among preschool-aged children . The hypothesis was : Sticker rewards influence the perception of pain as measured by the Oucher scale following a finger stick to check hemoglobin . Preschoolers from Headstart Centers in a southeastern city were recruited for the study . The age range of participants was between 3 and 5 years . The children were assigned r and omly into two groups : those receiving stickers ( Group I ) , and those not receiving a sticker ( Group II ) . Subsequently , each participant 's pain level was assessed using the Oucher scale within 1 minute of the finger stick . There was no statistically significant difference in pain scale ratings between the two groups when comparing whether or not a cartoon sticker was given t ( -.937 , df 128 , P = .351 ; 95 % confidence interval ) . This study was clinical ly significant in that nonpharmacological interventions were utilized in an attempt to reduce pain in young children . Future research should determine whether receiving rewards ( such as a cartoon sticker , adhesive b and ages , or small toys ) alone or in conjunction with distraction measures are efficacious in pain reduction in younger children",
"A total of 70 children between the ages of 3 and 6 years participated in two studies that tested the effect of ( a ) the sight of blood and ( b ) the application of a decorated adhesive b and age on pain intensity ratings following a fingerstick . In both studies , children were r and omly assigned to one of four groups . These groups allowed for the combinations of testing blood or no blood and the application of a decorated adhesive b and age or plain adhesive b and age . The Oucher ( Beyer , 1984 ) and the Poker Chip Tool ( Hester , 1979 ) were used as self-report measures of pain intensity at the time of the fingerstick and immediately after the application of the adhesive b and age . The pilot study recruited 20 children from two day care centers and subjected them to sham fingersticks . Results indicated that there were no differences across the groups in pain intensity ratings . However , there was a trend for the sight of blood to increase the child 's pain intensity rating . Age was a significant covariate across all groups , with younger children reporting higher levels of pain intensity . The second study took place in a pediatric test center of a metropolitan children 's hospital . Fifty outpatient children who were receiving fingersticks for preoperative or diagnostic testing were enrolled . Results indicated that there were no differences across groups , and age was only significant on the Poker Chip Tool . These results suggest that simple interventions and distractions are not sufficient to decrease perceived pain intensity ratings in young children",
"Study objective : Nitrous oxide ( N2O ) is an attractive agent for procedural analgesia and sedation of children in the emergency department ( ED ) . Despite increasing use , efficacy data for painful procedures are limited . This study aim ed to determine pain scores during ED procedural sedation with N2O in the ED setting . Methods : Prospect i ve observational study of N2O use as a sole agent for procedural analgesia at a tertiary children ’s hospital ED . Pain scores were obtained from patients and parents using visual analogue or faces scales , as appropriate . Parent and staff satisfaction with sedation and analgesia were assessed . Results : 124 children aged 1–17 years ( mean 8.1 ) underwent procedural analgesia with N2O for 131 procedures . Most procedures were orthopaedic ( 44 % ) or laceration repair ( 30 % ) . In 51 % of patients ( 95 % CI 42 % to 60 to 23 % ) pain scores remained unchanged and in 34 % ( 95 % CI 26 % to 43 % ) pain scores increased . Overall , 34 % ( 95 % CI 26 % to 43 % ) patients had intraprocedural scores of 50 mm or greater and 21 % ( 95 % CI 14 % to 29 % ) had pain scores of 70 mm or greater . Some procedures such as fracture reduction had a larger proportion of patients with high pain scores or 50 mm or greater ( 45 % ) and 70 mm or greater ( 29 % ) . Staff rated both sedation and analgesia as “ adequate ” in 92 % . Parents contacted in follow-up were satisfied or very satisfied with procedures in 96 % and sedations in 93 % . Conclusion : Data indicate that parents and staff are generally satisfied with N2O for procedural use in the ED . The efficacy of N2O as a sole agent in very painful procedures is limited",
"STUDY OBJECTIVE We compare adverse events , efficacy , and length of sedation of intravenous ( i.v . ) versus intramuscular ( i.m . ) ketamine procedural sedation and analgesia for orthopedic procedures in the emergency department ( ED ) . METHODS Pediatric patients receiving ketamine for orthopedic procedures were enrolled in a prospect i ve , r and omized , controlled trial in a children 's hospital ED . All patients were initially r and omized to receive ketamine either 1 mg/kg i.v . or 4 mg/kg i.m . Demographics , adverse events , sedation efficacy , and length of sedation were recorded . RESULTS Two hundred twenty-five patients were r and omized ( 116 i.v . , 109 i.m . ) . Two hundred eight patients , aged 14 months to 15 years , completed the study , 109 i.v . and 99 i.m . Respiratory adverse events were similar between groups ( i.v . 8.3 % versus i.m . 4.0 % ; odds ratio [ OR ] 0.47 ; 95 % confidence interval [ CI ] 0.14 to 1.6 ) . Vomiting in the ED was more common in the i.m . group ( 26.3 % versus 11.9 % ; OR 2.60 ; 95 % CI 1.2 to 5.9 ) . Using the Faces Pain Scale , patients in the i.m . group reported significantly less pain from the procedure . Video observers reported significantly lower distress in the i.m . group during the painful procedure ( Observation Score of Behavioral Distress scores 0.35 i.m . versus 0.74 i.v . ; mean difference 0.38 ; 95 % CI 0.04 to 0.72 ) . Length of sedation was significantly longer in the i.m . group ( median 129 versus 80 minutes ) . Satisfaction of sedation was high in parents and physicians , with no difference in reported satisfaction between groups . This study was terminated early because of nursing resistance based on the longer recovery times observed in patients receiving ketamine i.m . CONCLUSION In this study of pediatric sedation for orthopedic procedures , we found that ketamine 4 mg/kg i.m . was more effective than 1 mg/kg i.v . but demonstrated significantly longer recovery times and more vomiting",
"OBJECTIVE --To compare the anaesthetic properties of conventional intradermal 1 % plain lignocaine with a topical gel preparation of adrenaline ( 1:2000 ) and cocaine ( 4.7 % ) for use in treatment of children 's lacerations . METHODS --Children aged 3 - 16 years with lacerations ( not of the digits or mucous membranes ) were consecutively assigned to receive either adrenaline and cocaine ( AC ) or lignocaine . Pain scores , as perceived by patients , parents , and staff , were measured conventionally using Wong Baker faces and visual analogue scales on administration of the local anaesthetic and on suturing the wound in the AC group ( n = 56 ) and the lignocaine group ( n = 51 ) . RESULTS --Mean and median pain scores on administration of the anaesthetic in the AC group were significantly lower than in the lignocaine group as perceived by patient ( P mean and median pain scores between the two groups on suturing the wounds , as perceived by patient , parent and staff . There was a significantly higher number of \" failed \" anaesthetics ( pain scores 8 - 10 ) in the lignocaine group ( P acceptable by 84.5 % of parents in the AC group compared with 61 % of parents in the lignocaine group ( P significant complications in either group . CONCLUSIONS --Topical AC should be considered the local anaesthetic of first choice for suturing appropriate children 's lacerations",
"BACKGROUND Untreated immunization pain causes undue distress and contributes to underimmunization through physician , and possibly parental , resistance to multiple simultaneous injections . OBJECTIVE To compare the efficacies of two pain management methods in reducing immediate immunization injection pain and distress in school-aged children . DESIGN A r and omized , controlled clinical trial of eutectic mixture of local anesthetics ( EMLA ) cream and vapocoolant spray . PATIENTS Children aged 4 to 6 years and scheduled to receive diphtheria and tetanus toxoids and acellular pertussis vaccine ( DTaP ) during health supervision visits . INTERVENTIONS Enrolled children were r and omized to one of three treatment groups : 1 ) EMLA cream + distraction ; 2 ) vapocoolant spray + distraction ; or 3 ) distraction alone ( control ) . The specific pharmacologic pain control interventions consisted of EMLA cream ( 2.5 % lidocaine , 2.5 % prilocaine [ Astra Pharmaceutical Products , Inc , Westborough , MA ] $ 15 . 00/patient ; applied 60 minutes before injection ) and vapocoolant spray ( Fluori-Methane [ Gebauer Company , Clevel and , OH ] $ 0 . 50/patient ; applied via spray-saturated cotton ball for 15 seconds immediately before injection ) . MAIN OUTCOME MEASURES The blinded investigator ( BI ) measured ( by edited videotape ) cry duration and the number of pain behaviors using the Observational Scale of Behavioral Distress . Pain visual analog scales ( linear and faces scales ) were completed by the child , parent , nurse , and the BI . RESULTS Sixty-two children , aged 4.5 + /- 0.4 years ( mean + /- SD ) were r and omized . The three treatment groups had similar subject characteristics . All pain measures and cry duration were similar for EMLA and vapocoolant spray . Both EMLA and spray were significantly better than control . Results for spray vs control : cry duration ( seconds ) : 8.5 + /- 21.0 vs 38.6 + /- 50.5 ; number of pain behaviors : 1.2 + /- 1.9 vs. 3.1 + /- 2.1 ; child-scored faces scale : 2.0 + /- 2.4 vs. 4.1 + /- 2.3 ; parent-scored faces scale : 1.6 + /- 1.6 vs. 3.0 + /- 1.7 ; nurse-scored faces scale : 1.6 + /- 1.2 vs. 3.1 + /- 1.4 ; and BI-scored faces scale : 1.0 + /- 1.5 vs. 2.4 + /- 1.4 . CONCLUSIONS When combined with distraction , vapocoolant spray significantly reduces immediate injection pain compared with distraction alone , and is equally effective as , less expensive , and faster-acting than EMLA cream . As an effective , inexpensive , and convenient pain control method , vapocoolant spray may help overcome physician and parent resistance to multiple injections that leads to missed opportunities to immunize",
"This study examined pain and distress from needles in children undergoing blood sampling as a function of adult-child interaction and type of venous access ( i.e. , central external venous lines , internalized ports , or peripheral access via venipuncture ) . Participants were 55 pediatric oncology patients , aged 3 - 18 years , who were undergoing routine blood work . Pain ratings were obtained using the Faces Pain Scale-Revised ( FPS-R ) and conversation during the procedure was audio taped for coding using the Child-Adult Medical Procedure Interaction Scale-Revised ( CAMPIS-R ) . Children 's ratings of pain using the FPS-R were similar in the port ( M=2.57/10 , st and ard deviation [SD]=3.46 ) and peripheral ( M=2.56/10 , SD=3.24 ) groups , despite the fact that most children with internal ports were given a topical anesthetic . Similarly , there were no differences between port and peripheral groups in rates of child coping or distress , or parent and nurse observations of child pain . As would be expected , external line access was not associated with pain or distress , even among very young children , suggesting that they appropriately understood the pain rating scale . Results of the transcribed CAMPIS-R data indicate that the influences in adult-child interaction are bidirectional . Support was found for the well-established positive relationship between child distress and adult reassurance and empathy . Implication s for intervention and selection of central venous access devices are discussed",
"This study examined experimentally the effectiveness of preparatory information provided by parents in creating accurate expectations and reducing children 's procedural pain . Ear piercing was used as an analogue to minor painful medical procedures . Sixty children , aged 5 - 12 years , requesting ear piercing and accompanied by their parents , were r and omly assigned to a parental information or contact-control condition . Parents in the information group were asked to read their child a description of the procedures and sensations of ear piercing . Parents in the contact-control condition played picture games for the same amount of time . Expected pain was measured on a visual analogue scale ( VAS ) and the Faces Pain Scale-Revised ( FPS-R ) before and after the parental information or contact-control procedure . Experienced pain was measured on the same two scales immediately after the ear piercing . Prepared children had more accurate expectations and reported significantly less pain ( M=27.3 ) than non-prepared children ( M=49.8 ) . The validity of the measures was supported by strong correlations ( r=0.87 to 0.96 ) between the VAS and FPS-R. The findings suggest that parental provision of preparatory information creates accurate expectations and reduces pain for children",
"BACKGROUND It has been demonstrated that tramadol is an effective analgesic . We aim ed to compare postoperative analgesic effects of wound infiltration with tramadol ( T ) or bupivacaine ( B ) and intramuscular tramadol ( I ) after herniotomy in children . METHODS In this study , 75 children were r and omly assigned to group T , group B and group I. Wound infiltration was performed to the patients in group T ( 2 mg.kg-1 tramadol in 0.2 ml.kg-1 saline ) and group B ( 0.2 ml.kg-1 0.25 % bupivacaine ) into the surgical incision . Twenty minutes before the end of the surgery 2 mg.kg-1 tramadol was injected i.m . in group I. Faces pain scale was used for assessing pain severity . Patients with pain score>2 were treated with paracetamol . The frequency of side effects and analgesic use were recorded . Patients were discharged on the next day . RESULTS No side effects were recorded in any group . The pain scores of the patients at the first , fourth and eighth hours were significantly higher in group B and group I than group T ( P pain scores of the patients at the first hour were significantly higher in group I compared with group B ( P Average time to first analgesic requirement was significantly longer in group T ( 6.72+/-4.09 h after herniotomy than both group I ( 4.49+/-3.9 h ) and group B ( 6.04+/-3.7 h ) ( P tramadol may be a good choice for postoperative analgesia in children having inguinal herniotomy",
"BACKGROUND Ultrasound treatment prior to topical anesthetic application has been shown to speed anesthesia onset by enhancing anesthetic penetration into the skin . OBJECTIVE To evaluate a low-frequency ultrasound device to facilitate absorption of topical anesthetic in young children who require venipuncture . METHODS This was a prospect i ve controlled comparison of analgesic effect of a 5-minute application of liposomal lidocaine cream after ultrasound treatment , with a 30-minute application of liposomal lidocaine cream , in children aged 3 to 7 years undergoing venipuncture . Children rated the pain of the venipuncture using the Wong-Baker FACES Pain Rating Scale ( FACES ) ( 0 = no pain , 10 = maximal pain ) , and parents rated their child 's pain using a 100-mm ( 0 = no pain , 100 = maximal pain ) visual analogue scale ( VAS ) . Venipuncture skin sites were evaluated for effect immediately posttreatment , and at 24 to 72 hours post phlebotomy . RESULTS Seventy subjects were enrolled : the first 10 patients comprised a pilot series , receiving the ultrasonic treatment and liposomal lidocaine cream ; the next 60 subjects were r and omized , including 29 allocated to the ultrasound treatment group , and 31 r and omized to the 30-minute control treatment with liposomal lidocaine cream . Demographics were similar between the two groups . Mean child 's FACES scale results were similar : Ultrasound group 4.78 ( 95 % CI ; 3.06 , 6.52 ) , CONTROL group 4.32 ( 95 % CI ; 2.82 , 5.82 ) ( P = 0.72 ) ; and mean parent VAS scores were also the same : Ultrasound : 19.1 ( 95 % CI ; 10.3 , 27.8 ) , CONTROL : 23.2 ( 95 % CI ; 14.7 , 31.7 ) ( P = 0.87 ) . Skin effects immediately after ultrasound were limited to minor redness in 9/39 children and significant redness in 2/29 patients . CONCLUSION Ultrasound treatment speeds time of onset of liposomal lidocaine cream anesthesia in young children undergoing venipuncture . Side effects were mild in our population",
"OBJECTIVE To compare the level of pain among children treated according to the Atraumatic Restorative Treatment ( ART ) and the Conventional Restorative Treatment ( CRT ) . STUDY DESIGN Forty children of both genders , 4- to 7-years old , presenting Class I cavitated dentin lesions in primary molars were r and omly allocated to 2 groups . One group ( CRT ) received conventional restorative treatment using rotary instruments , while in the other one ( ART ) h and instruments were used to perform the restorations . All children were treated by the same operator A high-viscosity glass-ionomer cement ( Fuji IX ) was used to restore the teeth in both groups . Children 's pain was measured at the end of the first restorative treatment session using the Wong-Baker FACES Pain Rating Scale ( dependent variable ) . Age , gender , treatment time and treatment group were independent variables . ANOVA and ANCOVA tests were used to analyze the data . RESULTS The CRT procedure took longer than the ART procedure ( p ART group reported less pain than those from the CRT group ( p = 0.0037 ) . Four year olds reported more pain than 5- to 7-year olds ( p ART were less time consuming , children felt less pain when the ART approach was used , and younger children ( 4-years ) reported more pain than the older ones for both restorative treatments",
"To assess the sore throat pain model in children as an assay for systemic analgesic agents in children under double‐blind , placebo‐controlled conditions , we conducted a single‐dose parallel study that compared 10 mg/kg ibuprofen ( n = 39 ) , a new analgesic agent for children , and 15 mg/kg acetaminophen ( n = 38 ) , an approved analgesic for children , to placebo ( n = 39 ) in children from 2 to 12 years of age with acute sore throat . At ½ , 1 , 2 , 3 , 4 , 5 , and 6 hours ( 2 hours in the pediatrician 's office followed by 4 hours at home ) , children assessed pain intensity with a pain thermometer and pain relief with a smileyface scale . The parent and pediatrician assessed pain intensity and change in pain ; the parent also provided an overall evaluation at 6 hours . The children rated ibuprofen and acetaminophen as significantly effective compared with placebo ( p from placebo on both of their scales ( p 0.05 ) reduced oral temperature in children with baseline temperatures > 99 ° F. No treatment‐related adverse effects were observed . We conclude that the sore throat pain model is a sensitive assay for identification of the activity of oral analgesic drugs in children and that ibuprofen is an effective analgesic in children",
"OBJECTIVE To examine whether acetaminophen with codeine administered per rectum is an effective alternative for pain control compared with oral administration after an adenotonsillectomy . STUDY DESIGN A prospect i ve , r and omized control study . METHODS Seventy-five children aged 1 to 5 were recruited for this study . Each child was assigned r and omly to receive either rectal or oral postoperative pain medication . A journal with eight questions was kept for 10 days after the operation , and an overall survey of five questions was filled out at the first postoperative visit . RESULTS Postoperative pain was adequately controlled in those patients receiving suppositories when compared with those patients receiving oral pain medication . Adverse effects and total number of doses given per day were similar . Parents found the suppositories easy to administer , and more parents would switch or consider switching from oral pain medication to suppositories if given the choice . CONCLUSIONS The suppositories achieved equivalent pain control as oral medication with few side effects and good tolerance . Furthermore , many parents preferred the suppositories to oral medication in maintaining postoperative pain control because of ease of administration . If given the choice for future surgeries , many parents would switch or consider switching from oral pain medication to suppositories",
"PURPOSE To compare post-operative pain in children undergoing tonsillectomy by blunt dissection or electrocautery . METHOD Thirty-six children between the ages of 5 and 15 years were recruited for the study . Tonsillectomy was done in a st and ardized fashion with uniform anaesthetic practice s. Each child kept a pain diary for 10 days , recording pain twice daily on a Visual Analog Scale and Faces Pain Scale . Doses of analgesics were recorded . RESULTS There were no statistically significant differences in the pain scores for the groups , although there was a trend toward more pain in the blunt dissection group . There were more complications in this group , and these children used significantly more doses of acetaminophen . Sources of bias are discussed . CONCLUSION These results suggest a trend toward greater postoperative pain in children who have tonsillectomies by blunt dissection techniques",
"& NA ; The numerous pain rating scales using faces depicting varying degrees of distress to elicit reports of pain from children fall into two categories ; those with a neutral face as the ‘ no pain ’ anchor , and those with a smiling face as the ‘ no pain ’ anchor . This study examined the potentially biasing impact of these anchor types on children 's self‐reports of pain in response to a series of vignettes . Participants were 100 children stratified by age ( 5–6 years , 7–8 years , 9–12 years ) and r and omly assigned to one of three groups : ( 1 ) neutral scale/sensory instructions ; ( 2 ) smiling scale/sensory instructions ; ( 3 ) smiling scale/affective instructions . Children completed a faces scale , a VAS , and emotions ratings in response to four scenarios depicting : ( 1 ) no pain/negative emotions ; ( 2 ) pain/negative emotions ; ( 3 ) no pain/positive emotions ; ( 4 ) pain/positive emotions . Results showed that children who used the smiling scale had significantly higher pain scores for no pain and pain/negative emotions vignettes and significantly lower faces scale scores for pain/positive vignettes than children who used the neutral faces scale . Instructions varying in focus on sensory or affective qualities of pain had no effect on children 's pain ratings . Group differences in children 's ratings with the VAS and emotions measure suggested that rating pain with a smiling faces scale may alter a child 's concept of pain . Age differences indicated the younger children rated the negative emotion vignettes as more painful than the older children . These findings suggest that children 's pain ratings vary depending on the types of faces scale used , and that faces scales with smiling anchors may confound affective states with pain ratings",
"BACKGROUND / PURPOSE Minor surgical procedures in children , while usually not requiring general anesthesia , need effective control of pain , anxiety , and motion . Certain techniques of conscious sedation may result in loss of protective airway reflexes . Nitrous oxide , however , when inhaled at levels below 50 % maintains protective reflexes and does not require fasting or postprocedure monitoring . This study prospect ively examines the efficacy of nitrous oxide analgesia in children undergoing outpatient surgical procedures . METHODS Over a 2-year period ( 2000 to 2002 ) , 150 consecutive children were given nitrous oxide analgesia as an alternative to a general anesthetic , sedation , or local anesthetic alone . Nitrous oxide ( Wong-Baker Faces Scale ( 0 - 5 ) to score pain at different intervals ( preprocedure , at injection , during procedure , and postprocedure ) and event memories were tabulated . RESULTS Of 150 children , 5 were uncooperative and could not participate . One hundred forty-five children , ages 1 to 20 years ( Mean , 9.83 + /- 4.92 years ) successfully underwent procedures ( 58 cyst/nevus excisions , 49 abscess drainages , 38 other ) using nitrous . Two patients were too young to score pain . Pre- and postprocedure pain scores were significantly higher in the abscess group ( P pain scores less than 1 , with parents citing 100 % satisfaction with the technique . Of 128 children receiving local anesthesia , 107 ( 84 % ) had no recall of the injection . Complications were limited to 4 patients ; 2 experienced nausea , and 2 vomited . All resolved without interrupting the procedure . CONCLUSIONS Nitrous oxide analgesia is a cost-effective and efficacious alternative to conscious sedation or general anesthesia for minor pediatric surgical procedures . In the office or outpatient setting , the technique provides for almost pain/anxiety-free surgery , no postoperative monitoring , and a high degree of satisfaction for patients , parents , and staff",
"Abstract To examine the potential role for a placebo cream in reducing reported needle pain severity in children , and the impact of age‐related factors on pain self‐report , a convenience sample of 117 children scheduled for venipuncture were r and omly assigned to one of three treatments : ( a ) placebo cream with the suggestion that it might help reduce needle pain , ( b ) placebo cream with no indication as to the cream 's purpose , and ( c ) no cream ( control group ) . In allocation to treatment , children were stratified by age group , ( 3–7 , 8–11 , 12–17 years ) . They rated their needle pain severity ( both predicted and reported ) using the Faces Pain Scale , and rated their anxiety about the procedure using the Children 's Anxiety and Pain Scale . Children in the cream groups were also asked whether they thought the cream had helped . Using video‐tapes , an independent observer , blind to the placebo manipulation , rated each child 's reaction to the needle . For the two groups receiving cream , 83 % of those children told it might help stated that they believed it did , as compared with only 33 % of children who received the cream but were told nothing of its purpose . These beliefs , however , were not reflected in self‐report ratings of pain which showed no statistically significant treatment effect . Similarly , children who gave higher preprocedural anxiety ratings were no more likely to report less pain as a result of receiving the cream . There was , however , a treatment effect on the observer 's ratings : children receiving cream plus suggestion were assigned significantly lower ratings of pain‐related behaviour than those children who received the cream alone . While venipuncture was associated with only mild levels of pain , younger children , irrespective of treatment group , did report more pain than older children . Hierarchical regression analysis indicated that 60 % of the variance in self‐reported pain severity scores could be accounted for by how much the child thought the needle would hurt , how anxious the child was about receiving the needle , gender ( higher pain ratings associated with girls ) , and estimated body surface area ( higher pain ratings associated with smaller bodies ) . We conclude that the efficacy of placebo treatments for needle pain in children may depend on the suggestion of a possible benefit rather than upon treatment application per se",
"Objective : Orthopedic injuries comprise a majority of the indications for analgesia in the emergency department . Oxycodone and ibuprofen have demonstrated efficacy for this indication , but no studies have compared these drugs in children . Our objective was to investigate the effectiveness of oxycodone , ibuprofen , or their combination for the management of orthopedic injury-related pain in children . Methods : This prospect i ve , r and omized , double-blinded , clinical trial compared the effectiveness of oxycodone , ibuprofen , and the combination in children ( age , 6 - 18 years ) , with pain from a suspected orthopedic injury . Subjects were block-r and omized to receive 1 of the 3 treatment regimens . Pain was assessed with the Faces Pain Scale ( FPS ) and Visual Analog Scale at baseline , postimmobilization , 30 , 60 , 90 , and 120 minutes postmedication . The change in the FPS score over time was compared between the 3 treatment groups using a generalized estimating equation model . Results : Although all 3 treatment groups demonstrated a decrease in the FPS score over time , there were no significant differences between the groups . Among the 66 total children enrolled in the 3 treatment groups , there were no statistically significant differences in demographics or injury characteristics . There were 28 subjects with fractures . Immobilization of the injury demonstrated a significant reduction in the FPS score . Subjects in the combination treatment group reported more adverse effects . Conclusions : Oxycodone , ibuprofen , and the combination all provide effective analgesia for mild-to-moderate orthopedic injuries in children . Oxycodone or ibuprofen , alone , can be given , thereby avoiding the increase in adverse effects when given together",
"The effect of the topical application of a lignocaine-prilocaine cream ( EMLA ) on the pain of venous cannulation was tested in a double-blind manner . Sixty boys and girls between the ages of 4 and 10 yr who were to undergo surgery participated in the study . No analgesic premedication was given and the venous cannulation was performed during the preparation for general anaesthesia . Pain was assessed by the anaesthetist and the patient using a verbal rating scale and two different pictorial scales . The effect of EMLA in the alleviation of the pain of venous cannulation was considered significantly better than placebo by both anaesthetist ( P less than 0.001 ) and patient ( P less than 0.05 ) ( verbal scales ) . One conventional pictorial scale showed a statistically significant difference ( P less than 0.05 ) , but the other , based on facial expressions , did not . Local reactions to the cream were minor and transient in both groups",
"& NA ; This un‐blinded experimental study investigated the effectiveness of imagery , in addition to routine analgesics , in reducing tonsillectomy and /or adenoidectomy pain and anxiety after ambulatory surgery ( AS ) and at home . Seventy‐three children , aged 7–12 , were recruited from five AS setting s. Thirty‐six children r and omly assigned to the treatment group watched a professionally developed videotape on the use of imagery and then listened to a 30‐min audio tape of imagery approximately 1 week prior to surgery ( T1 ) . They listened to only the audio tape 1–4 h after surgery ( T2 ) , and 22–27 h after discharge from AS ( T3 ) . The 37 children in the attention‐control group received st and ard care . Pain and anxiety were measured at each time‐point in both groups . Measures of sensory pain were the Oucher and amount of analgesics used in AS and home ; affective pain was measured with the Facial Affective Scale ( FAS ) . Anxiety was measured using the State Trait Anxiety Inventory for Children ( STAIC ) . When controlling for trait anxiety and opioid and non‐opioid intake 1–4 h before the pain measures , MANCOVA showed significantly lower pain and anxiety in the treatment group at T2 , but not at T3 . When controlling for trait anxiety , a two‐way RM MANCOVA indicated no significant group differences in combined opioid and non‐opioid use between the groups , or between times . Appropriately trained health care providers should use imagery to reduce post‐operative pain following tonsillectomy and /or adenoidectomy in AS . Teaching parents about adequate home administration of analgesics may increase the effectiveness of imagery at home",
"PURPOSE This pilot study describes pain and anxiety associated with allergy testing ; tests distraction , specifically self-selected distraction ; and examines the relationship between pain , anxiety , and engagement with distraction . DESIGN AND METHODS An experimental design was used with a convenience sample of 32 adolescents from an allergist 's office r and omly assigned to three groups . Pain was measured by the adolescent pediatric pain tool ( APPT ) and FACES scale . RESULTS No differences in pain ratings were found among the groups . Less pain was associated with lower anxiety and greater engagement with distraction . Greater engagement with distraction occurred with less anxiety . PRACTICE IMPLICATION S Knowledge about allergy testing pain , anxiety , and engagement with distraction can assist nurses in preparing adolescents for this procedure",
"BACKGROUND Patient controlled epidural analgesia ( PCEA ) is uncommon in pediatric anesthesia . Because PCEA offers superior pain control compared with continuous epidural infusions in adults , we prospect ively evaluated the analgesia efficacy and safety of PCEA in children and adolescents following extensive spinal surgery . METHODS Following ethics committee approval , 100 consecutive children [ age median ( range ) 14 ( 6 - 19 ) years ] undergoing spinal surgery were studied until the seventh postoperative day , and 98 children received a PCEA . One or two epidural catheters were positioned under direct vision by the surgeon based on the number of vertebral segments operated upon . The epidural solution consisted of bupivacaine 0.0625 % , fentanyl 1 microg.ml(-1 ) and clonidine 0.6 microg.ml(-1 ) , delivered at a basal rate of 0.2 ml.kg(-1).h(-1 ) and a PCEA dose of 0.1 ml.kg(-1).h(-1)(max . 2 h(-1 ) ) . On the fourth postoperative day , PCEA was stopped and analgesia was continued with patient controlled analgesia ( PCA ) with morphine . RESULTS During the PCEA regimen , the maximal scores of the revized facial scale were below 4 at rest with a very high satisfaction rate ( > 90 % ) . Pain scores were higher during mobilization on the first postoperative day and when PCEA was switched to PCA . The overall incidence of adverse events was low and consisted primarily of technical problems and postoperative nausea and vomiting . Only two children experienced a complication requiring the discontinuation of the PCEA but there were no consequent adverse sequelae . CONCLUSIONS The present study demonstrates that PCEA provides excellent pain relief following extensive spinal surgery and is associated with a low incidence of adverse events . The use of PCEA should be encouraged in children and adolescents following extensive spinal surgery",
"OBJECTIVE /HYPOTHESIS The hypothesis tests whether sealing the tonsillectomy field with posterior pillar mucosa can prevent unwanted outcomes in pediatric tonsillectomy . STUDY DESIGN A prospect i ve , r and omized , single blinded study was conducted on a sample of 39 children between 3 and 15 years of age . After dissection and snare tonsillectomy , the tonsillar fossa was covered on one side using the palatopharyngus mucosa and the other side is used as control . Pain scores , healing , edema and infection at the operation site were investigated . METHODS The tonsillectomy sites were r and omly assigned into one of two groups . First group contained the ones with mucosal flap sealed over the operation site and the second group was kept as control with the operation site left uncovered . All of the patients received mild analgesics . The pain assessment is done on Days 1 , 3 , 5 , 7 and 10 postoperatively , by using Wong-Baker faces visual analog scale . On the 10th postoperative day , the operation field of each side is scored separately for edema , healing and infection . Statistical investigation was performed through a software program . RESULTS On first postoperative day , pain level difference was not statistically significant between the two groups ( p>0.01 ) . But from 3rd to 10th postoperative day , the pain level was found out to be lower in the mucosa sealed site ( p edema was significantly more ( p healing was better ( p Postoperative infection at operation site was not different between the groups ( p>0.01 ) . CONCLUSION Covering tonsillectomy field with mucosal palatopharyngeal arch flap significantly reduces pain after third postoperative day . The flap side had better healing when compared to denuded site . But the sutures in the mucosal flap may cause more tissue edema . Sutures have no significant effect on postoperative infection . Thus , mucosal flap may be used as an adjuvant surgical technique to decrease tonsillectomy pain of children in addition to the analgesic medication",
"This study explored whether global unidimensional self-report pain scales based on facial expression help children separately estimate the sensory and affective magnitude of post-operative pain . Ninety paediatric elective surgery patients ( in two age groups : 5 - 9 and 10 - 15 years ) used each of four scales to estimate pain intensity and pain affect during the first 2 days after surgery . The four scales were : Faces Pain Scale ( FPS ) , Facial Affective Scale ( FAS ) , and the Coloured Analogue Scale ( CAS ) ( one for intensity and one for unpleasantness ) . As hypothesised , ratings on the FPS correlated more highly with analogue scale ratings for intensity than for unpleasantness , whereas ratings on the FAS correlated more highly with those on the analogue scale for unpleasantness than for intensity . Factor analysis indicated that although all measures loaded on a single dimension of distress , there was an additional weaker factor corresponding to a unique contribution of the FAS . No systematic age effects were observed . It was concluded that the FPS and the FAS may partly measure different aspects of the postoperative pain experience in children , although shared instrument variance may obscure true estimates of covariation in ratings of intensity and affective magnitude . The clinical relevance of the present results remains to be determined",
"OBJECTIVE To collect data on pain management in paediatric oncology with respect to the WHO ladder approach . SETTING , DESIGN , PATIENTS AND METHODS : Eight German tertiary care paediatric oncology centres prospect ively documented all their in-patient pain treatment courses from June 1999 to December 2000 . Pain was scored using a 1 - 6 faces scale . RESULTS Two hundred and twenty four patients ( median age , 9 years ; range 0.2 - 32.1 ) were enrolled . Three hundred and thirty three pain episodes comprising a total of 2265 treatment days were documented . Pain was mostly therapy associated . The most frequently administered non-opioid analgesics were dipyrone and paracetamol . On WHO step 2 , tramadol was almost the only opioid used . During tramadol monotherapy average daily pain scores were lower than with a combination of tramadol and non-opioid analgesics . On WHO step 3 , morphine was at least part of the analgesic regimen on most treatment days . Strong opioids were combined with a non-opioid analgesic on 41 % of the treatment days . The mean intravenous morphine equivalence dose was 0.034 mg/kg/h . During opioid and non-opioid combination therapy , adverse effects were more frequent , and average pain scored higher than on opioid monotherapy . CONCLUSIONS WHO- guidelines were closely followed in Germany and seem to provide effective analgesia for children with cancer pain . In our patient group there is no evidence that a combination of an opioid with a non-opioid is more effective than opioid therapy alone in in-patient paediatric oncology pain treatment",
"The purpose of this study was to determine the effectiveness of parental positioning and distraction on the pain , fear , and distress of pediatric patients undergoing venipuncture . An experimental-comparison group design was used to evaluate 43 patients ( 20 experimental and 23 comparison ) who were 4 to 11 years old . Experimental participants used parental positioning and distraction . All participants rated their pain and fear ; parents and child life specialists ( CLS ) rated the child ’s fear , and CLS rated the child ’s distress . Self-reported pain and fear were highly correlated ( p Fear rated by CLS ( p distress between the two groups , a significant time trend was discovered ( p parental positioning-distraction intervention has the potential to enhance positive clinical outcomes with a primary benefit of decreased fear . Further research is warranted",
"INTRODUCTION The purpose of this study was to compare distress behaviors and perceptions of distress in 4- to 6-year-old children who received two immunization injections simultaneously with those in children who received their immunizations sequentially . METHOD This experimental study used a convenience sample of 46 children scheduled for pre-kindergarten examinations . The children were r and omly assigned to either a sequential injection or a simultaneous injection group . Direct observation and videotapes were made of the children 's behaviors before and after injection . Distress behaviors were analyzed with the Observation Scale of Behavioral Distress-Revised , and perceptions of distress were obtained from both children ( with the Wong-Baker Pain Rating Scale [ FACES ] ) and parents ( with the Visual Analog Scale ) . RESULTS Results of the Observation Scale of Behavioral Distress-Revised showed no significant differences in children 's distress behaviors between the two groups either before or after injection . The children 's self-reports of distress also showed no group differences . Parents ' perceptions of the children 's distress before and after injection were lower for the sequential group but were judged to be unrelated to the intervention . Given the opportunity to state a preference , however , parents preferred the simultaneous method . DISCUSSION The simultaneous procedure was not found to be associated with reduced distress behaviors ; however , parents preferred the simultaneous method",
"This prospect i ve double-blind study was design ed to assess the analgesic efficacy of ketorolac 0.5 % ophthalmic solution compared with placebo in 30 healthy children undergoing extraocular muscle recession for correction of strabismus . After paracetamol 20 mg.kg-1 preoperatively , a st and ard anaesthetic was given . There were no significant differences in Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) and faces pain scale ( FPS ) scores , requirement for supplementary analgesia or in postoperative vomiting between the two groups over the following 24 h. This study did not demonstrate improved postoperative analgesia when topical ketorolac eye drops were given in addition to paracetamol . This observed lack of efficacy may reflect difficulties in the use of CHEOPS and FPS in this age group with this pain model",
"Objectives : Our r and omized , double-blind , placebo-controlled study evaluates the possible benefit of peritonsillar infiltration with 0.75 % ropivacaine hydrochloride on the pain level after adenotonsillectomy in 3- to 7-year-old children . Methods : We r and omly administered intraoperative peritonsillar infiltration with 0.2 mL/kg ropivacaine 0.75 % ( group R ) or 0.2 mL/kg saline 0.9 % ( group F ) to sixty 3- to 7-year-old children ( ASA 1 or 2 ) who were undergoing adenotonsillectomy . Postoperative pain was assessed 6 and 24 hours after surgery by a 6-face Faces Pain Scale that allowed quantification of pain on a 100-mm horizontal line ( 0 = no pain ) . The number of rectal doses of acetaminophen-codeine required during the first postoperative day was recorded . Results : The pain scores did not differ between the groups , either 6 or 24 hours after surgery ( group F , 43 ± 26 , versus group R , 29 ± 23 , and group F , 24 ± 23 , versus group R , 30 ± 28 , respectively ) . Acetaminophen-codeine doses were similarly required in the two groups . Conclusions : Peritonsillar infiltration with 0.75 % ropivacaine does not provide any major postoperative analgesic effect in 3- to 7-year-old children after adenotonsillectomy . A possible clinical ly minor analgesia 6 hours after surgery is suggested",
"PURPOSE The purpose of this study was to assess children 's reactions and record their sensations while receiving a warmed local anesthetic solution for dental procedures ( 37 degrees C ; W ) compared with one at room temperature ( 21 degrees C ; RT ) . METHODS Forty-four children between the ages of 6 to 11 ( mean age = 7.9 + /- 2.2 years ) who were undergoing dental treatment participated in the study . A r and om crossover design was used . Each patient was r and omly assigned to receive either a W or a RT local anesthesia on the first visit and the alternate local anesthesia on the second visit . During the injection , the modified Behavioral Pain Scale ( BPS ) was used . For subjective evaluation , the Wong-Baker FACES Pain Rating Scale ( FPS ) and the Visual Analogue Scale ( VAS ) were used . RESULTS No significant difference was found between the W or RT local anesthesia when used during the first or second visit . In all parameters , children 's reactions to both types of injection were similar , with no statistically significant difference . Using the FPS , 19 boys ( 91 % ) ranked the experience of local anesthesia as a positive experience ( 0 to 2 in the scale ) while 4 boys ( 9 % ) ranked the same experience as negative . This was true for both types ( W and RT ) . All 21 girls who participated in the study ranked the local anesthesia experience using the FPS as a positive experience ( 0 to 2 in the scale ) . No significant difference was found in the mean VAS scores between the room-temperature group and the warm group ( 23.4 + /- 21.8 and 20.8 + /- 18.9 , respectively ) . CONCLUSIONS There is no advantage to warming local anesthetic solution prior to injection",
"Objectives : ( 1 ) To assess the acceptability of a gel solution of adrenaline ( epinephrine ) ( 1 in 2000 ) and cocaine ( 5 % ) for anaesthetising children ’s facial lacerations to the child , parent , and operator . ( 2 ) To assess the safety of the current protocol . Setting : The emergency unit of a large university hospital . Methods : All patients who were treated with topical adrenaline and cocaine ( topAC ) gel over a six month period were entered into a prospect i ve audit ( n = 75 ) . Patient details , the nature and cause of the injury , and any treatment carried out were all recorded . The acceptability to children over 3 years of age , was assessed by the use of the Wong Baker face scale , in which 0 represents “ no hurt ” and 5 represents “ hurts worst ” . The acceptability to both the parent and the operator was assessed by the use of a 0 to 9 Likert scale , where 0 represented “ very acceptable ” and 9 represented “ not at all ” acceptable . Results : ( 1 ) Children aged 3 years or older grade d their pain during the procedure as having a mean value of 1.17 on the Wong Baker ( 0 to 5 ) scale . Parents grade d acceptability on the Likert scale ( 0 to 9 ) with a mean score of 1.13 . Operators using the same grading system , recorded a mean score of 1.75 . ( 2 ) No toxic side effects were seen but the protocol was up date d in line with evidence . Conclusions : Topical adrenaline and cocaine is an effective anaesthetic for suturing children ’s facial lacerations and is acceptable to child , parent , and operator alike",
"The analgesic efficacy and safety of propacetamol , an injectable prodrug of acetaminophen , ( paracetamol ) were studied in 87 children ( 36 boys , 51 girls ; age 6 - 13 ; mean age 9.5 years ) immediately after limb surgery . Using a double-blind , r and omized , parallel group design , the effects of a single IV infusion of 30 mg.kg-1 propacetamol ( i.e. 15 mg.kg-1 acetaminophen ) were compared with a single injection of placebo ( PL ) . Efficacy was assessed on pain scores rated on a four-point verbal scale , a five-point visual scale ( faces ) and on a four-point relief verbal scale before administration ( T0 ) and 0.25 , 0.5 , 1 , 2 , 3 , 4 , 5 , 6 h after administration . At the end the global efficacy was rated by the physician on a five-point verbal scale . Propacetamol was statistically superior to placebo on all assessment criteria . Seven side-effects were recorded : five in the propacetamol group and two in the placebo group . 30 mg.kg-1 propacetamol provided a significantly greater analgesic effect than placebo in children after orthopaedic surgery",
"The objective of this study was to assess analgesic use and the use of a pain scoring system on those children presenting to a paediatric accident and emergency ( A&E ) department with a history of injury due to trauma . A r and om sample of patients who presented to a paediatric A&E department over a 6-week period with a history of limb trauma were prospect ively studied . Pain severity scores were assessed on arrival and at 10 , 30 and 60 minutes using the Douhit Faces Scale and any analgesia given or plaster application was noted . One hundred and seventy-two patients were studied . The median age was 10 years ( range 3–13 years ) and the majority , 56 % , were male . The mean initial pain scores were 2.7 ( range 1–4 ) for boys and 3.0 ( range 1–4 ) for girls . The presenting injuries were 103 upper or lower limb fractures and 69 ‘ soft tissue ’ injuries . Only 84 ( 49 % ) patients received analgesic medication in the department ( 30 % morphine ; 70 % paracetamol ) ; analgesia was not given to the remaining 88 ( 51 % ) . Of these , 7 declined analgesia , and 5 had already taken analgesia on arrival to A&E. Despite prompt triage ( median time 2 minutes , range 0–10 minutes ) , the median time from arrival to paracetamol administration was 20 minutes ( range 4–105 minutes ) and for morphine was 14 minutes ( range 2–57 minutes ) . Pain is a common symptom in patients presenting to A&E. Because children 's pain can be particularly difficult to assess , a pain scoring system such as the Douhit Faces Scale can be a useful means of pain assessment in the A&E setting . Despite increased awareness , pain is still under treated in the A&E department",
"OBJECTIVE : To compare the postoperative recovery of patients who undergo intracapsular to subcapsular Coblation tonsillectomy . STUDY DESIGN AND SETTING : This was a prospect i ve , r and omized , double-blinded study . A total of 69 children , aged 2 to 16 years , were r and omized to intracapsular ( n = 34 ) or subcapsular ( n = 35 ) tonsillectomy . The Coblation technique was used with both groups . Outcomes measures were assessed on postoperative day 1 or 2 and 5 or 6 . These included child and parental rating of pain with the Wong Faces pain scale , analgesic use , oral intake , and activity level . RESULTS : Intracapsular tonsillectomy patients had similar levels of pain to subcapsular tonsillectomy patients on day 1 or 2 . However , at day 5 or 6 , intracapsular tonsillectomy patients had significantly less pain than the subcapsular tonsillectomy patients . Intracapsular patients ate more and were more active at both time points . CONCLUSION AND SIGNIFICANCE : Children with obstructive sleep apnea who undergo tonsillectomy demonstrate better postoperative recovery after intracapsular tonsillectomy . The intracapsular versus subcapsular difference may be best appreciated at a delayed time point ( day 5 or 6 ) rather than early ( day 1 or 2 )",
"Objective To identify the structure of facial reaction to procedural pain and to determine the subset of facial actions that best describe the response . Design Observational . Setting Five rural and five urban physicians ' offices . Patients One hundred twenty-three children aged 4 to 5 years undergoing routine diphtheria , pertussis , tetanus , and polio immunization . Outcome Measures The Child Facial Coding System , comprising 13 discrete facial actions , was used to code each second of five 10-second phases from videotape : baseline , preneedle , needle , postneedle , and posth and ling . Parents and a technician provided visual analog scale ratings of children 's pain . Children provided a self-report using a Faces Pain Scale , and parents and nurses rated the children 's pain and anxiety using visual analog scales . Results A “ pain face ” similar to that reported in adults emerged with the onset of pain . Principal component analyses revealed the frequency and intensity of facial action during the needle phase could be represented by components reflecting pain sensation , a “ brave face , ” and the children 's expectations for pain . Children 's Faces Pain Scale and adult visual analog scale ratings were best predicted by components reflecting pain sensation and expectations of high pain . Conclusions These results provide a preliminary indication that the Child Facial Coding System can be reduced to components that reflect several aspects of children 's acute pain experience and predict self-reports and observer reports of children 's pain",
"OBJECTIVE The objective of this study is to evaluate the efficacy of sucralfate in alleviating posttonsilectomy morbidity in a pediatric group of patients . METHODS A prospect i ve , double-blind , r and omized , and placebo-controlled study comparing the irrigation of a solution containing either 1 g of sucralfate ( study group ) or 1 g of lactulose ( control group ) was performed on 69 children aged 3 - 12 years , who underwent tonsillectomy at the University Hospital of Brasilia Medical School . The children were r and omly assigned and each one used a solution containing sucralfate or lactulose to swish and swallow four times daily during 7 days . Eleven patients were excluded . The anesthetic was st and ardized and no premedication was used . Pain magnitude using an \" Oucher \" scale , nausea , vomiting , bleeding , earache , analgesic drug intake , changes in the interincisor teeth distance , and changes in the weight and temperature were assessed by the surgeon 6 , 24h , and 7 days after the surgery . RESULTS Patients in the study group had significantly lower pain scores in the initial 6 postoperative hours ( p significant for the other periods following the procedure or on the evaluation of the other indices . CONCLUSIONS The use of the sucralfate in pediatric patients undergoing tonsillectomy was not effective in reducing the postoperative morbidity according to the parameters used in this study . The surgical technique with careful mucosal dissection associated with postoperative caries could be more important in the reduction of posttonsilectomy morbidity",
"Parents need education about pain so they can support their hospitalized child and manage their child 's pain at home . The purpose of this study was to examine the effectiveness of a pain booklet on parental pain support to children experiencing postoperative pain . A r and omized , repeated measures , experimental design using a pain education booklet and a st and ard care comparison group was used to study parents of 51 children ( 3 to 16 years of age ) having cardiac surgery . Measurement techniques used to assess differences in parental pain management included : attitudes about pain medication , child and parent pain ratings ( Oucher ) , opioids used , recovery , satisfaction , and comfort in communication . Results indicate that children do report moderate levels of pain postoperatively . Parents who were exposed to the pain assessment and management for parents education booklet preoperatively significantly increased their knowledge and attitudes toward pain medication scores from pre- to post-test , whereas those in the control group remained stable . Post-test scores were not significantly different between groups . Child and parent pain ratings were significantly and positively correlated . Practice implication s include the use of an educational booklet about pain with parents before surgery to increase their knowledge about and attitudes toward pain management . Additionally , a parent may provide an alternative pain report when a child is unable to or unwilling to self-report their pain",
"Tramadol hydrochloride is a racemic mixture of two enantiomers . It has analgesic activity suitable for mild to moderate pain , part of its analgesic activity being modulated via mu receptors . Adult studies have raised the question of increased electroencephalographic activity . The study examined the analgesic efficacy , respiratory effects , and behavior plus recovery-influencing properties of tramadol in the pediatric patient . Day-case dental extraction children , aged 4 - 7 years having 6 or more extraction s , were studied . Tramadol drops , 3 mg/kg , plus oral midazolam , 0.5 mg/kg , were administered 30 minutes prior to a sevoflurane in N2O and O2 anesthetic . Forty children received this premedication treatment ( T ) and 10 entered a placebo control group ( P ) , where no tramadol was administered . Entry was r and om , double blind , and parallel . Analgesic efficacy was measured using the Oucher face pain scale ( OFPS ) , with responders scoring three or less . Respiration was measured by rate and oxygen saturation . Behavior and ease of mask induction were assessed on a 4-point scale . Recovery was measured with the Aldrete scale . Parameters were measured from 30 minute preanesthetic to 120 minute postanesthetic . Analgesic efficacy was shown , with an OFPS score of 11.42 ( SD 18.66 ) ( T ) and 29.80 ( SD 25.14 ) ( P ) ( P tramadol were 77.5 % versus 0 % on placebo ( P respiratory depression was seen ; rates and oxygen saturations were the same preanesthetic and postanesthetic . Similarly , the two groups had no cardiovascular differences . Preanesthetic behavior patterns were the same ( P > .05 ) , with 85 % of the tramadol group being drowsy but awake versus 90 % in the placebo group . Similarly satisfactory induction behavior was seen in 95 % of the tramadol group and 90 % of the placebo group . Recovery times were 48.6 minutes ( SD 32.3 ) ( T ) and 43.1 minutes ( SD 32.5 ) ( P ) ( P > .05 ) . It is concluded that tramadol at 3 mg/kg has no clinical respiratory depressant effect and that behavior and recovery times are unaffected . Analgesic efficacy is demonstrated",
"OBJECTIVE To quantify , using two pain assessment scales , the amount of change in pain severity required to achieve a clinical ly significant improvement in pain in children presenting to a pediatric emergency department ( ED ) with pain . METHODS Prospect i ve , descriptive study involving all children presenting to a pediatric ED between 5 and 16 years of age inclusive with acute pain . Children were excluded if they 1 ) were intoxicated or had altered sensorium , 2 ) were clinical ly unstable , 3 ) were non-English-speaking , or 4 ) were developmentally delayed . Written informed consent was obtained . Children were asked to mark their current pain severity on the st and ardized Color Analogue Scale ( CAS ) and Faces Pain Scale ( FPS ) . After each pain control intervention the child was asked to repeat these measurements and to describe whether his or her pain was \" much less , \" \" a little less , \" \" about the same , \" \" a little worse , \" or \" much worse \" compared with before . This process was repeated until the child was discharged from the ED or had a score of zero . The main outcome measure was the smallest change on the CAS or FPS necessary to cause the child to describe his or her pain as a \" little less . \" This was defined as the clinical ly significant change in pain . The \" ideal \" change in pain was defined as the amount of change necessary for the child to describe the pain as \" much less \" or at which point the child thought he or she no longer required any medicine to help the pain go away . RESULTS One hundred twenty-one children were enrolled with a mean age of 9.8 years ( SD + /- 3.15 ) . Males accounted for 56 % . Pain was traumatic in 65 % and nontraumatic in 35 % . A total of 153 pain comparisons were made using the CAS and 154 using the FPS . Only three children complained that their pain got worse ( two a little worse and one much worse ) . Pain was described as \" the same \" in 20 . Of the 60 pain comparisons judged to be a \" little less , \" the CAS score changed by a median of 2.0 cm [ interquartile ratio ( IQR ) 1 - 3 ] , and the FPS by 1.0 face ( IQR 1 - 2 ) . In the 71 children who judged their pain to be \" much less , \" the CAS decreased by a median of 4.0 cm ( IQR 2 - 5 ) and the FPS by 2.0 faces ( IQR 2 - 3 ) . CONCLUSIONS The assessment and treatment of pain in children are an important component of pediatric practice , especially in the ED . This study provides health care professionals and clinical investigators the information necessary to assess whether their method of pain control in children is clinical ly relevant",
"The effectiveness of a eutectic mixture lidocaine‐prilocaine topical anaesthetic cream ( EMLA ® ) patch compared with a placebo patch in the reduction of pain associated with intramuscular immunization was evaluated . As part of the study , 161 children ( aged 4‐6‐y ) undergoing routine diphtheria , pertussis , tetanus and polio ( DPTP ) immunization in five urban and five rural private office setting s were r and omly assigned to an EMLA ® patch ( n= 83 ) or a placebo patch control group ( n= 78 ) . Pain measurements included : child 's self‐report on a Faces Pain Scale ; facial action on the Child Facial Coding System ; the Children 's Hospital of Eastern Ontario Pain Scale and parent and technician ratings on a Visual Analogue Scale . Parents also rated their own and their child 's immunization‐related anxiety on a Visual Analogue Scale . The EMLA ® patch group had significantly less pain on all four pain measures compared with the placebo group . Of the children in the placebo group , 43 % had clinical ly significant pain , compared with 17 % of children in the EMLA ® patch group . No severe adverse symptoms occurred as a result of either EMLA ® or placebo patch application",
"OBJECTIVES To study the compliance of prescription , the efficacity and the adverse events of oral morphine used in the pediatric emergency department ( ED ) in traumatic pains . METHOD This prospect i ve study was conducted in the ED from october 2002 to september 2003 . Children aged six months to 16 years with a visual analogic scale ( VAS ) score higher than 70 or with a traumatic member deformation received oral morphine ( 0,5 mg/kg ) . Pain was assessed every 30 minutes using two scales : behavioral observation by the faces scale and objective pain scale ( OPS ) for children less than five years , behavioral observation by the faces scale and self-report by VAS for children older than five years . The compliance of prescription , the pain scores and the adverse events were studied . RESULTS Ninety-one children received oral morphine and seventy-four children were studied . Seventy per cent of prescriptions were in accordance with the recommendations . For patients younger than five years a rapid decrease of pain was observed in thirty minutes . The pain 's reduction was respectively 79 and 84 % with faces scale and OPS when they left ED . For children older than five years , pain 's reduction was more important and more rapid when pain assessment was made by nurses than when it was self-reported in the first hour ( pain reduction 58,2 and 36,1 % ) . When leaving , pain reduction was the same with the two different assessment s. No major adverse event was noted . CONCLUSION Use of oral morphine in ED is simple , with a few numbers of adverse events . None was severe . Efficiency is correct after 30 to 60 minutes",
"OBJECTIVE To measure differences in postoperative pain in children undergoing intracapsular tonsillectomy vs. extracapsular tonsillectomy . STUDY DESIGN Prospect i ve clinical trial carried out at a tertiary children 's hospital over 1 year . METHODS The study included 43 patients age 5 to 19 years with adenotonsillar hypertrophy , 27 undergoing extracapsular tonsillectomy and 16 undergoing intracapsular tonsillectomy . Tonsillectomy was performed in either an intracapsular or extracapsular fashion using bipolar electrosurgical scissors and monopolar suction cautery for hemostasis . Residents under faculty supervision performed all operations . Postoperative pain was assessed using the Wong-Baker Faces Pain Scale through postoperative day 10 . The patients recorded in a st and ardized diary pain scores and analgesic use . The main outcome measure was postoperative pain as measured by the Wong-Baker Faces Pain Scale . The quantity of postoperative pain medicine consumed was a secondary outcome measure . RESULTS Average postoperative pain for extracapsular tonsillectomy was 5.21 on a 10-point scale versus 2.75 for intracapsular tonsillectomy ( P Intracapsular tonsillectomy with bipolar scissors results in less postoperative pain than extracapsular tonsillectomy with bipolar scissors in children age 5 to 19 years",
"This study examined concurrent self-reports of pain intensity and behavioral responses in 25 children aged 3 - 7 yr . Behavioral ( Children 's Hospital of Eastern Ontario Pain Scale , CHEOPS ) and self-report ( the Oucher and Analogue Chromatic Continuous Scale ) measures of pain were obtained following major surgery . The two self-report measures were strongly and significantly correlated , and the pattern of scores over the 36-hr observation period was as expected . There was little relationship between the scores for the self-report and the behavioral measures . Many children who reported severe pain manifested few of the behavioral indicators of distress used in the CHEOPS . This behavioral response pattern may occur commonly in children experiencing pain after surgery and may limit the applicability of current behavioral scales as sole measures of pain intensity in younger children",
"Objective . To compare the Faces Pain Scale and Color Analogue Scale among children aged 6–12 years undergoing selected procedures ( Venipuncture , Intravenous cannulation , Intramuscular injection , Lumbar puncture , Bone marrow aspiration ) and to compare the procedural pain in a child as perceived by the child , parents and health care professionals using the above mentioned scales Methods . This was a prospect i ve , descriptive correlational study of children aged 6–12 years , who had undergone selected procedures . Children were assessed for their pain severity using Faces Pain Scale and Color Analogue Scale . Parents and health care professionals also independently assessed the child 's pain using the same scales Results . 181 children who fulfilled the eligibility criteria were enrolled in the study . There was a significant positive correlation ( r = > 0.8 ) between both the pain scales . There was fair to moderate positive correlation ( r = 0.29 to 0.58 ) of pain perception of child with parents and health care professionals Conclusions . Faces Pain Scale and Color Analogue Scales seem to be appropriate instruments for measuring pain intensity among Indian children aged 6–12 years undergoing selected",
"OBJECTIVE To compare the effectiveness of acetaminophen versus acetaminophen with codeine after pediatric tonsillectomy and adenoidectomy . STUDY DESIGN Prospect i ve , r and omized , double-blind study . METHODS Fifty-one children ages 3 to 12 years scheduled for outpatient tonsillectomy and adenoidectomy were studied . Patients were r and omly assigned to receive acetaminophen or acetaminophen with codeine in unlabeled bottles for postoperative pain control . The Wong-Baker FACES pain rating scale was used to help children quantify their level of pain after surgery . The level of pain , quantity of pain medication required , presence of side effects , and the percentage of a normal diet consumed was recorded for 10 postoperative days . RESULTS There was no difference ( P > .05 , all time points ) in the level of postoperative pain reported by the parents and children in the two groups . The acetaminophen with codeine group tended to have increased problems with nausea , emesis , and constipation , but these differences did not reach statistical significance . Children in the acetaminophen group consumed a significantly higher percentage of a normal diet on the first 6 postoperative days ( P pain control provided by acetaminophen and acetaminophen with codeine as measured by the Wong-Baker FACES pain rating scale . Postoperative oral intake was significantly higher in children treated with acetaminophen alone",
"OBJECTIVE To compare the efficacy of 3 different pharmacologic regimens to relieve pain and distress in children with cancer undergoing bone marrow aspirations ( BMAs ) and lumbar punctures ( LPs ) . DESIGN Retrospective cohort study with crossovers for some patients . PATIENTS AND METHODS The pain and distress ratings of patients undergoing BMAs ( n = 73 ) and LPs ( n = 105 ) were examined in a comparison of 3 different interventions : ( 1 ) a topical eutectic mixture of lidocaine and prilocaine ( EMLA cream ) , ( 2 ) oral midazolam and EMLA cream , or ( 3 ) propofol/fentanyl general anesthesia . The choice of the intervention depended on patient/parent request . A vali date d faces pain scale was completed by the child or parent following each BMA or LP . The faces pain scale includes ratings of the severity of pain ( from 0 = none to 5 = severe ) and ratings of how frightened ( from 0 = not scared to 5 = scared ) the child was prior to each procedure . Comparisons of the pain and distress ratings were made among all patients for their first procedure and also within individual patients who had received > 1 of the 3 interventions . Independent comparisons between the first treatments received by each patient were analyzed using Kruskal – Wallis tests . Comparisons of different crossover treatments received by individual patients were analyzed using Wilcoxon tests . RESULTS For all first procedures , mean ± SD pain and distress ratings during LPs were significantly lower when propofol/fentanyl was used ( n = 43 ; 0.4 ± 1.0 and 1.4 ± 1.7 ) versus either EMLA ( n = 29 ; 2.4 ± 1.7 and 2.9 ± 1.9 ) or midazolam/EMLA ( n = 33 ; 2.4 ± 1.8 and 2.7 ± 1.8 ) , respectively . Pain and distress ratings during BMAs were also significantly lower with propofol/fentanyl ( n = 29 ; 0.5 ± 1.0 and 1.2 ± 1.7 ) versus EMLA ( n = 21 ; 3.5 ± 1.6 and 3.3 ± 1.8 ) or midazolam/EMLA ( n = 23 ; 3.3 ± 1.5 and 3.0 ± 1.9 ) , respectively . When data were analyzed within each patient , these differences were also present . CONCLUSIONS Children receiving propofol/fentanyl general anesthesia experienced significantly less procedure-related pain and distress than did those receiving either EMLA or oral midazolam/EMLA ",
"Background : Historically , children have been undertreated for their pain , and they continue to undergo painful cutaneous procedures without analgesics . A new topical anesthetic , liposomal lidocaine 4 % cream ( Maxilene , RGR Pharma , Windsor , Ont . ) , has become available . It has pharmacologic properties that are superior to other topical anesthetics , including an onset of action of only 30 minutes . We sought to determine the success rate of cannulation , analgesic effectiveness , procedure duration and rate of adverse skin reactions when liposomal lidocaine is used before intravenous cannulation of children . Methods : In this double-blind r and omized controlled trial , children aged 1 month to 17 years received liposomal lidocaine or placebo before cannulation . Success on first cannulation attempt was recorded , and , among children 5 years and older , pain was evaluated before and after the attempt by the child , parents and research assistant using a vali date d measure ( Faces Pain Scale-Revised ) . For children younger than 5 years , pain was evaluated by the parents and research assistant only . The total duration of the procedure and adverse skin reactions were also recorded . Results : Baseline characteristics did not differ ( p > 0.05 ) between children who received liposomal lidocaine ( n = 69 ) and those who received placebo ( n = 73 ) . Cannulation on the first attempt was achieved in 74 % of children who received liposomal lidocaine compared with 55 % of those who received placebo ( p = 0.03 ) . Among children 5 years of age and older ( n = 67 ) , lower mean pain scores during cannulation were reported by those receiving liposomal lidocaine ( p = 0.01 ) . Similarly , lower mean pain scores during cannulation were reported by the parents and research assistant for all children who received liposomal lidocaine than for all those who received placebo ( p mean total procedure duration was shorter with liposomal lidocaine ( 6.7 v. 8.5 minutes ; p = 0.04 ) . The incidence of transient dermal changes was 23 % in both groups ( p = 1.0 ) . Conclusions : Use of liposomal lidocaine was associated with a higher intravenous cannulation success rate , less pain , shorter total procedure time and minor dermal changes among children undergoing cannulation . Its routine use for painful cutaneous procedures should be considered whenever feasible",
"We evaluated the analgesic efficacy of EMLA cream after repeated bone marrow aspirations or lumbar punctures ( LPs ) in children with cancer , and compared the ratings among patients , their parents , physicians , and nurses . Data from LPs were analyzed at the last procedure without EMLA ( T1 ) and the first and last procedures with EMLA ( T2 and T3 ) . Friedman 's nonparametric analysis of variance was used for statistical analysis . A total of 272 procedures in 29 children were analyzed . For 179 procedures without EMLA , physicians rated pain lower than other raters , and for the 93 with EMLA physicians rated pain less than the children . Children rated pain at T2 lower than at T1 or T3 . Physicians rated pain at T2 less than at T3 . Both children and physicians rated pain at T3 as not different from that at T1 . No differences were noted at these time points for other raters in LP distress ratings , or in bone marrow aspiration pain or distress ratings . Thus EMLA was associated with decreased pain ratings for LPs , but this effect was not sustainable with repeated procedures . The cream alone should not be relied on to control pain of bone marrow aspiration or repeated LPs in children . Physicians underestimated pain , which may have implication s for undertreatment in this patient population",
"Paediatric limb fracture is a common injury that presents frequently to the ED . The primary objective of the present study was to determine whether ibuprofen provides better analgesia than paracetamol for paediatric patients discharged with acute limb fractures . A prospect i ve , r and omized controlled study was conducted in a children 's ED . Children aged 5 - 14 years with an acute limb fracture were r and omized to be prescribed paracetamol 15 mg/kg/dose every 4 h or ibuprofen 10 mg/kg/dose every 8 h. Objective ( child-reported ) pain scores using the ' Faces ' pain scale were measured over a 48 h period . Child-reported pain did not differ significantly between the paracetamol and ibuprofen groups ( mean pain score paracetamol 2.8 [ 95 % CI 2.4 - 3.4 ] vs 2.7 [ 95 % CI 2.1 - 3.3 ] , P = 0.73 ) . Parent-reported sleep quality did not differ between the two groups ( P = 0.78 ) . Child-reported pain score decreased over the 48 h of measurement ( P side-effects detected between the two groups . The present study shows that in the outpatient paediatric population , ibuprofen does not provide better analgesia than paracetamol . Pain from an acute fracture can be managed by regular simple oral analgesia and immobilization",
"OBJECTIVE The purpose of this investigation was to compare child behavior before surgery with experience of pain and anxiety in relation to two techniques of tonsil surgery , to relate previous experiences of surgery/tonsillitis with anxiety and pain , and to compare the children 's , parent 's and nurse 's rating of pain . METHOD Ninety-two children ( 5 - 15 years ) with sleep-disordered breathing ( SDB ) and with or without recurrent tonsillitis were r and omized to partial tonsil resection/tonsillotomy ( TT ) or full tonsillectomy ( TE ) . MEASURES Parents : Child Behavior Checklist ( CBCL ) . Children : State-Trait-Anxiety Inventory for Children ( STAIC ) and seven-point Faces Pain Scale ( FPS ) . Parents/staff : seven-point Verbal Pain Rating Scale ( VPRS ) . Pain relievers were opoids , paracetamol and diclophenac . RESULTS These children with SDB scored significantly higher on CBCL than did normative groups , but no connection was observed between CBCL rating and experience of pain . There was no relation between pre-operative anxiety and pain . The post-operative anxiety level ( STAIC ) correlated with pain . The TE-group scored higher on STAIC after surgery . Previous experience of surgery or tonsillitis did not influence post-operative pain . The TE-group rated higher experience of pain despite more medication . The nurses scored pain lower than the parents/children and under-medicated . CONCLUSION SDB may influence children 's behavior , but with no relation to post-operative pain . The surgical method predicts pain better than does the child 's behavior rating . The nurses underestimated the pain experienced by the child",
"BACKGROUND Oral controlled-release morphine can provide effective analgesia through a non-invasive route and may facilitate outpatient management of severe episodes of sickle-cell pain . We compared the clinical efficacy and safety of oral morphine with continuous intravenous morphine in children with severe episodes of sickle-cell pain , by a double-blind , r and omised , parallel-group design . METHODS 56 children aged 5 - 17 years received loading doses of intravenous morphine of up to 0.15 mg/kg , followed by r and omly assigned oral morphine 1.9 mg/kg every 12 h plus intravenous placebo ( saline ) , or intravenous morphine 0.04 mg kg-1 h-1 , plus placebo tablet . Breakthrough pain was treated with oral , immediate-release morphine 0.4 mg/kg every 2 - 3 h as required . Pain was assessed daily at 0900 h , 1300 h , 1700 h , and 2100 h with a picture face scale , a pictorial scale ( Oucher ) , a behavioural-observational scale ( CHEOPS ) , and by an investigator . FINDINGS 50 children completed the study ( 28 boys , 22 girls ; mean age 11.2 years [ SD 3.5 ] ; mean oral morphine dose 2.99 mg/kg daily [ 0.75 ] ; mean intravenous morphine dose , 0.81 mg/kg daily [ 0.30 ] ) . Mean overall pain scores were similar for oral and intravenous morphine ( CHEOPS , 6.3 [ 1.5 ] vs 6.4 [ 1.4 ] , p = 0.8 ; Oucher , 31.5 [ 25.4 ] vs 39.2 [ 21.7 ] , p = 0.3 ; Faces , 2.2 [ 1.4 ] vs 2.4 [ 1.3 ] , p = 0.6 ; clinical rating , 1.7 [ 0.7 ] vs 1.9 [ 0.5 ] , p = 0.3 ) . Opioid analgesia was required for a mean of 4.2 days ( 1.7 ) and 5.4 days ( 2.6 ) , respectively ( p = 0.0591 ) . Pain scores from all scales correlated significantly ( r = 0.5865 - 0.8980 , p = 0.0001 ) . Frequency of rescue analgesia did not differ significantly between the oral and intravenous morphine groups ( 0.7 [ 0.8 ] vs 0.9 [ 0.7 ] doses daily , p = 0.2 ) . Frequency and severity of adverse events did not differ significantly . INTERPRETATION Oral , controlled-release morphine is a reliable , non-invasive alternative to continuous intravenous morphine for the management of painful episodes of sickle-cell disease in children",
"Summary : Intravenous cannulation in children aged 6–12 years is less painful after a 90‐min application of a Lidocaine/ Prilocaine cream followed by a 30‐min interval without cream , than cannulation immediately after a 60‐min application",
"OBJECTIVE To test the convergent validity of the Manchester pain scale when compared to the current ' gold st and ard ' in children 's pain assessment , the Oucher pain scale . METHOD One hundred and fifty two children presenting to the emergency department had pain scale assessment s using both the Manchester and Oucher pain scales . The order of presentation of the scales was r and omised . The degree of convergence between the scales was assessed using Spearman 's rank correlation as well as Bl and and Altman plots . RESULTS One hundred and thirteen children used numerical scales ; the correlation coefficient for these was 0.802 . Thirty nine children used pictorial scales ; the correlation coefficient was 0.820 . CONCLUSION There is strong convergent validity between the scales as demonstrated by a high degree of correlation between the numerical and pictorial scores generated by the Manchester and Oucher pain scales . The Manchester pain scale can be used to assess pain in children presenting to emergency departments",
"OBJECTIVE To examine whether microdebrider intracapsular tonsillotomy ( MT ) results in less postoperative pain compared with electrosurgical extracapsular tonsillectomy ( ET ) . DESIGN Prospect i ve , r and omized , double-blind , matched pair , clinical trial . SETTING Specialty care hospital . Patients Twelve male ( 48 % ) and 13 female ( 52 % ) children aged 5 to 15 years , with obstructive tonsillar hyperplasia were r and omized to have one tonsil removed by MT and the other by ET . INTERVENTIONS An angled endoscopic microdebrider was used to perform MT , and ET was performed by st and ard monopolar cautery technique . Parents and children were blinded to the side of MT and ET . Children rated the pain 0 to 5 by side using the Faces Pain Scale-Revised . Blinded data collection was via telephone daily for 2 weeks by a study nurse . MAIN OUTCOME MEASURES Primary : postoperative pain as recorded by Faces Pain Scale-Revised ; secondary , presence or absence of otalgia and postoperative bleeding . RESULTS Twenty-two children ( 88 % ) had tonsillectomy and adenoidectomy , while 3 children ( 12 % ) had tonsillectomy alone . On postoperative days 1 to 9 , children reported significantly less pain on the MT side compared with the ET side ( paired t test ; P otalgia , and it was always unilateral . For those children reporting otalgia , there was a 100 % correlation between the side of otalgia and the side of ET . There was no posttonsillectomy bleeding among the 25 children . CONCLUSION Microdebrider intracapsular tonsillotomy is significantly less painful compared with electrosurgical ET in children undergoing surgical intervention for obstructive tonsillar hypertrophy",
"AIMS To evaluate the effectiveness of an analgesic protocol with nitrous oxide and anaesthetic cream ( lidocaine and prilocaine , EMLA ) for children undergoing botulinum toxin injections . PATIENTS AND METHODS Prospect i ve study including 51 injection sessions , 34 children with a mean age of 5.94 ( range 2 - 15 ) and 209 injected muscles . Pain was evaluated with the Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) , the Visual Analogue Scale ( VAS ) and the Face Pain Scale ( FPS ) for the children and with a VAS for the parents . RESULTS CHEOPS score for the 51 sessions was 8.50 ( S.D. 3.56 ) . Forty-nine percent of scores were above the therapeutic threshold of 9 ; 25 % of the children evaluated the pain above the therapeutic threshold of 3 ; 44.74 % of the parents ' estimations exceeded 3 . No correlation was found between age , weight , number of injected muscle and CHEOPS score . CONCLUSION The association of MEOPA and anaesthetic cream is only effective for 50 % of children . This is much lower than treatments for other types of acute induced pain in children . Botulinum toxin injections and cerebral palsy children present certain specificities which require improvements in this analgesic protocol",
"Faces scales have become the most popular approach to eliciting children 's self-reports of pain , although different formats are available . The present study examined : ( a ) the potential for bias in children 's self-reported ratings of clinical pain when using scales with smiling rather than neutral ' no pain ' faces ; ( b ) levels of agreement between child and parent reports of pain using different faces scales ; and ( c ) preferences for scales by children and parents . Participants were 75 children between the ages of 5 and 12 years undergoing venepuncture , and their parents . Following venepuncture , children and parents independently rated the child 's pain using five different r and omly presented faces scales and indicated which of the scales they preferred and why . Children 's ratings across scales were very highly correlated ; however , they rated significantly more pain when using scales with a smiling rather than a neutral ' no pain ' face . Girls reported significantly greater levels of pain than boys , regardless of scale type . There were no age differences in children 's pain reports . Parents ' ratings across scales were also highly correlated ; however , parents also had higher pain ratings using scales with smiling ' no pain ' faces . The level of agreement between child and parent reports of pain was low and did not vary as a function of the scale type used ; parents overestimated their children 's pain using all five scales . Children and parents preferred scales that they perceived to be happy and cartoon-like . The results of this study indicate that subtle variations in the format of faces scales do influence children 's and parents ' ratings of pain in clinical setting",
"BACKGROUND tonsillectomy ( TE ) is currently the most common treatment for children with snoring and sleep apnea . Many of these children have not had any severe throat infections . To cure such children from their obstructive problems , without influencing the immunological function of the tonsils , tonsillotomy ( TT ) with CO2-laser was performed in a r and omized study comparing it to regular tonsillectomy , with special attention to postoperative pain and symptom recurrence . METHOD 41 children 3.5 - 8 years-old were included--21 ' TT 's ' and 20 ' TE 's ' . They were all operated under the same anesthesia and followed the same postoperative scheme for analgesia . A visual analogue scale for pain measurements with faces was used for the first 24 h. After that , each day until pain-free , the parents registered the child 's pain on a three grade d scale , what the child was able to eat , and the amount of analgesic drugs used . RESULTS all the children were cured from their breathing obstruction . The mean time used for the surgery was the same and no postoperative bleeding was seen in either group . ' TT children ' were pain-free after 5 days and ' TE children ' after 8 days . Eight to ten days after surgery , the TT-children had gained weight and the TE children lost weight significantly . The TE group used twice as much analgesic drugs as the TT group during the first postoperative week . The TT group was healed with normal-looking , but small tonsils after 8 - 10 days ; the TE group often still showed edema and crusts . At the one-year follow-up 2/21 among the ' TT-children ' snored , but did not require re-surgery . CONCLUSION tonsillotomy is much less painful than TE and children recover more quickly . Results with respect to breathing obstruction are almost the same for both methods at 1-year follow-up",
"As day case surgery increases , one needs to improve the management of pain in children at home . This study wished to determine whether the use of a self-report pain scale would result in children receiving more analgesia . Eighty-eight children aged four to 12 years undergoing tonsillectomy , whose parents agreed they could participate , were r and omly assigned into two groups . Group A received the routine postoperative advice and a three-day prescription of paracetamol , ibuprofen and codeine . In addition , group B used the Wong — Baker Faces Pain Scale . Seventy-two children completed the study . There was no difference in the total number of analgesics administered to children in the two groups ( p = 0.26 , Mann— Whitney U-test ) . It appears that a self-report pain scale does not improve the postoperative management of pain in children at home",
"Abstract Despite its importance in clinical practice , little research has examined memory for pain in children . This prospect i ve study tried to justify the use of children 's pain recall in clinical practice . The purpose of this study was to ( a ) investigate the accuracy of children 's recall of their worst and average pain intensity when controlling for the effects of repeated pain measurement and ( b ) examine the influence of children 's anxiety , age , general memory ability and pain coping strategies on this accuracy . The accuracy of children 's recalled pain intensities was studied in 55 in patients aged 5–16 years by comparing the level of recorded pain intensity with the level of recalled pain intensity 1 day and 1 week after recording using Bieri 's Faces Pain Scale . The accuracy of children 's recalled pain intensities was high and showed little decrement over 1 week . Older children had more accurate recall of their worst pain intensity . Anxiety , general memory ability and pain coping strategies were not related to accuracy of recalled pain intensities",
"OBJECTIVE To evaluate the effectiveness of audiovisual distraction compared with a blank TV screen in the reduction of pain associated with intramuscular immunization . DESIGN Subjects were r and omly assigned to watch television ( TV ) ( N = 29 ) or a blank TV screen ( control ) ( N = 33 ) during immunization , and were videotaped . Immediately after the injection , the children rated their pain . Videotapes were coded for pain behaviors and for distraction . t tests determined between-group mean differences and chi-square tests compared proportions for clinical ly significant self-reported pain . SETTING Two urban pediatric practice s in Halifax , Nova Scotia , Canada . SUBJECTS Five-year-old children ( N = 62 ) , undergoing diphtheria , polio , tetanus , and pertussis immunization , and their parents . INTERVENTIONS An age-appropriate musical cartoon or a blank TV screen . OUTCOME MEASURES Pain measurements were the children 's self-reports on Faces Pain Scale , facial actions on Child Facial Coding System , and Children 's Hospital of Eastern Ontario Pain Scale . Distraction was measured by mean time spent watching the TV screen . Parents rated their own and their child 's anxiety on a visual analogue scale . RESULTS There were no significant group differences for any pain or distraction measures . The relative risk estimate for clinical ly significant pain among the distraction group was 0.64 ( range : 0.23 - 1.80 ) . Higher levels of distraction ( i.e. , greater time looking at the TV screen ) related to lower levels of pain on all three pain measures . Only correlations with objective pain measures were statistically significant . CONCLUSIONS Watching cartoons did not distract children during needle injection nor reduce their pain . Looking at the TV screen was related to lower behavioral pain scores in the total sample",
"OBJECTIVE To investigate the influence of recommendations on the quality of postoperative pain management in children . DESIGN Prospect i ve . SETTING University Hospital Groningen , the Netherl and s. METHOD After interdisciplinary recommendations on postoperative pain were developed , the quality of postoperative pain management was investigated before implementation ( phase I ; n = 50 children aged 0 - 14 who underwent elective surgery ) , three months after the implementation ( phase II ; n = 51 ) , and nine months later ( phase III ; n = 50 ) . Quality was defined by a pain score ( for ages 0 to 4 with the ' Children 's Hospital of Eastern Ontario pain scale ' ( CHEOPS ) and for ages 4 - 14 with the Oucher scale ) and the prescription of analgetics : kind , dose , frequency , prescription by anaesthetist and doctor on the ward . Pain was scored every 2 hours during the first 24 hours after surgery . A CHEOPS score Pain measurement showed a statistically significant improvement of pain scores in time ( phase II and III compared with phase I : odds ratio : 2.5 ; 95 % confidence interval : 1.03 - 6.00 ; p score their pain by self-report ( Oucher ) showed the best results in all 3 phases of the study . The youngest children , i.e. less than 6 months old , showed inadequate results during the whole study . The greatest improvement in time during the first 12 hours was seen in the group of children older than 6 months . The recommendations were followed more strictly in younger children , and when continuous morphine was given . CONCLUSION Pain scores in children improved after the introduction of recommendations on postoperative pain . However , the improvement could not be attributed to factors like medication . Factors like a change in attitude towards pain could be responsible for this change",
"OBJECTIVE To evaluate and compare the reaction of children who received local anaesthesia with lidocaine 2 % with 1 : 100 000 epinephrine and articaine 4 % with 1 : 200 000 epinephrine and to assess the time of the onset , efficacy , duration of numbness of the soft tissues , children 's sensation after treatment to both anaesthetic solutions , as well as the occurrence of adverse events . SAMPLE S AND METHODS Sixty-two children ( 34 girls and 28 boys ) aged 5 - 13 years ( mean age 8.4 + /- 2.3 ) from two established paediatric dental clinics who needed similar operative procedures preceded by local anaesthesia were r and omly assigned to receive either lidocaine or articaine at their first or second visit . Modified Taddio 's behavioural pain scale was used to evaluate pain reaction during injection and treatment . The sensation after injection and treatment was evaluated using the Wong-Baker FACES pain rating scale . Parents recorded the time when the feeling of local anaesthesia in soft tissues disappeared . RESULTS Duration of numbness of soft tissues was significantly longer for articaine ( 3.43 + /- 0.7 h ) than for lidocaine ( 3.0 + /- 0.8 h ) ( P = 0.003 ) . No difference regarding the efficacy of the anaesthesia was observed . Reaction to pain was similar for both local anaesthetic solutions and no significant difference was found between genders . The efficacy of the anaesthesia was similar for both solutions . The feeling after treatment was similar for both solutions . The rate of adverse effects was similar for the two solutions . CONCLUSIONS Articaine 4 % with 1 : 200 000 epinephrine is as effective as lidocaine 2 % with 1 : 100 000 epinephrine . The effect of numbness of soft tissues was longer lasting with articaine than with lidocaine",
"OBJECTIVES : To compare postoperative tonsillectomy pain between 3 commonly used surgical devices : the Harmonic Ultrasonic Scalpel ( Ethicon Endo-Surgery , Cincinnati , OH ) , the Coblator ( ArthroCare Corp , Sunnyvale , CA ) , and electrocautery . STUDY DESIGN AND SETTING : A prospect i ve , r and omized trial . One hundred thirty-four patients were r and omly assigned to receive a tonsillectomy with 1 of 3 surgical devices . All patients were asked to fill out a postoperative diary . RESULTS : Statistically significant differences in pain scores were revealed between the Coblator and electrocautery ( P = 0.02 ) and between the Coblator and the Ultrasonic Scalpel ( P = 0.003 ) , with the Coblator having lower pain scores . Electrocautery and the Ultrasonic Scalpel did not differ significantly from each other . The Coblation method showed a strong trend toward quicker return to normal diet . CONCLUSION : Patients undergoing tonsillectomy with the Coblator device reported less pain over a 10-day period than patients undergoing tonsillectomy with electrocautery or the Ultrasonic Scalpel . Pain after tonsillectomy remains a major issue for our patients . The choice of surgical instrument appears to be one way to reduce this pain . EBM rating :",
"OBJECTIVE To compare intraoperative efficiency and postoperative recovery between cold dissection adenotonsillectomy ( CDA ) and coblation-assisted adenotonsillectomy ( CAA ) . METHODS A prospect i ve , r and omized , single-blind trial of pediatric patients aged 2 to 16 years undergoing adenotonsillectomy was conducted . Patients were r and omized to undergo either CDA or CAA . Measured intraoperative parameters included surgical duration and intraoperative blood loss . Measured postoperative parameters included a 14 day caregiver question naire that recorded a daily pain rating using the Wong-Baker FACES pain scale , pain medication use , days to return to a normal diet , and days to return to a normal caregiver routine . Postoperative complications were also recorded . Intraoperative and postoperative measures were statistically compared between groups . RESULTS Forty-six children with a mean age of 6.7 years ( 23 CDA and 23 CAA ) were r and omized and completed the study . Mean age and sex distributions were similar between groups ( P > .05 ) . Surgical times were significantly shorter for the CAA group versus the CDA group ( 11.2 min vs. 17.0 min , P Intraoperative blood loss was statistically lower for both the adenoidectomy and tonsillectomy portions of the procedure for the CAA group versus the CDA group ( P daily pain scores between groups ( P = .296 , analysis of variance ) . Both groups returned to normal diet ( P = .982 ) , and caregivers returned to their normal routine on similar postoperative days ( P = .631 ) . CONCLUSIONS CAA offers better operative speed and intraoperative hemostasis as compared with CDA . However , CAA does not result in poorer postoperative pain scores or recoveries despite these intraoperative advantages",
"BACKGROUND Pain treatment is one of the main concerns of paediatric anaesthesiologists . The purpose of this study was to assess and compare the quality of analgesia and stress suppression by morphine when used [ epidural ( single shot ) ( EP ) or with intravenous ( i.v . ) for patient-controlled analgesia ( PCA ) in children ] . METHODS Forty-four children , aged 5 - 15 years , and who were undergoing major genitourinary or lower abdominal surgery with a st and ardized general anaesthesia technique , were included in this study . In the EP group ( n=24 ) 0.1 mg x kg(-1 ) morphine in 0.2 ml x kg(-1 ) saline were given epidurally at the L3 - 4 level and in the PCA group ( n=20 ) 0.1 mg x kg-1 morphine was given i.v . immediately after intubation . Postoperative PCA bolus doses were 0.5 mg for patients weighing less than 20 kg , 1 mg for children weighing 20 - 30 kg and 1.5 mg for children weighing 30 - 40 kg . Blood sample s were withdrawn following induction and at 1 , 8 , 12 and 24 h after morphine administration for measurement of blood glucose , insulin , cortisol and morphine levels . Patients were observed for 24 h postoperatively ; heart rate , systolic blood pressure , respiratory rate , FACES pain scores , sedation scores and complications were recorded . RESULTS The PCA group received 0.56 + /- 0.33 mg x kg(-1 ) x day(-1 ) morphine . The FACES pain scores , sedation scores , cortisol , blood glucose and insulin levels were similar in both groups . Haemodynamic and respiratory evaluations and cortisol levels were stable but blood glucose and insulin changes at certain time periods were significant ( P Serum morphine levels and incidence of vomiting were different between groups ( P Serum morphine levels were similar at the first hour . CONCLUSIONS Both techniques provided sufficient pain relief and attenuated the hormonal response without life-threatening complications",
"OBJECTIVES To study the effects of music on anxiety and pain in children with cerebral palsy receiving acupuncture daily in a clinical setting . DESIGN A r and omized controlled trial . SETTING Acupuncture Unit at Shenzhen Hospital of Traditional Chinese Medicine in Shenzhen City of China . PARTICIPANTS Sixty children with cerebral palsy undergoing acupuncture . METHODS INTERVENTION Children listened to their favorite music or a blank disc for 30 min . MEASUREMENTS ( 1 ) the modified Yale preoperative anxiety scale for children 's anxiety ( mYPAS ) ; ( 2 ) children 's hospital of eastern Ontario pain scale ( CHEOPS ) and Wong-Baker faces pain rating scale ( FACES ) for pain intensity ; ( 3 ) vital signs including mean arterial blood pressure ( MAP ) , heart rate ( HR ) and respiratory rate ( RR ) . RESULTS An independent sample t-test showed significantly lower mYPAS scores in the music group 30 min after the intervention compared with the control group ( t=4.72 , P=0.00 ) . Significant differences between groups were found in mYPAS scores ( F=4.270 , d.f.=1 , P=0.043 , Partial eta(2)=0.069 ) and over treatment duration ( F=143.421 , d.f.=1.521 , P=0.000 , Partial eta(2)=0.712 ) . A significant interaction was also found ( F=4.298 , d.f.=1.521 , P=0.025 , Partial eta(2)=0.069 ) . LSD 's post hoc testing confirmed that the mYPAS scores significantly increased from the baseline to 1 min ( P=0.000 , 95 % CI 14.913 , 20.257 ) and then gradually decreased from 1 to 30min ( P=0.000 , 95 % CI -18.952 , -13.714 ) . For pain intensity scores , a highly significant time effect was found in both the CHEOPS ( F=87.347 , d.f.=2 , P=0.000 , Partial eta(2)=0.601 ) and FACES ( F=225.871 , d.f.=1.822 , P=0.000 , Partial eta(2)=0.796 ) , and a significant interaction effect was found as well ( F=4.369 , d.f.=2 , P=0.015 , Partial eta(2)=0.070 ; F=5.859 , d.f.=1.822 , P=0.005 , Partial eta(2)=0.092 ) . However , no significant difference between groups was present ( F=2.343 , d.f.=1 , P=0.131 , Partial eta(2)=0.039 ; F=3.738 , d.f.=1 , P=0.058 , Partial eta(2)=0.061 ) . Significant differences between groups were found in MAP and HR ( P effects in RR were apparent ( P>0.05 ) . A significant interaction effect was found in HR ( P MAP or RR ( P>0.05 ) . CONCLUSIONS This study demonstrates that listening to music while receiving acupuncture can relieve anxiety among children with cerebral palsy ; however , no effect was observed in terms of pain reduction . Further research is needed to explore the types of music which best impact an individual 's treatment . Whether music results in fewer accidents and side effects of acupuncture should be investigated . Music can be considered as adjunctive therapy in clinical situations that may be anxiety-provoking for children",
"OBJECTIVES : Tonsillectomy , with or without adenoidectomy , is one of the most common surgical procedures in pediatric otolaryngology . Pain is the main cause of morbidity in the postoperative period , where it is serious in some cases , leading to odynophagia and result ant complications such as dehydration . We evaluated the effect of topical clindamycin in the reduction of oropharyngeal pain in children who underwent adenotonsillectomy . Secondary outcomes were otalgia , analgesic use , oral bacterial count , type of diet , secondary bleeding , vomiting , fever , and weight loss . STUDY DESIGN : Double-blind , r and omized clinical trial . SETTING : Tertiary hospital . SUBJECTS AND METHODS : Eighty-two children of both sexes between four and 12 years of age who underwent adenotonsillectomy were allocated to receive topical clindamycin or placebo in the immediate preoperative , intraoperative , and eight-to12-hours postoperative periods . Pain was measured using a faces pain scale for five days . RESULTS : Reduction of oropharyngeal pain was significant with the use of clindamycin only on the first postoperative day ( 95 % confidence interval , 2.22 to 4.41 [ clindamycin ] vs 4.53 to 6.3 [ placebo ] ; P = .002 ) . No difference was observed in the aerobic and anaerobic counts by tongue swab between premedication and third-postoperative-day samplings . There were no differences with respect to reduction in otalgia , paracetamol use , return to normal diet , variation in weight , secondary hemorrhage , vomiting , and fever . CONCLUSION : The use of topical clindamycin was beneficial in reducing pain on the first postoperative day , without effect on subsequent days . Future investigations could examine the use of topical clindamycin not only in the first 12 hours but also during five days of follow-up",
"Background : A r and omized , double-blinded trial was performed to evaluate the efficacy and safety of the S-Caine Patch ™ ( ZARS , Inc. , Salt Lake City , UT ) , a eutectic mixture of lidocaine and tetracaine , for pain relief during venipuncture in children . Methods : With institutional review board approval , parental consent , and patient assent , 64 children who were scheduled for medically indicated vascular access at two centers were r and omly assigned ( 2:1 ) to receive either an S-Caine Patch ™ or a placebo patch for 20 min before venipuncture procedures . The primary outcome measure was the child ’s rating of pain during venipuncture using the Oucher pain scale . Additional measures of efficacy included the blinded investigator ’s and an independent observer ’s four-point categorical scores . Variables were compared between treatments using Mantel – Haenszel summary chi-square tests or Pearson chi-square tests . Results : The S-Caine Patch ™ produced significantly greater pain relief compared with placebo ( median Oucher scores of 0 vs. 60 ; P the S-Caine Patch ™ group reported no pain compared with 20 % of the children in the placebo patch group . The investigator estimated that 76 % of the children in the S-Caine Patch ™ group experienced no pain during venipuncture versus 20 % in the placebo patch group ( P = 0.001 ) . Independent observer ratings also favored the S-Caine Patch ™ ( P 0.001 ) . Mild skin erythema ( and edema ( of the S-Caine Patch ™ is effective in lessening pain associated with venipuncture procedures . Adverse events after S-Caine Patch ™ application were mild and transient",
"BACKGROUND EGD is essential to the investigation and treatment of GI disorders in children . Although safe , EGD has the potential for complications , in particular cardiopulmonary abnormalities associated with intravenous sedation . EGD is often performed in adults without sedation . Unse date d EGD is occasionally performed in children but has not been subjected to study . This study assessed the safety , efficacy , and feasibility of unse date d EGD in children . METHODS Selected , highly motivated children requiring EGD were offered the choice of sedation or no sedation for the procedure . Children recorded scores for pain ( face scale ) and anxiety ( vertical visual analogue scale ) before and after EGD . In addition , the times required to prepare the patient , perform the EGD , and recover the patient were recorded . RESULTS There was no difference in age , gender , or pre-EGD pain scores between children selecting sedation or no sedation . However , children selecting sedation had significantly higher pre-EGD anxiety scores than those who chose no sedation . Successful completion of EGD was similar for se date d ( 96.3 % ) and unse date d ( 95.2 % ) children . Post-EGD scores for anxiety were significantly decreased in those receiving sedation and unchanged in children who received no sedation . There was no significant change in post-EGD pain score in either group . Nearly 80 % of children undergoing unse date d EGD would elect to forego sedation if EGD was needed again . Total procedure time was significantly longer in se date d versus unse date d children , reflecting longer preparation and recovery . CONCLUSIONS Unse date d EGD can be performed safely and successfully in children with good patient tolerance . There was a significant decrease in total procedure time for children who have unse date d EGD . Unse date d EGD should be considered a viable option for motivated children",
"OBJECTIVE Visual analog pain scales are reliable measures in older children and adults ; however , pain studies that include young children often rely on parental or practitioner assessment s for measuring pain severity . The authors correlated patient , parental , and practitioner pain assessment s for young children with acute pain . METHODS This was a prospect i ve , descriptive study of a convenience sample of 63 emergency department patients aged 4 - 7 years , with acute pain result ing from acute illness or painful invasive procedures . A trained research assistant administered a structured pain survey containing demographic and historical features to all parents/guardians . Children assessed their pain severity using a vali date d ordinal scale that uses five different faces with varying degrees of frowning ( severe pain ) or smiling ( no pain ) . Each face was converted to a numeric value from 0 ( no pain ) to 4 ( severe pain ) . Parents and practitioners independently assessed their child 's pain using a vali date d 100-mm visual analog scale ( VAS ) marked \" most pain \" at the high end . Pairwise correlations between child , parent , and practitioner pain assessment s were performed using Spearman 's or Pearson 's test as appropriate . The association between categorical data was assessed using chi(2 ) tests . RESULTS Sixty-three children ranging in age from 4 to 7 were included . Mean age ( + /-SD ) was 5.7 ( + /-1.1 ) ; 42 % were female . Fifty-seven successfully completed the face scale . The distribution of the children 's scores was 0 - 17 % , 1 - 9 % , 2 - 30 % , 3 - 14 % , and 4 - 30 % . Mean parental and practitioner scores ( + /-SD ) on the VAS were 61 ( + /-26 ) mm and 37 ( + /-26 ) mm , respectively ( maximal = 100 mm ) . Correlation between child and parent scores was 0.47 ( p pain ratings by children , parents , and practitioners . It is unclear which assessment best approximates the true degree of pain the child is experiencing",
"OBJECTIVE . The Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-Free Powder Lidocaine or Placebo Treatment trial was a r and omized , single-dose , double-blind , phase 3 study investigating whether a needle-free powder lidocaine delivery system ( a sterile , prefilled , disposable system that delivers lidocaine powder into the epidermis ) produces effective local analgesia within 1 to 3 minutes for venipuncture and peripheral venous cannulation procedures in children . METHODS . Pediatric patients ( 3–18 years of age ) were r and omly assigned to treatment with the needle-free powder lidocaine delivery system ( 0.5 mg of lidocaine and 21 ± 1 bar of pressure ; n = 292 ) or a sham placebo system ( n = 287 ) at the antecubital fossa or the back of the h and 1 to 3 minutes before venipuncture or cannulation . All patients rated the administration comfort of the needle-free systems and the pain of the subsequent venous access procedures with the Wong-Baker Faces Pain Rating Scale ( from 0 to 5 ) . Patients 8 to 18 years of age also provided self-reports with a visual analog scale , and parents provided observational visual analog scale scores for their child 's venous access pain . Safety also was assessed . RESULTS . Immediately after administration , mean Wong-Baker Faces scale scores were 0.54 and 0.24 in the active system and sham placebo system groups , respectively . After venipuncture or cannulation , mean Wong-Baker Faces scale scores were 1.77 ± 0.09 and 2.10 ± 0.09 and mean visual analog scale scores were 22.62 ± 1.80 mm and 31.97 ± 1.82 mm in the active system and sham placebo system groups , respectively . Parents ' assessment s of their child 's procedural pain were also lower in the active system group ( 21.35 ± 1.43 vs 28.67 ± 1.66 ) . Treatment-related adverse events were generally mild and resolved without sequelae . Erythema and petechiae were more frequent in the active system group . CONCLUSIONS . The needle-free powder lidocaine delivery system was well tolerated and produced significant analgesia within 1 to 3 minutes",
"BACKGROUND Differences in pain response to two different M-M-R products have previously been demonstrated in 12-month old infants and in 4 â 6 year old children . Objective To determine if the acute and immediate pain response to two licensed M-M-R vaccine products ( using a self-report measure ) in children 4 - 6 years of age was similar to that demonstrated in younger infants . METHODS R and omized , double blind , study . Subjects were r and omly allocated to PriorixA ( SmithKline Beecham ) or M-M-R IIA ( Merck Frosst ) . The primary outcome measure was pain response to vaccination quantified using a self-report OUCHER pain scale . Secondary outcome measures included pain measurement by proxy ( physician and parent ) using a visual analog scale ( VAS ) and measurement of cry and cry duration immediately post-vaccination . RESULTS Of the 60 subjects enrolled , 30 received PriorixA and 30 received M-M-R IIA . There were no significant differences between the two groups on age , sex , or previous painful procedure . Post-vaccination , children in the M-M-R IIA group had higher median pain scores compared with children in the PriorixA group for VAS ( 12.5 vs. 2.0 , respectively by paediatricians , p=0.017 ; 18.5 vs. 5.0 , respectively by parents , p=0.235 ) , OUCHER ( 20 vs. 0.00 , respectively , p=0.047 ) . The median duration of crying post M-M-R IIA was higher compared with PriorixA ( 6 vs. 0 seconds , respectively , p=0.020 ) . Conclusion PriorixA was associated with significantly less pain compared with M-M-R IIA , at the time of injection",
"STUDY OBJECTIVE In children , the agreement between the many scales used to document the intensity of pain is not well known . Thus , to determine the agreement , we evaluate the visual analog scale , the st and ardized color analog scale , the Wong-Baker FACES Pain Rating Scale , and a verbal numeric scale in children with acute abdominal pain suggestive of appendicitis in a pediatric emergency department ( ED ) . METHODS Participants were children who were aged 8 to 18 years , presented to a pediatric ED with abdominal pain suggestive of appendicitis , and were recruited to participate in a r and omized controlled trial evaluating the efficacy of morphine . Patients were initially asked to grade their pain on a plasticized color analog scale , a paper visual analog scale , a paper Wong-Baker FACES Pain Rating Scale , and then with a verbal numeric scale . Thirty minutes after morphine or placebo administration , the assessment was repeated . All scores were then converted to a value of 0 to 100 . Agreements between scores were evaluated with the Bl and -Altman method , and the 95 % lower and upper limits were reported . We defined a priori the maximum limit of agreement at + /-20 mm . RESULTS A total of 87 children were included in the study , 58 of them with confirmed appendicitis . The 95 % limits of agreement for each pair of scales were visual analog scale/color analog scale -18.6 , 14.4 ; visual analog scale/Wong-Baker FACES Pain Rating Scale -20.1 , 33.7 ; visual analog scale/verbal numeric scale -30.2 , 20.7 ; color analog scale/Wong-Baker FACES Pain Rating Scale -18.5 , 36.3 ; color analog scale/verbal numeric scale -26.9 , 22.1 ; and Wong-Baker FACES Pain Rating Scale/verbal numeric scale -38.7 , 15.7 . CONCLUSION Our study suggests that only the visual analog scale and the color analog scale have acceptable agreement in children with moderate to severe acute abdominal pain . In particular , the verbal numeric scale is not in agreement with the other evaluated scales",
"Objective : To investigate the efficacy of nasal sumatriptan in migraine attacks of children and adolescents . Methods : A double-blind , placebo-controlled , two-way crossover trial was conducted in three hospital outpatient departments , with 8 to 17 year olds diagnosed with migraine serving as subjects ( International Headache Society 1988 ) . A single dose of sumatriptan nasal spray and a matching placebo were administered at home during two attacks . The sumatriptan dose was 10 mg for a body weight of 20 to 39 kg and 20 mg for those with a body weight of ≥40 kg . The primary efficacy endpoint was headache relief by two grade s on a 5- grade face scale at 2 hours . Results : Eighty-three patients used both treatments and 11 only the first . At 2 hours , the primary endpoint was reached nearly twice as often after sumatriptan ( n = 53/83 ; 64 % ) as after placebo ( n = 32/83 ; 39 % ) ( p = 0.003 ) . Already at 1 hour , headache relief was seen more often after sumatriptan ( n = 42/83 ; 51 % ) than after placebo ( n = 24/83 ; 29 % ) ( p = 0.014 ) . The difference was even more obvious in patients who received the 20-mg dose as well as in the intention-to-treat analyses ( n = 94 ) . Other endpoints , including child ’s preference and using rescue medication , also favored sumatriptan . The most common adverse effect was a bad taste after sumatriptan , reported in 29 % ( n = 26/90 ) of the attacks . No serious adverse effects were observed . Conclusion : Nasal sumatriptan is an effective and well-tolerated treatment for migraine attacks in children over 8 years of age",
"BACKGROUND We have compared ropivacaine with bupivacaine and lidocaine for ilioinguinal block in thirty children undergoing ambulatory inguinal hernia repair . METHODS Patients were assigned r and omly to receive 0.5 ml.kg(-1 ) of 0.2 % ropivacaine ( Group R , n = 10 ) , 0.25 % bupivacaine ( Group B , n = 10 ) or 1 % lidocaine ( Group L , n = 10 ) . The patients ' parents , who were not informed of the type of local anaesthetic employed , evaluated the postoperative pain at 2 h and 6 h after operation using the Wong-Baker FACES Pain Rating Scale . RESULTS There was a significant difference in the face scale score between Group R and Group L , and Group B and Group L. There was no difference in the face scale score between Group R and Group B. There were no complications or clinical evidence of local anaesthetic toxicity . CONCLUSIONS We have confirmed that bupivacaine and ropivacaine are more effective than lidocaine in the prevention of postoperative pain after children 's inguinal hernia repair . We suggest that ropivacaine 0.2 % is an alternative to bupivacaine 0.25 % for ilioinguinal block in ambulatory paediatric surgery",
"OBJECTIVE : To compare the postoperative recovery of patients receiving Coblation-assisted ( Arthrocare , Sunnyvale , CA ) intracapsular tonsillectomy with that of patients receiving traditional subcapsular electrocautery tonsillectomy . STUDY DESIGN AND SETTING : This was a prospect i ve , r and omized , double-blinded , controlled study . One hundred one children , aged 2 to 16 years , were r and omized to Coblation or to conventional electrocautery tonsillectomy . Only patients with the operative indication of obstructive sleep apnea were entered into the study . Intracapsular tonsillectomy was performed on the Coblation group , and traditional subcapsular dissection was performed on the electrocautery group . Adenoidectomy was performed with the curette in both groups . Outcome measures were assessed on days 1 , 3 , and 5 after surgery . These included child and parental rating of pain by using the Wong Faces pain scale , analgesic use , oral intake , and activity level . Patients , parents , and the nurse practitioner obtaining the outcome data were blinded to treatment arm . RESULTS : Treatment groups were similar in age , gender , and weight . Surgical time and estimated blood loss were similar . There were no complications in either group . Coblation patients had less pain and greater oral intake at all 3 time points . Percentage of normal activity level returned to > 70 % earlier and more frequently in Coblation patients . There was slightly decreased analgesic use on postoperative day 5 in the Coblation group . CONCLUSIONS AND SIGNIFICANCE : Children with obstructive sleep apnea undergoing tonsillectomy and adenoidectomy demonstrate significantly better postoperative recovery after Coblation-assisted intracapsular tonsillectomy",
"PURPOSE This research compared the effect of two forms of distraction on injection pain in a convenience sample of preschool children . DESIGN A quasi-experimental study of 105 children ( 53 girls and 52 boys ) ages 4 to 6 years needing DPT immunizations . Data were collected at three sites : two school-based immunization clinics and one public health center with a walk-in immunization program . METHODS Study children were r and omly assigned to receive one of three treatments with their DTP injection : touch , bubble-blowing , or st and ard care . Prior to injection , a measure of medical fear was obtained ( Child Medical Fear Scale ) and pain was measured through use of the Oucher Scale . DATA ANALYSIS Planned comparisons within analysis of variance ( ANOVA ) tested the differences in pain scores by treatment . Factorial ANOVA was used to determine the influence of age or gender on treatment , and the effect of medical fear on pain was analyzed using correlational statistics and factorial ANOVA . RESULTS Both forms of distraction , touch and bubble-blowing , significantly reduced pain perception . There were no interaction effects of either age or gender . Fear was a significant covariate , but distraction was effective even when fear was not held constant . CLINICAL IMPLICATION S Distraction appears to be an effective method for decreasing injection pain in young children . It is an easy , practical nursing intervention to help children cope with this common , painful experience",
"OBJECTIVES /HYPOTHESIS Pain is a major cause of morbidity after tonsillectomy . Although various efforts have been made to reduce pain , the use of oral analgesics , which can have adverse side effects , remains the st and ard of care . It is hypothesized that fibrin sealant , used to achieve hemostasis and enhance healing in many surgical procedures , might help decrease pain after this operation . STUDY DESIGN A prospect i ve , r and omized , blinded study was performed on 20 children aged 5 to 17 years who were undergoing tonsillectomy , to evaluate the efficacy of FIBRIN SEALANT in reducing postoperative pain . METHODS All patients pre-donated 40 mL of blood from which autologous concentrated fibrinogen was prepared by cryoprecipitation . In the fibrin sealant group , fibrinogen and topical bovine thrombin were sprayed onto the surgical site to form fibrin sealant at the conclusion of tonsillectomy . The 10 patients in the control group ( C ) received no fibrin sealant . Patients rated their level of pain immediately after surgery and at regular intervals for 3 days after surgery using the Wong-Baker Faces Pain Rating Scale ( 1 - 6 ) . Emesis , postoperative bleeding , medications , and adverse events were also evaluated . RESULTS At 7.00 P.M. on postoperative day ( POD ) 0 , the mean + /- SD fibrin sealant group pain score ( 2.9+/-0.41 units ) was significantly lower than for the C group ( 4.1+/-0.43 units ; P pain in the fibrin sealant group at 7:00 P.M. on POD 1 , with a mean of 3.5+/-0.43 units versus 2.4+/-0.48 units for C ( P = .15 ) . The odds of a patient in C experiencing emesis were 8.16 times higher , ( P fibrin sealant group . CONCLUSIONS Fibrin sealant significantly reduced pain the evening after pediatric tonsillectomy and also decreased the chance of experiencing emesis . Thus fibrin sealant may be clinical ly useful as an adjunct to tonsillectomy",
"OBJECTIVE To determine the analgesic effect and tolerability of a novel needle-free powder lidocaine delivery system in children undergoing venipuncture . STUDY DESIGN In this double-blind , placebo-controlled , single-center trial , 306 children age 3 to 18 years were r and omized to receive a needle-free powder lidocaine delivery system or matching sham placebo at the back of the h and 2 to 3 minutes before venipuncture . Venipuncture pain was self-reported using the Wong-Baker FACES scale ( in 3- to 12-year-olds ) and a 100-mm visual analog scale ( in 8- to 18-year-olds ) . Safety was assessed by adverse events , investigator skin site assessment s , and children 's self-report of the administration comfort of study treatments . Effect sizes were compared by 2- sample t test and Glass 's Delta approach . RESULTS Subjects receiving the needle-free powder lidocaine delivery system exhibited mean pain reductions ( effect size ) of 33 % to 46 % relative to sham placebo . Pain reductions were statistically significant for all ages combined and also for the youngest and oldest age strata . Self-reported administration comfort levels were similar in the active system and sham placebo groups . Incidences of adverse events and dermal reactions were low ; the most common dermal reaction was mild erythema . CONCLUSIONS The needle-free powder lidocaine delivery system was well tolerated and provided effective local analgesia when administered 2 to 3 minutes before venipuncture",
"Objective The objectives of this study were to use a self-report pain scale to examine child pain treatment thresholds after major surgery ( i.e. , the level of pain they are comfortable with before requiring analgesia ) , as well as to examine agreement between mother- , nurse- , and child-rated pain treatment thresholds . Methods Twenty-five children aged 6 to 16 years were interviewed for 3 consecutive days after major surgery . Subjects used the Faces Pain Scale to rate their current pain , worst postoperative pain , and pain level at which they would like to receive analgesia ( the pain treatment threshold ) . Parents and nurses also estimated the child pain treatment thresholds . Results For day 1 , mean pain was 1.86 of a maximum of 6 , mean worst pain was 4.16 , and mean pain treatment threshold was 2.28 . For day 2 , these values were 1.90 , 4.10 , and 2.54 , and for day 3 they were 1.62 , 4.56 , and 1.85 , respectively . Mean scores for all 3 days were as follows : pain , 1.79 ; worst pain , 4.15 ; and pain treatment threshold , 2.33 . Although mother – nurse ratings were correlated ( 0.471 ) , mother – child and nurse – child ratings were not significantly correlated . Using the pain treatment threshold as the criterion , 36 % of our subjects were undermedicated after the first day of surgery . Conclusion Pain treatment thresholds seem to be lower in children after major as compared with minor surgery . Parents and nurses are not accurate in rating child pain treatment thresholds . Parents tended to overestimate their child 's pain treatment threshold , whereas nurses were less consistent in their scoring",
"The psychometric characteristics of the Faces Pain Scale ( FPS ) were evaluated in three groups of preschool and school-aged children ( 3 . 5 - 4.5 ; 4.5 - 5.5 and 5.5 - 6.5 years , respectively ) . The FPS was adequately comprehended by even young children . It was easily administered and was valid and discriminating . It did not , however , possess the linear scalability cl aim ed by its authors",
"The purpose of this study was to determine the adequacy of the alternate forms reliability of three versions of the Oucher pain scale . Because the original large-sized posters were unwieldy for use by nurses with children in clinical setting s , it became necessary to reduce it in size . To determine whether the result ing tools were psychometrically equivalent to the original versions of the Oucher , this study was undertaken . In a group of 3- to 12-year-old children who underwent surgical or dental procedures ( n = 137 ) , scores were obtained after the procedure on small and large versions of the Oucher . The order of presentation of the two different Ouchers was r and omized . Findings revealed that correlation coefficients between the scores provided for the small and large versions of the Oucher were strong , positive , and significant for the Caucasian , African-American , and Hispanic versions in 3- to 12-year-old children . These results provided evidence of the adequacy of the alternate forms reliability of these scales",
"Objectives : To compare patient , guardian and professional assessment of acute pain in children presenting to an Emergency Department , and to examine whether there was a correlation between the scores obtained using the Faces and linear scales for each group . Methods : A prospect i ve , observational cohort study of 73 children aged 4–14 years attending a paediatric hospital Emergency Department between March and April 2002 with pain caused by an acute injury . The child 's pain on admission , as estimated by the child , their guardian and a healthcare professional ( nurse/doctor/emergency nurse practitioner ) was recorded using a Faces scale and a linear scale . Results : Professionals consistently score pain lower [ median linear scale score 3.1 ; interquartile range ( IQR ) 1.6–5.3 ] than do patients ( 6.6 ; 4.9–7.4 ) or guardians ( 6.0 ; 3.9–7.1 ) using both linear and Faces scales . There is a significant correlation between pain scores obtained using the two scales for professionals [ Spearman R value 0.88 ; 95 % confidence interval ( CI ) 0.82–0.93 ] , guardians ( 0.83 ; 0.74–0.89 ) and patients ( 0.42 ; 0.21–0.59 ) . Conclusion : Professionals score pain lower than do children or guardians . Similar pain scores are obtained using both a Faces and a linear scale . This study offers no support for the introduction of a uniform pain assessment tool in a paediatric Emergency Department setting",
"& NA ; Altogether 553 children ( 195 first grade rs , mean age 6.8 years , and 358 third grade rs , mean age 8.7 years ) participated in the development of a self‐report measure to assess the intensity of children 's pain . The first step was the derivation , from children 's drawings of facial expressions of pain , of 5 sets of 7 schematic faces depicting changes in severity of expressed pain from no pain to the most pain possible . With the set of faces that achieved the highest agreement in pain ordering , additional studies were conducted to determine whether the set had the properties of a scale . In one study , children rank‐ordered the faces on 2 occasions , separated by 1 week . All 7 faces were correctly ranked by 64 % ( retest 1 week later , 61 % ) of grade 1 children and by 86 % ( retest 89 % ) of grade 3 children . In a second study , the faces were presented in all possible paired combinations . All 7 faces were correctly placed by 62 % ( retest 86 % ) of the younger and by 75 % ( retest 71 % ) of the older subjects . A third study asked children to place faces along scale : a procedure allowing a check on the e quality of intervals . The fourth study checked on whether pain was acting as an underlying construct for ordering the faces in memory . We asked whether children perceived the set as a scale by asking if memory for an ordered set of faces was more accurate than for a r and om set . The final study checked , with 6‐year‐old children , the test‐retest reliability of ratings for recalled experiences of pain . Overall , the faces pain scale incorporates conventions used by children , has achieved strong agreement in the rank ordering of pain , has indications that the intervals are close to equal , and is treated by children as a scale . The test‐retest data suggest that it may prove to be a reliable index over time of self‐reported pain",
"OBJECTIVE The aim of the study was to determine the efficacy of ShotBlocker ( Bionix , Toledo , Ohio ) in reducing pediatric pain with intramuscular ( IM ) injections . METHODS A prospect i ve r and omized controlled trial was conducted in children aged 2 months to 17 years who required an IM injection . Children were r and omized to the no-intervention group or the ShotBlocker group . Demographic data and the number of IM injections were recorded . Perceived pain scores were obtained from nurses and caregivers using a 6-point Likert-type scale . Baker Wong Faces scale was used in children 36 months or older . Difficulty using the device was also rated by nurses on a 6-point scale . RESULTS One hundred sixty-five children were enrolled with 80 in the no-intervention arm and 85 in the ShotBlocker arm . The mean age of children was 45 months and 56 % were male . Perceived pain scores by nurses were higher for the no-intervention group ( 2.6 vs 1.8 , P Children aged 36 months and older ( n = 64 ) did not report a difference in pain scores ( 1.5 vs 1.3 , P = .6 ) ; however , in a subgroup of children 72 months or older , pain scores trended higher in the no-intervention group ( 1.3 vs 0.5 , P = .051 ) . Nurse-perceived difficulty of ShotBlocker use was low 1.39 ( + /-1.1 ) . CONCLUSIONS Nurses and caregivers noted lower pain scores in children assigned to the ShotBlocker group . These differences were not as evident when children rated their own pain",
"OBJECTIVES To determine whether the implementation of at-home psychological preparation programme for children and family prior to surgery can reduce anxiety for Japanese preschool children undergoing herniorrhaphy and their caregivers assessed as an appropriate outpatient care . METHODS Patients were r and omly assigned to either of two groups : the usual care group or the at-home preparation group . Both two groups viewed a patient-educational video for herniorrhaphy once as out patients with other patients prior to hospitalization . The control group later underwent surgery without any further preparation . The experimental group watched the same educational video at home again with an auxiliary booklet prior to hospitalization . Children 's anxiety was measured by the Wong-Baker FACES Rating Scale ( FACES Rating Scale ) , while caregivers ' anxiety was measured by the Spielberger 's State Trait Anxiety Inventory ( STAI ) . Both outcomes were measured repeatedly from pre-intervention to 1 month after surgery . RESULTS Of the eligible 161 patients participating , 158 ( 98.1 % ) were r and omly assigned to the control group ( n = 81 ) and the experimental group ( n = 77 ) , and 144 ( 89.4 % ) completed the study . The experimental group gained more information and knowledge about surgery from parents and showed significantly lower scores than the controls for FACES and STAI . CONCLUSION A specially design ed at-home preparation programme as an outpatient care is effective to encourage parent-child verbal interaction concerning surgery and reduce both children and caregivers ' anxiety associated with surgery",
"OBJECTIVES /HYPOTHESIS To determine if placement of autologous platelet-rich plasma ( PRP ) on the tonsil beds at the time of tonsillectomy would decrease postoperative pain and complications . STUDY DESIGN Double blind , r and omized , prospect i ve study . METHODS Seventy children were recruited to participate in the study , ranging in age from 4 to 15 years . They were r and omized to treatment ( PRP ) or control groups . The parents , patients , and nurses were blinded as to which group they were in . Postoperative pain scores were obtained using the FACES pain scale and recorded in a home diary . RESULTS Seventy patients were recruited to the study , and 12 did not su bmi t their diaries and were considered to drop out of the study . Demographic data were similar for both control and treatment groups . Median pain scores , medication use , days to normal diet , and office visits did not differ between the two groups . CONCLUSIONS PRP applied once at the time of tonsillectomy does not improve postoperative pain or recovery in pediatric patients"
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BACKGROUND Patients with diabetes mellitus are at increased risk of postoperative complications . Data from r and omised clinical trials and meta-analyses point to a potential benefit of intensive glycaemic control , targeting near-normal blood glucose , in patients with hyperglycaemia ( with and without diabetes mellitus ) being su bmi tted to surgical procedures . However , there is limited evidence concerning this question in patients with diabetes mellitus undergoing surgery . OBJECTIVES To assess the effects of perioperative glycaemic control for diabetic patients undergoing surgery . SEARCH METHODS Trials were obtained from search es of The Cochrane Library , MEDLINE , EMBASE , LILACS , CINAHL and ISIS ( all up to February 2012 ) . SELECTION CRITERIA We included r and omised controlled clinical trials that prespecified different targets of perioperative glycaemic control ( intensive versus conventional or st and ard care ) DATA COLLECTION AND ANALYSIS Two authors independently extracted data and assessed risk of bias . We summarised studies using meta- analysis or descriptive methods . MAIN RESULTS Twelve trials r and omised 694 diabetic participants to intensive control and 709 diabetic participants to conventional glycaemic control . The duration of the intervention ranged from just the duration of the surgical procedure up to 90 days . The number of participants ranged from 13 to 421 , and the mean age was 64 years . Comparison of intensive with conventional glycaemic control demonstrated the following results for our predefined primary outcomes : analysis restricted to studies with low or unclear detection or attrition bias for infectious complications showed a risk ratio ( RR ) of 0.46 ( 95 % confidence interval ( CI ) 0.18 to 1.18 ) , P = 0.11 , 627 participants , eight trials , moderate quality of the evidence ( grading of recommendations assessment , development and evaluation - ( GRADE ) ) . Evaluation of death from any cause revealed a RR of 1.19 ( 95 % CI 0.89 to 1.59 ) , P = 0.24 , 1365 participants , 11 trials , high quality of the evidence ( GRADE ) .On the basis of a posthoc analysis , there is the hypothesis that intensive glycaemic control may increase the risk of hypoglycaemic episodes if longer-term outcome measures are analysed ( RR 6.92 , 95 % CI 2.04 to 23.41 ) , P = 0.002 , 724 patients , three trials , low quality of the evidence ( GRADE ) . Analysis of our predefined secondary outcomes revealed the following findings : cardiovascular events had a RR of 1.03 ( 95 % CI 0.21 to 5.13 ) , P = 0.97 , 682 participants , six trials , moderate quality of the evidence ( GRADE ) when comparing the two treatment modalities ; and renal failure also did not show significant differences between intensive and regular glucose control ( RR 0.61 , 95 % CI 0.34 to 1.08 ) , P = 0.09 , 434 participants , two trials , moderate quality of the evidence ( GRADE ) . We did not meta-analyse length of hospital stay and intensive care unit ( ICU ) stay due to substantial unexplained heterogeneity . Mean differences between intensive and regular glucose control groups ranged from -1.7 days to 2.1 days for ICU stay and between -8 days to 3.7 days for hospital stay ( moderate quality of the evidence ( GRADE ) ) . One trial assessed health-related quality of life in 12/37 ( 32.4 % ) of participants in the intervention group and 13/44 ( 29.5 % ) of participants in the control group , and did not show an important difference ( low quality of the evidence ( GRADE ) ) in the measured physical health composite score of the short-form 12-item health survey ( SF-12 ) . None of the trials examined the effects of the interventions in terms of costs . AUTHORS ' CONCLUSIONS The included trials did not demonstrate significant differences for most of the outcomes when targeting intensive perioperative glycaemic control compared with conventional glycaemic control in patients with diabetes mellitus . However , posthoc analysis indicated that intensive glycaemic control was associated with an increased number of patients experiencing hypoglycaemic episodes . Intensive glycaemic control protocol s with near-normal blood glucose targets for patients with diabetes mellitus undergoing surgical procedures are currently not supported by an adequate scientific basis . We suggest that insulin treatment regimens , patient- and health-system relevant outcomes , and time points for outcome measures should be defined in a thorough and uniform way in future studies
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"BACKGROUND Glucose-insulin-potassium ( GIK ) administration is advocated on the premise of preventing hyperglycaemia and hyperlipidaemia during reperfusion after cardiac interventions . Current research has focused on hyperglycaemia , largely ignoring lipids , or other substrates . The present study examines lipids and other substrates during and after on-pump coronary artery bypass grafting and how they are affected by a hyperinsulinaemic normoglycaemic clamp . METHODS Forty-four patients were r and omized to a control group ( n=21 ) or to a GIK group ( n=23 ) receiving a hyperinsulinaemic normoglycaemic clamp during 26 h. Plasma levels of free fatty acid ( FFA ) , total and lipoprotein ( VLDL , HDL , and LDL)-triglycerides ( TG ) , ketone bodies , and lactate were determined . RESULTS In the control group , mean FFA peaked at 0.76 ( sem 0.05 ) mmol litre(-1 ) at early reperfusion and decreased to 0.3 - 0.5 mmol litre(-1 ) during the remaining part of the study . GIK decreased FFA levels to 0.38 ( 0.05 ) mmol litre(-1 ) at early reperfusion , and to low concentrations of 0.10 ( 0.01 ) mmol litre(-1 ) during the hyperinsulinaemic clamp . GIK reduced the area under the curve ( AUC ) for FFA by 75 % and for TG by 53 % . The reduction in total TG was reflected by a reduction in the VLDL ( -54 % AUC ) and HDL ( -42 % AUC ) fraction , but not in the LDL fraction . GIK prevented the increase in ketone bodies after reperfusion ( -44 to -47 % AUC ) , but was without effect on lactate levels . CONCLUSIONS Mild hyperlipidaemia was only observed during early reperfusion ( before heparin reversal ) and the hyperinsulinaemic normoglycaemic clamp actually result ed in hypolipidaemia during the largest part of reperfusion after cardiac surgery",
"BACKGROUND This study was undertaken to determine whether glucose-insulin-potassium ( GIK ) would improve myocardial performance and limit morbidity after coronary artery bypass grafting in diabetic patients . METHODS Forty consecutive coronary artery bypass grafting patients with medically treated diabetes mellitus were prospect ively r and omly assigned to either a GIK group ( n = 20 ; 500 mL D5W + 80 U regular insulin + 40 mEq KCl 30 mL/hour ) or a no-GIK group ( n = 20 ; D5W at 30 mL/hour ) . The GIK was begun at anesthetic induction and continued for 12 hours postoperatively . RESULTS Patients treated with GIK had higher postoperative cardiac indices ( 2.88 + /- 0.50 versus 2.20 + /- 0.39 L/minute per square meter ; p lower inotrope scores ( 0.40 + /- 0.68 versus 1.25 + /- 1.44 ; p = 0.05 ) , less weight gain ( 5.80 + /- 3.76 versus 13.85 + /- 6.52 pounds ; p times of ventilator support ( 8.35 + /- 2.60 versus 13.45 + /- 7.33 hours ; p = 0.0128 ) . They had a significantly lower prevalence of atrial fibrillation ( 15 % versus 60 % ; p = 0.003 ) , and shorter hospital stays ( 6.70 + /- 1.52 versus 10.15 + /- 6.62 days ; p = 0.02 ) . CONCLUSIONS Substrate enhancement with GIK in diabetic patients improved myocardial performance and result ed in faster recovery after coronary artery bypass grafting",
"Purpose A safe and effective insulin infusion algorithm that achieves rigorous intraoperative glycemic control in noncardiac surgery has yet to be formally characterized and evaluated . We therefore report the validation of the DeLit Trial insulin infusion algorithm . Methods Patients scheduled for major noncardiac surgery were r and omized to a target intraoperative blood glucose concentration of 4.4 - 6.1 mmoL·L−1 ( 80 - 110 mg·dL−1 ) intensive group or 10 - 11.1 mmoL·L−1 ( 180 - 200 mg·dL−1 ) conventional group . Glucose was managed with a dynamic intravenous insulin infusion algorithm . We compared the r and omized groups on glucose time-weighted average ( TWA ) , proportion of time spent within target , number of severe ( moderate ( ) hypoglycemic episodes , and within-patient variability in glucose concentrations expressed as st and ard deviation from the patient mean . Results One hundred eighty-seven patients were assigned to intensive glucose control , and 177 patients were assigned to conventional glucose control . Median ( lower quartile value [ Q1 ] , upper quartile value [ Q3 ] ) of intraoperative TWA for the intensive vs conventional groups was 6 [ 5.6 , 6.7 ] mmoL·L−1vs 7.7 [ 6.9 , 9.2 ] mmoL·L−1 , respectively ; P had slightly lower within-patient glucose variability than the conventional group ( 0.9 [ 0.7 , 1.3 ] mmoL·L−1vs 1.3 [ 0.8 , 1.8 ] mmoL·L−1 , respectively ; P had moderate hypoglycemia ( intensive group ) , but none experienced severe episodes . Conclusion Tight intraoperative glucose control in noncardiac surgery can be maintained successfully without serious hypoglycemic episodes . ( Clinical Trials.gov number , NCT00433251).RésuméObjectifNous ne disposons pas encore d’un algorithme de perfusion d’insuline formellement caractérisé et évalué , qui soit à la fois sécuritaire et efficace , et qui permette de maintenir un contrôle glycémique peropératoire rigoureux en chirurgie non cardiaque . C’est pourquoi nous rapportons la validation de notre algorithme de perfusion de l’insuline . MéthodeDes patients devant subir une chirurgie non cardiaque majeure ont été r and omisés à une concentration glycémique peropératoire cible de 4,4 - 6,1 mmoL·L−1 ( 80 - 110 mg·dL−1 ) dans le groupe intensif ou à une concentration de 10 - 11,1 mmoL·L−1 ( 180 - 200 mg·dL−1 ) dans le groupe conventionnel . La glycémie a été contrôlée à l’aide d’un algorithme dynamique de perfusion intraveineuse d’insuline . Nous avons comparé les groupes r and omisés en matière de moyenne pondérée dans le temps , de la proportion de temps passé à la concentration cible , du nombre d’épisodes d’hypoglycémie grave ( quatre-vingt-sept patients ont été attribués au groupe contrôle glycémique intensif , et 177 au groupe contrôle glycémique conventionnel . La médiane ( valeur du quartile inférieur [ Q1 ] , valeur du quartile supérieur [ Q3 ] ) de la moyenne pondérée dans le temps pour les groupes intensif vs conventionnel était de 6 ( 5,6 , 6,7 ) mmoL·L−1vs 7,7 ( 6,9 , 9,2 ) , respectivement ; P une variabilité chez un même patient légèrement plus basse que le groupe conventionnel ( 0,9 [ 0,7 , 1,3 ] mmoL·L−1vs 1,3 [ 0,8 , 1,8 ] mmoL·L−1 , respectivement ; P une hypoglycémie modérée ( groupe intensif ) , mais aucun patient n’a manifesté d’épisode grave . Conclusion Un contrôle glycémique peropératoire rigoureux peut être maintenu en chirurgie non cardiaque sans épisode hypoglycémique grave . ( Numéro de Clinical Trials.gov , NCT00433251 )",
"Background There is increasing evidence that tight blood glucose ( BG ) control improves outcomes in critically ill adults . Children show similar hyperglycaemic responses to surgery or critical illness . However it is not known whether tight control will benefit children given maturational differences and different disease spectrum . Methods / Design The study is an r and omised open trial with two parallel groups to assess whether , for children undergoing intensive care in the UK aged ≤ 16 years who are ventilated , have an arterial line in-situ and are receiving vasoactive support following injury , major surgery or in association with critical illness in whom it is anticipated such treatment will be required to continue for at least 12 hours , tight control will increase the numbers of days alive and free of mechanical ventilation at 30 days , and lead to improvement in a range of complications associated with intensive care treatment and be cost effective . Children in the tight control group will receive insulin by intravenous infusion titrated to maintain BG between 4 and 7.0 mmol/l . Children in the control group will be treated according to a st and ard current approach to BG management . Children will be followed up to determine vital status and healthcare re sources usage between discharge and 12 months post-r and omisation . Information regarding overall health status , global neurological outcome , attention and behavioural status will be sought from a subgroup with traumatic brain injury (TBI).A difference of 2 days in the number of ventilator-free days within the first 30 days post-r and omisation is considered clinical ly important . Conservatively assuming a st and ard deviation of a week across both trial arms , a type I error of 1 % ( 2-sided test ) , and allowing for non-compliance , a total sample size of 1000 patients would have 90 % power to detect this difference . To detect effect differences between cardiac and non-cardiac patients , a target sample size of 1500 is required . An economic evaluation will assess whether the costs of achieving tight BG control are justified by subsequent reductions in hospitalisation costs . Discussion The relevance of tight glycaemic control in this population needs to be assessed formally before being accepted into st and ard practice .Trial Registration Current Controlled Trials IS RCT",
"Objective : This study sought to determine whether aggressive glycemic control ( 90–120 mg/dL ) would result in more optimal clinical outcomes and less morbidity than moderate glycemic control ( 120–180 mg/dL ) in diabetic patients undergoing coronary artery bypass graft ( CABG ) surgery . Summary of Background Data : Maintaining serum glucose levels between 120 and 180 mg/dL with continuous insulin infusions decreases morbidity in diabetic patients undergoing CABG surgery . Studies in surgical patients requiring prolonged ventilation suggest that aggressive glycemic control ( patients is unknown . Methods : Eighty-two diabetic patients undergoing CABG were prospect ively r and omized to aggressive glycemic control ( 90–120 mg/dL ) or moderate glycemic control ( 120–180 mg/dL ) using continuous intravenous insulin solutions ( 100 units regular insulin in 100 mL : normal saline ) beginning at the induction of anesthesia and continuing for 18 hours after CABG . Primary end points were the incidence of major adverse events ( major adverse events = 30-day mortality , myocardial infa rct ion , neurologic events , deep sternal infections , and atrial fibrillation ) , the level of serum glucose , and the incidence of hypoglycemic events . Results : There were no differences in the incidence of major adverse events between the groups ( 17 moderate vs 15 aggressive ; P = 0.91 ) . Patients with aggressive control had a lower mean glucose at the end of 18 hours of insulin infusion ( 135 ± 12 mg/dL moderate vs 103 ± 17 mg/dL aggressive ; P higher incidence of hypoglycemic events ( 4 vs 30 ; P diabetic patients undergoing CABG surgery , aggressive glycemic control increases the incidence of hypoglycemic events and does not result in any significant improvement in clinical outcomes that can be achieved with moderate control . Clinical Trials.gov ( ID # NCT00460499",
"In a prospect i ve r and omised study in 20 insulin‐dependent diabetics who had minor surgery under general anaesthesia we compared the metabolic responses to intravenous glucose‐insulin‐potassium infusion with those who had conventional subcutaneous insulin administration . The former treatment result ed in lower blood glucose levels both during the infusion period ( p More blood glucose values were within the intended range of 5 to 10 mmol/litre in the glucose‐insulin‐potassium as compared to the conventional group ( 48 % versus 24 % ; p The levels of lactate , 3‐hydroxybutyrate , glycerol , alanine , glucagon , insulin and growth hormone did not differ between the two groups . The infusion regimen result ed in better glycaemic control both peri‐ and postoperatively than the conventional subcutaneous insulin regimen in insulin‐dependent diabetic patients who have minor surgery",
"BACKGROUND Hyperglycemia is common among patients admitted to intensive care units , and carries the risk for complications and prolonged ICU stay . With intensive insulin control of blood glucose , morbidity and mortality can be reduced . OBJECTIVES To determine whether intensive or conventional insulin control of blood glucose in hyperglycemic ICU patients correlated with the prognosis . METHODS Following admission to the ICU , hyperglycemic patients were r and omly assigned to a group treated intensively with insulin targeting glucose at 110 - 140 mg/dl , or to a conventional insulin therapy group , where glucose , upon exceeding 200 mg/dl , was controlled at 140 - 200 mg/dl . Rates of morbidity and mortality , hypoglycemic episodes , and insulin dosage were compared . RESULTS In the 41 patients treated intensively with insulin the glucose level was 142 + /- 14 mg/dl , as compared to 174+/-20 mg/dl in the 48 patients on conventional insulin treatment . Both groups were similar in age , acute physiology and chronic health evaluation score . Morbidity was also similar , except for increased vascular damage in the conventional treatment group and slightly shorter ICU stay in the intensive therapy group . Both groups had similar in-ICU , in-hospital , and 28 day mortalities , and similar rates of hypoglycemic episodes . The daily dosage of insulin was significantly higher with the conventional treatment ( P= 0.004 ) . CONCLUSIONS Intensive insulin treatment did not affect the mortality or morbidity rates in ICU patients . The increased insulin dosage of conventional insulin treatment was attributable to the group 's higher prevalence of diabetes . Future studies should address this bias and determine the optimal glucose target",
"OBJECTIVE Intensive insulin therapy ( IIT ) reduces morbidity and mortality in patients in surgical intensive care units . The aim of this study is to assess the effect of IIT using a closed-loop system in hepatectomized patients . RESEARCH DESIGN AND METHODS Patients were r and omly assigned to receive IIT using a closed-loop system : an artificial pancreas ( AP group ) or conventional insulin therapy using the sliding-scale method ( SS group ) . RESULTS The incidence of surgical-site infection in the AP group was significantly lower than that in the SS group . The length of hospitalization required for patients in the AP group was significantly shorter than that in the SS group . CONCLUSIONS Total hospital costs for patients in the AP group were significantly lower than for patients in the SS group . IIT using a closed-loop system maintained near-normoglycemia and contributed to a reduction in the incidence of SSI and total hospital costs due to shortened hospitalization",
"Background —This study sought to determine whether tight glycemic control with a modified glucose-insulin-potassium ( GIK ) solution in diabetic coronary artery bypass graft ( CABG ) patients would improve perioperative outcomes . Methods and Results —One hundred forty-one diabetic patients undergoing CABG were prospect ively r and omized to tight glycemic control ( serum glucose , 125 to 200 mg/dL ) with GIK or st and ard therapy ( serum glucose beginning before anesthesia and continuing for 12 hours after surgery . GIK patients had lower serum glucose levels ( 138±4 versus 260±6 mg/dL ; P a lower incidence of atrial fibrillation ( 16.6 % versus 42 % ; P = 0.0017 ) , and a shorter postoperative length of stay ( 6.5±0.1 versus 9.2±0.3 days ; P = 0.003 ) . GIK patients also showed a survival advantage over the initial 2 years after surgery ( P = 0.04 ) and decreased episodes of recurrent ischemia ( 5 % versus 19 % ; P = 0.01 ) and developed fewer recurrent wound infections ( 1 % versus 10 % , P = 0.03 ) . Conclusions —Tight glycemic control with GIK in diabetic CABG patients improves perioperative outcomes , enhances survival , and decreases the incidence of ischemic events and wound complications ",
"CONTEXT Elevated blood glucose levels occur frequently in the critically ill . Tight glucose control by intensive insulin treatment markedly improves clinical outcome . OBJECTIVE AND DESIGN This is a r and omized controlled trial comparing blood glucose control by a laptop-based model predictive control algorithm with a variable sampling rate [ enhanced model predictive control ( eMPC ) ; version 1.04.03 ] against a routine glucose management protocol ( RMP ) during the peri- and postoperative periods . SETTING The study was performed at the Department of Cardiac Surgery , University Hospital . PATIENTS A total of 60 elective cardiac surgery patients were included in the study . INTERVENTIONS Elective cardiac surgery and treatment with continuous insulin infusion ( eMPC ) or continuous insulin infusion combined with iv insulin boluses ( RMP ) to maintain euglycemia ( target range 4.4 - 6.1 mmol/liter ) were performed . There were 30 patients r and omized for eMPC and 30 for RMP treatment . Blood glucose was measured in 1- to 4-h intervals as requested by each algorithm during surgery and postoperatively over 24 h. MAIN OUTCOME MEASURES Mean blood glucose , percentage of time in target range , and hypoglycemia events were used . RESULTS Mean blood glucose was 6.2 + /- 1.1 mmol/liter in the eMPC vs. 7.2 + /- 1.1 mmol/liter in the RMP group ( P of time in the target range was 60.4 + /- 22.8 % for the eMPC vs. 27.5 + /- 16.2 % for the RMP group ( P severe hypoglycemia ( blood glucose Mean insulin infusion rate was 4.7 + /- 3.3 IU/h in the eMPC vs. 2.6 + /- 1.7 IU/h in the RMP group ( P Mean sampling interval was 1.5 + /- 0.3 h in the eMPC vs. 2.1 + /- 0.2 h in the RMP group ( P safe in maintaining euglycemia in cardiac surgery patients",
"Objectives Maintenance of normoglycemia with insulin reduces mortality and morbidity of critically ill patients . Here we report the factors determining insulin requirements and the impact of insulin dose vs. blood glucose control on the observed outcome benefits . Design A prospect i ve , r and omized , controlled trial . Setting A 56-bed predominantly surgical intensive care unit in a tertiary teaching hospital Patients and InterventionA total of 1,548 patients were r and omly assigned to either strict normalization of blood glucose ( 80–110 mg/dL ) with insulin infusion or the conventional approach , in which insulin is only given to maintain blood glucose levels at 180–200 mg/dL. Measurements and Main Results It was feasible and safe to achieve and maintain blood glucose levels at body mass index , history of diabetes , reason for intensive care unit admission , at-admission hyperglycemia , caloric intake , and time in intensive care unit as independent determinants of insulin requirements , together explaining 36 % of its variation . With nutritional intake increasing from a mean of 550 to 1600 calories/day during the first 7 days of intensive care , normoglycemia was reached within 24 hrs , with a mean daily insulin dose of 77 IU and maintained with 94 IU on day 7 . Insulin requirements were highest and most variable during the first 6 hrs of intensive care ( mean , 7 IU/hr ; 10 % of patients required > 20 IU/hr ) . Between day 7 and 12 , insulin requirements decreased by 40 % on stable caloric intake . Brief , clinical ly harmless hypoglycemia occurred in 5.2 % of intensive insulin-treated patients on median day 6 ( 2–14 ) vs. 0.8 % of conventionally treated patients on day 11 ( 2–10 ) . The outcome benefits of intensive insulin therapy were equally present regardless of whether patients received enteral feeding . Multivariate logistic regression analysis indicated that the lowered blood glucose level rather than the insulin dose was related to reduced mortality ( p critical illness polyneuropathy ( p bacteremia ( p = .02 ) , and inflammation ( p = .0006 ) but not to prevention of acute renal failure , for which the insulin dose was an independent determinant ( p = .03 ) . As compared with normoglycemia , an intermediate blood glucose level ( 110–150 mg/dL ) was associated with worse outcome . Conclusion Normoglycemia was safely reached within 24 hrs and maintained during intensive care by using insulin titration guidelines . Metabolic control , as reflected by normoglycemia , rather than the infused insulin dose per se , was related to the beneficial effects of intensive insulin therapy",
"& NA ; To assess the potential benefits of perioperative glucose administration , the plasma concentrations of insulin , free fatty acids , ketone bodies , amino acids , lactate , and pyruvate were measured in 20 patients undergoing partial gastrectomy . Ten patients received intravenous glucose at 10 g/h during the operation , and the other 10 patients , as control , received no glucose . Plasma glucose , insulin activity , pyruvate and alanine concentrations in the glucose‐receiving group increased significantly during the operation in comparison with the control group . In contrast , in the glucose‐receiving group the plasma ketone bodies and branched‐chain amino acids , especially leucine and isoleucine , decreased significantly during surgery . These results suggest that administration of glucose stimulated insulin secretion and result ed in accumulation of the substrates such as pyruvate and alanine which were utilized readily in the body . Glucose administration is useful in suppressing catabolism during upper abdominal surgery . ( Anesth Analg 1993;76:357‐61",
"OBJECTIVE To determine the safety and efficacy of an intensive insulin regimen compared with a conventional insulin regimen in general intensive care unit patients . METHODS A phase II , r and omised controlled trial was conducted in 70 critically ill patients in a closed multidisciplinary ICU of a university-affiliated tertiary hospital . We assessed patient characteristics at baseline . Trial process measures included number of blood glucose measurements per day and number in target range , type and quantity of caloric intake , patient outcome and insulin dosing . The primary outcome was the median blood glucose concentration . Secondary outcome measures were incidence of hypoglycaemia ( blood glucose level clinical sequelae of hypoglycaemia and hospital mortality . RESULTS Thirty-five patients were r and omised to each of the two groups . More blood glucose sample s were taken per day in the intensive insulin group ( 16 versus 9 ) , but the number of sample s in the normoglycaemic range was 48.5 % , compared with 79.8 % within the target glucose range in the conventional insulin group . The median ( interquartile range ) blood glucose concentrations in the intensive and conventional insulin therapy groups were 5.4 ( 5.1 - 5.7 ) mmol/L and 7.9 ( 7.2 - 9.0 ) mmol/L , respectively ( difference , 2.5 mmol/L ; P intensive insulin therapy group became hypoglycaemic versus none in the conventional insulin therapy group . There were no detected clinical sequelae of hypoglycaemia . CONCLUSION The intensive insulin regimen was effective in achieving the target blood glucose concentration , with clear separation from the conventional insulin regimen . Although the incidence of hypoglycaemia was increased , there was no detectable harm",
"OBJECTIVE We performed a r and omized trial to compare three insulin-titration protocol s for tight glycemic control ( TGC ) in a surgical intensive care unit : an absolute glucose ( Matias ) protocol , a relative glucose change ( Bath ) protocol , and an enhanced model predictive control ( eMPC ) algorithm . RESEARCH DESIGN AND METHODS A total of 120 consecutive patients after cardiac surgery were r and omly assigned to the three protocol s with a target glycemia range from 4.4 to 6.1 mmol/l . Intravenous insulin was administered continuously or in combination with insulin boluses ( Matias protocol ) . Blood glucose was measured in 1- to 4-h intervals as requested by the protocol s. RESULTS The eMPC algorithm gave the best performance as assessed by time to target ( 8.8 ± 2.2 vs. 10.9 ± 1.0 vs. 12.3 ± 1.9 h ; eMPC vs. Matias vs. Bath , respectively ; P 0.05 ) , average blood glucose after reaching the target ( 5.2 ± 0.1 vs. 6.2 ± 0.1 vs. 5.8 ± 0.1 mmol/l ; P , time in target ( 62.8 ± 4.4 vs. 48.4 ± 3.28 vs. 55.5 ± 3.2 % ; P , time in hyperglycemia > 8.3 mmol/l ( 1.3 ± 1.2 vs. 12.8 ± 2.2 vs. 6.5 ± 2.0 % ; P , and sampling interval ( 2.3 ± 0.1 vs. 2.1 ± 0.1 vs. 1.8 ± 0.1 h ; P risk range ( 2.9–4.3 mmol/l ) in the eMPC group was the longest ( 22.2 ± 1.9 vs. 10.9 ± 1.5 vs. 13.1 ± 1.6 ; P episode ( best TGC without increasing the risk of severe hypoglycemia while requiring the fewest glucose measurements . Overall , all protocol s were safe and effective in the maintenance of TGC in cardiac surgery patients",
"Background : A growing body of evidence suggests that hyperglycemia is an independent predictor of increased cardiovascular risk . Aggressive glycemic control in the intensive care decreases mortality . The benefit of glycemic control in noncardiac surgery is unknown . Methods : In a single-center , prospect i ve , unblinded , active-control study , 236 patients were r and omly assigned to continuous insulin infusion ( target glucose 100–150 mg/dl ) or to a st and ard intermittent insulin bolus ( treat glucose > 150 mg/dl ) in patients undergoing peripheral vascular bypass , abdominal aortic aneurysm repair , or below- or above-knee amputation . The treatments began at the start of surgery and continued for 48 h. The primary endpoint was a composite of all-cause death , myocardial infa rct ion , and acute congestive heart failure . The secondary endpoints were blood glucose concentrations , rates of hypoglycemia ( 150 mg/dl ) , graft failure or reintervention , wound infection , acute renal insufficiency , and duration of stay . Results : The groups were well balanced for baseline characteristics , except for older age in the intervention group . There was a significant reduction in primary endpoint ( 3.5 % ) in the intervention group compared with the control group ( 12.3 % ) ( relative risk , 0.29 ; 95 % confidence interval , 0.10–0.83 ; P = 0.013 ) . The secondary endpoints were similar . Hypoglycemia occurred in 8.8 % of the intervention group compared with 4.1 % of the control group ( P = 0.14 ) . Multivariate analysis demonstrated that continuous insulin infusion was a negative independent predictor ( odds ratio , 0.28 ; 95 % confidence interval , 0.09–0.87 ; P = 0.027 ) , whereas previous coronary artery disease was a positive predictor of adverse events . Conclusion : Continuous insulin infusion reduces perioperative myocardial infa rct ion after vascular surgery",
"The hyperglycemia usually observed in patients undergoing heart surgery with extracorporeal circulation ( EC ) represents a difficult therapeutic problem . We studied the effects of several regimens of insulin therapy on serum glucose ( SG ) in 24 noninsulin dependent diabetic patients ( NIDDs ) . The patients were r and omly divided in five groups ; group A received on IV bolus of 10.0 - 50.0 U/h according to glycosuria ; groups B , C , D and E were given a continuous iv insulin infusion of 2.5 , 5.0 , 7.5 and 10.0 U/h respectively . In 10 non-diabetic patients ( NDP ) SG levels were also measured , but insulin was not given . A mean of 5.0 l/m2 of body surface of fluids containing 300 g of glucose were administered to all patients during surgery . At the operations SG levels rose progressively soon after the anesthesia was started , reached the highest values during the period of EC , and decreased slowly in blood sample s taken after the EC phase and by 24h . This patterns was shown by all groups studied statistically significant lower SG levels , however , were observed in patients of group C , whose values were similar to those seen in the NDP group . Groups D and E had slightly higher SG levels than those of group C. An additional NIDDM patient with advanced chronic renal failure ( CRF ) , had a tendency to hypoglycemia even during the EC period in response to relatively low doses of insulin ( 2.5 U/h ) , given by a continuous iv infusion and , although the insulin administration was stopped , his SG levels remained well below the mean values of the other patients for the rest of the operation . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Continuous insulin infusion was not an effective mode of treatment in maintaining safe blood glucose levels ( diabetic patients requiring open-heart surgery . The two modifications investigated to gain better control of the blood glucose were a change in the base solution of the cardioplegia and the use of a sliding insulin scale . Fifty patients including Type I and Type II diabetics were selected for the purpose of this study . The patients were then r and omly divided into two groups categorized by the type of cardioplegic solution administered and the mode of insulin treatment . Group I patients received a dextrose 5%-based cardioplegic solution and blood glucose was treated via continuous intravenous insulin infusion . Group II patients received normal saline 0.9%-based cardioplegic solution and blood glucose was treated via sliding scale . Blood glucose levels were monitored pre- and postcardio- pulmonary bypass ( CPB ) and every 30 min while on CPB . Glucose values were analyzed by group t test . A p value of glucose values at each of the time intervals when the glucose values were recorded . In conclusion , Group II maintained an acceptable blood glucose level ( < 200 mg/dl ) throughout the entire intra- operative period , which suggests that the combination of the sliding insulin scale and modification of the base cardioplegic solution was an effective mode of treatment",
"BACKGROUND The aim of this trial was to compare multimodal optimization with conventional perioperative management in a consecutive series of patients undergoing gastrectomy procedures . METHODS According to r and omized controlled studies and conclusions made by meta-analyses in colorectal surgery , optimized perioperative measures were design ed and applied in gastrectomy surgery . Thirty-three patients were r and omized to the optimized group and 30 patients to a control group . Two groups were treated in 1 center by a single surgical team in different wards . Both groups used patient-controlled intravenous analgesia for postoperative analgesia . The primary end point was length of postoperative hospital stay . Secondary outcomes included bowel function recovery after surgery , perioperative changes of inflammatory factors , glucocorticoid , insulin resistance , and body composition . Perioperative complications and adverse events were also recorded . RESULTS The groups were similar in terms of age , sex ratio , and Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity ( POSSUM score ) . The optimized group was associated with a significantly shorter postoperative hospital stay compared with the conventional care group ( P Duration s of urinary catheterization and abdominal drainage were also less ( P well tolerated and was associated with an earlier recovery of gut function ( P Proinflammatory factors were less elevated and body composition was more stable in the optimized group than in controls . There were no differences in morbidity or mortality between the groups . CONCLUSIONS Optimization of care in gastrectomy can shorten postoperative hospital stay and provides multiple beneficial outcomes , including hastening the return of gut function , without increasing morbidity",
"CONTEXT Coronary artery bypass grafting ( CABG ) is complicated by ischemia-reperfusion injury jeopardizing myocyte survival . OBJECTIVE The aim of the study was to investigate whether glucose and insulin administration , while maintaining normoglycemia ( GIN therapy ) using a hyperinsulinemic-normoglycemic clamp technique , is cardioprotective in patients undergoing CABG . DESIGN AND SETTING We conducted a r and omized controlled trial at a tertiary care university teaching hospital . PATIENTS We studied 99 patients undergoing elective CABG . INTERVENTION Patients were r and omly assigned to receive either GIN from the beginning of surgery until 24 h after CABG ( GIN , n = 49 ) or st and ard metabolic care ( control , n = 50 ) . MAIN OUTCOME MEASURES We measured plasma concentrations of cardiac troponin I and free fatty acids , cardiac function as assessed by transesophageal echocardiography , glycogen content , glycogen synthase activity , and the expression of AMP-activated protein kinase ( AMPK ) and protein kinase B ( AKT ) in cardiomyocytes . RESULTS Patients receiving GIN therapy showed an attenuated release of cardiac troponin I ( P improved myocardial function ( P Systemic free fatty acid concentrations were suppressed ( P intracellular glycogen content and glycogen synthase activity were not altered . The AMPK activity remained unchanged during ischemia in the GIN group , whereas it increased in the control group ( P AKT phosphorylation before ischemia was observed ( P GIN . However , there was no evidence for AKT-dependent AMPK inhibition . CONCLUSIONS GIN therapy protects the myocardium and inhibits ischemia-induced AMPK activation ",
"Context Intensive insulin therapy used to maintain normoglycemia during intensive care after cardiac surgery improves perioperative outcomes . Its effect during cardiac surgery is unknown . Contributions The authors r and omly assigned 400 cardiac surgical patients to tight glycemic control ( blood glucose level , 4.4 to 5.6 mmol/L [ 80 to 100 mg/dL ] ) during surgery or usual intraoperative care . All patients received tight glycemic control in the cardiac intensive care unit . The groups had the same risk for perioperative adverse events ( risk ratio , 1.0 [ 95 % CI , 0.8 to 1.2 ] ) . The intensive treatment group had more strokes ( 8 vs. 1 ) and more deaths ( 4 vs. 0 ) than the conventional treatment group . Caution The authors performed the study at a single center . Implication s Maintaining normoglycemia during cardiac surgery does not improve outcomes and might worsen them . The Editors Hyperglycemia occurs frequently in patients with and without diabetes during cardiac surgery , especially during cardiopulmonary bypass surgery ( 1 , 2 ) . In a study by Van den Berghe and colleagues ( 3 ) , intensive insulin therapy after surgery reduced morbidity and death in critically ill patients , most of whom underwent cardiac surgery . As a result , professional organizations have recommended rigorous glycemic control in hospitalized patients ( 4 ) and strict glycemic control is now routine practice during the postoperative period in cardiac surgical patients . However , no consensus exists on the optimal management of intraoperative hyperglycemia in cardiac surgical patients because of the lack of evidence from r and omized trials . Research ers are increasingly extrapolating evidence from studies that assess the role of strict postoperative glycemic control in critically ill patients to advocate for intravenous insulin therapy for patients in the operating room ( 3 , 57 ) . Evidence , strictly from observational studies , suggests that tight intraoperative glycemic control may reduce postoperative complications ( 810 ) . We recently reported , in a retrospective , observational study of 409 cardiac surgical patients , that intraoperative hyperglycemia was an independent risk factor for perioperative complications , including death , after adjustment for postoperative glucose concentrations . Each 1.1-mmol/L ( 20 mg/dL ) increase in glucose concentration greater than 5.6 mmol/L ( > 100 mg/dL ) during surgery was associated with a 34 % increase in the likelihood of postoperative complications ( 8) . An association between intraoperative hyperglycemia and adverse outcomes based on observational studies does not prove causality . Because hyperglycemia can adversely affect immunity , wound healing , and vascular function , the concept that normoglycemia be maintained during the relatively brief duration of cardiac surgery seems plausible ( 1116 ) . On the other h and , the degree of intraoperative hyperglycemia may merely reflect the severity of underlying stress . If so , prevention of hyperglycemia might not reduce perioperative complications , and the risks and costs of intensive intraoperative glycemic management may outweigh the benefits . Simple , safe , and effective insulin infusion algorithms that achieve rigorous intraoperative glycemic control are lacking . To address these questions , we conducted a r and omized , controlled trial at 1 center to determine whether maintenance of near normoglycemia during cardiac surgery by using intraoperative intravenous insulin infusion reduced perioperative death and morbidity when added to rigorous postoperative glycemic control . Methods Design Overview This was a r and omized , open-label , controlled trial with blinded assessment . We r and omly assigned patients to receive intensive insulin therapy to maintain intraoperative glucose levels between 4.4 ( 80 mg/dL ) and 5.6 mmol/L ( 100 mg/dL ) or conventional treatment . By design , both groups were postoperatively treated with strict glycemic control to ensure that the observed difference in outcome could be attributed to the effects of intraoperative glycemic control . Setting We performed the study at St. Marys Hospital , Rochester , Minnesota , which is a tertiary care teaching hospital with 1157 beds and an average of more than 41000 admissions per year . Participants Adults undergoing elective cardiac surgery between July 2004 and April 2005 were eligible for enrollment in our study . We excluded patients who had off-pump cardiopulmonary bypass procedures . The Mayo Foundation Institutional Review Board , Rochester , Minnesota , approved the protocol . R and omization and Interventions Before we enrolled patients in our r and omized trial , we enrolled 20 patients in a 2-week pilot trial to ensure that the anesthesiologists in the operating room and the nursing staff in the intensive care units ( ICUs ) had adequate experience with the study insulin infusion algorithm . The 20 patients received intensive insulin therapy during surgery and for 24 hours after surgery . The pilot period data allowed us to modify the grade d insulin infusion to achieve desired glucose concentration goals . We built safety features into our infusion protocol to minimize hypoglycemia . We discontinued the infusion when glucose levels were less than 4.4 mmol/L ( glucose levels decreased to less than 3.3 mmol/L ( met eligibility criteria . We r and omly assigned patients to receive intensive or conventional intraoperative insulin therapy . R and omization was computer-generated with permuted blocks of 4 , with stratification according to surgeon , surgical procedure ( coronary artery bypass grafting [ CABG ] with or without other procedures and no CABG ) , and diabetes . The r and omization assignments were concealed in opaque , sealed , tamper-proof envelopes that were opened sequentially by study personnel after participants signed the patient consent form . We could not possibly know , before obtaining consent , the few patients who would not have intraoperative hyperglycemia ( glucose concentration of 5.6 mmol/L or more [ 100 mg/dL ] ) . Therefore , per protocol , patients who gave consent were r and omly assigned , and those whose glucose levels were less than 5.6 mmol/L ( Patients in the intensive treatment group received a continuous intravenous insulin infusion , 250 units of NovoLin R ( Novo Nordisk , Princeton , New Jersey ) in 250 mL of 0.45 % sodium chloride , when their blood glucose levels exceeded 5.6 mmol/L ( > 100 mg/dL ) . We adjusted the infusions to maintain blood glucose levels between 4.4 ( 80 mg/dL ) and 5.6 mmol/L ( 100 mg/dL ) . We adjusted the dose according to a st and ardized algorithm used by anesthesiologists ( Appendix Table 1 ) . Appendix Table 1 . Insulin Infusion Protocol * Conventional Treatment Patients in the conventional treatment group did not receive insulin during surgery unless their glucose levels exceeded 11.1 mmol/L ( 200 mg/dL ) . If glucose concentration was between 11.1 ( 200 mg/dL ) and 13.9 mmol/L ( 250 mg/dL ) , patients received an intravenous bolus of 4 units insulin every hour until the glucose concentration was less than 11.1 mmol/L ( intraoperative glucose concentration was greater than 13.9 mmol/L ( > 250 mg/dL ) , patients received an intravenous infusion of insulin that was continued until the glucose level was less than 8.3 mmol/L ( arterial plasma glucose concentration every 30 minutes , starting just before anesthetic induction by using hexokinase method on a Double P Modular System ( Roche Diagnostics , Indianapolis , Indiana ) . Intraoperative procedures , including cardiopulmonary bypass , monitoring , laboratory testing , and treatment , were left to the discretion of anesthesiologists and cardiac surgeons . There was no st and ard protocol for monitoring and managing intraoperative potassium levels . Postoperative Period Intravenous insulin infusion was started in patients in the conventional treatment group on their arrival in the ICU . Thereafter , both study groups were treated identically , with the intravenous insulin infusion rates adjusted by a nursing staff that was not involved with the study according to a st and ard protocol . The target blood glucose range was 4.4 ( 80 mg/dL ) to 5.6 mmol/L ( 100 mg/dL ) ( Appendix Table 1 ) . Arterial blood glucose levels were measured every 1 to 2 hours by using the Accu-Check Inform blood glucose monitoring system ( glucometer ) ( Roche Diagnostics ) . During the first 24 hours after surgery , patients were given only clear liquids by mouth ; we did not administer subcutaneous insulin or oral diabetic medications during this time . Thereafter , the hospital diabetes consulting service saw all patients and provided individualized recommendations for ongoing care . Outcomes and Measurements The primary outcome variable was a composite of death , sternal wound infections , prolonged pulmonary ventilation , cardiac arrhythmias ( new-onset atrial fibrillation , heart block requiring permanent pacemaker , or cardiac arrest ) , stroke , and acute renal failure within 30 days after surgery . Secondary outcome measures were length of stay in the ICU and hospital . Trained study personnel identified the occurrence of a complication through chart abstract ion by using confirmable , objective criteria in accordance with st and ardized definitions from the Society of Thoracic Surgeons ( STS ) data base committee ( 17 ) . Personnel who assessed outcomes were not aware of patient treatment assignment or of the study hypothesis . Follow-up Procedures We contacted patients by telephone and used a st and ardized telephone survey at 30 days after surgery to assess outcomes that occurred after discharge . We considered",
"BACKGROUND Cardiac surgery with cardiopulmonary bypass ( CPB ) induces an acute phase reaction that is implicated in the pathogenesis of several postoperative complications . Studies have shown that proinflammatory cytokines are increased by acute hyperglycemia . Recent evidence suggests that insulin has antiinflammatory properties . Therefore , we hypothesized that high-dose insulin therapy would attenuate the systemic inflammatory response to cardiopulmonary bypass and surgery in coronary artery bypass patients while maintaining normoglycemia . METHODS A total of 52 patients who presented for elective coronary artery bypass were r and omized to receive intraoperative intravenous insulin infusion , titrated to maintain blood glucose concentrations less than 180 mg/dL ( group I , n = 25 ) , or receive intraoperative fixed high dose of intravenous insulin infusion ( 5 mU/kg/min ) with dextrose 20 % infused separately to maintain a blood glucose level between 70 and 110 mg/dL ( group II , n = 27 ) . Blood sample s were collected at different time points to determine tumor necrosis factor alpha ( TNFalpha ) , interleukin 6 and 8 ( IL6 and IL8 ) , and complement factor 3 and 4 ( C3 and C4 ) . RESULTS Patients in both groups had similar preoperative characteristics . Patients in the high-dose insulin group had higher blood insulin concentrations and tighter blood glucose control . There were lower levels of IL6 ( 150 pg/dL vs 245 pg/dL , p = 0.03 ) , IL-8 ( 49 pg/dL vs 74 pg/dL , p = 0.05 ) , and TNFalpha ( 2.2 pg/dL vs 3.0 pg/dL , p = 0.04 ) in group II in the early postoperative period . CONCLUSIONS High-dose insulin therapy blunts the early postoperative surge in inflammatory response to CPB as reflected by decreased levels of IL6 , IL8 , and TNFalpha",
"Introduction Strict control of plasma glucose in diabetic and non-diabetic patients has been shown to improve outcome in several clinical setting s. There is extensive evidence that glucose can stimulate the production of pro-inflammatory cytokines such as tumor necrosis factor (TNF)-α and IL-6 , with no effect on the anti-inflammatory cytokine IL-10 . We hypothesized that strict glucose regulation results in a change in cytokine balance from a pro-inflammatory state to a more balanced anti-inflammatory condition . In a r and omized controlled trial we studied the effect of strict glycemic control on the local and systemic pro-inflammatory and anti-inflammatory balance in non-diabetic patients undergoing elective coronary artery bypass grafting with cardiopulmonary bypass . Methods After surgery patients were r and omly assigned to intensive insulin therapy ( blood glucose between 80 and 110 mg/dl ) or conventional insulin therapy ( blood glucose less than 200 mg/dl ) . At 0 , 1 , 2 , 4 , 8 , 12 , 16 and 24 hours after admission to the intensive care unit , plasma sample s and sample s from the mediastinal drains were obtained . We measured the concentrations of the pro-inflammatory cytokines TNF-α and IL-6 and the anti-inflammatory cytokine IL-10 by enzyme-linked immunosorbent assay . Results Both patient groups were comparable in demographics , clinical characteristics and peri-operative data . In the intensive treatment group , glucose levels were significantly lower than in the conventionally treated group . No differences were found between both groups in the concentrations of TNF-α , IL-6 and IL-10 in plasma sample s or in fluid draining the mediastinal cavity . Levels of IL-6 and IL-10 were significantly higher in mediastinal fluid sample s than in plasma sample s , suggesting a compartmentalized production of cytokines . Conclusion The protective effect of intensive insulin therapy in patients after cardiac surgery with cardiopulmonary bypass is not related to a change in cytokine balance from a pro-inflammatory to an anti-inflammatory pattern . Systemic cytokine levels are not representative of the local inflammatory response",
"Intensive insulin therapy ( IIT ) improves the outcome of prolonged critically ill patients , but concerns remain regarding potential harm and the optimal blood glucose level . These questions were addressed using the pooled data set of two r and omized controlled trials . Independent of parenteral glucose load , IIT reduced mortality from 23.6 to 20.4 % in the intention-to-treat group ( n = 2,748 ; P = 0.04 ) and from 37.9 to 30.1 % among long stayers ( n = 1,389 ; P = 0.002 ) , with no difference among short stayers ( 8.9 vs. 10.4 % ; n = 1,359 ; P = 0.4 ) . Compared with blood glucose of 110–150 mg/dl , mortality was higher with blood glucose > 150 mg/dl ( odds ratio 1.38 [ 95 % CI 1.10–1.75 ] ; P = 0.007 ) and lower with Only patients with diabetes ( n = 407 ) showed no survival benefit of IIT . Prevention of kidney injury and critical illness polyneuropathy required blood glucose strictly died ( P = 0.0004 ) without difference in hospital mortality . No new neurological problems occurred in survivors who experienced hypoglycemia in intensive care units ( ICUs ) . We conclude that IIT reduces mortality of all medical/surgical ICU patients , except those with a prior history of diabetes , and does not cause harm . A blood glucose target < 110 mg/day was most effective but also carried the highest risk of hypoglycemia",
"OBJECTIVE The purpose of this study was to test the hypothesis that a liberal blood glucose strategy ( 121 - 180 mg/dL ) is not inferior to a strict blood glucose strategy ( 90 - 120 mg/dL ) for outcomes in patients after first-time isolated coronary artery bypass grafting and is superior for glucose control and target blood glucose management . METHODS A total of 189 patients undergoing coronary artery bypass grafting were investigated in this prospect i ve r and omized study to compare 2 glucose control strategies on patient perioperative outcomes . Three methods of analyses ( intention to treat , completer , and per protocol ) were conducted . Observed power was robust ( > 80 % ) for significant results . RESULTS The groups were similar on preoperative hemoglobin A(1c ) and number of diabetic patients . The liberal group was found to be noninferior to the strict group for perioperative complications and superior on glucose control and target range management . The liberal group had significantly fewer patients with hypoglycemic events ( severe hypoglycemic events ( blood glucose variability , maximum blood glucose , and perioperative atrial fibrillation . CONCLUSIONS This study demonstrated that maintenance of blood glucose in a liberal range after coronary artery bypass grafting led to similar outcomes compared with a strict target range and was superior in glucose control and target range management . On the basis of the results of this study , a target blood glucose range of 121 to 180 mg/dL is recommended for patients after coronary artery bypass grafting as advocated by the Society of Thoracic Surgeons",
"OBJECTIVE Diabetes mellitus is a risk factor for death after coronary artery bypass grafting . Its relative risk may be related to the level of perioperative hyperglycemia . We hypothesized that strict glucose control with a continuous insulin infusion in the perioperative period would reduce hospital mortality . METHODS All patients with diabetes undergoing coronary artery bypass grafting ( n = 3554 ) were treated aggressively with either subcutaneous insulin ( 1987 - 1991 ) or with continuous insulin infusion ( 1992 - 2001 ) for hyperglycemia . Predicted and observed hospital mortalities were compared with both internal and external ( Society of Thoracic Surgeons 1996 ) multivariable risk models . RESULTS Observed mortality with continuous insulin infusion ( 2.5 % , n = 65/2612 ) was significantly lower than with subcutaneous insulin ( 5.3 % , n = 50/942 , P glucose control was significantly better with continuous insulin infusion ( 177 + /- 30 mg/dL vs 213 + /- 41 mg/dL , P death ( odds ratio 0.43 , P = .001 ) . Conversely , cardiogenic shock , renal failure , reoperation , nonelective operative status , older age , concomitant peripheral or cerebral vascular disease , decreasing ejection fraction , unstable angina , and history of atrial fibrillation increased the risk of death . For external comparison , observed mortality with continuous insulin infusion was significantly less than that predicted by the model ( observed/expected ratio 0.63 , P death ( odds ratio 0.50 , P = .005 ) to the constellation of risk factors in the Society of Thoracic Surgeons risk model . CONCLUSION Continuous insulin infusion eliminates the incremental increase in in-hospital mortality after coronary artery bypass grafting associated with diabetes . The protective effect of continuous insulin infusion may stem from the effective metabolic use of excess glucose to favorably alter pathways of myocardial adenosine triphosphate production . Continuous insulin infusion should become the st and ard of care for glycometabolic control in patients with diabetes undergoing coronary artery bypass grafting",
"BACKGROUND : The objective of this study was to investigate the relationship between different target levels of glucose and the clinical outcomes of patients undergoing cardiac surgery with cardiopulmonary bypass . METHODS : We design ed a prospect i ve study in a university hospital where 109 consecutive patients were enrolled during a six-month period . All patients were scheduled for open-heart surgery requiring cardiopulmonary bypass . Patients were r and omly allocated into two groups . One group consisted of 55 patients and had a target glucose level of 80–130 mg/dl , while the other contained 54 patients and had a target glucose level of 160–200 mg/dl . These parameters were controlled during surgery and for 36 hours after surgery in the intensive care unit . Primary outcomes were clinical outcomes , including time of mechanical ventilation , length of stay in the intensive care unit , infection , hypoglycemia , renal or neurological dysfunction , blood transfusion and length of stay in the hospital . The secondary outcome was a combined end-point ( mortality at 30 days , infection or length of stay in the intensive care unit of more than 3 days ) . A p-value of The mean glucose level during the protocol period was 126.69 mg/dl in the treated group and 168.21 mg/dl in the control group ( p the duration of mechanical ventilation , length of stay in the intensive care unit , blood transfusion , postoperative infection , hypoglycemic event , neurological dysfunction or 30-day mortality ( p>0.05 ) . CONCLUSIONS : In 109 patients undergoing cardiac surgery with cardiopulmonary bypass , both protocol s of glycemic control in an intraoperative setting and in the intensive care unit were found to be safe , easily achieved and not to differentially affect clinical outcomes",
"CONTEXT Hyperglycemia and hyperinsulinemia are common in intensive care unit ( ICU ) patients and relate to illness severity . Intensive insulin therapy ( IIT ) to maintain normoglycemia reduces morbidity and mortality . Blood glucose control explains this benefit because a high insulin dose is associated with adverse outcome . Mitogenic insulin effects could theoretically explain this link . OBJECTIVE To investigate further the association between insulin dose and adverse outcome , we studied the effect of IIT on circulating insulin levels , markers of insulin sensitivity , and the metabolic and mitogenic insulin signaling molecules in key tissues . DESIGN This is a sub analysis of a large r and omized , controlled study . SETTING The study was performed in a university hospital surgical ICU . PATIENTS A total of 339 critically ill patients , treated in ICU for at least a week , were included in this sub analysis . INTERVENTION Strict normoglycemia with IIT compared with conventional insulin therapy was performed . RESULTS Severalfold higher insulin doses than with conventional insulin therapy were required to maintain normoglycemia with IIT . However , serum insulin levels were only transiently higher with IIT , despite the much lower blood glucose levels . IIT normalized the elevated serum C-peptide levels and increased circulating adiponectin levels . The metabolic insulin signal was increased by IIT in muscle , but not in liver . The mitogenic insulin signal in either tissue was not affected by IIT . CONCLUSIONS Normoglycemia can be maintained in ICU patients without a sustained further elevation of insulinemia . Together with the increased adiponectin levels , this finding suggests that IIT may improve insulin sensitivity . Skeletal muscle , but not liver , revealed an increased metabolic insulin signal . The therapy did not impose mitogenic risk in these tissues",
"Introduction Critically ill patients can develop hyperglycaemia even if they do not have diabetes . Intensive insulin therapy decreases morbidity and mortality rates in patients in a surgical intensive care unit ( ICU ) and decreases morbidity in patients in a medical ICU . The effect of this therapy on patients in a mixed medical/surgical ICU is unknown . Our goal was to assess whether the effect of intensive insulin therapy , compared with st and ard therapy , decreases morbidity and mortality in patients hospitalised in a mixed ICU . Methods This is a prospect i ve , r and omised , non-blinded , single-centre clinical trial in a medical/surgical ICU . Patients were r and omly assigned to receive either intensive insulin therapy to maintain glucose levels between 80 and 110 mg/dl ( 4.4 to 6.1 mmol/l ) or st and ard insulin therapy to maintain glucose levels between 180 and 200 mg/dl ( 10 and 11.1 mmol/l ) . The primary end point was mortality at 28 days . Results Over a period of 30 months , 504 patients were enrolled . The 28-day mortality rate was 32.4 % ( 81 of 250 ) in the st and ard insulin therapy group and 36.6 % ( 93 of 254 ) in the intensive insulin therapy group ( Relative Risk [ RR ] : 1.1 ; 95 % confidence interval [ CI ] : 0.85 to 1.42 ) . The ICU mortality in the st and ard insulin therapy group was 31.2 % ( 78 of 250 ) and 33.1 % ( 84 of 254 ) in the intensive insulin therapy group ( RR : 1.06 ; 95%CI : 0.82 to 1.36 ) . There was no statistically significant reduction in the rate of ICU-acquired infections : 33.2 % in the st and ard insulin therapy group compared with 27.17 % in the intensive insulin therapy group ( RR : 0.82 ; 95%CI : 0.63 to 1.07 ) . The rate of hypoglycaemia ( ≤ 40 mg/dl ) was 1.7 % in the st and ard insulin therapy group and 8.5 % in the intensive insulin therapy group ( RR : 5.04 ; 95 % CI : 1.20 to 21.12 ) . Conclusions IIT used to maintain glucose levels within normal limits did not reduce morbidity or mortality of patients admitted to a mixed medical/surgical ICU . Furthermore , this therapy increased the risk of hypoglycaemia . Trial Registration clinical trials.gov Identifiers : 4374 - 04 - 13031 ; 094 - 2 in",
" Twenty seven insulin‐dependent diabetics , and six non‐diabetic subjects undergoing elective surgery have been studied . Twelve diabetics received continuous glucose‐insulin‐potassium ( GIK ) infiion for at least 4 hours after surgery terminated . Six diabetic patients having morning surgery received a proportion of their morning insulin dose with intravenous glucose ( 25 g ) before surgery and the remaining jve operated on in the afternoon received their morning insulin with breakfast . Non‐GIK groups were combined and compared with GIK . Postoperative diabetic treatment was the same in both groups . Plasma glucose changes were studied in all patients and other metabolites whenever possible",
"OBJECTIVES To determined the relationship between perioperative glucose control and postoperative nosocomial infection rate is 100 consecutive diabetic patients undergoing elective surgery . DESIGN AND PATIENTS One hundred initially uninfected diabetic patients undergoing elective surgery were prospect ively monitored for perioperative glucose control and postoperative nosocomial infection rate . Glucose control was determined by the attending surgeon or diabetologist . SETTING A large tertiary care hospital that serves as the in-patient facility for a local diabetes center . MAIN OUTCOME MEASURES All patients were screened for infection preoperatively . Only initially uninfected patients were enrolled , and all patients received perioperative antibiotic coverage . Perioperative glucose control and postoperative nosocomial infection rate were monitored prospect ively . APACHE II scores were determined on all patients . Patients were stratified into two groups : those with relatively \" good \" perioperative glucose control ( all values 220 mg/dL ) . Contingency tables were generated , comparing nosocomial infection rates vs perioperative glucose control . Correlation coefficients between APACHE II score and maximum and mean glucose values were also determined . RESULTS A serum glucose > 220 mg/dL on postoperative day one ( POD 1 ) was a sensitive ( 87.5 % ) but relatively nonspecific ( 33.3 % ) predictor of the later development of postoperative nosocomial infection . In patients with hyperglycemia ( > 220 mg/dL ) on POD 1 , the infection rate was 2.7 times that observed ( 31.3 % vs 11.5 % ) in diabetic patients with all serum glucose values \" serious \" postoperative infection increased to 5.7 when any POD 1 blood glucose level was > 220 mg/dL. On the basis of correlation coefficients between serum glucose values and APACHE II score , only 18 % of the variance in the highest serum glucose could be explained by disease severity alone . CONCLUSIONS We conclude that diabetic patients undergoing major cardiovascular or abdominal surgery have an increased risk of infection that is further exacerbated by early postoperative hyperglycemia . The high rate of nosocomial infection observed in diabetic patients with poor glucose control suggests that hyperglycemia itself may be an independent risk factor for the development of infection . Efforts to improve perioperative glucose homeostasis in diabetic patients may reduce the incidence of nosocomial infection and thereby improve outcome",
"Twenty-five insulin-treated diabetic patients were r and omly assigned postoperatively to 5 days of intravenous infusions of ProcalAmine ( 3 % amino acids , 3 % glycerol , and electrolytes ) or FreAmineIII + dextrose and electrolytes . The solutions were given isocalorically and isonitrogenously . Insulin was adjusted to keep glycemia at the level of 150 - 200 mg/dl . The ProcalAmine group by the 5th day had plasma glucose of 158 + /- 25 mg/dl and required 1.20 + /- 0.10 U/hr insulin . The FreAmine + dextrose group had plasma glucose of 169 + /- 53 mg/dl and required 2.28 + /- 0.13 U/hr . At all time points postsurgically , the ProcalAmine group required less insulin",
"BACKGROUND Intravenous glucose-insulin-potassium ( GIK ) may have a positive metabolic influence in patients with acute myocardial infa rct ion ( AMI ) who receive reperfusion therapy . The objective of this r and omized trial was to assess for the first time whether GIK improves myocardial salvage in patients with AMI . METHODS The Reevaluation of Intensified Venous Metabolic Support for Acute Infa rct Size Limitation ( REVIVAL ) trial is a r and omized , open-label study conducted among 312 patients with AMI . Patients were r and omly assigned to either the GIK therapy group ( n = 155 ) or the control group ( n = 157 ) . All patients were intended to receive reperfusion treatment , which was given in all but 5 patients ( 1.6 % ) . The primary end point of the study was salvage index , measured as the proportion of initial perfusion defect ( acute technetium-99 m sestamibi scintigraphy ) salvaged by therapy ( follow-up scintigraphy performed after 7 to 14 days ) . RESULTS The primary end point of the study , the salvage index , was in median 0.50 ( 25th , 75th percentiles : 0.18 , 0.87 ) in the GIK group and 0.48 ( 25th , 75th percentiles : 0.27 , 0.78 ) in the control group ( P = .96 ) . By 6 months , the mortality rate was 5.8 % in the GIK group and 6.4 % in the control group ( P = .85 ; relative risk , 0.92 ; 95 % CI , 0.37 to 2.26 ) . Subgroup analyses showed that GIK therapy was associated with increased salvage index only among diabetic patients ( mean difference , 0.19 ; 95 % CI , 0.01 to 0.37 ) . CONCLUSIONS The routine use of GIK therapy in patients with AMI is not associated with enhanced myocardial salvage . This therapy appears to improve myocardial salvage only among diabetic patients",
"BACKGROUND Diabetes mellitus is a risk factor for deep sternal wound infection after open heart surgical procedures . We previously showed that elevated postoperative blood glucose levels are a predictor of deep sternal wound infection in diabetic patients . Therefore , we hypothesized that aggressive intravenous pharmacologic control of postoperative blood glucose levels would reduce the incidence of deep sternal wound infection . METHODS In a prospect i ve study of 2,467 consecutive diabetic patients who underwent open heart surgical procedures between 1987 and 1997 , perioperative blood glucose levels were recorded every 1 to 2 hours . Patients were classified into two sequential groups : the control group included 968 patients treated with sliding-scale-guided intermittent subcutaneous insulin injections ( SQI ) ; the study group included 1,499 patients treated with a continuous intravenous insulin infusion in an attempt to maintain a blood glucose level of less than 200 mg/dL. There were no differences between these groups with respect to age , sex , procedure , bypass time , antibiotic prophylaxis , or skin preparation methods . RESULTS Compared with subcutaneous insulin injections , continuous intravenous insulin infusion induced a significant reduction in perioperative blood glucose levels , which led to a significant reduction in the incidence of deep sternal wound infection in the continuous intravenous insulin infusion group ( 0.8 % [ 12 of 1,499 ] ) versus the intermittent subcutaneous insulin injection group ( 2.0 % [ 19 of 968 ] , p = 0.01 by the chi2 test ) . Multivariate logistic regression revealed that continuous intravenous insulin infusion induced a significant decrease in the risk of deep sternal wound infection ( p = 0.005 ; relative risk , 0.34 ) , whereas obesity ( p deep sternal wound infection . CONCLUSIONS Use of perioperative continuous intravenous insulin infusion in diabetic patients undergoing open heart surgical procedures significantly reduces major infectious morbidity and its associated socioeconomic costs",
"Background : This r and omized , double‐blind , placebo‐controlled study was design ed to determine whether an intra‐operative , intravenous infusion of glucose – insulin – potassium ( GIK ) could be helpful in the prevention of myocardial ischemia and in the maintenance of intra‐operative cardiac performance in patients undergoing off‐pump coronary artery bypass ( OP‐CAB ) surgery ",
"OBJECTIVE To evaluate a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection . DESIGN Prospect i ve , r and omized clinical trial . PATIENTS Thirty patients who had pancreatic resection for pancreatic neoplasm . INTERVENTIONS Patients were prospect ively r and omized . Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas ( STG-22 ) . Glucose levels were controlled using either the sliding scale method ( sliding scale group , n = 13 ) or the artificial pancreas ( artificial pancreas group , n = 17 ) . MAIN OUTCOME MEASURES Incidence of severe hypoglycemia ( patients monitored with the artificial pancreas . The secondary outcome measure was the total amount of insulin required for glycemic control in the first 18 hours after pancreatic resection in each patient group . RESULTS In the sliding scale group , postoperative blood glucose levels rose initially before reaching a plateau of approximately 200 mg/dL between 4 and 6 hours after pancreatectomy . The levels remained high for 18 hours postoperatively . In the artificial pancreas group , blood glucose levels reduced steadily , reaching the target zone ( 80 - 110 mg/dL ) by 6 hours after surgery . The total insulin dose administered per patient during the first postoperative 18 hours was significantly higher in the artificial pancreas group ( mean [ SD ] , 107 [ 109 ] IU ) than the sliding scale group ( 8 [ 6 ] IU ; P hypoglycemia . CONCLUSIONS Perioperative use of an artificial endocrine pancreas to control pancreatogenic diabetes after pancreatic resection is an easy and effective way to maintain near-normal blood glucose levels . The artificial pancreas shows promise for use as insulin treatment for patients with pancreatogenic diabetes after pancreatic resection",
"Objective : The role of intensive insulin therapy in medical surgical intensive care patients remains unclear . The objective of this study was to examine the effect of intensive insulin therapy on mortality in medical surgical intensive care unit patients . Design : R and omized controlled trial . Setting s : Tertiary care intensive care unit . Patients : Medical surgical intensive care unit patients with admission blood glucose of > 6.1 mmol/L or 110 mg/dL. Intervention : A total of 523 patients were r and omly assigned to receive intensive insulin therapy ( target blood glucose 4.4–6.1 mmol/L or 80–110 mg/dL ) or conventional insulin therapy ( target blood glucose 10–11.1 mmol/L or 180–200 mg/dL ) . Measurements and Main Outcomes : The primary end point was intensive care unit mortality . Secondary end points included hospital mortality , intensive care unit and hospital length of stay , mechanical ventilation duration , the need for renal replacement therapy and packed red blood cells transfusion , and the rates of intensive care unit acquired infections as well as the rate of hypoglycemia ( defined as blood glucose ≤2.2 mmol/L or 40 mg/dL ) . There was no significant difference in intensive care unit mortality between the intensive insulin therapy and conventional insulin therapy groups ( 13.5 % vs. 17.1 % , p = 0.30 ) . After adjustment for baseline characteristics , intensive insulin therapy was not associated with mortality difference ( adjusted hazard ratio 1.09 , 95 % confidence interval 0.70–1.72 ) . Hypoglycemia occurred more frequently with intensive insulin therapy ( 28.6 % vs. 3.1 % of patients ; p the intensive insulin therapy and conventional insulin therapy in any of the other secondary end points . Conclusions : Intensive insulin therapy was not associated with improved survival among medical surgical intensive care unit patients and was associated with increased occurrence of hypoglycemia . Based on these results , we do not advocate universal application of intensive insulin therapy in intensive care unit patients . Trial Registration : Current Controlled Trials registry ( IS RCT N07413772 ) http://www.controlled-trials.com/IS RCT N07413772/07413772 ; 2005",
"The role of glucose-insulin-potassium ( GIK ) infusion in the management of acute coronary syndrome is controversial . Limited data are available on the effects of adjunctive high-dose GIK ( 30 % glucose , 50 IU of insulin , 80 mEq of potassium chloride infused at 1.5 ml/kg/hour over 24 hours ) on myocardial perfusion and left ventricular ( LV ) remodeling in patients treated with primary percutaneous coronary intervention ( PCI ) for ST-segment elevation myocardial infa rct ion . In this prospect i ve study , 73 patients were r and omized to receive GIK infusion ( n = 40 ) or saline ( placebo , n = 33 ) in addition to st and ard therapy . The primary end points were myocardial perfusion after PCI and LV remodeling at 6 months . Thrombolysis In Myocardial Infa rct ion frame count and myocardial blush grade were evaluated before and after reperfusion treatment . LV end-diastolic and end-systolic volumes , ejection fraction , and wall motion score index were assessed in each patient after PCI and after 6 months . Although no differences in final Thrombolysis In Myocardial Infa rct ion flow were observed between the 2 groups , myocardial blush grade 3 was more frequently achieved in the GIK group ( p months , ventricular remodeling was more often observed in the control group ( 24 % vs 3 % , p GIK infusion in adjunct to primary PCI in patients with ST-segment elevation myocardial infa rct ion was safe , improved myocardial perfusion after revascularization , and was associated with less LV remodeling at follow-up",
"BACKGROUND In diabetic patients , the combination of abciximab with stenting has been demonstrated to be the st and ard of care to reduce target vessel revascularization ( TVR ) and mortality . Moreover , a preprocedural hyperglycemia has been associated with a higher rate of TVR after an elective stent implantation . We sought to evaluate the effects of abciximab and /or preprocedural glycemic control on 30 and 180 days of TVR and on 1-year major adverse cardiac events ( MACE-cardiac mortality , TVR , and myocardial infa rct ion ) in diabetic patients undergoing elective coronary stenting . METHODS From January 2002 through May 2003 , diabetic patients undergoing elective stenting of de novo coronary artery lesions were r and omized to abciximab or placebo infusion . Preprocedural hyperglycemia was defined as fasting plasma glucose > or=126 mg/dL ( 7.0 mmol/L ) immediately before the procedure . RESULTS A total of 122 consecutive patients with diabetes ( 62.4 + /- 10.2 years , 80 men ) were enrolled in the study . Sixty-nine ( 56.5 % ) were r and omly assigned to receive abciximab ( 34 with and 35 without preprocedural hyperglycemia ) and 53 ( 43.5 % ) to placebo ( 23 with and 30 without hyperglycemia ) . Target vessel revascularization was significantly lower in diabetic patients who received abciximab at 30 days ( 2.9 % and 2.8 % vs 8.7 % and 6.6 % in nonabciximab group with or without hyperglycemia , respectively , P cumulative incidence of MACE was significantly higher among diabetic patients with preprocedural hyperglycemia ( 64.7 % and 65.2 % ) versus diabetic patients with preprocedural glycemic control ( 37.1 % and 40 % ) , treated with or without abciximab , respectively ( P rate of MACE , regardless of the use of abciximab , in diabetic patients undergoing elective coronary stenting",
"OBJECTIVE To evaluating the effect of different levels of blood glucose control on inflammatory response and prognosis of the patients in surgical intensive care unit ( SICU ) . METHODS One hundred and eighty-eight patients admitted to SICU were r and omly divided into three groups , blood glucose were controlled by insulin infusion . Group A ( 75 cases ) : the mean blood glucose ( MBG ) was maintained at the level of 4.4 - 6.1 mmol/L. Group B ( 75 cases ) : MBG was maintained at the level of 6.7 - 8.3 mmol/L. Group C ( 38 cases ) : MBG was maintained at the level of 10.0 - 11.1 mmol/L. Blood glucose control was achieved with an effected computerized protocol . The outcome was evaluated by days in ICU , days to wean mechanical ventilation , infection , amount of red blood cell transfusion , hospital mortality and ICU cost . RESULTS Compared with other groups , hypoglycemia ( red blood cell transfusion and infection were significantly reduced in Group A and Group B ( P days of mechanical ventilation and days in ICU in Group A were significantly reduced ( P Hospital mortality and ICU cost were reduced in Group A compared with the other groups ( P > 0.05 ) . CONCLUSIONS To maintain blood glucose in normal range with intensive insulin therapy has potential positive impact on SICU patients ' outcome and can reduce days in ICU and ICU cost . Further correlation research is needed to determine the best levels of blood glucose in ICU patients",
"BACKGROUND The optimal target range for blood glucose in critically ill patients remains unclear . METHODS Within 24 hours after admission to an intensive care unit ( ICU ) , adults who were expected to require treatment in the ICU on 3 or more consecutive days were r and omly assigned to undergo either intensive glucose control , with a target blood glucose range of 81 to 108 mg per deciliter ( 4.5 to 6.0 mmol per liter ) , or conventional glucose control , with a target of 180 mg or less per deciliter ( 10.0 mmol or less per liter ) . We defined the primary end point as death from any cause within 90 days after r and omization . RESULTS Of the 6104 patients who underwent r and omization , 3054 were assigned to undergo intensive control and 3050 to undergo conventional control ; data with regard to the primary outcome at day 90 were available for 3010 and 3012 patients , respectively . The two groups had similar characteristics at baseline . A total of 829 patients ( 27.5 % ) in the intensive-control group and 751 ( 24.9 % ) in the conventional-control group died ( odds ratio for intensive control , 1.14 ; 95 % confidence interval , 1.02 to 1.28 ; P=0.02 ) . The treatment effect did not differ significantly between operative ( surgical ) patients and nonoperative ( medical ) patients ( odds ratio for death in the intensive-control group , 1.31 and 1.07 , respectively ; P=0.10 ) . Severe hypoglycemia ( blood glucose level , conventional-control group ( P median number of days in the ICU ( P=0.84 ) or hospital ( P=0.86 ) or the median number of days of mechanical ventilation ( P=0.56 ) or renal-replacement therapy ( P=0.39 ) . CONCLUSIONS In this large , international , r and omized trial , we found that intensive glucose control increased mortality among adults in the ICU : a blood glucose target of 180 mg or less per deciliter result ed in lower mortality than did a target of 81 to 108 mg per deciliter . ( Clinical Trials.gov number , NCT00220987 .",
"BACKGROUND Similar to cardiac surgery patients , medical-surgical critically ill patients may benefit from intensive insulin therapy . The objectives of this pilot trial were to evaluate the feasibility of a r and omized trial of intensive insulin therapy with respect to ( a ) achieving target glucose values in the 2 ranges of 5 to 7 and 8 to 10 mmol/L and ( b ) uncovering problems with the protocol in anticipation of a larger trial . SETTING The trial was conducted in a 15-bed medical-surgical university-affiliated intensive care unit ( ICU ) . METHODS We included patients older than 18 years , expected to be in ICU for more than 72 hours , with a glucose value of more than 10 mmol/L within 48 hours of ICU admission . Exclusion criteria were diabetic ketoacidosis , severe hepatic failure or hepatic resection , pancreatitis , glucose of less than 2.2 mmol/L on admission to hospital , insulin infusion on admission to ICU , planned withdrawal of life support , and inability to obtain informed consent . Patients underwent concealed r and om allocation to a target glucose range of 5 to 7 or 8 to 10 mmol/L using pretested algorithms of insulin infusions . Dedicated glucometer measurement of arterial glucose values was calibrated daily to values measured in the laboratory . RESULTS We enrolled 20 patients with a mean ( SD ) Acute Physiology and Chronic Health Evaluation ( APACHE ) II score of 32 ( 10.2 ) ; 14 were insulin-dependent pre-ICU , and all were medical admissions . Mean glucose values were different in the 2 groups ( 7.1 + /- 2.6 vs 9.4 + /- 2.1 mmol/L , P intensive insulin therapy group had more glucose measurements performed than the control group , a similar proportion of values were within the target range ( 682 [ 42.4 % ] of 1607 values in the 5- to 7-mmol/L range ; 250 [ 38.7 % ] of 660 values in the 8- to 10-mmol/L range , P = .35 ) . Glucose values of less than 2.5 mmol/L developed 7 times in 5 patients , 4 of whom were in the intensive insulin therapy group ; however , no adverse consequences were documented . As expected , there were no differences in clinical ly important outcomes . CONCLUSIONS In this pilot trial of ICU patients with high illness severity , glucose values were in the 2 target ranges only 40 % of the time , using well-accepted initiation and maintenance insulin infusion algorithms . A large r and omized trial of glycemic control is feasible in this population to examine clinical ly important outcomes , but will require refined insulin algorithms and more comprehensive behavior change strategies to achieve target values",
"We conducted a r and omized , prospect i ve study to assess the effect of i.v . insulin on blood glucose control , development of ketone bodies and hormonal changes in 60 well-controlled , non-insulin-dependent diabetics ( NIDDM ) undergoing major surgery . In group A , patients were given only 0.9 % saline ; in group B , patients were given insulin as a continuous i.v . infusion ( 1.25 u. h-1 ) ; in group C , patients were given insulin 10 u. i.v . boluses every 2 h. Patients in all three groups were given insulin 5 u. when their intraoperative blood glucose concentration increased to greater than 11.1 mmol litre-1 . Blood glucose concentrations were measured every 15 min , from just before induction of anaesthesia to 2 h after surgery . Plasma lactate , pyruvate , ketone body , C-peptide and counter-regulatory hormone concentrations were also measured . Blood glucose concentrations in the three groups did not differ significantly . There was a mild-to-moderate increase in plasma ketone body concentrations in group A , but without any deleterious consequences . Plasma C-peptide concentrations decreased significantly in groups B and C , especially in patients given bolus injections of insulin . Plasma growth hormone concentrations also increased significantly in group B and C patients . This study indicated that the \" no insulin -- no glucose \" regimen was a simple , effective way to control blood glucose in well-controlled NIDDM patients , provided blood glucose was measured frequently and insulin used appropriately",
"BACKGROUND : Although hyperglycemia is a well-recognized risk factor in the context of cardiac surgery , the relevance of perioperative glycemic control for patients undergoing major noncardiac operations has received little attention . We design ed this study to assess the hyperglycemic response to liver resection , and to test the hypothesis that perioperative glucose and insulin administration while maintaining normoglycemia ( GIN therapy ) provides glycemic control superior to that achieved by the conventional use of insulin . METHODS : Patients were r and omly assigned to GIN therapy or st and ard therapy ( control group ) . In the GIN therapy group , insulin was administered at 2 mU · kg−1 · min−1 during surgery . At the end of surgery , the insulin infusion was decreased to 1 mU · kg−1 · min−1 and continued for 24 hours . Dextrose 20 % was infused at a rate adjusted to maintain blood glucose within the target range of 3.5 to 6.1 mmol · L−1 ( 63–110 mg · dL−1 ) . Patients in the st and ard therapy group received a conventional insulin sliding scale during and after surgery . The mean and SD of blood glucose as well as the percentage of blood glucose values within the target range were calculated . To evaluate intrasubject variability , the coefficient of variability ( CV ) of blood glucose was calculated for each patient . Episodes of severe hypoglycemia , i.e. , blood glucose the proportion of normoglycemic measurements . RESULTS : We studied 52 patients . The mean blood glucose value in patients receiving GIN therapy always remained within the target range . The blood glucose levels were lower in the GIN therapy group than in the st and ard therapy group ( during surgery , P receiving GIN therapy ( n = 19 ) , target glycemia was achieved in 90.1 % of the blood glucose measurements during surgery and in 77.8 % of the measurements after surgery . In diabetic patients receiving GIN therapy ( n = 7 ) , target glycemia was achieved in 81.2 % of the blood glucose measurements during surgery and in 70.5 % of the measurements after surgery . In nondiabetic patients receiving st and ard therapy ( n = 19 ) , target glycemia was achieved in 37.4 % of the blood glucose measurements during surgery and in 18.3 % of the measurements after surgery . In diabetic patients receiving st and ard therapy ( n = 7 ) , target glycemia was achieved in 4.3 % of the blood glucose measurements during surgery and in 2.9 % of the measurements after surgery . The SD and CV of blood glucose were smaller in the GIN therapy group than in the st and ard therapy group , especially in nondiabetic patients after surgery ( SD , P GIN therapy experienced severe hypoglycemia during surgery . One patient receiving GIN therapy experienced hypoglycemia in the intensive care unit after surgery without neurological sequelae . CONCLUSIONS : GIN therapy effectively provides normoglycemia in patients undergoing liver resection ( clinical trials.gov , NCT00774098 )",
"UNLABELLED Diabetic patients are at increased risk of wound infection after major surgery , but the effect of perioperative glucose control on postoperative wound infection rates after surgery is uncertain . We tested the effect of an insulin infusion on perioperative neutrophil function in diabetic patients scheduled for coronary artery bypass surgery . Participants ( n = 26 ) were r and omly allocated to receive either aggressive insulin therapy ( AIT ) or st and ard insulin therapy ( SIT ) during surgery . Blood was drawn for neutrophil testing before surgery , 1 h after the completion of cardiopulmonary bypass , and on the first postoperative day . Neutrophil phagocytic activity decreased to 75 % of baseline activity in the AIT group and to 47 % of baseline activity in the SIT group ( P neutrophil antibody-dependent cell cytotoxicity were found . This study documents a potentially beneficial effect of continuous insulin therapy in diabetic patients who require major surgery . IMPLICATION S A continuous insulin infusion and glucose control during surgery improves white cell function in diabetic patients and may increase resistance to infection after surgery",
"OBJECTIVE To investigate the influence of intensive insulin therapy on the results of postoperative patients with gastric cancer . METHODS Forty-six patients with gastric cancer underwent radical operation were r and omly divided into two groups : intensive group ( n=23 , to control blood glucose at 4.4 to 6.1 mmol/L ) and conventional group ( n=23 , to control blood glucose at 10.0 to 11.1 mmol/L ) . Fasting blood glucose ( FBG ) , fasting insulin ( FINS ) , tumor necrosis factor-alpha ( TNF-alpha ) , interleukin-6 ( IL-6 ) and C reaction protein ( CRP ) in 46 patients were detected dynamically during perioperative period . Insulin resistance index ( HOMA-IR ) were calculated using Homeostasis Model Assessment ( HOMA ) to evaluate insulin sensitivity . Postoperative complications and other clinical data were recorded . RESULTS No hypoglycemia occurred in the two groups . Compared with conventional group , morbidity and postoperative duration of fever , antibiotic use and the length of hospital stay in intensive group were significantly reduced ( P HOMA-IR and serum levels of TNF-alpha , IL-6 and CRP in patients of intensive group were significantly lower than those in conventional group ( P Intensive insulin therapy could counteract the state of high-inflammation and then improve the outcome of postoperative patients",
"OBJECTIVE To investigate the effects of intensive insulin therapy on insulin resistance(IR ) and serum proteins after radical gastrectomy . METHODS Twenty-two gastric cancer patients were r and omly divided into the control ( n=11 ) and intensive insulin therapy group ( n=11 ) , and underwent distal radical subtotal gastrectomy under epidural anesthesia . Fasting blood glucose ( FBG ) , fasting insulin ( FINS ) and serum proteins were assayed preoperatively and at day 1 , 3 , 7 postoperatively . Insulin resistance index was calculated using homeostasis model assessment ( HOMA ) . The length of hospital stay and postoperative complications were recorded respectively . RESULTS (1)The levels of FBG , FINS , lnHOMA-IR ( P incidence of insulin resistance were remarkably decreased by intensive insulin therapy after the surgical procedure.(2)The levels of serum transferrin ( TRF ) , prealbumin ( PRE ) and retinal binding protein ( RBP ) in the intensive insulin therapy group were significantly improved as compared to control group after operation(P duration of fever , antibiotic use , passage of gas by anus , length of hospital stay and the occurrence of postoperative complications were also significantly lower than those in control group(P routine therapy , the intensive insulin therapy has more beneficial effects on the patients undergone distal radical subtotal gastrectomy in decreasing the insulin resistance , improving the status of nutrition and preventing postoperative complications",
"Purpose An optimal target for glucose control in ICU patients remains unclear . This prospect i ve r and omized controlled trial compared the effects on ICU mortality of intensive insulin therapy ( IIT ) with an intermediate glucose control . Methods Adult patients admitted to the 21 participating medico-surgical ICUs were r and omized to group 1 ( target BG 7.8–10.0 mmol/L ) or to group 2 ( target BG 4.4–6.1 mmol/L ) . Results While the required sample size was 1,750 per group , the trial was stopped early due to a high rate of unintended protocol violations . From 1,101 admissions , the outcomes of 542 patients assigned to group 1 and 536 of group 2 were analysed . The groups were well balanced . BG levels averaged in group 1 8.0 mmol/L ( IQR 7.1–9.0 ) ( median of all values ) and 7.7 mmol/L ( IQR 6.7–8.8 ) ( median of morning BG ) versus 6.5 mmol/L ( IQR 6.0–7.2 ) and 6.1 mmol/L ( IQR 5.5–6.8 ) for group 2 ( p percentage of patients treated with insulin averaged 66.2 and 96.3 % , respectively . Proportion of time spent in target BG was similar , averaging 39.5 % and 45.1 % ( median ( IQR ) 34.3 ( 18.5–50.0 ) and 39.3 (26.2–53.6)% ) in the groups 1 and 2 , respectively . The rate of hypoglycaemia was higher in the group 2 ( 8.7 % ) than in group 1 ( 2.7 % , p was similar in the two groups ( 15.3 vs. 17.2 % ) . Conclusions In this prematurely stopped and therefore underpowered study , there was a lack of clinical benefit of intensive insulin therapy ( target 4.4–6.1 mmol/L ) , associated with an increased incidence of hypoglycaemia , as compared to a 7.8–10.0 mmol/L target . ( Clinical Trials.gov # NCT00107601 , EUDRA-CT Number : 200400391440 )",
"BACKGROUND To evaluate the impact of adjunctive high-dose glucose-insulin-potassium ( GIK ) on ST-segment elevation resolution in patients with ST-segment elevation myocardial infa rct ion ( MI ) . METHODS As part of a r and omized controlled trial of GIK versus no GIK in patients treated with primary percutaneous coronary intervention ( PCI ) for ST-elevation MI in a tertiary referral center , we analyzed ST-segment elevation resolution . Paired electrocardiographic recordings ( baseline and 3 hours after primary PCI ) were available in 612 ( 65 % ) of 940 patients . RESULTS We analyzed paired electrocardiograms of 310 patients r and omized to GIK and 302 control patients . Baseline characteristics of the groups were comparable . Combined complete ( > 70 % ) and partial ( 30%-70 % ) resolution was more commonly observed in the GIK group ( 87 % ) when compared with the control group ( 78 % ) , odds ratio 1.92 ( 95 % CI 1.23 - 3.02 , P = .004 ) ; 1-year mortality was lower in patients with combined complete and partial resolution compared with patients without resolution ( 3.8 % vs 10.3 % , P = .011 ) . There was no difference in 1-year mortality between GIK and control patients ( 5.5 % vs 4.3 % , P = .58 ) . CONCLUSIONS In patients with ST-elevation MI treated with primary PCI , addition of GIK is associated with improved ST-segment elevation resolution . ST-segment elevation resolution is related to improved 1-year survival . No benefit of GIK on 1-year outcome was observed . Future trials should investigate whether GIK-induced improvement of ST-segment elevation resolution results in more favorable clinical outcome",
"OBJECTIVE Although hyperglycemia is hypothesized to increase the short-term risk of infection , this hypothesis has not been well tested in a clinical setting . This study was design ed to assess the relationship of perioperative glycemic control to the subsequent risk of infectious complications . RESEARCH DESIGN AND METHODS A total of 411 adults with diabetes who underwent coronary artery surgery from 1990 to 1995 in the cardiac surgery service of an urban university hospital were included in a nonconcurrent prospect i ve cohort study based on chart review . Perioperative glycemic control was characterized by the mean of six capillary glucose measurements taken during the 36-h interval following surgery . The major outcomes studied were infections of leg and chest wounds , pneumonia , and urinary tract infections . RESULTS Mean postoperative glucose levels ranged from 121 to 352 mg/dl and were divided into quartiles : quartile 1 ( 121 - 206 mg/dl ) , quartile 2 ( 207 - 229 mg/dl ) , quartile 3 ( 230 - 252 mg/dl ) , and quartile 4 ( 253352 mg/dl ) . After simultaneous adjustment for age , sex , race , underlying comorbidity , acute severity of illness , and the length of the stay in the surgical intensive care unit , patients with higher mean capillary glucose readings were at increased risk of developing infections . Compared with people in the lowest quartile of postoperative glucose , those in quartiles 2 ( relative odds of infection [ 95 % CI ] = 1.17 [ 0.57 - 2.40 ] ) , 3 ( 1.86 [ 0.94 - 3.68 ] ) , and 4 ( 1.78 [ 0.86 - 3.47 ] ) were at progressively higher risk for infection ( P = 0.05 for trend ) . CONCLUSIONS In patients with diabetes who undergo coronary artery surgery , postoperative hyperglycemia is an independent predictor of short-term infectious complications . Physicians should consider a glucose concentration target of < or = 200 mg/dl to reduce the risk of infection",
"In this study we investigated the effects of preoperative oral carbohydrate administration on postoperative insulin resistance ( PIR ) , gastric fluid volume , preoperative discomfort , and variables of organ dysfunction in ASA physical status III-IV patients undergoing elective cardiac surgery , including those with noninsulin-dependent Type-2 diabetes mellitus . Before surgery , 188 patients were r and omized to receive a clear 12.5 % carbohydrate drink ( CHO ) , flavored water ( placebo ) , or to fast overnight ( control ) . CHO and placebo were treated in double-blind format and received 800 mL of the corresponding beverage in the evening and 400 mL 2 h before surgery . Patients were monitored from induction of general anesthesia until 24 h postoperatively . Exogenous insulin requirements to control blood glucose levels ≤10.0 mmol/L were used as a marker for PIR . Gastric fluid volume was measured by passive gastric reflux and preoperative discomfort using visual analog scales . Postoperative clinical and surgical data were recorded . Blood glucose levels and insulin requirements did not differ between groups . Patients receiving CHO and placebo were less thirsty compared with controls ( P cause increased gastric fluid volume or other adverse events . The CHO group required less intraoperative inotropic support after initiation of cardiopulmonary bypass weaning ( P not affect PIR . Clear fluids reduce thirst and may be recommended as a safe procedure in ASA III-IV patients . Further research is indicated to investigate possible cardioprotective effects of preoperative CHO intake",
"BACKGROUND Traditionally hyperglycemia in surgical in patients has been managed with six-hourly sliding-scale regular insulin . However , this approach is usually ineffective in preventing hyperglycemia since no basal insulin is provided . We compared glycemic control using NPH and regular insulin versus glargine insulin alone in patients after cardiovascular surgery on a general surgical ward . METHODS Ninety-four hyperglycemic patients were r and omized to subcutaneous insulin using twice-daily NPH/regular or once-daily glargine if they required at least 1 unit/h of intravenous insulin at the time of transfer from the ICU . NPH/regular was adjusted twice daily ; glargine was adjusted once daily . Blood glucose was measured four times daily and targeted to 80 - 140 mg/dL. RESULTS The mean blood glucose after NPH/regular ( 124 mg/dL ) and glargine ( 131 mg/dL ) was similar ( P = 0.065 ) . In the subgroup of patients with a history of diabetes , mean blood glucose was significantly lower after NPH/regular ( 133 mg/dL ) versus glargine ( 154 mg/dL ) ( P = 0.016 ) . Blood glucose less than 60 mg/dL was significantly less common after glargine ( 0.5 % ) as compared with NPH/regular ( 2 % ) ( P = 0.036 ) . CONCLUSIONS Once-daily glargine insulin provides good glycemic control in hyperglycemic patients after cardiovascular surgery . Although twice-daily NPH/regular insulin provided better control than glargine insulin monotherapy , the simplicity and safety of glargine insulin make it an attractive option for the management of postoperative hyperglycemia . Patients with established diabetes will achieve better glucose control with NPH/regular insulin as compared with glargine but have a higher incidence of hypoglycemia",
"The Bypass Angioplasty Revascularization Investigation 2 Diabetes ( BARI 2D ) is a National Institutes of Health (NIH)-sponsored r and omized clinical trial that evaluates treatment efficacy for patients with type 2 diabetes mellitus and angiographically documented stable coronary artery disease . Using a 2 x 2 factorial design , BARI 2D compares revascularization combined with aggressive medical treatment versus aggressive medical treatment alone ; simultaneously , BARI 2D compares 2 glycemic control strategies , insulin sensitization versus insulin provision . All patients have goals of glycosylated hemoglobin values following recommended medical guidelines . The primary end point of BARI 2D is all-cause 5-year mortality analyzed by intention to treat , and the principal secondary end point is the combination of death , myocardial infa rct ion , and stroke . A total of 2,368 patients have been enrolled at 49 clinical centers throughout North America , South America , and Europe . The study enrollment period was January 2001 through March 2005 , and the patient treatment and follow-up phase is expected to extend at least through May 2007 . Participants are treated at the local BARI 2D clinical sites on a monthly basis for the first 6 months and then every 3 months until the end of the study . Within BARI 2D , central management centers oversee the control of glycemia , plasma lipid levels , hypertension , and obesity . The r and omized clinical trial collects data on patient symptoms , clinical measurements , medications , and clinical events as well as data from central ized evaluations of angiograms , electrocardiograms , nuclear stress tests , blood and urine specimens , and relative economic costs",
"BACKGROUND Hyperglycemia and insulin resistance are common in critically ill patients , even if they have not previously had diabetes . Whether the normalization of blood glucose levels with insulin therapy improves the prognosis for such patients is not known . METHODS We performed a prospect i ve , r and omized , controlled study involving adults admitted to our surgical intensive care unit who were receiving mechanical ventilation . On admission , patients were r and omly assigned to receive intensive insulin therapy ( maintenance of blood glucose at a level between 80 and 110 mg per deciliter [ 4.4 and 6.1 mmol per liter ] ) or conventional treatment ( infusion of insulin only if the blood glucose level exceeded 215 mg per deciliter [ 11.9 mmol per liter ] and maintenance of glucose at a level between 180 and 200 mg per deciliter [ 10.0 and 11.1 mmol per liter ] ) . RESULTS At 12 months , with a total of 1548 patients enrolled , intensive insulin therapy reduced mortality during intensive care from 8.0 percent with conventional treatment to 4.6 percent ( P intensive insulin therapy was attributable to its effect on mortality among patients who remained in the intensive care unit for more than five days ( 20.2 percent with conventional treatment , as compared with 10.6 percent with intensive insulin therapy , P=0.005 ) . The greatest reduction in mortality involved deaths due to multiple-organ failure with a proven septic focus . Intensive insulin therapy also reduced overall in-hospital mortality by 34 percent , bloodstream infections by 46 percent , acute renal failure requiring dialysis or hemofiltration by 41 percent , the median number of red-cell transfusions by 50 percent , and critical-illness polyneuropathy by 44 percent , and patients receiving intensive therapy were less likely to require prolonged mechanical ventilation and intensive care . CONCLUSIONS Intensive insulin therapy to maintain blood glucose at or below 110 mg per deciliter reduces morbidity and mortality among critically ill patients in the surgical intensive care unit",
"STUDY OBJECTIVE To compare the effect of two different perioperative insulin management regimes on patients undergoing either major surgery ( vascular surgery ) or minor surgery ( vitrectomy ) . DESIGN Prospect i ve , double-blind r and omized trial . PATIENTS 48 insulin-treated type 2 diabetics aged 18 to 85 years were studied . SETTING University medical center . INTERVENTIONS Patients were divided into four groups of 12 patients each : Groups A and B ( major surgery ) , Groups C and D ( minor surgery ) . Group A and C patients were treated with a continuous modified glucose-insulin-potassium infusion according to blood glucose levels after intubation . Patients assigned to Groups B and D were treated with intermittent intravenous ( IV ) insulin injections when glucose levels exceeded 12 mmol L(-1 ) . MEASUREMENTS Glucose and potassium levels were measured every 15 minutes and 30 minutes during surgery and up to 4 hours post-surgery . Plasma levels of lactate , cortisol , glycerol , and free fatty acids were measured in arterial sample s after intubation ( S1 ) , after extubation ( S2 ) , and 4 hours after surgery ( S3 ) . MAIN RESULTS There were no significant differences of the patient characteristics among the four groups . There was no significant difference in the time course of plasma glucose levels and hormone variables measured among the four groups . One episode of hyperglycemia in Group D during the postoperative period was treated with 12 IV units of insulin . One patient in Group A and one in Group B received potassium intraoperatively ( 15 and 29 mmoL , respectively ) . Postoperatively , two other patients of Group A received 19 and 12,5 mmoL , respectively , and one of Group B received 20 mmoL potassium . CONCLUSIONS Both regimens result ed in relatively stable and comparable blood glucose levels throughout the perioperative period of the minor and major surgeries without differences in metabolic control as measured by levels of lactate , cortisol , glycerol and free fatty acids . Simplicity would favor the intermittent regimen to manage insulin treated type 2 diabetics ",
"OBJECTIVE To determine whether optimized glycemic control in type I diabetic recipients of renal allografts will prevent or delay diabetic renal lesions in the allograft . DESIGN Prospect i ve , controlled , and r and omized trial of glycemic control in an inception cohort of type I diabetic renal allograft recipients . The experimental group underwent maximized glycemic control , and the st and ard group was treated in the same way as other patients in the transplant clinic . Patients underwent baseline ( before transplant ) and 5-year posttransplant allograft biopsies . SETTING University of Minnesota Hospital and Clinic and the Clinical Research Center and Hennepin County Medical Center , Minneapolis . PATIENTS Type I diabetics with terminal diabetic renal failure undergoing renal transplantation . Forty-eight patients r and omized to maximized or st and ard control completed the trial . INTERVENTION Subcutaneous insulin given several times a day or continuously ( maximized group ) and once or twice each day ( st and ard group ) was used throughout the trial . A significant difference for hemoglobin A1 level was maintained ( mean + /- SD : st and ard , 0.117 + /- 0.013 ; maximized , 0.096 + /- 0.016 ; P trial was the difference between the groups in renal glomerular mesangial expansion as determined by electron microscopy . RESULTS There was a more than twofold increase in the volume fraction of mesangial matrix per glomerulus in the st and ard group ( mean + /- SD , 0.043 + /- 0.034 ) compared with the maximized group ( 0.019 + /- 0.038 ; P = .024 ) . The threefold increase in arteriolar hyalinosis , the greater widening of the glomerular basement membrane , and increase of volume fraction of the total mesangium in the patients who received st and ard treatment all approached significance ( P = .10 or less ) . The incidence of severe hypoglycemic episodes was greater in the maximized group ( 1.7 per patient per year ) than in the st and ard treatment group ( < 0.1 per patient per year ; P < .001 ) . CONCLUSIONS This trial indicates a causal relationship between hyperglycemia and an important lesion of diabetic nephropathy , mesangial matrix expansion , in renal allografts transplanted into diabetic recipients . In addition , the results with other lesions central to the development of diabetic nephropathy support the major conclusion",
"Background : Diabetes-induced gastroparesis is believed to increase fasting gastric fluid volume before elective surgery . Metoclopramide is routinely administered preoperatively to reduce gastric fluid volume in these patients . This study compared nondiabetic controls to non – insulin-dependent and insulin-dependent diabetics to determine the effect of metoclopramide , administered before surgery , on gastric volumes in patients who fasted before surgery . Methods : Control and diabetic patients fasted preoperatively before receiving either placebo or 10 mg intravenous metoclopramide 20 min before induction of anesthesia . After intubation , a gastric tube was placed , and stomach contents were aspirated with volumes compared among the groups . Results : Both groups of diabetic patients were older than the control group , and insulin-dependent patients had a higher incidence of comorbidities compared with the non – insulin-dependent group . Fasting blood sugar and hemoglobin A1C values were higher in both insulin-dependent and non – insulin-dependent patients . Gastric fluid volumes were similar in control , non – insulin-dependent , and insulin-dependent patients ( 8.0 ± 2.6 vs. 9.6 ± 4.1 vs. 17.7 ± 2.5 ml , respectively ) . In insulin-dependent diabetic patients , metoclopramide decreased gastric volume compared with placebo treatment ( 17.7 ± 2.5 vs. 7.8 ± 2.9 ml ; P = 0.027 ) . After stratification , a sub population of patients with poorly controlled diabetes , regardless of type , were identified to have increased gastric residual volumes . Conclusion : In elective surgical patients who have fasted before surgery , gastric volumes are minimal , even in diabetics with severe neuropathic symptoms . Metoclopramide prophylaxis to reduce gastric volumes seems to be unnecessary unless the patient has a prolonged history of poor blood glucose control",
"The metabolic response to the postoperative delivery of a sole glucose solution or a glucose-fructose-xylitol solution , and their effects upon carbohydrate metabolism , in patients with glucose tolerance impairment , were evaluated . Twenty four patients who showed an abnormal 75g-OGTT or were noninsulin-dependent diabetics were divided in two groups . The GFX-B group ( n = 11 ) received a 10.5 % solution , containing glucose , fructose and xylitol at 4:2:1 ratio , and the PHY-3 group ( n = 13 ) received a 10 % glucose solution , both , continuously infused for 3 days postoperatively . The infusion of PHY-3 tended to produce a higher increase in blood glucose than the infusion of GFX-B , that was significantly different on the 3POD ( P less than 0.05 ) . The increase in IRI and CPR was also significantly greater in PHY-3 group than in GFX-B group on the 3POD ( P less than 0.05 ) . We concluded that it was not only the slight lower glucose load of the GFX-B solution , but also , the different infused carbohydrate substrate which had influenced the magnitude of insulin secretion and the blood glucose level . Then , its use in glucose intolerant patients may be of some benefit to partially minimize the postoperative hyperglycemic response",
"Postoperative glucose control directly affects the incidence of deep sternal wound infection and death after patients with diabetes have undergone coronary artery bypass grafting . We compared the effect upon glucose control of continuous insulin infusion with that of glucometer-guided insulin injection after coronary artery bypass . Our prospect i ve , r and omized , controlled study involved patients with diabetes mellitus who underwent coronary artery bypass grafting in our hospital from January 2001 through January 2003 . Immediately after surgery , patients were r and omly assigned to receive continuous insulin infusion or conventional glucometer-guided injection to maintain blood glucose at a level between 150 and 200 mg/dL. The adequacy of postoperative blood glucose control and clinical outcome were evaluated . Of 93 patients studied , the incidence of sternal wound infection was 3.9 % among infusion patients and 4.8 % among injection patients ( P=0.587 ) . There was no significant difference in mortality rates ( infusion , 3.9 % ; injection , 2.4 % ; P=0.573 ) . Satisfactory blood glucose levels were achieved in significantly more patients undergoing infusion than injection ( 64.7 % vs 28.6 % , P blood glucose measurements were required to achieve control ( 23.4 vs 16.5 , P=0.001 ) , and good control was attained much sooner in the infusion group ( 21.4 vs 30.5 hr , P=0.013 ) . We conclude that continuous insulin infusion provides better control of postoperative blood glucose levels after coronary artery bypass grafting in patients with diabetes than does glucometer-guided insulin injection",
"Background This study was to compare the effect of intensive insulin therapy ( IIT ) to conventional insulin therapy ( CIT ) on postoperative outcomes among type 2 diabetes mellitus ( DM ) patients who underwent D2 gastrectomy for gastric cancer . Methods We r and omly assigned gastric cancer patients with type 2 DM who underwent radical gastrectomy to receive IIT ( maintenance of blood glucose at a level between 4.4 and 6.1 mmol/l ) with insulin infusion or CIT ( maintenance of blood glucose at a level between 10 and 11.1 mmol/l ) during the postoperative period . Results Of the 179 eligible patients , 92 patients were assigned to receive IIT and 87 patients to receive CIT . Mean blood glucose concentrations were lower in the intensive group ( IG ) than in the conventional group ( CG ) ( 5.5 ± 0.8 vs. 9.9 ± 1.0 mmol/l , P ) . Hypoglycemia occurred in 6 patients ( 6.5 % ) in the IG ( P = 0.029 ) versus in 1 patient ( 1.1 % ) in the CG . Hospital mortality did not differ significantly between two groups ( 4.3 % vs. 5.7 % , P = 0.742 ) . However , IIT significantly reduced morbidity ( from 18.4 to 7.6 % , P = 0.031 ) . Also , IIT shortened the days to suture removal , postoperative hospital stay , and postoperative duration of antibiotic use . The HOMA-IR score was lower at all time points in IG . Moreover , IIT increased the postoperative HLA-DR expression on monocytes on postoperative days 3 and 5 . Conclusions IIT significantly reduced short-term morbidity but not mortality among type 2 DM patients who underwent D2 gastrectomy for gastric cancer . Furthermore , a possible mechanism of suppression of the insulin resistance and improvement of HLA-DR expression may partially explain the benefits of IIT ",
"In this study , we sought a simple , easily implemented method of intraoperative control of blood glucose in diabetic patients in a large multispecialty teaching hospital . The Vellore regimen , which offers the advantages of a combined glucose insulin and variable rate infusion was evaluated . For every 1 to 50-mg/dL increase in blood glucose concentration more than 100 mg/dL , 1 U of insulin was added to the injection port of a 100-mL measured volume set containing 5 % dextrose in water . Hourly monitoring of blood glucose was performed . The blood glucose control was compared with the different existing techniques followed in the hospital in 204 r and omized patients : 98 in the study and 106 in the control group . The study group had a mean ±sd blood glucose value of 156 ± 36 mg/dL , and the control group ’s value was 189 ± 63 mg/dL ( P = 0.003 ) . The percentage of patients who were poorly controlled ( outside 100 to 200-mg/dL range ) decreased from 51 % to 28 % ( no patient less than 60 mg/dL ) with this regimen as compared with the control group in which it increased from 49 % to 72 % ( 10 patients less than 60 mg/ dL ) ( P = 0.0013 ) . We conclude that the Vellore regimen is simple , effective , and safe for intraoperative blood glucose control ",
"Objectives . Determine if pre-emptive daily insulin glargine surpasses regular insulin when needed for glycaemic control after cardiac surgery . Design . Prospect i ve , r and omized study of 43 patients ( scheduled for coronary artery bypass grafting ) with preoperatively diagnosed diabetes ( DM ) or pre-DM . Lantus group received insulin glargine daily from start of surgery while Actrapid group received regular insulin ( sliding scale ) when needed ( plasma glucose ( P-glu ) > 10 mmol/l ) . Primary endpoint was percent of pre- and post-pr and ial P-glu values within Target Intervals : Pre-pr and ial P-glu : 4.5–7 mmol/l ; post-pr and ial P-glu : 4.5–9 mmol/l . Study period 1–4 days after surgery . Tissue glucose was also measured continuously . Results . More than twice as many P-glu values were within Target Interval for Lantus patients as compared with Actrapid patients ( p . Area under the curve for glucose > 7 mmol/l was reduced by 61 % by Lantus ( p insulin studied here provides a major improvement in glycaemic control with a minimal incidence of hypoglycaemia and without an excessive increase in nursing burden",
"We compared two intravenous insulin regimens among 58 consecutive surgical patients who required perioperative insulin infusions . Patients were r and omized to either a st and ard glucose-insulin-potassium ( GIK ) infusion or a more complex , tailored two-pump protocol . Both methods provided similar overall glycemic control . However , the two-pump regimen result ed in a significantly greater proportion of finger-prick results in the target range both preoperatively ( 47.4 % vs 60.1 % ) and postoperatively ( 52.0 % vs 66.4 % ) . The length of stay ( 15 vs 16 days ) , duration of infusion ( 15 vs 16 hours , and number of medical and nursing incidents ( 18 % vs 20 % ) were similar : Although the two-punip protocol required more changes to the administration rate ( 2 vs 10 ) , this method was preferred by the nursing staff over the GIK regimen , result ed in more stable glucose control , and is likely to be associated with fewer clinical errors",
"BACKGROUND Frequently , the use of insulin is considered for metabolic control in postoperative patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . We sought to determine the best method for control of glucose in NIDDM non-insulin patients during postoperative care . METHODS Two algorithms were developed : subcutaneous administration of insulin ( SC ) , and continuous intravenous infusion ( IV ) . A r and omized , controlled clinical trial was design ed . In addition , both experimental groups were compared with a non-concurrent routinely managed group ( RM ) with insulin administration under no predetermined algorithm . Eligible patients were those subjected to major surgery under general anesthesia or spinal blockade . They were followed for 48 h after surgery . Target variables were capillary and central blood glucose , insulin dose administered , urine glucose and ketone strip determination , and development of hyper- or hypoglycemia . RESULTS A total of 62 patients were studied ( RM = 25 , SC = 19 , IV = 18 ) . Results for both experimental algorithms were similar except for the IV group that required less insulin per hour compared to SC ( 0.64 vs. 0.34 U/h ; p = 0.0003 ) . The RM control group showed poor control in all capillary glucose measurements ( 194.9 + /- 26.8 mg/dL ) compared with the two experimental algorithms ( SC = 129.9 + /- 21 ; IV = 131.6 + /- 20.4 ) ( p hyperglycemia events appeared in the RM group ( p = 0.016 ) . Only one hypoglycemia event occurred in the IV group . CONCLUSIONS Postoperative control of NIDDM is similar with both tested methods . The use of any of the algorithms studied improves metabolic control substantially because it st and ardizes postoperative management of the diabetic patient with timely determination of capillary blood glucose and insulin administration . However , IV administration has the advantage of accomplishing adequate control with a smaller insulin dose",
"AIMS We have different protocol s applied in our cardiac center for control of blood glucose ( BG ) , we like to see which protocol can achieve our goal . METHODS From a prospect i ve study of 120 diabetic patients r and omly assigned to either simple sliding scale or Braithwaite protocol who underwent open heart surgical procedures between 2005 and 2008 . The study group included 80 patients treated with Braithwaite protocol ; the control group included 40 patients treated with simple sliding scale in an attempt to maintain BG level less than 200 mg/dl . RESULTS In the study group all the patients were under 200 mg/dl at the end of 48 h postoperatively , which was not achieved in the control group ( P reduction in hospital stay in the study group compared to the control group ( mean in days 9.1+/-2.3/12.3+/-7.6 ) ( P no wound infection compared to the control group ( 0/5 cases ) . CONCLUSION The study showed that control of DM in peri-operative period using Braithwaite regimen was of great benefit and safety",
"AIMS To document the impact of intensive insulin therapy during intensive care on long-term ( 4 years ) outcome of high-risk cardiac surgery patients . METHODS AND RESULTS In this pre-planned sub- analysis and follow-up study of a large , r and omized controlled trial on the effects of intensive insulin therapy during critical illness , we assessed long-term outcome in the 970 patients who had been admitted after high-risk cardiac surgery ( mean+/-SD EuroSCORE of 6.0+/-3.7 ; EuroSCORE-predicted hospital mortality of 9.9 % ; observed hospital mortality of 7.5 % in the conventional insulin group and 3.4 % in the intensive insulin group ) . Long-term outcome was quantified as : ( a ) 4 years survival ; ( b ) incidence of hospital re-admission ; ( c ) level of activity and medical care requirements at 4 years as assessed by the Karnofsky score ; and ( d ) perceived health-related quality -of-life at 4 years as assessed by the Nottingham Health Profile . Four years after ICU admission , the number of post-hospital discharge deaths was similar in the two study groups , reflecting maintenance of the acute survival benefit with intensive insulin therapy . Survivors who had been treated with intensive insulin during ICU stay revealed a similar risk for hospital re-admission and a comparable level of dependency on medical care . There was no effect on quality -of-life in the total group , whereas the increased survival of sicker patients with at least 3 days of insulin therapy evoked a more compromised perceived quality -of-life , in particular regarding social and family life . CONCLUSION The short-term survival benefit obtained with insulin-titrated glycaemic control during intensive care after cardiac surgery was maintained after 4 years , without inducing increased medical care requirements but possibly at the expense of compromised perceived quality of social and family life",
"OBJECTIVES We assessed myocardial salvage achieved by reperfusion with percutaneous coronary interventions ( PCI ) and compared stenting with balloon angioplasty ( PTCA ) in patients with acute myocardial infa rct ion ( AMI ) ineligible for thrombolysis . BACKGROUND A substantial proportion of patients with AMI are currently considered ineligible for thrombolysis , and reperfusion treatment is frequently not recommended for them . It is not known whether these patients benefit from PCI . METHODS The Stent or PTCA for Occluded Coronary Arteries in Patients with Acute Myocardial Infa rct ion Ineligible for Thrombolysis ( STOPAMI-3 ) trial , a r and omized , open-label study , included 611 patients with AMI who were ineligible for thrombolysis ( lack of ST-segment elevation on the electrocardiogram , late presentation > 12 h after symptom onset , and contraindications to thrombolysis ) . Patients were r and omly assigned to receive either coronary artery stenting ( n = 305 ) or PTCA ( n = 306 ) . Scintigraphic myocardial salvage index ( proportion of the initial myocardial perfusion defect that was salvaged by reperfusion ) was the primary end point of the study . RESULTS A considerable myocardial salvage was achieved with both stenting and PTCA . In patients assigned to receive stenting , the median size of the salvage index was 0.54 ( 25th and 75th percentiles , 0.29 and 0.87 ) , as compared with a median of 0.50 ( 25th and 75th percentiles , 0.26 and 0.82 ) in the group assigned to receive PTCA ( p = 0.20 ) . Mortality at six months was 8.2 % in the group of patients assigned to receive stenting and 9.2 % in the group of patients assigned to receive PTCA ( p = 0.69 ) . CONCLUSIONS Patients with AMI who are currently considered ineligible for thrombolysis by conventional guidelines may greatly benefit from primary PCI . The benefit seems to be comparable when a strategy of stenting is compared with a strategy of PTCA in these patients",
"We have compared intraoperative glycaemic control , insulin requirements and metabolic and endocrine variables in 40 non-insulin-dependent diabetic patients ( NIDDM ) and 40 insulin-dependent diabetic patients ( IDDM ) undergoing general anaesthesia for elective procedures . Two i.v . insulin regimens were used : continuous i.v . infusion ( group A : 1.25 u.h-1 ) and repeated i.v . boluses ( 10 u./2 h ) . Blood concentrations of glucose were measured every 15 min from just before induction of anaesthesia until 2 h after surgery . Plasma lactate and pyruvate concentrations , ketone bodies , C-peptide and counter-regulatory hormones were also measured . Glycaemia did not differ significantly in the two types of diabetes , regardless of the insulin therapy used . The amounts of insulin administered were similar in NIDDM and IDDM . There was no significant difference for other metabolic variables . Plasma concentrations of growth hormone ( GH ) increased significantly during surgery , especially in IDDM patients , but this change did not alter intraoperative glycaemic control . We conclude that mean glycaemic control , insulin requirements and development of ketone bodies in NIDDM and IDDM patients did not differ during the operative period , regardless of the insulin regimen used . Therefore , during the operative period , it is not necessary to modify the insulin regimen according to the type of diabetes . The consequences of increased plasma GH concentrations on glycaemic control in IDDM patients after operation are unknown",
"Background : Intensive insulin therapy to maintain blood glucose at or below 6.11 mm reduces morbidity and mortality after cardiac surgery and morbidity in medical intensive care unit ( ICU ) patients . The authors investigated the clinical safety and outcome effects of intensive insulin therapy compared to conventional insulin therapy in patients receiving postoperative intensive care after neurosurgical procedures . Methods : In this prospect i ve r and omized controlled trial , 483 patients undergoing elective or emergency brain surgery were prospect ively and r and omly assigned either to intensive insulin therapy ( 241 patients ) , receiving insulin titrated to maintain blood glucose levels within the range of 4.44–6.11 mm , or to conventional insulin therapy ( 242 patients ) , receiving insulin to maintain blood glucose levels below 11.94 mm . Primary endpoint was incidence of hypoglycemia ( defined as blood glucose mm ) . Efficacy measures included the length of ICU stay , infection rate , and 6 months follow-up Glasgow outcome scale score and overall survival . Results : Hypoglycemia episodes were more frequent in patients receiving intensive insulin therapy , median ( min – max ) : 8 ( 0–23 ) versus 3 ( 0–4 ) ; P The length of stay in the ICU was shorter ( 6 vs. 8 days ; P = 0.0001 ) , and the infection rate was lower ( 25.7 % vs. 39.3 % ; P = 0.0018 ) . Glasgow outcome scale score and overall survival at 6 months were similar in the two groups . Conclusions : Intensive insulin therapy in patients admitted to a postoperative neurosurgical ICU after brain surgery is associated with iatrogenic hypoglycemia , but it can also reduce the infection rate and shorten the ICU stay"
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4117e51a-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Iron deficiency and iron deficiency anaemia ( IDA ) are common in young children . It has been suggested that the lack of iron may have important effects on children 's psychomotor development and cognitive function . OBJECTIVES To determine the effects of iron therapy on psychomotor development and cognitive function in iron deficient children less than 3 years of age . SEARCH STRATEGY The following data bases were search ed : COCHRANE LIBRARY ( 2000 ISSUE 4 ) MEDLINE ( 1966-August 2000 ) EMBASE ( 1980-August 2000 ) Latin American Data base ( LILACS ) PsycLIT Journal articles ( 1974-August 2000 ) PsycLIT Chapters and Books ( 1987-August 2000 ) The references of identified trials and of important review articles were scrutinised . Citation search es on trials from the primary search were performed within the Science Citation Index . Key authors were contacted . SELECTION CRITERIA Studies were included if children less than 3 years of age with evidence of iron deficiency anaemia were r and omly allocated to iron or iron and vitamin C versus a placebo or vitamin C alone and assessment of developmental status or cognitive function was carried out using st and ardised tests by observers blind to treatment allocation . DATA COLLECTION AND ANALYSIS Abstract s and titles of studies identified on search es of electronic data bases were read to determine whether they might meet the inclusion criteria . Full copies of those possibly meeting these criteria from electronic or other search es were assessed by two independent review ers . Differences of opinion about suitability for inclusion were resolved by discussion . Data were analysed separately depending on whether participants had iron assessment s were performed within one month of beginning iron therapy or later . MAIN RESULTS Five trials , including 180 children with IDA , examined the effects of iron therapy on measures of psychomotor development between 5 and 11 days of commencement of therapy . Data from four trials could be pooled . The pooled difference in pre to post treatment change in Bayley Scale PDI between iron treated and placebo groups was -3.2 ( 95%CI -7.24 , 0.85 ) and in Bayley Scale MDI , 0.55 ( 95 % CI -2.84 , 1.75 ) . Two studies , including 160 r and omised children with IDA , examined the effects of iron therapy on measures of psychomotor development more than 30 days after commencement of therapy . Aukett et al reported the mean number of skills gained after two months of iron therapy , using the Denver test . The intervention group gained 0.8 ( 95 % CI -0.18 , 1.78 ) more skills on average than the control group . Idjr and inata et al reported that the difference in pre to post treatment change in Bayley Scale PDI between iron treated and placebo groups after 4 months was 18.40 ( 95%CI 10.16 , 26.64 ) and in Bayley Scale MDI , 18.80 ( 95 % CI 10.19 , 27.41 ) . REVIEW ER 'S CONCLUSIONS There is no convincing evidence that iron treatment of young children with IDA has an effect on psychomotor development discernable within 5 - 11 days . The effect of longer term treatment remains unclear but the data would be compatible with clinical ly significant benefit . There is urgent need for further r and omised controlled trials with long term follow up
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"OBJECTIVE To determine whether extended oral iron therapy corrects lower developmental test scores in infants with iron-deficiency anemia . STUDY DESIGN Double-blind , controlled trial in Costa Rica involving 32 12- to 23-month-old infants with iron-deficiency anemia and 54 nonanemic control subjects . Anemic infants were treated with orally administered iron for 6 months ; half the nonanemic children were treated with iron and half with placebo . Developmental test scores and hematologic status were evaluated before treatment , after 3 months , and after 6 months . RESULTS Iron-deficient anemic infants received lower mental test scores than nonanemic infants at all three time points ( p motor test scores . More of the anemic infants were rated as unusually tearful and unhappy . Anemic infants came from families with lower maternal education and less support for child development and were less likely to be breast fed , were weaned earlier , and consumed more cow milk . CONCLUSIONS Lower mental test scores persisted in infants with iron-deficiency anemia despite extended oral iron therapy and an excellent hematologic response . Iron-deficiency anemia may serve as a marker for a variety of nutritional and family disadvantages that may adversely affect infant development",
"To assess the effects of iron therapy on developmental test scores in infants with iron deficiency anemia , 68 Guatemalan babies 6 to 24 months of age , with and without mild iron deficiency anemia , were tested with the Bayley Scales of Infant Development before and after one week of oral iron treatment . The two major findings of the study were developmental deficits in the anemic group prior to treatment , and lack of rapid improvement with short-term oral iron therapy . The mean pretreatment Mental Development Index of the anemic group was significantly lower than that of nonanemic infants . The anemic group 's pretreatment Psychomotor Development Index was also lower than that of the nonanemic control group . In a double-blind r and omized study , six to eight days of oral iron therapy did not reverse these deficits . Consequently , the deficits of the anemic group can not be unequivocably attributed to iron lack . However , no significant differences were found between anemic and nonanemic groups in birth histories , socioeconomic level , or general nutritional status which might otherwise explain the lower developmental test scores of the anemic babies ",
"Iron deficiency anemia has long been thought to have effects on the central nervous system ( CNS ) . Finding direct evidence of this in human infants , however , has been challenging . Auditory brainstem responses ( ABRs ) provide a noninvasive means of examining an aspect of the CNS that is rapidly maturing during the age period when iron deficiency is most common . ABRs represent the progressive activation of the auditory pathway from the acoustic nerve ( wave I ) to the lateral lemniscus ( wave V ) . The central conduction time ( CCT , or wave I-V interpeak latency ) is considered an index of CNS development because myelination of nerve fibers and maturation of synaptic relays lead to an exponential reduction in the CCT from birth to 24 mo . In 55 otherwise healthy , 6-mo-old Chilean infants ( 29 with iron deficiency anemia and 26 nonanemic control infants ) , the CCT was longer in those who had been anemic at 6 mo , with differences becoming more pronounced at 12- and 18-mo follow-ups despite effective iron therapy . The pattern of results --differences in latencies but not amplitudes , more effects on the late ABR components ( waves III and V ) , and longer CCTs ( as an overall measure of nerve conduction velocity)--suggested altered myelination as a promising explanation , consistent with recent laboratory work documenting iron 's essential role in myelin formation and maintenance . This study shows that iron deficiency anemia in 6-mo-old infants is associated with adverse effects on at least one aspect of CNS development and suggests the fruitfulness of study ing other processes that are rapidly myelinating during the first 2 y of life",
"Iron-deficient anaemic infants perform worse in tests of mental and motor development than do iron-sufficient infants of a comparable age . A r and omised , double-blind trial was done to monitor the effects of iron supplementation on performance in the Bayley scales of mental and motor development among 12 - 18-month-old infants in Indonesia . Iron-deficient anaemic infants ( n = 50 ) were assigned r and omly to receive dietary ferrous sulphate or placebo for 4 month . Similar treatment r and omisation was done among nonanaemic iron-deficient ( n = 29 ) and iron-sufficient ( n = 47 ) infants . Before intervention , the mean mental and motor scores of the iron-deficient anaemic infants were significantly ( p developmental delays were reversed among iron-deficient anaemic infants who had received iron but they remained the same among placebo-treated iron-deficient anaemic infants . Neither ferrous sulphate nor placebo had significant effects on the scores of the other two iron-status classes . The poor performance of 12 - 18-month-old iron-deficient anaemic infants in the Bayley scales of mental and motor development can be improved to the level of performance of iron-sufficient infants by treatment with ferrous sulphate",
"Eighteen- to 60-month-old iron-deficient anemic children given iron therapy ( n = 25 ) and a control group matched for mother 's educational level showed no significant difference in mean mental development score at baseline . The control group 's mean score was increased significantly over baseline score at 3 and 6 months and was significantly higher than the experimental group 's mean score at 3 months . Although the experimental group demonstrated hematologic correction over 6 months , mean mental development score showed no significant improvement . Scores for an iron deficient not anemic group given iron ( n = 22 ) , despite complete hematologic correction over the six months of observation , and for its control group , did not change significantly . Baseline scores for an iron-deficient not anemic placebo group ( n = 23 ) and for its control group were not significantly different . At 3 months the control group score had increased significantly , whereas that for the experimental group had not . When experimental and control subjects were matched on baseline mental development score , the control subjects experienced increases in scores over time , further confirming an impaired ability to improve scores with repeated testing in the experimental groups . Behavioral rating data ( responsiveness to examiner , responsiveness to environment , and emotional tone ) revealed significant differences between the iron-deficient anemic group and its control group at 3 and 6 months , with the control group rated more responsive , suggesting that iron deficiency , alone or in association with anemia , may have some lasting effect on behavior and development . Group differences were also found between the mean number of occurrences of multiple stressful events . Failure to show improvement in scores in the iron-deficient anemic group may reflect the fact that those children were less testable than were children in the control group , despite repeated testings , a theory supported by the infant behavior rating data . This may be related to some irreversible behavioral deficit or to an adverse environmental milieu ( e.g. , stress )",
"Previous work at this hospital and elsewhere has shown that anaemia in toddlers is common and is associated with psychomotor delay . It seemed unclear , however , whether this association was cause and effect or merely due to the same underprivileged environment . A double blind r and omised intervention study was , therefore , performed . After an initial assessment 97 children with anaemia ( haemoglobin 8 - 11 g/dl ) aged 17 - 19 months received either iron and vitamin C or vitamin C only ( control group ) for two months and were then reassessed . The children who received the iron had an increased rate of weight gain and more of them achieved the expected rate of development . While iron deficiency anaemia is unlikely to be the only factor in the slower development of children living in underprivileged circumstances , it can at least be easily identified and treated . Routine child health surveillance in such areas should include a haemoglobin determination",
"In a prospect i ve cohort study of 196 infants from birth to age 15 mo , the relationship of iron status to psychomotor development , the effect of a short-term trial of oral iron or placebo , and the effect of longer-term oral iron therapy was assessed . Development was assessed with the Bayley Scale of Infant Development in anemic , nonanemic , iron-deficient , and control children . Anemic infants had significantly lower indices than did control or nonanemic , iron-deficient infants . Control infants and nonanemic , iron-deficient infants performed comparably . No difference between the effect of oral administration of iron or placebo was noted after 10 d or 3 mo of iron therapy . A hemoglobin concentration of less than 105 g/L and anemia duration greater than 3 mo were correlated with significantly lower motor and mental scores , suggesting that when iron deficiency progresses to anemia , adverse influences in the performance of developmental tests appear and persist , despite iron therapy"
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4117e556-06ff-11f0-808a-c43d1ab1c353
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Background and purpose Secondary prevention in ischaemic stroke and transient ischaemic attack ( TIA ) is dominated by pharmacological interventions with evidence for non-pharmacological interventions being less robust . This systematic review and meta- analysis examines the impact of lifestyle interventions on secondary prevention in stroke or TIA . Methods A systematic literature search was performed . R and omised controlled trials ( RCTs ) examining the effectiveness of intervention packages incorporating any key component of health education/promotion/counselling on lifestyle and /or aerobic exercise compared to usual care ± a sham intervention in participants with ischaemic stroke or TIA were included . Outcomes of interest were mortality , cardiovascular disease ( CVD ) event rates , cardiovascular risk factors including blood pressure , lipid profiles and physical activity participation . Method ological quality was assessed . Statistical analyses determining treatment effect were conducted using Cochrane Review Manager Software . Results Seventeen RCTs were included . Data pooled from eight studies with a total of 2478 patients , demonstrated no effect in favour of lifestyle interventions compared to routine or sham interventions on mortality ( risk ratio ( RR ) = 1.13 ( 95 % confidence interval ( CI ) , 0.85–1.52 ) , I2 = 0 % ) . Data relating to CVD events were pooled from four studies ( 1013 patients ) , demonstrated non-significant findings ( RR = 1.16 ( 95 % CI , 0.80 - -1.71 ) , I2 = 0 % ) . Similar results were reported for total cholesterol . Physical activity participation demonstrated significant improvement [ SMD 0.24 ( 95 % CI , 0.08–0.41 ) , l2 = 47 % ] . Blood pressure reductions were noted but were non-significant when corrected for multimodal packages including enhanced pharmacotherapy compliance . Conclusions There is currently insufficient high quality research to support lifestyle interventions post-stroke or TIA on mortality , CVD event rates and cardio-metabolic risk factor profiles . Promising blood pressure reductions were noted in multimodal interventions which addressed lifestyle
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"OBJECTIVES To determine whether changes in strength or cardiorespiratory fitness after exercise training improve walking ability in individuals who have had a stroke . DESIGN A sham exercise-controlled , r and omized two-by-two factorial design , in which the two factors investigated were cycle training ( AEROBIC ) and resistance training ( STRENGTH ) . SETTING University exercise laboratory . PARTICIPANTS Fifty-two individuals with a history of stroke ( aged 63+/-9 ; time since stroke , 57+/-54 months ) . INTERVENTION Participants undertook 30 exercise sessions over 10 to 12 weeks . Depending on group allocation , individuals underwent aerobic cycling plus sham progressive resistance training ( PRT ) ( n=13 ) , sham cycling plus PRT ( n=13 ) , aerobic cycling plus PRT ( n=14 ) , or sham cycling plus sham PRT ( n=12 ) . MEASUREMENTS Primary outcomes were 6-minute walk distance , habitual and fast gait velocities , and stair climbing power . Secondary outcomes included measures of cardiorespiratory fitness ; muscle strength , power , and endurance ; and psychosocial attributes . RESULTS Neither AEROBIC nor STRENGTH improved walking distance or gait velocity significantly more than sham exercise , although STRENGTH significantly improved participants ' stair climbing power by 17 % ( P=.009 ) , as well as their muscle strength , power , and endurance ; cycling peak power output ; and self-efficacy . Conversely , AEROBIC improved indicators of cardiorespiratory fitness only . Cycling plus PRT produced larger effects than either single modality for mobility and impairment outcomes . CONCLUSION Single-modality exercises targeted at existing impairments do not optimally address the functional deficits of walking but do ameliorate the underlying impairments . The underlying cardiovascular and musculoskeletal impairments are significantly modifiable years after stroke with targeted robust exercise",
"Background and Purpose — The SPARCL trial showed that atorvastatin 80 mg/d reduces the risk of stroke and other cardiovascular events in patients with recent stroke or transient ischemic attack ( TIA ) . We tested the hypothesis that the benefit of treatment varies according to index event stroke subtype . Methods — Subjects with stroke or TIA without known coronary heart disease were r and omized to atorvastatin 80 mg/d or placebo . The SPARCL primary end point was fatal or nonfatal stroke . Secondary end points included major cardiovascular events ( MCVE ; stroke plus major coronary events ) . Cox regression models testing for an interaction with treatment assignment were used to explore potential differences in efficacy based on stroke subtype . Results — For subjects r and omized to atorvastatin versus placebo , a primary end point occurred in 13.1 % versus 18.6 % of those classified as having large vessel disease ( LVD , 15.8 % of 4,731 participants ) , in 13.1 % versus 15.5 % of those with small vessel disease ( SVD , 29.8 % ) , in 11.2 % versus 12.7 % of those with ischemic stroke of unknown cause ( 21.5 % ) , in 7.6 % versus 8.8 % of those with TIA ( 30.9 % ) , and in 22.2 % versus 8.3 % of those with hemorrhagic stroke ( HS , 2 % ) at baseline . There was no difference in the efficacy of treatment for either the primary end point ( LVD hazard ratio [ HR ] 0.70 , 95 % confidence interval [ CI ] 0.49 to 1.02 , TIA HR 0.81 , CI 0.57 to 1.17 , SVD HR 0.85 , CI 0.64 to 1.12 , unknown cause HR 0.87 , CI 0.61 to 1.24 , HS HR 3.24 , CI 1.01 to 10.4 ; P for heterogeneity=0.421 ) , or MCVEs ( P for heterogeneity=0.360 ) based on subtype of the index event . As compared to subjects with LVD strokes , those with SVD had similar MCVE rates ( 19.2 % versus 18.5 % over the course of the trial ) , and similar overall reductions in stroke and MCVEs . Conclusions — Atorvastatin 80 mg/d is similarly efficacious in preventing strokes and other cardiovascular events , irrespective of baseline ischemic stroke subtype",
"Objective : Despite evidence demonstrating that risk-factor management is effective in reducing recurrent cerebrovascular disease , there are very few structured care programmes for stroke survivors . The aim was to implement and evaluate an integrated care programme in stroke . Methods : 186 patients with stroke were r and omised to either the treatment ( integrated care ) or control ( usual care ) group and were followed up over 12 months . The Integrated Care for the Reduction of Secondary Stroke ( ICARUSS ) model of integrated care involved collaboration between a specialist stroke service , a hospital coordinator and a patient ’s general practitioner . The primary aim was to promote the management of vascular risk factors through ongoing patient contact and education . Results : In the 12 months poststroke , systolic blood pressure ( sBP ) decreased in the treatment group but increased in controls . The group difference was significant , and remained so when age , sex , disability and sBP at discharge were accounted for ( p = 0.04 ) . Treatment patients also exhibited better modification of body mass index ( p = 0.007 ) and number of walks taken ( p controls . Rankin scores indicated significantly reduced disability in treatment patients relative to controls in the year poststroke ( p = 0.003 ) . Conclusions : Through an integrated system of education , advice and support to both patient and GP , the ICARUSS model was effective in modifying a variety of vascular risk factors and therefore should decrease the likelihood or recurrent stroke or vascular event",
"Objectives To investigate if repeated verbal instructions about physical activity to patients with ischaemic stroke could increase long term physical activity . Design Multicentre , multinational , r and omised clinical trial with masked outcome assessment . Setting Stroke units in Denmark , China , Pol and , and Estonia . Participants 314 patients with ischaemic stroke aged ≥40 years who were able to walk—157 ( mean age 69.7 years ) r and omised to the intervention , 157 ( mean age 69.4 years ) in the control group . Interventions Patients r and omised to the intervention were instructed in a detailed training programme before discharge and at five follow-up visits during 24 months . Control patients had follow-up visits with the same frequency but without instructions in physical activity . Main outcome measures Physical activity assessed with the Physical Activity Scale for the Elderly ( PASE ) at each visit . Secondary outcomes were clinical events . Results The estimated mean PASE scores were 69.1 in the intervention group and 64.0 in the control group ( difference 5.0 ( 95 % confidence interval −5.8 to 15.9 ) , P=0.36 . The intervention had no significant effect on mortality , recurrent stroke , myocardial infa rct ion , or falls and fractures . Conclusion Repeated encouragement and verbal instruction in being physically active did not lead to a significant increase in physical activity measured by the PASE score . More intensive strategies seem to be needed to promote physical activity after ischaemic stroke . Trial registration Clinical Trials",
"Background and Purpose — Numerous effective strategies for the secondary prevention of cardiovascular events in high-risk patients have now been established . We sought to calculate the cumulative benefit of combining multiple strategies for preventing recurrent events in patients with a history of ischemic stroke or transient ischemic attack . Methods — A comprehensive literature search was undertaken to identify meta-analyses of r and omized controlled trials reporting on the efficacy of secondary prevention strategies . The baseline incidence of vascular events was modeled from the Life Long After Cerebral Ischemia study . Strategies were combined on a multiplicative scale and cumulative risk reductions were computed over a 5-year interval . Results — The combination of 5 proven strategies applied to survivors of an initial stroke or transient ischemic attack — dietary modification , exercise , aspirin , a statin , and an antihypertensive agent — could result in a cumulative relative risk reduction of 80 % . Given a 5-year major cardiovascular event rate of 24 % , this translates to a number needed to treat of about 5 . Further gains would result from applying multimodality therapy over longer intervals and enriching the base strategy with dual antiplatelet therapy , high-dose statins , and more intensive blood pressure – lowering . Even more benefit would be present in high-risk subgroups with the addition , where appropriate , of carotid endarterectomy , moderate intensity oral anticoagulants , glycemic control , and smoking cessation . Conclusions — At least four-fifths of recurrent vascular events in patients with cerebrovascular disease might be prevented by application of a comprehensive , multifactorial approach",
"Objective : To evaluate risk factor reduction and health-related quality of life following a 10-week cardiac rehabilitation programme in non-acute ischaemic stroke subjects . Design : Single-blinded r and omized control trial . Setting : Outpatient rehabilitation . Subjects : Forty-eight community-dwelling ischaemic stroke patients ( 38 independently mobile , 9 requiring assistance , 1 non-ambulatory ) were r and omly assigned to intervention or control groups by concealed allocation . Intervention : The trial consisted of a 10-week schedule with measures taken at weeks 1 and 10 . Both groups continued usual care ( excluding aerobic exercise ) ; intervention subjects attended 16 cycle ergometry sessions of aerobic-training intensity and two stress-management classes . Main outcome measures : Cardiac risk score ( CRS ) ; VO2 ( mL O2/kg per minute ) and Borg Rate of Perceived Exertion ( RPE ) assessed during a st and ardized ergometry test ; Hospital Anxiety and Depression Scale ( HADS ) ; Frenchay Activity Index ; Fasting Lipid Profiles and Resting Blood Pressure . Results : Group comparison with independent t-tests showed significantly greater improvement at follow-up by intervention subjects than controls in VO2 ( intervention 10.6 ±1.6 to 12.0 ± 2.2 , control 11.1 ±1.8 to 11.1 ±1.9 t=4.734 , P CRS ( intervention 13.4 ±10.1 to 12.4 ±10.5 , control 9.4 ±6.7 to 15.0 ±6.1 t=-2.537 , P RPE rating decreased in intervention subjects ( 13.4 ±12.2 to 12.4 ±2.0 ) and increased in controls ( 13.8 ±1.8 to 14.4 ±1.6 ) ; Mann — Whitney U ( U = 173.5 , P the HADS depression subscale in the intervention group alone ( 5.1 ±3.4 to 3.0 ±2.8 ) ( Wilcoxon signed ranks test Z=-3.278 , P non-acute ischaemic stroke patients can improve their cardiovascular fitness and reduce their CRS with a cardiac rehabilitation programme . The intervention was associated with improvement in self-reported depression ",
"INTRODUCTION AND OBJECTIVES To assess the efficacy of a comprehensive program of secondary prevention of cardiovascular disease in general practice . METHODS A cluster r and omized clinical trial was carried out in a regular general practice setting . Male and female patients aged under 86 years with a diagnosis of ischemic heart disease , stroke or peripheral artery disease were recruited between January 2004 and May 2005 . Study participants were seen at 42 health centers throughout the whole of Spain . The primary endpoint was the combination of all-cause mortality and hospital cardiovascular readmission at 3-year follow-up . RESULTS In total , 1224 patients were recruited : 624 in the intervention group and 600 in the control group . The primary endpoint was observed in 29.9 % ( 95 % confidence interval [ CI ] , 25.5 - 34.8 % ) in the intervention group and 25.6 % ( 22.3 - 29.2 % ) in the control group ( P=.15 ) . At the end of follow-up , 8.5 % ( 6.3 - 11.3 % ) in the intervention group and 11 % ( 7.4 - 16 % ) in the control group were smokers ( P=.07 ) . The mean waist circumference of patients in the intervention and control groups was 100.44 cm ( 95 % CI , 98.97 - 101.91 cm ) and 102.58 cm ( 95 % CI , 100.96 - 104.21 cm ) , respectively ( P=.07 ) . Overall , 20.9 % ( 15.6 - 27.7 % ) of patients in the intervention group and 29.6 % ( 23.9 - 36.1 % ) in the control group suffered from anxiety ( P=.05 ) , and 29.6 % ( 22.4 - 37.9 % ) in the intervention group and 41.4 % ( 35.8 - 47.3 % ) in the control group had depression ( P=.02 ) . CONCLUSIONS A comprehensive program of secondary prevention of cardiovascular disease in general practice was not effective in reducing cardiovascular morbidity and mortality . However , some factors associated with a healthy lifestyle were improved and anxiety and depression were reduced",
"BACKGROUND The study examined the effects of a 12-week health promotion intervention for a predominantly urban African-American population of stroke survivors . DESIGN A pre-test/post-test lag control group design was employed . PARTICIPANTS / SETTING Participants were 35 stroke survivors ( 9 male , 26 female ) recruited from local area hospitals and clinics . MAIN OUTCOME MEASURES Biomedical , fitness , nutritional , and psychosocial measures were employed to assess program outcomes . RESULTS Treatment group made significant gains over lag controls in the following areas : ( 1 ) reduced total cholesterol , ( 2 ) reduced weight , ( 3 ) increased cardiovascular fitness , ( 4 ) increased strength , ( 5 ) increased flexibility , ( 6 ) increased life satisfaction and ability to manage self-care needs , and ( 7 ) decreased social isolation . CONCLUSION A short-term health promotion intervention for predominantly African-American stroke survivors was effective in improving several physiological and psychological health outcomes",
"Objective : Little is known about the long-term effectiveness after stroke of interventions for behaviour modification and ensuring concordance with therapies . We describe a follow-up study of a previous r and omized controlled trial of a brief period of behaviour modification . The aim of this study was to determine outcomes three years after the initial intervention . Design : Survivors of the original cohort were contacted and asked to attend for follow-up interview , within a geriatric day hospital . This study was carried out in the Geriatric Day Hospital at Stobhill Hospital , Balornock Road , Glasgow . Interventions : Details of risk factor control , including blood pressure , cholesterol levels and diabetic control , were assessed . Question naires used in the initial study were repeated including the Geriatric Depression Scale score , Euroqol Perceived Health Status and Stroke Services Satisfaction Question naire . Main measures : Primary outcome was collective risk factor control . Clinical outcomes including recurrent cerebrovascular events , medication persistence and perceived health status were also recorded . Results : Mean length of follow-up was 3.6 years ( SD 0.43 ) . Of the 205 patients enrolled in the initial study , 102 patients attended for repeat interview ( 49 intervention/53 control ) . There were no significant differences in the percentage of controlled risk factors between groups ( intervention 51.7 % versus control 55.9 % , P = 0.53 ) . Similarities were observed in the number of recurrent clinical events and medication persistence between groups . No overall difference was observed in perceived health status , satisfaction with care or depression scores . Conclusions : Brief intervention with respect to behaviour modification and risk factor control does not appear to have any long-term benefit . These results must be cautiously interpreted in light of the small study number and further research is required",
"BACKGROUND This r and omized controlled trial tested the effectiveness of comprehensive , interdisciplinary postdischarge care management in improving a profile of indicators of health recovery and secondary prevention ( profile of health and prevention ) in stroke and transient ischemic attack ( TIA ) patients . METHODS Ninety-six stroke/TIA patients were r and omized to usual care or intervention at discharge from our acute stroke unit . The intervention group received an in-home biopsychosocial assessment by an advanced practice nurse at 1 month . A care plan was developed by an interdisciplinary team and implemented in collaboration with the patient 's primary care physician . The profile of health and prevention , measured at 3 months , was comprised of 5 domains : ( 1 ) Neuromotor Function , ( 2 ) Severe Complications , ( 3 ) Quality of Life , ( 4 ) Management of Risk for common poststroke complications and recurrent stroke , and ( 5 ) Stroke Knowledge . A single global hypothesis test across multiple end points was used to compare the 2 groups . RESULTS The intervention significantly improved the profile of health and prevention ( P Effect sizes ( in st and ard deviation units ) of the intervention on domains were .1 for Neuromotor Function ( 90 % confidence interval [ CI ] = -.3 to .5 ) ; .4 for Severe Complications ( 90 % CI = .1 to .8 ) ; .5 for Quality of Life ( 90 % CI = .1 to .9 ) ; .6 for Management of Risk for common poststroke complications and recurrent stroke ( 90 % CI = .3 to 1 . ) ; and 1.0 for Stroke Knowledge ( 90 % CI = .6 to 1.4 ) . CONCLUSIONS This model of care management result ed in a significantly better profile of health and prevention for stroke/TIA patients 3 months postdischarge",
"OBJECTIVES To compare the effects of 3 different exercise training regimens on cardiorespiratory fitness and coronary risk factor reduction in subjects with unilateral stroke . DESIGN A cluster assignment by residential location repeated- measures design . SETTING University-based medical center . PARTICIPANTS Fifty-five subjects with unilateral ischemic stroke were assigned to the following groups : intensity ( n=18 ) , duration ( n=19 ) , and therapeutic exercise ( n=18 ) . INTERVENTION A 14-week intervention with subjects r and omized to 1 of 3 interventions : ( 1 ) moderate intensity , shorter duration ( MISD ) exercise ( gradually increasing exercise intensity while keeping exercise duration constant at 30 min ) , ( 2 ) low-intensity , longer duration ( LILD ) exercise ( gradually increasing duration to 60 min while keeping exercise intensity constant ) , or ( 3 ) conventional therapeutic exercise ( TE ) consisting mainly of strength , balance , and range of motion activities . All groups exercised 3 days per week . MAIN OUTCOME MEASURES Peak oxygen consumption ( VO2peak ) , submaximal oxygen consumption ( VO2 ) , lipid panel , and resting blood pressure . RESULTS The MISD group attained more favorable effects on systolic ( P ) and diastolic blood pressure ( P and total cholesterol ( TC ) ( P MISD ( P triglycerides compared with TE ( P VO2peak and submaximal VO2 in any of the groups . CONCLUSIONS Overall , both MISD and LILD conditions achieved greater clinical and significant gains in coronary risk reduction compared with TE",
"Objective : To evaluate whether enhanced secondary prevention more significantly influences readiness to change health behaviour after minor stroke/transient ischaemic attack , compared with conventional stroke secondary prevention . Design : Single-blind r and omized control trial . Setting : Rural district general hospital outpatient clinic . Subjects : Fifteen women and 37 men with a mean age of 68.3 years with first minor stroke or transient ischaemic attack . Interventions : The intervention group received ‘ enhanced secondary prevention ’ ( additional advice , motivational interviewing and telephone support ) to change health behaviour . Both groups received ‘ conventional care ’ which included advice given during routine care . Main measures : The primary outcome was ‘ readiness to change behaviour ’ measured using a vali date d stroke specific score based on the transtheoretical model . Secondary outcomes were the Hospital Anxiety and Depression Scale , and self-reported alcohol consumption , smoking behaviour , exercise frequency , and fruit and vegetable consumption . Results : Analysis of the data for the 52 participants showed no statistical difference in the groups for the primary outcome of readiness to change behaviour . Statistically significant improvements for change in self-reported exercise were demonstrated ( P = 0.007 ) ; to 2—3 times per week in the intervention group compared to 0—1 times per week in the control group , and in fruit and vegetable consumption ( P = 0.033 ) ; to 10 portions of fruit and vegetables consumed per week in the intervention group compared to 1 or 2 portions a week for the control group . No evidence of a difference between groups was seen for alcohol consumption or Hospital Anxiety and Depression Scale . Conclusions : While no difference was demonstrated between the groups for readiness to change behaviour , a clinical ly significant effect in reported exercise behaviour and diet were demonstrated in the intervention group . This interesting finding indicates a dissonance between the behaviour scale and actual behaviour change , potentially indicating a lack of sensitivity of the scale to detect a change in this patient group",
"Lowering blood pressure ( BP ) in stroke survivors reduces the risk of recurrent stroke . We tested the hypothesis that a nurse-led nonpharmacologic intervention would lower the BP of participants in an intervention group compared with a control group . A total of 349 patients who had sustained acute stroke or transient ischemic attack were r and omly assigned to either usual care or to 4 home visits by a nurse . During the visits , the nurse measured and recorded BP and provided individually tailored counseling on a healthy lifestyle . A total of 303 patients completed the 1-year follow up . No change in systolic BP was noted in either the intervention group or the control group . Because of an increase in diastolic BP in the control group ( P = .03 ) , a difference in mean diastolic BP between the 2 groups was found at follow-up ( P = .007 ) . Mean BP at follow-up was 139/82 mm Hg in the intervention group and 142/86 mm Hg in the control group . Linear regression analysis demonstrated that BP at the point of discharge was the strongest predictor of BP 1 year later ( P proportion of patients on antihypertensive medication increased in the intervention group ( P = .002 ) . Patients were compliant with antihypertensive therapy , and 92 % of the hypertensive patients in the intervention group followed the advice to see a general practitioner ( GP ) for BP checkups . At follow-up , 187 patients ( 62 % ) were hypertensive , with no difference in the rate of hypertension seen between the groups . Our data indicate that home visits by nurses did not result in a lowering of BP . Patients complied with antihypertensive therapy and GP visits in the case of hypertension . Nonetheless , the majority of patients were hypertensive at the 1-year follow up",
"BACKGROUND Smoking cessation is widely recommended for secondary stroke prevention . However , little is known about the efficacy of smoking cessation intervention after stroke or transient ischemic attack ( TIA ) . METHODS Ninety-four smokers under age 76 , admitted with ischemic stroke or TIA were r and omized to minimal smoking cessation intervention or intensive smoking cessation intervention . All patients attended a 30-min individual counseling by the study nurse . Patients r and omized to intensive smoking cessation intervention also participated in a 5-session outpatient smoking cessation program by an authorized smoking cessation instructor , a 30-min outpatient visit after 6 weeks , and 5 telephone counseling sessions by the study nurse . Free sample s of nicotine replacement therapy were offered as part of the intensive smoking cessation program . Smoking cessation rates at 6 months were determined by self-report and verified by measurement of exhaled carbon monoxide ( CO ) . Fewer patients than expected were recruited , which renders this report a pilot study . RESULTS The 6-month self-reported smoking cessation rate was 37.8 % in the minimal intervention group and 42.9 % in the intensive intervention group . Smoking cessation rates verified by exhaled CO levels in the minimal intervention group and the intensive intervention group were 28.9 % and 32.7 % , respectively . No difference was found between the two groups ( χ(2 ) = 0.16 , p = .69 ) . CONCLUSIONS Overall smoking cessation rates were moderate and comparable to the results from other studies . Intensive smoking cessation intervention was not superior to short smoking cessation intervention . Thus , other factors than intensity of smoking cessation intervention might influence the smoking cessation rates after stroke or TIA",
"OBJECTIVE We sought to evaluate whether comprehensive postdischarge care management for stroke survivors is superior to organized acute stroke department care with enhanced discharge planning in improving a profile of health and well-being . METHODS This was a r and omized trial of a comprehensive postdischarge care management intervention for patients with ischemic stroke and National Institutes of Health Stroke Scale scores greater than or equal to 1 discharged from an acute stroke department . An advanced practice nurse performed an in-home assessment for the intervention group from which an interdisciplinary team developed patient-specific care plans . The advanced practice nurse worked with the primary care physician and patient to implement the plan during the next 6 months . The intervention and usual care groups were compared using a global and closed hypothesis testing strategy . Outcomes fell into 5 domains : ( 1 ) neuromotor function , ( 2 ) institution time or death , ( 3 ) quality of life , ( 4 ) management of risk , and ( 5 ) stroke knowledge and lifestyle . RESULTS Treatment effect was near 0 SD for all except the stroke knowledge and lifestyle domain , which showed a significant effect of the intervention ( P = .0003 ) . CONCLUSIONS Postdischarge care management was not more effective than organized stroke department care with enhanced discharge planning in most domains in this population . The intervention did , however , fill a postdischarge knowledge gap",
"Background – Transient ischemic attack ( TIA ) and stroke patients often show a striking lack of knowledge about their disease . We developed a computer program that provided health education fitting the educational level , risk profile and symptoms of patients and evaluated it in a r and omized controlled trial",
"SIR— Interventions with an educational or counselling component have been reported to be effective in a variety of patient groups to encourage smoking cessation [ 1 ] , lower blood pressure ( BP ) [ 2 , 3 ] , achieve modest reductions in cholesterol [ 4 ] , and promote weight loss [ 5 ] . Evaluation of the impact of education on physical outcomes is lacking in stroke disease , despite evidence that inadequate provision of information may adversely affect compliance with secondary prevention and psychosocial outcomes [ 6 ] . We describe a single-blind r and omised controlled trial of health education and counselling for patients with stroke or transient ischaemic attack ( TIA ) , and its effects on risk factors , satisfaction , mood and perceived health status",
"Purpose . To determine the effects of the physical activity promotion programs Rehabilitation & Sports ( R&S ) and Active after Rehabilitation ( AaR ) on sport and daily physical activity 1 year after in- or outpatient rehabilitation . Design . Subjects in intervention rehabilitation centers were r and omized into a group receiving R&S only ( n = 315 ) and a group receiving R&S and AaR ( n = 284 ) . Subjects in six control centers ( n = 603 ) received usual care . Setting . Ten Dutch rehabilitation centers . Subjects . Subjects consisted of 1202 rehabilitation patients . Most frequent diagnoses were stroke , neurological disorders , and back disorders . Intervention . Both the sport stimulation program ( R&S ) and the daily physical activity promotion program ( AaR ) consisted of personalized tailored counseling . Measures . Two sport outcomes and two daily physical activity outcomes were assessed with question naires at baseline and 1 year after rehabilitation . Analysis . Multilevel analyses comparing both intervention groups to the control group . Results . The R&S program showed no significant effects . Intention-to-treat analyses in the R&S + AaR group showed borderline significant improvements in one sport ( odds ratio [ OR ] = 1.66 , p = .02 ) and both physical activity outcomes ( OR = 1.68 , p = .01 and regression coefficient = 10.78 , p = .05 ) . On-treatment analyses in the R&S + AaR group showed similar but stronger effects . Conclusions . The combination of the R&S and AaR programs improved physical activity behavior and sport participation 1 year after in- or outpatient rehabilitation . The R&S program alone did not have any effects"
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INTRODUCTION Colorectal surgery has been associated with a complication rate of 15 - 20 % and mean post-operative inpatient stays of 6 - 11 days . The principles of enhanced recovery after surgery ( ERAS ) are well established and have been developed to optimise peri-operative care and facilitate discharge . The purpose of this systematic review is to present an up date d review of peri-operative care in colorectal surgery from the available evidence and ERAS group recommendations . METHODS Systematic search es of the PubMed and Embase ™ data bases and the Cochrane library were conducted . A h and search of bibliographies of identified studies was conducted to identify any additional articles missed by the initial search strategy . RESULTS A total of 59 relevant studies were identified . These included six r and omised controlled trials and seven clinical controlled trials that fulfilled the inclusion criteria . These studies showed reductions in duration of inpatient stays in the ERAS groups compared with more traditional care as well as reductions in morbidity and mortality rates . CONCLUSIONS Review ing the data reveals that ERAS protocol s have a role in reducing post-operative morbidity and result in an accelerated recovery following colorectal surgery . Similarly , both primary and overall hospital stays are reduced significantly . However , the available evidence suggests that ERAS protocol s do not reduce hospital readmissions or mortality . These findings help to confirm that ERAS protocol s should now be implemented as the st and ard approach for peri-operative care in colorectal surgery
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"Background Enhanced Recovery After Surgery ( ERAS ) programs are associated with reduced hospital morbidity and mortality . The aim of the present study was to evaluate whether the introduction of ERAS care improved the adverse events in colorectal surgery . In a cohort study , mortality , morbidity , and length of stay were compared between ERAS patients and carefully matched historical controls . Methods Patients were matched for their type of disease , the type of surgery , P-Possum ( Portsmouth-Possum ) , CR-Possum ( Colorectal-Possum ) Physiological and Operative Score for Enumeration of Mortality and Morbidity ( POSSUM ) , gender , and American Society of Anesthesiologists ( ASA ) grade . The primary outcome measures of this study were mortality and morbidity . Secondary outcome measures were fluid intake , length of hospital stay , the number of relaparotomies , and the number of readmissions within 30 days . Data on the ERAS patients were collected prospect ively . Results Sixty-one patients treated according to the ERAS program were compared with 122 patients who received conventional postoperative care . The two groups were comparable with respect to age , ASA grade , P-Possum ( Portsmouth-Possum ) , CR-Possum ( Colorectal-Possum ) score , type of surgery , stoma formation , type of disease , and gender . Morbidity was lower in the ERAS group compared to the control group ( 14.8 % versus 33.6 % respectively ; P = fluid and spent fewer days in the hospital ( median 6 days , range 3–50 vs. median 9 days , range 3–138 ; P = 0.032 ) . There was no difference between the ERAS and the control group for mortality ( 0 % vs. 1.6 % ; P = 0.55 ) and readmission rate ( 3.3 % vs. 1.6 % ; P = 0.60 ) . Conclusion Enhanced Recovery After Surgery program reduces morbidity and the length of hospital stay for patients undergoing elective colonic or rectal surgery",
"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 : To evaluate the feasibility of a fast-track ( FT ) program and it ’s effect on postoperative recovery . Methods : All patients , scheduled for elective segmental colorectal resection were treated in a FT program ( FT group ) . Data were compared to a control group operated for elective colorectal resections and treated in a traditional care program ( TC group ) . Data from the FT group were collected prospect ively , data from the TC group retrospectively . Outcome parameters included the number of successfully applied FT modalities , patient satisfaction , morbidity rate , re-operation rate , primary ( PHS ) and total hospital stay ( THS ) , and readmission rate . Results : One-hundred and seven patients were included ( 55 FT group vs. 52 TC group ) . The groups were comparable for patient characteristics such as age and cr-POSSUM score ( p = 0.22 and p = 0.40 ) . An average of 7.4 of 13 predefined FT modalities were successfully achieved per patient . Patient satisfaction was comparable ( p = 0.84 ) . Seven versus 5 patients required a re-operation in the FT and TC groups , respectively ( p = 0.52 ) . Morbidity rate was comparable ( n = 16 vs. 15 , p = 0.83 ) . Median PHS was 4.0 vs. 6.0 days and median THS was 4.0 vs. 6.5 days in the FT and TC groups ( p PHS and THS were shorter in the FT group without affecting patient satisfaction",
" 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",
"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",
"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 Bowel preparation prior to colonic surgery usually includes antibiotic therapy together with mechanical bowel preparation ( MBP ) . Mechanical bowel preparation may cause discomfort to the patient , prolonged hospitalization , and water and electrolyte imbalance . It was assumed that with the improvement in surgical technique together with the use of more effective prophylactic antibiotics , it was possible that MBP would no longer be necessary . HYPOTHESIS There is no statistical difference in the postoperative results of patients who undergo elective colon resection with MBP as compared with those who have no MBP . DESIGN AND PATIENTS The study includes all patients who had elective large bowel resection at Campus Golda between April 1 , 1999 , and March 31 , 2002 . Emergency operations were not included . The patients were r and omly assigned to the 2 study groups ( with or without MBP ) according to identification numbers . All patients were treated with intravenous and oral antibiotics prior to surgery . The patients in the MBP group received Soffodex for bowel preparation . RESULTS A total of 329 patients participated in the study , 165 without MBP and 164 with MBP . The 2 groups were similar in age , sex , and type of surgical procedure . Two hundred sixty-eight patients ( 81.5 % ) underwent surgery owing to colorectal cancer and 61 patients ( 18.5 % ) owing to benign disease . The hospitalization period was longer in the bowel-prepared group ( mean + /- SD , 8.2 + /- 5.1 days ) as compared with the nonprepared group ( mean + /- SD , 8.0 + /- 2.7 days ) . However , this difference was not statistically significant . The time until the first bowel movement was similar between the 2 groups : a mean + /- SD of 4.2 + /- 1.3 days in the nonprepared group as compared with a mean + /- SD of 4.3 + /- 1.1 days in the prepared group ( P = NS ) . Four patients ( 1.2 % ) died in the postoperative course owing to acute myocardial infa rct ion and pulmonary embolism . Sixty-two patients ( 37.6 % ) of the non-MBP group suffered from postoperative complications as compared with 77 patients ( 46.9 % ) of the MBP group . CONCLUSION Our results suggest that no advantage is gained by preoperative MBP in elective colorectal surgery",
"Recent studies have suggested that MBP does not lower the risk of postoperative septic complications after elective colorectal surgery . This r and omized clinical trial assessed whether preoperative MBP is beneficial in elective colonic surgery",
"PURPOSE : Despite the universal use of bowel preparation before colonoscopy and colorectal surgery , the physiologic effects have not been described in a st and ardized setting . This study was design ed to investigate the physiologic effects of bowel preparation . METHODS : In a prospect i ve study , 12 healthy volunteers ( median age , 63 years ) underwent bowel preparation with bisacodyl and sodium phosphate . Fluid and food intake were st and ardized according to weight , providing adequate calorie and oral fluid intake . Before and after bowel preparation , weight , exercise capacity , orthostatic tolerance , plasma and extracellular volume , balance function , and biochemical parameters were measured . RESULTS : Bowel preparation led to a significant decrease in exercise capacity ( median , 9 percent ) and weight ( median , 1.2 kg ) . Plasma osmolality was significantly increased from 287 to 290 mmol kg−1 , as well as increased phosphate and urea concentrations , whereas calcium and potassium concentrations decreased significantly after bowel preparation . No differences in plasma or extracellular volumes were seen . Orthostatic tolerance and balance function did not change after bowel preparation . CONCLUSIONS : Bowel preparation has significant adverse physiologic effects , which may be attributed to dehydration . The majority of these findings is small and may not be of clinical relevance in otherwise healthy patients undergoing bowel preparation and following recommendations for oral fluid intake",
"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 "
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OBJECTIVE To develop evidence -based recommendations for the management of fibromyalgia syndrome . METHODS A multidisciplinary task force was formed representing 11 European countries . The design of the study , including search strategy , participants , interventions , outcome measures , data collection and analytical method , was defined at the outset . A systematic review was undertaken with the keywords " fibromyalgia " , " treatment or management " and " trial " . Studies were excluded if they did not utilise the American College of Rheumatology classification criteria , were not clinical trials , or included patients with chronic fatigue syndrome or myalgic encephalomyelitis . Primary outcome measures were change in pain assessed by visual analogue scale and fibromyalgia impact question naire . The quality of the studies was categorised based on r and omisation , blinding and allocation concealment . Only the highest quality studies were used to base recommendations on . When there was insufficient evidence from the literature , a Delphi process was used to provide basis for recommendation . RESULTS 146 studies were eligible for the review . 39 pharmacological intervention studies and 59 non-pharmacological were included in the final recommendation summary tables once those of a lower quality or with insufficient data were separated . The categories of treatment identified were antidepressants , analgesics , and " other pharmacological " and exercise , cognitive behavioural therapy , education , dietary interventions and " other non-pharmacological " . In many studies sample size was small and the quality of the study was insufficient for strong recommendations to be made . CONCLUSIONS Nine recommendations for the management of fibromyalgia syndrome were developed using a systematic review and expert consensus
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"OBJECTIVES To study the effect of a combination of thalassotherapy , exercise and patient education in people with fibromyalgia . METHODS Patients with fibromyalgia , selected from a rheumatology out-patient department and from members of the Dutch fibromyalgia patient association , were pre-r and omized to receive either 2(1/2 ) weeks of treatment in a Tunisian spa resort , including thalassotherapy , supervised exercise and group education ( active treatment ) or treatment as usual ( control treatment ) . Primary outcome measure was health-related quality of life , measured with the R AND -36 question naire . Secondary measures included the Fibromyalgia Impact Question naire , the McGill Pain Question naire , the Beck Depression Inventory , tender point score and a 6-min treadmill walk test . RESULTS Fifty-eight participants receiving the active treatment reported significant improvement on R AND -36 physical and mental component summary scales . For physical health , differences from the 76 controls were statistically significant after 3 months , but not after 6 and 12 months . A similar pattern of temporary improvement was seen in the self-reported secondary measures . Tender point scores and treadmill walk tests improved more after active treatment , but did not reach significant between-group differences , except for walk tests after 12 months . CONCLUSIONS A combination of thalassotherapy , exercise and patient education may temporarily improve fibromyalgia symptoms and health-related quality of life",
"The aim of this study was to investigate the effect of connective tissue massage in the treatment of individuals with fibromyalgia . The results of this r and om study of 48 individuals diagnosed with fibromyalgia ( 23 in the treatment group and 25 in the reference group ) show that a series of 15 treatments with connective tissue massage conveys a pain relieving effect of 37 % , reduces depression and the use of analgesics , and positively effects quality of life . The treatment effects appeared gradually during the 10-week treatment period . Three months after the treatment period about 30 % of the pain relieving effect was gone , and 6 months after the treatment period pain was back to about 90 % of the basic value . As long as there is a lack of effective medical treatment for individuals with fibromyalgia , they ought to be offered treatments with connective tissue massage . However , further studies are needed in the mechanisms behind the treatment effects . Copyright 1999 European Federation of Chapters of the International Association for the Study of Pain",
"A quasi-experimental design was used to assess a multimodal pain treatment program for female patients with fibromyalgia to ascertain immediate and long-term effects . Laboratory and self-report pain measures together with psychological measures were obtained from patients who were tested up to 6 months after treatment . Comparison data were also obtained from fibromyalgia patients who failed to qualify for the treatment program because of insurance coverage . Immediate and long-term treatment effects were evident with the psychological measures and the subjective pain measures but not with the laboratory pain measures . Participants who attended the month-long multimodal program achieved significant and positive changes on most of the outcome measures . However , relapse prevention must be addressed",
"OBJECTIVE To assess the efficacy and safety of duloxetine , a serotonin and norepinephrine reuptake inhibitor , in subjects with primary fibromyalgia , with or without current major depressive disorder . METHODS This study was a r and omized , double-blind , placebo-controlled trial conducted in 18 outpatient research centers in the US . A total of 207 subjects meeting the American College of Rheumatology criteria for primary fibromyalgia were enrolled ( 89 % female , 87 % white , mean age 49 years , 38 % with current major depressive disorder ) . After single-blind placebo treatment for 1 week , subjects were r and omly assigned to receive duloxetine 60 mg twice a day ( n = 104 ) or placebo ( n = 103 ) for 12 weeks . Co- primary outcome measures were the Fibromyalgia Impact Question naire ( FIQ ) total score ( score range 0 - 80 , with 0 indicating no impact ) and FIQ pain score ( score range 0 - 10 ) . Secondary outcome measures included mean tender point pain threshold , number of tender points , FIQ fatigue , tiredness on awakening , and stiffness scores , Clinical Global Impression of Severity ( CGI-Severity ) scale , Patient Global Impression of Improvement ( PGI-Improvement ) scale , Brief Pain Inventory ( short form ) , Medical Outcomes Study Short Form 36 , Quality of Life in Depression Scale , and Sheehan Disability Scale . RESULTS Compared with placebo-treated subjects , duloxetine-treated subjects improved significantly more ( P = 0.027 ) on the FIQ total score , with a treatment difference of -5.53 ( 95 % confidence interval -10.43 , -0.63 ) , but not significantly more on the FIQ pain score ( P = 0.130 ) . Compared with placebo-treated subjects , duloxetine-treated subjects had significantly greater reductions in Brief Pain Inventory average pain severity score ( P = 0.008 ) , Brief Pain Inventory average interference from pain score ( P = 0.004 ) , number of tender points ( P = 0.002 ) , and FIQ stiffness score ( P = 0.048 ) , and had significantly greater improvement in mean tender point pain threshold ( P = 0.002 ) , CGI-Severity ( P = 0.048 ) , PGI-Improvement ( P = 0.033 ) , and several quality -of-life measures . Duloxetine treatment improved fibromyalgia symptoms and pain severity regardless of baseline status of major depressive disorder . Compared with placebo-treated female subjects ( n = 92 ) , duloxetine-treated female subjects ( n = 92 ) demonstrated significantly greater improvement on most efficacy measures , while duloxetine-treated male subjects ( n = 12 ) failed to improve significantly on any efficacy measure . The treatment effect on significant pain reduction in female subjects was independent of the effect on mood or anxiety . Duloxetine was safely administered and well tolerated . CONCLUSION In this r and omized , controlled , 12-week trial ( with a 1-week placebo lead-in phase ) , duloxetine was an effective and safe treatment for many of the symptoms associated with fibromyalgia in subjects with or without major depressive disorder , particularly for women , who had significant improvement across most outcome measures",
"OBJECTIVE To compare 2 exercise modalities , aerobic fitness training and stretching exercises , in patients with fibromyalgia ( FM ) in relation to function , pain , quality of life , depression , and anxiety , and to correlate the cardiorespiratory fitness gain with symptom improvement . METHODS Seventy-six women with FM between 18 and 60 years old were r and omized to either an aerobic program or stretching program , for 20 weeks . They were evaluated at the beginning of the program and after 10 and 20 weeks in relation to the improvement of aerobic fitness , flexibility , function , Fibromyalgia Impact Question naire ( FIQ ) , Short-form Health Survey ( SF-36 ) , and depression and anxiety levels . Ventilatory anaerobic threshold ( VT ) and maximum oxygen uptake ( VO2max ) were determined by expired gas analyses . RESULTS Aerobic exercise was superior to stretching in relation to VO2 max , VT , function , depression , pain , and the emotional aspects and mental health domains of SF-36 . Patients in the stretching group showed no improvement in depression , \" role emotional , \" and \" mental health . \" No association was noted between improvement in aerobic fitness as measured by VT and the improvement of pain , function , or scores in FIQ and SF-36 . CONCLUSION Our results confirm that aerobic exercise is beneficial to patients with FM , but the cardiorespiratory fitness gain is not related to improvement of FM symptoms",
"OBJECTIVE Fibromyalgia syndrome ( FMS ) is characterized by widespread musculoskeletal pain and lowered pain threshold . Other prominent symptoms include disordered sleep and fatigue . FMS affects an estimated 2 % of the population , predominantly women . This trial was design ed to evaluate the efficacy and safety of pregabalin , a novel alpha(2)-delta lig and , for treatment of symptoms associated with FMS . METHODS This multicenter , double-blind , 8-week , r and omized clinical trial compared the effects of placebo with those of 150 , 300 , and 450 mg/day pregabalin on pain , sleep , fatigue , and health-related quality of life in 529 patients with FMS . The primary outcome variable was the comparison of end point mean pain scores , derived from daily diary ratings of pain intensity , between each of the pregabalin treatment groups and the placebo group . RESULTS Pregabalin at 450 mg/day significantly reduced the average severity of pain in the primary analysis compared with placebo ( -0.93 on a 0 - 10 scale ) ( P /=50 % improvement in pain at the end point ( 29 % , versus 13 % in the placebo group ; P = 0.003 ) . Pregabalin at 300 and 450 mg/day was associated with significant improvements in sleep quality , fatigue , and global measures of change . Pregabalin at 450 mg/day improved several domains of health-related quality of life . Dizziness and somnolence were the most frequent adverse events . Rates of discontinuation due to adverse events were similar across all 4 treatment groups . CONCLUSION Pregabalin at 450 mg/day was efficacious for the treatment of FMS , reducing symptoms of pain , disturbed sleep , and fatigue compared with placebo . Pregabalin was well tolerated and improved global measures and health-related quality of life",
"OBJECTIVE To study , for the first time , service utilization and costs in fibromyalgia , a prevalent syndrome associated with high levels of pain , functional disability , and emotional distress . METHODS Five hundred thirty-eight fibromyalgia patients from 6 rheumatology centers were enrolled in a 7-year prospect i ve study of fibromyalgia outcome . Patients were assessed every 6 months with vali date d , mailed question naires which included questions regarding fibromyalgia symptoms and severity , utilization of services , and work disability . RESULTS Fibromyalgia patients averaged almost 10 outpatient medical visits per year , and when nontraditional treatments were considered , this number increased to approximately 1 visit per month . Patients were hospitalized at a rate of 1 hospitalization every 3 years . In each 6-month study period , patients used a mean of 2.7 fibromyalgia-related drugs . Costs increased over the course of the study . The mean yearly per-patient cost in 1996 dollars was $ 2,274 . However , results were skewed by high utilizers , and many patients used few services and had limited costs . Total costs and utilization were independently associated with the number of self-reported comorbid or associated conditions , functional disability , and global disease severity . Compared with patients with other rheumatic disorders , those with fibromyalgia were more likely to have lifetime surgical interventions , including back or neck surgery , appendectomy , carpal tunnel surgery , gynecologic surgery , abdominal surgery , and tonsillectomy , and were more likely than other rheumatic disease patients to report comorbid or associated conditions . Almost 50 % of hospitalizations occurring during the study were related to fibromyalgia-associated symptoms . CONCLUSION The average yearly cost for service utilization among fibromyalgia patients is $ 2,274 . Fibromyalgia patients have high lifetime and current rates of utilization of all types of medical services . They report more symptoms and comorbid or associated conditions than patients with other rheumatic conditions , and symptom reporting is linked to service utilization and , to a lesser extent , functional disability and global disease severity ",
"OBJECTIVE To study the effect of fluoxetine ( FL ) and amitriptyline ( AM ) , alone and in combination , in patients with fibromyalgia ( FM ) . METHODS Nineteen patients with FM completed a r and omized , double-blind crossover study , which consisted of 4 6-week trials of FL ( 20 mg ) , AM ( 25 mg ) , a combination of FL and AM , or placebo . Patients were evaluated on the first and last day of each trial period . Outcome measures included a tender point score , the Fibromyalgia Impact Question naire ( FIQ ) , the Beck Depression Inventory ( BDI ) scale , and visual analog scales ( VAS ) for global well-being ( 1 completed by the physician and 1 by the patient ) , pain , sleep trouble , fatigue , and feeling refreshed upon awakening . RESULTS Both FL and AM were associated with significantly improved scores on the FIQ and on the VAS for pain , global well-being , and sleep disturbances . When combined , the 2 treatments worked better than either medication alone . Similar , but nonsignificant , improvement occurred in the BDI scale , the physician global VAS , and the VAS for fatigue and feeling refreshed upon awakening . Trends were less clear for the tender point score . CONCLUSION Both FL and AM are effective treatments for FM , and they work better in combination than either medication alone",
"OBJECTIVE To determine the efficacy of a 12-week individualized home-based exercise programme on physical functioning , pain severity and psychological distress for women with fibromyalgia ( FM ) . METHODS Seventy-nine women with a primary diagnosis of FM were r and omized to a 12-week individualized home-based moderate-intensity exercise programme or to a usual care control group . Outcomes were functional capacity ( Fibromyalgia Impact Question naire ) , pain severity and psychological distress . Outcomes were measured at study entry , at the end of the 12-week intervention , and at 3 and 9 months following completion of the intervention . RESULTS On the basis of intention-to-treat analyses , a significant improvement in functional capacity at 3 and 9 months following treatment for participants in the exercise group who were more functionally disabled at study entry was observed . At both 3 and 9 months post-treatment , the mean estimated benefit of the intervention was more than 10 points [ -12.3 ( 95 % CI , -21.9 to -2.8 ) ; -10.8 ( 95 % CI , -21.5 to -0.2 ) ] . Compared with the control group , statistically significant improvements in upper body pain were evident in the exercise group at post-treatment . These between-group differences in upper body pain were maintained at 3 and 9 months post-treatment . No statistically significant group differences on lower body pain and psychological distress were found . CONCLUSIONS Home-based exercise , a relatively low-cost treatment modality , has the potential to improve important health outcomes in FM",
"OBJECTIVE To assess the efficacy and safety of pramipexole , a dopamine 3 receptor agonist , in patients with fibromyalgia . METHODS In this 14-week , single-center , double-blind , placebo-controlled , parallel-group , escalating-dose trial , 60 patients with fibromyalgia were r and omized 2:1 ( pramipexole : placebo ) to receive 4.5 mg of pramipexole or placebo orally every evening . The primary outcome was improvement in the pain score ( 10-cm visual analog scale [ VAS ] ) at 14 weeks . Secondary outcome measures were the Fibromyalgia Impact Question naire ( FIQ ) , the Multidimensional Health Assessment Question naire ( MDHAQ ) , the pain improvement scale , the tender point score , the 17- question Hamilton Depression Inventory ( HAM-d ) , and the Beck Anxiety Index ( BAI ) . Patients with comorbidities and disability were not excluded . Stable dosages of concomitant medications , including analgesics , were allowed . RESULTS Compared with the placebo group , patients receiving pramipexole experienced gradual and more significant improvement in measures of pain , fatigue , function , and global status . At 14 weeks , the VAS pain score decreased 36 % in the pramipexole arm and 9 % in the placebo arm ( treatment difference -1.77 cm ) . Forty-two percent of patients receiving pramipexole and 14 % of those receiving placebo achieved > or = 50 % decrease in pain . Secondary outcomes favoring pramipexole over placebo included the total FIQ score ( treatment difference -9.57 ) and the percentages of improvement in function ( 22 % versus 0 % ) , fatigue ( 29 % versus 7 % ) , and global ( 38 % versus 3 % ) scores on the MDHAQ . Compared with baseline , some outcomes showed a better trend for pramipexole treatment than for placebo , but failed to reach statistical significance , including improvement in the tender point score ( 51 % versus 36 % ) and decreases in the MDHAQ psychiatric score ( 37 % versus 28 % ) , the BAI score ( 39 % versus 27 % ) , and the HAM-d score ( 29 % versus 9 % ) . No end points showed a better trend for the placebo arm . The most common adverse events associated with pramipexole were transient anxiety and weight loss . No patient withdrew from the study because of inefficacy or an adverse event related to pramipexole . CONCLUSION In a subset of patients with fibromyalgia , approximately 50 % of whom required narcotic analgesia and /or were disabled , treatment with pramipexole improved scores on assessment s of pain , fatigue , function , and global status , and was safe and well-tolerated",
"Abstract Objectives : To evaluate cardiovascular fitness exercise in people with fibromyalgia Design : R and omised controlled trial Setting : Hospital rheumatology out patients . Group based classes took place at a “ healthy living centre . ” Participants : 132 patients with fibromyalgia . Interventions : Prescribed grade d aerobic exercise ( active treatment ) and relaxation and flexibility ( control treatment ) . Main outcome measures : Participants ' self assessment of improvement , tender point count , impact of condition measured by fibromyalgia impact question naire , and short form McGill pain question naire . Results : Compared with relaxation exercise led to significantly more participants rating themselves as much or very much better at three months : 24/69 ( 35 % ) v 12/67 ( 18 % ) , P=0.03 . Benefits were maintained or improved at one year follow up when fewer participants in the exercise group fulfilled the criteria for fibromyalgia ( 31/69 v 44/67 , P=0.01 ) . Peoplein the exercise group also had greater reductions in tender point counts ( 4.2 v 2.0 , P=0.02 ) and in scores on the fibromyalgia impact question naire ( 4.0 v 0.6 , P=0.07 ) . Conclusions : Prescribed grade d aerobic exercise is a simple , cheap , effective , and potentially widely available treatment for fibromyalgia",
"OBJECTIVE To determine the effectiveness of a muscle strengthening program compared to a stretching program in women with fibromyalgia ( FM ) . METHODS Sixty-eight women with FM were r and omly assigned to a 12 week , twice weekly exercise program consisting of either muscle strengthening or stretching . Outcome measures included muscle strength ( main outcome variable ) , flexibility , weight , body fat , tender point count , and disease and symptom severity scales . RESULTS No statistically significant differences between groups were found on independent t tests . Paired t tests revealed twice the number of significant improvements in the strengthening group compared to the stretching group . Effect size scores indicated that the magnitude of change was generally greater in the strengthening group than the stretching group . CONCLUSION Patients with FM can engage in a specially tailored muscle strengthening program and experience an improvement in overall disease activity , without a significant exercise induced flare in pain . Flexibility training alone also results in overall improvements , albeit of a lesser degree",
"BACKGROUND AND PURPOSE The purpose s of this study were : ( 1 ) to assess the effectiveness of a 16-week progressive program of home-based , videotape-based , low-impact aerobic exercise on physical function and signs and symptoms of fibromyalgia in previously sedentary women aged 20 to 55 years and ( 2 ) to compare the effects of 1 long exercise bout versus 2 short exercise bouts per training day ( fractionation ) on physical function , signs and symptoms of fibromyalgia , and exercise adherence . SUBJECTS One hundred forty-three sedentary women were r and omly assigned to 1 of 3 groups : a group who trained using a long bout of exercise ( LBE group , n=51 ) , a group who trained using short bouts of exercise ( SBE group , n=56 ) , and a group who performed no exercise ( NE group , n=36 ) . METHODS The SBE group exercised twice daily , and the LBE group worked out once daily . Both groups progressed in total daily training duration from 10 to 30 minutes , 3 to 5 times a week , for 16 weeks . Physical and psychological well-being , symptoms , and self-efficacy were evaluated using a multivariate analysis of variance . RESULTS Dropout rates for the NE , SBE , and LBE groups were 14 % , 38 % , and 29 % , respectively . The NE group differed from the LBE group in disease severity , self-efficacy , and psychological well-being ( midtest , efficacy analysis ) and from the SBE group in disease severity and self-efficacy ( posttest , efficacy analysis ) . Exercise adherence was greater for the LBE group than for the SBE group between weeks 5 and 8 of the training program . No other differences between exercise groups were found . DISCUSSION AND CONCLUSION Progressive , home-based , low-impact aerobics improved physical function and fibromyalgia symptoms minimally in participants who completed at least two thirds of the recommended exercise . Fractionation of exercise training provided no advantage in terms of exercise adherence , improvements in fibromyalgia symptoms or physical function . High attrition rates and problems with exercise adherence were experienced in both exercise groups",
"& NA ; This was a 12‐week , r and omized , double‐blind , placebo‐controlled trial to assess the efficacy and safety of duloxetine , a selective serotonin and norepinephrine reuptake inhibitor , in 354 female patients with primary fibromyalgia , with or without current major depressive disorder . Patients ( 90 % Caucasian ; mean age , 49.6 years ; 26 % with current major depressive disorder ) received duloxetine 60 mg once daily ( QD ) ( N=118 ) , duloxetine 60 mg twice daily ( BID ) ( N=116 ) , or placebo ( N=120 ) . The primary outcome was the Brief Pain Inventory average pain severity score . Response to treatment was defined as ≥30 % reduction in this score . Compared with placebo , both duloxetine‐treated groups improved significantly more ( P the Brief Pain Inventory average pain severity score . A significantly higher percentage of duloxetine‐treated patients had a decrease of ≥30 % in this score ( duloxetine 60 mg QD ( 55 % ; P ; duloxetine 60 mg BID ( 54 % ; P=0.002 ) ; placebo ( 33 % ) ) . The treatment effect of duloxetine on pain reduction was independent of the effect on mood and the presence of major depressive disorder . Compared with patients on placebo , patients treated with duloxetine 60 mg QD or duloxetine 60 mg BID had significantly greater improvement in remaining Brief Pain Inventory pain severity and interference scores , Fibromyalgia Impact Question naire , Clinical Global Impression of Severity , Patient Global Impression of Improvement , and several quality ‐of‐life measures . Both doses of duloxetine were safely administered and well tolerated . In conclusion , both duloxetine 60 mg QD and duloxetine 60 mg BID were effective and safe in the treatment of fibromyalgia in female patients with or without major depressive disorder",
"The aim of this paper is to assess whether patient-centred consultations are more effective than the usual style of consultations used by general practitioners with patients suffering from benign chronic musculoskeletal pain and fibromyalgia . It also seeks to evaluate the differential characteristics of these two clinical groups of symptoms . The study was design ed as a cluster r and omised and simple blind trial . Twenty general practitioners took part and 110 patients were recruited . Compared with patients who received the usual treatment from their family physician , those who received a patient-centred approach showed greater improvement after 1 year in terms of psychological distress ( anxiety ) and number of tender points , as well as showing positive trends in some important outcomes such as pain intensity . Significantly better results were observed in those patients suffering chronic pain than in those with fibromyalgia , particularly as regards associated symptoms , self-rated pain and physical mobility as measured by the Nottingham health profile",
"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",
"OBJECTIVE To determine whether abnormalities of peripheral and central nociceptive sensory input processing exist outside areas of spontaneous pain in patients with fibromyalgia ( FM ) as compared with controls , by using quantitative sensory testing ( QST ) and a neurophysiologic paradigm independent from subjective reports . METHODS A total of 164 out patients with FM who were attending a self-management program were invited to participate in the study . Data for 85 patients were available and were compared with those for 40 non-FM controls matched for age and sex . QST was performed using thermal , mechanical , and electrical stimuli at locations of nonspontaneous pain . Pain assessment was 2-fold and included use of subjective scales and the spinal nociceptive flexion reflex ( NFR ) , a specific physiologic correlate for the objective evaluation of central nociceptive pathways . Question naires regarding quality of life and the impact of FM were available . RESULTS Participants were mainly middle-aged women , with a mean disease duration of 8 years . Between-group differences were significant for neurophysiologic , clinical , and quality of life measures . In patients with FM , peripheral QST showed significantly altered cold and heat pain thresholds , and tolerance to cold pain was radically reduced . The median NFR threshold in patients with FM ( 22.7 mA [ range 17.5 - 31.7 ] ) was significantly decreased compared with that in controls ( 33 mA [ range 28.1 - 41 ] ) . A cutoff value of sensitivity of 73 % and specificity of 80 % for detecting central allodynia in the setting of FM . CONCLUSION Our results strongly , although indirectly , point to a state of central hyperexcitability of the nociceptive system in patients with FM . The NFR can be used to assess central allodynia in FM . It may also help discriminate patients who may benefit from use of central ly acting analgesics",
"PURPOSE To assess the efficacy of fluoxetine in the treatment of patients with fibromyalgia . SUBJECTS AND METHODS Sixty out patients ( all women , aged 21 - 71 years ) with fibromyalgia were r and omly assigned to receive fluoxetine ( 10 - 80 mg/d ) or placebo for 12 weeks in a double-blind , parallel-group , flexible-dose study . The primary outcome measures were the Fibromyalgia Impact Question naire total score ( score range , 0 [ no impact ] to 80 ) and pain score ( score range , 0 - 10 ) . Secondary measures included the McGill Pain Question naire , change in the number of tender points , and total myalgic score . RESULTS In the intent-to-treat analysis , women who received fluoxetine ( mean [ + /- SD ] dose , 45 + /- 25 mg/d ) had significant ( P = 0.005 ) improvement in the Fibromyalgia Impact Question naire total score compared with those who received placebo , with a difference of -12 ( 95 % confidence interval [ CI ] : -19 to -4 ) . They also had significant ( P = 0.002 ) improvement in the Fibromyalgia Impact Question naire pain score ( difference , -2.2 [ 95 % CI : -3.6 to -0.9 ] ) , as well as in the Fibromyalgia Impact Question naire fatigue ( P = 0.05 ) and depression ( P = 0.01 ) scores and the McGill Pain Question naire ( P = 0.01 ) , when compared with subjects who received placebo . Although counts for the number of tender points and total myalgic scores improved more in the fluoxetine group than in the placebo group , these differences were not statistically significant . CONCLUSIONS In a 12-week , flexible-dose , placebo-controlled trial , fluoxetine was found to be effective on most outcome measures and generally well tolerated in women with fibromyalgia",
"OBJECTIVE To determine the prevalence and clinical correlations of an anomaly consisting of electroencephalographic ( EEG ) waves within the alpha frequency b and during non-rapid eye movement ( NREM ) sleep in patients with fibromyalgia , and to evaluate the alpha NREM sleep anomaly as a predictor of response to amitriptyline . METHODS Twenty-two patients with fibromyalgia were studied in a 2-month , double-blind , crossover trial of amitriptyline ( 25 mg/day ) versus placebo . Nocturnal EEGs were conducted on 2 consecutive nights at baseline and at the end of each 2-month treatment period . RESULTS Six patients ( 27 % ) had a clinical response to amitriptyline , while none responded to placebo ( P = 0.02 ) . Treatment with amitriptyline or placebo did not result in any changes in the alpha ratings during NREM sleep . Only 8 patients ( 36 % ) exhibited the alpha NREM sleep anomaly at baseline . Those patients reported more sleep difficulty , but otherwise were clinical ly indistinguishable from those without this EEG sleep anomaly . Lower baseline alpha NREM sleep ratings were seen in responders to amitriptyline than in nonresponders , but these differences did not reach statistical significance . CONCLUSION The alpha NREM sleep anomaly is present in only a small proportion of patients with fibromyalgia . It does not correlate with disease severity nor is it affected by treatment with amitriptyline . A larger sample size will be needed to adequately assess the value of this sleep anomaly in predicting the response to amitriptyline",
"Objective The aim of this study was to compare pool-based exercise and balneotherapy in fibromyalgia syndrome ( FMS ) patients . Methods Fifty female patients diagnosed with FMS according to the American College of Rheumatism ( ACR ) criteria were r and omly assigned to two groups : group 1 ( n=25 ) with pool-based exercise , and in group 2 ( n=25 ) balneotherapy was applied in the same pool without any exercise for 35 min three times a week for 12 weeks . In both groups , pre- ( week 0 ) and post-treatment ( weeks 12 and 24 ) evaluation was performed by one of the authors , who was blind to the patient group . Evaluation parameters included pain , morning stiffness , sleep , tender points , global evaluation by the patient and the physician , fibromyalgia impact question naire , chair test , and Beck depression inventory . Statistical analysis was done on data collected from three evaluation stages . Results Twenty-four exercise and 22 balneotherapy patients completed the study . Pretreatment ( week 0 ) measurements did not show any difference between the groups . In group 1 , statistically significant improvement was observed in all parameters ( P chair test at both weeks 12 and 24 . In group 2 , week 12 measurements showed significant improvement in all parameters ( P chair test and Beck depression inventory . Week 24 evaluation results in group 2 showed significant improvements in pain and fatigue according to visual analogue scale ( VAS ) , 5-point scale , number of tender points , algometric and myalgic scores , and patient and physician global evaluation ( P morning stiffness , sleep , fibromyalgia impact question naire ( FIQ ) , chair test , and Beck depression inventory parameters in this group . Comparison of the two groups based on the post-treatment ( weeks 12 and 24 ) percent changes and difference scores relative to pretreatment ( week 0 ) values failed to show a significant difference between the groups for any parameter except Beck depression inventory ( P pool-based exercise had a longer-lasting effect on some of the FMS symptoms , but statistical analysis failed to show a significant superiority of pool-based exercise over balneotherapy without exercise . While we believe that exercise is a gold st and ard in FMS treatment , we also suggest in light of our results that balneotherapy is among the valid treatment options in FMS , and further research regarding the type and duration of the exercise programs is necessary",
"OBJECTIVE To determine whether women with fibromyalgia benefit from strength training . DESIGN R and omized controlled trial . SETTING Testing was completed at the university and training was completed at a local community wellness facility . PARTICIPANTS Twenty-nine women ( age range , 18 - 54 y ) with fibromyalgia participated . Subjects were r and omly assigned to a control ( n=14 ; wait-listed for exercise ) or strength ( n=15 ) group . After the first 4 weeks , 7 ( 47 % ) women dropped from the strength group . INTERVENTION Subjects underwent 12 weeks of training on 11 exercises , 2 times a week , performing 1 set of 8 to 12 repetitions at 40 % to 60 % of their maximal lifts and were progressed to 60 % to 80 % . MAIN OUTCOME MEASURES Subjects were measured for strength , functionality , tender point sensitivity , and fibromyalgia impact . RESULTS The strength group significantly ( P upper- ( strength , 39+/-11 to 42+/-12 kg ; control , 38+/-13 to 38+/-12 kg ) and lower- ( strength , 68+/-28 to 82+/-25 kg ; control , 61+/-25 to 61+/-26 kg ) body strength . Upper-body functionality measured by the Continuous-Scale Physical Functional Performance test improved significantly ( strength , 44+/-11 to 50+/-16U ; control , 51+/-11 to 49+/-13U ) after training . Tender point sensitivity and fibromyalgia impact did not change . CONCLUSIONS Strength training improved strength and some functionality in women with fibromyalgia . Interventions with resistance have important implication s on independence and quality of life issues for women with fibromyalgia ",
"Fibromyalgia syndrome is a systemic disorder of widespread pain which is thought to result from abnormal pain processing within the central nervous system . There are no currently approved treatments for this indication . Antidepressants appear , however , to be effective , especially those with an action on noradrenergic neurotransmission . The objective of the present study was to test the efficacy of the dual action noradrenaline and serotonin reuptake inhibitor antidepressant , milnacipran , in the treatment of fibromyalgia . The 125 patients , who were enrolled in a double-blind , placebo-controlled , flexible dose escalation trial , were r and omized to receive placebo or milnacipran for 4 weeks of dose escalation ( up to 200 mg/day ) , followed by 8 weeks at a constant dose . The study evaluated the efficacy and safety of milnacipran for the treatment of pain and associated symptoms such as fatigue , depressed mood and sleep . 75 % of milnacipran-treated patients reported overall improvement , compared with 38 % in the placebo group ( p milnacipran-treated patients reported at least 50 % reduction in pain intensity , compared with 14 % of placebo-treated patients ( p milnacipran patients escalated to the highest dose ( 200 mg/day ) with no tolerability issues . Most adverse events were mild to moderate in intensity , and transient in duration . These results suggest that milnacipran may have the potential to relieve not only pain but several of the other symptoms associated with fibromyalgia",
"& NA ; An outpatient , r and omized , double‐blind , placebo‐controlled clinical trial was conducted to evaluate the efficacy and safety of tramadol in the treatment of the pain of fibromyalgia syndrome . One hundred patients with fibromyalgia syndrome , ( 1990 American College of Rheumatology criteria ) , were enrolled into an open‐label phase and treated with tramadol 50–400 mg/day . Patients who tolerated tramadol and perceived benefit were r and omized to treatment with tramadol or placebo in the double‐blind phase . The primary efficacy outcome measurement was the time ( days ) to exit from the double‐blind phase because of inadequate pain relief , which was reported as the cumulative probability of discontinuing treatment because of inadequate pain relief . One hundred patients entered the open‐label phase ; 69 % tolerated and achieved benefit with tramadol . These patients were then r and omized to continue tramadol ( n = 35 ) or convert to a placebo ( n = 34 ) during a 6week , double‐blind treatment period . The Kaplan‐Meier estimate of cumulative probability of discontinuing the double blind period because of inadequate pain relief was significantly lower in the tramadol group compared with the placebo group ( p = 0.001 ) . Twenty ( 57.1 % ) patients in the tramadol group successfully completed the entire double‐blind phase compared with nine ( 27 % ) in the placebo group ( p = .015 ) . These results support the efficacy of tramadol over a period of 6 weeks in a double blind study for the treatment of the pain of fibromyalgia in a group of patients who had been determined to tolerate it and perceive a benefit",
"OBJECTIVE Chronic widespread pain , the clinical hallmark of the fibromyalgia syndrome , is associated with other physical and psychological symptoms both in patients studied in a clinical setting and in those identified in the community . The present study was undertaken to examine the hypothesis that psychological and physical indicators of the process of somatization predict the development of new chronic widespread pain . METHODS In this population -based prospect i ve study , 1,658 adults ages 18 - 65 years completed a detailed pain question naire , which included a pain drawing . They also completed the following psychosocial instruments : General Health Question naire , Somatic Symptom Checklist , Fatigue Question naire , and Illness Attitude Scales . Individuals were followed up at 12 months , at which time 1,480 ( 93 % of subjects still living at their baseline address ) provided data on pain status , using the same instruments . RESULTS At baseline , 825 subjects were classified as pain free and 833 as having pain not satisfying criteria for chronic widespread pain . Of those , 18 ( 2 % ) and 63 ( 8 % ) , respectively , were classified as having chronic widespread pain at followup . After adjustment for age and sex , there were strong relationships between baseline test scores and subsequent risk of chronic widespread pain ( odds ratio for the Somatic Symptom Checklist 3.3 ; odds ratio for the Illness Behavior subscale of the Illness Attitude Scales 9.0 ) . All 95 % confidence intervals excluded unity . These associations were independent of baseline pain status . CONCLUSION Subjects who are free of chronic widespread pain are at increased future risk of its development if they display other aspects of the process of somatization . Data from this population -based prospect i ve study lend powerful support to the hypothesis that chronic widespread pain can be one manifestation of the somatization of distress",
"OBJECTIVE To compare the relative efficacy and tolerability of amitriptyline , cyclobenzaprine , and placebo in the treatment of fibromyalgia , and to identify predictors of response to amitriptyline and cyclobenzaprine . METHODS Two hundred eight patients who fulfilled the American College of Rheumatology criteria for the classification of fibromyalgia were entered into a 6-month prospect i ve , double-blind , multicenter trial and were r and omized to 1 of 3 treatment groups : amitriptyline , cyclobenzaprine , or placebo . RESULTS After 1 month , 21 % , 12 % , and 0 % of the amitriptyline , cyclobenzaprine , and placebo patients , respectively , had significant clinical improvement ( amitriptyline versus placebo P = 0.002 , cyclobenzaprine versus placebo P = 0.02 , amitriptyline versus cyclobenzaprine P not significant ) . These percentages increased to 36 % , 33 % , and 19 % , respectively , at the 6-month assessment ( P not significant ) . The nature and frequency of side effects reported by patients treated with amitriptyline and those reported by patients treated with cyclobenzaprine were similar . A normal Minnesota Multiphasic Personality Inventory ( MMPI ) profile at baseline was predictive of clinical improvement at the 1-month evaluation ( odds ratio 3.3 , 95 % confidence interval 1.2 - 9.0 ) . However , neither the MMPI profile nor any of the demographic , clinical , or functional parameters evaluated at baseline predicted long-term response . CONCLUSION Our data confirm the short-term efficacy of amitriptyline and cyclobenzaprine in a small percentage of patients with fibromyalgia . Long-term efficacy could not be demonstrated because of a higher-than-expected placebo response . Predictors of response to these drugs could not be determined",
"OBJECTIVE To determine the effectiveness of self-management education and physical training in decreasing fibromyalgia ( FMS ) symptoms and increasing physical and psychological well being . METHODS A pretest-posttest control group design was used . Ninety-nine women with FMS were r and omly assigned to 1 of 3 groups ; 86 completed the study . The education only group received a 6-week self-management course . The education plus physical training group received the course and 6 h of training design ed to assist them to exercise independently . The control group got treatment after 3 months . RESULTS The experimental programs had a significant positive impact on quality of life and self-efficacy . Helplessness , number of days feeling bad , physical dysfunction , and pain in the tender points decreased significantly in one or both of the treated groups when retested 6 weeks after the end of the program . Longterm followup of 67 treated subjects showed significant positive changes on the Fibromyalgia Impact Question naire primarily in the physical training group . Among all subjects , 87 % were exercising at least 3 times/week for 20 min or more ; 46 % said they had increased their exercise level since participating in the program ; 70 % were practicing relaxation strategies as needed ; 46 % were working at least half time as opposed to 37 % at pretest . CONCLUSION Self-efficacy of the treated groups was enhanced significantly by the program . Other changes were smaller and more delayed than had been expected . Recommendations for future trials include a longer education program , more vigorous physical training , and longterm followup",
"OBJECTIVE To study the usefulness of moclobemide and amitriptyline in the treatment of fibromyalgia ( FM ) in females without psychiatric disorder . METHODS In the present four centre , 12 week study , 130 female FM patients not suffering from psychiatric disorders were r and omized to receive amitriptyline ( AMI ; 25 37.5 mg ) , moclobemide ( MOCLO ; 450 - 600 mg ) or identical placebo . RESULTS Seventy-four , 54 and 49 per cent of patients on AMI , MOCLO and placebo , respectively , were judged as responders . The patients on AMI also managed best regarding the respective improvements during the trial in general health , pain , sleep quality and quantity , and fatigue on visual analogue scales ( VAS ) , the areas of the Nottingham Health Profile ( NHP ) , as well as in the three Sheehan 's functional disability scales . In the within-group comparisons , MOCLO also improved pain assessed both on VAS and on the NHP pain dimension , but the improvement was invali date d by the poor success of the drug with regard to sleep . The tolerabilities of all three drugs were comparable . CONCLUSION The study indicates that MOCLO may not be helpful in FM patients free from clinical ly meaningful psychiatric problems",
"OBJECTIVE To investigate the effects of 21 weeks ' progressive strength training on neuromuscular function and subjectively perceived symptoms in premenopausal women with fibromyalgia ( FM ) . METHODS Twenty one women with FM were r and omly assigned to experimental ( FMT ) or control ( FMC ) groups . Twelve healthy women served as training controls ( HT ) . The FMT and HT groups carried out progressive strength training twice a week for 21 weeks . The major outcome measures were muscle strength and electromyographic ( EMG ) recordings . Secondary outcome measures were pain , sleep , fatigue , physical function capacity ( Stanford Health Assessment Question naire ) , and mood ( short version of Beck 's depression index ) . RESULTS Female FMT subjects increased their maximal and explosive strength and EMG activity to the same extent as the HT group . Moreover , the progressive strength training showed immediate benefits on subjectively perceived fatigue , depression , and neck pain of training patients with FM . CONCLUSIONS The strength training data indicate comparable trainability of the neuromuscular system of women with FM and healthy women . Progressive strength training can safely be used in the treatment of FM to decrease the impact of the syndrome on the neuromuscular system , perceived symptoms , and functional capacity . These results confirm the opinion that FM syndrome has a central rather than a peripheral or muscular basis",
"PURPOSE To evaluate the efficacy and safety of a combination analgesic tablet ( 37.5 mg tramadol/325 mg acetaminophen ) for the treatment of fibromyalgia pain . METHODS This 91-day , multicenter , double-blind , r and omized , placebo-controlled study compared tramadol/acetaminophen combination tablets with placebo . The primary outcome variable was cumulative time to discontinuation ( Kaplan-Meier analysis ) . Secondary measures at the end of the study included pain , pain relief , total tender points , myalgia , health status , and Fibromyalgia Impact Question naire scores . RESULTS Of the 315 subjects who were enrolled in the study , 313 ( 294 women [ 94 % ] , mean [ + /- SD ] age , 50 + /- 10 years ) completed at least one postr and omization efficacy assessment ( tramadol/acetaminophen : n = 156 ; placebo : n = 157 ) . Discontinuation of treatment for any reason was less common in those treated with tramadol/acetaminophen compared with placebo ( 48 % vs. 62 % , P = 0.004 ) . Tramadol/acetaminophen-treated subjects also had significantly less pain at the end of the study ( 53 + /- 32 vs. 65 + /- 29 on a visual analog scale of 0 to 100 , P pain relief ( 1.7 + /- 1.4 vs. 0.8 + /- 1.3 on a scale of -1 to 4 , P Fibromyalgia Impact Question naire scores ( P = 0.008 ) . Indexes of physical functioning , role-physical , body pain , health transition , and physical component summary all improved significantly in the tramadol/acetaminophen-treated subjects . Discontinuation due to adverse events occurred in 19 % ( n = 29 ) of tramadol/acetaminophen-treated subjects and 12 % ( n = 18 ) of placebo-treated subjects ( P = 0.09 ) . The mean dose of tramadol/acetaminophen was 4.0 + /- 1.8 tablets per day . CONCLUSION A tramadol/acetaminophen combination tablet was effective for the treatment of fibromyalgia pain without any serious adverse effects",
"OBJECTIVE To evaluate the effect of exercise on mood and physical function in individuals with fibromyalgia . METHODS Subjects were r and omly assigned to an exercise ( EX ) or control ( CTL ) group . EX subjects participated in 3 30-minute exercise classes per week for 23 weeks . Subjects were tested at entry and at 6 , 12 , and 23 weeks . Tests included the Beck Depression Inventory ( BDI ) , 6-minute walk , State-Trait Anxiety Inventory ( STAI ) , Mental Health Inventory ( MHI ) , Fibromyalgia Impact Question naire ( FIQ ) , Arthritis Self-Efficacy Scale ( ASES ) , and a measure of tender points and knee strength . RESULTS Fifty subjects ( 27 EX , 23 CTL ) completed the study , and 31 ( 15 EX , 16 CTL ) met criteria for efficacy analyses . In efficacy analyses , significant improvements were seen for EX subjects in 6-minute walk distances , BDI ( total , cognitive/ affective ) , STAI , FIQ , ASES , and MHI ( 3 of 5 subscales ) scores . These effects were reduced but remained during intent-to-treat analyses . CONCLUSION Exercise can improve the mood and physical function of individuals with fibromyalgia",
"Abstract . Fibromyalgia syndrome ( FMS ) is a very common rheumatological diagnosis . There are various treatment modalities . This study was planned to investigate the effects of balneotherapy in the treatment of FMS . A total of 42 primary fibromyalgia patients diagnosed according to American College of Rheumatology criteria were included in the study . Their ages ranged between 30 and 55 years . Patients were r and omly assigned to two groups . None of them had had a cardiovascular disease before . Group 1 ( n=22 ) received 20-min bathing , once a day and five times per week . Patients participated in the study for 3 weeks ( total of 15 sessions ) . Group 2 ( n=20 ) was accepted as the control group . Patients were evaluated by the number of tender points , Visual Analogue Scale for pain , Beck 's Depression Index for depression , and Fibromyalgia Impact Question naire for functional capacity . Measurements were assessed initially , after the therapy , and at the end of the 6th month . In group 1 , there were statistically significant differences in numbers of tender points , Visual Analogue scores , Beck 's Depression Index , and Fibromyalgia Impact Question naire scores after the therapy program ( P number of tender points ( P Visual Analogue scores , and Fibromyalgia Impact Question naire ( P Beck 's Depression Index scores compared to the control group ( P>0.05 ) . Patients with FMS mostly complain about pain , anxiety , and the difficulty in daily living activities . This study shows that balneotherapy is effective and may be an alternative method in treating fibromyalgia patients",
"& NA ; Amitriptyline and cyclobenzaprine have shown some efficacy in treatment of the generalised pain syndrome , fibromyalgia . The aim of this study was to examine the efficacy of antidepressant dosages of the serotonin re‐uptake inhibitor citalopram in fibromyalgia . In a double‐blind , placebo‐controlled study 22 patients with fibromyalgia were r and omized to treatment with citalopram for 4 weeks at a dosage of 20 mg a day while 21 received placebo . After 4 weeks the dosage was increased to 40 mg for a further 4 weeks if the subjects did not report a marked improvement . After the end of treatment ( 8 weeks ) no changes were observed in self‐ assessment of symptoms , physician 's global assessment , tender points , Beck depression score or voluntary muscle strength and no differences were observed between the groups . Citalopram showed no demonstrable effect on this group of pain patients . The strength of the study was sufficient to exclude an effect of citalopram of more than 1 steps of 10 on the categoric scales for pain , fatigue and general condition ( 95 % confidence limit ) , which indicates that the sample size was sufficiently large",
"Objective : To determine the efficacy of a serotonin receptor ( 5‐HT3 ) antagonist in the treatment of fibromyalgia ( FM ) in a prospect i ve , r and omized , double‐blind , placebo‐controlled , multicentre trial . Methods : Twenty‐one female patients ( age 21–63 years ) with FM according to the American College of Rheumatology classification criteria for FM were assigned r and omly to either a placebo group or to receive a daily intravenous bolus injection of 5 mg tropisetron for 5 days . Results : In patients receiving tropisetron , the visual analogue scale ( VAS ) score for pain decreased by 28.9 compared with a decrease of 6.8 in the placebo group [ probability (p)=0.063 ; effect size : 0.794 ] . Similar results were obtained using a body diagram pain score as a secondary efficacy parameter : mean pain reduction was 27.2 in the tropisetron group , versus 2.8 in the placebo group ( p=0.038 ; effect size : 0.902 ) . Conclusion : 5‐HT3 receptor antagonists provide significant pain relief for a group of FM patients"
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Introduction Task shifting interventions have been implemented to improve health and address health inequities . Little is known about how inequity and vulnerability are defined and measured in research on task shifting . We conducted a systematic review to identify how inequity and vulnerability are identified , defined and measured in task shifting research from high-income countries . Methods and analysis We implemented a novel search process to identify programs of research concerning task shifting interventions in high-income countries . We search ed MEDLINE , Embase , CINAHL , PsycINFO , Web of Science , and CENTRAL to identify articles published from 2004 to 2016 . Each program of research incorporated a “ parent ” r and omized trial and “ child ” publications or sub- studies arising from the same research group . Two investigators extracted ( 1 ) study details , ( 2 ) definitions and measures of health equity or population vulnerability , and ( 3 ) assessed the quality of the reporting and measurement of health equity and vulnerability using a five-point scale developed for this study . We summarized the findings using a narrative approach . Results Fifteen programs of research met inclusion criteria , involving 15 parent r and omized trials and 62 child publications . Included programs of research were all undertaken in the United States , among Hispanic- ( 5/15 ) , African- ( 2/15 ) , and Korean-Americans ( 1/15 ) , and low socioeconomic status ( 2/15 ) , rural ( 2/15 ) and older adult population s ( 2/15 ) . Task shifting interventions included community health workers , peers , and a variety of other non-professional and lay workers to address a range of non-communicable diseases . Some research provided robust analyses of the affected population s ’ health inequities and demonstrated how a task shifting intervention redressed those concerns . Other studies provided no such definitions and measured only biomedical endpoints . Conclusion Included studies vary substantially in the definition and measurement of health inequity and vulnerability . A more precise theoretical and evaluative framework for task shifting is recommended to effectively achieve the goal of equitable health
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"OBJECTIVE To measure the effect of faith community nurse referrals versus telephone-assisted physician appointments on blood pressure control among persons with elevated blood pressure at health fairs . METHODS R and omized community-based intervention trial conducted from October 2006 to October 2007 of 100 adults who had an average blood pressure reading equal to or above a systolic of 140 mm Hg or a diastolic of 90 mm Hg obtained at a faith community nurse-led church health event . Participants were r and omized to either referral to a faith community nurse or to a telephone-assisted physician appointment . The average enrollment systolic blood pressure ( SBP ) was 149 ± 14 mm Hg , diastolic blood pressure ( DBP ) was 87 ± 11 mm Hg , 57 % were uninsured and 25 % were undiagnosed at the time of enrollment . RESULTS The follow-up rate was 85 % at 4 months . Patients in the faith community nurse referral arm had a 7 ± 15 mm Hg drop in SBP versus a 14 ± 15 mm Hg drop in the telephone-assisted physician appointment arm ( p = 0.04 ) . Twenty-seven percent of the patients in the faith community nurse referral arm had medication intensification compared to 32 % in the telephone-assisted physician appointment arm ( p = 0.98 ) . CONCLUSIONS Church health fairs conducted in low-income , multiethnic communities can identify many people with elevated blood pressure . Facilitating physician appointments for people with elevated blood pressure identified at health fairs confers a greater decrease in SBP than referral to a faith community nurse at four months",
" BACKGROUND African American ( AA ) women with Type 2 diabetes mellitus ( T2DM ) in the rural south experience less weight loss and poorer glycemic control in traditional diabetes management programs compared to Caucasians . This paper describes the design , rationale , and baseline characteristics from an innovative community health worker ( CHW ) delivered intervention program in this population . METHODS / DESIGN This prospect i ve trial r and omized rural AA women with uncontrolled T2DM ( HbA1c ≥ 7.0 ) to receive a behaviorally-centered , culturally-tailored lifestyle intervention during 16 contacts from a trained AA CHW or 16 approved diabetes educational mailings . Changes from baseline in glycosylated hemoglobin levels ( HbA1c ) , blood pressure ( BP ) , weight , body mass index ( BMI ) , self-reported dietary and physical activity patterns , and psychosocial measures including diabetes distress , empowerment , depression , self-care , medication adherence , and life satisfaction will be assessed at 6- and 12-months . BASELINE RESULTS Two hundred AA women ( mean age = 53.09 ± 10.89 years ) with T2DM from impoverished rural communities were enrolled . Baseline data demonstrated profoundly uncontrolled diabetes of long term duration ( mean HbA1c = 9.11 ± 1.82 ; mean BMI = 37.68 ± 8.20 ; mean BP = 134.51 ± 20.39/84.19 ± 11.68 ; 10.5 ± 0.7 years ) . Self-care behavior assessment revealed poor dietary and medication adherence and sedentary lifestyle . Most psychosocial measures ranged within normal limits . CONCLUSION The present sample of AA women from impoverished rural communities exhibited significantly uncontrolled T2DM of long duration with associated obesity and poor lifestyle behaviors . An innovative CHW led lifestyle intervention may lead to more effective strategies for T2DM management in this population",
"Introduction Community health workers ( CHWs ) can improve diabetes outcomes ; however , questions remain about translating research findings into practical low-intensity models for safety-net providers . We tested the effectiveness of a home-based low-intensity CHW intervention for improving health outcomes among low-income adults with diabetes . Methods Low-income patients with glycated hemoglobin A1c ( HbA1c ) of 8.0 % or higher in the 12 months before enrollment from 3 safety-net providers were r and omized to a 12-month CHW-delivered diabetes self-management intervention or usual care . CHWs were based at a local health department . The primary outcome was change in HbA1c from baseline enrollment to 12 months ; secondary outcomes included blood pressure and lipid levels , quality of life , and health care use . Results The change in HbA1c in the intervention group ( n = 145 ) ( unadjusted mean of 9.09 % to 8.58 % , change of −0.51 ) compared with the control group ( n = 142 ) ( 9.04 % to 8.71 % , change of −0.33 ) was not significant ( P = .54 ) . In an analysis of participants with poor glycemic control ( HbA1c > 10 % ) , the intervention group had a 1.23-point greater decrease in HbA1c compared with controls ( P = .046 ) . For the entire study population , we found a decrease in reported physician visits ( P improvement in health-related quality of life ( P = .07 ) in the intervention group compared with the control group . Conclusion A low-intensity CHW-delivered intervention to support diabetes self-management did not significantly improve HbA1c relative to usual care . Among the subgroup of participants with poor glycemic control ( HbA1c > 10 % at baseline ) , the intervention was effective",
"BACKGROUND Although African American adults bear a disproportionate burden from diabetes mellitus ( DM ) , few r and omized controlled trials have tested culturally appropriate interventions to improve DM care . METHODS We r and omly assigned 542 African Americans with type 2 DM enrolled in an urban managed care organization to either an intensive or minimal intervention group . The intensive intervention group consisted of all components of the minimal intervention plus individualized , culturally tailored care provided by a nurse case manager ( NCM ) and a community health worker ( CHW ) , using evidence -based clinical algorithms with feedback to primary care providers ( eg , physicians , nurse practitioners , or physician assistants ) . The minimal intervention consisted of mailings and telephone calls every 6 months to remind participants about preventive screenings . Data on diabetic control were collected at baseline and at 24 months by blind observers ; data emergency department ( ER ) visits and hospitalizations were assessed using administrative data . RESULTS At baseline , participants had a mean age of 58 years , 73 % were women , and 50 % were living in poverty . At 24 months , compared with the minimal intervention group , those in the intensive intervention group were 23 % less likely to have ER visits ( rate difference [ RD ] , -14.5 ; adjusted rate ratio [ RR ] , 0.77 ; 95 % confidence interval [ CI ] , 0.59 - 1.00 ) . In on-treatment analyses , the rate reduction was strongest for patients who received the most NCM and CHW visits ( RD , -31.0 ; adjusted RR , 0.66 ; 95 % CI , 0.43 - 1.00 ; rate reduction downward arrow 34 % ) . CONCLUSION These data suggest that a culturally tailored intervention conducted by an NCM/CHW team reduced ER visits in urban African Americans with type 2 DM . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00022750",
"Background : Older adults after myocardial infa rct ion ( MI ) are a vulnerable group who may benefit from interventions to improve health outcomes . The use of a peer advisor or an advanced practice nurse ( APN ) to provide a self-efficacy intervention is a promising method of improving health outcomes after MI . Aims : The purpose of this paper was to compare the effect of two self-efficacy interventions , a peer advisor and an APN , to a group who received st and ard care after MI . Methods : The study was a three-group r and omized clinical trial with a peer advisor intervention group , an APN intervention group , and a st and ard care group . Outcome data were collected in the hospital after MI and by telephone at 12 weeks after hospital discharge , after the interventions were completed . Results : At 12 weeks after MI , there were no significant differences between the 3 groups in health outcomes . There were similar changes in self-efficacy for performing recovery behaviors , the actual performance of recovery behavior , physical and mental health across both intervention groups and the st and ard care group . Conclusions : Although the data did not vali date the benefits of these self-efficacy interventions , future efforts at identifying changes in health outcomes may need to use more discrete measurements that are more sensitive to changes in the older unpartnered adult after an MI",
"OBJECTIVE The Northern Manhattan Diabetes Community Outreach Project evaluated whether a community health worker ( CHW ) intervention improved clinical ly relevant markers of diabetes care in adult Hispanics . RESEARCH DESIGN AND METHODS Participants were adult Hispanics , ages 35–70 years , with recent hemoglobin A1c ( A1C ) ≥8 % ( ≥64 mmol/mol ) , from a university-affiliated network of primary care practice s in northern Manhattan ( New York City , NY ) . They were r and omized to a 12-month CHW intervention ( n = 181 ) , or enhanced usual care ( educational material s mailed at 4-month intervals , preceded by phone calls , n = 179 ) . The primary outcome was A1C at 12 months ; the secondary outcomes were systolic blood pressure ( SBP ) , diastolic blood pressure , and LDL-cholesterol levels . RESULTS There was a nonsignificant trend toward improvement in A1C levels in the intervention group ( from unadjusted mean A1C of 8.77 to 8.40 % ) , as compared with usual care ( from 8.58 to 8.53 % ) ( P = 0.131 ) . There was also a nonsignificant trend toward an increase in SBP and LDL cholesterol in the intervention arm . Intervention fidelity , measured as the number of contacts in the intervention arm ( visits , phone contacts , group support , and nutritional education ) , showed a borderline association with greater A1C reduction ( P = 0.054 ) . When assessed separately , phone contacts were associated with greater A1C reduction ( P = 0.04 ) . CONCLUSIONS The trend toward A1C reduction with the CHW intervention failed to achieve statistical significance . Greater intervention fidelity may achieve better glycemic control , and more accessible treatment models , such as phone-based interventions , may be more efficacious in socioeconomically disadvantaged population ",
"OBJECTIVE To compare a peer leader ( PL ) versus a community health worker ( CHW ) telephone outreach intervention in sustaining improvements in HbA1c over 12 months after a 6-month diabetes self-management education ( DSME ) program . RESEARCH DESIGN AND METHODS One hundred and sixteen Latino adults with type 2 diabetes were recruited from a federally qualified health center and r and omized to 1 ) a 6-month DSME program followed by 12 months of weekly group sessions delivered by PLs with telephone outreach to those unable to attend or 2 ) a 6-month DSME program followed by 12 months of monthly telephone outreach delivered by CHWs . The primary outcome was HbA1c . Secondary outcomes were cardiovascular disease risk factors , diabetes distress , and diabetes social support . Assessment s were conducted at baseline , 6 , 12 , and 18 months . RESULTS After DSME , the PL group achieved a reduction in mean HbA1c ( 8.2–7.5 % or 66–58 mmol/mol , P reduction in HbA1c ( 7.8 vs. 7.3 % or 62 vs. 56 mmol/mol , P = 0.0004 ) post–6 month DSME ; however , it was attenuated at 18 months ( −0.3 % or −3.3 mmol/mol from baseline , within-group P = 0.234 ) . Only the PL group maintained improvements achieved in blood pressure at 18 months . At the 18-month follow-up , both groups maintained improvements in waist circumference , diabetes support , and diabetes distress , with no significant differences between groups . CONCLUSIONS Both low-cost maintenance programs led by either a PL or a CHW maintained improvements in key patient-reported diabetes outcomes , but the PL intervention may have additional benefit in sustaining clinical improvements beyond 12 months",
"OBJECTIVE Most of the day-to-day care for heart failure ( HF ) is done by the patient at home and requires skill in self-care . In this r and omized controlled trial ( RCT ) we tested the efficacy of a community-based skill-building intervention on HF self-care , knowledge and health-related quality of life ( HRQL ) at 1- and 3-months . METHODS An ethnically diverse sample ( n=75 ) of patients with HF ( 53 % female ; 32 % Hispanic , 27 % Black ; mean age 69.9±10 years ) was r and omized to the intervention group ( IG ) or a wait-list control group ( CG ) . The protocol intervention focused on tactical and situational HF self-care skill development delivered by lay health educators in community senior centers . Data were analyzed using mixed ( between-within subjects ) ANOVA . RESULTS There was a significant improvement in self-care maintenance [ F(2,47)=3.42 , p=.04 , ( Cohen 's f=.38 ) ] , self-care management [ F(2,41)=4.10 , p=.02 , ( Cohen 's f=.45 ) and HF knowledge [ F(2,53)=8.00 , p=.001 ( Cohen 's f=.54 ) ] in the IG compared to the CG . CONCLUSIONS The skill-building intervention improved self-care and knowledge but not HRQL in this community-dwelling sample . PRACTICE IMPLICATION S Delivering an intervention in a community setting using lay health educators provides an alternative to clinic- or home-based teaching that may be useful across diverse population s and geographically varied setting",
"PURPOSE Poor blood pressure control is common in the United States . We conducted a study to determine whether health coaching with home titration of antihypertensive medications can improve blood pressure control compared with health coaching alone in a low-income , predominantly minority population . METHODS We r and omized 237 patients with poorly controlled hypertension at a primary care clinic to receive either home blood pressure monitoring , weekly health coaching , and home titration of blood pressure medications if blood pressures were elevated ( n = 129 ) vs home blood pressure monitoring and health coaching but no home titration ( n = 108 ) . The primary outcome was change in systolic blood pressure from baseline to 6 months . RESULTS Both the home-titration arm and the no – home-titration arm had a reduction in systolic blood pressure , with no significant difference between them . When both arms were combined and analyzed as a before-after study , there was a mean decrease in systolic blood pressure of 21.8 mm Hg ( P primary care visits from 3.5 in the 6 months before the study to 2.6 during the 6-month study period ( P reduction in blood pressure . CONCLUSIONS Blood pressure control in a low-income , minority population can be improved by teaching patients to monitor their blood pressure at home and having nonprofessional health coaches assist patients , in particular , by counseling them on medication adherence . The improved blood pressure control can be achieved while reducing the time spent by physicians",
"BACKGROUND African American men with hypertension ( HTN ) in low socioeconomic urban environments continue to achieve poor rates of HTN control . METHODS In a 5-year r and omized clinical trial with 309 hypertensive urban African American men aged 21 to 54 years , the effectiveness of a more intensive educational/behavioral/pharmacologic intervention provided by a nurse practitioner/community health worker/physician team was compared to less intensive information and referral intervention . Changes in behavioral factors , health care utilization , blood pressure ( BP ) control , left ventricular hypertrophy ( LVH ) , and renal insufficiency were evaluated . RESULTS Follow-up rates exceeded 89 % of available men . The ranges of mean annual systolic BP/diastolic BP change from the baseline to each year follow-up were -3.7 to -10.1/-4.9 to -12.3 mm Hg for the more intensive group and + 3.4 to -3.0/-1.8 to -8.7 mm Hg for the less intensive group . The annual proportion of men with controlled BP ( LVH than the less intensive group and 17 % of the men were deceased primarily due to narcotic or alcohol intoxication ( 36 % ) and cardiovascular causes ( 19 % ) . CONCLUSIONS An appropriate educational/behavioral intervention significantly improved BP control and reduced some sequelae of HTN in a young African American male population . Improvement in risk factors other than HTN was limited and sustained control of HTN was difficult to maintain during 5 years",
"Objective : To evaluate the health effectiveness of community health workers among three groups ( intervention , attentional control and control groups ) of Hispanic adults with uncontrolled ( HbA1c > 8 % ) type 2 diabetes mellitus . Methods : This was a r and omized clinical trial involving 180 English- and Spanish-speaking Hispanic individuals with uncontrolled type 2 diabetes mellitus , 40–74 years of age , who received diabetes care at an outpatient , public , urban hospital . Repeated- measures analysis of variance was used to evaluate the effect of time and group on the primary outcome measure and secondary outcomes . Group differences in the percentage of participants achieving at least 1 % reduction in HbA1c levels were assessed using chi-square tests . Results : Patients ’ ages ranged from 44 to 74 years , 40 % were male , 97 % preferred Spanish and seven Spanish-speaking countries were identified as country of origin . Relative to the control and attentional control groups , the intervention group showed greater HbA1c reduction from baseline to 12 months and was the group with the highest percentage of participants showing 1 % or more HbA1c reduction . Conclusion : Integration of community health workers improved disease control for patients with type 2 diabetes mellitus during the intervention phase . Peer-driven/interactive ways to sustain diabetes control need to be explored",
"BACKGROUND The purpose of the present analysis is to examine changes in rural children 's asthma self-management after they received lay health educator (LHE)-delivered classes . METHODS Elementary schools were r and omly assigned to the treatment or attention-control condition and their participating students received either asthma education or general health promotion education , respectively . The triethnic sample was composed of 183 children ( 46 % Hispanic , 29.5 % non-Hispanic white , 22 % African American , and 2.6 % other categories ) who had a mean age of 8.78 years ( SD = 1.24 ) . The time frame from baseline to postintervention was 12 weeks . RESULTS Repeated measures analysis of variance found main effects in changes in scores for children 's asthma knowledge , asthma self-management , self-efficacy for managing asthma symptoms , and metered dose inhaler ( MDI ) technique and significant group interaction effects for the treatment intervention on the measures of children 's asthma knowledge , asthma self-management , and MDI technique . CONCLUSIONS The delivery of an asthma health education intervention by trained LHEs to school-aged children was an effective means for improving children 's knowledge and skills in asthma self-management",
"OBJECTIVES To test a new cognitive behavioral therapy for insomnia ( CBT-I ) program design ed for use by nonclinicians . DESIGN R and omized controlled trial . SETTING Department of Veterans Affairs healthcare system . PARTICIPANTS Community-dwelling veterans aged 60 and older who met diagnostic criteria for insomnia of 3 months duration or longer ( N = 159 ) . INTERVENTION Nonclinician \" sleep coaches \" delivered a five-session manual-based CBT-I program including stimulus control , sleep restriction , sleep hygiene , and cognitive therapy ( individually or in small groups ) , with weekly telephone behavioral sleep medicine supervision . Controls received five sessions of general sleep education . MEASUREMENTS Primary outcomes , including self-reported ( 7-day sleep diary ) sleep onset latency ( SOL-D ) , wake after sleep onset ( WASO-D ) , total wake time ( TWT-D ) , and sleep efficiency ( SE-D ) ; Pittsburgh Sleep Quality Index ( PSQI ) ; and objective sleep efficiency ( 7-day wrist actigraphy , SE-A ) were measured at baseline , at the posttreatment assessment , and at 6- and 12-month follow-up . Additional measures included the Insomnia Severity Index ( ISI ) , depressive symptoms ( Patient Health Question naire-9 ( PHQ-9 ) ) , and quality of life ( Medical Outcomes Study 12-item Short-form Survey version 2 ( SF-12v2 ) ) . RESULTS Intervention subjects had greater improvement than controls between the baseline and posttreatment assessment s , the baseline and 6-month assessment s , and the baseline and 12-month assessment s in SOL-D ( -23.4 , -15.8 , and -17.3 minutes , respectively ) , TWT-D ( -68.4 , -37.0 , and -30.9 minutes , respectively ) , SE-D ( 10.5 % , 6.7 % , and 5.4 % , respectively ) , PSQI ( -3.4 , -2.4 , and -2.1 in total score , respectively ) , and ISI ( -4.5 , -3.9 , and -2.8 in total score , respectively ) ( all P SE-A , PHQ-9 , or SF-12v2 . CONCLUSION Manual-based CBT-I delivered by nonclinician sleep coaches improves sleep in older adults with chronic insomnia",
"OBJECTIVES We assessed whether community health workers ( CHWs ) could improve glycemic control among Mexican Americans with diabetes . METHODS We recruited 144 Mexican Americans with type 2 diabetes between January 2006 and September 2008 into the single-blinded , r and omized controlled Mexican American Trial of Community Health Workers ( MATCH ) and followed them for 2 years . Participants were assigned to either a CHW intervention , delivering self-management training through 36 home visits over 2 years , or a bilingual control newsletter delivering the same information on the same schedule . RESULTS Intervention participants showed significantly lower hemoglobin A1c levels than control participants at both year 1 Δ = -0.55 ; P = .021 ) and year 2 ( Δ = -0.69 ; P = .005 ) . We observed no effect on blood pressure control , glucose self-monitoring , or adherence to medications or diet . Intervention participants increased physical activity from a mean of 1.63 days per week at baseline to 2.64 days per week after 2 years . CONCLUSIONS A self-management intervention delivered by CHWs result ed in sustained improvements in glycemic control over 2 years among Mexican Americans with diabetes . MATCH adds to the growing body of evidence supporting the use of CHWs to reduce diabetes-related health disparities",
"OBJECTIVES To confirm the effectiveness of community health workers ' involvement as counselors or case managers in a self-help diabetes management program in 2009 to 2014 . METHODS Our open-label , r and omized controlled trial determined the effectiveness of a self-help intervention among Korean Americans aged 35 to 80 years in the Baltimore-Washington metropolitan area with uncontrolled type 2 diabetes . We measured and analyzed physiological and psychobehavioral health outcomes of the community health worker-counseled ( n = 54 ) and registered nurse (RN)-counseled ( n = 51 ) intervention groups in comparison with the control group ( n = 104 ) . RESULTS The community health workers ' performance was comparable to that of the RNs for both psychobehavioral outcomes ( e.g. , self-efficacy , quality of life ) and physiological outcomes . The community health worker-counseled group showed hemoglobin A1C reductions from baseline ( -1.2 % , -1.5 % , -1.3 % , and -1.6 % , at months 3 , 6 , 9 , and 12 , respectively ) , all of which were greater than reductions in the RN-counseled ( -0.7 % , -0.9 % , -0.9 % , and -1.0 % ) or the control ( -0.5 % , -0.5 % , -0.6 % , and -0.7 % ) groups . CONCLUSIONS Community health workers performed as well as or better than nurses as counselors or case managers in a self-help diabetes management program in a Korean American community",
"OBJECTIVE Symptoms of emotional distress related to diabetes have been associated with inadequate self-care behaviors , medication non-adherence , and poor glycemic control that may predispose patients to premature death . African American women , in whom diabetes is more common and social support is often insufficient , may be at particularly high risk . The objective of this study was to examine the impact of lowering diabetes-related emotional distress on glycemic control and associated behavioral correlates in rural African American women with uncontrolled type 2 diabetes ( T2D ) . DESIGN Post-hoc analysis of prospect i ve , r and omized , controlled trial . SETTING Rural communities in the southeastern United States . PATIENTS 129 rural middle-aged African American women with uncontrolled type 2 diabetes (T2D)(A1C ≥ 7.0 ) . PRIMARY INDEPENDENT VARIABLE Diabetes-related distress . MAIN OUTCOME MEASURES Changes from baseline to 12-month follow-up in diabetes-related distress , and associated changes in medication adherence , self-care activities , self-efficacy , and glycemic control ( A1C ) . RESULTS Patients with a reduction in diabetes-related distress ( n=79 ) had significantly greater improvement in A1C , medication adherence , self-care activities , and self-efficacy compared with those in whom diabetes distress worsened or was unchanged ( n=50 ) . Changes in distress were also significantly and inversely correlated with improvements in medication adherence , self-care activities , and self-efficacy . CONCLUSIONS Among rural African American women , reductions in diabetes-related distress may be associated with lower A1C and improvements in self-efficacy , self-care behaviors , and medication adherence ",
"Abstract Objective : Puerto Rican children suffer disproportionately from asthma . Project CURA tested the efficacy of a community health worker ( CHW ) intervention to improve use of inhaled corticosteroids ( ICS ) and reduce home asthma triggers in Puerto Rican youth in Chicago . Methods : This study employed a behavioral r and omized controlled trial design with a community-based participatory research approach . Medications and technique were visually assessed ; adherence was determined using dose counters . Home triggers were assessed via self-report , visual inspection and salivary cotinine . All participants received education on core asthma topics and self-management skills . Participants in the CHW arm were offered home education by the CHW in four visits over four months . The attention control arm received four newsletters covering the same topics . Results : While most of the participants had uncontrolled persistent asthma , . In the CHW arms , 67 % of participants received the full four-visit intervention . In the Elementary school cohort ( n = 51 ) , the CHW arm had lower odds of having an ICS ( OR = 0.2 ; p = 0.02 ) at 12-months ; no differences were seen in other outcomes between arms at any time point . The only significant treatment arm difference in the high school cohort ( n = 50 ) was in inhaler technique where the CHW arm performed 18.0 % more steps correct at five months ( p number of participants with ICS or reduce home asthma triggers , important lessons were learned including challenges to CHW intervention fidelity and the need for CHWs to partner with clinical providers",
"OBJECTIVE To evaluate the effectiveness of a community health worker (CHW)-delivered lifestyle intervention for African American women with type 2 diabetes . METHODS Participants were r and omized to either 16 phone-based lifestyle intervention sessions aim ed at making small changes in their diet and activity or 16 educational mailings sent across 12 months . Main outcomes included glycosylated hemoglobin ( HbA1c ) , blood pressure ( BP ) , and weight ( kg ) changes . RESULTS Two hundred middle-aged ( mean = 53 ± 10.24 years ) , rural , African American women with moderate obesity ( mean BMI = 37.7 ± 8.02 ) and type 2 diabetes ( mean HbA1c = 9.1 ± 1.83 ) were enrolled . At 12 months , the intervention group exhibited no significant differences in HbA1c ( -0.29 ± 1.84 vs. + 0.005 ± 1.61 ; P = 0.789 ) or BP ( -1.01 ± 20.46/+0.66 ± 13.24 vs. + 0.22 ± 25.33/-2.87 ± 1.52 ; P = 0.100 ) but did exhibit greater weight loss ( -1.35 ± 6.22 vs. -0.39 ± 4.57 kg , respectively ; P = 0.046 ) compared with controls . Exploratory post hoc analyses revealed that participants not using insulin had significantly greater reductions in HbA1c ( -0.70 ± 1.86 vs. + 0.07 ± 2.01 ; P = 0.000 ) , diastolic BP ( -5.17 ± 14.16 vs. -3.40 ± 14.72 mmHg ; P = 0.035 ) , and weight ( -2.36 ± 6.59 vs. -1.64 ± 4.36 kg ; P = 0.003 ) compared to controls not on insulin . CONCLUSIONS A phone-based CHW intervention result ed in no significant improvements in HbA1c or BP but did demonstrate modest improvements in weight . Women not using insulin showed significant improvements in all primary outcomes",
"Introduction Task shifting interventions are intended to both deliver clinical ly effective treatments to reduce disease burden and address health inequities or population vulnerability . Little is known about how health equity and population vulnerability are defined and measured in research focused on task shifting . This systematic review will address the following questions : Among task shifting interventions in high-income setting s that have been studied using r and omised controlled trials or variants , how are health inequity or population vulnerability identified and defined ? What methods and indicators are used to describe , characterise and measure the population ’s baseline status and the intervention ’s impacts on inequity and vulnerability ? Methods and analysis Studies were identified through data base search es ( MEDLINE , Embase , CINAHL , PsycINFO and Web of Science ) . Eligible studies will be r and omised controlled trials published since 2004 , conducted in high-income countries , concerning task shifting interventions to treat any disease , in any population that may face health disadvantage as defined by the PROGRESS-Plus framework ( place of residence , race/ethnicity/culture/ language , occupation , gender/sex , religion , social capital , socioeconomic position , age , disability , sexual orientation , other vulnerable groups ) . We will conduct independent and duplicate title and abstract screening , then identify related papers from the same programme of research through further data base and manual search ing . From each programme of research , we will extract study details , and definitions and measures of health equity or population vulnerability based on the PROGRESS-Plus framework . Two investigators will assess the quality of reporting and measurement related to health equity and vulnerability using a scale developed for this study . A narrative synthesis will highlight similarities and differences between the gathered studies and offer critical analyses and implication s. Ethics and dissemination This review does not involve primary data collection , does not constitute research on human subjects and is not subject to additional institutional ethics review or informed consent procedures . Dissemination will include open-access peer- review ed publication and academic conference presentations . PROSPERO Registration Number CRD42017049959"
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Fructose is widely used as a sweetener in the production of many foods , yet the relation between fructose intake and cholesterol remains uncertain . In this study , we performed a systematic review and meta- analysis of human , controlled , feeding trials involving isocaloric fructose exchange for other carbohydrates to quantify the effects of fructose on serum total cholesterol ( TC ) , LDL cholesterol ( LDL-C ) , and HDL cholesterol ( HDL-C ) in adult humans . Weighted mean differences were calculated to determine changes from baseline cholesterol concentrations by means of generic , inverse variance , r and om-effect models . The Heyl and Method ological Quality was used to assess the quality of the study . Subgroup analyses and meta-regression were conducted to explore the possible influences of study characteristics . Twenty-four trials ( with a total of 474 participants ) were included in the meta- analysis . In an overall pooled estimate , it was shown that fructose exerted no effect on HDL-C. Meta-regression analysis indicated that fructose dose was positively correlated with the effect sizes of TC and LDL-C. Subgroup analyses showed that isocaloric fructose exchange for carbohydrates increased TC by 13.0 mg/dL [ ( 95 % CI : 4.7 , 21.3 ) ; P = 0.002 ] and LDL-C by 11.6 mg/dL [ ( 95 % CI : 4.4 , 18.9 ) ; P = 0.002 ] at > 100 g fructose/d . However , no effect was shown on TC or LDL-C when the fructose intake was ≤100 g/d . In conclusion , it was shown that very high fructose intake ( > 100 g/d ) increases serum LDL-C and TC concentrations . Larger , longer , and higher- quality human , controlled , feeding trials are needed to confirm these results
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" Twelve carbohydrate-sensitive men selected due to their abnormally high insulin responses to a sucrose load and 12 men with normal insulin responses were fed diets containing 0 , 7.5 , and 15 % fructose for 5 wk each in a cross-over design . The diets contained 43 % total carbohydrate , 42 % fat , and 15 % protein . Initial fasting total cholesterol and low-density lipoprotein cholesterol were higher in the hyperinsulinemic men than in the controls . Diastolic blood pressure was not affected by diet , but systolic blood pressure was slightly higher after the men consumed the 0 % fructose diet . Free fatty acids were not different . Total plasma cholesterol and low-density lipoprotein cholesterol were higher after the men consumed 7.5 and 15 % fructose than when they consumed the 0 % fructose diet . Plasma triglyceride increased significantly as fructose in the diets of the hyperinsulinemics increased , but was not affected in the controls . These changes in blood lipids are associated with heart disease",
"BACKGROUND About 9 % of average dietary energy intake in the United States comes from fructose . Such a high consumption raises concern about the metabolic effects of this sugar . OBJECTIVE The objective of this study was to determine the effect of dietary fructose on plasma lipids . DESIGN The study was conducted in the General Clinical Research Center at Fairview-University of Minnesota Medical Center . The participants were 24 healthy adult volunteers ( 12 men and 12 women ; 6 of each sex were aged /=40 y ) . All subjects received 2 isoenergetic study diets assigned by using a r and omized , balanced crossover design . One diet provided 17 % of energy as fructose . The other diet was sweetened with glucose and was nearly devoid of fructose . Each diet was fed for 6 wk . Both diets were composed of common foods and contained nearly identical amounts of carbohydrate , protein , fat , fiber , cholesterol , and saturated , monounsaturated , and polyunsaturated fatty acids . All meals were prepared in the metabolic kitchen of the General Clinical Research Center . RESULTS The responses to the study diets differed by sex . In men , the fructose diet produced significantly higher fasting , postpr and ial , and daylong plasma triacylglycerol concentrations than did the glucose diet . The daylong plasma triacylglycerol concentration after 6 wk of the fructose diet was 32 % greater in men than the corresponding concentration during the glucose diet ( P : fructose diet had no significant effect on fasting or postpr and ial plasma triacylglycerol concentrations in women . The fructose diet also had no persistent effect on fasting plasma cholesterol , HDL cholesterol , or LDL cholesterol in either men or women . CONCLUSIONS Dietary fructose was associated with increased fasting and postpr and ial plasma triacylglycerol concentrations in men . Diets high in added fructose may be undesirable , particularly for men . Glucose may be a suitable replacement sugar",
"Ten hyperinsulinemic and 11 nonhyperinsulinemic men consumed for 5 wk each in a cross-over design a diet , similar to one currently consumed in the United States , with 20 % of the kilocalories from either fructose or high-amylose cornstarch to determine the effects of the two diets on various blood metabolites considered to be risk factors associated with heart disease . In the hyperinsulinemic men the intake of fructose as compared with cornstarch significantly increased total triglycerides and their lipoprotein distribution ; total and very-low-density lipoprotein cholesterol ; apoproteins B-100 , C-II , C-III ; and uric acid . In the nonhyperinsulinemic men total triglycerides , total and low-density lipoprotein cholesterol and uric acid were significantly greater after the consumption of fructose than after cornstarch . The results indicate that in a diet high in saturated fatty acids and cholesterol , fructose increases the levels of risk factors associated with heart disease , especially in hyperinsulinemic men",
"The determine the effect of different foods on the blood glucose , 62 commonly eaten foods and sugars were fed individually to groups of 5 to 10 healthy fasting volunteers . Blood glucose levels were measured over 2 h , and expressed as a percentage of the area under the glucose response curve when the same amount of carbohydrate was taken as glucose . The largest rises were seen with vegetables ( 70 + /- 5 % ) , followed by breakfast cereals ( 65 + /- 5 % ) , cereals and biscuits ( 60 + /- 3 % ) , fruit ( 50 + /- 5 % ) , dairy products ( 35 + /- 1 % ) , and dried legumes ( 31 + /- 3 % ) . A significant negative relationship was seen between fat ( p less than 0.01 ) and protein ( p less than 0.001 ) and postpr and ial glucose rise but not with fiber or sugar content",
"The effect of dietary fructose ( 20 % of carbohydrate calories , 45 - 65 g day-1 for 4 weeks ) on glycaemic control , serum lipid , lipoprotein and apoprotein A-I and A-II concentrations and on insulin sensitivity was studied in 10 type 2 diabetic patients . The study was done in a r and omized , double-blind fashion with crystalline fructose or placebo administered evenly during 4 meals or snacks per day . The patients were hospitalized throughout the study periods . The fasting plasma glucose concentration decreased during the fructose ( from 10.7 + /- 1.4 mmol l-1 to 8.0 + /- 0.8 mmol l-1 , P control diet ( from 10.1 + /- 0.9 mmol l-1 to 8.0 + /- 0.7 mmol l-1 , P mean diurnal blood glucose concentration also fell both during the fructose ( from 10.8 + /- 0.5 mmol l-1 to 8.4 + /- 0.3 mmol l-1 , P HbA1 concentration improved ( P Insulin sensitivity increased by 34 % ( P Serum insulin , triglyceride , apoprotein A-I and A-II concentrations , body weight , blood pressure and blood lactate remained unchanged during both diets . In conclusion , substitution of moderate amounts of fructose for complex carbohydrates can improve glycaemic control and insulin sensitivity in patients with type 2 diabetes",
"An increasing amount of fructose in the diet is suggested to play a causal role in the pathogenesis of the metabolic syndrome , type 2 diabetes and fatty liver . Our aim was to investigate and compare the effects of very high fructose and very high glucose in hyperenergetic diets on glucose and lipid metabolism and on fat depots in healthy humans . We conducted an exploratory , prospect i ve , r and omised , single-blinded , intervention trial . Participants in addition to a balanced weight-maintaining diet received 150 g of fructose or glucose/d for 4 weeks . Insulin sensitivity was estimated from oral glucose tolerance tests . Visceral and subcutaneous abdominal fat was determined with MRI . Liver fat and intramyocellular lipids of the tibialis anterior muscle were measured with (1)H magnetic resonance spectroscopy . A total of twenty healthy subjects ( fructose group n 10 and glucose group n 10 ; twelve males and eight females ) completed the study . They had a mean age of 30·5 ( SEM 2·0 ) years and a mean BMI of 25·9 ( SEM 0·5 ) kg/m(2 ) . Insulin sensitivity appeared to decrease both in the fructose and glucose groups . TAG markedly increased in the fructose group . No strong alterations or treatment effects were found for liver fat , visceral fat , subcutaneous abdominal fat and intramyocellular lipids of the tibialis anterior muscle . In conclusion , the effects of very high fructose and very high glucose in hyperenergetic diets on glucose metabolism and body fat composition were not different in the healthy participants of the present study . However , elevation of plasma TAG seemed to be fructose-specific",
" Using a crossover design , eight healthy volunteers r and omly received physiologic amounts ( ⅓ of each subject 's total carbohydrate intake ) of either fructose or sucrose as the primary source of simple sugar , incorporated into isocaloric diets comprised of typical American foods . After 7 and 14 days of consuming either of the two sugars , no change occurred in fasting glucose or insulin levels . In addition , total triglyceride , totalcholesterol , low-density-lipoprotein ( LDL ) cholesterol , and high-density-lipoprotein ( HDL ) cholesterol concentrations were unaltered . Since our study used conventional foods in normal eating patterns rather than contrived formulas or excessive amounts of simple sugar , our data indicate that there is no difference between sucrose or fructose on various lipid components or glucose and fasting insulin levels in the “ real world ” innormal subjects"
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PURPOSE To provide guidelines for patient recall regimen , professional maintenance regimen , and at-home maintenance regimen for patients with tooth- and implant-borne removable and fixed restorations . METHODS The American College of Prosthodontists ( ACP ) convened a scientific panel of experts appointed by the ACP , American Dental Association ( ADA ) , Academy of General Dentistry ( AGD ) , and American Dental Hygienists Association ( ADHA ) who critically evaluated and debated recently published findings from 2 systematic review s on this topic . The major outcomes and consequences considered during formulation of the clinical practice guidelines ( CPGs ) were risk for failure of tooth- and implant-borne restorations . The panel conducted a round table discussion of the proposed guidelines , which were debated in detail . Feedback was used to supplement and refine the proposed guidelines , and consensus was attained . RESULTS A set of CPGs was developed for tooth-borne restorations and implant-borne restorations . Each CPG comprised of 1 ) patient recall ; 2 ) professional maintenance , and 3 ) at-home maintenance . For tooth-borne restorations , the professional maintenance and at-home maintenance CPGs were subdivided for removable and fixed restorations . For implant-borne restorations , the professional maintenance CPGs were subdivided for removable and fixed restorations and further divided into biological maintenance and mechanical maintenance for each type of restoration . The at-home maintenance CPGs were subdivided for removable and fixed restorations . CONCLUSION The clinical practice guidelines presented in this document were initially developed using the 2 systematic review s. Additional guidelines were developed using expert opinion and consensus , which included discussion of the best clinical practice s , clinical feasibility and risk-benefit ratio to the patient . To the authors ' knowledge , these are the first CPGs addressing patient recall regimen , professional maintenance regimen , and at-home maintenance regimen for patients with tooth-borne and implant-borne restorations . This document serves as a baseline with the expectation of future modifications when additional evidence becomes available
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"OBJECTIVES The aim of this cohort study was to evaluate the safety and the acceptability of an electric toothbrush used on the peri-implant mucosa of implants placed in the aesthetic area . METHODS One hundred consecutive patients rehabilitated with implants positioned in the maxillary aesthetic area were recruited . Implants had to be restored at least 6 months prior to baseline . At baseline , subjects were provided with Oral-B Professional Care 7000 and received appropriate instructions to brush twice a day over a 12-month period . Papillary bleeding index , recession and probing depth were measured at baseline and at 3 , 6 , and 12 months . RESULTS Ninety-eight ( 98 ) patients completed the study . There was an overall reduction of recession ( mean 0.2 mm ) of borderline statistical significance . All of the changes occurred at the first followup visit ( P=0.09 ) and persisted thereafter . The statistical analyses regarding the probing depth found a highly significant decrease over time ( mean 0.3 mm ) . The bleeding score showed a gradual decrease over time , with a reduction at 12 months by more than half ( 0.65 ) in comparison with the baseline ( 1.50 ) and was shown to be highly significant ( Wilcoxon sign-rank test : P adverse effects such as ulcerations or desquamation . A high score of satisfaction by the patients using the electric toothbrush was reported ( 94 % would continue to use it ) . CONCLUSION The electric toothbrush Oral B Professional Care 7000 appears to be safe for patients with fixed prosthesis on implants in aesthetic areas . Successive r and omised clinical trials are needed to compare this instrument with other therapeutic devices for mechanical plaque control",
"BACKGROUND The purpose of this statement is to up date the recommendations by the American Heart Association ( AHA ) for the prevention of infective endocarditis that were last published in 1997 . METHODS AND RESULTS A writing group was appointed by the AHA for their expertise in prevention and treatment of infective endocarditis , with liaison members representing the American Dental Association , the Infectious Diseases Society of America , and the American Academy of Pediatrics . The writing group review ed input from national and international experts on infective endocarditis . The recommendations in this document reflect analyses of relevant literature regarding procedure-related bacteremia and infective endocarditis , in vitro susceptibility data of the most common microorganisms that cause infective endocarditis , results of prophylactic studies in animal models of experimental endocarditis , and retrospective and prospect i ve studies of prevention of infective endocarditis . MEDLINE data base search es from 1950 to 2006 were done for English- language papers using the following search terms : endocarditis , infective endocarditis , prophylaxis , prevention , antibiotic , antimicrobial , pathogens , organisms , dental , gastrointestinal , genitourinary , streptococcus , enterococcus , staphylococcus , respiratory , dental surgery , pathogenesis , vaccine , immunization , and bacteremia . The reference lists of the identified papers were also search ed . We also search ed the AHA online library . The American College of Cardiology/AHA classification of recommendations and levels of evidence for practice guidelines were used . The paper was subsequently review ed by outside experts not affiliated with the writing group and by the AHA Science Advisory and Coordinating Committee . CONCLUSIONS The major changes in the up date d recommendations include the following : ( 1 ) The Committee concluded that only an extremely small number of cases of infective endocarditis might be prevented by antibiotic prophylaxis for dental procedures even if such prophylactic therapy were 100 % effective . ( 2 ) Infective endocarditis prophylaxis for dental procedures is reasonable only for patients with underlying cardiac conditions associated with the highest risk of adverse outcome from infective endocarditis . ( 3 ) For patients with these underlying cardiac conditions , prophylaxis is reasonable for all dental procedures that involve manipulation of gingival tissue or the periapical region of teeth or perforation of the oral mucosa . ( 4 ) Prophylaxis is not recommended based solely on an increased lifetime risk of acquisition of infective endocarditis . ( 5 ) Administration of antibiotics solely to prevent endocarditis is not recommended for patients who undergo a genitourinary or gastrointestinal tract procedure . These changes are intended to define more clearly when infective endocarditis prophylaxis is or is not recommended and to provide more uniform and consistent global recommendations",
"OBJECTIVES To compare the interproximal cleansing efficacy of the novel , waist-shaped Circum brush ( Topcaredent , Switzerl and ; CB ) with that of a straight soft interdental brush ( IB ) ( TePe , Sweden ; SB ) on posterior surfaces . MATERIAL & METHODS Eight patients after completion of initial periodontal therapy abolished oral hygiene for 3 days . Baseline plaque scores ( PlI , Silness & Löe ) were assessed on eight surfaces of all premolars and molars . Subsequently , an instructed nurse applied at r and om one of the two IB , three times per interdental space . Following this , registration of the PlI was repeated by the same blinded examiner . After a 2-week recovery , patients abolished oral hygiene practice s for another 3 days . Again , pre- and post-brushing PlI were recorded by the same examiner . The second IB was now applied . RESULTS Patient mean PlI and site PlI were evaluated before and after application of the SB or CB respectively . Paired t-tests were performed to yield statistically significant differences . The reduction of biofilm from before to after the use of the IB on a subject basis was highly significant ( P mean PlI after the use of the CB was significantly lower than after the use of the SB ( P more biofilm had been removed by applying CB compared with SB ( P higher reduction of biofilm in favour of the CB ( P reduction of the PlI in the mid-interproximal portion , both mesially and distally did not differ significantly between CB and ST . No biofilm reduction was seen on the buccal sites with either IB . CONCLUSION The application of the waist-shaped Circum IB result ed in significantly lower PlI scores than the use of a straight IB . This was predominantly due to the higher cleansing effect of the waist-shaped CB on the buccal and lingual line angles",
"The aim of this study was to assess and observe the oral hygiene and gingival condition in patients before and after fixed prosthodontic therapy through a 12-month period in combination with oral hygiene instructions . It was also analysed how factors , such as type of fixed prosthodontic appliance , constructive material , the position of a fixed partial denture ( FPD ) in the mouth , age and gender influenced oral hygiene . The dental arches were divided into three segments each and teeth and gingiva were examined using the Plaque and Gingiva Index by Silness and Löe , and for the mineralized deposits assessment the Calculus Index by Green and Vermillion was employed . The preliminary examination was conducted before the prosthodontic therapy , and the reexaminations were carried out 14 days , 1 , 6 and 12 months after crown and /or FPD placement . A total of 93 subjects from the original study group of 146 patients attended all clinical examinations , while the rest was excluded . The sample consisted of 60 women , 33 men at age between 21 and 95 ( average 51.8 ) . A total of 39 patients had single crowns ( C ) , 50 FPDs and 5 C+FPD . The frequency of plaque found during the preliminary visit was higher than that found in the other periods ( p better oral hygiene levels than patients with FPDs or C+FPDs ( p = 0.001 ) . Our results revealed no significant difference in oral hygiene status among patients with FPDs made of different material s ( p = 0.083 ) . The worst hygiene levels were found in patients with fixed prosthodontic appliances in both jaws ( p = 0.012 ) . Younger patients showed better hygiene levels than the older ones ( p = 0.002 ) . Our research showed that appropriate educational and motivational measures can lead to improved oral hygiene , even after FPD placement . Presumably , the oral health in a group of adult patients can be kept acceptable by providing a prophylactic oral hygiene program",
"BACKGROUND Long-term follow-up studies ( i.e. , over 5 years ) , focusing on prosthetic outcomes and maintenance of implant-supported reconstructions in the edentulous maxilla , are scarce in the literature . PURPOSE The purpose of this study was to evaluate and report 10-year data on outcomes and maintenance of screw-retained implant-supported full-arch casted titanium-resin prostheses in the edentulous maxilla . MATERIAL S AND METHODS In the r and omized control trial cohort of 24 patients , the outcome and maintenance of 23 bridges were registered . RESULTS One patient dropped out of the study prior to the 10-year control . Of the 23 remaining patients , 21 still had their original frameworks ; one framework fractured after 8 years and one was remade after 7 years to create better support for the acrylic . The remaining 23 prostheses showed criteria of success , survival , and failure in 9 , 82 , and 9 % , respectively . Tightening of two assembly screws was necessary in one patient . No detrimental effects were seen because of long cantilever extensions or opposing dentition . A total of 4.7 resin-related complications per prosthesis were observed ; tooth fracture was the most common prosthetic complication . There was an indication of greater prevention in the number of resin-related complications with the use of lingual gold onlay compared with a resilient mouth guard , 0.71 and 1.67 , respectively per bridge . The bridges were removed and reinserted 0.83 times per patient . No abutment or abutment screw fractures were registered . CONCLUSION Fracture or wear of the reconstruction material s were considered predictable risks when using resin-based suprastructure material s. Status of opposing dentition and length of cantilevers did not confer additional risk . The use of a lingual gold onlay indicated prevention of resin-related complications . Future research should focus on the suprastructure material s to predict better overall treatment results of implant-supported full-arch bridges in the edentulous maxilla",
"AIM To determine the incidence of peri-implantitis in individuals with mucositis in a 5-year follow-up study . MATERIAL AND METHODS A sample of 212 partially edentulous individuals , rehabilitated with dental implants , underwent periodontal and peri-implant clinical examinations in 2005 ( baseline ) . Five years later , 80 individuals who had been diagnosed with mucositis in the baseline examination were re-examined . These individuals were divided into two groups : one group with preventive maintenance during the study period ( GTP ; n = 39 ) , and another group without preventive maintenance ( GNTP ; n = 41 ) . The following parameters were clinical ly evaluated : plaque index , bleeding on periodontal and peri-implant probing , periodontal and peri-implant probing depth , suppuration and peri-implant bone loss . The influence of biological and behavioural risk variables associated with the occurrence of peri-implantitis was analysed using univariate and multivariate logistic regression analyses . RESULTS The incidence of peri-implantitis in the global sample was 31.2 % ( GNTP = 43.9 % and GTP = 18.0 % ) . CONCLUSION The absence of preventive maintenance in individuals with pre-existing peri-implant mucositis was associated with a high incidence of peri-implantitis . Clinical parameters , such as bleeding on peri-implant probing , periodontal probing depth and the presence of periodontitis were associated with a higher risk of developing peri-implantitis",
"The soft and periodontal tissues surrounding dental implants are particularly susceptible to bacteria invasion and inflammatory reactions due to complex histological structures . This study was carried out to investigate the influence of a propolis-containing hygienic agent on selected oral health parameters , oral microflora , and the condition of periodontal health . Sixteen subjects who underwent an oral rehabilitation with dental implants were selected and r and omly assigned into two groups , which received a newly formulated propolis-containing toothpaste ( 3 % ( CA ) ) or a negative control without an active ingredient ( CC ) . Approximal plaque index ( API ) , oral hygiene index ( OHI , debris component ) , and sulcus bleeding index ( SBI ) were assessed in three subsequent stages . During the first and last examinations , the swabs were employed for microbiological inoculation . Propolis-containing toothpaste was found to be distinctively effective in improving oral health and the occurrence of gingivitis triggered by dental plaque . The qualitative and quantitative changes in oral bacteria spectrum were observed . Antibacterial measures containing propolis might be used as a natural adjuvant to other active substances in individuals with a high risk of periodontal problems against pathogenic oral microflora",
"OBJECTIVE To determine the effectiveness of a water flosser in reducing the bleeding on probing ( BOP ) index around dental implants as compared to flossing . METHODS AND MATERIAL S Patients with implants were r and omly assigned to one of two groups in this examiner-masked , single-center study . The study compared the efficacy of a manual toothbrush paired with either traditional string floss or a water flosser . RESULTS The primary outcome was the reduction in the incidence of BOP after 30 days . There were no differences in the percent of bleeding sites between the groups at baseline . At 30 days , 18 of the 22 ( 81.8 % ) implants in the water flosser group showed a reduction in BOP compared to 6 of the 18 ( 33.3 % ) in the floss group ( P=0.0018 ) . CONCLUSIONS These results demonstrate that the water flosser group had statistically significantly greater bleeding reduction than the string floss group . The authors concluded that water flossing may be a useful adjuvant for implant hygiene maintenance",
"PURPOSE To analyze maintenance service of fixed maxillary prostheses and overdentures based on conventional gold bars or titanium bars and frameworks fabricated with computer-aided design /computer-assisted manufacture ( CAD/CAM ) technology . MATERIAL S AND METHODS Forty-one patients participated ; 16 received an implant overdenture with a gold bar ( gold OD ) , 12 received a CAD/CAM-fabricated implant OD with a titanium bar ( Ti OD ) , and 13 received a CAD/CAM implant-supported fixed prosthesis ( IFP ) . The bars and frameworks were screw-retained at the implant level . Maintenance service performed during the first 2 years was recorded and compared between the three groups . After this 2-year period , the Oral Health Impact Profile ( OHIP ) was administered . RESULTS For ODs ( gold , Ti ) most service consisted of activation of the matrices . Fractures of matrices and bar extensions occurred only in the gold OD group , and 65 % of these patients exhibited hyperplasia of the peri-implant mucosa . The maintenance rates were 1.24 ( gold OD ) , 1.36 ( Ti OD ) , and 0.98 ( IFP ) . These differences were not statistically significant . Retightening of occlusal screws was not necessary in any group . The probability that a complication occurred in the first year was high ( 60 % to 70 % ) and statistically not different between the three groups . The probability that a second complication occurred was significantly lower for the IFP group versus the gold OD group . The mean OHIP values were 1.7 ( IFP ) , 6.7 ( gold OD ) , and 7.3 ( Ti OD ) ; ratings in the IFP group were significantly better . CONCLUSIONS Maintenance service was typical for implant prostheses in the edentulous maxilla . Direct screw retention at the implant level without abutments had a favorable effect in all groups . A trend toward a reduction in problems was observed with the CAD/CAM superstructures . The OHIP confirmed high satisfaction , but quality of life appeared to be slightly higher with fixed prostheses",
"Objectives The objective of this study was to assess the effectiveness of a supervised implementation of the “ Oral health care Guideline for Older people in Long-term care Institutions ” ( OGOLI ) in The Netherl and s. Material s and methods A sample of 12 care homes in the Netherl and s was allocated r and omly to an intervention or control group . While the residents in the control group received oral health care as before , the intervention consisted of a supervised implementation of the OGOLI . Results At baseline , the overall r and om sample comprised 342 residents , 52 % in the intervention group and 48 % in the control group . At 6 months , significant differences were observed between the intervention and the control group for mean dental as well as denture plaque , with a beneficial effect for the intervention group . The multilevel mixed-model analyses conducted with the plaque scores at 6 months as outcome variables showed that the reduction by the intervention was only significant for denture plaque . Conclusions Supervised implementation of the OGOLI was more effective than non-supervised implementation in terms of reducing mean plaque scores at 6 months . However , the multilevel mixed-model analysis could not exclusively explain the reduction of mean dental plaque scores by the intervention . Clinical relevance A supervised implementation of an oral health care guideline improves oral health of care home residents",
"BACKGROUND Oral hygiene and health of the institutionalized elderly are frequently described as inadequate . OBJECTIVES This r and omized and single-blinded ( outcome evaluation ) study compared three types of intervention for improving oral hygiene with a control . The purpose was to investigate whether there were any significant differences between the intervention and control groups . METHODS One hundred and six participants living in long-term care homes in South-West Germany were recruited and r and omly divided into four groups-three therapy groups and one control group . For all three therapy groups , teeth and dentures were cleaned professionally and individual instruction was given . One of these groups was also re-instructed and remotivated by a dentist ( n = 27 ) . One also received help from , and was remotivation by , staff educated in dental hygiene ( n = 26 ) . The third therapy group was not remotivated after professional cleaning of teeth and dentures ( n = 26 ) . For the control group , there was no intervention ( n = 23 ) . The main target clinical data were mean plaque ( plaque-control record , O'Leary ) , gingival bleeding ( Ainamo/Bay ) , and denture hygiene indices . For assessment of the difference between being in an intervention group and in a control group , mixed-model analysis for repeated measurements was performed for each main target variable . In addition , target clinical data were evaluated in long-term follow-up after 3 years . RESULTS Compared with controls , denture hygiene , plaque , and gingival bleeding indices were significantly lower in the intervention groups over a twelve-week period ( mixed model for repeated measurements ; P Estimates of effects between control and each treatment group were comparable among the three therapy groups ; however , even though two of the groups received further help and instruction . Long-term follow-up showed that all indices were significantly worse than at the last study recall ( P Professional cleaning of teeth and dentures , with individual instruction , can be recommended to improve oral hygiene . However , the effect decreases over time and renewal of the intervention is necessary",
"AIM Supportive therapy to maintain dental implants is increasingly important . This study examined the effect of a 0.3 % triclosan/2 % copolymer dentifrice on oral biofilms and gingival inflammation ( GI ) on dental implants and peri-implant tissues . MATERIAL S AND METHODS One hundred and twenty adults with a dental implant and contra-lateral tooth were enrolled in this 6 month , double-blind , two-treatment , parallel group study . Sixty subjects were r and omly assigned to a triclosan/copolymer dentifrice test group and 60 subjects to a fluoride dentifrice control group and instructed to brush twice daily for 6 months . At baseline , 3 , and 6 months , a calibrated dentist assessed dental plaque , GI and collected supragingival dental plaque for microbiological analysis . RESULTS Subjects in the triclosan/copolymer group demonstrated significantly lower levels of dental plaque , gingivitis , and bleeding on probing at 3 and 6 months at both the implant and contra-lateral tooth compared with the fluoride group ( p Gram-negative anaerobes in the triclosan/copolymer group ( p 90 % reductions in Aggregatibacter actinomycetemcomitans , Campylobacter rectus , Eubacterium saburreum , Fusobacterium nucleatum , Porphyromonas gingivalis , Prevotella melaninogenica , Solobacterium moorei , and Tannerella forsythia . CONCLUSIONS Twice daily use of a triclosan/copolymer dentifrice may enhance dental implant maintenance by reducing dental plaque and GI",
"PURPOSE The aim of the present study was to investigate plaque levels following sonic-powered and manual toothbrushing in subjects with dental implants . MATERIAL S AND METHODS This study included 36 male and 47 female partially edentulous patients ( age range 45 - 78 years , mean age 59.8 years ) that were r and omly assigned to one of two treatment groups : the sonic toothbrush group ( n = 42 ; Philips Sonicare FlexCare ® toothbrush ) or the manual toothbrush group ( n = 41 ; Oral-B P40 ® ) . Clinical , microbiological and immunological examinations were performed blinded at baseline and after 3 , 6 , 9 and 12 months . Microbiological analyses were performed by real-time polymerase chain reaction . Immunological analyses ( prostagl and in E2 ) were performed by chromatography-electrospray spectrometry . RESULTS The plaque index difference between baseline and 12 months at implants showed no significant difference between sonic or manual toothbrushing in a two-sided Mann-Whitney test ( W = 773.5 , P = 0.426 , 95 % CI -0.64 to 0.20 ) . At the end of the study , there were no significant changes in plaque index , bleeding on probing , gingival index , pocket probing depth , gingival recession , clinical attachment level or the microbiological and immunological outcomes at implants or teeth in either group . CONCLUSIONS This study uncovered no significant difference between sonic and manual toothbrushing for plaque reduction at implants and teeth . Both toothbrushes maintain healthy peri-implant soft tissue",
"OBJECTIVE The aim of this study was to compare the use of two chlorhexidine-based antimicrobial agents as an adjunct to mechanical therapy for the treatment of peri-implant mucositis . MATERIAL S AND METHODS Thirty patients with peri-implant mucositis were included in the study and r and omized in two groups . In addition to mechanical therapy , group A was treated with chlorhexidine 0.2 % mouthwash , while group B was treated with chlorhexidine 1 % gel . Probing depth , plaque index and bleeding index were recorded at each scheduled follow-up visit : ten days , 1 month and 3 months after giving the patients the assigned formulation . Patients had to fill in a question naire investigating their satisfaction and ease of use of the product . RESULTS A total of 23 patients ( 13 in group A and 10 in group B ) attended all the follow-up visits . Chlorhexidine 0.2 % mouthwash and chlorhexidine 1 % gel were equally useful in the treatment of peri-implant mucositis leading to the reduction in inflammatory parameters . Probing depth decreased over time in both groups . Patients showed preference for gel formulation even if they found it more difficult to use . CONCLUSIONS Adjunctive treatment with different chlorhexidine formulations was beneficial to the treatment of peri-implant mucositis . Besides , no differences could be found between 0.2 % mouthwash and 1 % gel",
"OBJECTIVE To better underst and the role of the professional oral health care for elderly in improving geriatric oral health , the effects of short-term professional oral health care ( once per week for 1 month ) on oral microbiological parameters were assessed . METHODS Parallel , open-labelled , r and omize-controlled trial was undertaken in a nursing home for elderly in Shizuoka , Japan . Thirty-four dentate elderly over 74 years were r and omly assigned from ID number to the intervention ( 17/34 ) and control ( 17/34 ) groups . The outcomes were changes in oral microbiological parameters ( number of bacteria in unstimulated saliva ; whole bacteria , Streptococcus , Fusobacterium and Prevotella : opportunistic pathogens detection : and index of oral hygiene evaluation [ Dental Plaque Index , DPI ] ) within the intervention period . Each parameter was evaluated at before and after intervention period . Four elderly were lost from mortality ( 1 ) , bone fracture ( 1 ) , refused to participate ( 1 ) and multi-antibiotics usage ( 1 ) . Finally , 30 elderly were analysed ( 14/intervention and 16/control ) . RESULTS At baseline , no difference was found between the control and intervention groups . After the intervention period , the percentage of Streptococcus species increased significantly in the intervention group ( Intervention , 86 % [ 12/14 ] ; Control , 50 % [ 8/16 ] : Fisher 's , right-tailed , P DPI significantly improved in the intervention group ( Intervention , 57 % [ 8/14 ] ; Control , 13 % [ 2/16 ] : Fisher 's , two-tailed , P DPI extended for 3 months after intervention . None of side effects were reported . CONCLUSION The short-term professional oral health care can improve oral conditions in the elderly",
"OBJECTIVES The purpose of this study was to determine the effect of two different preventive oral hygiene education and motivation programmes on the plaque and gingival index , as well as denture hygiene of patients provided with removable partial denture ( RPD ) during a 12-month follow-up . MATERIAL AND METHODS A total of 53 partially edentulous patients were recruited for this study . The presence or absence of plaque and gingival bleeding by gentle probing was scored on all tooth surfaces at the preliminary visit . The plaque and gingival indexes were measured using the Löe index . Following treatment , the patients were r and omly divided into three groups . In Control Group I , subjects were instructed to continue their personal oral hygiene routine . In Group II , participants were given verbal instructions and a self-educational manual on oral hygiene without illustrations . In Group III , oral hygiene guidance was delivered using a combination of verbal instructions and a self-teaching manual . To evaluate the effect of the different modes of instruction , the presence or absence of plaque and gingival bleeding was scored on all tooth surfaces ( day zero examination ) and re-examined 7 , 15 and 30 days , 3 , 6 and 12 months following RPD placement . The state of denture hygiene was evaluated 7 , 15 and 30 days and 3 , 6 and 12 months following rehabilitation . Parametric statistics was applied to dental plaque and gingival indexes . For accumulation of plaque and calculus on the RPD , non-parametric statistic was applied . RESULTS The frequency of plaque found during the preliminary visit was higher than that found in the other periods . With regard to gingival index , significant difference was found between the preliminary visit examination and other periods . There was a significant difference in the plaque accumulation on the denture surface between groups I and III . CONCLUSION The different methods of oral hygiene instruction used in this study indicate that the type of education was not of significant importance",
"OBJECTIVES The aim of the present study was to test the hypothesis that an additional full-mouth disinfection results in a greater clinical and microbiological improvement compared with sole mechanical debridement within one session in patients with peri-implant mucositis and treated chronic periodontitis . MATERIAL AND METHODS The study included 13 partially edentulous patients ( mean age 51.5 years ) with treated chronic periodontitis and 36 dental implants with mucositis ( bleeding on probing and /or a gingival index > or = 1 at least at one site at baseline , absence of peri-implant bone loss during the last 2 years before baseline ) . After r and omized assignment to a test and a control group , patients received a one-stage full-mouth scaling with or without chlorhexidine . Clinical and microbiological examination was performed at baseline , after 1 , 2 , 4 and 8 months . Additional microbial sample s were taken 24 h after treatment . Microbiological analysis was performed by real-time polymerase chain reaction . RESULTS Both treatment modalities result ed in significant reductions of probing depth at implant sites after 8 months , with no significant group differences . The bacteria at implants and teeth could be reduced in every group 24 h after treatment ; however , this reduction was not significant after 8 months . CONCLUSIONS Both treatment modalities led to an improvement of the clinical parameters and a temporary reduction of the microflora at implants with mucositis , but without significant inter-group differences after 8 months",
"OBJECTIVE The aim of this prospect i ve study was to assess the outcomes of an implant maintenance protocol for implants supporting a full-arch rehabilitation . MATERIAL S AND METHODS Sixty-one patients ( 28 women and 33 men ) treated with immediately loaded full-arch rehabilitation , both m and ibular and maxillary , supported by a combination of two tilted and two axial implants , were included in the study . Patients were scheduled for follow-up visits every 6 months for + 2 years , then yearly up to 4 years . Each patient received professional oral hygiene treatment and detailed oral hygiene instructions . During each visit , modified plaque index , bleeding index and probing depth were assessed . The presence of peri-implant tissue inflammation was also evaluated . RESULTS Mean observation time , considering both m and ible and maxilla , was 18.3 months ranging from 6 months to 5 years . Both plaque and bleeding indexes frequency decreased over time . Probing depth was stable ( 2.46 ± 0.5 mm at 4 years ) . Only three implants were lost due to peri-implantitis ( 1.4 % at 12 months ) , whereas the incidence of peri-implant mucositis was less than 10 % in each considered period . CONCLUSIONS The adoption of a systematic hygienic protocol is effective in keeping low the incidence of peri-implant mucositis as well as in controlling plaque accumulation and clinical attachment loss ",
"OBJECTIVE Colgate Total toothpaste has been demonstrated to be highly effective in plaque and gingivitis control . The effect of triclosan on root caries and on the survival of dental crowns ( fixed dental prosthetic treatment ) has not been evaluated . In order to examine these important variables , a r and omized controlled clinical trial was conducted comparing Colgate Total toothpaste with triclosan , and an identical fluoride toothpaste without triclosan . METHODS Adult subjects were r and omly assigned to a test group using Colgate Total plus Whitening toothpaste with triclosan , and a control group using Colgate sodium fluoride toothpaste without triclosan . By the end of the study , following three years of product use , an evaluation was performed to compare baseline data to the three-year data for root caries and dental crown survival . Clinical root caries was evaluated by the Katz RCI- Root Caries Index . Within-treatment analysis for each dentifrice was conducted using a paired t-test . Between-treatment analysis was performed using Analysis of Covariance ( ANCOVA ) . For fixed dental prosthetic treatment evaluation , dental crowns were dichotomized for success and failure at the end of the study . Within-treatment analysis for each dentifrice was conducted using a paired t-test . Between-treatment analysis was performed using the Bonferroni test . RESULTS One-thous and , three-hundred , and fifty-seven subjects ( 1,357 ) completed the study . Regarding root caries , at termination of the study the Colgate Total group presented a mean score of 1.14 + /- 1.75 and a + 5.6 % change from baseline , while the sodium fluoride toothpaste presented a mean of 1.25 + /- 1.88 and a + 43.2 % change from baseline ( p adjusted mean root caries increment was 0.07 + /- 0.03 for the Colgate Total group , and 0.38 + /- 0.03 for the sodium fluoride toothpaste group ( p crowns , at termination of the study the Colgate Total group presented a mean score of 5.38 + /- 3.70 and a + 1.1 % change from baseline , while the sodium fluoride toothpaste without triclosan presented a mean of 5.75 + /- 3.86 and a + 3.8 % change from baseline ( p for multiple comparisons ) dental crowns failure increment was 0.09 + /- 0.03 for the Colgate Total group , and 0.31 + /- 0.02 for the sodium fluoride toothpaste group ( p root caries and dental crown failure scores , both favoring the triclosan toothpaste ( Colgate Total ) . The significantly lower root caries and observed dental crown failure scores among the Colgate Total toothpaste users indicate an effect of the triclosan and the copolymer system . These results are important and could provide a strong and valuable public health measure",
"STATEMENT OF PROBLEM The diagnostic value of radiographs for interproximal caries detection on nonrestored teeth is well investigated . However , little is known about the use of radiographs in the diagnosis of secondary caries localized at crown margins . PURPOSE The aim of this study was to correlate clinical findings with regard to secondary caries with the findings of a radiographic evaluation . MATERIAL S AND METHODS One hundred r and omly selected patients who underwent restorations with fixed prostheses and were exhibiting at least one secondary carious lesion were included in the study . A total of 820 restorations ( test group , 730 interproximal surfaces of 365 single crowns and 910 interproximal surfaces of 455 fixed partial denture retainer crowns ) and 1024 interproximal surfaces of 512 nonrestored teeth ( control group ) were investigated clinical ly , with the use of modified California Dental Association criteria , and radiographically for interproximal carious lesions . The extension of the lesions was rated to be initial ( with no cavitation ) , early ( with cavitation limited to orthodentin ) , or deep ( with cavitation ) . The data were statistically analyzed for normal distribution , and the frequency of the findings was calculated in absolute numbers and as a percentage . Statistically significant differences were determined by use of the chi(2 ) test ( P percentage of secondary caries and the duration of the crowns in situ . RESULTS Secondary caries was diagnosed clinical ly in 11.2 % of 1640 interproximal surfaces but only in 8.3 % radiographically . In contrast , the frequency of interproximal carious lesions diagnosed clinical ly in nonrestored teeth increased with the use of radiographs from 3.3 % to 4.1 % . CONCLUSION Within the limits of this study , the results confirm that radiographs improve the diagnostic sensitivity for interproximal caries in nonrestored teeth . However , for the diagnosis of secondary caries in crowned teeth , the clinical examination is more reliable than the radiographic evaluation",
"PURPOSE This prospect i ve study evaluated the influence of self-reported prosthesis hygiene regimens and prosthesis usage habits on the presence of oral mucosal lesions ( OMLs ) in complete removable and /or partial removable dental ( CRDP/PRDP ) prosthesis wearers ( PWs ) . MATERIAL S AND METHODS Between January 2009 and January 2011 , the conventional oral mucosa of 400 consecutive PWs ( 252 women ; 148 men ) , aged between 29 and 86 years , were examined clinical ly . Information was derived considering the type and age of the prosthesis , hygiene level , frequency and style of prosthesis cleaning , overnight prosthesis use , storage conditions , and systemic diseases . Non-prosthesis- and prosthesis-related OMLs were identified . The data were analyzed using univariate ( Chi-square ) and multivariate ( logistic regression ) tests to assess the development of OMLs as a function of the selected variables . Odds ratios ( OR ) were calculated at 95 % confidence intervals ( CI ; α = 0.05 ) . RESULTS Of the 400 PWs , 21.5 % had CRDP , 52.5 % PRDP , and 25.8 % CRD/PRD prostheses . Thirty-two percent of the PWs cleaned their prosthesis once a day . Brushing the prosthesis with toothbrush and soap/toothpaste was the most commonly practice d cleaning regimen ( 85.8 % ) . More than half ( 64.5 % ) of the PWs used their prosthesis overnight . Among all PWs , 37.8 % had a prosthesis-related OML . Stomatitis Newton Type II ( 46 % ) and Type III ( 38 % ) were the most common OMLs . OML frequency was higher in PWs having CRDPs than those having PRDPs ( p 0.05 ) . Overnight prosthesis use ( p = 0.003 , OR : 13.65 ; 95 % CI : 1.7 - 109.3 ) , denture age ≥11 years ( p = 0.017 , OR : 1.72 ; 95 % CI : 1.1 - 2.7 ) , and immersion in water and solution ( p = 0.023 , OR : 1.13 ; 95 % CI : 0.02 - 1.02 ) affected the incidence of OML significantly . Hypertension was the most common systemic disease ( 31.5 % ) . CONCLUSION Overnight use , denture age , and storage conditions of CRDP or PRDPs demonstrated a more significant impact on OML incidence than frequency of cleaning . Oral healthcare programs for removable PWs should specifically provide education on prosthesis usage instructions",
"OBJECTIVE To determine the effects of a 0.2 % alcohol-free chlorhexidine mouthwash applied twice a day during 30 days in patients over 65 years of age . MATERIAL S AND METHODS A r and omized , double-blind , placebo-controlled study was made of 70 denture wearers over 65 years of age . The study subjects were r and omly assigned to one of the two groups ( chlorhexidine or placebo ) . The patients were instructed to complete a first whitening phase with a duration of 1 week , followed by a 30-day treatment period . The following data were collected : Silness and Löe plaque index , gingival index , the number of colony-forming units of C and ida albicans at the start and end of treatment and the possible adverse effects of chlorhexidine . RESULTS Significant differences were observed in the evolution of the Silness and Löe plaque index and gingival index in the two groups , as well as in the number of colony-forming units of C. albicans between the start and end of treatment . CONCLUSIONS These results suggest that the clinical benefits of antiplaque , antigingivitis mouthrinses in both study groups",
"OBJECTIVE To compare a supervised versus a non-supervised implementation of an oral health care guideline in Fl and ers ( Belgium ) . BACKGROUND The key factor in realising good oral health is daily oral hygiene care . In 2007 , the Dutch guideline ' Oral health care in care homes for elderly people ' was developed to improve oral health of institutionalised elderly . MATERIAL S AND METHODS A r and om sample of 12 nursing homes was r and omly allocated to the intervention or the control group . Representative sample s of 30 residents in each home were monitored during a 6-month study period . The intervention included a supervised implementation of the guideline . RESULTS At the 6-month follow-up , only a small but statistically significant ( p = 0.002 ) beneficial effect ( 0.32 ) of the intervention was observed for denture plaque after adjustment for baseline value and the r and om effect of the institution . In the linear mixed regression models , including a r and om institution effect , difference in denture plaque level was no longer statistically significant at the 5 % level . CONCLUSION Only denture hygiene has been improved by the supervised implementation , although with lower benefits than presumed . Factors on institutional level , difficult to assess quantitatively , may play an important role in the final result",
"OBJECTIVE The objective of the present clinical study was to assess the effect of the use of a dentifrice containing triclosan on peri-implant mucositis in subjects that had been restored with dental implants . METHODS The trial was design ed as a double-blind , r and omized , two-treatment , parallel-group clinical study . Sixty male and female subjects , aged 30 - 70 years , were recruited . All subjects had lost teeth due to periodontal disease , and had been restored with a minimum of two implants at least one year prior to the start of the trial . Subjects were r and omly assigned to two treatment groups . The subjects in the test group ( Test ) brushed their teeth and implant-supported restorations with a dentifrice containing triclosan , while the control subjects brushed with a sodium fluoride dentifrice . Only subjects with a minimum of one implant site showing clinical signs of peri-implant mucositis , i.e. , bleeding after probing , were enrolled in the study . Clinical examinations were performed at baseline , and after three and six months . The following parameters were scored : Probing pocket depth ( PPD ) , bleeding on probing ( BoP ) , and plaque . The change from baseline within each treatment group at three months and six months was evaluated for all parameters using ANOVA and ANCOVA . RESULTS Subjects with peri-implant mucositis who used a dentifrice containing 0.3 % triclosan , as an adjunct to mechanical tooth brushing , exhibited significantly fewer clinical signs of inflammation than subjects who used a regular fluoride dentifrice at six months . The BoP scores were reduced from 53.8 % to 29.1 % in the Test group , whereas in the same interval there was an increase from 52.3 % to 58.8 % in the Control group . Furthermore , the individual mean PPD , as well as the frequency of sites with 5 mm and > or = 6 mm deep pockets , were reduced significantly more in the Test than in the Control group . CONCLUSION The regular use of a dentifrice containing triclosan may reduce the clinical signs of inflammation in the mucosa adjacent to dental implants",
"The safety , efficacy and acceptability of an oscillating/rotating powered toothbrush was assessed in patients rehabilitated with fixed prostheses on implants . One hundred consecutive patients ( aged 18–80 ; mean 56.3 ; 51 females ) , who met the inclusion /exclusion criteria and who participated in a regular annual recall scheme , were enrolled . They were instructed on how to use the powered toothbrush , as well as on classical interdental plaque control . The electric toothbrush had to be used twice daily for 2 min . The following periodontal parameters were measured at baseline and at 3 months , 6 months and 12 months : presence/absence of gingival and /or mucosal ulceration/desquamation ; sulcus bleeding index ; probing pocket depth ; periodontal pocket-bleeding index and gingival recession . At 3 months and at the end of the study , patients completed a question naire concerning the overall acceptability and convenience of the powered toothbrush , as compared with their habitual manual toothbrush . A total of 80 patients completed the study . No dropouts were related to the use of the powered toothbrush . All parameters improved over the course of the study . The mean overall pocket depth decreased from 3.3 mm at baseline to 3.0 mm at 12 months , while the mean decrease in recession was 0.1 mm at 12 months . During the 1-year observation , there was a slight gain in periodontal attachment level . Gingival ulcerations were not observed at any point in the study . High scores for convenience and comfort of the powered toothbrush were reported , and the majority ( 95 % ) said that they would continue to use it for habitual oral hygiene . It is concluded that the powered toothbrush investigated is effective , safe and comfortable for patients rehabilitated by means of oral implant-supported prostheses",
"Root caries is prevalent in elderly disabled nursing home residents in Denmark . This study aim ed to compare the effectiveness of tooth brushing with 5,000 versus 1,450 ppm of fluori date d toothpaste ( F-toothpaste ) for controlling root caries in nursing home residents . The duration of the study was 8 months . Elderly disabled residents ( n = 176 ) in 6 nursing homes in the Copenhagen area consented to take part in the study . They were r and omly assigned to use one of the two toothpastes . Both groups had their teeth brushed twice a day by the nursing staff . A total of 125 residents completed the study . Baseline and follow-up clinical examinations were performed by one calibrated examiner . Texture , contour , location and colour of root caries lesions were used to evaluate lesion activity . No differences ( p values > 0.16 ) were noted in the baseline examination with regards to age , mouth dryness , wearing of partial or full dentures in one of the jaws , occurrence of plaque and active ( 2.61 vs. 2.67 ; SD , 1.7 vs.1.8 ) or arrested lesions ( 0.62 vs. 0.63 ; SD , 1.7 vs. 1.7 ) between the 5,000 and the 1,450 ppm fluoride groups , respectively . Mean numbers of active root caries lesions at the follow-up examination were 1.05 ( 2.76 ) versus 2.55 ( 1.91 ) and mean numbers of arrested caries lesions were 2.13 ( 1.68 ) versus 0.61 ( 1.76 ) in the 5,000 and the 1,450 ppm fluoride groups , respectively ( p < 0.001 ) . To conclude , 5,000 ppm F-toothpaste is significantly more effective for controlling root caries lesion progression and promoting remineralization compared to 1,450 ppm F-toothpaste",
"BACKGROUND There is a lack of clinical studies on the self-aligning attachment system ( Locator(R ) ; Zest Anchors , Inc. homepage , Escondido , CA , USA ) for two-implant-retained overdentures in the edentulous m and ible . Therefore , a comparison of the Locator with two traditional design s ( a rotational gold matrix and a rubber O-ring type ) in clinical 1-year use was conducted . MATERIAL S AND METHODS From 2003 to 2007 , 60 patients received two Osseotite(R ) TG St and ard implants ( BIOMET 3i Implant Innovations , Palm Beach Gardens , FL , USA ) in the intraforaminal area of the edentulous m and ible . The implants were left unloaded for 3.5 months , r and omized to three different attachment systems , and loaded through a m and ibular overdenture . Twenty-three patients received a self-aligning attachment system ( Locator ) and 33 patients a ball attachment ( Dal-Ro(R)[BIOMET 3i Implant Innovations]n = 25 ; TG-O-Ring(R)[Cendres & Metaux SA , Biel-Bienne , Switzerl and ] n = 8) . After 12 months of delivery of the overdentures , the oral situation was evaluated : prosthodontic maintenance and biologic complications , subjective patients ' experience , and oral health-related life quality ( Oral Health Impact Profile [ OHIP-G 49 ] ) . RESULTS After 1-year of clinical service , 8 of 120 implants were lost ( 9.6 % ) . The Locator system brought up 34 prosthetic complications , especially the need for change of the male parts or activation because of loss of retention . The TG-O-Ring patients showed 14 complications , most of them the change of the O-Rings . The patients with the Dal-Ro abutment had seven minor complications in 12 months of clinical use . Biologic complications and patients ' oral health-related life quality showed no significant difference among the three experimental groups . CONCLUSIONS Prosthodontic maintenance was restricted to loss of retention for all systems . Within the observation period of this study , the self-aligning attachment system showed a higher rate of maintenance than the ball attachments . The patients ' oral health-related life qualities as well as the biologic parameters do not differ when using the three abutment systems",
"PURPOSE To evaluate telescopic crown ( TC ) , bar , and locator attachments used in removable four implant-supported overdentures for patients with edentulous maxillae . MATERIAL S AND METHODS A total of 30 maxillary edentulous patients were enrolled in a 3-year prospect i ve study . Ten patients ( group A ) were treated with overdentures supported by TCs , 10 patients ( group B ) with overdentures supported by bar attachments , and 10 patients ( group C ) with overdentures supported by locator attachments . A total of 120 implants were used to restore oral function . During the 3-year follow-up period , implant survival and success rates , biologic and mechanical complications , prosthodontic maintenance efforts , and patient satisfaction were evaluated . RESULTS All 30 patients were available for the 3-year follow-up and exhibited 100 % implant survival and success rates . Peri-implant marginal bone resorption was not statistically significant for the three groups . There were lower plaque , bleeding , gingiva , and calculus indices in group C compared with groups A and B. The number of prosthodontic maintenance visits revealed eight complications in the TC group , seven complications in the bar group , and four complications in the locator group . However , there were no differences in the clinical effects of the overdentures in the three groups . CONCLUSION Within the limits of this prospect i ve study , it was concluded that the locator system produced superior clinical results compared with the TC and bar attachments in terms of peri-implant hygiene parameters , the frequency of prosthodontic maintenance measures , cost , and ease of denture preparation . However , longer-term prospect i ve studies are required to confirm these results"
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OBJECTIVE To evaluate the effects of high-intensity interval training ( HIIT ) , in comparison with those of continuous exercise , on functional capacity and cardiovascular variables in patients with COPD , through a systematic review and meta- analysis of r and omized controlled trials . METHODS We search ed PubMed , the Physiotherapy Evidence Data base , the Cochrane Central Register of Controlled Trials , and EMBASE , as well as performing h and search es , for articles published up through January of 2017 . We included studies comparing exercise regimens of different intensities , in terms of their effects on functional capacity and cardiovascular variables in patients with COPD . RESULTS Of the 78 articles identified , 6 were included in the systematic review and meta- analysis . Maximal oxygen consumption ( VO2max ) did not differ significantly between HIIT and control interventions . That was true for relative VO2max ( 0.03 mL/kg/min ; 95 % CI : -3.05 to 3.10 ) and absolute VO2max ( 0.03 L/min , 95 % CI : -0.02 to 0.08 ) . CONCLUSIONS The effects of HIIT appear to be comparable to those of continuous exercise in relation to functional and cardiovascular responses . However , our findings should be interpreted with caution because the studies evaluated present a high risk of bias , which could have a direct influence on the results
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"Limited information is available regarding the physiological responses to different types of exercise training in patients with severe chronic obstructive pulmonary disease ( COPD ) . The aim of this study was two fold : firstly , to investigate the physiological response to training at 60 % of achieved peak load in patients with severe COPD ; and secondly to study the effects of interval ( I ) versus continuous ( C ) training in these patients . Twenty-one patients with COPD ( mean+/-SD forced expiratory volume in one second : 37+/-15 % of predicted , normoxaemic at rest ) were evaluated at baseline and after 8 weeks ' training . Patients were r and omly allocated to either I or C training . The training was performed on a cycle ergometer , 5 days a week , 30 min daily . The total work load was the same for both training programmes . C training result ed in a significant increase in oxygen consumption ( V'O2 ) ( 17 % , p minute ventilation (V'E)/V'O2 ( p dioxide production ( V'CO2 ) ( p lactic acid production , being most pronounced in the C-trained group ( -31 % , p peak work load ( 17 % , p leg pain ( p lung function , but maximal inspiratory mouth pressure increased in both groups by 10 % ( C : p interval or continuous training in chronic obstruction pulmonary disease , which might be a reflection of specific training effects in either oxidative or glycolytic muscle metabolic pathways . Further work is required to determine the role of the different exercise programmes and the particular category of patients for whom this might be beneficial",
"Abstract Objective : The aim of this study was to investigate the effects of moderate continuous training ( MCT ) and high intensity aerobic interval training ( AIT ) on systolic ventricular function and aerobic capacity in COPD patients . Methods : Seventeen patients with COPD ( 64 ± 8 years , 12 men ) with FEV1 of 52.8 ± 11 % of predicted , were r and omly assigned to isocaloric programs of MCT at 70 % of max heart rate ( HR ) for 47 minutes ) or AIT ( ∼90 % of max HR for 4 × 4 minutes ) three times per week for 10 weeks . Baseline cardiac function was compared with 17 age- and sex-matched healthy individuals . Peak oxygen uptake ( VO2-peak ) and left ( LV ) and right ventricular ( RV ) function examined by echocardiography , were measured at baseline and after 10 weeks of training . Results : At baseline , the COPD patients had reduced systolic function compared to healthy controls ( p the training , AIT and MCT increased VO2-peak by 8 % and 9 % and work economy by 7 % and 10 % , respectively ( all p both improved ( p training . Stroke volume increased by 17 % and 20 % , LV systolic tissue Doppler velocity ( S ’ ) by 18 % and 17 % and RV S ’ by 15 % after AIT and MCT , respectively ( p Conclusion : Systolic cardiac function is reduced in COPD . Both AIT and MCT improved systolic cardiac function . In contrast to other patient groups studied , higher exercise intensity does not seem to have additional effects on cardiac function or aerobic capacity in COPD patients",
"Context Exercise training improves quality of life in patients with chronic obstructive pulmonary disease , but many of these patients can not tolerate continuous exercise . The effects of intermittent exercise are not known . Contribution The authors r and omly assigned 100 in patients with chronic obstructive pulmonary disease in a 3-week respiratory rehabilitation program to receive either high-intensity continuous exercise or high-intensity exercise alternating with low-intensity exercise ( interval exercise ) . After 5 weeks , the 2 groups had similar respiratory symptoms in daily activities and 6-minute walking distance , but the interval exercise group adhered better to the exercise protocol . Caution s The study focused on initiation of exercise and not on outpatient or home-based maintenance of exercise . Implication s For pulmonary rehabilitation , interval exercise is as effective as continuous high-intensity exercise and is better tolerated . The Editors Low exercise capacity is an important systemic manifestation of advanced chronic obstructive pulmonary disease ( COPD ) associated with poor health-related quality of life , exacerbations , and death ( 14 ) . Physical exercise , therefore , represents an important element of COPD management ( 5 , 6 ) . If performed under supervision during respiratory rehabilitation , exercise training improves health-related quality of life and may improve prognosis ( 79 ) . Dyspnea and leg fatigue limit the ability of patients with COPD to exercise , and patient response to exercise is highly variable ( 10 ) . It is challenging to find endurable exercise programs that are still effective . Current guidelines recommend endurance exercise at constant and high intensity ( 70 % of maximum exercise capacity ) ( 11 , 12 ) . For example , if a patient achieves 100 watts in an incremental exercise test , workload would be set at 70 watts for the entire exercise session of at least 20 minute 's duration . Strong evidence from r and omized trials shows that patients achieve clinical ly important improvements of health-related quality of life and exercise capacity with a continuous exercise protocol ( 1316 ) . However , patients with severe COPD are often unable to tolerate continuous exercise ( 17 ) , which can be frustrating for them and can limit their long-term adherence to exercise programs . Effective alternatives to continuous exercise are required to offer this important intervention to more patients with COPD . The American Thoracic Society and the European Respiratory Society state , on the basis of 2 r and omized trials ( 18 , 19 ) , that interval exercise may be an alternative . The benefits of interval exercise may be similar to those of continuous training , but this method is associated with less dyspnea ( 11 , 12 ) . Although studies indicated that interval exercise is well tolerated ( 1821 ) , evidence about its effectiveness relative to continuous exercise is inconclusive ; previous trials had method ological limitations and were small ( 22 ) . Because of perceived better tolerability of interval exercise , r and omized trials should be explicitly design ed to show that interval exercise is no less effective ( clinical noninferiority ) ( 22 ) . Thus , the aim of our trial was to assess whether interval exercise is no less effective than high-intensity continuous exercise in patients with severe COPD and whether patient tolerance of the interval exercise protocol is superior to that of continuous exercise . Methods Design Overview We conducted a r and omized , controlled noninferiority trial to compare the effects of interval exercise with those of high-intensity continuous exercise in patients with severe COPD . We previously described the detailed study protocol ( 23 ) and report this trial following the recommendations of the extended Consoli date d St and ards of Reporting Trials ( CONSORT ) statement for noninferiority and equivalence trials ( 24 ) . Setting The trial took place in a public rehabilitation clinic , Klinik Barmelweid , in Aargau , Switzerl and . The ethics committee of the Kantonsspital Aarau , Aargau , Switzerl and , approved the study protocol , and all study participants provided written informed consent . Participants We screened patients admitted to the respiratory medicine unit and included consecutive patients following inclusion criteria similar to those of previous respiratory rehabilitation trials ( 7 ) : COPD as defined by FEV1FVC ratio less than 70 % of predicted , FEV1 less than 50 % of predicted after bronchodilation corresponding to Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) stage III to IV ( 5 ) , and German as first or daily language . Exclusion criteria included cardiovascular , musculoskeletal , or neurologic disorders that inhibited physical exercise or the performance of exercise tests ( 6 ) . We also excluded patients who had received a diagnosis of cancer ( excluding skin cancer ) within the past 2 years and were undergoing treatment . R and omization and Interventions A third party not involved in the execution of the trial ( DatInf GmbH , Tuebingen , Germany ) provided online central r and omization using a computerized minimization procedure , thereby ensuring concealment of r and omization ( 25 ) . Stratification variables were exercise capacity ( 6-minute walking distance presence of affective disorders ( Hospital Anxiety Depression Scale scores stability of pulmonary condition ( stable or exacerbation within the last 8 weeks ) , and the need for oxygen at rest ( Pao 2 55 mm Hg ) . Patients followed an inpatient respiratory rehabilitation of approximately 3 week 's duration that included 12 to 15 exercise sessions . On weekdays , patients usually participated in 1 exercise session . Twelve physical therapists worked with an approximately equal number of patients from both treatment groups . Apart from exercise , the rehabilitation program was identical for both groups and included breathing therapy , relaxation therapy , guided walking tours , and patient education ( 23 ) . At discharge , physiotherapists prescribed home-based exercise for each patient . Patients with cycle ergometers at home were instructed to exercise for at least 20 minutes per day . If no cycle ergometers were available , daily walking , swimming , or stair climbing was prescribed . High-Intensity Continuous Exercise Patients r and omly assigned to this intervention exercised on electromagnetically braked cycle ergometers ( Ergometrics 900S , Ergoline , Bitz , Germany ) with a target workload of 70 % or more of maximum exercise capacity ( Figure 1 ) . This exercise protocol has been used in earlier respiratory rehabilitation trials ( 7 ) . To determine maximum exercise capacity , patients pedaled unloaded for 3 minutes at 20 watts to warm up . Then , we used increments of 7.5 watts per minute until patients had to stop because of symptoms or cardiovascular stopping criteria . In each exercise session , patients completed a warm-up period of 2 minutes at 20 % of maximum exercise capacity , high-intensity exercise for 20 minutes , and a run-out phase of 2 minutes ( gradual decrease from 70 % to 0 % ) . If patients could not sustain the workload because of perceived dyspnea ( modified Borg [ 26 ] ratings > 5 on a scale from 0 to 10 ) or because heart rate exceeded safety limits , physical therapists let patients rest for 1 minute before continuing in the assigned phase . If patients had to rest more than twice per session , physical therapists lowered the workload by steps of 10 % of baseline maximum exercise capacity for the following exercise sessions . If workload was too low ( modified Borg ratings workload by steps of 10 % of baseline maximum exercise capacity . Figure 1 . Exercise protocol s. Interval Exercise The target workload for this group was 50 % ( high-intensity intervals ) and 10 % ( low-intensity intervals ) of short-term maximum exercise capacity as determined by a steep ramp test ( 27 , 28 ) . The steep ramp test is an incremental cycle ergometer test in which patients pedal cycle ergometers unloaded for 2 minutes and then at increments of 25 watts every 10 seconds until they can not maintain a pedaling frequency above 50 pedals per minute or their heart rate exceeds the limit set by the normal incremental exercise test . We used the steep ramp test because workload for interval exercise can be underestimated if it is based on normal incremental exercise tests ( 28 ) . Fifty percent of short-term maximum exercise capacity corresponds , on average , to 90 % to 100 % of normal maximum exercise capacity ( 27 ) . We chose a workrecovery ratio of 1:2 that prevents high lactate accumulation and is well tolerated by patients ( 28 ) . In each session , patients had a warm-up period of 2 minutes at 10 % of the short-term maximum exercise capacity and then exercised for 20 minutes alternating between high-intensity intervals for 20 seconds and low-intensity intervals for 40 seconds ( Figure 1 ) . Patients also had a slowdown period of 2 minutes before completing the training session . We adjusted the exercise load for each patient individually if workload was too high or too low as described earlier ; physiotherapists lowered or increased the workload by steps of 10 % of short-term maximum exercise capacity , but the length of intervals remained constant ( 23 ) . Outcomes and Measurements Our primary outcome for effectiveness was the difference from baseline in Chronic Respiratory Question naire ( CRQ ) scores 5 weeks after r and omization as measured by the self-administered German- language version ( 29 , 30 ) with st and ardized dyspnea questions ( 31 ) . The CRQ is a widely used instrument in respiratory rehabilitation and measures dyspnea , fatigue , emotional functioning , and ability to cope with COPD ( 7 , 32 ) . Domain and total ( average of domains ) scores are presented on a Likert-type scale from 1 ( most severe impairment ) to 7 ( no impairment ) . We selected assessment at 5 weeks after r and omization as the primary outcome",
"STUDY OBJECTIVES To compare the effectiveness of two forms of exercise training in pulmonary rehabilitation . DESIGN A prospect i ve , r and omized , unblinded , 8-week trial . SETTING A hospital-based outpatient pulmonary rehabilitation program . PATIENTS Forty patients ( 20 patients in each group ) with COPD who were referred for pulmonary rehabilitation . INTERVENTIONS We compared the short-term effectiveness of a high-intensity , lower-extremity endurance program with a low-intensity , multicomponent calisthenics program for the rehabilitation of patients with COPD . The high-intensity group trained predominately on the stationary bicycle and treadmill , with a goal of exercising at > or = 80 % of maximal level determined from incremental testing for 30 min per session . The low-intensity group performed predominately classroom exercises for approximately 30 min per session . For both groups , twice-weekly sessions were held for 8 weeks . The primary outcome measure was health status , measured using the Chronic Respiratory Disease Question naire . Other outcomes included peak oxygen consumption on incremental treadmill exercise testing , exertional dyspnea , treadmill endurance time , the number of sit-to-st and repetitions and arm lifts in 1 min , overall dyspnea , and question naire-rated functional status . MEASUREMENTS AND RESULTS Both groups showed significant postrehabilitation improvement in exercise variables , exertional and overall dyspnea , functional performance , and health status . Patients in the high-intensity group showed greater increases in treadmill endurance and greater reductions in exertional dyspnea , whereas those in the low-intensity group showed greater increases in arm-endurance testing . Both groups had similar improvements in overall dyspnea , functional performance , and health status . CONCLUSIONS Despite differences in exercise performance , both high-intensity , lower-extremity endurance training and low-intensity calisthenics led to similar short-term improvements in question naire-rated dyspnea , functional performance , and health status",
"PURPOSE The present study compared the effects of aerobic endurance training at different intensities and with different methods matched for total work and frequency . Responses in maximal oxygen uptake ( VO2max ) , stroke volume of the heart ( SV ) , blood volume , lactate threshold ( LT ) , and running economy ( CR ) were examined . METHODS Forty healthy , nonsmoking , moderately trained male subjects were r and omly assigned to one of four groups:1 ) long slow distance ( 70 % maximal heart rate ; HRmax ) ; 2)lactate threshold ( 85 % HRmax ) ; 3 ) 15/15 interval running ( 15 s of running at 90 - 95 % HRmax followed by 15 s of active resting at 70 % HRmax ) ; and 4 ) 4 x 4 min of interval running ( 4 min of running at 90 - 95 % HRmax followed by 3 min of active resting at 70%HRmax ) . All four training protocol s result ed in similar total oxygen consumption and were performed 3 d.wk for 8 wk . RESULTS High-intensity aerobic interval training result ed in significantly increased VO2max compared with long slow distance and lactate-threshold training intensities ( P V O2max from 60.5 to 64.4 mL x kg(-1 ) x min(-1 ) and 55.5 to 60.4 mL x kg(-1 ) x min(-1 ) . SV increased significantly by approximately 10 % after interval training ( P High-aerobic intensity endurance interval training is significantly more effective than performing the same total work at either lactate threshold or at 70 % HRmax , in improving VO2max . The changes in VO2max correspond with changes in SV , indicating a close link between the two",
"Underst and ing of what constitutes a training load adequate to induce training effects in patients with chronic obstructive pulmonary disease ( COPD ) is still evolving . The present study investigated whether interval training ( IT ) is effective in terms of inducing measurable improvements in physiological response and compared its effects on exercise tolerance ( ET ) and quality of life to those of continuous training ( CT ) . Thirty-six COPD patients , with a forced expiratory volume in one second of 45±4 % of the predicted value ( mean±sem ) , were r and omly assigned to CT ( exercise at 50 % of baseline peak work-rate ) or IT ( work for 30 s at 100 % of peak work-rate alternating with 30‐s rest intervals ) groups that cycled 40 min·day−1 and 2 days·week−1 for 12 weeks . After training , both groups showed significantly improved ET ( IT , 57±6 to 71±8 W ; CT , 57±5 to 70±6 W ) and total quality -of-life score of the Chronic Respiratory Disease Question naire ( IT , 77±3 to 88±2 ; CT , 78±3 to 93±2 ) . At identical levels of exercise , minute ventilation was significantly reduced ( IT , 35.8±2.5 to 31.7±2.5 L·min−1 ; CT , 36.4±2.7 to 32.5±2.7 L·min−1 ) . The magnitude of improvement in these variables was not significantly different among groups . The present data exp and on the principles of exercise prescription for chronic obstructive pulmonary disease patients by demonstrating that interval training elicits substantial training effects , which are similar in magnitude to those produced by continuous training at half the exercise intensity but double the exercise time",
"BACKGROUND AND OBJECTIVES The benefits of pulmonary rehabilitation for patients with COPD depend on the intensity of training . Traditional pulmonary rehabilitation programmes ( PRPs ) do not consistently achieve high-intensity training and have variable training effects . This study examined the effects of high-intensity exercise training on cardiac and pulmonary function in COPD patients . METHODS Patients with COPD participated in a 6-week , cardiopulmonary exercise test-based PRP . Spirometry , 6-min walking distance and cardiopulmonary exercise test were used to evaluate cardiopulmonary function , respiratory muscle strength and endurance at rest , during exercise and before and after the programme . Patients were encouraged to complete high-intensity exercise with a targeted training intensity of at least 75 % maximum oxygen uptake ( VO(2 ) ) . RESULTS Thirty-four COPD patients were enrolled into the study ; 16 completed the high-intensity training , 18 did not . At the end of the 12-session PRP , submaximal exercise capacity ( 6-min walking distance , 461.8 + /- 77.2 - 502.7 + /- 66.9 m , P FVC ( 2.47 + /- 0.70 - 2.70 + /- 0.62 L , P = 0.024 ) at rest , maximal exercise capacity ( peak VO(2 ) , 1001.6 + /- 286.4 - 1116.1 + /- 320.4 mL/min , P = 0.020 ) and work efficiency ( 7.3 + /- 1.4 - 8.4 + /- 1.8 mL/min/watt , P = 0.026 ) . There was no statistically significant difference between the two groups in the change in the physiological parameters before and after exercise . CONCLUSIONS Exercise training in a PRP improved submaximal exercise capacity . Only patients who completed high-intensity exercise training showed improvements in maximal exercise capacity , FVC and work efficiency",
"BACKGROUND Current literature lacks solid evidence on the improvement of heart rate variability ( HRV ) after exercise training in patients with COPD . OBJECTIVES We aim ed to investigate changes in HRV after two exercise training programs in patients with COPD and to investigate the determinants of these eventual changes . METHODS Forty patients with COPD ( FEV(1 ) 39 ± 13%pred ) were r and omized into high ( n = 20 ) or low ( n = 20 ) intensity exercise training ( 3-month duration ) , and had their HRV assessed by the head-up tilt test before and after either protocol s. Baseline spirometry , level of daily physical activity , exercise capacity , body composition , functional status , health-related quality of life and muscle force were also assessed to investigate the determinants of improvement in HRV after the training program . RESULTS There was a significant improvement in HRV only after the high-intensity protocol ( pre versus post ; SDNN 29 ± 15 ms versus 36 ± 19 ms ; rMSSD 22 ± 14 ms versus 28 ± 22 ms ; p Higher values of biceps brachialis strength , time spent walking in daily life and SDNN at baseline were determinants of improvement in HRV after the training program . CONCLUSIONS High-intensity exercise training improves HRV at rest and during orthostatic stimulus in patients with COPD . Better baseline total HRV , muscle force and daily physical activity level are predictors of HRV improvements after the training program ",
"Both interval ( IT ) and continuous ( CT ) exercise training results in an improvement of aerobic capacity in patients with chronic obstructive pulmonary disease ( COPD ) ; however , their effects on cardiac autonomic function remains unclear . The aim of our study was to evaluate the effect of a supervised CT vs IT on autonomic cardiac function in COPD patients",
"BACKGROUND : The effects of different exercise training programs on the level of physical activity in daily life in patients with COPD remain to be investigated . OBJECTIVE : In patients with COPD we compared the effects of 2 exercise/training regimens ( a high-intensity whole-body endurance- and -strength program , and a low-intensity calisthenics- and -breathing-exercises program ) on physical activity in daily life , exercise capacity , muscle force , health-related quality of life , and functional status . METHODS : We r and omized 40 patients with COPD to perform either endurance- and -strength training ( no. = 20 , mean ± SD FEV1 40 ± 13 % of predicted ) at 60–75 % of maximum capacity , or calisthenics- and -breathing-exercises training ( no. = 20 , mean ± SD FEV1 39 ± 14 % of predicted ) . Both groups underwent 3 sessions per week for 12 weeks . Before and after the training programs the patients underwent activity monitoring with motion sensors , incremental cycle-ergometry , 6-min walk test , and peripheral-muscle-force test , and responded to question naires on health-related quality of life and functional status ( activities of daily living , pulmonary functional status , and dyspnea ) . RESULTS : Time spent active and energy expenditure in daily life were not significantly altered in either group . Exercise capacity and muscle force significantly improved only in the endurance- and -strength group . Health-related quality of life and functional status improved significantly in both groups . CONCLUSIONS : Neither training program significantly improved time spent active or energy expenditure in daily life . The training regimens similarly improved quality of life and functional status . Exercise capacity and muscle force significantly improved only in the high-intensity endurance- and -strength group",
"PURPOSE The purpose of this study was to compare the effects of interval training ( IT ) and continuous steady-pace training ( CT ) in patients with COPD . METHODS Patients ( n = 21 ) ( mean forced expiratory volume in 1 second ( [ FEV1 ] = 44.6 % ± 13.9 % ) were r and omized to IT , and 20 patients ( mean FEV1 = 41.7 % ± 12.6 % ) to CT . Outcome measures included 6-minute walk distance , maximal work capacity , endurance exercise time during constant workload exercise at 60 % to 70 % of maximal work capacity , and quality of life including fatigue and dyspnea . Participants exercised 3 times per week for 8 weeks , and total work was the same for both training regimens . RESULTS Significant improvement in mean score was observed in each variable within each of the 2 groups : 6-minute walk distance ( IT = 158 ± 178 ft , CT = 106 ± 165 ft ) ; maximal work capacity ( IT = 10.0 ± 13.0 W , CT = 11.5 ± 13.1 W ) ; endurance exercise time ( IT = 15.0 ± 12.5 minutes , CT = 18.7 ± 10.6 minutes ) ; and quality of life domains , fatigue ( IT = 3.1 ± 3.0 , CT = 2.8 ± 4.7 ) , and dyspnea ( IT = 4.4 ± 5.3 , CT = 5.4 ± 5.1 ) . There was no significant difference in the extent of improvement between the 2 training regimens for any of the outcome variables . CONCLUSION Compared with CT , IT was well tolerated and produced similar improvements in exercise performance and quality of life ",
"STUDY OBJECTIVES To investigate the response to interval exercise ( IE ) training by looking at changes in morphologic and biochemical characteristics of the vastus lateralis muscle , and to compare these changes to those incurred after constant-load exercise ( CLE ) training . DESIGN R and omized , controlled , parallel , two-group study ( IE vs CLE training ) . SETTING Multidisciplinary , outpatient , hospital-based , pulmonary rehabilitation program . PATIENTS Nineteen patients with stable advanced COPD ( mean + /- SEM FEV1 , 40 + /- 4 % predicted ) . INTERVENTIONS Patients ( n = 10 ) assigned to IE training exercised at a mean intensity of 124 + /- 15 % of baseline peak exercise capacity ( peak work rate [ Wpeak ] ) with 30-s work periods interspersed with 30-s rest periods for 45 min/d . Patients ( n = 9 ) allocated to CLE training exercised at a mean intensity of 75 + /- 5 % Wpeak for 30 min/d . Patients exercised 3 d/wk for 10 weeks . MEASUREMENTS AND RESULTS Needle biopsies of the right vastus lateralis muscle were performed before and after rehabilitation . After IE training , the cross-sectional areas of type I and IIa fibers were significantly increased ( type I before , 3,972 + /- 455 microm2 ; after , 4,934 + /- 467 microm2 [ p = 0.004 ] ; type IIa before , 3,695 + /- 372 microm2 ; after , 4,486 + /- 346 microm2 [ p = 0.008 ] ) , whereas the capillary-to-fiber ratio was significantly enlarged ( from 1.13 + /- 0.08 to 1.24 + /- 0.07 [ p = 0.013 ] ) . Citrate synthase activity increased ( from 14.3 + /- 1.4 to 20.5 + /- 4.2 micromol/min/g ) , albeit not significantly ( p = 0.097 ) . There was also a significant improvement in Wpeak ( by 19 + /- 5 % ; p = 0.04 ) and in lactate threshold ( by 17 + /- 5 % ; p = 0.02 ) . The magnitude of changes in all the above variables was not significantly different compared to that incurred after CLE training . During training sessions , however , ratings of dyspnea and leg discomfort , expressed as fraction of values achieved at baseline Wpeak , were significantly lower ( p IE training ( 73 + /- 9 % and 60 + /- 8 % , respectively ) compared to CLE training ( 83 + /- 10 % and 87 + /- 13 % , respectively ) . CONCLUSIONS High-intensity IE training is equally effective to moderately intense CLE training in inducing peripheral muscle adaptations ; however , IE is associated with fewer training symptoms",
"The aim of this study was to compare the effects of interval training ( 3-min intervals ) with continuous training on peak exercise capacity ( W peak ) , physiological response , functional capacity , dyspnoea , mental health and health-related quality of life ( HRQoL ) in patients with moderate or severe COPD . Sixty patients exercised twice weekly for 16 weeks after r and omisation to interval- or continuous training . Target intensity was 80 % of baseline W peak in the interval group ( I-group ) and 65 % in the continuous group ( C-group ) . Patients were tested by spirometry , ergometer cycle test , cardiopulmonary test and a 12 min walk test . Dyspnoea was measured by the dyspnoea scale from Chronic Obstructive Disease Question naire ( CRDQ ) , mental health by Hospital Anxiety and Depression scale ( HAD ) and HRQoL by the Medical Outcomes Survey Short Form 36 ( SF-36 ) . After training , W peak , peak oxygen uptake ( VO(2 ) peak ) and exhaled carbon dioxide ( VCO(2 ) peak ) increased significantly in both groups , no significant differences between the groups . Minute ventilation ( V(E ) peak ) increased only in the C-group . At identical work rates ( isotime ) VO(2 ) , VCO(2 ) and V(E ) were significantly more decreased in the I-group than in the C-group ( p Functional capacity , dyspnoea , mental health , and HRQoL improved significantly in both groups , no difference between the groups . Interval training and continuous training were equally potent in improving peak exercise capacity , functional exercise capacity , dyspnoea , mental health and HRQoL in patients with moderate or severe COPD . At isotime , the physiological response to training differed between the groups , in favour of the interval training",
"UNLABELLED In a controlled/ prospect i ve clinical trial we examined 125 patients with moderate COAD , 84 of which performed a high-intensity training program on cycle ergometers . METHODS All participants ( controls n = 39 , training-group n = 84 , age 48.7 versus 48.1 years , FEV1 62.3 % vs. 63.1 % of predicted ) were examined spiroergometrically ( ramp protocol , increment 10 W/min ) , the anaerobic threshold ( AT ) determined and a training intensity calculated ( AT + 40 % of the difference to peak exercise ) . Training was carried out on cycle ergometers with 5 training units weekly at 40 minutes each . We aim ed at a minimum of 22 training units during 4 weeks . RESULTS Both groups improved in the lung function at rest ( FEV1 + 11 % versus + 12 % in the controls ) . Only for the training group we found a statistically significant improvement in maximum exercise capacity ( O2 uptake + 286.4 ml vs. + 72.4 ml , maximum workrate + 20.0 watts vs. + 5.7 W ) , of the anaerobic threshold ( AT improved by 8.4 watts vs. 5.1 W ) as well as in the metabolic load ( lactate decreased by 1.3 mmol vs. 0.2 mmol , ventilation decreased by 3.8 l/min vs. 2.3 l/min ) . In most subscales of the SF-36 question naire quality of living improved more clearly in the training group , whereas the LAQ question naire showed no group-specific differences and no improvement after training . CONCLUSION We conclude from the result that a high intensity training program can be recommended as a useful and low-risk component in pulmonary rehabilitation programs",
"OBJECTIVES Peak VO2 , as measure of physical performance is central to a correct preoperative evaluation in patients with both non-small-cell lung cancer ( NSCLC ) and chronic obstructive pulmonary disease ( COPD ) because it is closely related both to operability criteria and the rate of postoperative complications . Strategies to improve peak VO2 , as a preoperative pulmonary rehabilitation programme ( PRP ) , should be considered favourably in these patients . In order to clarify the role of pulmonary rehabilitation , we have evaluated the effects of 3-week preoperative high-intensity training on physical performance and respiratory function in a group of patients with both NSCLC and COPD who underwent lobectomy . METHODS We studied 40 patients with both NSCLC and COPD , age Patients were r and omly divided into two groups ( R and S ) : Group R underwent an intensive preoperative PRP , while Group S underwent only lobectomy . We evaluated peak VO2 in all patients at Time 0 ( T0 ) , after PRP/before surgery in Group R/S ( T1 ) and 60 days after surgery , respectively , in both groups ( T2 ) . RESULTS There was no difference between groups in peak VO2 at T0 , while a significant difference was observed both at T1 and T2 . In Group R , peak VO2 improves significantly from T0 to T1 : 14.9 ± 2.3 - 17.8 ± 2.1 ml/kg/min ± st and ard deviation ( SD ) , P S peak VO2 did not change from T0 to T1 and significantly deteriorates from T1 to T2 : 14.5 ± 1.2 - 11.4 ± 1.2 ml/kg/min ± SD , P CONCLUSIONS PRP was a valid preoperative strategy to improve physical performance in patients with both NSCLC and COPD and this advantage was also maintained after surgery",
"PURPOSE : The success of long-term exercise training ( ExT ) programs resides in the integration between exercise prescription and patient compliance with home training . One of the crucial issues for the patients is the underst and ing of appropriate exercise intensity . We compared 2 methods of home ExT , based on walking . METHODS : Forty-seven patients with chronic obstructive pulmonary disease were recruited and underwent respiratory function , exercise capacity evaluation with a 6-minute walk test , and treadmill tests . Physical activity was monitored by a multisensor Armb and ( SenseWear , Body Media , Pittsburgh , PA ) . Patients were r and omly assigned to 2 different home training methods and assessed again after 6 and 12 months ; group A1 : speed walking paced by a metronome , and group A2 : walking a known distance in a fixed time . RESULTS : Thirty-six patients completed the study . All subjects showed a significant improvement in the 6-minute walk test after 1 year but the improvement was higher in A1 than in A2 ( P Physical activity levels were significantly higher at T12 versus baseline only in group A1 ( P metronome to maintain the rate of walking during home ExT seems to be beneficial , allowing patients to achieve and sustain the optimal exercise intensity , and result ing in greater improvement compared to simply using a fixed time interval exercise",
"Background : Pulmonary rehabilitation ( PR ) programs are beneficial to patients with chronic obstructive pulmonary disease ( COPD ) , and lower-extremity training is considered a fundamental component of PR . Nevertheless , the isolated effects of each PR component are not well established . Objective : We aim ed to evaluate the effects of a cycle ergometry exercise protocol as the only intervention in a group of COPD patients , and to compare these results with a control group . Methods : 25 moderate-to-severe COPD patients were evaluated regarding pulmonary function , respiratory muscle strength , exercise capacity , quality of life and body composition . Patients were allocated to one of two groups : ( a ) the trained group ( TG ; n = 13 ; 6 men ) was su bmi tted to a protocol of 24 exercise sessions on a cycle ergometer , with training intensity initially set at a heart rate ( HR ) close to 80 % of maximal HR achieved in a maximal test , and load increase based on dyspnea scores , and ( b ) the control group ( CG ; n = 12 ; 6 men ) with no intervention during the protocol period . Results : TG showed within-group significant improvements in endurance cycling time , 6-min walking distance test , maximal inspiratory pressure and in the domain ‘ dyspnea ’ related to quality of life . Despite the within-group changes , no between-group significant differences were observed . Conclusion : In COPD patients , the results of isolated low-to-moderate intensity cycle ergometer training are not comparable to effects of multimodality and high-intensity training programs"
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BACKGROUND Atrial fibrillation ( AF ) is an increasingly prevalent condition in the ageing population , with significantly associated morbidity and mortality . Surgical and catheter ablative strategies both aim to reduce mortality and morbidity through freedom from AF . This review consoli date s all currently available comparative data to evaluate these two interventions . METHODS A systematic search was conducted across MEDLINE , PubMed , Embase , Cochrane Central Register of Controlled Trials and the Cochrane Data base of Systematic Review s from January 2000 until August 2013 . All studies were critically appraised and only those directly comparing surgical and catheter ablation were included . RESULTS Seven studies were deemed suitable for analysis according to the inclusion criteria . Freedom from AF was significantly higher in the surgical ablation group versus the catheter ablation group at 6-month , 12-month and study endpoint follow-up periods . Subgroup analysis demonstrated similar trends , with higher freedom from AF in the surgical ablation group for paroxysmal AF patients . The incidence of pacemaker implantation was higher , while no difference in stroke or cardiac tamponade was demonstrated for the surgical versus catheter ablation groups . CONCLUSIONS Current evidence suggests that epicardial ablative strategies are associated with higher freedom from AF , higher pacemaker implantation rates and comparable neurological complications and cardiac tamponade incidence to catheter ablative treatment . Other complications and risks were poorly reported , which warrants further r and omized controlled trials ( RCTs ) of adequate power and follow-up duration
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"Objective To assess the efficacy of video-assisted minimally invasive surgical vs. catheter ablation for the long-st and ing persistent AF . Methods We performed a retrospective comparative analysis in a series of 166 long-st and ing persistent AF patients treated between 2006 and 2009 with either video-assisted minimally invasive ablation ( 83 patients ) , or catheter ablations ( 83 patients ) . The catheter group was screened using a ‘ pair-matched case-control ’ methodology in order to select appropriate statistical comparison c and i date s out of 169 long-st and ing persistent AF patients which were potentially suitable for surgery , but have been treated with catheter approaches in order to balance major prognostic factors between the two groups . Follow-up for all patients ranged from 1 to 3.6 years . Results No patient died postoperatively . One patient suffered from stroke in the surgical group but recovered before discharge . Freedom from AF was obtained in 59.0 % and 74.7 % during follow-up in the catheter group and the surgical group respectively ( P = 0.047 ) . Patients in the catheter group had a significantly higher rate of recurrent arrhythmia ( P = 0.011 , hazard ratio : 0.555 , 95 % CI : 0.354 to 0.872 ) compared with the surgically treated group . The freedom from antiarrhythmic drugs was 44.6 % in the catheter group and 61.4 % in the surgical group ( P = 0.043 ) . Conclusions The video-assisted minimally invasive ablation was safe and effective , and had an optimistic success rate for patients with long-st and ing persistent AF in our retrospective comparative study . Thus , further r and omized studies addressing this issue seem to be justified",
"Background — Catheter ablation ( CA ) and minimally invasive surgical ablation ( SA ) have become accepted therapy for antiarrhythmic drug – refractory atrial fibrillation . This study describes the first r and omized clinical trial comparing their efficacy and safety during a 12-month follow-up . Methods and Results — One hundred twenty-four patients with antiarrhythmic drug – refractory atrial fibrillation with left atrial dilatation and hypertension ( 42 patients , 33 % ) or failed prior CA ( 82 patients , 67 % ) were r and omized to CA ( 63 patients ) or SA ( 61 patients ) . CA consisted of linear antral pulmonary vein isolation and optional additional lines . SA consisted of bipolar radiofrequency isolation of the bilateral pulmonary vein , ganglionated plexi ablation , and left atrial appendage excision with optional additional lines . Follow-up at 6 and 12 months was performed by ECG and 7-day Holter recording . The primary end point , freedom from left atrial arrhythmia > 30 seconds without antiarrhythmic drugs after 12 months , was 36.5 % for CA and 65.6 % for SA ( P=0.0022 ) . There was no difference in effect for subgroups , which was consistent at both sites . The primary safety end point of significant adverse events during the 12-month follow-up was significantly higher for SA than for CA ( n=21 [ 34.4 % ] versus n=10 [ 15.9 % ] ; P=0.027 ) , driven mainly by procedural complications such as pneumothorax , major bleeding , and the need for pacemaker . In the CA group , 1 patient died at 1 month of subarachnoid hemorrhage . Conclusion — In atrial fibrillation patients with dilated left atrium and hypertension or failed prior atrial fibrillation CA , SA is superior to CA in achieving freedom from left atrial arrhythmias after 12 months of follow-up , although the procedural adverse event rate is significantly higher for SA than for CA . Clinical Trial Registration — URL : http:// clinical trials.gov . Unique identifier : NCT00662701",
"BACKGROUND In our previous prospect i ve and r and omized study , we have demonstrated that the concomitant surgical ablation using saline-irrigated cooled tip radiofrequency ablation ( SICTRA ) system is more effective than subsequent circumferential pulmonary vein isolation ( CPVI ) combined with substrate modification in treating patients with long-st and ing persistent atrial fibrillation ( LS-AF ) and rheumatic heart disease ( RHD ) undergoing cardiac surgery during middle-term follow-up . Whether this strategy also decreases longer-term arrhythmia recurrence is unknown . This study describes the 4-year efficacy of SICTRA for these patients . Furthermore , we seek to compare the electrophysiological characteristics for recurrent atrial tachyarrhythmia ( ATa ) at the session of catheter ablation between two groups . METHODS Long-term follow-up was performed in 95 patients who underwent the catheter ablation strategy ( n=47 , Group A ) or SICTRA ( n=48 , Group B ) combined with valvular surgery for symptomatic LS-AF patients with RHD . RESULTS After one procedure , Group B had a significantly higher freedom from ATa compared with Group A ( 29/48 vs 15/47 , P=0.005 ) after a mean follow-up of 54 months ( range 48 to 63 months ) . Catheter-based mapping and ablation of recurrent ATa showed larger amounts of macro-reentrant atrial tachycardias ( ATs ) in Group B and higher incidence of pulmonary vein ( PV ) recovery in Group A. After multiple catheter ablations for recurrent ATa , sinus rhythm ( SR ) could be maintained equally between two groups . CONCLUSIONS Single procedure success seems to be higher with SICTRA but repeated catheter ablation potentially results in comparable outcomes in treating patients with LS-AF and RHD during long-term follow-up . More macro-reentrant ATs and more PV recoveries are identified to be responsible for ATa in SICTRA and catheter ablation group , respectively",
"Background —The Cox Maze procedure for treatment of medically refractory atrial fibrillation ( AF ) is limited by its complexity and requirement for cardiopulmonary bypass . Long-term follow-up and success using criteria established by the Heart Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society consensus statement have not been reported for surgical AF ablation . We describe the results of using a thorascopic approach and radiofrequency energy to perform bilateral pulmonary vein isolation and left atrial ganglionic plexi ablation for treatment of AF . Methods and Results —Forty-five ( 33 paroxysmal ; 12 persistent ) consecutive patients underwent thorascopic bilateral radiofrequency pulmonary vein isolation , ganglionic plexi ablation , ligament of Marshall ablation , and left atrial appendage exclusion by a single surgeon . Forty-three patients were prospect ively followed without antiarrhythmic drugs for a minimum of 1 year with a 30-day continuous event monitor or pacemaker interrogation at 6 and 12 months . Failure was defined as any atrial tachyarrhythmia of > 30 seconds ’ duration occurring > 90 days after surgery . Mean follow-up was 516±181 days ( 202 to 858 days ) . Twenty-eight ( 65 % ) patients had no atrial tachyarrhythmia > 30 seconds by 1 year , and 15 ( 35 % ) patients had atrial tachyarrhythmia recurrences by 1 year . Eight of 15 patients with recurrent AF had catheter ablation result ing in elimination and /or reduction of AF episodes in 7 of 8 patients . Four of 15 patients had AF elimination or reduction with antiarrhythmic drugs alone . Three patients did not benefit from surgery and received rate control only . There were no deaths ; 1 phrenic nerve injury and 2 pleural effusions were the only major complications . Conclusions —The single procedure success at 1-year follow-up for surgical pulmonary vein isolation and ganglionic plexi ablation is 65 % . Atrial tachyarrhythmia recurrences after surgery are usually responsive to catheter ablation and /or antiarrhythmic drugs ",
"Purpose Minimally invasive surgical ablation for atrial fibrillation ( AF ) has shown good results and low complications incidence . Our objective was to evaluate feasibility and efficacy of this technique in our center . Methods The procedure included pulmonary vein isolation , ganglionic plexi ablation , ligament of Marshall resection , and left atrial appendage exclusion through beating heart minimally invasive bilateral thoracotomies . Patients were monitored daily by telemedicine during the first 4 months and then by quarterly 24-h Holter monitoring or by implantable cardiac monitor . Ablation success was defined as freedom from any atrial tachyarrhythmia recurrence lasting more than 30 s and from antiarrhythmic drugs . All patients were followed up for a minimum of 12 months . Results Twenty-two consecutive patients with AF , paroxysmal in 27 % and persistent in 73 % , were treated . Mean age was 63 ± 10 years , 86 % were men . Seventy-three percent of patients had previously undergone to one or more catheter ablations . Median follow-up period was 22 months ( 25 ° –75 ° percentile , 20–27 ) . Patients free from any arrhythmia recurrence for at least 6 consecutive months discontinued antiarrhythmic therapy . Ablation was successful in 73 % of patients at 12 months . Freedom from AF recurrences independently from antiarrhythmic therapy status was 91 % at 12 months . Results were consistent in patients that reached 24 months follow-up . There were no deaths . Complications were : one conversion to sternotomy owing to thoracic adherences , one pacemaker implant , and one postoperative hemothorax requiring surgical revision . Conclusions Our results show that minimally invasive surgical ablation was feasible and gave satisfactory results at long-term term follow-up in patients with AF",
"AIMS Pulmonary vein isolation ( PVI ) can be considered for treatment of symptomatic atrial fibrillation ( AF ) . Nowadays , in addition to transcatheter ablation , thoracoscopic surgical PVI is available . The aim of this study is to compare clinical outcome of surgical with transcatheter PVI as first invasive treatment strategy of AF . METHODS AND RESULTS From June 2009 to November 2011 , 33 patients underwent minimally invasive surgical PVI , and were matched ( 1:2 fashion ) retrospectively according to age , sex , and AF type , with 66 patients who underwent transcatheter PVI . Success was defined as freedom from atrial arrhythmias on 24 h Holter monitoring without use of anti-arrhythmic drugs ( AADs ) at 1 year . Mean age was 52 ± 10 years , 82 % were male . Paroxysmal AF was present in 76 patients ( 77 % ) , persistent AF in 23 ( 23 % ) patients . None underwent prior ablations , and failed on 1.2 ± 0.6 AADs . At 12 months , complete freedom from atrial arrhythmias without AADs in the surgical PVI group was 88 % compared with 41 % in the transcatheter PVI group ( P was 91 vs. 62 % , in the surgical vs. transcatheter PVI group , respectively ( P = 0.002 ) . Complications occurred in seven ( 21 % ) surgical PVI patients , and three ( 5 % ) transcatheter PVI patients ( P = 0.015 ) . CONCLUSION In present matched study comparing a surgical with transcatheter PVI treatment strategy in symptomatic AF patients failed on AADs , but without prior ablations , a surgical PVI strategy was more effective to prevent recurrence of atrial arrhythmias , than a transcatheter PVI treatment strategy . However , complications were more frequent with surgical PVI",
"BACKGROUND Advances in technology such as epicardial bipolar radiofrequency pulmonary vein isolation , ganglionated plexi identification , and isolation and thoracoscopic left atrial appendage exclusion have enabled less invasive surgical options for management of atrial fibrillation . METHODS We performed a prospect i ve , nonr and omized study of consecutive patients with symptomatic paroxysmal atrial fibrillation undergoing a video-assisted , minimally invasive surgical ablation procedure . The procedure consisted of bilateral , epicardial pulmonary vein isolation with bipolar radiofrequency , partial autonomic denervation , and selective excision of the left atrial appendage . Minimum follow-up was 1 year with long-term monitoring ( 24-hour continuous , 14-day event or pacemaker interrogation ) . RESULTS Between March 2005 and January 2008 , 52 patients ( 35 male ) , mean age 60.3 years ( range , 42 - 79 years ) underwent the procedure . The left atrial appendage was isolated in 88.0 % ( 44/50 ) . Average hospital stay was 5.2 days ( range 3 - 10 days ) . There were no operative deaths or major adverse cardiac events . On long-term monitoring , freedom from atrial fibrillation/flutter/tachycardia was 86.3 % ( 44/51 ) and 80.8 % ( 42/52 ) at 6 and 12 months , respectively . Antiarrhythmic drugs were stopped in 33 of 37 patients and warfarin in 30 of 37 of the patients in whom ablation was successful at 12 months . Freedom from symptoms attributed to atrial fibrillation/flutter/tachycardia was 78.0 % ( 39/50 ) at 6 months and 63.8 % ( 30/47 ) at 12 months . CONCLUSIONS Minimally invasive surgical ablation is effective in the management of paroxysmal atrial fibrillation as evidence d by freedom from atrial arrythmias by long-term monitoring at 12 months . Measuring success using clinical symptoms underestimated clinical success as compared with long-term monitoring",
"R and omized controlled trials comparing atrial fibrillation patients who underwent concomitant mitral valve surgery and surgical ablation , versus mitral valve surgery alone , will be included . Six electronic data bases including MEDLINE , EMBASE , PubMed , Cochrane Central Register of Controlled Trials , Cochrane Data base of Systematic Review s , and Data base of Abstract s of Review s of Effectiveness will be search ed for original published studies . The reference lists of all retrieved articles will be review ed to further identify potentially relevant r and omized controlled studies . Experimental or observational studies will be included in the present review . Only studies in English will be included . Case reports , series with less than ten patients , abstract s , editorials , and expert opinions will be excluded . Two review ers will independently appraise the studies using a st and ard form , and extract data based on methodology , quality criteria , and outcome measures . All data will be extracted and tabulated from the relevant articles ’ texts , tables , and figures and checked by an additional review er . The studies will be assessed qualitatively using tools design ed to measure the risk of bias , as recommended by the Cochrane Collaboration ( Oxford , United Kingdom )",
"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"
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BACKGROUND Fibrates are a class of drugs characterised by mainly lowering high triglyceride , raising high-density lipoprotein ( HDL ) cholesterol , and lowering the small dense fraction of low-density lipoprotein ( LDL ) cholesterol . Their efficacy for secondary prevention of serious vascular events is unclear , and to date no systematic review focusing on secondary prevention has been undertaken . OBJECTIVES To assess the efficacy and safety of fibrates for the prevention of serious vascular events in people with previous cardiovascular disease ( CVD ) , including coronary heart disease and stroke . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ; Issue 9 , 2014 ) on the Cochrane Library , MEDLINE ( OVID , 1946 to October week 1 2014 ) , EMBASE ( OVID , 1980 to 2014 week 41 ) , the China Biological Medicine Data base ( CBM ) ( 1978 to 2014 ) , the Chinese National Knowledge Infrastructure ( CNKI ) ( 1979 to 2014 ) , Chinese Science and Technique Journals Data base ( VIP ) ( 1989 to 2014 ) . We also search ed other re sources , such as ongoing trials registers and data bases of conference abstract s , to identify further published , unpublished , and ongoing studies . SELECTION CRITERIA We included r and omised controlled trials ( RCTs ) in which a fibrate ( for example gemfibrozil , fenofibrate ) was compared with placebo or no treatment . We excluded RCTs with only laboratory outcomes . We also excluded trials comparing two different fibrates without a placebo or no-treatment control . DATA COLLECTION AND ANALYSIS Two review authors independently selected trials for inclusion , assessed risk of bias , and extracted the data . We contacted authors of trials for missing data . MAIN RESULTS We included 13 trials involving a total of 16,112 participants . Eleven trials recruited participants with history of coronary heart disease , two trials recruited participants with history of stroke , and one trial recruited participants with a mix of people with CVD . We judged overall risk of bias to be moderate . The meta- analysis ( including all fibrate trials ) showed evidence for a protective effect of fibrates primarily compared to placebo for the primary composite outcome of non-fatal stroke , non-fatal myocardial infa rct ion ( MI ) , and vascular death ( risk ratio ( RR ) 0.88 , 95 % confidence interval ( CI ) 0.83 to 0.94 ; participants = 16,064 ; studies = 12 ; I(2 ) = 45 % , fixed effect ) . Fibrates were moderately effective for preventing MI occurrence ( RR 0.86 , 95 % CI 0.80 to 0.93 ; participants = 13,942 ; studies = 10 ; I(2 ) = 24 % , fixed effect ) . Fibrates were not effective against all-cause mortality ( RR 0.98 , 95 % CI 0.91 to 1.06 ; participants = 13,653 ; studies = 10 ; I(2 ) = 23 % ) , death from vascular causes ( RR 0.95 , 95 % CI 0.86 to 1.05 ; participants = 13,653 ; studies = 10 ; I(2 ) = 11 % , fixed effect ) , and stroke events ( RR 1.03 , 95 % CI 0.91 to 1.16 ; participants = 11,719 ; studies = 6 ; I(2 ) = 11 % , fixed effect ) . Excluding clofibrate trials , as the use of clofibrate was discontinued in 2012 due to safety concerns , the remaining class of fibrates were no longer effective in preventing the primary composite outcome ( RR 0.90 , 95 % CI 0.79 to 1.03 ; participants = 10,320 ; studies = 7 ; I(2 ) = 50 % , r and om effects ) . However , without clofibrate data , fibrates remained effective in preventing MI ( RR 0.85 , 95 % CI 0.76 to 0.94 ; participants = 8304 ; studies = 6 ; I(2 ) = 47 % , fixed effect ) . There was no increase in adverse events with fibrates compared to control . Subgroup analyses showed the benefit of fibrates on the primary composite outcome to be consistent irrespective of age , gender , and diabetes mellitus . AUTHORS ' CONCLUSIONS Moderate evidence showed that the fibrate class can be effective in the secondary prevention of composite outcome of non-fatal stroke , non-fatal MI , and vascular death . However , this beneficial effect relies on the inclusion of clofibrate data , a drug that was discontinued in 2002 due to its unacceptably large adverse effects . Further trials of the use of fibrates in population s with previous stroke and also against a background treatment with statins ( st and ard of care ) are required
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"Objective —To assess whether adding a fibrate to statin therapy reduces residual cardiovascular risk associated with elevated triglycerides and low high-density lipoprotein cholesterol , The Evaluation of Choline Fenofibrate ( ABT-335 ) on Carotid Intima-Media Thickness ( cIMT ) in Subjects with Type IIb Dyslipidemia with Residual Risk in Addition to Atorvastatin Therapy ( FIRST ) trial evaluated the effects of fenofibric acid ( FA ) treatment on cIMT in patients with mixed dyslipidemia on atorvastatin . Approach and Results —This multicenter , double-blind , placebo-controlled study was performed in patients with mixed dyslipidemia ( fasting triglycerides , ≥150 mg/dL ; high-density lipoprotein cholesterol , ⩽45 [ men ] or 55 mg/dL [ women ] ; low-density lipoprotein cholesterol , ⩽100 mg/dL once and averaging ⩽105 mg/dL ) and a history of coronary heart disease or risk equivalent . Patients on background atorvastatin ( continued on starting dose or titrated to 40 mg , if needed ) were r and omized to FA 135 mg or placebo . The primary end point was rate of change from baseline through week 104 of the mean posterior-wall cIMT , measured by ultrasound . In patients with controlled low-density lipoprotein cholesterol while on atorvastatin background therapy , rate of change in posterior-wall cIMT was similar with FA plus atorvastatin ( −0.006 mm/y ) versus atorvastatin monotherapy ( 0.000 mm/y ; P=0.22 ) . FA plus atorvastatin was favored ( P history of coronary artery disease , cIMT > 0.795 mm , triglycerides 170 to 235 mg/dL , and statin use at entry . Adverse events were consistent with the known safety profiles of both drugs ; however , FA plus atorvastatin was associated with a greater incidence of renal-related adverse events compared with atorvastatin monotherapy ( 6.5 % versus 0.9 % ) . Conclusions —Compared with atorvastatin monotherapy , FA plus atorvastatin did not further decrease cIMT progression in high-risk patients with mixed dyslipidemia",
"BACKGROUND Studies have shown that treatment of hyperlipidemia , especially lowering of plasma LDL levels , retards the progression of coronary atherosclerosis and prevents clinical cardiovascular events . No such studies have focused on subjects with low levels of HDL cholesterol . METHODS AND RESULTS We r and omly assigned 395 post-coronary bypass men , who had an HDL cholesterol concentration , to receive gemfibrozil 1200 mg/d or placebo . Coronary angiography was performed at baseline and after , on average , 32 months of therapy . Changes in coronary dimensions were assessed by computer-assisted analysis . Average on-trial serum triglyceride concentrations were 1.69+/-0.68 and 1.02+/-0.37 , total cholesterol 5.48+/-0.68 and 4.83+/-0.63 , LDL cholesterol 3.84+/-0.59 and 3.39+/-0.56 , and HDL cholesterol 0.88+/-0.15 and 0.98+/-0.17 mmol/L in the placebo and gemfibrozil groups , respectively ( mean+/-SD , each P change in per-patient means of average diameters of native coronary segments was -0.04+/-0.11 mm in the placebo group and -0.01+/-0.10 mm in the gemfibrozil group ( P=.009 ) . The equivalent changes in minimum luminal diameters of stenoses were -0.09+/-0.18 and -0.04+/-0.15 mm , respectively ( P=.002 ) . A similar , albeit nonsignificant , trend toward treatment benefit was found in the predefined primary study end point , segments unaffected by grafts and those distal to graft insertions . In aortocoronary bypass grafts , 23 subjects ( 14 % ) assigned to placebo had new lesions in the follow-up angiogram , compared with 4 subjects ( 2 % ) assigned to gemfibrozil ( P Gemfibrozil therapy retarded the progression of coronary atherosclerosis and the formation of bypass-graft lesions after coronary bypass surgery in men with low HDL cholesterol as their main lipid abnormality",
"BACKGROUND Although cardiovascular disease and low high-density lipoprotein ( HDL ) cholesterol are common in people with renal insufficiency , data addressing the cardiovascular benefits of fibric acid derivatives in this population are sparse . We conducted a post hoc subgroup analysis of a r and omized double-blind , placebo-controlled trial to determine whether gemfibrozil is effective and safe for secondary prevention of cardiovascular events in individuals with chronic renal insufficiency ( CRI ) . METHODS Using an analysis plan that was developed a priori , we analyzed data from the Veterans ' Affairs High-Density Lipoprotein Intervention Trial ( VA-HIT ) study ; a r and omized trial of gemfibrozil versus placebo in 2531 men with established coronary disease , an HDL cholesterol level of 40 mg/dL ( 1.0 mmol/L ) or less , and a low-density lipoprotein ( LDL ) cholesterol level of 140 mg/dL ( 3.6 mmol/L ) or less . Of these , 1046 men had CRI as defined by creatinine clearance . RESULTS The incidence of the primary outcome ( coronary death or nonfatal myocardial infa rct ion ) was lower in participants with CRI who received gemfibrozil compared to placebo [ hazard ratio ( HR ) 0.73 ; 95 % CI 0.56 - 0.96 , P= 0.02 ) . The cumulative incidence of the primary end point was reduced from 24.3 % to 18.2 % . In subjects with CRI , gemfibrozil also significantly reduced the risk of the combined outcome of coronary death , nonfatal myocardial infa rct ion , or stroke ( HR 0.74 , 95 % CI 0.58 - 0.95 , P= 0.02 ) , but not the need for coronary revascularization ( HR 0.85 , 95 % CI 0.66 - 1.10 , P= 0.21 ) or total mortality ( HR 1.03 , 95 % CI 0.78 - 1.35 , P= 0.85 ) . The overall incidence of adverse effects was similar in individuals receiving gemfibrozil and placebo . However , the risk of sustained increases in serum creatinine was increased in gemfibrozil recipients compared with placebo ( 5.9 vs. 2.8 % , P= 0.02 ) . CONCLUSION Gemfibrozil appears effective for secondary prevention of cardiovascular events in individuals with mild to moderate chronic renal insufficiency and HDL cholesterol of 40 mg/dL or less . However , the benefit and safety of gemfibrozil in people with more severe impairment of kidney function requires further study",
"Objective : To assess the effect of bezafibrate on the risk of coronary heart disease and stroke in men with lower extremity arterial disease . Design : Double blind placebo controlled r and omised trial . Setting : 85 general practice s and nine hospital vascular clinics . Participants : 1568 men , mean age 68.2 years ( range 35 to 92 ) at recruitment . Interventions : Bezafibrate 400 mg daily ( 783 men ) or placebo ( 785 men ) . Main outcome measures : Combination of coronary heart disease and of stroke . All coronary events , fatal and non-fatal coronary events separately , and strokes alone ( secondary end points ) . Results : Bezafibrate did not reduce the incidence of coronary heart disease and stroke . There were 150 and 160 events in the active and placebo groups respectively ( relative risk 0.96 , 95 % confidence interval 0.76 to 1.21 ) . There were 90 and 111 major coronary events in the active and placebo groups respectively ( 0.81 , 0.60 to 1.08 ) , of which 64 and 65 were fatal ( 0.95 , 0.66 to 1.37 ) and 26 and 46 non-fatal ( 0.60 , 0.36 to 0.99 ) . Beneficial effects on non-fatal events were greatest in men aged coronary events ( 0.38 , 0.20 to 0.72 ) . There were no significant effects in older men . There were 60 strokes in those on active treatment and 49 in those on placebo ( 1.34 , 0.80 to 2.01 ) . There were 204 and 195 deaths from all causes in the two groups respectively ( 1.03 , 0.83 to 1.26 ) . Bezafibrate reduced the severity of intermittent claudication for up to three years . Conclusions : Bezafibrate has no effect on the incidence of coronary heart disease and of stroke combined but may reduce the incidence of non-fatal coronary events , particularly in those aged coronary events may also be reduced",
"Background Raised levels of both triglycerides and fibrinogen , each of which are reduced by bezafibrate , may contribute to lower extremity arterial disease ( LEAD ) . This condition is characterized by a particularly high incidence of coronary heart disease ( CHD ) and stroke , but is little studied thus far in r and omised controlled trials . Method Patients were recruited through 85 practice s in the British Medical Research Council General Practice Research Framework and through nine hospital vascular clinics . The treatment regimen , which is double-blind and placebo-controlled , is bezafibrate 400 mg/day . The 1568 patients recruited represent 86 % of those eligible at screening . Results None of the anticipated side effects ( mainly gastrointestinal ) differed between the two groups . Nearly 80 % of the total person-years accrued at 3 years were spent on trial treatment . Bezafibrate significantly reduced total cholesterol by approximately 8.0 % and low-density lipoprotein (LDL)-cholesterol by approximately 9.0 % , and increased high-density lipoprotein (HDL)-cholesterol by approximately 11.0 % initially , falling to about 6.0 % at 3 years . Triglycerides were significantly reduced by about 23.0 % and fibrinogen by about 14.0 % . Plasma creatinine rose by approximately 11 % in those on active treatment . All of these effects were highly significant ( P Bezafibrate had no effect on the level of C-reactive protein ( CRP ) . Conclusion The trial recruited an unusually high proportion of eligible patients , ensuring the general applicability of its results . The fibrinogen-lowering and lipid-modifying effects of bezafibrate were confirmed . Although bezafibrate lowers fibrinogen , it has no effect on CRP ; this suggests that the reduction in fibrinogen is due to an effect on its metabolism rather than suppression of an inflammatory response",
"OBJECTIVE To determine whether serum lipid intervention , in addition to conventional diabetes treatment , could alter cardiovascular outcomes in type 2 diabetes . RESEARCH DESIGN AND METHODS There were 164 type 2 diabetic subjects ( 117 men , 47 women ) without a history of clinical cardiovascular disease r and omized to receive either bezafibrate or placebo daily on a double-blind basis in addition to routine diabetes treatment and followed prospect ively for a minimum of 3 years . Serial biochemical and noninvasive vascular assessment s , carotid and femoral artery B-mode ultrasound measurements , and those pertaining to coronary heart disease (CHD)— clinical history , the World Health Organization ( WHO ) cardiovascular question naire , and resting and exercise electrocardiogram (ECG)—were recorded . RESULTS Bezafibrate treatment was associated with significantly greater reductions over 3 years in median serum triglyceride ( −32 vs. 4 % , P = 0.001 ) , total cholesterol ( −7 vs. −0.3 % , P = 0.004 ) , and total−to-HDL cholesterol ratio ( −12 vs. −0.0 % , P = 0.001 ) , and an increase in HDL cholesterol ( 6 vs. −2 % , P = 0.02 ) as compared with placebo . There was a trend toward a greater reduction of fibrinogen ( −18 vs. −6 % , P = 0.08 ) at 3 years . No significant differences between the two groups were found in the progress of ultrasonically measured arterial disease . In those treated with bezafibrate , there was a significant reduction ( P = 0.01 , log-rank test ) in the combined incidence of Minnesota-coded probable ischemic change on the resting ECG and of documented myocardial infa rct ion . CONCLUSIONS Improving dyslipidemia in type 2 diabetic subjects had no effect on the progress of ultrasonically measured arterial disease , although the lower rate of “ definite CHD events ” in the treated group suggests that this might result in a reduction in the incidence of coronary heart disease ",
"Background Statin-fibrate combination therapy has been used to treat patients with acute coronary syndrome ( ACS ) complicated by elevated triglycerides ( TG ) and decreased high density lipoprotein cholesterol ( HDL-C ) . The purpose of this study was to evaluate the influence of the combination therapy on lipids profile and apolipoprotein A5 ( apoA5 ) level in patients with ACS . Methods One hundred and four patients with ACS were recruited and r and omly assigned into two groups : one was statin group ( n = 52 ) , given atorvastatin ( 20 mg QN ) or other statins with equivalent dosages ; the other was combination group ( n = 52 ) , given the same dose of statin plus bezafibrate ( 200 mg BID ) . Follow-up visits were scheduled at the end of 6 and 12 weeks post treatment . Serum apoA5 levels were determined using a commercial available ELISA kit . Results ( 1 ) Compared with that of statin monotherapy , statin-bezafibrate combination treatment not only result ed in a significant reduction of TG , TC and LDL-C levels , ( all p HDL-C and apoA5 levels ( p percentage changes of TC , TG , LDL-C and apoA5 levels in both groups were even bigger at 12 weeks after treatment than that at 6 weeks ( all p achieving lipid-control target were higher in statin-bezafibrate combination treatment group than those in statin monotherapy group ( all p apoA5 level was positively correlated with TG ( r = 0.359 , p = 0.009 ) . However , a negative correlation was observed between apoA5 and TG ( r = -0.329 , p = 0.017 ) after 12 weeks treatment . Conclusions Statin and fibrate combination therapy is more effective than statin alone in achieving a comprehensive lipid control for ACS patients . Serum apoA5 elevation after statin and fibrate combination treatment could be due to the synergistic effect of both drugs on hypertriglyceridemia control",
"BACKGROUND Bezafibrate has effects on lipid metabolism and haemostatic function . We undertook a double-blind , placebo-controlled intervention trial , the Bezafibrate Coronary Atherosclerosis Intervention Trial ( BECAIT ) , to establish whether bezafibrate ( 200 mg three times daily ) could retard or prevent the progression of atherosclerotic lesions in dyslipidaemic male survivors of myocardial infa rct ion who were younger than 45 years at the time of the event . METHODS 92 patients completed an initial 3-month period of dietary intervention and were r and omly assigned to treatment with bezafibrate or placebo . Dietary intervention continued throughout the trial . Coronary angiography was done at baseline and after 2 and 5 years . 81 patients ( 42 bezafibrate treated and 39 placebo treated ) who underwent baseline angiography and at least one post-treatment angiogram were included in the efficacy analysis . The primary endpoint was change in mean minimum lumen diameter . FINDINGS The mean minimum lumen diameter decreased from baseline to the last angiographic assessment ( 2 or 5 years ) by 0.06 mm ( 95 % CI 0.15 reduction to 0.01 increase ) in the bezafibrate group and by 0.17 mm ( 0.33 reduction to 0.09 increase ) in the placebo group . The treatment effect was therefore 0.13 mm ( 95 % CI 0.10 to 0.15 ; p=0.049 ) . Parallel treatment effects , although not statistically significant , were observed for the secondary angiographic endpoints ( mean segment diameter 0.02 mm [ 0.01 - 0.04 ] and percentage stenosis -3.41 % [ -4.00 to -2.98 ] ) . The cumulative coronary event rate was significantly lower among bezafibrate-treated than among placebo-treated patients ( three vs 11 patients ; p=0.02 ) . There were significant treatment effects of bezafibrate for serum concentrations of cholesterol ( -9 % ; p very-low-density-lipoprotein ( VLDL ) cholesterol ( -35 % ; p serum triglycerides ( -31 % ; p VLDL triglycerides ( -37 % ; p plasma fibrinogen ( -12 % ; p=0.001 ) , whereas low-density ( LDL ) cholesterol concentrations did not change . High density lipoprotein ( HDL ) cholesterol increased significantly with bezafibrate ( 9 % ; p=0.02 ) . INTERPRETATION The results show that bezfibrate improves dyslipidaemia , lowers plasma fibrinogen , slows the progression of focal coronary atherosclerosis , and reduces coronary events in young survivors of myocardial infa rct ion",
"Background —A low level of HDL cholesterol has been identified as a risk factor for stroke in observational studies . Methods and Results —Our objective was to determine whether treatment aim ed at raising HDL cholesterol and lowering triglycerides reduces stroke in men with coronary heart disease and low levels of both HDL and LDL cholesterol . The study was a placebo-controlled , r and omized trial conducted in 20 Veterans Affairs medical centers . A total of 2531 men with coronary heart disease , with mean HDL cholesterol 0.82 mmol/L ( 31.5 mg/dL ) and mean LDL cholesterol 2.9 mmol/L ( 111 mg/dL ) , were r and omized to gemfibrozil 1200 mg/d or placebo and were followed up for 5 years . Strokes were confirmed by a blinded adjudication committee . Relative risks were derived from Cox proportional hazards models . There were 134 confirmed strokes , 90 % of which were ischemic . Seventy-six occurred in the placebo group ( 9 fatal ) and 58 in the gemfibrozil group ( 3 fatal ) , for a relative risk reduction , adjusted for baseline variables , of 31 % ( 95 % CI , 2 % to 52 % , P = 0.036 ) . The reduction in risk was evident after 6 to 12 months . Patients with baseline HDL cholesterol below the median may have been more likely to benefit from treatment than those with higher HDL cholesterol . Conclusions —In men with coronary heart disease , low HDL cholesterol , and low LDL cholesterol , gemfibrozil reduces stroke incidence ",
"BACKGROUND We investigated whether combination therapy with a statin plus a fibrate , as compared with statin monotherapy , would reduce the risk of cardiovascular disease in patients with type 2 diabetes mellitus who were at high risk for cardiovascular disease . METHODS We r and omly assigned 5518 patients with type 2 diabetes who were being treated with open-label simvastatin to receive either masked fenofibrate or placebo . The primary outcome was the first occurrence of nonfatal myocardial infa rct ion , nonfatal stroke , or death from cardiovascular causes . The mean follow-up was 4.7 years . RESULTS The annual rate of the primary outcome was 2.2 % in the fenofibrate group and 2.4 % in the placebo group ( hazard ratio in the fenofibrate group , 0.92 ; 95 % confidence interval [ CI ] , 0.79 to 1.08 ; P=0.32 ) . There were also no significant differences between the two study groups with respect to any secondary outcome . Annual rates of death were 1.5 % in the fenofibrate group and 1.6 % in the placebo group ( hazard ratio , 0.91 ; 95 % CI , 0.75 to 1.10 ; P=0.33 ) . Prespecified subgroup analyses suggested heterogeneity in treatment effect according to sex , with a benefit for men and possible harm for women ( P=0.01 for interaction ) , and a possible interaction according to lipid subgroup , with a possible benefit for patients with both a high baseline triglyceride level and a low baseline level of high-density lipoprotein cholesterol ( P=0.057 for interaction ) . CONCLUSIONS The combination of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular events , nonfatal myocardial infa rct ion , or nonfatal stroke , as compared with simvastatin alone . These results do not support the routine use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular risk in the majority of high-risk patients with type 2 diabetes . ( Clinical Trials.gov number , NCT00000620 .",
"Objective In a r and omized 5-yr multi-intervention trial , we tested the efficacy of intensified health education ( IHE ) in improving metabolic control and reducing the level of coronary risk factors and incidence of ischemic heart disease ( IHD ) . Research Design and Methods Within the intervention group , the benefit of clofibric acid was evaluated in a double-blind study . One thous and one hundred thirty-nine newly diagnosed middle-aged ( 30- to 55-yr-old ) patients with non-insulindependent diabetes mellitus ( NIDDM ) entered the study . They were classified as diet controlled after a 6- wk screening phase with conventional dietary treatment . During the follow-up , the control group ( n = 378 ) was cared for at different diabetes outpatient clinics with a st and ardized surveillance . The intervention group ( n = 761 ) had a structured IHE that included dietary advice , antismoking and antialcohol education , and ways to enhance physical activity . Results R and omly , 379 of the IHE patients received 1.6 g clofibric acid/day , and the others received placebo . IHE result ed in improved glucose control ( adjusted fasting blood glucose ) levels after 5 yr ( control subjects 9.27 mM , IHE group 8.71 mM , and IHE plus clofibric acid group 8.60 mM , P better glycemic control was achieved with fewer antidiabetic drugs . After 5 yr , antidiabetic drugs were prescribed to 47 % of the control subjects , 28 % of the IHE group , and 34 % of the IHE plus clofibric acid group ( cutoff limit for drug application was postpr and ial blood glucose of ≥13.87 mM ) . The ratio of polyunsaturated to saturated fatty acids ( 0.26 vs. 0.40 , P 0.01 ) and physical activity ( 174 vs. 327 scores , P , and blood pressure , tobacco , and alcohol consumption were significantly reduced by IHE . However , IHE had no effect on calorie intake , percentage of fat in the diet ( 45 % ) , and body weight . The most important finding was the significant increase of blood cholesterol in all three groups ( + 0.47 , + 0.36 , and + 0.34 mM , respectively ) . Clofibric acid only prevented the increase of triglyceride levels ( + 0.56 , + 0.24 , and + 0.05 mM , respectively ) . The incidence rate per 1000 for myocardial infa rct ion was 30.3 for control subjects , 53.6 for the IHE group , and 55.6 for the IHE plus clofibric acid group . The corresponding rates for IHD incidence were 90.9 , 97.8 , and 98.8 , respectively . Men suffered more frequently from myocardial infa rct ion , whereas women developed ECG criteria for IHD more frequently . Among the 35 cases of death , besides cardiovascular diseases , liver cirrhosis and neoplasia were the predominant causes . The death rate per 1000 in control subjects was 46.2 , 30.6 in the IHE group , and 27 among patients with IHE plus clofibric acid . Conclusions IHE was of substantial benefit for the control of glycemia , significantly diminished the need for antidiabetic drugs , and reduced a cluster of risk factors but had no effect on the control of blood lipids . This could be one major reason for the failure of IHE , effective lowering of blood pressure , and clofibric acid to prevent cardiovascular complications . Clofibric acid was only effective in reducing triglycerides",
"Summary A double blind clinical trial of one year duration was performed to compare the activity of halofenate ( 1 000 mg once a day ) and of clofibrate ( 1 000 mg twice a day ) on plasma levels of cholesterol , triglycerides and uric acid in 20 hyperlipidaemic patients .Statistical analysis showed that clofibrate provokes a significant decrease of cholesterol and triglycerides , a slight ( p>0.05 ) increase of uric acid . Halofenate did not influence significantly any of three levels . Noteworthy is the decrease in uric acid,.caused by halofenate ( 18 % after 24 weeks -p basal uric acid values were normal . Clinical ly both drugs were well tolerated . Alkaline phosphatase levels significantly decreased during treatment with clofibrate",
"BACKGROUND Atherosclerosis is the most common complication of diabetes . Correction of hyperglycaemia helps to prevent microvascular complications but has little effect on macrovascular disease . Post-hoc analyses of diabetic sub population s in lipid intervention trials suggest that correction of lipoprotein abnormalities will lead to a decrease in coronary-artery disease . The Diabetes Atherosclerosis Intervention Study ( DAIS ) was specifically design ed to assess the effects of correcting lipoprotein abnormalities on coronary atherosclerosis in type 2 diabetes . METHODS 731 men and women with type 2 diabetes were screened by metabolic and angiographic criteria . 418 were r and omly assigned micronised fenofibrate ( 200 mg/day ) or placebo for at least 3 years . They were in good glycaemic control ( mean haemoglobin A1c 7.5 % ) , had mild lipoprotein abnormalities , typical of type 2 diabetes , and at least one visible coronary lesion . Half had no previous clinical coronary disease . Initial and final angiograms followed a st and ard protocol and were analysed by a computer-assisted quantitative approach . Missing data for the primary endpoints ( minimum lumen diameter , mean segment diameter , and mean percentage stenosis ) were imputed . Analyses were by intention to treat . FINDINGS Total plasma cholesterol , HDL-cholesterol , LDL-cholesterol , and triglyceride concentrations all changed significantly more from baseline in the fenofibrate group ( n=207 ) than in the placebo group ( n=211 ) . The fenofibrate group showed a significantly smaller increase in percentage diameter stenosis than the placebo group ( mean 2.11 [ SE 0.594 ] vs 3.65 [0.608]% , p=0.02 ) , a significantly smaller decrease in minimum lumen diameter ( -0.06 [ 0.016 ] vs -0.10 [ 0.016 ] mm , p=0.029 ) , and a non-significantly smaller decrease in mean segment diameter ( -0.06 [ 0.017 ] vs -0.08 [ 0.018 ] mm , p=0.171 ) . The trial was not powered to examine clinical endpoints , but there were fewer in the fenofibrate group than the placebo group ( 38 vs 50 ) . INTERPRETATION DAIS suggests that treatment with fenofibrate reduces the angiographic progression of coronary-artery disease in type 2 diabetes . This effect is related , at least partly , to the correction of lipoprotein abnormalities , even those previously judged not to need treatment",
"BACKGROUND Coronary heart disease patients with low high-density lipoprotein cholesterol ( HDL-C ) levels , high triglyceride levels , or both are at an increased risk of cardiovascular events , but the clinical impact of raising HDL-C or decreasing triglycerides remains to be confirmed . METHODS AND RESULTS In a double-blind trial , 3090 patients with a previous myocardial infa rct ion or stable angina , total cholesterol of 180 to 250 mg/dL , HDL-C to receive either 400 mg of bezafibrate per day or a placebo ; they were followed for a mean of 6.2 years . The primary end point was fatal or nonfatal myocardial infa rct ion or sudden death . Bezafibrate increased HDL-C by 18 % and reduced triglycerides by 21 % . The frequency of the primary end point was 13 . 6 % on bezafibrate versus 15.0 % on placebo ( P=0.26 ) . After 6.2 years , the reduction in the cumulative probability of the primary end point was 7.3 % , ( P=0.24 ) . In a post hoc analysis in the subgroup with high baseline triglycerides ( > or = 200 mg/dL ) , the reduction in the cumulative probability of the primary end point by bezafibrate was 39.5 % ( P=0.02 ) . Total and noncardiac mortality rates were similar , and adverse events and cancer were equally distributed . CONCLUSIONS Bezafibrate was safe and effective in elevating HDL-C levels and lowering triglycerides . An overall trend in a reduction of the incidence of primary end points was observed . The reduction in the primary end point in patients with high baseline triglycerides ( > or = 200 mg/dL ) requires further confirmation",
"Controlled clinical trials have demonstrated the efficacy of reducing the blood levels of low-density lipoprotein cholesterol in reducing the incidence of coronary artery disease in hypercholesterolemic middle-aged men . However , a similar reversibility of the risk of coronary artery disease has not been demonstrated for high-density lipoprotein cholesterol elevation and triglyceride reduction . Therefore , the effect of administering 400 mg of bezafibrate retard daily versus placebo ( double blind ) to patients with myocardial infa rct ion preceding r and omization by 6 months to 5 years , or a clinical ly manifest anginal syndrome documented by objective evidence of dynamic myocardial ischemia , or both , is being investigated . Three thous and subjects ( aged 45 to 74 years ) are being enrolled from 19 cardiac departments in Israel , with total serum cholesterol between 180 and 250 mg/dl , high-density lipoprotein cholesterol In addition , low-density lipoprotein cholesterol concentrations are required to be lipid-modifying therapy , exhibiting > or = 1 prespecified exclusion criterion or not giving informed consent , or a combination , are not r and omized . The primary end points for evaluating efficacy are the incidence of fatal and nonfatal myocardial infa rct ion , and sudden death . The hypothesized effect of bezafibrate administration under the aforementioned protocol is to reduce an estimated cumulative end point event incidence of > or = 15 % by 20 to 25 % over an average follow-up period of 6.25 years , through early 1998 , when the last patient recruited will have completed 5 years . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE To compare the lipid-lowering efficacies of simvastatin and gemfibrozil in NIDDM patients with combined ( mixed ) hyperlipidemia ( CHL ) or isolated hypercholesterolemia ( IHC ) . RESEARCH DESIGN AND METHODS Patients with primary dyslipidemia and NIDDM were recruited for this double-blind , double-dummy comparison study from 10 Finnish centers . After a 4-week placebo run-in period , they were r and omly assigned to simvastatin or gemfibrozil . The simvastatin group ( n = 47 ) received 10 mg once nightly for 8 weeks , 20 mg for the next 8 weeks , and 40 mg for the third 8-week period . The gemfibrozil group ( n = 49 ) received 600 mg twice daily throughout the 24 weeks . The lipid-lowering efficacies of both drugs were compared in all patients as well as separately in patients with CHL and IHC . RESULTS In all patients , simvastatin reduced LDL and total cholesterol and the LDL-to-HDL cholesterol ratio more effectively , whereas gemfibrozil was more effective in elevating HDL cholesterol and decreasing triglyceride levels . The drug effects differed according to lipid phenotype at baseline . Simvastatin decreased LDL cholesterol levels by 30–40 % in both phenotypes . Gemfibrozil caused a 15 % reduction in LDL cholesterol in IHC but no change in CHL patients . Simvastatin produced 15–30 % reductions in triglyceride levels in CHL but no change in IHC patients . Gemfibrozil caused reductions in triglycerides in CHL ( 50 % and more ) and in IHC ( 40 % ) patients , with 12–18 % increases in HDL cholesterol in these groups . CONCLUSIONS Simvastatin is useful in both CHL and IHC patients , whereas gemfibrozil can be used in patients with high triglyceride and low or normal LDL cholesterol levels ",
"In a r and omized , double-blind five-year trial , we tested the efficacy of simultaneously elevating serum levels of high-density lipoprotein ( HDL ) cholesterol and lowering levels of non-HDL cholesterol with gemfibrozil in reducing the risk of coronary heart disease in 4081 asymptomatic middle-aged men ( 40 to 55 years of age ) with primary dyslipidemia ( non-HDL cholesterol greater than or equal to 200 mg per deciliter [ 5.2 mmol per liter ] in two consecutive pretreatment measurements ) . One group ( 2051 men ) received 600 mg of gemfibrozil twice daily , and the other ( 2030 men ) received placebo . Gemfibrozil caused a marked increase in HDL cholesterol and persistent reductions in serum levels of total , low-density lipoprotein ( LDL ) , and non-HDL cholesterol and triglycerides . There were minimal changes in serum lipid levels in the placebo group . The cumulative rate of cardiac end points at five years was 27.3 per 1,000 in the gemfibrozil group and 41.4 per 1,000 in the placebo group -- a reduction of 34.0 percent in the incidence of coronary heart disease ( 95 percent confidence interval , 8.2 to 52.6 ; P less than 0.02 ; two-tailed test ) . The decline in incidence in the gemfibrozil group became evident in the second year and continued throughout the study . There was no difference between the groups in the total death rate , nor did the treatment influence the cancer rates . The results are in accord with two previous trials with different pharmacologic agents and indicate that modification of lipoprotein levels with gemfibrozil reduces the incidence of coronary heart disease in men with dyslipidemia ",
"During screening in the Helsinki Heart Study ( HHS ) , a 5-year coronary primary prevention trial with gemfibrozil , some 600 dyslipidaemic individuals were detected who exhibited symptoms and signs of possible coronary heart disease ( CHD ) . These subjects were excluded from the primary study . To secure successful conduct in the HSS , an ancillary protocol was developed for the treatment of these individuals . Three-hundred and eleven subjects were r and omized to receive gemfibrozil 600 mg twice daily and 317 subjects to receive a matching placebo over 5 years in a double-blind fashion . The end-point rate , consisting of fatal and non-fatal myocardial infa rct ion and cardiac death , did not differ significantly between the placebo and gemfibrozil groups . The same was true for total mortality . Missing key prognostic factors , e.g. true prevalence of CHD , extent of coronary artery obstructions , degree of left ventricular dysfunction , and their distribution in the groups render the results less reliable and hence the data can not be used to refute the thesis that treatment of dyslipidaemia in manifest CHD in successful",
"Abstract A controlled trial of Clofibrate in 95 patients with established cerebral vascular disease is described . The level of serum cholesterol is significantly lowered in patients on treatment compared with control patients . There is no evidence to indicate that lowering the level of serum cholesterol in patients with established cerebral vascular disease has affected either the incidence of further episodes of cerebral ischaemia or the mortality rate",
"BACKGROUND Although it is generally accepted that lowering elevated serum levels of low-density lipoprotein ( LDL ) cholesterol in patients with coronary heart disease is beneficial , there are few data to guide decisions about therapy for patients whose primary lipid abnormality is a low level of high-density lipoprotein ( HDL ) cholesterol . METHODS We conducted a double-blind trial comparing gemfibrozil ( 1200 mg per day ) with placebo in 2531 men with coronary heart disease , an HDL cholesterol level of 40 mg per deciliter ( 1.0 mmol per liter ) or less , and an LDL cholesterol level of 140 mg per deciliter ( 3.6 mmol per liter ) or less . The primary study outcome was nonfatal myocardial infa rct ion or death from coronary causes . RESULTS The median follow-up was 5.1 years . At one year , the mean HDL cholesterol level was 6 percent higher , the mean triglyceride level was 31 percent lower , and the mean total cholesterol level was 4 percent lower in the gemfibrozil group than in the placebo group . LDL cholesterol levels did not differ significantly between the groups . A primary event occurred in 275 of the 1267 patients assigned to placebo ( 21.7 percent ) and in 219 of the 1264 patients assigned to gemfibrozil ( 17.3 percent ) . The overall reduction in the risk of an event was 4.4 percentage points , and the reduction in relative risk was 22 percent ( 95 percent confidence interval , 7 to 35 percent ; P=0.006 ) . We observed a 24 percent reduction in the combined outcome of death from coronary heart disease , nonfatal myocardial infa rct ion , and stroke ( P rates of coronary revascularization , hospitalization for unstable angina , death from any cause , and cancer . CONCLUSIONS Gemfibrozil therapy result ed in a significant reduction in the risk of major cardiovascular events in patients with coronary disease whose primary lipid abnormality was a low HDL cholesterol level . The findings suggest that the rate of coronary events is reduced by raising HDL cholesterol levels and lowering levels of triglycerides without lowering LDL cholesterol levels ",
"BACKGROUND Diabetes risk is often complicated by a mixed hyperlipoproteinemia not sufficiently controlled by a single antihyperlipidemic drug ; however , there are some concerns about the safety of combined statin and fibrate treatments . OBJECTIVE The aim of this study was to compare the efficacy and safety profile of fluvastatin + fenofibrate combination therapy and those of fluvastatin monotherapy in the treatment of combined hyperlipidemia , type 2 diabetes mellitus ( DM ) , and coronary heart disease ( CHD ) ( ie , high risk for cardiovascular disease [ CVD ] ) . METHODS This 12-month , r and omized , double-blind , controlled trial was conducted at the University of Pavia , Pavia , Italy . Patients aged 18 to 80 years with combined hyperlipidemia , type 2 DM , and CHD were r and omly assigned to receive combination therapy with extended-release fluvastatin 80 mg + micronized fenofibrate 200 mg or monotherapy with extended-release fluvastatin 80 mg . All treatments were given in tablet form , once daily with the evening meal , for 12 months . Lipid variables ( low-density lipoprotein cholesterol [ LDL-C ] , high-density lipoprotein cholesterol [ HDL-C ] , total cholesterol [ TC ] , and triglycerides [ TG ] ) at 6 and 12 months were the primary efficacy variables , and glycemic status ( glycosylated hemoglobin [ HbA(1c ) ] , fasting plasma glucose , and postpr and ial plasma glucose levels ) at 6 and 12 months was the secondary efficacy variable . Tolerability was assessed using physical examination , including vital-sign assessment , body-weight measurement , electrocardiography , adverse events , and laboratory tests . A pharmacoeconomic analysis of both treatment regimens was also carried out using the incremental cost-effectiveness ratio ( ICER ) . RESULTS A total of 48 patients ( 24 men , 24 women ; mean [ SD ] age , 60 [ 5 ] years ) were enrolled . After 6 months , all primary efficacy variables , except for TG level , showed significant improvements from baseline only in the combination-therapy group ( changes : LDL-C , -25 % ; HDL-C , + 12 % ; and TC , -19 % ; all , P lipid variables showed significant improvements over baseline in both groups ( all , P LDL-C , HDL-C , and TG were found in the combination-therapy group ( -35 % , + 34 % , -32 % , respectively ) versus the monotherapy group ( -25 % , + 14 % , -17 % , respectively ; all , P change from baseline in HbA(1c ) level was significant with combination therapy ( -12 % vs -7 % ; P well tolerated , with no significant differences in the incidences of adverse events between the 2 groups . The ICER showed that each 1 % decrease in LDL-C level achieved with the fenofibrate + fluvastatin combination added a cost of 14.97 Euros/y ( US 12.25 US dollars/y ) , and each 1 % increase in HDL-C level added a cost of 7.48 Euros/y ( 6.12/y US dollars ) , over the cost of monotherapy . CONCLUSIONS In this selected sample of patients with combined hyperlipidemia , type 2 DM , and CHD , the combination of extended-release fluvastatin + micronized fenofibrate was associated with a more improved lipid profile than fluvastatin monotherapy , and was a well-tolerated and cost-effective therapeutic choice to treat these patients at high risk for CVD",
"BACKGROUND Patients with type 2 diabetes mellitus are at increased risk of cardiovascular disease , partly owing to dyslipidaemia , which can be amenable to fibrate therapy . We design ed the Fenofibrate Intervention and Event Lowering in Diabetes ( FIELD ) study to assess the effect of fenofibrate on cardiovascular disease events in these patients . METHODS We did a multinational , r and omised controlled trial with 9795 participants aged 50 - 75 years , with type 2 diabetes mellitus , and not taking statin therapy at study entry . After a placebo and a fenofibrate run-in phase , we r and omly assigned patients ( 2131 with previous cardiovascular disease and 7664 without ) with a total-cholesterol concentration of 3.0 - 6.5 mmol/L and a total-cholesterol/HDL-cholesterol ratio of 4.0 or more or plasma triglyceride of 1.0 - 5.0 mmol/L to micronised fenofibrate 200 mg daily ( n=4895 ) or matching placebo ( n=4900 ) . Our primary outcome was coronary events ( coronary heart disease death or non-fatal myocardial infa rct ion ) ; the outcome for prespecified subgroup analyses was total cardiovascular events ( the composite of cardiovascular death , myocardial infa rct ion , stroke , and coronary and carotid revascularisation ) . Analysis was by intention to treat . The study was prospect ively registered ( number IS RCT N 64783481 ) . FINDINGS Vital status was confirmed on all but 22 patients . Averaged over the 5 years ' study duration , similar proportions in each group discontinued study medication ( 10 % placebo vs 11 % fenofibrate ) and more patients allocated placebo ( 17 % ) than fenofibrate ( 8 % ; p coronary event ( relative reduction of 11 % ; hazard ratio [ HR ] 0.89 , 95 % CI 0.75 - 1.05 ; p=0.16 ) . This finding corresponds to a significant 24 % reduction in non-fatal myocardial infa rct ion ( 0.76 , 0.62 - 0.94 ; p=0.010 ) and a non-significant increase in coronary heart disease mortality ( 1.19 , 0.90 - 1.57 ; p=0.22 ) . Total cardiovascular disease events were significantly reduced from 13.9 % to 12.5 % ( 0.89 , 0.80 - 0.99 ; p=0.035 ) . This finding included a 21 % reduction in coronary revascularisation ( 0.79 , 0.68 - 0.93 ; p=0.003 ) . Total mortality was 6.6 % in the placebo group and 7.3 % in the fenofibrate group ( p=0.18 ) . Fenofibrate was associated with less albuminuria progression ( p=0.002 ) , and less retinopathy needing laser treatment ( 5.2%vs 3.6 % , p=0.0003 ) . There was a slight increase in pancreatitis ( 0.5%vs 0.8 % , p=0.031 ) and pulmonary embolism ( 0.7%vs 1.1 % , p=0.022 ) , but no other significant adverse effects . INTERPRETATION Fenofibrate did not significantly reduce the risk of the primary outcome of coronary events . It did reduce total cardiovascular events , mainly due to fewer non-fatal myocardial infa rct ions and revascularisations . The higher rate of starting statin therapy in patients allocated placebo might have masked a moderately larger treatment benefit",
"BACKGROUND The independent contributions of subfractions of high-density lipoprotein ( HDL ) cholesterol ( HDL2 and HDL3 ) and apolipoproteins in predicting the risk of myocardial infa rct ion are unclear . Prospect i ve data are sparse , but HDL2 is widely believed to be a more important predictor than HDL3 . METHODS Blood sample s were collected at base line from 14,916 men ( ages , 40 to 84 years ) who were participants in the Physicians ' Health Study . After five years of follow-up , plasma sample s from 246 men with new myocardial infa rct ion ( case subjects ) were analyzed together with specimens from 246 men matched to them for age and smoking status who had not had a myocardial infa rct ion . RESULTS The levels of total cholesterol and apolipoprotein B-100 were significantly associated with an increased risk of myocardial infa rct ion ( data on levels of low-density lipoprotein cholesterol were unavailable ) . Both HDL cholesterol and HDL2 levels were associated with a substantially decreased risk of myocardial infa rct ion , but the HDL3 level was the strongest predictor ; the relative risk was 0.3 ( 95 percent confidence interval , 0.2 to 0.6 ) for those in the fifth of the group with the highest HDL3 levels , as compared with the fifth with the lowest levels . The benefit of a higher HDL cholesterol level was most pronounced among those with lower total cholesterol levels . Levels of apolipoprotein A-I and apolipoprotein A-II were also associated with decreased risk . However , the levels of HDL subfractions and apolipoproteins did not add significantly to the value of a multivariate model that included the ratio of total to HDL cholesterol in predicting myocardial infa rct ion , whereas that ratio remained a significant independent predictor of risk . After adjustment for other risk factors , a change of one unit in the ratio of total to HDL cholesterol was associated with a 53 percent change in risk ( 95 percent confidence interval , 26 percent to 85 percent ) . CONCLUSIONS This study underscores the importance of HDL cholesterol in predicting the risk of myocardial infa rct ion and demonstrates protective effects of both the HDL3 and HDL2 subfractions of HDL cholesterol . We found little or no predictive value for the levels of apolipoproteins A-I , A-II , and B or HDL subfractions after conventional risk factors and the ratio of total to HDL cholesterol were considered",
"The relationship of future clinical coronary heart-disease ( C.H.D. ) to the plasma-high-density-lipoprotein (H.D.L.)-cholesterol concentration has been examined in a 2-year case-control follow-up study of 6595 men aged 20 - 49 years living in the municipality of Tromsø , Norway . Measurements were also made of the cholesterol concentration in lower-density ( i.e. , density less than 1 - 603 g/ml ) lipoproteins , plasma-triglycerides , systolic and diastolic blood-pressures , relative body-weight , and cigarette consumption . Discriminant-function analysis showed that coronary risk was inversely related to H.D.L.-cholesterol concentration and directly related to density less than 1 - 063 cholesterol . These relationships were independent of each other and of the other measured variables , which showed no significant differences between the cases and controls . H.D.L. cholesterol made a three-fold greater contribution to the prediction of future C.H.D. than did density less than 1 - 063 cholesterol in this cohort of young men . These findings support the proposal that a low H.D.L. concentration is a common antecedent of clinical C.H.D. and is important in accelerating the progression of coronary atherosclerosis"
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Background In medical practice , the tendency to remove an inflamed gallbladder is deeply rooted . Cholecystectomy , however , is associated with relatively high complication rates , and therefore the decision whether or not to perform surgery should be well considered . For some patients , the surgical risk – benefit profile may favour conservative treatment . The objective of this study was to examine the short- and long-term outcome of conservative treatment of patients with acute calculous cholecystitis . Methods A systematic search of MEDLINE , Embase and Cochrane Library data bases was performed . Prospect i ve studies reporting on the success rate of conservative treatment ( i.e. non-invasive treatment ) of acute cholecystitis during index admission were included , as well as prospect i ve and retrospective studies reporting on the recurrence rate of gallstone-related disease during long-term follow-up ( i.e. ≥12 months ) after initial non-surgical management . Study selection was undertaken independently by two review ers using predefined criteria . The risk of bias was assessed . The pooled success and mortality rate during index admission and the pooled recurrence rate of gallstone-related disease during long-term follow-up were calculated using a r and om-effects model . Results A total of 1841 patients were included in 10 r and omized controlled trials and 14 non-r and omized studies . Conservative treatment during index admission was successful in 87 % of patients with acute calculous cholecystitis and in 96 % of patients with mild disease . In the long term , 22 % of the patients developed recurrent gallstone-related disease . Pooled analysis showed a success rate of 86 % ( 95 % CI 0.8–0.9 ) , a mortality rate of 0.5 % ( 95 % CI 0.001–0.009 ) and a recurrence rate of 20 % ( 95 % CI 0.1–0.3 ) . Discussion Conservative treatment of acute calculous cholecystitis during index admission seems feasible and safe , especially in patients with mild disease . During long-term follow-up , less than a quarter of the patients appear to develop recurrent gallstone-related disease , although this outcome is based on limited data
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"Background The aim if this study was to compare percutaneous drainage ( PD ) of the gallbladder to emergency cholecystectomy ( EC ) in a well-defined patient group with sepsis related to acute calculous/acalculous cholecystitis ( ACC/AAC ) . Methods Between 2001 and 2007 , all consecutive patients of our ICU treated by either PD or EC were retrospectively analyzed . Cases were collected from a prospect i ve data base . Percutaneous drainage was performed by a transhepatic route and EC by open or laparoscopic approach . Patients ’ general condition and organ dysfunction were assessed by two vali date d scoring systems ( SAPS II and SOFA , respectively ) . Morbidity , mortality , and long-term outcome were systematic ally review ed and analyzed in both groups . Results Forty-two patients [ median age = 65.5 years ( range = 32–94 ) ] were included ; 45 % underwent EC ( ten laparoscopic , nine open ) and 55 % PD ( n = 23 ) . Both patient groups had similar preoperative characteristics . Percutaneous drainage and EC were successful in 91 and 100 % of patients , respectively . Organ dysfunctions were similarly improved by the third postoperative/postdrainage days . Despite undergoing PD , two patients required EC due to gangrenous cholecystitis . The conversion rate after laparoscopy was 20 % . Overall morbidity was 8.7 % after PD and 47 % after EC ( P = 0.011 ) . Major morbidity was 0 % after PD and 21 % after EC ( P = 0.034 ) . The mortality rate was not different ( 13 % after PD and 16 % after EC , P = 1.0 ) and the deaths were all related to the patients ’ preexisting disease . Hospital and ICU stays were not different . Recurrent symptoms ( 17 % ) occurred only after ACC in the PD group . Conclusions In high-risk patients , PD and EC are both efficient in the resolution of acute cholecystitis sepsis . However , EC is associated with a higher procedure-related morbidity and the laparoscopic approach is not always possible . Percutaneous drainage represents a valuable intervention , but secondary cholecystectomy is m and atory in cases of acute calculous cholecystitis",
"Background : The role of laparoscopic cholecystectomy for acute cholecystitis is not yet clearly established . The aim of this prospect i ve r and omized study was to evaluate the safety and feasibility of laparoscopic cholecystectomy for acute cholecystitis and to compare the results with delayed cholecystectomy . Methods : Between January 2001 and November 2002 , 40 patients with a diagnosis of acute cholecystitis were assigned r and omly to early laparoscopic cholecystectomy within 24 h of admission ( early group , n = 20 ) or to initial conservative treatment followed by delayed laparoscopic cholecystectomy , 6 to 12 weeks later ( delayed group , n = 20 ) . Results : There was no significant difference in the conversion rates ( early , 25 % vs delayed , 25 % ) , operating times ( early , 104 min vs delayed , 93 min ) , postoperative analgesia requirements ( early , 5.3 days vs delayed , 4.8 days ) , or postoperative complications ( early , 15 % vs delayed , 20 % ) . However , the early group had significantly more blood loss ( 228 vs 114 ml ) and shorter hospital stay ( 4.1 vs 10.1 days ) . Conclusions : Early laparoscopic cholecystectomy for acute cholecystitis is safe and feasible , offering the additional benefit of a shorter hospital stay . It should be offered to patients with acute cholecystitis , provided the surgery is performed within 72 to 96 h of the onset of symptoms",
"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",
"OBJECTIVE A prospect i ve r and omized study was undertaken to compare early with delayed laparoscopic cholecystectomy for acute cholecystitis . SUMMARY BACKGROUND DATA Laparoscopic cholecystectomy for acute cholecystitis is associated with high complication and conversion rates . It is not known whether there is a role for initial conservative treatment followed by interval elective operation . METHOD During a 26-month period , 99 patients with a clinical diagnosis of acute cholecystitis were r and omly assigned to early laparoscopic cholecystectomy within 72 hours of admission ( early group , n = 49 ) or delayed interval surgery after initial medical treatment ( delayed group , n = 50 ) . Thirteen patients ( four in the early group and nine in the delayed group ) were excluded because of refusal of operation ( n = 6 ) , misdiagnosis ( n = 5 ) , contraindication for surgery ( n = 1 ) , or loss to follow-up ( n = 1 ) . RESULTS Eight of 41 patients in the delayed group underwent urgent operation at a median of 63 hours ( range , 32 to 140 hours ) after admission because of spreading peritonitis ( n = 3 ) and persistent fever ( n = 5 ) . Although the delayed group required less frequent modifications in operative technique and a shorter operative time , there was a tendency toward a higher conversion rate ( 23 % vs. 11 % ; p = 0.174 ) and complication rate ( 29 % vs. 13 % ; p = 0.07 ) . For 38 patients with symptoms exceeding 72 hours before admission , the conversion rate remained high after delayed surgery ( 30 % vs. 17 % ; p = 0.454 ) . In addition , delayed laparoscopic cholecystectomy prolonged the total hospital stay ( 11 days vs. 6 days ; p recuperation period ( 19 days vs. 12 days ; p morbidity and conversion rate of laparoscopic cholecystectomy for acute cholecystitis . Early operation within 72 hours of admission has both medical and socioeconomic benefits and is the preferred approach for patients managed by surgeons with adequate experience in laparoscopic cholecystectomy",
"Background Current recommendations for treating acute calculus cholecystitis include the use of intravenous antibiotics , although these recommendations were never tested scientifically . The aim of this study was to evaluate the role of intravenous antibiotic therapy in patients with mild acute calculus cholecystitis . Methods In this prospect i ve , r and omized controlled trial , 84 patients with a diagnosis of mild acute calculus cholecystitis were r and omly assigned to supportive treatment only or supportive treatment with intravenous antibiotic treatment ( 42 patients in each arm ) . Patients were followed through their index admission and until delayed laparoscopic cholecystectomy was performed . Results The two study groups did not differ in their demographic data or in the clinical presentation and disease severity . Analysis was conducted on the intent-to-treat basis . Patients in the intravenous antibiotics arm resumed a liquid diet earlier ( 1.7 vs. 2.2 days , p = 0.02 ) but did not significantly differ in resumption of regular diet ( 2.8 vs. 3.2 days , p = 0.16 ) or hospital length of stay ( LOS ) ( 3.9 vs. 3.8 days , p = 0.89 ) . Patients in the intravenous antibiotics arm had rates of percutaneous cholecystostomy tube placement ( 12 vs. 5 % , p = 0.43 ) , readmissions ( 19 vs. 13 % , p = 0.73 ) , and perioperative course similar to those not receiving antibiotics . The overall hospital LOS , including initial hospitalization and subsequent cholecystectomy , was similar for both groups ( 5.6 vs. 5.1 days , p = 0.29 ) . Eight ( 19 % ) patients in the supportive arm were crossed over to the intravenous antibiotic arm during the index admission . Conclusions Intravenous antibiotic treatment does not improve the hospital course or early outcome in most of the patients with mild acute calculus cholecystitis",
"The aim of this prospect i ve , r and omized study was to determine whether laparoscopic cholecystectomy should be performed as an early or a delayed operation in patients with acute cholecystitis . After diagnostic workup , patients were r and omized to one of two groups : ( 1 ) early laparoscopic cholecystectomy ( i.e. , within 7 days after onset of symptoms ) or ( 2 ) initial conservative treatment followed by delayed laparoscopic cholecystectomy 6 to 8 weeks later . Seventy-four patients were placed in the early-operation group , and 71 patients were assigned to the delayed-operation strategy . There was no significant difference in conversion rates ( early 31 % vs. delayed 29 % ) , operating times ( early 98 [ range 30 to 355 ] minutes vs. delayed 100 [ 45 to 280 ] minutes ) , or complications . Failure with the conservative treatment strategy was noted in 26 % of these patients . The total hospital stay was significantly shorter in the early group ( 5 [ range 3 to 63 ] days ) vs. the delayed group ( 8 [ range 4 to 50 ] days ; P conversion rate , early laparoscopic cholecystectomy offered significant advantages in the management of acute cholecystitis compared to a conservative strategy . The greatest advantage was a reduced total hospital stay",
"The most common indications for emergency operative intervention in the treatment of sigmoid diverticulitis are peritonitis and failure of medical therapy . Primary resection and diversion ( Hartmann 's procedure ) followed by delayed colostomy closure is the current st and ard of emergency surgical care . Guidelines for best operative strategy , however , remain controversial and continue to evolve based on recent comparative review s of surgical outcomes . Primary resection and anastomosis with or without proximal diversion and laparoscopic lavage are alternatives to Hartmann 's procedure that may provide an improved outcome in properly selected patients . Ongoing changes in the historical paradigm of the surgical approach to this disease m and ate the need for large multicentered prospect i ve r and omized trials to determine the best surgical strategy under emergent conditions for the treatment of diverticulitis . The current literature is review ed with suggestions for a management algorithm",
"Background . The role of early laparoscopic cholecystectomy for acute cholecystitis with cholelithiasis is not yet established . The aim of our prospect i ve r and omized study was to evaluate the safety and feasibility of early LC for acute cholecystitis and to compare the results with delayed LC . Methods . Between March 2007 to December 2008 , 50 patients with diagnosis of acute cholecystitis were assigned r and omly to early group , n = 25 ( LC within 24 hrs of admission ) , and delayed group , n = 25 ( initial conservative treatment followed by delayed LC , 6–8 weeks later ) . Results . We found in our study that the conversion rate in early LC and delayed LC was 16 % and 8 % , respectively , Operation time for early LC was 69.4 min versus 66.4 min for delayed LC , postoperative complications for early LC were 24 % versus 8 % for delayed LC , and blood loss was 159.6 mL early group versus 146.8 mL for delayed group . However early LC had significantly shorter hospital stay ( 4.1 days versus 8.6 days ) . Conclusions . Early LC for acute cholecystitis with cholelithiasis is safe and feasible , offering the additional benefit of shorter hospital stay . It should be offered to the patients with acute cholecystitis , provided that the surgery is performed within 96 hrs of acute symptoms by an experienced surgeon",
"Objective : Acute cholecystitis is a common disease , and laparoscopic surgery is the st and ard of care . Background : Optimal timing of surgery for acute cholecystitis remains controversial : either early surgery shortly after hospital admission or delayed elective surgery after a conservative treatment with antibiotics . Methods : The ACDC ( “ Acute Cholecystitis — early laparoscopic surgery versus antibiotic therapy and Delayed elective Cholecystectomy ” ) study is a r and omized , prospect i ve , open-label , parallel group trial . Patients were r and omly assigned to receive immediate surgery within 24 hours of hospital admission ( group ILC ) or initial antibiotic treatment , followed by delayed laparoscopic cholecystectomy at days 7 to 45 ( group DLC ) . For infection , all patients were treated with moxifloxacin for at least 48 hours . Primary endpoint was occurrence of predefined relevant morbidity within 75 days . Secondary endpoints were as follows : ( 1 ) 75-day morbidity using a scoring system ; ( 2 ) conversion rate ; ( 3 ) change of antibiotic therapy ; ( 4 ) mortality ; ( 5 ) costs ; and ( 6 ) length of hospital stay . Results : Morbidity rate was significantly lower in group ILC ( 304 patients ) than in group DLC ( 314 patients ): 11.8 % versus 34.4 % . Conversion rate to open surgery and mortality did not differ significantly between groups . Mean length of hospital stay ( 5.4 days vs 10.0 days ; P total hospital costs ( & OV0556;2919 vs & OV0556;4262 ; P morbidity and costs . Therefore , we believe that immediate laparoscopic cholecystectomy should become therapy of choice for acute cholecystitis in operable patients . ( NCT00447304",
"BACKGROUND Current treatment options for acute calculous cholecystitis include either early cholecystectomy , or conservative treatment consisting of intravenous antibiotics and an interval cholecystectomy several weeks later . Percutaneous drainage is reserved for patients in whom conservative therapy failed or as a salvage procedure for high risk patients . OBJECTIVE To identify clinical and radiographic factors leading to failure of conservative treatment . METHODS We prospect ively collected data on consecutive patients admitted with the diagnosis of acute cholecystitis . Parameters were compared between patients who were successfully treated conservatively and those who required percutaneous cholecystostomy . Logistic regression analysis was performed to identify predictors for failure of conservative treatment . RESULTS The study population comprised 103 patients with a median age of 60 who were treated for acute cholecystitis . Twenty-seven patients ( 26.2 % ) required PC . On univariate analysis , age above 70 years , diabetes , elevated white blood cell count , tachycardia ( > 100 beats/min ) at admission , and a distended gallbladder ( > 5 cm transverse diameter ) were found to be significantly more common in the PC group ( P WBC was higher in the PC group throughout the initial 48 hours . On multivariate analysis , age above 70 ( odds ratio 3.6 ) , diabetes ( OR 9.4 ) , tachycardia at admission ( OR 5.6 ) , and a distended gallbladder ( OR 8.5 ) were predictors for cholecystostomy ( P gallbladder are predictors for failure of conservative treatment and such patients should be considered for early cholecystostomy . Persistently elevated WBC ( > 15,000 ) suggests refractory disease and should play a central role in the clinical follow-up and decision-making process for elderly patients with acute cholecystitis",
"BACKGROUND The aim of the present study was to compare the risk of observation versus that of cholecystectomy in acute cholecystitis in patients r and omly allocated to delayed operation or conservative treatment . METHODS One-hundred- and -eighty patients were considered for participation in the study ; 71 were excluded according to predefined criteria and 45 did not join for other reasons . The remaining 64 patients were r and omized to cholecystectomy ( n = 31 ) or observation ( n = 33 ) . R and omized patients were contacted regularly and followed up for a median of 67 months . All gallstone-related hospital contacts were registered in both r and omized and excluded patients . RESULTS Gallstone-related complications or emergency admissions for pain occurred in six patients in the operation group ( 19 % ; 95 % CI 5%-33 % ) and in 12 patients ( 36 % ; 9 % CI 20%-53 % ) in the observation group . Twenty-seven of 31 patients r and omized to cholecystectomy had a cholecystectomy at a median of 3.6 months after r and omization , and , of these , 3 ( 11 % ; 95 % CI 0%-23 % ) suffered a major and 7 ( 26 % ; 95 % CI 9%-42 % ) a minor complication . Ten patients r and omized to observation later had their gallbladders removed , 1 ( 10 % ; 95 % CI 0%-29 % ) patient had a major and 1 ( 10 % ; 95 % CI 0%-29 % ) a minor complication . We found no mortality after cholecystectomy . CONCLUSIONS We found a certain risk of subsequent gallstone-related events following conservative treatment of acute cholecystitis , but the data also show that cholecystectomy should not necessarily be compulsory after acute cholecystitis",
"Abstract . Our objective was to compare the effectiveness of percutaneous cholecystostomy ( PC ) vs conservative treatment ( CO ) in high-risk patients with acute cholecystitis . The study was r and omized and comprised 123 high-risk patients with acute cholecystitis . All patients fulfilled the ultrasonographic criteria of acute inflammation and had an APACHE II score ≥12 . Percutaneous cholecystostomy guided by US or CT was successful in 60 of 63 patients ( 95.2 % ) who comprised the PC group . Sixty patients were conservatively treated ( CO group ) . One patient died after unsuccessful PC ( 1.6 % ) . Resolution of symptoms occurred in 54 of 63 patients ( 86 % ) . Eleven patients ( 17.5 % ) died either of ongoing sepsis ( n=6 ) or severe underlying disease ( n=5 ) within 30 days . Seven patients ( 11 % ) were operated on because of persisting symptoms ( n=3 ) , catheter dislodgment ( n=3 ) , or unsuccessful PC ( n=1 ) . Cholecystolithotripsy was performed in 5 patients ( 8 % ) . Elective surgery was performed in 9 cases ( 14 % ) . No further treatment was needed in 32 patients ( 51 % ) . In the CO group , 52 patients ( 87 % ) fully recovered and 8 patients ( 13 % ) died of ongoing sepsis within 30 days . All successfully treated patients showed clinical improvement during the first 3 days of treatment . Percutaneous cholecystostomy in high-risk patients with acute cholecystitis did not decrease mortality in relation to conservative treatment . Percutaneous cholecystostomy might be suggested to patients not presenting clinical improvement following 3 days of conservative treatment , to critically ill intensive care unit patients , or to c and i date s for percutaneous cholecystolithotripsy",
"Abstract Background . Cholecystectomy is routinely recommended to prevent recurrent disease after an initial episode of acute cholecystitis . Therefore , r and omized controlled trials have mainly focused on the timing of surgery , but many patients scheduled for cholecystectomy have deferred surgery with long periods of symptom-free intervals . Our present aim is to examine the long-term feasibility and safety of observation compared with surgery . Methods . Trial of 64 patients with acute cholecystitis previously r and omized to observation or cholecystectomy , which examined outcome in terms of completed r and omized treatment and appearance of further symptoms and the need for surgical treatment . Thirty-three patients were r and omized to observation and 31 patients to cholecystectomy . Median follow-up was 14 years . Results . Of the 33 patients r and omized to observation , 11 ( 33 % ) experienced a new event of gallstone-related disease ( eight ( 24.2 % ) had acute cholecystitis ) and 11 ( 33 % ) were operated . No significant difference ( p = 0.565 ) was found between the two r and omized groups with regard to recurrent disease or complications . Virtually no surgery took place after 5 years of follow-up . The difference in completed r and omized treatment between the groups was not significant ( p = 0.077 ) . Long-term mortality was equal in those operated and in those observed . Conclusions . Twenty-four percent of the patients experienced recurrent cholecystitis , but escalation of disease severity or increased mortality was not observed . Long-term observation after acute cholecystitis was feasible in two-thirds of the patients as the risk for recurrent disease was negligible after 5 years",
"BACKGROUND Percutaneous cholecystostomy ( PC ) is an alternative treatment in acute cholecystitis ( AC ) in high-risk or elderly patients although its advantage over emergency cholecystectomy has not yet been established . STUDY DESIGN AC prospect i ve data base analysis in high-risk patients treated by PC ( group 1 , 29 patients ) or emergency cholecystectomy ( group 2 , 32 patients ) . Surgical risk was estimated by physiological POSSUM , Charlson , Apache II , and American Society of Anesthesiologists ( ASA ) scores . RESULTS The groups showed homogeneity concerning age and surgical risk . PC allowed AC resolution in 19 patients ( 70.4 % ) , but 8 ( 29.6 % ) needed emergency cholecystectomy . Morbidity and mortality rates were 31 % and 17.2 % , respectively . Mortality was significantly associated with ASA IV ( P = .01 ) . In group 2 , the morbidity rate was 28.1 % without mortality . There was no statistical difference in morbidity ( P = .6 ) although mortality was significantly higher in group 1 ( P = .02 ) . CONCLUSIONS PC seems of little benefit and ought to be left for those very old patients with surgical contraindication",
"BACKGROUND Emergency laparoscopic cholecystectomy has been advocated for the treatment of acute cholecystitis ; however it can be a difficult task , especially in public hospitals , with relatively high conversion and complication rates . Percutaneous cholecystostomy is a simple and effective procedure allowing patients to recover from the acute event and undergo elective laparoscopic surgery at a later stage . METHODS We prospect ively assessed a protocol of initial conservative treatment in patients admitted with acute cholecystitis . Patients who did not respond to medical treatment were treated by percutaneous cholecystostomy . Following discharge the patients were seen in the outpatient clinic and elective laparoscopic cholecystectomy was considered and scheduled as necessary . The details of the operation were collected with emphasis on complications and conversion rate . RESULTS During a 3-year period , 224 patients who were admitted with acute calculous cholecystitis entered the protocol . Fifty-four patients did not improve under medical treatment and percutaneous cholecystostomy was performed . In spite of adequate drainage , 5 patients still did not improve : 3 patients were successfully operated upon urgently and recovered , while 2 patients who had severe concomitant diseases and multi-organ failure , died . Forty-nine patients were discharged with the catheter and later re-evaluated for elective operation . In 7 patients common bile duct stones were found and were removed by ERCP prior to the elective operation . Twenty-five patients underwent delayed laparoscopic cholecystectomy with a low conversion rate ( 8 % ) , and only minor complications ( 16 % ) . CONCLUSIONS Conservative treatment and delayed operation is still an acceptable choice in the treatment of acute cholecystitis . Percutaneous cholecystostomy is an effective tool , with high success rate and low morbidity , and allows for better pre-operative evaluation of the biliary system and safe interval laparoscopic surgery . Laparoscopic cholecystectomy after drainage of the gall bladder is a low morbidity procedure with relatively low conversion rate",
"Treatment of acute cholecystitis is still under debate . The aim of this study was to evaluate the efficacy of early laparoscopic cholecystectomy ( ELC ) in comparison with conservative treatment followed by delayed laparoscopic cholecystectomy ( DLC ) in the management of acute cholecystitis . This prospect i ve comparative study involved two groups of patients presenting with acute cholecystitis within 72 hours of the onset of symptoms . ELC was performed in 82 consecutive patients , whereas DLC was performed in 87 patients who previously underwent medical treatment . Surgical variables , hospital stay , and postoperative morbidity were evaluated in both groups . Time of surgery and conversion rate were lower in the ELC group . Postoperative morbidity was similar in both groups . Overall hospital stay was shorter in the ELC group . ELC within 72 hours of the onset of acute cholecystitis is a safe procedure with better results than DLC in terms of surgical timing , conversion rate , and hospital stay",
"The aim of this prospect i ve r and omized study was to define the optimum management between early and delayed laparoscopic cholecystectomy for patients with acute cholecystitis",
"BACKGROUND AND STUDY AIMS Surgery in elderly patients with acute cholecystitis is quite a high-risk procedure . The recent finding that activated pancreatic enzyme is present in sterile bile from the acutely inflamed gallbladder suggests that obstruction at the level of the common channel is a possible precipitating factor . It was therefore hypothesized that an initial endoscopic sphincterotomy in patients with acute cholecystitis might improve the clinical course . PATIENTS AND METHODS A prospect i ve unselected series of 105 patients over 65 years of age ( 52 men , 53 women ; mean age 78 ) suffering from acute cholecystitis were initially treated on a r and om basis with either conservative methods or endoscopic sphincterotomy . Within the first 72 h after the onset of symptoms , all 52 patients in the endoscopic sphincterotomy group were managed by endoscopic retro grade cholangiopancreatography ( ERCP ) , combined with endoscopic sphincterotomy in 50 cases . The main study parameter was the need for emergency cholecystectomy within the first week after admission . RESULTS Biliary sepsis requiring emergency surgery occurred in 15 patients in the conservatively treated group , in contrast with none of the 52 patients in the endoscopic sphincterotomy group ( P Iatrogenic complications after endoscopic sphincterotomy occurred in three patients , one of whom required surgery , while two were managed by conservative means . The clinical course improved , avoiding the need for emergency cholecystectomy and other interventions , in 48 patients in the endoscopic sphincterotomy group and in 36 patients in the conservatively treated group ( P clinical course after endoscopic sphincterotomy improved in the majority of elderly patients suffering from acute cholecystitis , suggesting that early relief of obstruction at the level of the common channel reduces the risk of developing biliary sepsis . The majority of these patients can undergo surgery electively or can receive further conservative treatment",
"BACKGROUND Patients with acute cholecystitis are treated in Hospital . The aim of the study was to analyze the security and efficacy of treating not-operated-on patients with acute cholecystitis in Hospital in the Home ( HIH ) . METHODS Prospect i ve study from January 2010 to May 2011 including all patients diagnosed with acute cholecystitis , not operated on and without comorbidities admitted to HIH Unit from the Emergency Department Short Stay Unit and Observation Unit . Patients were treated with ertapenem for at least one week . Intravenous treatment was followed by oral therapy to complete 14 days of antibiotic treatment . Patient characteristics , clinical course , need for return to hospital during admission to HIH , and admission to hospital in the month after discharge from HIH are analyzed . RESULTS 25 patients were included . Mean age was 59 years ( 34 - 82 ) . Upon arrival to the Emergency Department , all patients suffered abdominal pain , 60 % had fever , and 32 % vomiting . 48 % of patients had a leukocyte count over 13,000 cells/μl . All patients had cholelithiasis and a distended gallbladder . 56 % showed thickening of the gallbladder wall . Fluid accumulation around the gallbladder was noted in 16 % of the cases . Murphy 's sign proved positive in 44 % . All patients showed a favorable course . No patient required hospital readmission during stay in HIH or in the month after discharge . All patients expressed their satisfaction with treatment at home . CONCLUSIONS Patients with acute cholecystitis and without comorbidities can be safely and effectively treated in HIH after a short monitoring period in hospital"
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BACKGROUND Screening programmes can potentially identify people at high cardiovascular risk and reduce cardiovascular disease ( CVD ) morbidity and mortality . However , there is currently not enough evidence showing clear clinical or economic benefits of systematic screening-like programmes over the widely practised opportunistic risk assessment of CVD in primary care setting s. OBJECTIVES The primary objective of this review was to assess the effectiveness , costs and adverse effects of systematic risk assessment compared to opportunistic risk assessment for the primary prevention of CVD . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) on the Cochrane Library , MEDLINE , EMBASE on 30 January 2015 , and Web of Science Core Collection and additional data bases on the Cochrane Library on 4 December 2014 . We also search ed two clinical trial registers and checked reference lists of relevant articles . We applied no language restrictions . SELECTION CRITERIA We selected r and omised controlled trials ( RCTs ) that assessed the effects of systematic risk assessment , defined as a screening-like programme involving a predetermined selection process of people , compared with opportunistic risk assessment which ranged from no risk assessment at all to incentivised case finding of CVD and related risk factors . Participants included healthy adults from the general population , including those who are at risk of CVD . DATA COLLECTION AND ANALYSIS Two review authors independently selected studies . One review author extracted data and assessed them for risk of bias and a second checked them . We assessed evidence quality using the GRADE approach and present this in a ' Summary of findings ' table . MAIN RESULTS Nine completed RCTs met the inclusion criteria , of which four were cluster-r and omised . We also identified five ongoing trials . The included studies had a high or unclear risk of bias , and the GRADE ratings of overall quality were low or very low . The length of follow-up varied from one year in four studies , three years in one study , five or six years in two studies , and ten years in two studies . Eight studies recruited participants from the general population , although there were differences in the age ranges targeted . One study recruited family members of cardiac patients ( high risk assessment ) . There were considerable differences between the studies in the interventions received by the intervention and control groups . There was insufficient evidence to stratify by the types of risk assessment approaches . Limited data were available on all-cause mortality ( risk ratio ( RR ) 0.97 , 95 % confidence interval ( CI ) 0.92 to 1.02 ; 3 studies , 103,571 participants , I² = 0 % ; low- quality evidence ) and cardiovascular mortality ( RR 1.00 , 95 % CI 0.90 to 1.11 ; 2 studies , 43,955 participants , I² = 0 % ) , and suggest that screening has no effect on these outcomes . Data were also limited for combined non-fatal endpoints ; overall , evidence indicates no difference in total coronary heart disease ( RR 1.01 , 95 % CI 0.95 to 1.07 ; 4 studies , 5 comparisons , 110,168 participants , I² = 0 % ; low- quality evidence ) , non-fatal coronary heart disease ( RR 0.98 , 95 % CI 0.89 to 1.09 ; 2 studies , 43,955 participants , I² = 39 % ) , total stroke ( RR 0.99 , 95 % CI 0.90 to 1.10 ; 2 studies , 79,631 participants , I² = 0 % , low- quality evidence ) , and non-fatal stroke ( RR 1.17 , 95 % CI 0.94 to 1.47 ; 1 study , 20,015 participants ) .Overall , systematic risk assessment appears to result in lower total cholesterol levels ( mean difference ( MD ) -0.11 mmol/l , 95 % CI -0.17 to -0.04 , 6 studies , 7 comparisons , 12,591 participants , I² = 57 % ; very low- quality evidence ) , lower systolic blood pressure ( MD -3.05 mmHg , 95 % CI -4.84 to -1.25 , 6 studies , 7 comparisons , 12,591 participants , I² = 82 % ; very low- quality evidence ) and lower diastolic blood pressure ( MD -1.34 mmHg , 95 % CI -1.76 to -0.93 , 6 studies , 7 comparisons , 12,591 participants , I² = 0 % ; low- quality evidence ) . One study assessed adverse effects and found no difference in psychological distress at five years ( 1126 participants ) . AUTHORS ' CONCLUSIONS The results are limited by the heterogeneity between trials in terms of participants recruited , interventions and duration of follow-up . Limited data suggest that systematic risk assessment for CVD has no statistically significant effects on clinical endpoints . There is limited evidence to suggest that CVD systematic risk assessment may have some favourable effects on cardiovascular risk factors . The completion of the five ongoing trials will add to the evidence base
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"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 —Family members of patients with cardiovascular disease ( CVD ) may be at increased risk due to shared genes and lifestyle . Hospitalization of a family member with CVD may represent a “ motivational moment ” to take preventive action . Methods and Results —A r and omized , controlled clinical trial was conducted in healthy adult family members ( N=501 ; 66 % female ; 36 % nonwhite ; mean age , 48 years ) of patients hospitalized with CVD to evaluate a special intervention ( SI ) with personalized risk factor screening , therapeutic lifestyle-change counseling , and progress reports to physicians versus a control intervention ( CIN ) on the primary outcome , mean percent change in low-density lipoprotein cholesterol ( LDL-C ) , and other risk factors . Vali date d dietary assessment s and st and ardized risk factors were obtained at baseline and 1 year ( 94 % follow-up ) . At baseline , for 93 % of subjects , saturated fat comprised ≥7 % of total caloric intake , and 79 % had nonoptimal LDL-C levels ( of which 50 % were unaware ) . There was no difference in the SI versus the CIN with respect to the mean percent change in LDL-C ( −1 % versus −2 % , respectively ; P=0.64 ) , owing to a similar significant reduction in LDL-C in both groups ( −4.4 mg/dL and −4.5 mg/dL , respectively ) . Diet score significantly improved in the SI versus the CIN ( P=0.04 ) . High-density lipoprotein cholesterol declined significantly in the CIN but not in the SI ( −3.2 % [ 95 % CI , −5.1 to −1.3 ] versus + 0.3 % [ 95 % CI , −1.7 to + 2.4 ] ; P=0.01 ) . At 1 year , SI subjects were more likely than controls to exercise > 3 days per week ( P=0.04 ) . Conclusion —The SI was not more effective than the CIN in reducing the primary end point , LDL-C. The screening process identified many family members of hospitalized patients with CVD who were unaware of their risk factors , and further work is needed to develop and test interventions to reduce their CVD risk",
"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 ",
"Background Primary care provides most of the evidence -based chronic disease prevention and screening services offered by the healthcare system . However , there remains a gap between recommended preventive services and actual practice . This trial ( the BETTER Trial ) aim ed to improve preventive care of heart disease , diabetes , colorectal , breast and cervical cancers , and relevant lifestyle factors through a practice facilitation intervention set in primary care . Methods Pragmatic two-way factorial cluster RCT with Primary Care Physicians ’ practice s as the unit of allocation and individual patients as the unit of analysis . The setting was urban Primary Care Team practice s in two Canadian provinces . Eight Primary Care Team practice s were r and omly assigned to receive the practice -level intervention or wait-list control ; 4 physicians in each team ( 32 physicians ) were r and omly assigned to receive the patient-level intervention or wait-list control . Patients r and omly selected from physicians ’ rosters were stratified into two groups : 1 ) general and 2 ) moderate mental illness . The interventions involved a multifaceted , evidence -based , tailored practice -level intervention with a Practice Facilitator , and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored ‘ prevention prescription ’ . The primary outcome was a composite Summary Quality Index of 28 evidence -based chronic disease prevention and screening actions with pre-defined targets , expressed as the ratio of eligible actions at baseline that were met at follow-up . A cost-effectiveness analysis was conducted . Results 789 of 1,260 ( 63 % ) eligible patients participated . On average , patients were eligible for 8.96 ( SD 3.2 ) actions at baseline . In the adjusted analysis , control patients met 23.1 % ( 95 % CI : 19.2 % to 27.1 % ) of target actions , compared to 28.5 % ( 95 % CI : 20.9 % to 36.0 % ) receiving the practice -level intervention , 55.6 % ( 95 % CI : 49.0 % to 62.1 % ) receiving the patient-level intervention , and 58.9 % ( 95 % CI : 54.7 % to 63.1 % ) receiving both practice - and patient-level interventions ( patient-level intervention versus control , P extra cost of the intervention was $ 26.43CAN ( 95 % CI : $ 16 to $ 44 ) per additional action met . Conclusions A Prevention Practitioner can improve the implementation of clinical ly important prevention and screening for chronic diseases in a cost-effective manner",
"Background The Portuguese National Health Directorate has issued clinical practice guidelines on prescription of anti-inflammatory drugs , acid suppressive therapy , and antiplatelets . However , their effectiveness in changing actual practice is unknown . Methods The study will compare the effectiveness of educational outreach visits regarding the improvement of compliance with clinical guidelines in primary care against usual dissemination strategies . A cost-benefit analysis will also be conducted . We will carry out a parallel , open , superiority , r and omized trial directed to primary care physicians . Physicians will be recruited and allocated at a cluster-level ( primary care unit ) by minimization . Data will be analyzed at the physician level . Primary care units will be eligible if they use electronic prescribing and have at least four physicians willing to participate . Physicians in intervention units will be offered individual educational outreach visits ( one for each guideline ) at their workplace during a six-month period . Physicians in the control group will be offered a single unrelated group training session . Primary outcomes will be the proportion of cyclooxygenase-2 inhibitors prescribed in the anti-inflammatory class , and the proportion of omeprazole in the proton pump inhibitors class at 18 months post-intervention . Prescription data will be collected from the regional pharmacy cl aims data base . We estimated a sample size of 110 physicians in each group , corresponding to 19 clusters with a mean size of 6 physicians . Outcome collection and data analysis will be blinded to allocation , but due to the nature of the intervention , physicians and detailers can not be blinded . Discussion This trial will attempt to address unresolved issues in the literature , namely , long term persistence of effect , the importance of sequential visits in an outreach program , and cost issues . If successful , this trial may be the cornerstone for deploying large scale educational outreach programs within the Portuguese National Health Service . Trial registration Clinical Trials.gov number NCT01984034",
"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",
"Incidence and mortality results are presented from an international controlled trial of multifactorial prevention of coronary heart disease , involving r and omization of 66 factories ( 49 781 men ) in U.K. , Belgium , Italy and Pol and ( Cracow ) . Results for Pol and ( Warsaw ) are not yet complete . Net average reductions in risk factors ( all subjects ) were 1.2 % for plasma cholesterol , 8.9 % for daily cigarettes , 0.4 % for weight , 2.0 % for systolic blood pressure , and 11.1 % for a combined risk estimate . Greater reductions occurred in high-risk subjects ( 19.4 % for the combined estimate ) . The net overall reduction in CHD rates was 7.4 % ( 95 % confidence interval -29 to + 15 % ) for deaths ( 722 cases ) , and 3.9 % ( 95 % confidence interval -10 to + 2 % ) for fatal CHD + non-fatal myocardial infa rct ion ( 1502 cases ) . Among men aged 40 - 49 the reduction for this end-point was 15 % ; at ages 50 - 59 there was a small net increase . All-causes deaths after an early adverse trend showed 2.7 % reduction overall . There were large differences between centres , ranging from a 5 % net increase in CHD for U.K. to a decrease of 24 % in Belgium . In Belgium the decrease both in CHD and in all deaths was significant at the 5 % level . The effect on CHD in the different centres correlated broadly with their changes in risk factors . It is concluded that reduction in major coronary risk factors in industrial population s is possible , but it depends on adequate re sources ; the results support the hypotheses that CHD risk in middle-aged men is reversible and that community intervention can be beneficial",
"The identification of asymptomatic individuals at risk for near-term atherothrombotic events to ensure optimal preventive treatment remains a challenging goal . In the BioImage Study , novel approaches are tested in a typical health-plan population . Based on certain demographic and risk characteristics on file with Humana Inc , a total of 7,687 men 55 to 80 years of age and women 60 to 80 years of age without evidence of atherothrombotic disease but presumed to be at risk for near-term atherothrombotic events were enrolled between January 2008 and June 2009 . Those who met the prespecified eligibility criteria were r and omized to a telephonic health survey only ( survey only : n = 865 ) , st and ard risk assessment ( Framingham only : n = 718 ) , or comprehensive risk assessment in a dedicated mobile facility equipped with advanced imaging tools ( n = 6,104 ) . Baseline examination included assessment of cardiovascular risk factors and screening for sub clinical ( asymptomatic ) atherosclerosis with quantification of coronary artery calcification by computed tomography ( CT ) , measurement of intima-media thickness , presence of carotid atherosclerotic plaques and abdominal aortic aneurysm by ultrasound , and ankle brachial index . Participants with one or more abnormal screening test results underwent advanced imaging with contrast-enhanced magnetic resonance imaging for carotid and aortic plaques , contrast-enhanced coronary CT angiography for luminal stenosis and noncalcified plaques , and 18F-fluorodeoxyglucose-positron emission tomography/CT for carotid and aortic plaque inflammation . Plasma , PAXgene RNA , and DNA sample s were obtained , frozen , and stored for future biomarker discovery studies . All individuals will be followed until 600 major atherothrombotic events have occurred in those undergoing imaging . The BioImage Study will help identify those patients with sub clinical atherosclerosis who are at risk for near-term atherothrombotic events and enable a more personalized management of care",
"Abstract Objective : To determine the effectiveness of health checks , performed by nurses in primary care , in reducing risk factors for cardiovascular disease and cancer . Design : R and omised controlled trial . Setting : Five urban general practice s in Bedfordshire . Subjects : 2205 men and women who were r and omly allocated a first health check in 1989 - 90 and a re-examination in 1992 - 3 ( the intervention group ) ; 1916 men and women who were r and omly allocated an initial health check in 1992 - 3 ( the control group ) . All subjects were aged 35 - 64 at recruitment in 1989 . Main outcome measures : Serum total cholesterol concentration , blood pressure , body mass index , and smoking prevalence ( with biochemical validation of cessation ) ; self reported dietary , exercise , and alcohol habits . Results : Mean serum total cholesterol was 3.1 % lower in the intervention group than controls ( difference 0.19 mmol/l ( 95 % confidence interval 0.12 to 0.26 ) ; in women it was 4.5 % lower ( P Self reported saturated fat intake was also significantly lower in the intervention group . Systolic and diastolic blood pressures and body mass index were respectively 1.9 % , 1.9 % , and 1.4 % lower in the intervention group ( P cholesterol concentration > /=8 mmol/l , but no significant differences in the number with diastolic blood pressure > /=100 mm Hg or body mass index > /=30 kg/m2 . There was no significant difference between the two groups in prevalence of smoking or excessive alcohol use . Annual rechecks were no more effective than a single recheck at three years , but health checks led to a significant increase in visits to the nurse according to patients ' degree of cardiovascular risk . Conclusions : The benefits of health checks were sustained over three years . The main effects were to promote dietary change and reduce cholesterol concentrations ; small differences in blood pressure may have been attributable to accommodation to measurement . The benefits of systematic health promotion in primary care are real , but must be weighed against the costs in relation to other priorities . Key messages Key messages There is little effect on smoking or alcohol use , and more targeted approaches to modifying these behaviours may be appropriate Systematic implementation of health checks might lead to a reduction in risk of myocardial infa rct ion among those who attend of about 5 - 15 % ; men , who are at higher risk , show less change than women Health checks consume substantial re sources , and their effect is attenuated by non-attendance The benefits of health promotion through primary care must be weighed against their costs and in relation to other",
"Abstract Two quite different approaches have been taken to the evaluation of screening programs in the Health Insurance Plan of New York ( HIP ) . In one , a highly specific end result is at issue . The central question in this project is whether periodic screening with mammography and clinical examination of the breast results in a reduction in mortality from breast cancer in the female population . The project is being conducted as a r and omized clinical trial with study and control groups selected from the enrolled population of HIP . Of 31,000 study group women contacted , 20,200 , or 65 % participated in at least one examination . The other study is concerned with whether the impact of a multiple array of services , automated multiphasic health testing , and follow-up paramedical and medical services , on health status and health care behavior is greater among the poor than the rest of the population . The results of the breast cancer study provide clear evidence that over the short run period of 5 years of follow-up , the study women have about one-third lower mortality from breast cancer than the controls . Reduction in breast cancer mortality was found at ages 50 and over but not at ages 40–49 years . In the multiphasic health testing study , preliminary analysis of the data confirms one of the initial assumptions of the study , i.e. that a significant gap exists between the poverty and nonpoverty groups in the occurrence of health problems . A higher proportion of the poverty group reported a health complaint or specific condition . The study indicated that this group was also likely to report these problems with greater frequency and greater severity of the complaints ",
"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",
"Objective To estimate the potential population impact of different screening strategies for identifying and treating people at high risk of cardiovascular disease , including strategies using routine data for cardiovascular risk stratification , in light of the UK government ’s recommended national strategy to screen all adults aged 40 - 74 for cardiovascular risk . Design Modelling study using data from a prospect i ve cohort , EPIC-Norfolk ( European Prospect i ve Investigation of Cancer-Norfolk ) . Setting An English county . Participants 16 970 men and women aged 40 - 74 and free from cardiovascular disease and diabetes at baseline . Main outcome measures The main outcomes were the population attributable fraction , the number needed to screen to prevent one new case of cardiovascular disease , the number needed to treat to prevent one new case of cardiovascular disease , and the number of new cardiovascular events that could be prevented . Relative risk reductions for estimated treatment effects were derived from meta-analyses of clinical trials or guidelines from the National Institute for Health and Clinical Excellence . Results 1362 cardiovascular events occurred over 183 586 person years of follow-up . Compared with the recommended government strategy , a stepwise screening approach using a simple risk score incorporating routine data could prevent a similar number ( lower to upper estimates ) of new cardiovascular events annually in the United Kingdom ( 26 789 , 20 778 to 36 239 ) and 25 134 ( 19 450 to 34 134 ) , respectively ) but requiring only 60 % of the population to be invited to attend a vascular risk assessment . A similar number of cardiovascular events ( 25 016 , 19 563 to 33 372 ) could also be prevented by inviting everyone aged 50 - 74 for a vascular assessment . Using a participant completed Finnish diabetes risk score question naire or anthropometric cut-off points for risk prestratification was less effective . Conclusions Compared with the UK government ’s recommended national strategy to screen all adults aged 40 - 74 for cardiovascular risk , an approach using routine data for cardiovascular risk stratification before inviting people at high risk for a vascular risk assessment may be similarly effective at preventing new cases of cardiovascular disease , with potential cost savings",
"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 Multiphasic Health Checkup Evaluation Study , a long-term clinical trial , has been completed . A study group of 5156 men and women age 35 - 54 at entry was urged to have annual multiphasic health checkups ( MHCs ) for 16 years . A control group of 5557 comparable subjects was not so urged but was followed up in a comparable fashion . The mean and median number of MHCs per person were 6.8 and 6 , respectively , in the study group and 2.8 and 1 , respectively , in the control group . During 16 years the study group experienced a 30 % reduction ( p less than 0.05 ) in deaths from pre-specified \" potentially postponable \" causes , largely associated with lower death rates from colorectal cancer and hypertension . This reduction was most pronounced in the early years of the study . The two groups did not differ to a statistically significant degree in mortality from all other causes ( 84 % of total mortality ) or in total mortality . There was no difference in self-reported disability in the overall groups . In the setting of our prepaid health care plan where MHCs were already available on a voluntary basis , a program of urging middle-aged persons to undergo regular MHCs brought about a substantial reduction in mortality from preselected diseases",
"An extensive and growing number of review s of the published literature demonstrate that health research publications have frequent deficiencies . Of particular concern are poor reports of r and omised trials , which make it difficult or impossible for readers to assess how the research was conducted , to evaluate the reliability of the findings , or to place them in the context of existing research evidence . As a result , published reports of trials often can not be used by clinicians to inform patient care or to inform public health policy , and the data can not be included in systematic review s. Reporting guidelines are design ed to identify the key information that research ers should include in a report of their research . We describe the history of reporting guidelines for r and omised trials culminating in the CONSORT Statement in 1996 . We detail the subsequent development and extension of CONSORT and consider related initiatives aim ed at improving the reliability of the medical research literature",
"BACKGROUND There have been many reports of the adverse psychological effects of screening . Here we discuss the results of a r and omized controlled study --one of the first to address this issue . AIM To determine the extent to which participation in a population -based intervention programme that aims to reduce the risk of cardiovascular diseases raises concerns about health , or undermines a belief in the ability to reduce that risk . METHOD A r and omized controlled trial involving 13 general practice s in Engl and , Wales and Scotl and was conducted . Two thous and , nine hundred and eighty-four middle-aged men and women undergoing cardiovascular risk-screening and intervention , and a r and omized comparison group of 3,576 men and women from the same practice s , who were not offered the intervention , were compared on three outcomes : perception of current health , perceived risk of suffering a heart attack , and perceived ability to reduce the risk of suffering a heart attack . RESULTS We found no evidence to suggest that participation in this one-year , population -based intervention programme , to reduce the risk of cardiovascular disease raised concerns about health or risk of a heart attack ; indeed , those in the intervention group were slightly more optimistic about their health . Alterations in perceptions of current health and the risk of suffering a heart attack were associated directly with true alterations in risk factors . A more noticeable effect on participants in this intervention programme was a reduction in their perceived ability to further reduce their risks of a heart attack . This was associated with a decrease in weight and with quitting smoking . CONCLUSION Contemporary screening and intervention programmes in primary care , aim ed at reducing risk of cardiovascular disease , do not necessarily lead to raised anxiety or concern about health . A more subtle effect of screening would appear to be one of reassurance in the face of continuing , albeit reduced , risk",
"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",
"Aims : The intention was to investigate whether preventive health checks and health discussion s are cost effective . Methods : In a r and omized trial the authors compared two intervention groups ( A and B ) and one control group . In 1991 2,000 30- to 49-year-old persons were invited and those who accepted were r and omized . Both intervention groups were offered a broad ( multiphasic ) screening including cardiovascular risk and a personal letter including screening results and advice on healthy living . Individuals in group A could contact their family physician for a normal consultation whereas group B were given fixed appointments for health consultations . The follow-up period was six years . Analysis was carried out on the ` ` intention to treat ' ' principle . Outcome parameters were life years gained , and direct and total health costs ( including productivity costs ) , discounted by 3 % annually . Costs were based on register data . Univariate sensitivity analysis was carried out . Results : Both intervention groups have significantly better life expectancy than the control group ( no intervention ) . Group B and ( A ) significantly gain 0.14 ( 0.08 ) life years more than the control group . There were no differences in average direct ( 3,255 ( 3,703 ) versus 4,186 ) and total costs ( 10,409 ( 9,399 ) versus 10,667 ) . The effect in group B is , however , better than in group A with no significant differences in costs . The results are insensitive to a range of assumptions regarding costs , effects , and discount rates . Conclusions : Preventive health screening and consultation in primary care in 30- to 49-year-olds produce significantly better life expectancy without extra direct and total costs over a six-year follow-up period",
"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 ",
"All male inhabitants of the city of Göteborg , who were born between 1915 - 1922 and 1924 - 1925 were included in the trial , and were 47 to 55 years of age on entry to the study in 1970 to 1973 . One-third of these men were r and omly allocated to an intervention group , whilst the other two-thirds acted as controls . Men of all social classes , employed as well as unemployed , health conscious as well as careless , were invited , with 75 % of these responding to the invitation . The intervention group contained 10,000 men and the control group 20,000 men . The intervention group were given advice on diet , both individually and in groups , the type of advice depending upon serum cholesterol level . Smokers were advised to stop smoking , and men with elevated blood pressure were treated with antihypertensive drugs . Due to the large size of the groups and because they formed a r and om population sample , it was assumed that they had similar characteristics at the start of the trial . Risk factors were only measured in the intervention group at this time , followed by intervention . This design feature solved several ethical problems with regard to no treatment in the control group . These men were , however , subjected to health examinations and treatment as well as general health advice . Risk factor levels were measured in the intervention group , and also in r and om sub sample s ( 11 % ) of the control group after 4 and 10 years . Serum cholesterol , blood pressure and smoking decreased among men in both groups , and only slightly more in the intervention group . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Abstract Objective : To measure costs and cost effectiveness of the British family heart study cardiovascular screening and intervention programme . Design : Cost effectiveness analysis of r and omised controlled trial . Clinical and re source use data taken from trial and unit cost data from external estimates . Setting : 13 general practice s across Britain . Subjects : 4185 men aged 40 - 59 and their 2827 partners . Intervention : Nurse led programme using a family centred approach , with follow up according to degree of risk . Main outcome measures : Cost of the programme itself ; overall short term cost to NHS ; cost per 1 % reduction in coronary risk at one year . Results : Estimated cost of putting the programme into practice for one year was £ 63 per person ( 95 % confidence interval £ 60 to £ 65 ) . The overall short term cost to the health service was £ 77 per man ( £ 29 to £ 124 ) but only £ 13 per woman ( -£48 to £ 74 ) , owing to differences in utilisation of other health service re sources . The cost per 1 % reduction in risk was £ 5.08 per man ( £ 5.92 including broader health service costs ) and £ 5.78 per woman ( £ 1.28 taking into account wider health service savings ) . Conclusions : The direct cost of the programme to a four partner practice of 7500 patients would be approximately £ 58 000 . Annually , £ 8300 would currently be paid to a practice of this size working to the maximum target on the health promotion b and s , plus any additional reimbursement of practice staff salaries for which the practice qualified . The broader short term costs to the NHS may augment these costs for men but offset them considerably for women . Key messages Patient specific data from the British family heart study are used in this detailed cost effectiveness analysis The costs of the programme to general practitioners was estimated with reasonable precision : an average four partner practice of 7500 patients will require 1.75 nurse years to implement this programme , costing £ 58 000 The direct costs of the programme may not be fully reimbursed under the current health promotion b and ing scheme The broader impact on drug costs and use of other health care re sources is uncertain , and larger trials will be needed to estimate these important",
"BACKGROUND A substantial part of cardiovascular disease prevention is delivered in primary care . Special attention should be paid to the assessment of cardiovascular risk factors . According to the Dutch guideline for cardiovascular risk management , the heavy workload of cardiovascular risk management for GPs could be shared with advanced practice nurses . AIM To investigate the clinical effectiveness of practice nurses acting as substitutes for GPs in cardiovascular risk management after 1 year of follow-up . DESIGN OF STUDY Prospect i ve pragmatic r and omised trial . SETTING Primary care in the south of the Netherl and s. Six centres ( 25 GPs , six nurses ) participated . METHOD A total of 1626 potentially eligible patients at high risk for cardiovascular disease were r and omised to a practice nurse group ( n = 808 ) or a GP group ( n = 818 ) in 2006 . In total , 701 patients were included in the trial . The Dutch guideline for cardiovascular risk management was used as the protocol , with st and ardised techniques for risk assessment . Changes in the following risk factors after 1 year were measured : lipids , systolic blood pressure , and body mass index . In addition , patients in the GP group received a brief question naire . RESULTS A larger decrease in the mean level of risk factors was observed in the practice nurse group compared with the GP group . After controlling for confounders , only the larger decrease in total cholesterol in the practice nurse group was statistically significant ( P = 0.01 , two-sided ) . CONCLUSION Advanced practice nurses are achieving results , equal to or better than GPs for the management of risk factors . The findings of this study support the involvement of practice nurses in cardiovascular risk management in Dutch primary care",
"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",
"Abstract Objective : To measure the costs and cost effectiveness of the Oxcheck cardiovascular risk factor screening and intervention programme . Design : Cost effectiveness analysis of a r and omised controlled trial using clinical and economc data taken from the trial . Setting : Five general practice s in Luton and Dunstable , Engl and . Subjects : 2205 patients who attended a health check in 1989 - 90 and were scheduled for re-examination in 1992 - 3 ( intervention group ) ; 1916 patients who attended their initial health check in 1992 - 3 ( control group ) . Participants were men and women aged 35 - 64years . Intervention : Health check conducted by nurse , with health education and follow up according to degree of risk . Main outcome measures : Cost of health check programme ; cost per 1 % reduction in coronary risk . Results : Health check and follow up cost £ 29.27 per patient . Estimated programme cost per 1 % reduction in coronary risk per participant was between £ 1.46 and £ 2.25 ; it was nearly twice as much for men as women . Conclusions : The cost to the practice of implementing Oxcheck-style health checks in an average sized practice of 7500 patients would be £ 47 000 , a proportion of which could be paid for through staff pay reimbursements and B and Three health promotion target payments . This study highlights the considerable difficulties faced when calculating the costs and benefits of a health promotion programme . Economic evaluations should be integrated into the protocol s of r and omised controlled trials to enable judgments to be made on the relative cost effectiveness of different prevention strategies . Key messages Research was undertaken to estimate the cost of the health checks and relate the cost to changes in the relative risk of cardiovascular disease The immediate cost of implementing Oxcheck-style health checks in an average sized practice of 7500 patients would be £ 47 000 , which is comparable with the immediate cost of a cervical screening programme The actual costs to the practice would be substantially reduced by staff pay reimbursements and health promotion target payments Further research is required to estimate the wider costs of health checks result ing from the additional use of health care",
"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",
"This 1-year , group-r and omized , intervention-control study looked at the effectiveness of a primary prevention , community-based program for reducing cardiovascular ( CV ) risk factors in women . Women between the ages of 20 and 50 were recruited through community contacts , including religious and academic institutions , health clinics , and large local employers in the Duluth , Minnesota , and Superior , Wisconsin , area . All study activities took place in neighborhood places of worship . Screenings at baseline and 12 months included physical and laboratory measurements addressing CV risk factors and assessment of the women 's knowledge about CV disease in women . All participants received an individualized review of their CV risk factors and recommendations for modifying them , along with educational literature about CV disease in women . The control group had limited follow-up compared with the intervention group , who participated in general CV health classes and received a follow-up phone call and information about health re sources . The study showed that education and one-on-one follow-up significantly change behavior . Comprehensive community-based screening and individualized review decrease women 's risk for CV disease",
"Objectives - To evaluate changes in plasma cholesterol following health screening and health discussion s in general practice . Design - R and omised prospect i ve population -based study conducted over a period of 5 years . Setting - Primary care , all general practitioners ( GPs ) in a welldefined area . Subjects - A r and om sample of inhabitants aged 30 - 49 years in January 1991 , registered with a local GP was invited to participate . The participants ( 1507 persons , or 75.4 % of the 2000 invited ) were r and omly allocated to two intervention groups and a control group . Main outcome measures - Plasma cholesterol , percentage of subjects with plasma cholesterol higher than 7 mmol/l . Results - After 5 years of intervention , plasma cholesterol in the whole population was significantly lower in the intervention groups compared to the control group . The decrease was most pronounced ( 0.5 mmol/l ) in subjects at high cardiovascular risk . The percentage of high-risk individuals with a cholesterol level higher than 7 mmol/l was significantly lower in the intervention groups compared to the control group ( 9.8 % vs 6.2 % , p = 0.04 ) , corresponding to a 37 % reduction . Conclusions - The study shows that the health checks had a measurable impact on plasma cholesterol levels , the most pronounced effect is seen among individuals at high cardiovascular risk",
"South-East London Screening Study Group ( Department of Community Medicine , St Thomas 's Hospital and Medical School , London SE1 1EH , Engl and ) . A controlled trial of multiphasic screening in middle-age : results of the South-East London Screening Study . International Journal of Epidemiology 1977;6:357 - 63 . The results of a controlled trial of multiphasic screening in general practice are presented . In 1967 , 7229 individuals aged between 40 and 64 years were r and omly allocated into either a Screening or Control group . The Screening group were invited to attend two screening sessions held about two years apart , while the Control group continued to receive conventional medical care . Both groups were then invited to undergo a health survey in 1972 - 73 which revealed no significant differences in morbidity between the two groups . Careful follow-up permitted detailed Screening-Control comparisons of various outcome measures -consultation and hospital admission rates , certified sickness absence from work , and mortality . Nine years after the initial screening , no significant differences were found between the two groups in any of the outcome measures . It is estimated that a similar screening programme for the entire middle-aged UK population would cost 142 million pounds at 1976 prices",
"Background A pilot project cardiovascular prevention was implemented in S and well ( West Midl and s , UK ) . This used electronic primary care records to identify untreated patients at high risk of cardiovascular disease then invited these high risk patients for assessment by a nurse in their own general practice . Those found to be eligible for treatment were offered treatment . During the pilot a higher proportion of high risk patients were started on treatment in the intervention practice s than in control practice s. Following the apparent success of the prevention project , it was intended to extend the service to all practice s across the S and well area . However the pilot project was not a robust evaluation . There was a need for an efficient evaluation that would not disrupt the planned rollout of the project . Methods / design Project nurses will sequentially implement targeted cardiovascular case finding in a phased way across all general practice s , with the sequence of general practice s determined r and omly . This is a stepped wedge r and omised controlled trial design . The target population is patients aged 35 to 74 , without diabetes or cardiovascular disease whose ten-year cardiovascular risk , ( determined from data in their electronic records ) is ≥20 % . The primary outcome is the number of high risk patients started on treatment , because these data could be efficiently obtained from electronic primary care records . From this we can determine the effects of the case finding programme on the proportion of high risk patients started on treatment in practice s before and after implementation of targeted case finding . Cost-effectiveness will be modelled from the predicted effects of treatments on cardiovascular events and associated health service costs . Alongside the implementation it is intended to interview clinical staff and patients who participated in the programme in order to determine acceptability to patients and clinicians . Practical considerations meant that 26 practice s in S and well could be r and omised , including about 6,250 patients at high risk of cardiovascular disease . This gives sufficient power for evaluation . Discussion It is possible to design a stepped wedge r and omised controlled trial using routine data to determine the primary outcome to evaluate implementation of a cardiovascular prevention programme",
"BACKGROUND The aim of this study was to investigate the long-term effects of one general health screening on mortality . METHOD After stratification and r and omization of a population of 450,000 inhabitants , two groups were formed , an intervention group of 3064 people and a control group of 29,122 people . From the National Cause of Death Register , data were collected as regards death and causes of deaths for 1970 - 1990 . RESULTS Multivariate analysis was used to correct for known confounders . We then found no differences between the groups regarding deaths from all causes , cardiovascular diseases , cancer or accidents and poisoning . CONCLUSIONS One general health screening seems to have little , if any value in preventing fatal diseases",
"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",
"In the Study of Men Born in 1913 it was possible to investigate the influence of repeated health examinations on mortality in a prospect i ve cohort study . On January 1 , 1963 , 1010 men in the experimental grop and 1956 in the control group were alive . The experimental group took part in repeated examinations in 1963 , 1967 , 1973 and 1980 . Overt diseases were treated accordingly . Newly detected hypertension was also treated . By the end of a 15-year-long observation period , the cumulative mortality in the experimental group ( 14.5 % ) was not significantly lower than that in the control group ( 15.7 % ) . In the experimental group , 855 took part . The mortality was significantly higher in the non-participating group . The autopsy frequency decreased for in-hospital deaths but increased for deaths outside hospital during the study period",
"A clinical controlled trial was design ed to determine the impact of Automated Multiphasic Health Testing on morbidity and attitudes . Three strata comprising 574 families ( lower-income group enrolled in health maintenance organization , lower-income not enrolled in such a project , and a middle-income group employed by a utility company ) were interviewed to obtain information on utilization , morbidity , health status , and attitudes . Sixty percent of adults in each stratum were then screened . All families were interviewed again one year later . The only significant difference found between screened and non-screened subjects was an increase in nights hospitalized for screened subjects . Physicians were interviewed to determine what abnormalities were found and what treatment was required for project and privately referred patients of these physicians . Previously unknown abnormalities prompted retesting for confirmation in only 28 per cent of the cases and even less often led to treatment",
"Within a community-wide heart disease prevention effort , it was hypothesized that personalized risk factor screening and education would result in modified health behaviors and reduced risk factor levels for coronary heart disease . Adults from a population sample were r and omized to a community-wide screening and education program or were excluded from that program for 1 year . At the end of that year , both groups were measured for risk factor levels and related health behaviors . Those who received the screening and education program had significantly lower risk factor levels and other evidence of health behavior change , including lower blood cholesterol ( 206.9 vs 211.5 mg/dl ) , lower diastolic blood pressure ( 68.7 vs 70.0 mm Hg ) , lower resting heart rate ( 71.4 vs 72.7 bpm ) , and increased selection of low-fat and low-sodium meals in local restaurants . These data suggest that systematic risk factor screening and education may result in lower population risk for coronary heart disease",
"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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Recently , there is a growing interest in surgical variables that are intraoperatively controlled by orthopaedic surgeons , including lower leg alignment , component positioning and soft tissues balancing . Since more tight control over these factors is associated with improved outcomes of unicompartmental knee arthroplasty and total knee arthroplasty ( TKA ) , several computer navigation and robotic-assisted systems have been developed . Although mechanical axis accuracy and component positioning have been shown to improve with computer navigation , no superiority in functional outcomes has yet been shown . This could be explained by the fact that many differences exist between the number and type of surgical variables these systems control . Most systems control lower leg alignment and component positioning , while some in addition control soft tissue balancing . Finally , robotic-assisted systems have the additional advantage of improving surgical precision . A systematic search in PubMed , Embase and Cochrane Library result ed in 40 comparative studies and three registries on computer navigation reporting outcomes of 474,197 patients , and 21 basic science and clinical studies on robotic-assisted knee arthroplasty . Twenty-eight of these comparative computer navigation studies reported Knee Society Total scores in 3504 patients . Stratifying by type of surgical variables , no significant differences were noted in outcomes between surgery with computer-navigated TKA controlling for alignment and component positioning versus conventional TKA ( p = 0.63 ) . However , significantly better outcomes were noted following computer-navigated TKA that also controlled for soft tissue balancing versus conventional TKA ( mean difference 4.84 , 95 % Confidence Interval 1.61 , 8.07 , p = 0.003 ) . A literature review of robotic systems showed that these systems can , similarly to computer navigation , reliably improve lower leg alignment , component positioning and soft tissues balancing . Furthermore , two studies comparing robotic-assisted with computer-navigated surgery reported superiority of robotic-assisted surgery in controlling these factors . Manually controlling all these surgical variables can be difficult for the orthopaedic surgeon . Findings in this study suggest that computer navigation or robotic assistance may help managing these multiple variables and could improve outcomes . Future studies assessing the role of soft tissue balancing in knee arthroplasty and long-term follow-up studies assessing the role of computer-navigated and robotic-assisted knee arthroplasty are needed
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"A number of studies have reported a significant improvement of the postoperative alignment , when computer-navigated total knee arthroplasty ( TKA ) was compared with conventional techniques . However , no studies are available on the functional and patient-relevant outcomes after computer-assisted knee replacement . In a prospect i ve , r and omized trial comparing 27 computer-assisted TKAs with 25 conventional implantations , the Knee Society Score was used to assess functional status , and the WOMAC question naire was used to record the disease-specific , patient-relevant outcome . At a twelve-month follow-up no significant difference was detected between the two patient groups in either the scores or the number of complications and range of postoperative knee flexion . The results are in agreement with those reported in other studies on the effect of conventional TKA . With the patient group of this size it can be concluded that computer-navigated TKA gives short-term resuits comparable with those achieved by conventional methods of implantation",
"The optimal mode of fixation in total knee arthroplasty ( TKA ) is a subject of debate . We enrolled 100 TKA patients r and omized to cemented or cementless fixation . Knee Society Scores ( KSS ) , Oxford scores and pain visual analog scales ( VAS ) were collected pre-operatively and post-operatively . Two-year follow-up was obtained for 93 patients . The mean VAS trended higher for the cementless group at 4 months ( P=0.06 ) . At 2 years , the KSS functional scores , Oxford scores , and self-reported questions for satisfaction , less pain and better function were similar but the cemented group had higher KSS clinical scores ( 96.4 vs. 92.3 , P=0.03 ) . More radiolucencies were seen in cementless knees ( P revision for instability and one cemented knee was revised for infection . Cementless TKA showed equivalent survivorship ( revision for any reason as the endpoint ) compared to cemented TKA at this early follow-up . Close monitoring of radiolucencies is important with continued follow-up",
"INTRODUCTION The use of robotics in total knee arthroplasty ( TKA ) has been shown to minimise human error , as well as improve the accuracy and precision of component implantation and mechanical axis alignment . The present study aim ed to demonstrate that robot-assisted TKA using ROBODOC ® is safe and capable of producing a consistent and accurate postoperative mechanical axis . METHODS We prospect ively recruited 27 consecutive patients who underwent robot-assisted TKA between May and December 2012 . Two patients were excluded from the study due to intraoperative technical problems with the robot . Long-leg radiography and computed tomography were performed prior to surgery , and used for mechanical axis measurements and component sizing . DigiMatch ™ ROBODOC ® Surgical System software version 4.3.6 ( Curexo Technology Corp , Fremont , CA , USA ) was used in all cases to perform bone cuts in accordance with the preoperative plan . RESULTS The postoperative coronal mechanical alignment was within 3 degrees , with a mean alignment of -0.4 ± 1.7 degrees , confirming the accuracy of the preoperative surgical plan and bone cuts . The mean operating time was 96 ± 15 min , and preoperative planning yielded 100 % implant sizing accuracy . CONCLUSION Robotics has the potential to enable surgeons to consistently attain ideal postoperative alignment . The use of bone movement monitors and an integrated navigation system enhances the safety profile of ROBODOC ® by minimising errors . However , the role of the surgeon in TKA is still vital , as the surgeon is ultimately in charge of planning the surgery , its execution and ensuring soft tissue balance during TKA",
"The accuracy and efficiency of automated cutting guides in CAS systems have not been previously compared with conventional CAS techniques . Therefore , it is not yet clear if these more advanced technologies are warranted . We hypothesized that a novel automated cutting guide with CAS for total knee arthroplasty would be more efficient and more accurate than conventional navigation with sequential cutting blocks . Twelve cadaver legs were used in total . Each leg was r and omly assigned to either an automated guide positioning or a conventional freeh and computer-navigated guide positioning . The guide positions postosseous fixation and the final bone-cut surfaces were digitized and compared to the targeted cutting planes . The final location of the impacted trial implant was also digitized and compared to the planned implant location . The time for each step and the total time taken to prepare the femur were measured for both groups . The mean femoral preparation time was shorter with the automated cutting guide than the conventional method ( 5.5 min versus 13.8 min , p average deviation in the final bone resections from the planned resections was significantly lower for the automated cutting guide in the frontal/rotational plane ( 0.55 ° versus 1.1 ° ) , sagittal plane ( 0.75 ° versus 2.0 ° ) , and cut height direction ( 0.56 mm versus 1.6 mm ) . Therefore , based on these results , we concluded that automated cutting-guide positioning result ed in more efficient and more accurate femoral cuts in comparison to the conventional navigation method in a cadaveric model",
"Purpose Manufacturers of total knee arthroplasty ( TKA ) have introduced narrower femurs to improve bone-implant fit . However , few studies have reported the clinical consequences of mediolateral oversizing . Our hypothesis was that component oversizing negatively influences the results after TKA . Methods One hundred and twelve prospect ively followed patients with 114 consecutive TKA ( 64 females and 50 males ) were retrospectively assessed . The mean age of the patients was 72 years ( range , 56 to 85 years ) . The dimensions of the femur and tibia were measured on a preoperative CT-scan and were compared with those of the implanted TKA . The influence of size variation on the clinical outcomes 1 year after surgery was assessed . Results Mediolateral overhang was observed in at least one area in 66 % of the femurs ( 84 % in females and 54 % in males ) and 61 % of the tibia ( 81 % in females and 40 % in males ) . Twenty-two patients presented no overhang in any area and 16 had overhang in all studied zones . The increase in the Pain and KOOS scores were 43 ± 21 and 36 ± 18 in the patients without overhang and 31 ± 19 and 25 ± 13 in patients with overhang ( p = 0.033 ; p = 0.032 ) . Knee flexion was 127 ° ± 7 and 121 ° ± 11 , respectively . Regression and latent class analysis showed a significant negative correlation between overall oversizing and overall outcome . Conclusions This study confirms that oversizing may lead to worse clinical results in TKA . The clinical consequences are that surgeons should pay attention not to oversize implants during implantation nd that oversizing should be ruled out in case of so called unexplained pain . Level of evidence IV",
"Unicompartmental knee arthroplasty ( UKA ) allows replacement of a single compartment in patients with limited disease . However , UKA is technically challenging and relies on accurate component positioning and restoration of natural knee kinematics . This study examined the accuracy of dynamic , real-time ligament balancing using a robotic-assisted UKA system . Surgical data obtained from the computer system were prospect ively collected from 51 patients ( 52 knees ) undergoing robotic-assisted medial UKA by a single surgeon . Dynamic ligament balancing of the knee was obtained under valgus stress prior to component implantation and then compared to final ligament balance with the components in place . Ligament balancing was accurate up to 0.53 mm compared to the preoperative plan , with 83 % of cases within 1 mm at 0 ° , 30 ° , 60 ° , 90 ° , and 110 ° of flexion . Ligamentous laxity of 1.31 ± 0.13 mm at 30 ° of flexion was corrected successfully to 0.78 ± 0.17 mm ( P Robotic-assisted UKA allows accurate and precise reproduction of a surgical balance plan using dynamic , real-time soft-tissue balancing to help restore natural knee kinematics , potentially improving implant survival and functional outcomes ",
"This study was aim ed to compare robotic-assisted implantation of a total knee arthroplasty with conventional manual implantation . We controlled , r and omized , and review ed 72 patients for total knee arthroplasty assigned to undergo either conventional manual implantation ( excluding navigation-assisted implantation cases ) of a Zimmer LPS prosthesis ( Zimmer , Warsaw , Ind ) ( 30 patients : group 1 ) or robotic-assisted implantation of such a prosthesis ( 32 patients : group 2 ) . The femoral flexion angle ( gamma angle ) and tibial angle ( delta angle ) in the lateral x-ray of group 1 were 4.19 + /- 3.28 degrees and 89.7 + /- 1.7 degrees , and those of group 2 were 0.17 + /- 0.65 degrees and 85.5 + /- 0.92 degrees . The major complications were from improper small skin incision during a constraint attempt of minimally invasive surgery and during bulk fixation frame pins insertion . Robotic-assisted technology had definite advantages in terms of preoperative planning , accuracy of the intraoperative procedure , and postoperative follow-up , especially in the femoral flexion angle ( gamma angle ) and tibial flexion angle ( delta angle ) in the lateral x-ray , and in the femoral flexion angle ( alpha angle ) in the anteroposterior x-ray . But a disadvantage was the high complication rate in early stage",
"We conducted a prospect i ve , r and omized study to compare the short-term results of minimally invasive and computer-assisted total knee arthroplasty ( MICA-TKA ) with those of conventional total knee arthroplasty ( C-TKA ) for 12-month follow-up . A total of 87 subjects who met the inclusion and exclusion criteria of the study were prospect ively r and omized consecutively into two groups : the C-TKA group ( Group A , n = 44 ) and the MICA-TKA technique ( Group B , n = 43 ) . All the operations were performed by the same senior surgeon . Before surgery and at follow-up , patients were evaluated by the same observer . Tourniquet time as well as total blood loss was compared . Knee Society scores ( KSSs ) , Knee Society functional scores ( KSFSs ) , range of motion ( ROM ) , and radiographic results were assessed and reported preoperatively and at 12-month follow-up . Of these patients , 82 ( Group A 42 ; Group B 40 ) were available for 12-month evaluation . The two groups were found to be similar in terms of coronal mechanical axis . Similarly , the femoral rotational profile revealed that the prosthesis in Group A was implanted with similar internal rotation to Group B. The average blood loss in patients of Group B was significantly reduced as compared to patients of Group A. No significant difference was detected in terms of tourniquet time . Clinical results in Group B , with regard to ROMs and KSSs , as well as KSFSs were significantly superior to that in Group A. Based on the results obtained from this study , it is demonstrated that MICA-TKA leads to a similarly accurate restoration of leg alignment and component orientation compared to the C-TKA . Moreover , MICA-TKA produces superior clinical results to that of C-TKA . However , there is clearly a need for additional high- quality clinical trials with long-term follow-up to confirm the clinical benefits of MICA-TKA",
"We evaluated the influence of CT-free or CT-based computer assisted orthopaedic surgery ( CAOS ) on the alignment of total knee prostheses ( TK ) and micromotion of tibial components . This r and omised study compared 19 CT-free , 17 CT-based CAOS TK , and a matched control group of 21 conventionally placed TK . Using Roentgen stereophotogrammetric analysis ( RSA ) the migration was measured . The alignment and component positions were measured on radiographs . No significant difference in leg and tibial component alignment was present between the three groups . A significant difference was found for micromotion in subsidence , with the conventional group having a mean of 0.16 mm , compared to the CT-free group at 0.01 mm and the CT-based group at −0.05 mm . No clinical significant difference in alignment was found between CAOS and conventionally operated TK . More subsidence of the tibial component was seen in the conventional group compared to both CAOS groups at two year follow-up . RésuméBut de l'étude : Evaluer l'influence de la navigation avec ou sans scanner sur l'alignement des prothèses totales du genou et sur la micromobilité du composant tibial . Matériel et méthode : nous avons réalisé une étude r and omisée comparant 19 prothèses naviguées sans scanner , 17 prothèses naviguées avec scanner , croisées avec un groupe contrôle de 21 patients avec mise en place d'une prothèse par voie conventionnelle . Nous avons utilisé la méthode RSA pour mesurer la migration . L'alignement et les composants étaient mesurés sur les radiographies . Résultats : il n'y a pas de différence significative au niveau de l'alignement des composants pour les trois groupes , par contre il existe une différence significative en ce qui concerne la migration . Dans le groupe conventionnel celle-ci est d'environ 0,16 mm , 0,01 mm dans le groupe navigation sans scanner et 0,05 mm dans le groupe navigation avec scanner . Conclusion : il n'y a pas de différence significative dans l'alignement des prothèses totales du genou lors de la mise en place d'une prothèse totale avec ou sans navigation par contre , il existe une micromobilité avec petite migration du composant tibial si l'on compare le groupe conventionnel avec les groupes navigués",
"Purpose Computer-assisted surgery ( CAS ) for total knee arthroplasty ( TKA ) has become increasingly common over the last decade . There are several reports including meta-analyses that show improved alignment , but the clinical results do not differ . Most of these studies have used a bone referencing technique to size and position the prosthesis . The question arises whether CAS has a more pronounced effect on strict ligamentous referencing TKAs . Methods We performed a prospect i ve cohort study comparing clinical outcome of navigated TKA ( 43 patients ) with that of conventional TKA ( 122 patients ) . Patients were assessed preoperatively , and 2 and 12 months postoperatively by an independent study nurse using vali date d patient-reported outcome tools as well as clinical examination . Results At 2 months , there was no difference between the two groups . However , after 12 months , CAS was associated with significantly less pain and stiffness , both at rest and during activities of daily living , as well as greater overall patient satisfaction . Conclusion The present study demonstrated that computer-navigated TKA significantly improves patient outcome scores such as WOMAC score ( P = 0.002 ) and Knee Society score ( P = 0.040 ) 1 year after surgery in using a ligament referencing technique . Furthermore , 91 % were extremely or very satisfied in the CAS TKA group versus 70 % after conventional TKA ( P = 0.007 )",
"Background Navigation was introduced into total knee arthroplasty ( TKA ) to improve accuracy of component position , function and survival of implants . This study was design ed to assess the outcome of navigated TKA in comparison with conventional implantation with the focus on rotational component position and clinical mid-term results . Methods In a prospect ively r and omized single-blinded approach , 90 patients with primary gonarthrosis were assigned to three different groups . Thirty patients each were assigned to NexGen LPS without and with navigation ( groups 1 and 2 ) , and 30 patients to navigation with the Stryker Scorpio PS ( group 3 ) . The navigation system used was the imageless Stryker KneeTrac , version 1.0 . Clinical outcome was assessed by a blinded observer applying the Knee Society Score ( KSS ) and a visual analogue scale ( VAS ) for pain . CT scans and radiographs were conducted prior to and 12 weeks after index surgery . Results Seventy-nine patients were available for clinical evaluation at 3 ± 0.4 years follow-up . Four implants had to be revised for early loosening or infection ( 4.4 % ) . Four patients had died and three patients were not able to follow the invitation for clinical assessment . Functional results in the KSS were significantly lower after navigated TKA . Operation time and incisions with navigation were significantly longer . Significantly less radiological outliers with navigation were found for coronal alignment of the femur , only . Conclusion In this series , no beneficial effect for navigation in TKA could be shown assessing clinical data , as functional results in the presented series seemed to be lower after first generation navigated TKA . The clinical mid- to long-term value of navigation remains to be evaluated in larger patient series or meta-analyses at longer follow-up . Trial registration numberDRKS",
"Background A combination of two emerging technologies , computer-assisted navigation and minimally invasive surgery , in total knee arthroplasty has gained increasing interests from orthopedic surgeons around the world . To date , there has never been any midterm study for clinical and radiographic outcomes from using an electromagnetic computer-assisted navigation system . In this study , we aim ed to systematic ally compare clinical and radiographic outcomes of minimally invasive surgery in total knee arthroplasty ( MIS-TKA ) performed with and without electromagnetic computer-assisted navigation at immediate and midterm follow-ups . Methods A total of 151 patients ( 160 knees ) who underwent MIS-TKA were r and omized to be operated with electromagnetic computer-assisted navigation ( group I : 75 patients , 80 knees ) or without the navigation ( group II : 76 patients , 80 knees ) . The clinical and radiographic outcomes of immediate , 6-week postoperative follow-up and average 6.1-year follow-up were compared . Results On immediate , 6-week postoperative follow-up , clinical and radiographic outcomes did not reveal any difference between the two groups except for the fact that the operative time was longer in the navigation group . On 6.1-year follow-up , a total of 58 patients ( 63 knees ) from group I and 58 patients ( 61 knees ) from group II were reevaluated . There were no significant differences in clinical and radiographic loosening and in complications between the two groups . Conclusion In this study , no significant differences of clinical and radiographic outcomes were found for immediate and midterm follow-ups of MIS-TKA performed with and without electromagnetic computer-assisted navigation except for the additional operating time in the navigation group",
"Introduction : A functional total knee replacement has to be well aligned , which implies that it should lie along the mechanical axis and in the correct axial and rotational planes . Incorrect alignment will lead to abnormal wear , early mechanical loosening , and patellofemoral problems . There has been increased interest of late in total knee arthroplasty with robotic assistance . This study was conducted to determine whether robot-assisted total knee arthroplasty is superior to the conventional surgical method with regard to the precision of implant positioning . Material s and Methods : Twenty knee replacements , comprising ten robot-assisted procedures and ten conventional operations , were performed on ten cadavers . Two experienced surgeons performed the surgeries . Both procedures on each cadaver were performed by the same surgeon . The choice of which procedure was to be performed first was r and omized . Following implantation of the prosthesis , the mechanical axis deviation , femoral coronal angle , tibial coronal angle , femoral sagittal angle , tibial sagittal angle , and femoral rotational alignment were measured via 3D CT scanning . These variables were then compared with the preoperatively planned values . Results : In the knees that underwent robot-assisted surgery , the mechanical axis deviation ranged from −1.94 ° to 2.13 ° ( mean : −0.21 ° ) , the femoral coronal angle from 88.08 ° to 90.99 ° ( mean : 89.81 ° ) , the tibial coronal angle from 89.01 ° to 92.36 ° ( mean : 90.42 ° ) , the tibial sagittal angle from 81.72 ° to 86.24 ° ( mean : 83.20 ° ) , and the femoral rotational alignment from 0.02 ° to 1.15 ° ( mean : 0.52 ° ) in relation to the transepicondylar axis . In the knees that underwent conventional surgery , the mechanical axis deviation ranged from −3.19 ° to 3.84 ° ( mean : −0.48 ° ) , the femoral coronal angle from 88.36 ° to 92.29 ° ( mean : 90.50 ° ) , the tibial coronal angle from 88.15 ° to 91.51 ° ( mean : 89.83 ° ) , the tibial sagittal angle from 80.06 ° to 87.34 ° ( mean : 84.50 ° ) , and the femoral rotational alignment from 0.32 ° to 4.13 ° ( mean : 2.76 ° ) in relation to the transepicondylar axis . In the conventional knee replacement group , there were two instances of outliers outside the range of 3 ° varus/valgus for the mechanical axis deviation . The robot-assisted knee replacements showed significantly superior femoral rotational alignment results compared with conventional surgery ( p = 0.006 ) . There was no statistically significant difference between robot-assisted and conventional total knee arthroplasty with regard to the other variables . All the measurements showed high intra-observer and inter-observer reliability . Conclusion : Robot-assisted total knee arthroplasty showed excellent precision in the sagittal and coronal planes of the 3D CT scan . In particular , the robot-assisted technique showed better accuracy in femoral rotational alignment compared to the conventional surgery , despite the fact that the surgeons who performed the operations were more experienced and familiar with the conventional method than with robot-assisted surgery . It can thus be concluded that robot-assisted total knee arthroplasty is superior to conventional total knee arthroplasty",
"The purpose of this study was to determine whether differences in clinical , functional , or radiographic outcomes existed at 5-year follow-up between patients who underwent computer-assisted or manual total knee arthroplasty ( TKA ) . Seventy-eight consecutive TKAs were performed by a single surgeon who had extensive experience performing computer-assisted and manual TKA . The manual group ( n=40 ) and computer-assisted group ( n=38 ) were similar with regard to age , sex , diagnosis , body mass index , surgical technique , implants , perioperative management , Knee Society scores , and anteroposterior mechanical axis . Sixty-three ( manual group , n=34 ; computer-assisted group , n=29 ) patients were available for final follow-up . At 5-year follow-up , no statistically significant differences were found in Knee Society knee score ( P=.289 ) , function score ( P=.272 ) , range of motion ( P=.284 ) , pain score ( P=.432 ) , or UCLA activity score ( P=.109 ) between the 2 groups . Postoperative radiographs showed a significant difference in the mechanical axis ( P=.004 ) between the 2 groups ; however , both groups achieved a neutral mechanical axis of ±3 ° ( computer-assisted group mean , 2.0 ° ; manual group mean , -0.24 ° ).When TKA was performed by an experienced surgeon , no significant difference was identified at 5-year follow-up between patients who underwent computer-assisted vs manual TKA",
"Purpose The use of computer-assisted surgery ( CAS ) in total knee arthroplasty ( TKA ) results in better limb and implant alignment compared to conventional TKA ; however , it is unclear whether this translates to better mid- to long-term clinical outcome . This prospect i ve r and omised study comparing CAS and conventional TKA reports the functional and patient perceived outcomes at a follow-up of 5 years . The hypothesis was that there would be a difference in functional outcome or quality of life after mid-term follow-up . Methods Sixty-seven patients were available for physical and radiological examination at 5 years . The Knee Society Score ( KSS ) was used to describe functional outcome and the Euroquol question naire for quality of life . Results The mean total KSS for the CAS group improved from 91.1 ( SD 22.3 ) points preoperatively to 157.4 ( SD 21.9 ) and 150.2 ( SD 30.4 ) points at 2 and 5 years , respectively . In the conventional group , the mean total KSS was 99.6 ( SD 18.6 ) points preoperatively and 151.1 ( SD 26.0 ) and 149.0 ( SD 28.0 ) points at 2 and 5 years , respectively . The mean quality of life score improved from 48.2 ( SD 16.5 ) points preoperatively to 67.4 ( SD 16.3 ) and 66.8 ( SD 22.2 ) points at 2 and 5 years in the CAS group , and from 52.2 ( SD 17.1 ) points preoperatively to 65.6 ( SD 14.6 ) and 61.7 ( SD 19.3 ) points at 2 and 5 years , respectively , in the conventional TKA group . These differences were not statistically significant . There were radiolucent lines up to 2 mm in 11 knees ( four CAS , seven conventional ) , but there were no changes in implant position . Conclusions There were no significant differences in functional or patient perceived outcome after mid-term follow-up in this study .Level of evidence",
"BACKGROUND The literature lacks studies that confirm whether the improved radiographic alignment that can be achieved with computer-navigated total knee arthroplasty improves patients ’ activities of daily living or the durability of total knee prostheses . The purpose of this study was to determine whether computer-navigated total knee arthroplasty improves the clinical function , alignment , and survivorship of the components . METHODS We prospect ively compared the results of 520 patients with osteoarthritis who underwent computer-navigated total knee arthroplasty for one knee and conventional total knee arthroplasty for the other . The assignment of the knee to navigation or not was done r and omly . There were 452 women ( 904 knees ) and sixty-eight men ( 136 knees ) with a mean age of sixty-eight years ( range , forty-nine to eighty-eight years ) at the time of the index arthroplasty . The mean follow-up period was 10.8 years ( range , ten to twelve years ) . The patients were assessed clinical ly and radiographically with the rating system of the Knee Society and with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) score at three months , one year , and annually thereafter . RESULTS Total knee scores , knee function scores , pain scores , WOMAC scores , knee motion , and activity scores did not show statistically significant differences between the two groups preoperatively or at the time of the final follow-up . Alignment and the survivorship of the components were not significantly different between the two groups . The Kaplan-Meier survivorship with revision as the end point at 10.8 years was 98.8 % ( 95 % confidence interval [ CI ] , 0.96 to 1.00 ) in the computernavigated total knee arthroplasty group and 99.2 % ( 95 % CI , 0.96 to 1.00 ) in the conventional total knee arthroplasty group . CONCLUSIONS Our data demonstrated no difference in clinical function or alignment and survivorship of the components between the knees that underwent computer-navigated total knee arthroplasty and those that underwent conventional total knee arthroplasty",
"Background Several studies have shown mechanical alignment influences the outcome of TKA . Robotic systems have been developed to improve the precision and accuracy of achieving component position and mechanical alignment . Questions / purpose sWe determined whether robotic-assisted implantation for TKA ( 1 ) improved clinical outcome ; ( 2 ) improved mechanical axis alignment and implant inclination in the coronal and sagittal planes ; ( 3 ) improved the balance ( flexion and extension gaps ) ; and ( 4 ) reduced complications , postoperative drainage , and operative time when compared to conventionally implanted TKA over an intermediate-term ( minimum 3-year ) followup period . Methods We prospect ively r and omized 100 patients who underwent unilateral TKA into one of two groups : 50 using a robotic-assisted procedure and 50 using conventional manual techniques . Outcome variables considered were postoperative ROM , WOMAC scores , Hospital for Special Surgery ( HSS ) knee scores , mechanical axis alignment , flexion/extension gap balance , complications , postoperative drainage , and operative time . Minimum followup was 41 months ( mean , 65 months ; range , 41–81 months ) . Results There were no differences in postoperative ROM , WOMAC scores , and HSS knee scores . The robotic-assisted group result ed in no mechanical axis outliers ( > ± 3 ° from neutral ) compared to 24 % in the conventional group . There were fewer robotic-assisted knees where the flexion gap exceeded the extension gap by 2 mm . The robotic-assisted procedures took an average of 25 minutes longer than the conventional procedures but had less postoperative blood drainage . There were no differences in complications between groups . Conclusions Robotic-assisted TKA appears to reduce the number of mechanical axis alignment outliers and improve the ability to achieve flexion-extension gap balance , without any differences in clinical scores or complications when compared to conventional manual techniques . Level of Evidence Level I , therapeutic study . See Instructions for Authors for a complete description of levels of evidence",
"We previously compared the component alignment in total knee replacement using a computer-navigated technique with a conventional jig-based method . We r and omly allocated 71 patients to undergo either computer-navigated or conventional replacement . An improved alignment was seen in the computer-navigated group . The patients were then followed up post-operatively for two years , using the Knee Society score , the Short Form-36 health survey , the Western Ontario and McMaster Universities osteoarthritis index , the Bartlett Patellar pain question naire and the Oxford knee score , to assess functional outcome . At two years post-operatively 60 patients were available for assessment , 30 in each group and 62 patients completed a postal survey . No patient in either group had undergone revision . All variables were analysed for differences between the groups either by Student 's t-test or the Mann-Whitney U test . Differences between the two groups did not reach significance for any of the outcome measures at any time point . At two years postoperatively , the frequency of mild to severe anterior pain was not significantly different ( p = 0.818 ) , varying between 44 % ( 14 ) for the computer-navigated group , and 47 % ( 14 ) for the conventionally-replaced group . The Bartlett Patellar score and the Oxford knee score were also not significantly different ( t-test p = 0.161 and p = 0.607 , respectively ) . The clinical outcome of the patients with a computer-navigated knee replacement appears to be no different to that of a more conventional jig-based technique at two years post-operatively , despite the better alignment achieved with computer-navigated surgery",
"Purpose The objective of this prospect i ve study was to compare the functional outcome of conventional measured resection technique and computer-assisted gap balancing technique in TKA . Methods 140 patients were r and omized into two groups . The conventional measured resection technique without computer navigation was performed in Group 1 and the computer-assisted gap balancing technique in Group 2 . Range of motion , clinical laxity assessment with KT-1000 arthrometer , postoperative radiological films and various functional knee scores were documented at 6 months and 2 years . Results At 2 years , there were significantly more patients ( five patients , 7 % ) in the Group 1 with flexion contractures of more than 5 ° ( P = 0.05 ) . There were significantly more outliers in the Group 1 ( eight patients , 11 % ) , who demonstrated anterior tibial translation > 5 mm , than Group 2 ( two patients , 3 % ) ( P = 0.041 ) . The total excursion at 20 ° was significantly higher in Group 1 at 6 months ( P = 0.012 ) and after 2 years ( P = 0.031 ) . Group 2 was able to demonstrate significantly better limb alignment with fewer outliers ( more than 3 ° varus/valgus ) than Group 1 . At 6-month follow-up , Group 2 demonstrated better outcomes in Function Score ( P = 0.040 ) and Total Oxford Score ( P = 0.031 ) . At 2-year review , Group 2 had better outcome in the Total Oxford Score ( 0.030 ) . Conclusion Computer-assisted gap balancing technique was able to achieve more precise soft tissue balance and restoration of limb alignment with better knee scores as compared to the conventional measured resection technique in total knee arthroplasty . Level of evidence",
"In a prospect i ve r and omized control trial comparing computer-assisted vs conventional total knee arthroplasty , we previously reported that patients with coronal alignment within 3 ° of neutral had superior international knee society and Short-Form 12 ( SF-12 ) physical scores at 6 weeks , 3 months , 6 months , and 12 months after surgery . Computer-assisted total knee arthroplasty achieved greater accuracy in implant alignment , and this correlated with better knee function and quality of life . At 5 years , 90 of 111 patients assessed in our original study were review ed . Coronal alignment within 3 ° of neutral continued to be correlated with superior International Knee Society and SF-12 scores . Coronal alignment greater than 3 ° was associated with a significant decline in SF-12 mental health scores",
"The most common reasons for revision of unicompartmental knee arthroplasty ( UKA ) are loosening and pain . Cementless components may reduce the revision rate . The aim of this study was to compare the fixation and clinical outcome of cementless and cemented Oxford UKAs . A total of 43 patients were r and omised to receive either a cemented or a cementless Oxford UKA and were followed for two years with radiostereometric analysis ( RSA ) , radiographs aligned with the bone-implant interfaces and clinical scores . The femoral components migrated significantly during the first year ( mean 0.2 mm ) but not during the second . There was no significant difference in the extent of migration between cemented and cementless femoral components in either the first or the second year . In the first year the cementless tibial components subsided significantly more than the cemented components ( mean 0.28 mm ( sd 0.17 ) vs. 0.09 mm ( sd 0.19 mm ) ) . In the second year , although there was a small amount of subsidence ( mean 0.05 mm ) there was no significant difference ( p = 0.92 ) between cemented and cementless tibial components . There were no femoral radiolucencies . Tibial radiolucencies were narrow ( cementless ( 6 of 21 ) than cemented ( 13 of 21 ) components at two years . There were no complete radiolucencies with cementless components , whereas five of 21 ( 24 % ) cemented components had complete radiolucencies . The clinical scores at two years were not significantly different ( p = 0.20 ) . As second-year migration is predictive of subsequent loosening , and as radiolucency is suggestive of reduced implant-bone contact , these data suggest that fixation of the cementless components is at least as good as , if not better than , that of cemented devices",
"Purpose . To compare the short-term functional outcome after computer-assisted total knee arthroplasty ( TKA ) versus conventional TKA . Methods . 23 men and 67 women aged 48 to 80 years were r and omised to undergo ( 1 ) conventional TKA using an intramedullary guide , ( 2 ) conventional TKA using an extramedullary guide , or ( 3 ) computer-assisted TKA . Two senior surgeons performed all the TKAs using the same TKA system and the st and ard anteromedial arthrotomy with eversion of the patella . Patients were assessed by physiotherapists before and 6 months and 2 years after TKA using the Short Form-36 Health Survey , Oxford Knee Score , and Knee Society Score . Results . Of the 90 patients , 67 and 70 were assessed at 6 months and 2 years after TKA , respectively . No patient developed deep infection or required revision surgery . Functional outcomes of the 3 groups did not differ significantly at the corresponding follow-ups . Conclusion . Significant improvement in the functional outcome was not shown in patients treated with computer-assisted TKA , compared with conventional TKA . Thus , computer-assisted TKA has limited additional short-term benefits . Further studies with longer follow-up are required to examine the benefits of computer-assisted TKA",
" Seventy-one patients were r and omly allocated to undergo either computer-navigated or conventional arthroplasty . A statistically significant improvement in alignment was seen in the computer-navigated cohort . Five-year functional outcome was assessed using the Knee Society , Short Form-36 , Western Ontario and McMaster Universities Osteoarthritis Index , and a patient satisfaction score . At 5 years , 46 patients were available for assessment ( 24 navigated and 22 conventional knees ) . No patients had undergone revision . No statistically significant difference was seen in any component of any measure of outcome between navigated and conventional cohorts . Longitudinal data showed function to be well maintained with no difference in functional score between 2 and 5 years in either cohort . Despite achieving better alignment , 5 years postoperatively , the functional outcome with computer-navigated knee arthroplasty appears to be no different to that implanted using a conventional jig-based technique",
"This report compares the radiologic and early clinical results of total knee arthroplasty ( TKA ) performed by the same surgeon using 3 techniques . In this prospect i ve study , 75 knees were r and omized to conventional technique ( 25 knees ) , image-free navigation system ( 25 knees ) , or minimally invasive surgery ( MIS ) ( 25 knees ) . Age range of the 43 women ( 65 knees ) and 5 men ( 10 knees ) was 58 to 81 years . Posterior stabilized knee prosthesis was used in all patients . Data was collected according to Knee Society System for radiologic evaluation of x-rays . Knee Society clinical ( KS-C ) and functional knee scores were measured preoperatively and at 6 weeks , 3 months , 6 months , 1 year , and 2 years . The postoperative KS-C was not statistically better in the MIS group ( mean , 88 ± 11.5 ; range , 70 - 100 ) than the conventional ( mean , 85.9 ± 7.8 ; range , 74 - 94 ) ( P=.68 ) or navigation group ( mean , 85 ± 11 ; range , 63 - 100 ) ( P=.59 ) . Mean postoperative delta ( mechanical axis ) angle was significantly different ( P=.014 ) : 2.38 ° in the conventional group ( SD=2.88 ° ; 95 % CI , 1.19 ° -3.57 ° ; range , -1.59 ° to 6.86 ° ) , 0.61 ° in the navigation group ( SD=2.07 ° ; 95 % CI , -0.24 ° to 1.46 ° ; range , -2.07 ° to 4.25 ° ) , and 4.25 ° in the MIS group ( SD=6.52 ° ; 95 % CI , 1.56 ° -6.94 ° ; range , -6.72 ° to 15.60 ° ) . Significant difference could be elicited between navigation-assisted and MIS groups , with navigation-assisted surgery providing more accurate alignment of the mechanical axis ( P=.014 ) . Of the three techniques , navigation-assisted surgery gives superior prosthesis alignment and promising longevity of TKA",
"We performed a prospect i ve , r and omised controlled trial of unicompartmental knee arthroplasty comparing the performance of the Acrobot system with conventional surgery . A total of 27 patients ( 28 knees ) awaiting unicompartmental knee arthroplasty were r and omly allocated to have the operation performed conventionally or with the assistance of the Acrobot . The primary outcome measurement was the angle of tibiofemoral alignment in the coronal plane , measured by CT . Other secondary parameters were evaluated and are reported . All of the Acrobot group had tibiofemoral alignment in the coronal plane within 2 degrees of the planned position , while only 40 % of the conventional group achieved this level of accuracy . While the operations took longer , no adverse effects were noted , and there was a trend towards improvement in performance with increasing accuracy based on the Western Ontario and McMaster Universities Osteoarthritis Index and American Knee Society scores at six weeks and three months . The Acrobot device allows the surgeon to reproduce a pre-operative plan more reliably than is possible using conventional techniques which may have clinical advantages",
"We compared postoperative flexion contracture in navigated total knee arthroplasty ( TKA ) versus conventional TKA . Two groups ( Group 1 : conventional , Group 2 : navigated ) of 235 consecutive patients matched for age and gender were retrospectively compared . Range of motion , mechanical axes , Knee Society Scores , Oxford Knee Scores and Short Form-36 ® ( SF-36 ) scores were collected prospect ively and compared preoperatively and at 2years following TKA . At 2years , patients who underwent navigated TKA averaged significantly lesser flexion contracture of 1 degree compared to 6 degrees in patients who underwent conventional TKA . There were a significantly larger proportion of outliers in the conventional group . Computer navigation results in less severe flexion contracture and less frequent flexion contracture of more than 5 degrees as compared to conventional techniques ",
"BACKGROUND Unicompartmental knee arthroplasty(UKA ) has become a treatment of choice for many patients with isolated unicomparmental arthritis due to its specific advantages over total knee arthroplasty , but few studies have compared conventional and navigational UKA with similar instrumentation on mid- to long-term results . We investigated whether the use of imageless navigation can improve implant positioning and clinical outcomes of UKA at a long-term follow-up compared to the conventional technique . METHODS We prospect ively studied clinical and radiological results in 68 patients with an average age of 64.0 years ( range , 50 to 81 years ) who received UKA between January 2003 and December 2005 using the conventional or navigational technique . Clinical evaluations were performed preoperatively and the last follow-up included knee range of motion , Hospital for Special Surgery ( HSS ) scores , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) scores and Visual Analogue Scale ( VAS ) pain score . For radiologic evaluation , the mechanical alignment of the lower limb was measured using mechanical femoro-tibial angle ( mFTA ) and Kennedy protocol . RESULTS After an average 9-year follow-up ( range , 7.4 to 10.8 years ) , the navigation group showed better coronal alignments of the components , fewer radiological outliers and better clinical scores , but similar estimated 10-year prosthesis survival rates . CONCLUSION This study indicates that the use of navigation significantly contributes to the desired mechanical axis and improved component placement as compared to the conventional technique . LEVEL OF EVIDENCE Prospect i ve comparative study , Level III",
"This prospect i ve study describes the outcome of the first 1000 phase 3 Oxford medial unicompartmental knee replacements ( UKRs ) implanted using a minimally invasive surgical approach for the recommended indications by two surgeons and followed up independently . The mean follow-up was 5.6 years ( 1 to 11 ) with 547 knees having a minimum follow-up of five years . At five years their mean Oxford knee score was 41.3 ( sd 7.2 ) , the mean American Knee Society Objective Score 86.4 ( sd 13.4 ) , mean American Knee Society Functional Score 86.1 ( sd 16.6 ) , mean Tegner activity score 2.8 ( sd 1.1 ) . For the entire cohort , the mean maximum flexion was 130 ° at the time of final review . The incidence of implant-related re-operations was 2.9 % ; of these 29 re-operations two were revisions requiring revision knee replacement components with stems and wedges , 17 were conversions to a primary total knee replacement , six were open reductions for dislocation of the bearing , three were secondary lateral UKRs and one was revision of a tibial component . The most common reason for further surgical intervention was progression of arthritis in the lateral compartment ( 0.9 % ) , followed by dislocation of the bearing ( 0.6 % ) and revision for unexplained pain ( 0.6 % ) . If all implant-related re-operations are considered failures , the ten-year survival rate was 96 % ( 95 % confidence interval , 92.5 to 99.5 ) . If only revisions requiring revision components are considered failures the ten-year survival rate is 99.8 % ( confidence interval 99 to 100 ) . This is the largest published series of UKRs implanted through a minimally invasive surgical approach and with ten-year survival data . The survival rates are similar to those obtained with a st and ard open approach whereas the function is better . This demonstrates the effectiveness and safety of a minimally invasive surgical approach for implanting the Oxford UKR",
"Purpose We performed this study to determine whether the use of imageless navigation reduces revision rates after total knee arthroplasty ( TKA ) . Methods Data of 1,121 consecutive primary TKA with a follow-up of one to six years were retrospectively analysed . Following the conversion of the st and ard technique from conventional to navigated procedures , these data included the last 342 conventional and first 779 navigated procedures performed in our clinic . Demographic and perioperative covariates were recorded . All patients were asked by post to report instances of revisions . Results Data of 1,054 patients ( 94 % ) were complete . Mean follow-up was 3.9 years for conventional and 2.4 years for navigated operations . Cumulative revision rate averaged 4.7 % for conventional and 2.3 % for navigated procedures . Cox ’s proportional hazard model was used to assess the effect of covariates on survival , result ing in significantly lower revision rates for older patients ( p reduced revision rate for navigated operations was mainly caused by a significantly reduced rate of aseptic implant loosening ( 1.9 % vs. 0.1 % , p = 0.024 ) . Conclusions Our study showed lower revision rates when computer navigation was used . However , due to the retrospective uncontrolled design , further prospect i ve trials will be necessary to further evaluate this effect",
"Purpose . To compare the 2-year outcome of total knee arthroplasty ( TKA ) using the measured resection versus the gap balancing techniques . Methods . 21 men and 31 women aged 41 to 89 ( mean , 73 ) years who underwent primary TKA by a single surgeon for osteoarthritis and had an American Society of Anesthesiologists I or II physical status were prospect ively studied . Patients were r and omised to undergo computer-assisted TKA using the measured resection technique ( n=26 ) or the gap balancing technique ( n=26 ) . At the 2-year followup , patients were assessed by a single orthopaedic registrar blinded to the type of surgery using the Knee Society score ( KSS ) , functional Knee Society score ( FKSS ) , and revised Oxford Knee score ( ROKS ) . Results . In the measured resection group , the mean KSS , FKSS , and ROKS increased from 34.3 , 48 , and 21 to 85.9 , 89.6 , and 36.5 , respectively . In the gap balancing group , the respective scores increased from 35.4 , 50 , and 22.5 to 89.1 , 92.4 , and 40.6 . Postoperative with the gap balancing technique ; the respective p values were 0.46 , 0.44 , and 0.12 . Conclusion . Improvements in the knee scores were comparable with the 2 techniques",
"In the literature , studies of computer-assisted total knee arthroplasty ( TKA ) after mid-term period are not conclusive and long-term data are rare . In a prospect i ve , r and omized , comparative study 100 conventional TKAs ( group REG ) were compared with 100 computer-assisted TKAs ( group NAV ) . Minimum follow-up was 5years . No difference in implant failure was found with 1.1 % in group NAV versus 4.6 % in group REG ( P=0.368 ) . Group NAV showed a significantly less mean deviation of mechanical limb axis ( P=0.015 ) , more TKAs ( 90 % versus 81 % in group REG ) were within 3 ° varus/valgus and a higher tibial slope and lateral distal femoral angle ( LDFA ) accuracy was found ( P≤0.034 ) . Clinical investigational parameters showed no differences ( P≥0.058 ) . Insall and HSS score total were also higher in group NAV ( P≤0.016 )",
"Increasing evidence suggests performing total knee arthroplasty using computer navigation can lead to more accurate surgical positioning of the components and knee alignment compared to a conventional operating technique without computer assistance . The use of robotic technology could theoretically take this accuracy one level further because it uses navigation in combination with ultimate mechanical precision , which could eliminate or reduce the inevitable margin of error during mechanical preparation of the bony cuts of total knee arthroplasty by the surgeon . We prospect ively followed 25 consecutive cases using an active surgical robot . The minimum followup was 5.1 years ( mean , 5.5 years ; range , 5.1 - 5.8 years ) . Our results demonstrate excellent implant positioning and alignment was achieved within the 1 ° error of neutral alignment in all three planes in all cases . Despite this technical precision , the excessive operating time required for the robotic implantation , the technical complexity of the system , and the extremely high operational costs have led us to ab and on this procedure and direct our interest more toward smart semiactive robotic systems . Level of Evidence : Level IV , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence",
" A total of 208 patients were enrolled in a multicenter , prospect i ve r and omized , institutional review board-approved study that compared preoperative surgical plan to postoperative 2-dimensional radiographic alignment measured by a blinded review er for primary total knee arthroplasty ( TKA ) implanted using computer-assisted surgery ( CAS ) compared with conventional TKA instrumentation . The results demonstrated a statistically significant improvement in the coronal tibial component alignment ( P the mechanical axis , femoral coronal/sagittal , and tibial sagittal alignment . Knee Society Score knee and function scores and 6-minute walk test were equivalent between the 2 treatment groups at all postoperative intervals . There was a statistically significant increase in the skin-skin time ( P the time until first bone cut ( P CAS knees compared with those implanted with conventional instrumentation . The use of CAS in this r and omized clinical trial conducted at high-volume centers did not offer a clinical ly meaningful improvement in postoperative alignment , clinical , functional , or safety outcomes compared with conventional TKA",
"Total knee replacement ( TKR ) is a common procedure for treatment of severe gonarthrosis , but the outcome may be unsatisfactory due to primary malalignment of the prosthetic components . In order to improve precision and accuracy of this surgical procedure , a commercial robotic surgical system ( CASPAR ) has been adapted to assist the surgeon in the preoperative planning and intraoperative execution of TKR . So far , 70 patients with idiopathic gonarthrosis were successfully treated with a robot-assisted technique in our institution . No major adverse events related to the use of the robotic system have been observed . The mean difference between preoperatively planned and postoperatively achieved tibiofemoral alignment was 0.8 degrees ( 0 - 4.1 degrees ) in the robotic group vs. 2.6 degrees ( 0 - 7 degrees ) in a manually operated historical control group of 50 patients . A clear advantage of robot-assisted TKR seems to be the ability to execute a highly precise preoperative plan based on computed tomography ( CT ) scans . Due to better alignment of the prosthetic components and improved bone-implant fit , implant loosening is anticipated to be diminished which may be most evident in non-cemented prostheses . Current disadvantages such as the need for placement of fiducial markers , increased operating times and higher overall costs have to be resolved in the future",
"Robot-assisted Total Knee Arthroplasty ( TKA ) improves the accuracy and precision of component implantation and mechanical axis ( MA ) alignment . Joint-line restoration in robot-assisted TKA is not widely described and joint-line deviation of>5 mm results in mid-flexion instability and poor outcomes . We prospect ively r and omised 60 patients into two groups : 31 patients ( robot-assisted ) , 29 patients ( conventional ) . No MA outliers ( > ±3 ° from neutral ) or notching was noted in the robot-assisted group as compared with 19.4 % ( P=0.049 ) and 10.3 % ( P=0.238 ) respectively in the conventional group . The robot-assisted group had 3.23 % joint-line outliers ( > 5 mm ) as compared to 20.6 % in the conventional group ( P=0.049 ) . Robot-assisted TKA produces similar short-term clinical outcomes when compared to conventional methods with reduction of MA alignment and joint-line deviation outliers",
"BACKGROUND Studies on minimally invasive computer-assisted total knee arthroplasty ( MICA-TKA ) have shown promising results , but are limited by short follow-up . The purpose of this study was to compare the midterm radiographic features and functional outcomes between patients who underwent MICA-TKA and conventional TKA . METHODS A total of 108 patients who were r and omized to undergo MICA-TKA or conventional TKA during 2004 and 2005 were contacted for a prospect i ve follow-up review . Patients who were lost to contact , have passed away , or declined to participate in the study were excluded . Objective functional measurements and radiographs were obtained for assessment . RESULTS By the time of this study , 2 patients from the conventional group had undergone revision TKA , one due to infection and one due to aseptic loosening . A total of 67 patients ( 62.04 % ) were followed up for an average period of 9.07 years ( 8.51 - 9.61 years ) . At follow-up , functional scores were comparable between the 2 groups . No significant intergroup differences were found in mechanical knee alignment and component placement angle in the coronal views . No statistical or clinical significance were noticed in radiographic signs of component loosening . CONCLUSIONS MICA-TKA provided similar clinical , functional , and radiographic outcomes compared with conventional TKA after an average of 9-year follow-up . This technique can be used to exploit its short-term advantages without compromising midterm outcomes"
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Postural instability is common in Parkinson ’s disease ( PD ) , often contributing to falls , injuries , and reduced mobility . In the clinical setting , balance disorder is commonly diagnosed using clinical tests and balance scales , but it is suggested that the most sensitive measurement is the force platform . The aim of this systematic review was to summarize the methods and various posturographic procedures used to assess the body balance and gait in PD . A systematic review was conducted of papers published from 2000 to 2017 . Data bases search ed were PubMed and EBSCO . Studies must have involved patients with PD , used force platform or motion analysis system as a measurement tool , and described posturographic procedure . The Physiotherapy Evidence Data base ( PEDro ) scale was used to assess the method ological quality of the included studies . A total of 32 studies met the inclusion criteria . The PEDro scores ranged from 5 to 7 points . The analysis of the objective methods assessing balance disorders revealed a large discrepancy in the duration and procedures of measurements . The number of repetitions of each trial fluctuated between 1 and 8 , and the duration of a single trial ranged from 10 to 60 seconds . Overall , there are many scales and tests used to assess the balance disorders and disabilities of people with PD . Although in many included studies the authors have used posturography as a method to evaluate the postural instability of PD patients , the results are contradictory . To solve this issue , it is indicated to establish a “ gold st and ard ” of procedures of measures of balance
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"Abstract Judgement of the ability to recover balance after a sudden shoulder pull is used as a clinical measure of postural instability in Parkinson ’s disease . To further evaluate its merits , we compared this ‘ retropulsion test ’ with dynamic posturography in 23 Parkinson patients . Dynamic posturography involved 20 serial ‘ toe-up ’ support surface rotations , which induced backward body sway . We found a moderate correlation ( Spearman ’s ρ = 0.54 ; P between the retropulsion test and body sway after platform rotations during the ‘ off ’ phase , but no correlation during the ‘ on ’ phase ( Spearman ’s ρ = 0.43 ; P = 0.11 ) . These results cast doubt on the use of the retropulsion test as a measure of postural instability in Parkinson ’s disease",
"The evidence -based medicine ( EBM ) related concepts of hierarchy of evidence , meta-analyses , confidence intervals , study design , etc . are nowadays so widespread , that clinicians willing to use today 's medical literature with underst and ing have no choice but to become familiar with EBM principles and method ologies . Although surgeons may perceive that evidence -based medicine m and ates a strict adherence to r and omised trials , it more accurately involves informed and effective use of all types of evidence ( from meta- analysis of r and omised trials to individual case series and case reports . With the ever-increasing amount of available information , surgeons must consider a shift in paradigm from traditional practice to one that involves question formulation , validity assessment of available studies and appropriate application of research evidence to individual patients",
"Underlying somatosensory processing deficits of joint rotation velocities may cause patients with Parkinson ’s disease ( PD ) to be more unstable for fast rather than slow balance perturbations . Such deficits could lead to reduced proprioceptive amplitude feedback triggered by perturbations , and thereby to smaller or delayed stabilizing postural responses . For this reason , we investigated whether support surface perturbation velocity affects balance reactions in PD patients . We examined postural responses of seven PD patients ( OFF medication ) and eight age-matched controls following backward rotations of a support-surface platform . Rotations occurred at three different speeds : fast ( 60 deg/s ) , medium ( 30 deg/s ) or slow ( 3.8 deg/s ) , presented in r and om order . Each subject completed the protocol under eyes open and closed conditions . Full body kinematics , ankle torques and the number of near-falls were recorded . Patients were significantly more unstable than controls following fast perturbations ( 26 % larger displacements of the body ’s centre of mass ; P near-falls occurred in patients for fast rotations . Balance correcting ankle torques were weaker for patients than controls on the most affected side , but were stronger than controls for the least affected side . These differences were present both with eyes open and eyes closed ( P greater instability and discriminated Parkinson patients better from controls than slow rotations . Although ankle torques on the most affected side were weaker , patients partially compensated for this by generating larger than normal stabilizing torques about the ankle joint on the least affected side . Without this compensation , instability may have been greater",
"1 . This study investigates the effects of parkinsonism and of dopamine replacement therapy ( levodopa ) on scaling the magnitude of automatic postural responses based on sensory feedback and on predictive central set . Surface reactive torques and electromyographic ( EMG ) activity in response to backward surface translations were compared in patients with parkinsonism ON and OFF levodopa and in elderly control subjects . Correlations between the earliest postural responses [ initial rate of change of torque and integrated EMG ( IEMG ) ] and translation velocity provided a measure of postural magnitude scaling using somatosensory feedback . Correlations of responses with expected translation amplitude provided a measure of scaling dependent on predictive central set because the responses preceded amplitude completion . 2 . Parkinsonian EMG responses in six leg and trunk muscles were not later than in elderly control subjects . In fact , quadriceps antagonist latencies were earlier than normal , result ing in coactivation at the knee not present in control subjects . EMG activation was fragmented , with short burst duration s and high tonic levels that often returned to baseline with multiple bursts . In addition , parkinsonian responses showed smaller-than-normal agonist extensor bursts and larger-than-normal activation in tibialis and rectus femorus antagonist flexors . 3 . Although parkinsonian subjects scaled postural responses to both displacement velocities and amplitudes , their torque response were smaller than those of elderly controls , especially in response to the largest displacement amplitudes . The gain ( slope ) of postural response magnitude scaling to displacement velocity was similar for parkinsonian and control subjects , although parkinsonian subjects had smaller torques . Parkinsonian subjects were also able to use prediction to scale responses to small expected displacement amplitudes , but many patients did not generate the larger plantarflexion torques required at larger displacement amplitudes . Reduced torque at large amplitudes was associated with less agonist gastrocnemius IEMG , increased tibialis antagonist burst responses , and increased tibialis tonic background activity . 4 . Levodopa further reduced the already low magnitude of initial torque and IEMG responses to displacement velocities and amplitudes in parkinsonian patients . The ability to scale postural responses to velocity feedback was not affected by levodopa , but the ability to scale responses to large displacement amplitudes based on central set was worsened by levodopa . Levodopa also significantly reduced the tonic , background levels of EMG , particularly the distal gastrocnemius and tibialis activity . 5 . High baseline muscle tone was apparent in parkinsonian subjects from their high background EMG activity in quiet stance , especially in tibialis and quadriceps , and the slow initial velocity of center of mass falling in response to displacements . By reducing tone , levodopa reduced passive stiffness to perturbations without increasing EMG burst magnitudes , result ing in less resistance to external displacements and thus faster center of body mass ( COM ) displacements . 6 . The biggest postural deficit in parkinsonian subjects was not in response latency , pattern , or reactive or predictive scaling of response magnitude , but in quickly generating an adequate level of postural force . Dopamine improved tonic background postural tone but further weakened automatic postural responses to external displacements . Thus the basal ganglia may participate in postural control by regulating appropriate levels of background postural tone and by enabling adequate force generation for resisting external displacements",
"The current study evaluated the effects of disease severity on the control of obstacle crossing in people with idiopathic Parkinson 's disease ( PD ) . Forty-five subjects participated in the study , including 15 patients with mild PD ( classified as stage 1 to 1.5 of the Hoehn and Yahr Rating Scale ) , 15 patients with moderate PD ( classified as stage 2 to 3 of the Hoehn and Yahr Rating Scale ) , and 15 neurologically healthy individuals . Groups were matched by sex , age , body mass , and body height . The obstacle crossing task required participants to walk along a pathway and step over an obstacle ( half of the knee height , positioned in the middle of the pathway ) . Patients were tested in a typically medicated state . Kinematic data were recorded using an optoelectronic tridimensional system . The outcome measures included spatiotemporal measures of obstacle avoidance . There were no significant differences between patients with mild PD and healthy individuals . Patients with moderate PD exhibited shorter distances for leading toe clearance and leading foot placement after the obstacle than did healthy individuals . Patients with moderate PD tended to exhibit a lower leading horizontal mean velocity during obstacle crossing than did healthy individuals . We found significant negative relationships between obstacle crossing measures and disease severity ( score on the motor section of the Unified Parkinson 's Disease Rating Scale ) . These findings suggest that disease severity affects locomotor behavior during obstacle crossing in PD . Specifically , obstacle avoidance was not affected in the early stages of PD ; however , bradykinesia and hypometria influenced obstacle crossing in patients with moderate PD",
"BACKGROUND The voluntary , maximum inclined posture reflects the self-perceived limits of stability . Parkinson 's disease is associated with small , bradykinetic postural weight shifts while st and ing but it is unclear whether this is due to reduced limits of stability and /or to the selection of abnormal strategies for leaning . The aim of this study was to investigate the effects of Parkinson 's disease and levodopa medication on voluntary limits of stability and strategies used to reach these limits . METHODS Fourteen subjects with Parkinson 's disease ( OFF and ON levodopa ) and 10 age-matched controls participated in the study . Functional limits of stability were quantified as the maximum center of pressure excursion during voluntary forward and backward leaning . Postural strategies to achieve functional limits of stability were assessed by ( i ) body segments alignment , ( ii ) the difference between center of pressure and center of mass in preparation for a lean , ( iii ) the timing and the velocity of the preparation phase . FINDINGS Functional limits of stability were significantly smaller in subjects with Parkinson 's disease compared to control subjects . Subjects with Parkinson 's disease maintained their stooped posture while leaning , initiated leaning with a smaller difference between center of pressure and center of mass and had a slower leaning velocity compared to control subjects . Levodopa enlarged the limits of stability in subjects with Parkinson 's disease because of an increase in maximum forward , but not backward leans , but did not significantly improve postural alignment , preparation for a leaning movement , or velocity of leaning . INTERPRETATION Parkinson 's disease reduces functional limits of stability as well as the magnitude and velocity of postural preparation during voluntary , forward and backward leaning while st and ing . Levodopa improves the limits of stability but not the postural strategies used to achieve the leaning",
"Various clinical tests and balance scales have been used to assess postural stability and the risk of falling in patients with idiopathic Parkinson 's disease ( IPD ) . Quantitative posturography allows a more objective assessment but the findings in previous studies have been inconsistent and few studies have investigated which posturographic measures correlate best with a history of falling . The purpose of this study was to determine the efficacy of clinical tests , balance scales , and stable-platform posturography in detecting postural instability and discriminating between fallers and non-fallers in a home-dwelling PD cohort . Forty-eight PD subjects ( Hoehn & Yahr stage 1 - 3 ) and 17 age-matched controls had the following assessment s : Activities-specific Balance Confidence scale , Berg Balance Scale , Unified Parkinson 's Disease Rating Scale ( UPDRS ) ( motor ) , pull-test , timed up- and -go , static posturography , and dynamic posturography to assess multidirectional leaning balance . Of the clinical assessment s , all but the pull-test were closely correlated with a history of falling . Static posturography discriminated between PD fallers and controls but not between PD fallers and non-fallers , whereas dynamic posturography ( reaction time , velocity , and target hit-time ) also discriminated between fallers and non-fallers . Our findings suggest that this combination of clinical and posturographic measures would be useful in the prospect i ve assessment of falls risk in PD patients . A further prospect i ve study is now required to assess their predictive value . © 2013 Movement Disorder Society"
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Background Fish oil supplementation has been shown to be associated with a lower risk of metabolic syndrome and benefit a wide range of chronic diseases , such as cardiovascular disease , type 2 diabetes and several types of cancers . However , the evidence of fish oil supplementation on glucose metabolism and insulin sensitivity is still controversial . This meta- analysis summarized the exist evidence of the relationship between fish oil supplementation and insulin sensitivity and aim ed to evaluate whether fish oil supplementation could improve insulin sensitivity . Methods We search ed the Cochrane Library , PubMed , Embase data base for the relevant studies up date to Dec 2016 . Two research ers screened the literature independently by the selection and exclusion criteria . Studies were pooled using r and om effect models to estimate a pooled SMD and corresponding 95 % CI . This meta- analysis was performed by Stata 13.1 software . Results A total of 17 studies with 672 participants were included in this meta- analysis study after screening from 498 published articles found after the initial search . In a pooled analysis , fish oil supplementation had no effects on insulin sensitivity compared with the placebo ( SMD 0.17 , 95%CI -0.15 to 0.48 , p = 0.292 ) . In subgroup analysis , fish oil supplementation could benefit insulin sensitivity among people who were experiencing at least one symptom of metabolic disorders ( SMD 0.53 , 95 % CI 0.17 to 0.88 , p of insulin sensitivity , doses of omega-3 polyunsaturated fatty acids ( n-3 PUFA ) of fish oil supplementation or duration of the intervention . The sensitivity analysis indicated that the results were robust . Conclusions Short-term fish oil supplementation is associated with increasing the insulin sensitivity among those people with metabolic disorders
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"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",
"BACKGROUND n-3 Fatty acids lower blood pressure , improve lipids , and benefit other cardiovascular disease risk factors . Effects on glycemia in patients with type 2 diabetes are uncertain . OBJECTIVE We determined whether purified eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) have differential effects on glycemic control , including insulin sensitivity and stimulated insulin secretion ; 24-h ambulatory blood pressure ; and serum lipids in type 2 diabetic patients with treated hypertension . DESIGN In a double-blind , placebo-controlled trial of parallel design , 59 subjects were r and omly assigned to consume 4 g EPA , DHA , or olive oil/d for 6 wk while continuing to consume their usual diet . RESULTS Thirty-nine men and 12 postmenopausal women with a mean ( + /- SE ) age of 61.2 + /- 1.2 y completed the study . In comparison with the change from baseline in fasting glucose in the olive oil group , fasting glucose in the EPA and DHA groups increased 1.40 + /- 0.29 mmol/L ( P = 0.002 ) and 0.98 + /- 0.29 mmol/L ( P = 0.002 ) , respectively . Neither EPA nor DHA had significant effects on glycated hemoglobin , fasting insulin or C-peptide , insulin sensitivity or secretion , or blood pressure . Serum triacylglycerols in the EPA and DHA groups decreased 19 % ( P = 0.022 ) and 15 % ( P = 0.022 ) , respectively . There were no significant changes in serum total , LDL , or HDL cholesterol , although HDL(2 ) cholesterol in the EPA and DHA groups increased 16 % ( P = 0.026 ) and 12 % ( P = 0.05 ) , respectively . HDL(3 ) cholesterol decreased 11 % ( P = 0.026 ) with EPA supplementation . CONCLUSIONS EPA and DHA had similar benefits on lipids but adverse effects on short-term glycemic control in hypertensive diabetic patients . The overall implication s for cardiovascular disease require long-term evaluation",
"Purpose The aim of this study was to compare the effects of fibrates and omega-3 fatty acids on lymphocyte secretory function and systemic inflammation in patients with isolated hypertriglyceridemia . Methods The study included 107 patients with isolated hypertriglyceridemia who received bezafibrate ( 200 mg twice daily ) , omega-3 fatty acids ( 1 g twice daily ) or placebo for 12 weeks . The lipid profile , fasting and 2-h post-glucose load plasma glucose levels , homeostasis model assessment index ( HOMA ) , plasma high-sensitivity C-reactive protein ( hsCRP ) levels and lymphocyte release of interleukin-2 , interferon-γ and tumor necrosis factor-α were assessed at baseline , on the day of r and omization , and after 4 and 12 weeks of treatment . Results Both bezafibrate and omega-3 fatty acids reduced plasma triglyceride levels . Bezafibrate additionally decreased total and low-density lipoprotein-cholesterol levels and the HOMA and insignificantly decreased post-glucose load plasma glucose , as well as increased high-density lipoprotein-cholesterol . Bezafibrate treatment was associated with a reduction in lymphocyte release of interleukin-2 , interferon-γ and tumor necrosis factor-α , which was accompanied by a reduction in plasma hsCRP levels . Omega-3 fatty acid did not significantly reduce lymphocyte cytokine release and plasma hsCRP . The anti-inflammatory effects of both drugs did not correlate with their action on plasma lipids , but in the case of the former the effect was related to the improvement in insulin sensitivity . Conclusion Our results indicate that bezafibrate is superior to omega-3 fatty acid in inhibiting systemic inflammation and lymphocyte secretory function ",
"Hepatic accumulation of lipid substrates perturbs apolipoproteinB-100 ( apoB ) metabolism in insulin-resistant , obese subjects and may account for increased risk of cardiovascular disease . In a placebo-controlled trial , we examined the independent and combined effects of decreasing cholesterol synthesis with atorvastatin ( 40 mg/day ) and triglyceride synthesis with fish oils ( 4 g/day ) on apoB kinetics . The subjects were 48 viscerally obese , insulin-resistant men with dyslipidemia who were studied in a fasted state . We found that atorvastatin significantly decreased plasma apoB-containing lipoproteins ( P fractional catabolic rate ( FCR ) of VLDL- , IDL- , and LDL-apoB ( P Fish oils significantly decreased plasma levels of triglycerides and VLDL-apoB ( P VLDL-apoB secretion rate ( P conversion of VLDL to LDL ( P placebo , combined treatment with atorvastatin and fish oils decreased VLDL-apoB secretion ( P FCR of apoB in each lipoprotein fraction ( P percent conversion of VLDL to LDL ( P insulin resistance . In conclusion , in visceral obesity , atorvastatin increased hepatic clearance of all apoB-containing lipoproteins , whereas fish oils decreased hepatic secretion of VLDL-apoB. The differential effects of atorvastatin and fish oils on apoB kinetics support their combined use in correcting defective apoB metabolism in obese , insulin-resistant subjects",
"OBJECTIVE The aim of this study was to determine the role of omega-3 supplementation on NEFA concentration , insulin sensitivity and resistance , and glucose and lipid metabolism in type 2 diabetic patients . SUBJECTS AND METHODS Forty-four type 2 diabetic patients were r and omly recruited into two groups . Group A received 4 g/day omega-3 soft gels , and group B received a placebo for 10 wks . Blood sample s were collected after 12-h fast . Physical activity records , three-day food records , and anthropometric measurements were obtained from all participants at the beginning and end of the study . RESULTS Omega-3 supplementation caused a significant reduction in NEFA in the intervention group compared with the placebo group ( P = 0.009 ) . Additionally , the administration of omega-3 result ed in significantly greater changes ( Diff ) for the intervention group in various parameters , such as insulin and Quicki indices compared with the placebo group ( P Omega-3 fatty acid supplementation in type 2 diabetic patients improved insulin sensitivity , probably due to the decrease in NEFA concentrations",
"OBJECTIVE To determine whether dietary supplementation with fish oil adversely affects glycemic control in patients with hypertension . DESIGN R and omized , double-blind , placebo-controlled study . PATIENTS 78 persons with untreated hypertension recruited from a population survey . INTERVENTION Participants were r and omly assigned to receive eicosapentaenoic and docosahexaenoic acids , 4 g/d , or corn oil placebo , 4 g/d , for 16 weeks . MEASUREMENTS An oral glucose tolerance test ; assessment s of insulin release , glucose disposal , and insulin sensitivity done using the hyperglycemic clamp technique to keep plasma glucose levels at 10 mmol/L for 180 minutes ; assessment of insulin sensitivity done using a euglycemic hyperinsulinemic clamp technique ( infusing insulin and glucose to keep plasma glucose levels at 5 mmol/L ) ; assessment s of lipid levels and blood pressure . Measurements were done before and after intervention . RESULTS Changes in integrated glucose and insulin response after the oral glucose challenge did not differ between the fish oil and corn oil groups after intervention ( -0.6 + /- 0.7 compared with -1.0 + /- 0.6 mmol/L [ P > 0.3 ] for integrated glucose and 143 + /- 76 compared with 169 + /- 84 pmol/L [ P > 0.3 ] for insulin response ) . Changes in first-phase insulin release ( 34 + /- 72 pmol/L in the fish oil group compared with 191 + /- 112 pmol/L in the corn oil group [ P > 0.3 ] ) , second-phase insulin release ( 179 + /- 66 pmol/L compared with 257 + /- 122 pmol/L [ P > 0.3 ] ) , and insulin sensitivity index ( -0.03 + /- 0.01 compared with -0.01 + /- 0.01 [ mumol/kg.min divided by pmol/L ] ; P > 0.3 ) were also similar in both groups after treatment . Fish oil lowered systolic blood pressure by 3.8 mm Hg more than control ( P = 0.04 ) and lowered diastolic blood pressure by 2.0 mm Hg more than control ( P = 0.10 ) . After fish oil treatment , triglyceride levels decreased by 0.28 + /- 0.08 mmol/L more than control ( P = 0.01 ) , and very-low-density lipoprotein cholesterol levels decreased by 0.13 + /- 0.04 mmol/L more than control ( P = 0.01 ) . CONCLUSION Fish oil , in doses that reduce blood pressure and lipid levels in hypertensive persons , does not adversely affect glucose metabolism",
"INTRODUCTION Diabetes mellitus is the most common metabolic disorder in humans , and its incidence is increasing rapidly worldwide . Although polyunsaturated fatty acids have beneficial effects on diabetes mellitus , previous data regarding the possible positive effects of n-3 fatty acids on glycaemic indices were inconclusive . We conducted a double-blind r and omised clinical trial to determine the effects of eicosapentaenoic acid ( EPA ) , an n-3 polyunsaturated fatty acid , on overweight patients with type 2 diabetes mellitus ( T2DM ) . METHODS This double-blind , placebo-controlled r and omised clinical trial was conducted on a total of 67 overweight patients with T2DM for a duration of three months . Of these 67 patients , 32 received 2 g purified EPA daily , while 35 received a placebo of 2 g corn oil daily . The patients ' fasting plasma glucose ( FPG ) , serum insulin , glycated haemoglobin ( HbA1c ) and insulin sensitivity indices were assessed . RESULTS After three months of EPA supplementation , the group that received EPA showed significant decreases in FPG ( p homeostasis model assessment of insulin resistance ( HOMA-IR ) ( p = 0.032 ) , when compared to the placebo group . EPA supplementation result ed in decreased serum insulin levels , with the levels between the EPA and placebo groups showing a significant difference ( p = 0.004 ) . CONCLUSION The results of our study indicate that EPA supplementation could improve insulin sensitivity . It was able to decrease serum insulin , FPG , HbA1c and HOMA-IR . EPA could have beneficial effects on glycaemic indices in patients with T2DM",
"BACKGROUND Observational and experimental studies suggest that the amount of vitamin E ingested in food and in supplements is associated with a lower risk of coronary heart disease and atherosclerosis . METHODS We enrolled a total of 2545 women and 6996 men 55 years of age or older who were at high risk for cardiovascular events because they had cardiovascular disease or diabetes in addition to one other risk factor . These patients were r and omly assigned according to a two-by-two factorial design to receive either 400 IU of vitamin E daily from natural sources or matching placebo and either an angiotensin-converting-enzyme inhibitor ( ramipril ) or matching placebo for a mean of 4.5 years ( the results of the comparison of ramipril and placebo are reported in a companion article ) . The primary outcome was a composite of myocardial infa rct ion , stroke , and death from cardiovascular causes . The secondary outcomes included unstable angina , congestive heart failure , revascularization or amputation , death from any cause , complications of diabetes , and cancer . RESULTS A total of 772 of the 4761 patients assigned to vitamin E ( 16.2 percent ) and 739 of the 4780 assigned to placebo ( 15.5 percent ) had a primary outcome event ( relative risk , 1.05 ; 95 percent confidence interval , 0.95 to 1.16 ; P=0.33 ) . There were no significant differences in the numbers of deaths from cardiovascular causes ( 342 of those assigned to vitamin E vs. 328 of those assigned to placebo ; relative risk , 1.05 ; 95 percent confidence interval , 0.90 to 1.22 ) , myocardial infa rct ion ( 532 vs. 524 ; relative risk , 1.02 ; 95 percent confidence interval , 0.90 to 1.15 ) , or stroke ( 209 vs. 180 ; relative risk , 1.17 ; 95 percent confidence interval , 0.95 to 1.42 ) . There were also no significant differences in the incidence of secondary cardiovascular outcomes or in death from any cause . There were no significant adverse effects of vitamin E. CONCLUSIONS In patients at high risk for cardiovascular events , treatment with vitamin E for a mean of 4.5 years had no apparent effect on cardiovascular outcomes",
"BACKGROUND Increase in obesity and metabolic syndrome are associated with increases in insulin resistance ( IR ) and type 2 diabetes mellitus . Results from animal intervention studies and human epidemiological studies suggest that n-3 polyunsaturated fatty acids can prevent and reverse IR , but results from human intervention studies have varied . Results from some human and animal studies suggest that docosahexaenoic acid ( 22:6n-3 ; DHA ) may be more effective than eicosapentaenoic acid ( 20:5n-3 ; EPA ) in the prevention of IR . METHODS By using a placebo-controlled , parallel study design , we examined the effects of DHA supplementation ( 3 grams/day , 90 days ) in the absence of EPA on glucocentric and lipocentric markers of IR in hypertriglyceridemic men ( n=14 - 17/group ) . RESULTS DHA supplementation increased fasting plasma glucose concentration by 4.7 % ( P ( insulin and homeostasis model assessment of insulin resistance [ HOMA-IR ] ) or postpr and ial insulin and glucose concentrations ( areas under curves for insulin and glucose , Matsuda index ) . Glucose increased by 2.7 % in the placebo group and was not significant ; increases in glucose in the two groups did not differ from each other . DHA decreased circulating concentrations of several lipocentric markers of IR , including plasma concentrations of nonesterified fatty acids ( 13.0 % ) , small , dense low-density lipoprotein ( LDL ) particles ( 21.7 % ) , and ratio of tryglycerides to high-density lipoprotein cholesterol ( TG/HDL-C ) ( 34.0 % ) ( P lipocentric markers of IR are more responsive to DHA supplementation than the glucocentric markers . Future studies with DHA in prediabetic subjects and direct measures of insulin sensitivity are needed",
"OBJECTIVE The aim of this study was to evaluate the long-term ( 6-month ) effects of moderate fish oil supplementation on insulin sensitivity and plasma lipoproteins in NIDDM patients with hypertriglyceridemia . RESEARCH DESIGN AND METHODS The study has been performed according to a r and omized double-blind placebo-controlled design with a parallel group sequence . After a washout period of 4 weeks and a run-in period of 3 weeks , 16 NIDDM patients with hypertriglyceridemia ( triglyceride [ TG ] , 2.25–5.65 mmol/l ) were r and omly assigned to either fish oil ( 2.7 g/day eicosapentaenoic plus docosahexaenoic acid for 2 months , then 1.7 g/day for 4 more months ) ( n = 8) or placebo ( n = 8) . Diet and hypoglycemic drugs remained unchanged throughout the whole experiment . At baseline and after 6 months , insulin sensitivity was measured by euglycemic hyperinsulinemic clamp ( insulin infused , 2.0 mIU · kg−1 body wt · min−1 ) . At the same time , blood glucose control , fasting and postpr and ial serum insulin and nonesterified fatty acid ( NEFA ) concentrations , and fasting plasma lipoprotein concentrations were evaluated . RESULTS In the group treated with ffish oil compared with the baseline , there was : 1 ) a significant reduction in both plasma TG ( 2.92 ± 0.23 vs. 3.85 ± 0.32 [ mean ± SE ] mmol/l , P and VLDL-TG ( 2.35 ± 0.24 vs. 4.25 ± 0.66 mmol/l , P significant changes in blood glucose control ; 2 ) a significant reduction in fasting NEFA concentrations ( 572 ± 100 vs. 825 ± 131 μmol/l , P significant enrichment in long-chain ω-3 fatty acids of erythrocyte membrane phospholipids . In the placebo group , there were no changes in any of the variables analyzed . The insulin-mediated glucose uptake was unchanged in both groups ( fish oil , 4.04 ± 0.82 mg · kg−1 · min−1 at baseline and 3.96 ± 0.50 mg · kg−1 · min−1 at 6 months ; placebo , 3.51 ± 0.62 mg · kg−1 · min−1 at baseline and 4.09 ± 0.49 mg · kg−1 · min−1 at 6 months ) . CONCLUSIONS In NIDDM patients with hypertriglyceridemia , moderate amounts of fish oil induce a long-term significant reduction in plasma triglycerides , VLDL triglycerides , and NEFA and a significant enrichment in the erythrocyte phospholipid content of long-chain ω-3 fatty acids , without deteriorating blood glucose control . However , this amount of ω-3 fatty acids was unable to improve insulin sensitivity in this group of patients",
"BACKGROUND The beneficial effects of n-3 polyunsaturated fatty acids on reducing cardiovascular risks are well documented . However , the relative effect on some markers of macrophage activation and vascular function is unclear . OBJECTIVE The primary objective of this study was to investigate the effects of docosahexaenoic acid (DHA)-enriched fish oil on the marker of monocyte/macrophage activation factor soluble CD163 , asymmetric dimethyl arginine ( ADMA ) , and insulin resistance in type 2 diabetic patients . METHODS In this double-blind r and omized controlled trial , 72 type 2 diabetic patients with an age between 30 - 70 years and body mass index ( BMI ) of 18.5 to 40 kg/m(2 ) were r and omly assigned to receive 2.4-g DHA-enriched fish oil or placebo per day for 8 weeks . Anthropometric measurements , biochemical , and body composition analyses were assessed at baseline and end of study . Analysis of covariance ( ANCOVA ) was conducted by controlling for possible confounders to assess between-group differences . RESULTS Serum levels of sCD163 , triglycerides , waist circumference ( WC ) , and weight to height ratio ( WHtR ) decreased significantly in the fish oil group when compared with the control group . Serum ADMA concentration decreased in the fish oil group with no significant between-group differences . Controlling for confounders revealed that the differences observed in sCD163 , triglycerides , WC , and WHtR remained statistically significant . CONCLUSIONS Short-time fish oil supplementation decreased serum sCD163 , triglycerides levels , WC , and WHtR in T2DM patients . Because of the positive relationship between sCD163 levels and some T2DM and obesity-related complications , it seems that DHA can be considered as a key intervention in obesity and T2DM",
"OBJECTIVE Offspring of patients with type 2 diabetes ( OPDs ) exhibits endothelial dysfunction ( ED ) associated with a chronic inflammatory state . N-3 polyunsaturated fatty acids ( n-3 PUFA ) may have antioxidant and anti-inflammatory properties that are beneficial for cardiovascular and metabolic health . Therefore , in the present study , we tested the hypothesis that dietary supplementation with fish oil rich in n-3 PUFA may improve ED in otherwise healthy OPDs . METHODS AND DESIGN A double-blind , placebo-controlled trial was conducted with 50 OPDs . Participants were r and omized to treatment with either placebo or n-3 PUFA ( 2g/day ) for 12 weeks . Before and after treatment we evaluated endothelial function ( using flow-mediated dilation ( FMD ) of the brachial artery ) , circulating inflammatory markers ( adiponectin , TNF-alpha , and high sensitivity-CRP ) , and insulin resistance ( QUICKI ) . RESULTS No significant changes were observed in study outcomes in subjects treated with placebo . By contrast , when compared with baseline values , subjects treated with n-3 PUFA had significant improvement in FMD ( 9.1+/-5.8 % vs. 11.7+/-4.4 % , p=0.02 ) that was accompanied by decreased plasma triglycerides ( 117+/-73mg/dl vs. 86+/-44mg/dl , p=0.001 ) and TNF-alpha levels ( 8.9+/-2.3pg/ml vs. 6.8+/-2.7pg/ml , p=0.001 ) , and a trend towards increased plasma adiponectin levels ( 7.8+/-4.5microg/ml vs. 9.5+/-5.1microg/ml , p=0.09 ) . When data were analyzed by multiple regression analysis , decreased TNF-alpha after treatment with n-3 PUFA predicted increased FMD . CONCLUSION Dietary supplementation with n-3 PUFA significantly improved endothelial function and reduced pro-inflammatory markers in OPDs . Thus , fish oil consumption may have beneficial cardiovascular and metabolic health effects in otherwise healthy subjects predisposed to diabetes and its vascular complications",
"OBJECTIVE The beneficial effects of fish and n-3 polyunsaturated fatty acids ( PUFAs ) consumption on atherosclerosis have been reported in numerous epidemiological studies . However , to the best of our knowledge , the effects of a fish-based diet intervention on endothelial function have not been investigated . Therefore , we studied these effects in postmenopausal women with type 2 diabetes mellitus ( T2DM ) . MATERIAL S/ METHODS Twenty-three postmenopausal women with T2DM were assigned to two four-week periods of either a fish-based diet ( n-3 PUFAs ≧ 3.0 g/day ) or a control diet in a r and omized crossover design . Endothelial function was measured with reactive hyperemia using strain-gauge plethysmography and compared with the serum levels of fatty acids and their metabolites . Endothelial function was determined with peak forearm blood flow ( Peak ) , duration of reactive hyperemia ( Duration ) and flow debt repayment ( FDR ) . RESULTS A fish-based dietary intervention improved Peak by 63.7 % , Duration by 27.9 % and FDR by 70.7 % , compared to the control diet . Serum n-3 PUFA levels increased after the fish-based diet period and decreased after the control diet , compared with the baseline ( 1.49 vs. 0.97 vs. 1.19 mmol/l , p between serum n-3 PUFA levels and endothelial function . An increased ratio of epoxyeicosatrienoic acid/dihydroxyeicosatrienoic acid was observed after a fish-based diet intervention , possibly due to the inhibition of the activity of soluble epoxide hydrolase . CONCLUSIONS A fish-based dietary intervention improves endothelial function in postmenopausal women with T2DM . Dissociation between the serum n-3 PUFA concentration and endothelial function suggests that the other factors may contribute to this phenomenon"
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4117e8b2-06ff-11f0-808a-c43d1ab1c353
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PURPOSE OF REVIEW Refractory dyspnoea is a common and difficult to treat symptom in advanced disease . Accurate assessment helps to guide treatment and prognosis . RECENT FINDINGS The absence of commonly agreed assessment tools has been a significant barrier to improving care through inhibition of clinical research and limitation of clinicians ' ability to assess the effectiveness of their interventions . Two recently published systematic review s on measurement tools for breathlessness identified a variety of tools but none could be recommended as gold st and ard . Validation of these tools in palliative care seems more appropriate than development of new tools . For clinical purpose s , the combination of a unidimensional tool to assess dyspnoea severity and a multidimensional tool to evaluate the impact on a person 's quality of life seem most appropriate . This review discusses the present evidence and puts forward a strategy for assessment and measurement of the symptom in clinical practice . SUMMARY Despite a variety of measurement tools none can be recommended as gold st and ard for the assessment of dyspnoea . A combination of unidimensional and multidimensional tools seems to be the best for clinical assessment . Measurement of dyspnoea has to be seen in context with the person 's history , physical examination and diagnostic tests
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"This study compared the use of a simple verbal 0 - 10 numerical rating scale ( verbal NRS ) and a visual analog scale ( VAS ) for the rating of dyspnea during exercise in a group of young and older subjects . Twelve younger ( 32+/-9 yr ) and 12 older ( 71+/-7 yr ) subjects used either the verbal NRS or the VAS in a r and omised fashion to rate dyspnea during 60 s of uphill treadmill walking ( range 5.6 - 8.8 km h(-1 ) ) performed at either a low ( 17 % grade ) or high workload ( 26 % grade ) and then during recovery . Rating scales were evaluated twice on separate days ( day 1 and day 2 ) at each workload . While the verbal NRS scores proved to be reliable throughout exercise and recovery , VAS scores were significantly ( p Verbal NRS ratings were consistently greater than VAS ratings at both workloads ( p intra-class correlation coefficients for rating peak dyspnea using either the VAS or verbal NRS were consistently lower for the older subjects ( range : r=0.54 - 0.67 ) than the younger subjects ( range : r=0.70 - 0.86 ) . Overall , subjects preferred the verbal NRS to the VAS . These results suggest that the verbal NRS compares favourably with the VAS for rating dyspnea during exercise without mask or mouthpiece . However , when rating peak dyspnea both scales appear less reliable when used by the older compared to young subjects",
"A health status instrument for use in clinical trials must be valid ( measuring what it is supposed to measure ) and responsive ( able to detect clinical ly important change ) . Approaches to measuring health status in clinical trials include using a battery of instruments , a general instrument which provides a profile of the patient 's health , an instrument that generates a health utility , or an instrument that focuses on the problems associated with a particular disease . Disease-specific instruments have been used in clinical trials in chronic airflow limitation ( CAL ) . The Oxygen Cost Diagram is simple and easy to administer , but responsiveness and validity are unproven . The Transition Dyspnoea Index is valid and responsive , but is difficult to use in trials in which multiple measurements are desired . The Chronic Respiratory Disease Question naire has proved valid and responsive in controlled trials in CAL patients . Health status measures should be included in all clinical trials in CAL",
"1 . The intensity of breathlessness during exercise was measured in ten normal subjects using a visual analogue scale ( VAS ) and a Borg scale to compare the use of the scales and their repeatability , both within the duration of a period of exercise and between tests . For each scale , subjects performed two exercise tests separated by a period of 2 - 6 weeks . Each exercise test consisted of two cycles of progressively increasing and decreasing workload . 2 . All subjects felt confidently able to use both scales to quantify their feelings of breathlessness exclusively of other sensation . Equal preference was expressed for use of a particular scale . 3 . With both scales there was a large intersubject variation in the relationship between dyspnoea score and minute ventilation ( VE ) ( P less than 0.01 ) , and in the range of the scale used . 4 . There was a good correlation between the VAS and Borg scores at each level of VE ( r2 = 0.71 ) , but the VAS score was used over a wider range than the Borg score . 5 . The relationship between VE and the dyspnoea score measured by the two techniques was predominantly linear . The mean r2 for VAS score/VE was 0.68 ( SD 0.19 ) and for Borg score/VE the mean r2 was 0.75 ( SD 0.13 ) . 6 . The relationships VAS score/VE and Borg score/VE were unaffected by the direction in which the workload was varied ( P greater than 0.05 ) . 7 . VE , measured at each work rate , did not differ between the two cycles ( P greater than 0.05 ) or between the 2 days ( P greater than 0.05 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Dyspnea in patients with advanced cancer is a common symptom that is difficult to treat . This study investigated whether oxygen helps to relieve rest dyspnea in patients with advanced cancer . In a single-blind controlled trial , oxygen and air were administered in r and om order to hospice patients reporting dyspnea at rest . Measurements of arterial oxygen saturation , lung function , and dyspnea ( using a visual analogue scale [ VAS ] and Borg score ) were made before and after each gas had been given for 15 min . Data from 38 patients were used : analysis of variance revealed that mean VAS levels during baseline conditions , breathing room air ( 59 mm ) , were significantly reduced after administration of either air ( 48 mm ; p oxygen ( 45 mm ; p mean VAS scores between oxygen and air administration . There was no statistically significant order of treatment effect . There was no difference in the response to oxygen or air in patients with a history of cardiopulmonary disease . The improvement in dyspnea with oxygen could not be predicted from a subject 's initial level of hypoxia . Results suggested that benzodiazepines may potentiate the effect of oxygen . The overall conclusion is that oxygen and air can have a significant effect in reducing dyspnea at rest in patients with advanced cancer",
"The Palliative Care Outcome Scale ( POS ) is a multidimensional instrument covering physical , psychosocial , spiritual , organizational , and practical concerns . This study vali date d the German version of the POS and used the tool in different palliative care setting s in Germany and Austria . Patients and staff were asked to complete the POS three times and evaluate the question naire and the translation afterwards . One hundred eighteen patients ( 44 male , 74 female , mean age 63 years , all suffering from advanced cancer ) completed the POS one time , 55 patients two times , and 36 patients three times . Spearman 's rho was highly significant for pain , other symptoms , anxiety , and life worthwhile in the first two assessment s. The third assessment showed significant correlations for pain , other symptoms , anxiety , and family anxiety . Seventy-seven of 87 patients answered questions regarding the scale and the translation . All questions other than \" Over the past 3 days , have you felt good about yourself ? \" were underst and able for patients . Almost half of the staff was undecided whether the tool was reflecting the patients ' condition . In contrast , the majority of patients liked it . Thus , the German version of the POS is well accepted by patients and staff and appears to be valid , although there are some areas where the scale would benefit from expansion to more closely capture staff and patient concerns",
"The optimal method of assessing the effect of treatment on the day-to-day function of patients with chronic airflow limitation is not established . Therefore , we examined the performance of the Six Minute Walk test , a rating of dyspnea following the test and three different question naires measuring dyspnea in daily activities , in a controlled trial of inhaled salbutamol and oral theophylline in 24 patients with primarily fixed chronic airflow limitation . Clinical ly important and statistically significant effects of salbutamol and theophylline on dyspnea during day-to-day activities were detected by each measure , but the Chronic Respiratory Question naire ( CRQ ) appeared more powerful than either the Oxygen Cost Diagram or the Medical Research Council Dyspnea Question naire as modified by the R and Corporation . Changes in the CRQ dyspnea score showed a higher correlation with changes in spirometry , walk test score , dyspnea following the walk test , and global ratings of dyspnea than did the other two measures . Results of the walk test demonstrated statistically significant salbutamol and theophylline effects , but suggested that no added benefit could be obtained with both drugs ; the rating of dyspnea following the walk test , however , was consistent with an additive effect . We conclude that the CRQ is a responsive , valid measure of functional status for clinical trials in chronic lung disease , and that when the six minute walk is used as a measure of outcome , dyspnea following the walk test should be measured",
"OBJECTIVES : To develop an outcome measure for patients with advanced cancer and their families which would cover more than either physical symptoms or quality of life related questions . To vali date the measure in various specialist and non-specialist palliative care setting s throughout the UK . DESIGN : A systematic literature review of measures appropriate for use in palliative care setting s was conducted . In conjunction with a multidisciplinary project advisory group , questions were chosen for inclusion into the scale based on whether they measured aspects of physical , psychological , or spiritual domains pertinent to palliative care , and whether similar items had shown to be valid as part of another measure . A staff completed version was developed to facilitate data collection on all patients throughout their care , and a patient completed version was design ed to enable the patient to contribute to the assessment of their outcomes when possible . A full validation study was conducted to evaluate construct validity , internal consistency , responsiveness to change over time , and test-retest reliability . Assessment s were timed . SETTING : Eight centres in Engl and and Scotl and providing palliative care , including inpatient care , outpatient care , day care , home care , and primary care . PATIENTS : A total of 450 patients entered care during the study period . Staff collected data routinely on patients in care long enough to be assessed ( n = 337 ) . Of these , 262 were eligible for patient participation ; 148 ( 33 % ) went on to complete a question naire . MAIN MEASURES : The Palliative Care Outcome Scale ( POS ) , the European Organisation for Research on Cancer Treatment , and the Support Team Assessment Schedule . RESULTS : The POS consists of two almost identical measures , one of which is completed by staff , the other by patients . Agreement between staff and patient ratings was found to be acceptable for eight out of 10 items at the first assessment . The measure demonstrated construct validity ( Spearman rho = 0.43 to 0.80 ) . Test/re-test reliability was acceptable for seven items . Internal consistency was good ( Cronbach 's alpha = 0.65 ( patients ) , 0.70 ( staff ) ) . Change over time was shown , but did not reach statistical significance . The question naire did not take more than 10 minutes to complete by staff or patients . CONCLUSION : The POS has acceptable validity and reliability . It can be used to assess prospect ively palliative care for patients with advanced cancer",
"We report the development of an arm exercise test to assess breathlessness in patients with lung cancer who are breathless at low levels of exertion . Exercise consisted of raising the arm over 40 cm , either the dominant arm only ( n=10 ) or both arms alternating at minute intervals ( n=12 ) . Subjects breathed through a mouthpiece , and ventilation ( VE ) and oxygen uptake ( VO(2 ) ) were measured . Following familiarization , three tests were performed over one week to explore repeatability , and sensitivity was assessed in a fourth test . Arm exercise was generally well tolerated and increased breathlessness , VE , and VO(2 ) . The commonest factor limiting exercise was arm fatigue , although four patients in the two-arm test also reported breathlessness . Repeatability for breathlessness score and VE was best in the two-arm test . The added resistance used to assess sensitivity could not be detected . The two-arm test offers a potential means of assessing the effects of an intervention on breathlessness and E in patients for whom a cycle or treadmill exercise test is unsuitable",
"Since the relationships between pulmonary function , exercise capacity , and functional state or quality of life are generally weak , a self report question naire has been developed to determine the effect of treatment on quality of life in clinical trials . One hundred patients with chronic airflow limitation were asked how their quality of life was affected by their illness , and how important their symptoms and limitations were . The most frequent and important items were used to construct a question naire evaluating four dimensions : dyspnoea , fatigue , emotional function , and the patient 's feeling of control over the disease ( mastery ) . Reproducibility , tested by repeated administration to patients in a stable condition , was excellent : the coefficient of variation was less than 12 % for all four dimensions . Responsiveness ( sensitivity to change ) was tested by administering the question naire to 13 patients before and after optimisation of their drug treatment and to another 28 before and after participation in a respiratory rehabilitation programme . In both cases large , statistically significant improvements in all four dimensions were noted . Changes in question naire score were correlated with changes in spirometric values , exercise capacity , and patients ' and physicians ' global ratings . Thus it has been shown that the question naire is precise , valid , and responsive . It can therefore serve as a useful disease specific measure of quality of life for clinical trials",
"Reducing the number of items in a health-related quality of life instrument will enhance efficiency . However , it is important to maintain measurement properties . We determined the effect of reducing items from each domain ( dyspnea , fatigue , emotion and mastery ) of the 20-item Chronic Respiratory Question naire ( CRQ ) . Three r and omized trials of respiratory rehabilitation provided data . We removed items one at a time from each domain in three orders : by item impact , item responsiveness , and at r and om . Responsiveness , test-retest reliability and construct validity were evaluated at each step . Responsiveness and reliability , evaluated by intraclass correlation coefficients ( ICC ) , were reduced marginally as the number of items was reduced to two items per domain . The deterioration was greatest when reducing from two items to one . To detect a particular effect , sample size would increase by about 10 % when reducing the number of items in a domain to 2 . Construct validity showed a more marked deterioration . Reducing to two items per domain would maintain responsiveness and reliability of the CRQ at an acceptable level , with a trade-off of reduced construct validity and increase in sample size requirements"
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4117e8f8-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Exercise programmes are often recommended for managing ankylosing spondylitis ( AS ) , to reduce pain and improve or maintain functional capacity . OBJECTIVES To assess the benefits and harms of exercise programmes for people with AS . SEARCH METHODS We search ed CENTRAL , the Cochrane Library , MEDLINE Ovid , EMBASE Ovid , CINAHL EBSCO , PEDro , Scopus , and two trials registers to December 2018 . We search ed reference lists of identified systematic review s and included studies , h and search ed recent relevant conference proceedings , and contacted experts in the field . SELECTION CRITERIA We included reports of r and omised controlled trials ( RCT ) of adults with AS that compared exercise therapy programmes with an inactive control ( no intervention , waiting list ) or usual care . DATA COLLECTION AND ANALYSIS We used st and ard Cochrane methodology . MAIN RESULTS We included 14 RCTs with 1579 participants with AS . Most participants were male ( 70 % ) , the median age was 45 years ( range 39 to 47 ) , and the mean symptom duration was nine years . The most frequently used exercises were those design ed to help improve strength , flexibility , stretching , and breathing . Most exercise programmes were delivered along with drug therapy or a biological agent . We judged most of the studies at unclear or high risk of bias for several domains . All 14 studies provided data obtained immediately upon completion of the exercise programme . The median exercise programme duration was 12 weeks ( interquartile range ( IQR ) 8 to 16 ) . Three studies ( 146 participants ) provided data for medium-term follow-up ( 24 weeks after completion of the exercise programmes ) . Nine studies compared exercise programmes to no intervention ; five studies compared them to usual care ( including physiotherapy , medication , or self-management).Exercise programmes versus no interventionAll data were obtained immediately upon completion of the exercise programme . For physical function , measured by a self-reporting question naire ( the Bath Ankylosing Spondylitis Functional Index ( BASFI ) scale , 0 to 10 ; lower is better ) , moderate- quality evidence showed a no important clinical ly meaningful improvement with exercise programmes ( mean difference ( MD ) -1.3 , 95 % confidence interval ( CI ) -1.7 to -0.9 ; 7 studies , 312 participants ; absolute reduction 13 % , 95 % CI 17 % to 9%).For pain , measured on a visual analogue scale ( VAS , 0 to 10 , lower is better ) , low- quality evidence showed an important clinical ly meaningful reduction of pain with exercise ( MD -2.1 , 95 % CI -3.6 to -0.6 ; 6 studies , 288 participants ; absolute reduction 21 % , 95 % CI 36 % to 6%).For patient global assessment of disease activity , measured by a self-reporting question naire ( the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) scale , 0 to 10 , lower is better ) , moderate- quality evidence showed no important clinical ly meaningful reduction with exercise ( MD -0.9 , 95 % CI -1.3 to -0.5 ; 6 studies , 262 participants ; absolute reduction 9 % , 95 % CI 13 % to 5%).For spinal mobility , measured by a self-reporting question naire ( the Bath Ankylosing Spondylitis Metrology Index ( BASMI ) scale , 0 to 10 , lower is better ) , very low- quality evidence showed an improvement with exercise ( MD -0.7 95 % , -1.3 to -0.1 ; 5 studies , 232 participants ) with no important clinical meaningful benefit ( absolute reduction 7 % , 95 % CI 13 % to 1%).For fatigue , measured on a VAS ( 0 to 10 , lower is better ) , very low- quality evidence showed a no important clinical ly meaningful reduction with exercise ( MD -1.4 , 95 % CI -2.7 to -0.1 ; 2 studies , 72 participants ; absolute reduction 14 % , 95 % CI 27 % to 1%).Exercise programmes versus usual careAll data were obtained immediately upon completion of the exercise programme . For physical function , measured by the BASFI scale , moderate- quality evidence showed an improvement with exercise ( MD -0.4 , 95 % CI -0.6 to -0.2 ; 5 studies , 1068 participants ) . There was no important clinical meaningful benefit ( absolute reduction 4 % , 95 % CI 6 % to 2%).For pain , measured on a VAS ( 0 to 10 , lower is better ) , moderate- quality evidence showed a reduction of pain with exercise ( MD -0.5 , 95 % CI -0.9 to -0.1 ; 2 studies , 911 participants ; absolute reduction 5 % , 95 % CI 9 % to 1 % ) . No important clinical meaningful benefit was found . For patient global assessment of disease activity , measured by the BASDAI scale , low- quality evidence showed a reduction with exercise ( MD -0.7 , 95 % CI -1.3 to -0.1 ; 5 studies , 1068 participants ) , but it was not clinical ly important ( absolute reduction 7 % , 95 % CI 13 % to 1 % ) with important clinical meaningful benefitFor spinal mobility , measured by the BASMI scale , very low- quality evidence found a no important clinical ly meaningful improvement with exercise ( MD -1.2 , 95 % CI -2.8 to 0.5 ; 2 studies , 85 participants ; absolute reduction 12 % , 95 % CI 5 % less to 28 % more ) . There was no important clinical meaningful benefit . None of the studies measured fatigue . Adverse effectsWe found very low- quality evidence of the effect of exercise versus either no intervention , or usual care . We are uncertain of the potential for harm of exercises , due to low event rates , and a limited number of studies reporting events . AUTHORS ' CONCLUSIONS We found moderate- to low- quality evidence that exercise programmes probably slightly improve function , may reduce pain , and probably slightly reduce global patient assessment of disease activity , when compared with no intervention , and measured upon completion of the programme . We found moderate- to low- quality evidence that exercise programmes probably have little or no effect on improving function or reducing pain , when compared with usual care , and may have little or no effect on reducing patient assessment of disease activity , when measured upon completion of the programmes . We are uncertain whether exercise programmes improve spinal mobility , reduce fatigue , or induce adverse effects
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[
"OBJECTIVES This study aims to assess the impact of a structured education and home exercise programme in daily practice patients with ankylosing spondylitis . METHODS A total of 756 patients with ankylosing spondylitis ( 72 % males , mean age 45 years ) participated in a 6-month prospect i ve multicentre controlled study , 381 of whom were r and omised to an education intervention ( a 2-hour informative session about the disease and the implementation of a non-supervised physical activity programme at home ) and 375 to st and ard care ( controls ) . Main outcome measures included Bath Ankylosing Spondylitis Disease Activity and Functional Index ( BASDAI , BASFI ) . Secondary outcome measures were 0 - 10 cm visual analog scale ( VAS ) for total pain , nocturnal pain and global disease activity and quality of life ( ASQoL ) , knowledge of disease ( self-evaluation ordinal scale ) and daily exercise ( diary card ) . RESULTS At 6 months , the adjusted mean difference between control and educational groups for BASDAI was 0.32 , 95 % confidence interval ( CI ) 0.10 - 0.54 , p=0.005 , and for BASFI 0.31 , 95%CI 0.12 - 0.51 , p=0.002 . Significant differences were found also in VAS for total pain , patient´s global assessment and in ASQoL. Patients in the education group increased their knowledge about the disease and its treatments significantly ( p CONCLUSIONS A structured education and home exercise programme for patients with ankylosing spondylitis in daily practice was feasible and helped to increase knowledge and exercise . Although statistically significant , the magnitudes of the clinical benefits in terms of disease activity and physical function were poor",
"Fernández-de-las-Peñas C , Alonso-Blanco C , Morales-Cabezas M , Miangolarra-Page JC : Two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2005;84:407–419 . Objective : The purpose of this clinical trial was to evaluate the impact of a 4-month comprehensive protocol of strengthening and flexibility exercises developed by our research group versus conventional exercises for patients with Ankylosing Spondylitis ( AS ) on functional and mobility outcomes . Design : R and omized controlled trial . Forty-five patients diagnosed with AS according to the modified criteria of New York were allocated to control or experimental groups using a r and om numbers table . The control group was treated with a conventional protocol of physical therapy in AS , whereas the experimental group was treated with the protocol suggested by our research group . The conventional intervention consisted of 20 exercises : motion and flexibility exercises of the cervical , thoracic , and lumbar spine ; stretching of the shortened muscles ; and chest expansion exercises . The experimental protocol is based on the postural affectation of the AS and the treatment of the shortened muscle chains in these patients according to the Global Posture Reeducation ( GPR ) method . This intervention employs specific strengthening and flexibility exercises in which the shortened muscle chains are stretched and strengthened . The study lasted 4 mos . During this period , patients received a weekly group session managed by an experienced physiotherapist . Each session lasted an hour , and there were 15 total sessions . Changes in activity , mobility , and functional capacity were evaluated by an assessor blinded to the intervention , using the following previously vali date d scores from the Bath group : BASMI ( tragus to wall distance , modified Schöber test , cervical rotation , lumbar side flexion , and intermalleolar distance ) , BASDAI ( The Bath Ankylosing Spondylitis Disease Activity Index ) , and BASFI ( The Bath Ankylosing Spondylitis Functional Index ) . Results : Both groups showed an improvement ( prepost scores ) in all the outcome measures , mobility measures of the BASMI index , as well as in BASFI and BASDAI indexes . In the control group , the improvement in tragus to wall distance ( P = 0.009 ) and in lumbar side flexion ( P = 0.02 ) was statistically significant . Although the rest of the outcomes also improved , they did not reach a significant level ( P > 0.05 ) . In the experimental group , the improvement in all the clinical measures of the BASMI index ( P the BASFI index ( P = 0.003 ) was statistically significant . The intergroup comparison between the improvement ( prepost scores ) in both groups showed that the experimental group obtained a greater improvement than the control group in all the clinical measures of the BASMI index , except in tragus to wall distance , as well as in the BASFI index . Conclusions : The experimental protocol developed by our research group , based on the GPR method and specific strengthening and flexibility exercises of the muscle chains , offers promising results in the management of patients suffering from AS . Further trials on this topic are required",
"Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose",
"Objective : To investigate the effect of high-intensity exercise on emotional distress , fatigue , and ability to do a full day ’s activities in patients with axial spondyloarthritis ( axSpA ) . Method : A total of 28 physically inactive axSpA patients were r and omized to either an exercise group ( EG ) , which performed 12 weeks of cardiorespiratory and strength exercises , or a control group ( CG ) , which received treatment as usual . The outcomes reported in this paper are secondary outcomes in the trial and included emotional distress ( General Health Question naire-12 , 0–36 , 36 = worst ) , fatigue [ numeric rating scale ( NRS ) , 0–10 , 10 = worst ] , and ability to do a full day ’s activities ( NRS , 0–10 , 10 = worst ) . Post-intervention differences were assessed by analysis of covariance with baseline values as covariates . Results : Twenty-four patients were included in the analyses . All patients in the EG followed the exercise protocol . The EG had a statistically significant beneficial effect [ mean group differences ( 95 % confidence interval ) ] on emotional distress [ −5.8 , ( −9.7 , −1.9 ) , p 0.01 ] , fatigue [ −2.4 , ( −4.3 , −0.4 ) , p = 0.02 ] , and ability to do a full day ’s work [ −2.2 , ( −3.9 , −0.4 ) , p = 0.02 ] compared to the CG . Conclusion : This pilot study showed promising effects of cardiorespiratory and strength exercises on emotional distress , fatigue , and ability to do a full day ’s activities in patients with axSpA. The findings need to be confirmed in a larger trial",
"We investigated the effects of home-based daily exercise on joint mobility , functional capacity , pain , and depression in patients with ankylosing spondylitis ( AS ) . The patients were r and omly assigned to a wait-list control group or to an exercise-therapy group . The exercise-therapy group performed a 20-min exercise program once per day for 8 consecutive weeks . After 8 weeks , compared with the control group , the exercise group showed improvements in joint mobility ( cervical flexion , extension , shoulder flexion , abduction , hip abduction , and knee flexion ) , finger – floor distance , and functional capacity . Pain and depression scores were significantly lower after the exercise program in the exercise group than in the control group . These findings indicate that exercise therapy increases joint mobility and functional capacity , and decreases pain and depression in patients with AS . Home-based exercise , which is easily accessible to patients , might be an effective intervention for AS",
"IMPORTANCE The 2008 Physical Activity Guidelines for Americans recommended a minimum of 75 vigorous-intensity or 150 moderate-intensity minutes per week ( 7.5 metabolic-equivalent hours per week ) of aerobic activity for substantial health benefit and suggested additional benefits by doing more than double this amount . However , the upper limit of longevity benefit or possible harm with more physical activity is unclear . OBJECTIVE To quantify the dose-response association between leisure time physical activity and mortality and define the upper limit of benefit or harm associated with increased levels of physical activity . DESIGN , SETTING , AND PARTICIPANTS We pooled data from 6 studies in the National Cancer Institute Cohort Consortium ( baseline 1992 - 2003 ) . Population -based prospect i ve cohorts in the United States and Europe with self-reported physical activity were analyzed in 2014 . A total of 661,137 men and women ( median age , 62 years ; range , 21 - 98 years ) and 116,686 deaths were included . We used Cox proportional hazards regression with cohort stratification to generate multivariable-adjusted hazard ratios ( HRs ) and 95 % CIs . Median follow-up time was 14.2 years . EXPOSURES Leisure time moderate- to vigorous-intensity physical activity . MAIN OUTCOMES AND MEASURES The upper limit of mortality benefit from high levels of leisure time physical activity . RESULTS Compared with individuals reporting no leisure time physical activity , we observed a 20 % lower mortality risk among those performing less than the recommended minimum of 7.5 metabolic-equivalent hours per week ( HR , 0.80 [ 95 % CI , 0.78 - 0.82 ] ) , a 31 % lower risk at 1 to 2 times the recommended minimum ( HR , 0.69 [ 95 % CI , 0.67 - 0.70 ] ) , and a 37 % lower risk at 2 to 3 times the minimum ( HR , 0.63 [ 95 % CI , 0.62 - 0.65 ] ) . An upper threshold for mortality benefit occurred at 3 to 5 times the physical activity recommendation ( HR , 0.61 [ 95 % CI , 0.59 - 0.62 ] ) ; however , compared with the recommended minimum , the additional benefit was modest ( 31 % vs 39 % ) . There was no evidence of harm at 10 or more times the recommended minimum ( HR , 0.69 [ 95 % CI , 0.59 - 0.78 ] ) . A similar dose-response relationship was observed for mortality due to cardiovascular disease and to cancer . CONCLUSIONS AND RELEVANCE Meeting the 2008 Physical Activity Guidelines for Americans minimum by either moderate- or vigorous-intensity activities was associated with nearly the maximum longevity benefit . We observed a benefit threshold at approximately 3 to 5 times the recommended leisure time physical activity minimum and no excess risk at 10 or more times the minimum . In regard to mortality , health care professionals should encourage inactive adults to perform leisure time physical activity and do not need to discourage adults who already participate in high-activity levels",
"Despite advances in pharmacological therapy , physical treatment continues to be important in the management of ankylosing spondylitis ( AS ) . The objective of the present study was to evaluate the effects and tolerability of combined spa therapy and rehabilitation in a group of AS patients being treated with TNF inhibitors . Thirty AS patients attending the Rheumatology Unit of the University of Padova being treated with TNF inhibitors for at least 3 months were r and omized and assessed by an investigator independent from the spa staff : 15 were prescribed 10 sessions of spa therapy ( mud packs and thermal baths ) and rehabilitation ( exercises in a thermal pool ) and the other 15 were considered controls . The patients in both groups had been receiving anti-TNF agents for at least three months . The outcome measures utilized were BASFI , BASDAI , BASMI , VAS for back pain and HAQ . The evaluations were performed in all patients at the entry to the study , at the end of the spa treatment , and after 3 and 6 months . Most of the evaluation indices were significantly improved at the end of the spa treatment , as well as at the 3 and 6 months follow-up assessment s. No significant alterations in the evaluation indices were found in the control group . Combined spa therapy and rehabilitation caused a clear , long-term clinical improvement in AS patients being treated with TNF inhibitors . Thermal treatment was found to be well tolerated and none of the patients had disease relapse",
"Aims : To evaluate effects of physiotherapeutic intervention in terms of self- and manual mobilization on chest expansion , vital capacity , posture , spine mobility and experienced consequences of the disease in patients with ankylosing spondylitis . Design : A prospect i ve , r and omized controlled study . Methods : Thirty-two men , aged between 23 and 60 years , with ankylosing spondylitis were r and omized to active or no treatment for eight weeks . Physiotherapeutic intervention included individualized self- and manual mobilization for 1 hour twice a week and individually adjusted home exercises . Two blinded investigators made the assessment s of chest expansion , posture and spinal mobility before and after the treatment period . The patient filled in three and the physiotherapist one of the four Bath Ankylosing Spondylitis scales ( BAS scales ) . Results : In the treatment group chest expansion increased at the level of processus xiphoideus ( P posture improved in the cervical ( C7—wall distance ) ( P Thoracic and lumbar spine flexion improved ( P sagittal range of motion P Bath Ankylosing Spondylitis Metrology Index total scoring improved ( P scales showed no differences between groups . At four months follow-up of the treatment group , cervical spine posture , lumbar flexion and range of motion as well as BAS Metrology Index were still improved . Conclusion : This study shows that eight weeks of self- and manual mobilization treatment improved chest expansion , posture and spine mobility in patients with ankylosing spondylitis",
"Background Physical therapy is recommended for the management of axial spondyloarthritis ( axSpA ) and flexibility exercises have traditionally been the main focus . Cardiovascular ( CV ) diseases are considered as a major health concern in axSpA and there is strong evidence that endurance and strength exercise protects against CV diseases . Therefore , the aim of this study was to investigate the efficacy of high intensity endurance and strength exercise on disease activity and CV health in patients with active axSpA. Methods In a single blinded r and omized controlled pilot study the exercise group ( EG ) performed 12 weeks of endurance and strength exercise while the control group ( CG ) received treatment as usual . The primary outcome was the Ankylosing Spondylitis ( AS ) Disease Activity Score ( ASDAS ) . Secondary outcomes included patient reported disease activity ( Bath AS Disease Activity Index [ BASDAI ] ) , physical function ( Bath AS Functional Index [ BASFI ] ) , and CV risk factors measured by arterial stiffness ( Augmentation Index [ Alx ] ) and Pulse Wave Velocity [ PWV ] ) , cardiorespiratory fitness ( VO2 peak ) and body composition . ANCOVA on the post intervention values with baseline values as covariates was used to assess group differences , and Mann Whitney U-test was used for outcomes with skewed residuals . Results Twenty-eight patients were included and 24 ( EG , n = 10 , CG , n = 14 ) completed the study . A mean treatment effect of −0.7 ( 95%CI : −1.4 , 0.1 ) was seen in ASDAS score . Treatment effects were also observed in secondary outcomes ( mean group difference [ 95%CI ] ) : BASDAI : −2.0 ( −3.6 , −0.4 ) , BASFI : −1.4 ( −2.6 , −0.3 ) , arterial stiffness ( estimated median group differences [ 95 % CI ] ) : AIx ( % ) : −5.3 ( −11.0 , −0.5 ) , and for PVW ( m/s ) : −0.3 ( −0.7 , 0.0 ) , VO2 peak ( ml/kg/min ) ( mean group difference [ 95%CI ] : 3.7 ( 2.1 , 5.2 ) and trunk fat ( % ) : −1.8 ( −3.0 , −0.6 ) . No adverse events occurred . Conclusion High intensity exercise improved disease activity and reduced CV risk factors in patients with active axSpA. These effects will be further explored in a larger trial . Trial Registration Clinical Trials.gov",
"Objective : To vali date and refine two sets of c and i date criteria for the classification/diagnosis of axial spondyloarthritis ( SpA ) . Methods : All Assessment of SpondyloArthritis international Society ( ASAS ) members were invited to include consecutively new patients with chronic ( ⩾3 months ) back pain of unknown origin that began before 45 years of age . The c and i date criteria were first tested in the entire cohort of 649 patients from 25 centres , and then refined in a r and om selection of 40 % of cases and thereafter vali date d in the remaining 60 % . Results : Upon diagnostic work-up , axial SpA was diagnosed in 60.2 % of the cohort . Of these , 70 % did not fulfil modified New York criteria and , therefore , were classified as having “ non-radiographic ” axial SpA. Refinement of the c and i date criteria result ed in new ASAS classification criteria that are defined as : the presence of sacroiliitis by radiography or by magnetic resonance imaging ( MRI ) plus at least one SpA feature ( “ imaging arm ” ) or the presence of HLA-B27 plus at least two SpA features ( “ clinical arm ” ) . The sensitivity and specificity of the entire set of the new criteria were 82.9 % and 84.4 % , and for the imaging arm alone 66.2 % and 97.3 % , respectively . The specificity of the new criteria was much better than that of the European Spondylarthropathy Study Group criteria modified for MRI ( sensitivity 85.1 % , specificity 65.1 % ) and slightly better than that of the modified Amor criteria ( sensitivity 82.9 , specificity 77.5 % ) . Conclusion : The new ASAS classification criteria for axial SpA can reliably classify patients for clinical studies and may help rheumatologists in clinical practice in diagnosing axial SpA in those with chronic back pain . Trial registration number : NCT00328068",
"OBJECTIVE The purpose was to evaluate the effectiveness of a progressive muscle strengthening program using a Swiss ball for AS patients . METHODS Sixty patients with AS were r and omized into the intervention group ( IG ) or the control group ( CG ) . Eight exercises were performed by the IG patients with free weights on a Swiss ball two times per week for 16 weeks . The evaluations were performed by a blinded evaluator at baseline and after 4 , 8 , 12 and 16 weeks using the following instruments : the one-repetition maximum test ( 1 RM ) , BASMI , BASFI , HAQ-S , SF-36 , 6-minute walk test , time up and go test , BASDAI , ASDAS , ESR and CRP dosage and Likert scale . RESULTS There was a statistical difference between groups for : strength ( 1 RM capacity ) in the following exercises : abdominal , rowing , squat , triceps and reverse fly ( p 6-minute walk test ( p timed up and go test ( p=0.025 ) and Likert scale ( p functional capacity evaluation using the BASFI , HAQ-S , BASMI , SF-36 , TUG , ASDAS , ESR and CPR dosage . CONCLUSIONS Progressive muscle strengthening using a Swiss ball is effective for improving muscle strength and walking performance in patients with AS",
"Epidemiological studies suggest a dose-response relationship exists between physical activity and cognitive outcomes . However , no direct data from r and omized trials exists to support these indirect observations . The purpose of this study was to explore the possible relationship of aerobic exercise dose on cognition . Underactive or sedentary participants without cognitive impairment were r and omized to one of four groups : no-change control , 75 , 150 , and 225 minutes per week of moderate-intensity semi-supervised aerobic exercise for 26-weeks in a community setting . Cognitive outcomes were latent residual scores derived from a battery of 16 cognitive tests : Verbal Memory , Visuospatial Processing , Simple Attention , Set Maintenance and Shifting , and Reasoning . Other outcome measures were cardiorespiratory fitness ( peak oxygen consumption ) and measures of function functional health . In intent-to-treat ( ITT ) analyses ( n = 101 ) , cardiorespiratory fitness increased and perceived disability decreased in a dose-dependent manner across the 4 groups . No other exercise-related effects were observed in ITT analyses . Analyses restricted to individuals who exercised per- protocol ( n = 77 ) demonstrated that Simple Attention improved equivalently across all exercise groups compared to controls and a dose-response relationship was present for Visuospatial Processing . A clear dose-response relationship exists between exercise and cardiorespiratory fitness . Cognitive benefits were apparent at low doses with possible increased benefits in visuospatial function at higher doses but only in those who adhered to the exercise protocol . An individual ’s cardiorespiratory fitness response was a better predictor of cognitive gains than exercise dose ( i.e. , duration ) and thus maximizing an individual ’s cardiorespiratory fitness may be an important therapeutic target for achieving cognitive benefits . Trial Registration Clinical Trials.gov",
"OBJECTIVE To study the effect of tumor necrosis factor α ( TNFα ) inhibitors on progressive spinal damage in patients with ankylosing spondylitis ( AS ) . METHODS All AS patients meeting the modified New York criteria who had been monitored prospect ively and had at least 2 sets of spinal radiographs a minimum of 1.5 years apart were included in the study ( n=334 ) . The patients received st and ard therapy , which included nonsteroidal antiinflammatory drugs and TNFα inhibitors . Radiographic severity was assessed by the modified Stoke Ankylosing Spondylitis Spine Score ( mSASSS ) . Patients with a rate of AS progression that was ≥1 mSASSS unit/year were considered progressors . Univariable and multivariable regression analyses were done . Propensity score matching and sensitivity analysis were performed . A zero-inflated negative binomial ( ZINB ) model was used to analyze the effect of TNFα inhibitors on the change in the mSASSS with varying followup periods . Potential confounders , such as disease activity ( as assessed by the Bath Ankylosing Spondylitis Disease Activity Index ) , the erythrocyte sedimentation rate , C-reactive protein level , HLA-B27 positivity , sex , age at onset , smoking burden ( number of pack-years ) , and baseline damage , were included in the model . RESULTS TNFα inhibitor treatment was associated with a 50 % reduction in the odds of progression , with an odds ratio ( OR ) of 0.52 ( 95 % confidence interval [ 95 % CI ] 0.30 - 0.88 , P=0.02 ) . Patients with a delay of > 10 years in starting therapy were more likely to experience progression as compared to those who started earlier ( OR 2.4 [ 95 % CI 1.09 - 5.3 ] , P=0.03 ) . In the ZINB model , the use of TNFα inhibitors significantly reduced disease progression when the gap between radiographs was > 3.9 years . The protective effect of TNFα inhibitors was stronger after propensity score matching . CONCLUSION Treatment with TNFα inhibitors appears to reduce radiographic progression in AS patients , especially with early initiation and with longer duration of followup",
"The objective of this study was to investigate the effects of Pilates on pain , functional status , and quality of life in patients with ankylosing spondylitis . The study was performed as a r and omized , prospect i ve , controlled , and single-blind trial . Fifty-five participants ( 30 men , 25 women ) who were under a regular follow-up protocol in our Rheumatology Clinic with the diagnosis of AS according to the modified New York criteria were included in the study . The participants were r and omly assigned into two groups : in group I , Pilates exercise program of 1 h was given by a certified trainer to 30 participants 3 times a week for 12 weeks , and in group II , design ed as the control group , 25 participants continued previous st and ard treatment programs . In groups , pre-(week 0 ) and post treatment ( week 12 and week 24 ) evaluation was performed by one of the authors who was blind to the group allocation . Primary outcome measure was functional capacity . Evaluation was done using the Bath Ankylosing Spondylitis Functional Index ( BASFI ) . Exploratory outcome measures were Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , Bath Ankylosing Spondylitis Metrology Index ( BASMI ) , Chest expansion , and ankylosing spondylitis quality of life ( ASQOL ) question naire . In group I , BASFI showed significant improvement at week 12 ( P = 0.031 ) and week 24 ( P = 0.007 ) . In group II , this parameter was not found to have significantly changed at week 12 and week 24 . Comparison of the groups showed significantly superior results for group I at week 24 ( P = 0.023 ) . We suggest Pilates exercises as an effective and safe method to improve physical capacity in AS patients . Our study is the first clinical study design ed to investigate the role of Pilates method in AS treatment . We believe that further research with more participants and longer follow-up periods could help assess the therapeutic value of this popular physical exercise method in AS",
"Objective . To assess the 2- ( T1 ) and 6-month ( T2 ) followup effects on pain , spine mobility , physical function , and disability outcome of a rehabilitation intervention in patients with ankylosing spondylitis ( AS ) stabilized with tumor necrosis factor ( TNF ) inhibitor therapy . Methods . Sixty-two out patients ( 49 men , 13 women , mean age 47.5 ± 10.6 yrs ) were r and omized to rehabilitation plus an educational-behavioral ( n = 20 ) program , to an educational-behavioral program only ( n = 20 ) , or to a control group ( n = 22 ) . The educational-behavioral program included 2 educational meetings and 12 rehabilitation exercise sessions ( stretching , strengthening , chest and spine/hip joint flexibility exercises ) , which patients then performed at home . Outcome assessment at the end of rehabilitation training ( T1 ) and at T2 was based on spinal pain intensity in the previous 4 weeks by self-report visual analog scale ( VAS ; 100 mm : 0 = no pain , 100 = maximum pain ) , BASMI , BASFI , BASDAI , and on chest expansion and the active range of motion of the cervical and lumbar spine measured by a pocket goniometer . Results . The 3 groups were comparable at baseline . On intragroup comparison at T1 , the rehabilitation group showed significant improvement in the BASMI and BASDAI , in chest expansion , and in most spinal active range of motion measurements . BASFI and cervical and lumbar VAS scores improved in both the rehabilitation and educational-behavioral groups . The positive results achieved in the rehabilitation group were maintained at the 6-month followup . Conclusion . Combining intensive group exercise with an educational-behavioral program can provide promising results in the management of patients with clinical ly stabilized AS on TNF inhibitor treatment",
"BACKGROUND Exergames are a well-known type of game based on a virtual avatar 's body movements . This hightech approach promotes an active lifestyle . OBJECTIVES The aim of this r and omized controlled trial was to evaluate the effects of exergames on pain , disease activity , functional capacity and quality of life in patients with ankylosing spondylitis ( AS ) . MATERIAL AND METHODS The study involved 60 patients , who were r and omized into either the exergame group ( EG ) or the control group ( CG ) . The EG patients engaged in exergaming , and CG patients did not engage in any exercises . The exergaming sessions were performed five times a week for eight weeks ( 40 sessions in total ) . The patients were assessed before and after the eight-week program on a visual analog scale ( VAS ) , the Bath Ankylosing Spondylitis Functional Index ( BASFI ) , the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) and the Ankylosing Spondylitis Quality of Life ( ASQOL ) question naire . RESULTS A statistically significant improvement was observed in VAS , BASFI , BASDAI and ASQoL scores in the EG group after completion of the exercise program ( p exergame platform to help patients with spondyloarthropathies to adopt a more physically active lifestyle . The results of this study suggest that exergames increase physical activity and decrease the pain scores in AS patients and also could , therefore , be feasible and safe",
"OBJECTIVE To evaluate the mean overall effects over a 1-year period of a multidisciplinary in-patient rehabilitation programme for patients with ankylosing spondylitis . DESIGN Observer-blinded , r and omized controlled trial , with assessment s made after 4 and 12 months . PATIENTS Forty-six patients received a 3-week in-patient rehabilitation programme and 49 patients received treatment as usual . METHODS Primary outcomes were disease activity measured with the Bath Ankylosing Spondylitis Disease Activity Scale ( BASDAI ) , and function measured with the Bath Ankylosing Spondylitis Functional Index ( BASFI ) . Secondary outcomes included well-being , spinal and hip mobility , and health-related quality of life measured with the Medical Outcome Study Short Form-36 . Overall treatment effects were estimated with Mixed models repeated measures analyses . RESULTS Significant overall treatment effects in favour of the rehabilitation group were found in the BASDAI score ( mean difference over the 1-year period -10.0 , 95 % confidence interval : -3.7 to -16.3 ) , in well-being ( -7.3 , 95 % confidence interval : -1.0 to -14.7 ) , and in the Medical Outcome Study Short Form-36 variables social functioning , role physical , role mental and bodily pain ( mean differences ranging from 5.8 ( pain ) to 10.7 ( role physical ) ) . CONCLUSION A 3-week in-patient rehabilitation programme had positive overall effects on disease activity , pain , function and well-being , and should be considered an important complement to medical disease management in persons with ankylosing spondylitis",
"OBJECTIVES To investigate gender-attributable differences regarding clinical outcome [ disease activity , physical function and quality of life ( QoL ) ] and radiographic damage in patients with AS over time . METHODS Data from the Outcome in AS International Study were used . Disease activity was assessed by the BASDAI , ASDAS and CRP ; physical function by BASFI ; QoL by the Short Form-36 , Ankylosing Spondylitis Quality of Life ( ASQoL ) score and European Quality Of Life scale ; and radiographic damage by the modified Stoke AS Spine Score ( mSASSS ) . Cross-sectional comparative analyses were done at baseline . Next , separate models were created to assess gender-attributable differences on each outcome measure over time using time-adjusted generalized estimating equations . RESULTS A total of 216 patients [ 154 ( 72.3 % ) males , mean age 43.6 years ( s.d . 12.7 ) , symptom duration 20.5 years ( s.d . 11.8 ) , mean follow-up duration 8.3 years ( s.d . 4.1 ) ] were included . At baseline , male compared with female patients had lower self-reported disease activity ( BASDAI 3.2 vs 3.9 , P = 0.03 ) but more radiographic damage ( mSASSS 13.8 vs 6.5 , P = 0.02 ) . No significant gender-attributable differences in other clinical parameters were found . In multivariable analysis , male gender was significantly associated with a better ASQoL ( B = -1.18 , 95 % CI : -2.17 , -0.20 , P = 0.02 ) , and in a separate model with a higher mSASSS over time ( B = 8.24 , 95 % CI : 4.38 , 12.09 , P disease activity or physical function over time were found . However , radiographic damage was more severe in males . Furthermore , males had a better QoL over time",
"OBJECTIVE To evaluate the effect of infliximab on progression of structural damage over 2 years in patients with ankylosing spondylitis ( AS ) . METHODS In the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy ( ASSERT ) , a r and omized , double-blind , placebo-controlled trial of the efficacy of infliximab compared with placebo , 279 patients with active AS received either placebo through week 24 and then infliximab 5 mg/kg from week 24 through week 96 ( n=78 ) or infliximab 5 mg/kg from baseline through week 96 , administered every 6 weeks after a loading dose ( n=201 ; these patients were the focus of the radiographic analyses ) . Radiographic findings in patients from the ASSERT trial were indistinguishable from those in a historical control cohort of patients who had no prior use of anti-tumor necrosis factor agents ( from the Outcome in Ankylosing Spondylitis International Study [ OASIS ] data base ; n=192 ) . Radiographic progression of structural damage from baseline to the 2-year followup was scored using the modified Stoke Ankylosing Spondylitis Spine Score ( mSASSS ) . All images were scored in one batch . RESULTS Median changes in the mSASSS from baseline to year 2 were 0.0 for both the OASIS and the ASSERT cohorts ( P=0.541 ) . Mean changes in the mSASSS were also similar between the OASIS and ASSERT cohorts ( mean+/-SD change over 2 years 1.0+/-3.2 and 0.9+/-2.6 , respectively ) . In addition , results from sensitivity analyses did not show a statistically significant difference in the mSASSS between the OASIS and ASSERT cohorts . CONCLUSION AS patients who received infliximab from baseline through week 96 did not show a statistically significant difference in inhibition of structural damage progression at year 2 , as assessed using the mSASSS scoring system , when compared with radiographic data from the historical control OASIS cohort . Improvements in clinical outcomes and spinal inflammation have been previously demonstrated with the use of infliximab therapy",
"OBJECTIVE Our previous r and omized clinical trial showed a 4-month home physiotherapy program was effective for patients with ankylosing spondylitis . This followup study reports on 22 control patients who received the previously withheld treatment and 24 experimental patients who received followup treatment as needed . METHODS The primary outcome measure was spinal mobility measured by fingertip-to-floor distance using a portable measuring device specially design ed and vali date d for this study . RESULTS Following treatment , fingertip-to-floor distance did not change in control patients ( P2 = 0.145 ) . Between 4 and 8 months , fingertip-to-floor distance did not change in experimental patients ( P2 = 0.143 ) ; however , initial improvement achieved was maintained . The experimental group at 4 months was better than the control group at 8 months ( P2 = 0.038 ) . CONCLUSION The home physiotherapy treatment program must be delivered as rigorously as it was in the initial trial to be effective . The benefit from this treatment program can be maintained with very little intervention",
"Objective To investigate the influence of non-steroidal anti-inflammatory drugs ( NSAIDs ) intake on radiographic spinal progression over 2 years in patients with ankylosing spondylitis ( AS ) and non-radiographic axial spondyloarthritis ( SpA ) . Methods 164 patients with axial SpA ( 88 with AS and 76 with non-radiographic axial SpA ) were selected for this analysis based on availability of spinal radiographs at baseline and after 2 years of follow-up and the data on NSAIDs intake . Spinal radiographs were scored by two trained readers in a concealed r and omly selected order according to the modified Stoke Ankylosing Spondylitis Spine Score ( mSASSS ) system . An index of the NSAID intake counting both dose and duration of drug intake was calculated . Results High NSAIDs intake ( NSAID index≥50 ) in AS was associated with lower likelihood of significant radiographic progression defined as an mSASSS worsening by ≥2 units : OR=0.15 , 95 % CI 0.02 to 0.96 , p=0.045 ( adjusted for baseline structural damage , elevated C reactive protein ( CRP ) and smoking status ) in comparison with patients with low NSAIDs intake ( NSAID index with baseline syndesmophytes plus elevated CRP : mean mSASSS progression was 4.36±4.53 in patients with low NSAIDs intake versus 0.14±1.80 with high intake , p=0.02 . In non-radiographic axial SpA , no significant differences regarding radiographic progression between patients with high and low NSAIDs intake were found . Conclusion A high NSAIDs intake over 2 years is associated with retarded radiographic spinal progression in AS . In non-radiographic axial SpA this effect is less evident , probably due to a low grade of new bone formation in the spine at this stage"
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4117e934-06ff-11f0-808a-c43d1ab1c353
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AIM The aim of this review was to determine the effectiveness of h and splinting for improving h and function in children with cerebral palsy ( CP ) and brain injury . METHOD A systematic review with meta-analyses was conducted . Only r and omized and quasi-r and omized controlled trials in which all participants were children aged 0 to 18 years with CP or brain injury and a h and splint ( cast , brace , or orthosis ) were included . RESULTS Six studies met the inclusion criteria . No study included participants with a brain injury ; therefore , the results relate only to CP . Five studies investigated ' non-functional h and splints ' and one investigated a ' functional h and splint ' . Moderate- quality evidence indicated a small benefit of non-functional h and splints plus therapy on upper limb skills over therapy alone ( st and ard mean difference [SMD]=0.81 , 95 % confidence interval [CI]=0.03 - 1.58 ) , although benefits were diminished 2 to 3 months after splint wearing stopped ( SMD=0.35 , CI -0.06 to 0.77 ) . INTERPRETATION In children with CP , h and splints may have a small benefit for upper limb skills . However , results are diminished after splint wearing stops . Given the costs - potential negative cosmesis and discomfort for the child - clinicians must consider whether h and splinting is clinical ly worthwhile . Further method ologically sound research regarding h and splinting combined with evidence -based therapy is needed to investigate whether the small clinical effect is meaningful
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"Background and Purpose — Studies on adult stroke patients have demonstrated functional changes in cortical excitability , metabolic rate , or blood flow after motor therapy , measures that can fluctuate rapidly over time . This study evaluated whether evidence could also be found for structural brain changes during an efficacious rehabilitation program . Methods — Chronic stroke patients were r and omly assigned to receive either constraint-induced movement therapy ( n=16 ) or a comparison therapy ( n=20 ) . Longitudinal voxel-based morphometry was performed on structural MRI scans obtained immediately before and after patients received therapy . Results — The group receiving constraint-induced movement therapy exhibited far greater improvement in use of the more affected arm in the life situation than the comparison therapy group . Structural brain changes paralleled these improvements in spontaneous use of the more impaired arm for activities of daily living . There were profuse increases in gray matter in sensory and motor areas both contralateral and ipsilateral to the affected arm that were bilaterally symmetrical , as well as bilaterally in the hippocampus . In contrast , the comparison therapy group failed to show gray matter increases . Importantly , the magnitude of the observed gray matter increases was significantly correlated with amount of improvement in real-world arm use . Conclusions — These findings suggest that a previously overlooked type of brain plasticity , structural remodeling of the human brain , is harnessed by constraint-induced movement therapy for a condition once thought to be refractory to treatment : motor deficit in chronic stroke patients",
"It has recently been suggested that lycra garments are helpful for children with cerebral palsy ( CP ) . Twelve children , with athetosis , ataxia , and spasticity , were fitted with lycra garments ( Kendall‐Camp UK Ltd ) . Scores on the Paediatric Evaluation of Disability Inventory ( PEDI ) scales were determined before and after wearing the garment for at least 6 hours a day for 6 weeks . Five children with motor problems representative of the whole group were investigated during a reach‐ and ‐grasp task by kinematic motion analysis ; reflective markers were used with and without the garment . Carers were given a question naire concerning the practicalities of using the garments . All 12 children made improvements in at least one of the functional scales of the PEDI , and scores for the whole group showed significant gains ( Wilcoxon X2 test , self‐help p mobility p social p children made gains of at least one scale of the caregiver assistance scores , two of the children showed losses ( due to difficulties removing the garment for toileting ) , and four showed no change . Motion analysis indicated that ( 1 ) two children with athetosis had improved proximal stability in sitting and in smoothness of arm movements , ( 2 ) one child with ataxia had improved in proximal and distal stability , and ( 3 ) two children with spasticity had more jerky movements , although one improved in proximal stability . All children had problems in wearing the garments , including problems with toileting and incontinence of urine ; the parents of only one child wanted to continue using it . Results suggest that the functional benefit of lycra garments for children with CP is mainly due to improvements in proximal stability but this should be weighed against the inconvenience and loss of independence ",
"AIMS To determine changes in upper limb movement substructures that denote fluency of movement in children with cerebral palsy ( CP ) following lycra ( ® ) splint wear . Secondarily , to explore the efficacy of lycra ( ® ) splints for those with spastic and dystonic hypertonia . DESIGN R and omised clinical trial whereby participants were r and omised to parallel groups with waiting list control . METHOD Sixteen children ( mean age 11.5 years SD=2.2 ) with hypertonic upper limb involvement ( 13 hemiplegia , 4 quadriplegia ) were recruited . Children were r and omly allocated either to a control group or to wear the lycra ( ® ) splint for a period of three months . Three-dimensional ( 3D ) upper limb kinematics was used to assess four functional tasks at baseline , on initial lycra ( ® ) splint application , three months after lycra ( ® ) splint wear , and immediately after splint removal . Movement substructures of the motion of the wrist joint center were analysed . RESULTS A significant difference was observed between baseline and three months of lycra ( ® ) splint wear in the movement substructures ; movement time , percentage of time and distance in primary movement , jerk index , normalised jerk and percentage of jerk in primary and secondary movements . The magnitude of changes in normalised jerk and the percentage of jerk in the primary movement from baseline to three months was greatest in children with dystonic hypertonia . CONCLUSIONS The results indicate that lycra ( ® ) arm splinting induced significant changes in movement substructures and motor performance in children with CP . This research demonstrates that fluency of movement can be quantified and is amenable to change with intervention",
"A prospect i ve study was design ed to determine whether the combined use of neuromuscular electrical stimulation ( NMES ) and dynamic bracing was more effective than use of either alone in reducing upper-extremity spasticity in children with spastic hemiplegic cerebral palsy . Twenty-four patients ( 12 males , 12 females ; mean age 8y 7mo [ SD 4y 2mo ] ; age range 3 - 18y ) diagnosed with spastic hemiplegic CP were r and omly allocated to three groups : group 1 had two 30-minute sessions of NMES a day applied on the antagonist extensors without bracing ; group 2 had two 30-minute sessions of dynamic bracing per day ; and group 3 had two 30-minute sessions of NMES and dynamic bracing every day . Treatment was continued for 6 months in all groups and applied only to the affected extremity . Patients were evaluated before therapy , at monthly intervals during the therapy , and 3 months after completion of the therapy . Three measures of outcome were taken : the Melbourne Assessment , grip strength , and posture evaluation with Zancolli 's classification . The therapist performing the outcome assessment s was blinded as to groups . Statistically significant differences were found in all three measures for only those treated with combined NMES and dynamic bracing . However , this significant effect lasted for only 2 months after discontinuation of the treatment . We conclude that the combined use of NMES and bracing is more effective than either alone but requires continuous application",
"OBJECTIVES To investigate the effects of lycra ® arm splint wear on goal attainment and three dimensional ( 3D ) kinematics of the upper limb and trunk in children with cerebral palsy ( CP ) . DESIGN R and omised clinical trial whereby participants were r and omised to parallel groups with waiting list control . PARTICIPANTS Sixteen children with CP ( hypertonia ) aged 9 to 14 years . INTERVENTION Three months lycra arm splint wear combined with goal directed training . MAIN OUTCOME MEASURE Goal attainment scale , and 3D upper limb and trunk kinematics across four upper limb movement tasks . RESULTS 17/18 children achieved their movement goals following three months of splinting . Selected joint kinematics improved on immediate splint application . Further improvements in joint kinematics were demonstrated following 3 months of splint wear , particularly in elbow extension , shoulder flexion and abduction and in thorax flexion . Only improvements in movement compensations at the thorax remained following removal of the splint . CONCLUSIONS The lycra ® arm splint , made a quantifiable change to the attainment of movement goals of importance to the child . Furthermore , improvements were demonstrated in selected maximum range of movement and joint kinematics during functional tasks at the elbow and shoulder joints and thorax segment in children with CP ",
"Background . Constraint-induced movement therapy ( CIMT ) promotes h and function using intensive unimanual practice along with restraint of the less-affected h and . CIMT has not been compared with a treatment with equivalent dosing frequency and intensity in children with cerebral palsy ( CP ) . Objectives . The authors report a r and omized trial comparing CIMT and a bimanual intervention ( h and -arm intensive bimanual therapy ; HABIT ) that maintains the intensity of practice associated with CIMT but where children are engaged in functional bimanual tasks . Methods . A total of 42 participants with hemiplegic CP between the ages of 3.5 and 10 years ( matched for age and h and function ) were r and omized to receive 90 hours of CIMT or an equivalent dosage of functional bimanual training ( HABIT ) conducted in day-camp environments . A physical therapist blinded to treatment allocation tested h and function before and after treatment . The primary outcomes were changes in Jebsen-Taylor Test of H and Function ( JTTHF ) and Assisting H and Assessment ( AHA ) scores . Secondary measures included the Goal Attainment Scale ( GAS ) . Results . Both the CIMT and HABIT groups demonstrated comparable improvement from the pretest to immediate posttest in the JTTHF and AHA ( P CIMT and bimanual training lead to similar improvements in h and function . A potential benefit of bimanual training is that participants may improve more on self-determined goals",
"AIM Conventional constraint-based therapies are intensive and dem and ing to implement , particularly for children . Modified forms of constraint-based therapies that are family-centred may be more acceptable and feasible for families of children with cerebral palsy (CP)-but require rigorous evaluation using r and omized trials . The aim of this study was to determine the effects of modified constraint-induced therapy compared with intensive occupational therapy on activities of daily living and upper limb outcomes in children with hemiplegic CP . METHOD In this assessor-blinded pragmatic r and omized trial , 50 children ( 27 males , 23 females ; age range 19 mo-7 y 10 mo ) with hemiplegic CP were r and omized using a concealed allocation procedure to one of two 8-week interventions : intensive occupational therapy ( n = 25 ) , or modified constraint-induced therapy ( n = 25 ) . Manual Ability Classification System ( MACS ) levels of the participants were , level I n = 2 , II n = 37 , III n = 8 , and level IV n = 1 ; Gross Motor Function Classification System ( GMFCS ) levels were , level I n = 33 , level II n = 15 , and level III n = 1 . Participants were recruited through three specialist CP centres in Australia and r and omized between January 2008 and April 2010 . Children r and omized to modified constraint-induced therapy wore a mitt on the unaffected h and for 2 hours each day , during which time the children participated in targeted therapy . The primary outcome was the Canadian Occupational Performance Measure ( COPM -- measured on a 10-point scale ) at completion of therapy . Other outcome measures were Goal Attainment Scaling , Assisting H and Assessment , Pediatric Motor Activity Log , Modified Ashworth Scale , Modified Tardieu Scale , and a parent question naire . Assessment s were carried out at 10 weeks and 6 months following r and omization . RESULTS All participants were included in the analysis . Between-group differences for all outcomes were neither clinical ly important nor statistically significant . The mean difference in COPM was 0.3 ( 95 % confidence interval [ CI ] -0.8 to 1.4 ; p=0.61 ) and mean difference in COPM satisfaction was 0.1 ( 95 % CI -1.1 to 1.2 ; p=0.90 ) . Minor adverse events were reported by five of the 25 participants in the modified constraint-induced therapy group and by one of the 25 in the intensive occupational therapy group . All adverse events were related to participants ' lack of acceptance of therapy . INTERPRETATION Modified constraint-induced therapy is no more effective than intensive occupational therapy for improving completion of activities of daily living or upper limb function in children with hemiplegic CP",
"AIM To determine if constraint-induced movement therapy ( CIMT ) is more effective than bimanual training ( BIM ) in improving upper limb activity outcomes for children with congenital hemiplegia in a matched-pairs r and omized trial . METHOD Sixty-three children ( mean age 10.2 , SD 2.7 , range 5 - 16 y ; 33 males , 30 females ) , 16 in Manual Ability Classification System level I , 46 level II , and 1 level III and 16 in Gross Motor Function Classification level I , 47 level II ) were r and omly allocated to either CIMT or BIM group day camps ( 60 hours over 10 days ) . The Melbourne Assessment of Unilateral Upper Limb Function assessed unimanual capacity of the impaired limb and Assisting H and Assessment evaluated bimanual coordination at baseline , 3 and 26 weeks , scored by blinded raters . RESULTS After concealed r and om allocation , there was no baseline difference between groups . CIMT had superior outcomes compared with BIM for unimanual capacity at 26 weeks ( estimated mean difference [ EMD ] 4.4 , 95 % confidence interval [ CI ] 2.2 - 6.7 ; p improvements in bimanual performance at 3 weeks , with gains maintained by BIM at 26 weeks ( EMD 2.3 ; 95 % CI 0.6 - 4.0 ; p = 0.008 ) . Interpretation Overall , there were only small differences between the two training approaches . CIMT yielded greater changes in unimanual capacity of the impaired upper limb compared with BIM . Results generally reflect specificity of practice , with CIMT improving unimanual capacity and BIM improving bimanual performance . Considerable inter-individual variation in response to either intervention was evident . Future research should consider serial sequencing unimanual then BIM approaches to optimize upper limb outcomes for children with congenital hemiplegia",
"Children with hemiplegic cerebral palsy ( CP ) have impairments in bimanual coordination above and beyond their unilateral impairments . Recently we developed h and -arm bimanual intensive therapy ( HABIT ) , using the principles of motor learning , and neuroplasticity , to address these bimanual impairments . A single-blinded r and omized control study of HABIT was performed to examine its efficacy in children with hemiplegic CP with mild to moderate h and involvement . Twenty children ( age range 3 y 6 mo-15 y 6 mo ) were r and omized to either an intervention ( n=10 : seven males , three females ; mean age 8 y 7 mo , SD 4 y ) or a delayed treatment control group ( n=10 : seven males , three females ; mean age 6 y 10 mo , SD 2 y 4 mo ) . Children were engaged in play and functional activities that provided structured bimanual practice 6 hours per day for 10 days . Each child was evaluated immediately before and after the intervention , and again at 1-month post-intervention . Children in the intervention group demonstrated improved scores on the Assisting H and Assessment , increased involved extremity use measured using accelerometry and a caregiver survey , bimanual items of the Bruininks-Oseretsky Test of Motor Proficiency , and the simultaneity of completing a draw-opening task with two h and s ( p children with hemiplegic CP , HABIT appears to be efficacious in improving bimanual h and use",
"AIM The aim of this study was to determine the immediate effect of wearing a wrist and thumb brace on the performance of bimanual activities in children with spastic hemiplegic cerebral palsy . METHOD In a pre- and post-test cohort study of 25 children ( age range 4 - 11y ; mean age 8y 4mo [ SD 2y 2mo ] ; 16 males , 9 females ) with spastic hemiplegic cerebral palsy with a Zancolli classification h and score of I , IIA , or IIB ( mild and moderate h and dysfunction ; children with a Zancolli classification of III - severe h and dysfunction - were excluded from this study ) , performance of bimanual activities was evaluated with the Assisting H and Assessment ( AHA ) on three occasions : one assessment with a static wrist and thumb brace placed on the affected h and and two other assessment s without a brace . The differences between AHA scores obtained at the three assessment s were evaluated using the repeated measures analysis of variance . RESULTS Performance of bimanual activities while wearing the brace improved significantly compared to performance without the brace ( p mean AHA score increased by 3.2 ( 95 % confidence interval 2.1 - 4.3 ) from 59.1 to 62.3 . The scores of the two assessment s without the brace did not differ significantly . INTERPRETATION In children with spastic hemiplegic cerebral palsy , bracing of the wrist and thumb immediately improves spontaneous use of the affected upper limb in bimanual activities , possibly because bracing permits a more functional h and position",
"OBJECTIVE : The goal was to assess the effectiveness of an occupational therapy home program ( OTHP ) , compared with no OTHP , with respect to function and parent satisfaction with child function , participation , goal attainment , and quality of upper limb skill in school-aged children with cerebral palsy . METHODS : Thirty-six children with cerebral palsy ( mean age : 7.7 years ; male : 69 % ; Gross Motor Function Classification System : level I , 47 % ; level II , 14 % ; level III , 16 % ; level IV , 7 % ; level V , 16 % ; spasticity , 85 % ; dyskinesia , 14 % ; ataxia , 3 % ) were r and omly and equally assigned to OTHPs for 8 or 4 weeks or to no OTHP . The primary end point was Canadian Occupational Performance Measure scores 8 weeks after baseline . Secondary measures were recorded at 4 and 8 weeks . RESULTS : Eight weeks of OTHP produced statistically significant differences in function and parent satisfaction with function , compared with no OTHP . Parents in the 4-week OTHP group did not discontinue use at 4 weeks , as instructed , and continued for 8 weeks ; results demonstrated statistically significant differences , compared with no OTHP . There was no difference in primary or secondary end point measures between intervention groups . CONCLUSION : Pediatricians can advise families that OTHPs developed with a collaborative , evidence -based approach and implemented by parents at home were clinical ly effective if implemented 17.5 times per month for an average of 16.5 minutes per session"
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4117e970-06ff-11f0-808a-c43d1ab1c353
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Introduction The efficacy and the optimal type and volume of aerobic exercise ( AE ) in fibromyalgia syndrome ( FMS ) are not established . We therefore assessed the efficacy of different types and volumes of AE in FMS . Methods The Cochrane Library , EMBASE , MEDLINE , PsychInfo and SPORTD ISCUS ( through April 2009 ) and the reference sections of original studies and systematic review s on AE in FMS were systematic ally review ed . R and omised controlled trials ( RCTs ) of AE compared with controls ( treatment as usual , attention placebo , active therapy ) and head-to-head comparisons of different types of AE were included . Two authors independently extracted articles using predefined data fields , including study quality indicators . Results Twenty-eight RCTs comparing AE with controls and seven RCTs comparing different types of AE with a total of 2,494 patients were review ed . Effects were summarised using st and ardised mean differences ( 95 % confidence intervals ) by r and om effect models . AE reduced pain ( -0.31 ( -0.46 , -0.17 ) ; P fatigue ( -0.22 ( -0.38 , -0.05 ) ; P = 0.009 ) , depressed mood ( -0.32 ( -0.53 , -0.12 ) ; P = 0.002 ) and limitations of health-related quality of life ( HRQOL ) ( -0.40 ( -0.60 , -0.20 ) ; P improved physical fitness ( 0.65 ( 0.38 , 0.95 ) ; P Pain was significantly reduced post treatment by l and -based and water-based AE , exercises with slight to moderate intensity and frequency of two or three times per week . Positive effects on depressed mood , HRQOL and physical fitness could be maintained at follow-up . Continuing exercise was associated with positive outcomes at follow-up . Risks of bias analyses did not change the robustness of the results . Few studies reported a detailed exercise protocol , thus limiting subgroup analyses of different types of exercise . Conclusions An aerobic exercise programme for FMS patients should consist of l and -based or water-based exercises with slight to moderate intensity two or three times per week for at least 4 weeks . The patient should be motivated to continue exercise after participating in an exercise programme
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"The purpose of this study was to compare the effects of aerobic training with a muscle-strengthening program in patients with fibromyalgia . Thirty women with fibromyalgia were r and omized to either an aerobic exercise ( AE ) program or a strengthening exercise ( SE ) program for 8 weeks . Outcome measures included the intensity of fibromyalgia-related symptoms , tender point count , fitness ( 6-min walk distance ) , hospital anxiety and depression ( HAD ) scale , and short-form health survey ( SF-36 ) . There were significant improvements in both groups regarding pain , sleep , fatigue , tender point count , and fitness after treatment . HAD-depression scores improved significantly in both groups while no significant change occurred in HAD-anxiety scores . Bodily pain subscale of SF-36 and physical component summary improved significantly in the AE group , whereas seven subscales of SF-36 , physical component summary , and mental component summary improved significantly in the SE group . When the groups were compared after treatment , there were no significant differences in pain , sleep , fatigue , tender point count , fitness , HAD scores , and SF-36 scores . AE and SE are similarly effective at improving symptoms , tender point count , fitness , depression , and quality of life in fibromyalgia",
"OBJECTIVE A subset of fibromyalgia ( FM ) patients have a dysfunctional hypothalamic-pituitary-insulin-like growth factor 1 ( IGF-1 ) axis , as evidence d by low serum levels of IGF-1 and a reduced growth hormone ( GH ) response to physiologic stimuli . There is evidence that pyridostigmine ( PYD ) improves the acute response of GH to exercise in FM patients . The purpose of this study was to evaluate the clinical effectiveness of 6 months of PYD and group exercise on FM symptoms . METHODS FM patients were r and omized to 1 of the following 4 groups : PYD plus exercise , PYD plus diet recall but no exercise , placebo plus exercise , and placebo plus diet recall but no exercise . The primary outcome measures were the visual analog scale ( VAS ) score for pain , tender point count , and total myalgic score . Secondary outcome measures were the total score on the Fibromyalgia Impact Question naire ( FIQ ) and FIQ VAS scores for individual symptoms ( fatigue , poor sleep , stiffness , and anxiety ) , as well as quality of life ( QOL ) and physical fitness ( lower body strength/endurance , upper and lower body flexibility , balance , and time on the treadmill ) . RESULTS A total of 165 FM patients completed baseline measurements ; 154 ( 93.3 % ) completed the study . The combination of PYD and exercise did not improve pain scores . PYD groups showed a significant improvement in sleep and anxiety in those who completed the study and in QOL in those who complied with the therapeutic regimen as compared with the placebo groups . Compared with the nonexercise groups , the 2 exercise groups demonstrated improvement in fatigue and fitness . PYD was generally well tolerated . CONCLUSION Neither the combination of PYD plus supervised exercise nor either treatment alone yielded improvement in most FM symptoms . However , PYD did improve anxiety and sleep , and exercise improved fatigue and fitness . We speculate that PYD may have improved vagal tone , thus benefiting sleep and anxiety ; this notion warrants further study",
"OBJECTIVES To study the effect of a combination of thalassotherapy , exercise and patient education in people with fibromyalgia . METHODS Patients with fibromyalgia , selected from a rheumatology out-patient department and from members of the Dutch fibromyalgia patient association , were pre-r and omized to receive either 2(1/2 ) weeks of treatment in a Tunisian spa resort , including thalassotherapy , supervised exercise and group education ( active treatment ) or treatment as usual ( control treatment ) . Primary outcome measure was health-related quality of life , measured with the R AND -36 question naire . Secondary measures included the Fibromyalgia Impact Question naire , the McGill Pain Question naire , the Beck Depression Inventory , tender point score and a 6-min treadmill walk test . RESULTS Fifty-eight participants receiving the active treatment reported significant improvement on R AND -36 physical and mental component summary scales . For physical health , differences from the 76 controls were statistically significant after 3 months , but not after 6 and 12 months . A similar pattern of temporary improvement was seen in the self-reported secondary measures . Tender point scores and treadmill walk tests improved more after active treatment , but did not reach significant between-group differences , except for walk tests after 12 months . CONCLUSIONS A combination of thalassotherapy , exercise and patient education may temporarily improve fibromyalgia symptoms and health-related quality of life",
"Objectives : To assess the effectiveness of multidisciplinary rehabilitation in the treatment of fibromyalgia in comparison to st and ard medical care . Methods : Seventy-nine men and women were r and omly assigned to one of two groups . The intervention group consisted of a rheumatologist and physical therapist intake and discharge , 18 group supervised exercise therapy sessions , 2 group pain and stress management lectures , 1 group education lecture , 1 group dietary lecture , and 2 massage therapy sessions . The control group consisted of st and ard medical care with the patients ' family physician . Outcome measures included self-perceived health status , pain-related disability , average pain intensity , depressed mood , days in pain , hours in pain , prescription and nonprescription medication usage , and work status . Outcomes were measured at the end of the 6-week intervention and at 15-month follow-up . Results : Thirty-five out of 43 patients from the intervention group and 36 out of 36 patients from the control group completed the study . There were no statistically significant differences between the 2 groups prior to intervention . Intention-to-treat analysis revealed that the intervention group , in comparison to the control group , experienced statistically significant changes at intervention completion in self-perceived health status , average pain intensity , pain related disability , depressed mood , days in pain , and hours in pain , but no significant differences in nonprescription drug use , prescription drug use , or work status . At 15 months , all health outcomes retained their significance except health status . Nonprescription and prescription drug use demonstrated significant reductions at 15 months . Binary logistic regression indicated that long-term changes in Pain Disability Index were influenced by long-term exercise adherence and income status . Conclusions : Positive health-related outcomes in this mostly unresponsive condition can be obtained with a low-cost , group multidisciplinary intervention in a community-based , non clinical setting",
"A quasi-experimental design was used to assess a multimodal pain treatment program for female patients with fibromyalgia to ascertain immediate and long-term effects . Laboratory and self-report pain measures together with psychological measures were obtained from patients who were tested up to 6 months after treatment . Comparison data were also obtained from fibromyalgia patients who failed to qualify for the treatment program because of insurance coverage . Immediate and long-term treatment effects were evident with the psychological measures and the subjective pain measures but not with the laboratory pain measures . Participants who attended the month-long multimodal program achieved significant and positive changes on most of the outcome measures . However , relapse prevention must be addressed",
"OBJECTIVE To evaluate the feasibility of 8 months of supervised exercise therapy in warm water and its effects on the impact of fibromyalgia on physical and mental health and physical fitness in affected women . METHODS Thirty women with fibromyalgia were r and omly assigned to an exercise therapy group ( n = 15 ) or a control group ( inactive ) ( n = 15 ) . The impact of fibromyalgia on physical and mental health was assessed using the Fibromyalgia Impact Question naire and the anxiety state with State-Trait Anxiety Inventory . Physical fitness was measured using the following tests : Canadian Aerobic Fitness ; h and -grip dynamometry ; 10-metre walking ; 10-step stair-climbing and blind 1-leg stance . RESULTS After 8 months of training , the exercise therapy group improved compared with the control group in terms of physical function ( 20 % ) , pain ( 8 % ) , stiffness ( 53 % ) , anxiety ( 41 % ) , depression ( 27 % ) , Fibromyalgia Impact Question naire total scores ( 18 % ) , State-Trait Anxiety Inventory score ( 22 % ) , aerobic capacity ( 22 % ) , balance ( 30 % ) , functional capacity for walking ( 6 % ) , stair-climbing with no extra weight ( 14 % ) and stair-climbing 10 kg-weighted ( 25 % ) . CONCLUSION Eight months of supervised exercise in warm water was feasible and led to long-term improvements in physical and mental health in patients with fibromyalgia at a similar magnitude to those of shorter therapy programmes",
"OBJECTIVE To compare 2 exercise modalities , aerobic fitness training and stretching exercises , in patients with fibromyalgia ( FM ) in relation to function , pain , quality of life , depression , and anxiety , and to correlate the cardiorespiratory fitness gain with symptom improvement . METHODS Seventy-six women with FM between 18 and 60 years old were r and omized to either an aerobic program or stretching program , for 20 weeks . They were evaluated at the beginning of the program and after 10 and 20 weeks in relation to the improvement of aerobic fitness , flexibility , function , Fibromyalgia Impact Question naire ( FIQ ) , Short-form Health Survey ( SF-36 ) , and depression and anxiety levels . Ventilatory anaerobic threshold ( VT ) and maximum oxygen uptake ( VO2max ) were determined by expired gas analyses . RESULTS Aerobic exercise was superior to stretching in relation to VO2 max , VT , function , depression , pain , and the emotional aspects and mental health domains of SF-36 . Patients in the stretching group showed no improvement in depression , \" role emotional , \" and \" mental health . \" No association was noted between improvement in aerobic fitness as measured by VT and the improvement of pain , function , or scores in FIQ and SF-36 . CONCLUSION Our results confirm that aerobic exercise is beneficial to patients with FM , but the cardiorespiratory fitness gain is not related to improvement of FM symptoms",
"OBJECTIVE To assess the utility of an exercise program , which included aerobic , flexibility and strengthening elements , in the treatment of fibromyalgia ( FM ) . FM is a chronic musculoskeletal condition characterized by diffuse musculoskeletal pain and aching . It has been suggested that aerobic exercise is helpful in its treatment . METHODS We studied 60 patients who met American College of Rheumatology criteria for FM and had no significant comorbidities . Measurements performed on each patient at the pre and post study assessment included the number of tender points ( TP ) , total myalgic scores ( TM ) , aerobic fitness ( AF ) , flexibility and isokinetic strength . After initial evaluation patients were r and omly assigned to either an exercise or a relaxation group . Each group met 3 times per week for 6 weeks for 1 h of supervised exercise or relaxation . All patients data were stored in a computerized data base and statistical analysis was performed on all pre and post study assessment s. RESULTS Thirty-eight patients ( 18 exercise and 20 relaxation ) completed the study . Analysis of our data showed no significant difference between the groups in their pre study assessment . Post study assessment s , however , showed a significant improvement between the exercise and relaxation groups in TP ( p TM ( p AF ( p Exercise is helpful in the management of FM in the short term . It also shows that FM patients can undertake an exercise program which includes aerobic , flexibility , and strength training exercises without adverse effects . The long term utility of this type of exercise requires further evaluation",
"OBJECTIVE Treatment recommendations for fibromyalgia ( FM ) include regular physical exercise . In this prospect i ve study we examined predictors for adherence to stretching and aerobic exercises in women provided with an individualized home based program . METHODS Thirty-nine women kept exercise diaries for 12 weeks . RESULTS For both types of exercise , women who were less physically fit at baseline engaged in more exercise during the program . Yet for stretching , more lower body pain at baseline predicted engaging in less stretching exercise over time , whereas for aerobic exercise , more baseline upper body pain predicted more exercise over time . As time passed , participants with higher baseline physical fitness and /or older age were reducing their aerobic exercise practice at significantly faster rates , as were those women with higher baseline stress . CONCLUSION Given that adequate levels of adherence were limited to about half of the participants for both types of exercise , steps to reduce barriers to exercise ( e.g. , stress ) need to be taken when prescribing exercise in the treatment of FM",
"Objective : To evaluate the efficacy of a treatment programme for patients with fibromyalgia ( FM ) based on self management , using pool exercises and education . Methods : R and omised controlled trial with a 6 month follow up to evaluate an outpatient multidisciplinary programme ; 164 patients with FM were allocated to an immediate 6 week programme ( n = 84 ) or to a waiting list control group ( n = 80 ) . The main outcomes were changes in quality of life , functional consequences , patient satisfaction and pain , using a combination of patient question naires and clinical examinations . The question naires included the Fibromyalgia Impact Question naire ( FIQ ) , Psychological General Well-Being ( PGWB ) index , regional pain score diagrams , and patient satisfaction measures . Results : 61 participants in the treatment group and 68 controls completed the programme and 6 month follow up examinations . Six months after programme completion , significant improvements in quality of life and functional consequences of FM were seen in the treatment group as compared with the controls and as measured by scores on both the FIQ ( total score p = 0.025 ; fatigue p = 0.003 ; depression p = 0.031 ) and PGWB ( total score p = 0.032 ; anxiety p = 0.011 ; vitality p = 0.013 , ) . All four major areas of patient satisfaction showed greater improvement in the treatment than the control groups ; between-group differences were statistically significant for “ control of symptoms ” , “ psychosocial factors ” , and “ physical therapy ” No change in pain was seen . Conclusion : A 6 week self management based programme of pool exercises and education can improve the quality of life of patients with FM and their satisfaction with treatment . These improvements are sustained for at least 6 months after programme completion",
"OBJECTIVE The aim of this study was to investigate the effectiveness of a 6-week traditional exercise program with supplementary whole-body vibration ( WBV ) in improving health status , physical functioning , and main symptoms of fibromyalgia ( FM ) in women with FM . METHODS Thirty-six ( 36 ) women with FM ( mean + /- st and ard error of the mean age 55.97 + /- 1.55 ) were r and omized into 3 treatment groups : exercise and vibration ( EVG ) , exercise ( EG ) , and control ( CG ) . Exercise therapy , consisting of aerobic activities , stretching , and relaxation techniques , was performed twice a week ( 90 min/day ) . Following each exercise session , the EVG underwent a protocol with WBV , whereas the EG performed the same protocol without vibratory stimulus . The Fibromyalgia Impact Question naire ( FIQ ) was administered at baseline and 6 weeks following the initiation of the treatments . Estimates of pain , fatigue , stiffness , and depression were also reported using the visual analogue scale . RESULTS A significant 3 x 2 ( group x time)-repeated measures analysis of variance interaction was found for pain ( p = 0.018 ) and fatigue ( p = 0.002 ) but not for FIQ ( p = 0.069 ) , stiffness ( p = 0.142 ) , or depression ( p = 0.654 ) . Pain and fatigue scores were significantly reduced from baseline in the EVG , but not in the EG or CG . In addition , the EVG showed significantly lower pain and fatigue scores at week 6 compared to the CG , whereas no significant differences were found between the EG and CG ( p > 0.05 ) . CONCLUSION Results suggest that a 6-week traditional exercise program with supplementary WBV safely reduces pain and fatigue , whereas exercise alone fails to induce improvements",
"Introduction Physical therapy in warm water has been effective and highly recommended for persons with fibromyalgia , but its efficiency remains largely unknown . Should patients or health care managers invest in this therapy ? The aim of the current study was to assess the cost-utility of adding an aquatic exercise programme to the usual care of women with fibromyalgia . Methods Costs to the health care system and to society were considered in this study that included 33 participants , r and omly assigned to the experimental group ( n = 17 ) or a control group ( n = 16 ) . The intervention in the experimental group consisted of a 1-h , supervised , water-based exercise sessions , three times per week for 8 months . The main outcome measures were the health care costs and the number of quality -adjusted life-years ( QALYs ) using the time trade-off elicitation technique from the EuroQol EQ-5D instrument . Sensitivity analyses were performed for variations in staff salary , number of women attending sessions and time spent going to the pool . The cost effectiveness acceptability curves were created using a non-parametric bootstrap technique . Results The mean incremental treatment costs exceeded those for usual care per patient by € 517 for health care costs and € 1,032 for societal costs . The mean incremental QALY associated with the intervention was 0.131 ( 95 % CI : 0.011 to 0.290 ) . Each QALY gained in association with the exercise programme cost an additional € 3,947/QALY ( 95 % CI : 1,782 to 47,000 ) for a health care perspective and € 7,878/QALY ( 3,559 to 93,818 ) from a societal perspective . The curves showed a 95 % probability that the addition of the water-based programme is a cost-effective strategy if the ceiling of inversion is € 14,200/QALY from a health care perspective and € 28,300/QALY from a societal perspective . Conclusion The addition of an aquatic exercise programme to the usual care regime for fibromyalgia in women is cost effective in terms of both health care costs and societal costs . However , the characteristics of facilities ( distance from the patients ' homes and number of patients that can be accommo date d per session ) are major determinants to consider before investing in such a programme . Trial registration Current controlled trials IS RCT N53367487",
"Abstract Objectives : To evaluate cardiovascular fitness exercise in people with fibromyalgia Design : R and omised controlled trial Setting : Hospital rheumatology out patients . Group based classes took place at a “ healthy living centre . ” Participants : 132 patients with fibromyalgia . Interventions : Prescribed grade d aerobic exercise ( active treatment ) and relaxation and flexibility ( control treatment ) . Main outcome measures : Participants ' self assessment of improvement , tender point count , impact of condition measured by fibromyalgia impact question naire , and short form McGill pain question naire . Results : Compared with relaxation exercise led to significantly more participants rating themselves as much or very much better at three months : 24/69 ( 35 % ) v 12/67 ( 18 % ) , P=0.03 . Benefits were maintained or improved at one year follow up when fewer participants in the exercise group fulfilled the criteria for fibromyalgia ( 31/69 v 44/67 , P=0.01 ) . Peoplein the exercise group also had greater reductions in tender point counts ( 4.2 v 2.0 , P=0.02 ) and in scores on the fibromyalgia impact question naire ( 4.0 v 0.6 , P=0.07 ) . Conclusions : Prescribed grade d aerobic exercise is a simple , cheap , effective , and potentially widely available treatment for fibromyalgia",
"OBJECTIVE To compare the effectiveness of biofeedback/relaxation , exercise , and a combined program for the treatment of fibromyalgia . METHODS Subjects ( n = 119 ) were r and omly assigned to one of 4 groups : 1 ) biofeedback/relaxation training , 2 ) exercise training , 3 ) a combination treatment , or 4 ) an educational/attention control program . RESULTS All 3 treatment groups produced improvements in self-efficacy for function relative to the control condition . In addition , all treatment groups were significantly different from the control group on tender point index scores , reflecting a modest deterioration by the attention control group rather than improvements by the treatment groups . The exercise and combination groups also result ed in modest improvements on a physical activity measure . The combination group best maintained benefits across the 2-year period . CONCLUSION This study demonstrates that these 3 treatment interventions result in improved self-efficacy for physical function which was best maintained by the combination group",
"BACKGROUND AND PURPOSE The purpose s of this study were : ( 1 ) to assess the effectiveness of a 16-week progressive program of home-based , videotape-based , low-impact aerobic exercise on physical function and signs and symptoms of fibromyalgia in previously sedentary women aged 20 to 55 years and ( 2 ) to compare the effects of 1 long exercise bout versus 2 short exercise bouts per training day ( fractionation ) on physical function , signs and symptoms of fibromyalgia , and exercise adherence . SUBJECTS One hundred forty-three sedentary women were r and omly assigned to 1 of 3 groups : a group who trained using a long bout of exercise ( LBE group , n=51 ) , a group who trained using short bouts of exercise ( SBE group , n=56 ) , and a group who performed no exercise ( NE group , n=36 ) . METHODS The SBE group exercised twice daily , and the LBE group worked out once daily . Both groups progressed in total daily training duration from 10 to 30 minutes , 3 to 5 times a week , for 16 weeks . Physical and psychological well-being , symptoms , and self-efficacy were evaluated using a multivariate analysis of variance . RESULTS Dropout rates for the NE , SBE , and LBE groups were 14 % , 38 % , and 29 % , respectively . The NE group differed from the LBE group in disease severity , self-efficacy , and psychological well-being ( midtest , efficacy analysis ) and from the SBE group in disease severity and self-efficacy ( posttest , efficacy analysis ) . Exercise adherence was greater for the LBE group than for the SBE group between weeks 5 and 8 of the training program . No other differences between exercise groups were found . DISCUSSION AND CONCLUSION Progressive , home-based , low-impact aerobics improved physical function and fibromyalgia symptoms minimally in participants who completed at least two thirds of the recommended exercise . Fractionation of exercise training provided no advantage in terms of exercise adherence , improvements in fibromyalgia symptoms or physical function . High attrition rates and problems with exercise adherence were experienced in both exercise groups",
"BACKGROUND Self-management has increasingly been recommended as part of st and ard care for fibromyalgia , a common , poorly understood condition with limited treatment options . Data that assess popular self-management recommendations are scarce . We evaluated and compared the effectiveness of 4 common self-management treatments on function , symptoms , and self-efficacy in women with fibromyalgia . METHODS A total of 207 women with confirmed fibromyalgia were recruited from September 16 , 2002 , through November 30 , 2004 , and r and omly assigned to 16 weeks of ( 1 ) aerobic and flexibility exercise ( AE ) ; ( 2 ) strength training , aerobic , and flexibility exercise ( ST ) ; ( 3 ) the Fibromyalgia Self-Help Course ( FSHC ) ; or ( 4 ) a combination of ST and FSHC ( ST-FSHC ) . The primary outcome was change in physical function from baseline to completion of the intervention . Secondary outcomes included social and emotional function , symptoms , and self-efficacy . RESULTS Improvements in the mean Fibromyalgia Impact Question naire score in the 4 groups were -12.7 for the ST-FSHC group , -8.2 for the AE group , -6.6 for the ST group , and -0.3 for the FSHC group . The ST-FSHC group demonstrated greater improvement than the FSHC group ( mean difference , -12.4 ; 95 % confidence interval [ CI ] , -23.1 to -1.7 ) . The ST-FSHC ( mean difference , 13.6 ; 95 % CI , 2.3 to 24.9 ) and AE ( mean difference , 13.1 ; 95 % CI , 1.6 to 25.6 ) groups had similar improvements in physical function scores on the 36-Item Short-Form Health Survey . Bodily pain scores on the 36-Item Short-Form Health Survey improved in the ST-FSHC ( 14.8 ) , AE ( 13.2 ) , and ST ( 5.7 ) groups . Social function , mental health , fatigue , depression , and self-efficacy also improved . The beneficial effect on physical function of exercise alone and in combination with education persisted at 6 months . CONCLUSIONS Progressive walking , simple strength training movements , and stretching activities improve functional status , key symptoms , and self-efficacy in women with fibromyalgia actively being treated with medication . The benefits of exercise are enhanced when combined with targeted self-management education . Our findings suggest that appropriate exercise and patient education be included in the treatment of fibromyalgia",
"UNLABELLED Aging of the worldwide population is a concern of most governmental entities , spanning practically all areas of prevention and rehabilitation . Aging leads to physiological alterations that result in adverse social and financial effects . There is a trend to emphasize prevention , which is less expensive and socially more desirable than therapeutic intervention . PURPOSE To assess the effect of a program of aquatic versus non-aquatic respiratory exercises on respiratory muscle strength in healthy aged persons . METHODS The respiratory muscle strength was measured in 81 subjects between 60 and 65 years , 59 of which completed the program . Subjects were r and omized into 3 groups . G(aquatic ) undertook a program of respiratory exercise in an aquatic environment . G(non-aquatic ) undertook the same program in a non-aquatic environment . G(control ) acted as the negative control . Programs were applied three times a week for 10 consecutive weeks . Subsequently , subjects were reevaluated , and results compared to each individual 's pre-treatment own result and between the groups . The data were statistically analyzed using the paired t test and the Sign test . Comparisons between the groups were performed through parametric and nonparametric variance . A comparison of G(aquatic ) and G(non-aquatic ) versus G(control ) was performed using the Dunnett test . RESULTS A significant improvement in the inspiratory muscle strength in the G(aquatic ) group compared to the G(control ) , group was found , suggesting beneficial effects mediated by the aquatic exercise . The expiratory muscles did not show significant alterations . CONCLUSION Aquatic respiratory exercise improves the inspiratory muscle strength of healthy aged persons . However , neither aquatic nor non-aquatic respiratory exercise influences the expiratory muscle strength",
"OBJECTIVE To evaluate the effects of 6 months of pool exercise combined with a 6 session education program for patients with fibromyalgia syndrome ( FM ) . METHODS The study population comprised 58 patients , r and omized to a treatment or a control group . Patients were instructed to match the pool exercises to their threshold of pain and fatigue . The education focused on strategies for coping with symptoms and encouragement of physical activity . The primary outcome measurements were the total score of the Fibromyalgia Impact Question naire ( FIQ ) and the 6 min walk test , recorded at study start and after 6 mo . Several other tests and instruments assessing functional limitations , severity of symptoms , disabilities , and quality of life were also applied . RESULTS Significant differences between the treatment group and the control group were found for the FIQ total score ( p = 0.017 ) and the 6 min walk test ( p physical function , grip strength , pain severity , social functioning , psychological distress , and quality of life . CONCLUSION The results suggest that a 6 month program of exercises in a temperate pool combined with education will improve the consequences of FM",
"The aim of this study was to evaluate the effectiveness of aerobic exercise in water pool compared with aerobic exercise performed in sea by women with fibromyalgia ( FM ) . A total of 46 patients were r and omly allocated into two groups : pool group ( 23 patients ) and sea group ( 23 patients ) that performed the same aerobic exercise program . Patients were evaluated baseline and after 12 weeks using : VAS , number of tender points , FIQ , SF-36 , PSQI , and BDI . Both groups improved significantly in post-treatment for all the evaluated variables . There were no significant differences between two groups , except for BDI ( F = 2.418 , P Aerobic exercise program performed in water ( pool or sea ) was effective for patients with FM . However , sea water exercises have been shown to bring more advantages related to emotional aspects . Then , exercise performed sea water ( thalassotherapy ) is an option for effective treatment with low cost for patients with FM",
"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",
"OBJECTIVES To evaluate the effects of a 16-week exercise therapy in a chest-high pool of warm water through applicable tests in the clinical practice on the global symptomatology of women with fibromyalgia ( FM ) and to determine exercise adherence levels . DESIGN A r and omized controlled trial . SETTING Testing and training were completed at the university . PARTICIPANTS Middle-aged women with FM ( n=60 ) and healthy women ( n=25 ) . INTERVENTION A 16-week aquatic training program , including strength training , aerobic training , and relaxation exercises . MAIN OUTCOME MEASURES Tender point count ( syringe calibrated ) , health status ( Fibromyalgia Impact Question naire ) ; sleep quality ( Pittsburgh Sleep Quality Index ) ; physical ( endurance strength to low loads tests ) , psychologic ( State Anxiety Inventory ) , and cognitive function ( Paced Auditory Serial Addition Task ) ; and adherence 12 months after the completion of the study . RESULTS For all the measurements , the patients showed significant deficiencies compared with the healthy subjects . Efficacy analysis ( n=29 ) and intent-to-treat analysis ( n=34 ) of the exercise therapy was effective in decreasing the tender point count and improving sleep quality , cognitive function , and physical function . Anxiety remained unchanged during the follow-up . The exercise group had a significant improvement of health status , not associated exclusively with the exercise intervention . There were no changes in the control group . Twenty-three patients in the exercise group were exercising regularly 12 months after completing the program . CONCLUSIONS An exercise therapy 3 times a week for 16 weeks in a warm pool could improve most of the symptoms of FM and cause a high adherence to exercise in unfit women with heightened FM symptomatology . The therapeutic intervention 's effects can be assessed through applicable tests in the clinical practice",
"BACKGROUND This pilot study was design ed to test the efficacy of a physical activity program for improving psychological variables and fibromyalgia syndrome ( FMS ) symptoms and to provide preliminary evidence regarding the effects on perceived cognitive symptoms and objective ly measured cognitive performance by FMS patients . METHODS Sixteen women diagnosed with FMS were r and omly assigned to an 18-week physical activity program or to a control condition . Psychological measures , FMS symptoms , perceived cognitive function , objective measures of cognition , and walking capacity were assessed at baseline and posttest . RESULTS At posttest , there were significant differences in fatigue ( effect size , ES=1.86 ) , depression ( ES=1.27 ) , FMS symptoms ( ES=1.56 ) , self-reported cognitive symptoms ( ES=1.19 ) , and delayed recall performance ( ES=1.16 ) between the physically active group and the control group , indicating that the FMS patients benefited from physical activity . Beneficial effects were also observed for 6 of the 7 objective measures of cognition and ranged from small to large ( ESs=0.26 to 1.06 ) . CONCLUSIONS Given that all FMS patients do not respond well to conventional treatments , these beneficial effects of physical activity are important . Future studies with larger sample s are warranted to test the reliability of the findings for the objective measures of cognition",
"OBJECTIVE To evaluate the efficacy of a 6-week exercise and educational program for patients with fibromyalgia . METHODS Forty-one subjects were r and omly assigned to the program or served as waiting list controls . Program outcome was assessed with a 6-minute walk test , the Fibromyalgia Impact Question naire , a Self-Efficacy Scale , and a \" knowledge \" question naire ( based on information provided during the educational sessions ) . Waiting list control subjects subsequently completed the program . Program outcome was reassessed 3 or 6 months post-program . RESULTS The program produced significant improvements in 6-minute walk distance , well-being , fatigue , self-efficacy ( for controlling pain and other symptoms ) , and knowledge . At followup , immediate gains in walk distance , well-being , and self-efficacy were maintained , but gains in fatigue and knowledge were lost . CONCLUSION Short-term exercise and educational programs can produce immediate and sustained benefits for patients with fibromyalgia . The benefits of our program may be due to exercise or education since both interventions were given",
"Forty-two patients with primary fibromyalgia were r and omized into a 20-week program consisting of either cardiovascular fitness ( CVR ) training or simple flexibility exercises ( FLEX ) that did not lead to enhanced cardiovascular fitness . Patients were supervised by the same medical fitness instructors . Patients in neither group had contact with members of the other group , and were blinded as to the exercise taught to the alternative group . Groups met for 60 minutes 3 times each week . The compliance rate was 90 % . Thirty-eight patients completed the study ( 18 with CVR training and 20 with FLEX ) . Blind assessment s ( st and ardized in preliminary trials to achieve acceptable inter-rater agreement ) were performed by the same 2 examiners . After 20 weeks , patients receiving CVR training showed significantly improved cardiovascular fitness scores compared with those receiving FLEX training ( t[35 ] = -4.22 , P less than 0.003 ) . Logistic regression analysis showed clinical ly and statistically significant improvements in pain threshold scores , which were measured directly over fibrositic tender points , in patients undergoing CVR ( t[35 ] = 2.21 , P less than 0.04 ) . There was also a trend toward improvement in pain scores ( visual analog scale ) in the CVR group , but this did not reach statistical significance . There was no improvement in the percentage of body area affected by fibrositic symptoms or the number of nights per week or hours per night of disturbed sleep ( self-report inventories ) . However , compared with the FLEX group , the CVR-trained patients improved significantly in both patient and physician global assessment scores . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE To analyze the long-term efficacy of 2 interventions for female fibromyalgia ( FM ) patients : 1 ) cognitive-behavioral therapy ( CBT ) , and 2 ) a physical exercise (PE)-based strategy . METHODS We conducted a prospect i ve , long-term , r and omized , parallel clinical trial . The outcome variables are physical activity , aerobic capacity , and results of the Fibromyalgia Impact Question naire ( FIQ ) , Short Form 36 , Beck Anxiety and Depression Inventory , Chronic Pain Self-Efficacy Scale , and Chronic Pain Coping Inventory . All were measured at baseline , posttreatment , 6 months , and 1 year . The duration of both treatments was 8 weeks . RESULTS Some items of the FIQ and some strategies to cope with pain improved significantly in both groups after treatment . All variables measuring functional capacity improved significantly in the PE group , whereas only physical activity of the vertebral column improved in the CBT group . There were no differences in anxiety , depression , and self efficacy after treatment in either group . After 1 year of followup , most of the parameters had returned to baseline values in both groups . However , in the PE group , functional capacity remained significantly better . CONCLUSIONS PE and CBT improve clinical manifestations in FM patients only for short periods of time . Improvement in self efficacy and physical fitness are not associated with improvement in clinical manifestations",
"OBJECTIVE To examine the effectiveness of concurrent strength and endurance training on muscle strength , aerobic and functional performance , and symptoms in postmenopausal women with fibromyalgia ( FM ) . DESIGN R and omized controlled trial . SETTING Local gym and university research laboratory . PARTICIPANTS Twenty-six women with FM . INTERVENTION Progressive and supervised 21-week concurrent strength and endurance training . MAIN OUTCOME MEASURES Muscle strength of leg extensors , upper extremities , and trunk ; peak oxygen uptake ( Vo(2)peak ) , maximal workload ( Wmax ) , and work time ; 10-m walking and 10-step stair-climbing time and self-reported functional capacity ( Health Assessment Question naire ) ; and symptoms of FM . RESULTS After concurrent strength and endurance training , the groups differed significantly in Wmax ( P=.001 ) , work time ( P=.001 ) , concentric leg extension force ( P=.043 ) , walking ( P=.001 ) and stair-climbing ( P time , and fatigue ( P=.038 ) . The training led to an increase of 10 % ( P=.004 ) in Wmax and 13 % ( P=.004 ) in work time on the bicycle but no change in Vo(2)peak . CONCLUSIONS Concurrent strength and endurance training in low to moderate volume improves the muscle strength of leg extensors , Wmax , work time , and functional performance as well as perceived symptoms , fatigue in particular . Concurrent strength and endurance training is beneficial to postmenopausal women with FM without adversities , but more extensive studies are needed to confirm the results",
"The present study sought to evaluate the efficacy of a 12-week multidisciplinary rehabilitation programme mainly emphasizing physiotherapy , for patients with either fibromyalgia syndrome or chronic , widespread pain . Forty-three non-r and omized female patients with fibromyalgia syndrome or chronic , widespread pain were assigned to the programme or served as waiting-list controls . The outcome was assessed with the Body Awareness Scale-Health , the Multidimensional Pain Inventory , the Quality of Life Scale , the Visual Analogue Scale and a pain drawing . Both groups were reassessed after 3 and 6 months , the treatment group also after 1 year . The treatment group improved in quality of movement and in vegetative disturbances according to the Body Awareness Scale-Health after the programme . At the 3-month and 1-year follow-ups the improvements were partly sustained . The control group showed deterioration after 3 and 6 months in three of the main scales of the Body Awareness Scale-Health . This clinical trial of a rehabilitation programme , proved beneficial for improving quality of movement and reducing the experience of vegetative disturbances",
"OBJECTIVE To determine the efficacy of training in fibromyalgia ( FM ) , we compared the effects of high intensity fitness training ( HIF ) and low intensity fitness training ( LIF ) . METHODS Thirty-seven female patients with FM were r and omly allocated to either a HIF group ( n = 19 ) or a LIF group ( n = 18 ) . Four patients ( 1 HIF group , 3 LIF group ) refused to participate after r and omization but before the start of the intervention . They were excluded from the analysis . Assessment s were performed at baseline and after 20 weeks of HIF or LIF . The primary outcome was patient 's global assessment [ on 100 mm visual analog scale ( VAS ) ] . Secondary endpoints were pain , number of tender points , total myalgic score , physical fitness , health status , and psychological distress . RESULTS One patient in the HIF group ( n = 18 ) and 2 in the LIF group ( n = 15 ) stopped training sessions during the course of the study . Nine of 18 patients in the HIF group compared to 8 of 15 patients in the LIF group achieved a participation rate of 67 % or more . Most important reasons for nonadherence were postexercise pain and fatigue , time consumption , and stress . The VAS for global well being improved slightly from 64 to 56 mm in the HIF group , and did not change in the LIF group ( 58 to 61 mm ) ( p = 0.07 ) . The Wmax ( physical fitness ) changed modestly from 110 to 123 watt in the HIF group , and from 97 to 103 watt in the LIF group ( p = 0.3 ) . VAS for pain increased from 53 to 64 mm in the HIF group and from 52 to 54 mm in the LIF group . The large st and ard deviations around mean change in global assessment s , number of tender points , total myalgic score , and psychological distress ( by SCL-90 ) severely influenced the power to detect within- and between-group differences . Analysis limited to those patients who accomplished a high attendance rate ( > 67 % ) showed similar results . CONCLUSION High intensity physical fitness training compared to low intensity physical fitness training leads to only modest improvements in physical fitness and general well being in patients with FM , and does not positively affect psychological status and general health",
"OBJECTIVE To examine the effectiveness of a supervised aerobic exercise program , a self-management education program , and the combination of exercise and education for women with fibromyalgia ( FM ) . METHODS One hundred fifty-two women were r and omized into one of 4 groups : exercise-only , education-only , exercise and education , or control . The duration of the study was 12 weeks . All subjects were analyzed at 3 times : before study , immediately upon completion , and 3 months after completion of the intervention program on measures of disability , self-efficacy , fitness , tender point count , and tender point tenderness . Of the 152 women , complete data were available for 95 and 69 who complied with the protocol . In order to determine the group time interaction , a 2 way analysis of variance with repeated measures was used for each measure . RESULTS The only significant group time interaction was reported with the compliance analysis for the Self-Efficacy Coping with Other Symptoms subscale and the Six Minute Walk . If the program was followed , the combination of a supervised exercise program and group education provided persons with FM with a better sense of control over their symptoms . Fitness improved in the 2 groups undergoing supervised aerobic exercise programs . However , the improvement in fitness was maintained at followup in the exercise-only group and not the combined group . Conclusion . Subjects receiving the combination of exercise and education and who complied with the treatment protocol improved their perceived ability to cope with other symptoms . In addition , a supervised exercise program increased walking distance at post-test , an increase that was maintained at followup in the exercise-only group . Results demonstrate the challenges with conducting exercise and education studies in persons with FM",
"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",
"To determine and compare short- and long-term effects of aerobic exercise ( AE ) , stress management treatment ( SMT ) , and treatment-as-usual ( TAU ) in fibromyalgia , 60 patients were r and omized to 14 weeks of treatment by either AE , SMT or TAU . Outcome measures at baseline , midway through treatment , at treatment completion , and at 4 year follow up included a patient made drawing of pain distribution , dolorimetry of tender points , ergometer cycle test , global subjective improvement , and VAS registration s of : pain , disturbed sleep , lack of energy , and depression . Both AE and SMT showed positive short-term effects . AE was the overall most effective treatment , despite being subject to the most sceptical patient attitude prior to the study . At follow up , there were no obvious group differences in symptom severity , which for AE seemed to be due to a considerable compliance problem",
"Objective The aim of this study was to compare pool-based exercise and balneotherapy in fibromyalgia syndrome ( FMS ) patients . Methods Fifty female patients diagnosed with FMS according to the American College of Rheumatism ( ACR ) criteria were r and omly assigned to two groups : group 1 ( n=25 ) with pool-based exercise , and in group 2 ( n=25 ) balneotherapy was applied in the same pool without any exercise for 35 min three times a week for 12 weeks . In both groups , pre- ( week 0 ) and post-treatment ( weeks 12 and 24 ) evaluation was performed by one of the authors , who was blind to the patient group . Evaluation parameters included pain , morning stiffness , sleep , tender points , global evaluation by the patient and the physician , fibromyalgia impact question naire , chair test , and Beck depression inventory . Statistical analysis was done on data collected from three evaluation stages . Results Twenty-four exercise and 22 balneotherapy patients completed the study . Pretreatment ( week 0 ) measurements did not show any difference between the groups . In group 1 , statistically significant improvement was observed in all parameters ( P chair test at both weeks 12 and 24 . In group 2 , week 12 measurements showed significant improvement in all parameters ( P chair test and Beck depression inventory . Week 24 evaluation results in group 2 showed significant improvements in pain and fatigue according to visual analogue scale ( VAS ) , 5-point scale , number of tender points , algometric and myalgic scores , and patient and physician global evaluation ( P morning stiffness , sleep , fibromyalgia impact question naire ( FIQ ) , chair test , and Beck depression inventory parameters in this group . Comparison of the two groups based on the post-treatment ( weeks 12 and 24 ) percent changes and difference scores relative to pretreatment ( week 0 ) values failed to show a significant difference between the groups for any parameter except Beck depression inventory ( P pool-based exercise had a longer-lasting effect on some of the FMS symptoms , but statistical analysis failed to show a significant superiority of pool-based exercise over balneotherapy without exercise . While we believe that exercise is a gold st and ard in FMS treatment , we also suggest in light of our results that balneotherapy is among the valid treatment options in FMS , and further research regarding the type and duration of the exercise programs is necessary",
"OBJECTIVE To evaluate the short- and long-term efficacy of exercise therapy in a warm , waist-high pool in women with fibromyalgia . METHODS Thirty-four women ( mean + /- SD tender points 17 + /- 1 ) were r and omly assigned to either an exercise group ( n = 17 ) to perform 3 weekly sessions of training including aerobic , proprioceptive , and strengthening exercises during 12 weeks , or to a control group ( n = 17 ) . Maximal unilateral isokinetic strength was measured in the knee extensors and flexors in concentric and eccentric actions at 60 degrees /second and 210 degrees /second , and in the shoulder abductors and adductors in concentric contractions . Health-related quality of life ( HRQOL ) was assessed using the EQ-5D question naire ; pain was assessed on a visual analog scale . All were measured at baseline , posttreatment , and after 6 months . RESULTS The strength of the knee extensors in concentric actions increased by 20 % in both limbs after the training period , and these improvements were maintained after the de-training period in the exercise group . The strength of other muscle actions measured did not change . HRQOL improved by 93 % ( P = 0.007 ) and pain was reduced by 29 % ( P = 0.012 ) in the exercise group during the training , but pain returned close to the pretraining level during the subsequent de-training . However , there were no changes in the control group during the entire period . CONCLUSION The therapy relieved pain and improved HRQOL and muscle strength in the lower limbs at low velocity in patients with initial low muscle strength and high number of tender points . Most of these improvements were maintained long term",
"UNLABELLED Fibromyalgia ( FM ) , a rheumatological disorder of unknown origin , is characterized by both physical and psychological symptoms . Although inconclusive results have been reported for most treatment modalities , exercise appears to have universal support for decreasing the myriad of symptoms associated with FM . Weaknesses in the literature , however , prevent conclusive statements regarding exercise prescription and concomitant impact on FM symptomology . PURPOSE The current pilot study attempted to examine the effect of a 24-wk walking program at predetermined intensities on FM . METHODS Initial design was a r and omized control trial with high- and low-intensity exercise groups , and a control group . Subsequent nonr and omized control trials were based on actual exercise behavior . RESULTS No differences between initial groups were identified . By collapsing groups , heart rate ( HR ) decreased ( P Functional impairments were reduced 54 % weeks 0 - 24 , with exercise having a large impact ( omega2 = 0.30 ) on this decrease . By reassigning groups , impact of FM on current health status decreased in the low-intensity group ( P influence of exercise on pain ( omega2 = 0.51 ) , with greater pain in the high-intensity group . CONCLUSIONS A larger number of subjects and direct supervision of the training program to increase compliance is necessary to clarify the effects of a walking program on the manifestations of FM . Results indicate that intensity of the walking program is an important consideration . Individuals with FM can adhere to low-intensity walking programs two to three times per week , possibly reducing FM impact on daily activities",
"OBJECTIVE To determine the feasibility of conducting a r and omized controlled trial of a 12-week exercise intervention in children with fibromyalgia ( FM ) and to explore the effectiveness of aerobic exercise on physical fitness , function , pain , FM symptoms , and quality of life ( QOL ) . METHODS FM patients ages 8 - 18 years were r and omized to a 12-week exercise intervention of either aerobics or qigong . Both groups participated in 3 weekly training sessions . Program adherence and safety were monitored at each session . Data were collected at 3 testing sessions , 2 prior to and 1 after the intervention , and included FM symptoms , function , pain , QOL , and fitness measures . RESULTS Thirty patients participated in the trial . Twenty-four patients completed the program ; 4 patients dropped out prior to training and 2 dropped out of the aerobics program . Better adherence was reported in the aerobics group than in the qigong group ( 67 % versus 61 % ) . Significant improvements in physical function , functional capacity , QOL , and fatigue were observed in the aerobics group . Anaerobic function , tender point count , pain , and symptom severity improved similarly in both groups . CONCLUSION It is feasible to conduct an exercise intervention trial in children with FM . Children with FM tolerate moderate-intensity exercise without exacerbation of their disease . Significant improvements in physical function , FM symptoms , QOL , and pain were demonstrated in both exercise groups ; the aerobics group performed better in several measures compared with the qigong group . Future studies may need larger sample sizes to confirm clinical improvement and to detect differences in fitness in childhood FM",
"OBJECTIVE To compare hydrotherapy ( HT ) and conventional physiotherapy ( CP ) in the treatment of fibromyalgia ( FM ) , regarding quality of life ( QOL ) , total sleep time ( TST ) , and total nap time ( TNT ) . METHODS Fifty out patients , all female , 30 - 60 years old , diagnosed with FM , were r and omly assigned to two groups to carry out 3 weeks of treatment with HT or CP . In the beginning and in the end of treatment , patients were evaluated with the SF-36 question naire to measure QOL and the sleep diary for TST and TNT . Data analyses were blind . RESULTS All 24 HT patients increased 1h in TST compared to 19 CP patients . TNT decreased in the HT group . QOL improved for the two groups in all domains when pre- and post-intervention were compared , but there was no difference between groups . CONCLUSION HT is more effective than CP to improve TST and to decrease TNT in FM patients",
"OBJECTIVE To determine the effectiveness of self-management education and physical training in decreasing fibromyalgia ( FMS ) symptoms and increasing physical and psychological well being . METHODS A pretest-posttest control group design was used . Ninety-nine women with FMS were r and omly assigned to 1 of 3 groups ; 86 completed the study . The education only group received a 6-week self-management course . The education plus physical training group received the course and 6 h of training design ed to assist them to exercise independently . The control group got treatment after 3 months . RESULTS The experimental programs had a significant positive impact on quality of life and self-efficacy . Helplessness , number of days feeling bad , physical dysfunction , and pain in the tender points decreased significantly in one or both of the treated groups when retested 6 weeks after the end of the program . Longterm followup of 67 treated subjects showed significant positive changes on the Fibromyalgia Impact Question naire primarily in the physical training group . Among all subjects , 87 % were exercising at least 3 times/week for 20 min or more ; 46 % said they had increased their exercise level since participating in the program ; 70 % were practicing relaxation strategies as needed ; 46 % were working at least half time as opposed to 37 % at pretest . CONCLUSION Self-efficacy of the treated groups was enhanced significantly by the program . Other changes were smaller and more delayed than had been expected . Recommendations for future trials include a longer education program , more vigorous physical training , and longterm followup",
"OBJECTIVE To compare the therapeutic effects of physical fitness training or biofeedback training with the results of usual care in patients with fibromyalgia ( FM ) . METHODS One hundred forty-three female patients with FM ( American College of Rheumatology criteria ) were r and omized into 3 groups : a fitness program ( n = 58 ) , biofeedback training ( n = 56 ) , or controls ( n = 29 ) . Half the patients in the active treatment groups also received an educational program aim ed at improving compliance . Assessment s were done at baseline and after 24 weeks . The primary outcome was pain [ visual analog scale ( VAS ) ] . Other endpoints were the number of tender points , total myalgic score ( dolorimetry ) , physical fitness , functional ability ( Arthritis Impact Measurement Scale and Sickness Impact Profile ) , psychological distress ( Symptom Checklist-90-Revised ) , patient global assessment ( 5 point scale ) , and general fatigue ( VAS ) . RESULTS Baseline scores were similar in all 3 groups . Altogether 25 ( 17.5 % ) patients dropped out ; they were similarly distributed over all groups : 14 patients after r and omization and 11 ( 8 % ) during the study . A true high impact level for fitness training was not attained by any patient . After treatment , no significant differences in change scores of any outcome were found between the groups ( ANOVA , p > 0.05 ) . All outcome measures showed large variations intra- and interindividually . The educational program did not result in higher compliance with training sessions ( 62 % vs 71 % ) . Analysis of the subgroup of subjects with a high attendance rate ( > 67 % ) also showed no improvement . CONCLUSION In terms of training intensity and maximal heart rates , the high impact fitness intervention had a low impact benefit . Therefore effectiveness of high impact physical fitness training can not be demonstrated . Thus compared to usual care , the fitness training ( i.e. , low impact ) and biofeedback training had no clear beneficial effects on objective or subjective patient outcomes in patients with FM",
"OBJECTIVES To compare the cognitive function performance in patients with fibromyalgia ( FM ) with respect healthy controls and to evaluate the short-term efficacy of exercise therapy in a warm , chest-high pool on pain and cognitive function in women with FM . METHODS Sixty middle-aged women with FM were r and omly assigned to either an exercise training group ( n = 35 ) to perform 3 sessions per week of aquatic training ( 32 degrees C ) including mobility , aerobic , strengthening , and relaxation exercises for 16 weeks , or a control group ( n = 25 ) . Twenty-five healthy women matched for age , weight , body mass index , and educational and physical activity levels were recruited . Pain was assessed in patients using a syringe calibrated like a pressure dolorimeter , and a visual analog scale . The severity of FM was evaluated using the Fibromyalgia Impact Question naire . Cognitive function was measured in healthy individuals and patients using several st and ardized neuropsychological tests . All patients were measured at baseline and post-treatment . RESULTS At baseline , the healthy group evidence d cognitive performance that was significantly superior to the group of patients with FM in all of the neuropsychological tests . The exercise group significantly improved their pain threshold , tender point count , self-reported pain , severity of FM , and cognitive function , while in the control group the differences were not significant . CONCLUSION An exercise therapy three times per week for 16 weeks in a warm-water pool is an adequate treatment to decrease the pain and severity of FM well as to improve cognitive function in previously unfit women with FM and heightened painful symptomatology",
"OBJECTIVE To compare the clinical effectiveness of aerobic exercise in the water with walking/jogging for women with fibromyalgia ( FM ) . METHODS Sixty sedentary women with FM , ages 18 - 60 years , were r and omly assigned to either deep water running ( DWR ) or l and -based exercises ( LBE ) . Patients were trained for 15 weeks at their anaerobic threshold . Visual analog scale of pain , Fibromyalgia Impact Question naire ( FIQ ) , Beck Depression Inventory , Short Form 36 Health Survey ( SF-36 ) , and a patient 's global assessment of response to therapy ( PGART ) were measured at baseline , week 8 , and week 15 . Statistical analysis included all patients . RESULTS Four patients dropped out from each group . Both groups improved significantly at week 15 compared with baseline , with an average 36 % reduction in pain intensity . For PGART , 40 % of the DWR group and 30 % of the LBE group answered \" much better \" at posttreatment . FIQ total score and FIQ depression improvements in the DWR group were faster ( week 8) than the LBE group and kept improving ( week 15 ; P improvements in SF-36 role emotional ( P = 0.006 ) . No significant between-group differences were observed for peak oxygen uptake and other outcomes . CONCLUSION DWR is a safe exercise that has been shown to be as effective as LBE regarding pain . However , it has been shown to bring more advantages related to emotional aspects . Aerobic gain was similar for both groups , regardless of symptom improvement . Therefore , DWR could be studied as an exercise option for patients with FM who have problems adapting to LBE or lower limbs limitations",
"OBJECTIVE To determine the safety , feasibility and consequences of a program of progressive strength training and cardiovascular exercise in women with fibromyalgia syndrome ( FMS ) . METHODS Fifteen women with confirmed FMS were monitored for injury and exercise compliance , and assessed for muscle strength ( 1-repetition maximum technique ) , cardiovascular endurance ( 6-minute walk test ) , and functional status ( Fibromyalgia Impact Question naire [ FIQ ] ) before and after a 20-week exercise intervention . RESULTS Zero injuries and an 81 % compliance rate occurred during training . Improvement was seen in muscle strength of the lower ( 191 + /- 75 to 265 + /- 67 pounds ; P body , 6-minute walk distance ( 530 + /- 80 to 629 + /- 74 meters ; P FIQ score ( 44 + /- 9 to 32 + /- 14 ; P program of progressive strength training and cardiovascular exercise can be safe , well tolerated , and effective at improving muscle strength , cardiovascular endurance and functional status in women with FMS without exacerbating symptoms . This program may also contribute to a reduction in the severity of several symptoms",
"OBJECTIVE To evaluate the effect of exercise on mood and physical function in individuals with fibromyalgia . METHODS Subjects were r and omly assigned to an exercise ( EX ) or control ( CTL ) group . EX subjects participated in 3 30-minute exercise classes per week for 23 weeks . Subjects were tested at entry and at 6 , 12 , and 23 weeks . Tests included the Beck Depression Inventory ( BDI ) , 6-minute walk , State-Trait Anxiety Inventory ( STAI ) , Mental Health Inventory ( MHI ) , Fibromyalgia Impact Question naire ( FIQ ) , Arthritis Self-Efficacy Scale ( ASES ) , and a measure of tender points and knee strength . RESULTS Fifty subjects ( 27 EX , 23 CTL ) completed the study , and 31 ( 15 EX , 16 CTL ) met criteria for efficacy analyses . In efficacy analyses , significant improvements were seen for EX subjects in 6-minute walk distances , BDI ( total , cognitive/ affective ) , STAI , FIQ , ASES , and MHI ( 3 of 5 subscales ) scores . These effects were reduced but remained during intent-to-treat analyses . CONCLUSION Exercise can improve the mood and physical function of individuals with fibromyalgia",
"PURPOSE To evaluate the effects of a 12-wk period of aquatic training and subsequent detraining on health-related quality of life ( HRQOL ) and physical fitness in females with fibromyalgia . METHODS Thirty-four females with fibromyalgia were r and omly assigned into two groups : an exercise group , who exercised for 60 min in warm water , three times a week ( N = 17 ) ; and a control group , who continued their habitual leisure-time activities ( N = 17 ) . HRQOL was assessed using the Short Form 36 question naire and the Fibromyalgia Impact Question naire . Physical fitness was measured using the following tests : Canadian Aerobic Fitness , h and grip dynamometry , 10-m walking , 10-step stair climbing , and blind one-leg stance . Outcomes were measured at baseline , after treatment , and after 3 months of detraining . RESULTS After 12 wk of aquatic exercise , significant positive effects of aquatic training were found in physical function , body pain , general health perception , vitality , social function , role emotional problems and mental health , balance , and stair climbing . After the detraining period , only the improvements in body pain and role emotional problems were maintained . CONCLUSION The present water exercise protocol improved some components of HRQOL , balance , and stair climbing in females with fibromyalgia , but regular exercise and higher intensities may be required to preserve most of these gains",
"OBJECTIVE To compare a supervised 12-week aerobic exercise class with unsupervised home aerobic exercises in the treatment of patients with fibromyalgia . METHODS This was a 48-week r and omized single ( observer ) blind study in a teaching hospital rheumatology and physiotherapy department . The subjects were 74 patients who fulfilled the American College of Rheumatology criteria for fibromyalgia . Results and conclusions . A 12-week exercise class programme with home exercises demonstrated no benefit over a single physiotherapy session with home exercises in the treatment of pain in patients with fibromyalgia . Neither group ( nor the groups combined ) showed an improvement in pain compared with baseline . There was some significant benefit in psychological well-being in the exercise class group and perhaps a slowing of functional deterioration in this group",
"OBJECTIVE To identify predictors of maintenance of exercise for women with fibromyalgia ( FM ) . METHODS Women with FM who had been r and omized to the exercise arm of a clinical trial were studied prospect ively during and 3 months following treatment . Subjects completed exercise logs weekly and returned the data via postal mail . Outcome variables were duration of aerobic and stretching exercises . Two separate multivariate models for longitudinal data were built with adjustment for in-treatment adherence and time . Pretreatment characteristics ( self efficacy , pain , disability , stress , exercise barriers and benefits , and age ) and changes during treatment ( pain , disability , stress , and exercise barriers and benefits ) were considered potential predictors of exercise maintenance . RESULTS Stretching significantly decreased in the 3 months following treatment . High stress at baseline and increases in stress during treatment were associated with poor maintenance of stretching . Disability at baseline ( measured with the Fibromyalgia Impact Question naire ) , an increase in barriers to exercise during treatment , and increases in upper-body pain during treatment were associated with worse maintenance of aerobic exercise in the 3 months following treatment . CONCLUSION The maintenance of an exercise program in women with FM appears to be contingent on being able to deal with stress , pain , barriers to exercise , and disability",
" Sixty eight adult patients of fibromyalgia were included in this prospect i ve study from the Outpatient Department of Physical Medicine and Rehabilitation of Bangab and hu Sheikh Mujib Medical University ( BSMMU ) , Dhaka during the period of January 2003 to June 2003 . Study sample s were assigned into two treatment groups : Group A ( n = 38 ) with exercise by static bicycle and aerobic walking in addition to tricyclic antidepressant and analgesic and Group B ( n = 30 ) was non exercise group , treated with tricyclic antidepressant and analgesic only . The total duration of treatment was 16 weeks . Pre-treatment ( week 0 ) and post treatment ( week 16 ) evaluation was performed in both groups . Evaluation parameters included pain grade , number of trigger points , occurrence of arousal at night , frequency of micturition and global evaluation by the physician . After 16 weeks , mean improvement of exercise group and non exercise group was 48 % and 39 % respectively but this difference was not statistically significant . Therefore , from this study it was observed that aerobic exercise showed no significant benefit to fibromyalgia patients",
"Abstract : Fibromyalgia ( FM ) is a disorder characterised by diffuse widespread musculoskeletal aching and stiffness and multiple tender points [ 1 ] . Its pathophysiology is poorly understood . The influence of aerobic endurance exercise on pain in patients with FM was investigated . Twenty-seven patients ( 25 female , 2 male ) participated in a controlled clinical study and performed 12 weeks of jogging , walking , cycling or swimming following a given schedule . Twelve sedentary FM patients ( 11 female , 1 male ) served as controls . Before and after training both the study and the control groups were evaluated spiroergometrically . Tender point pain was quantified by dolorimetry . The painful body surface was estimated by a pain body diagram , and its intensity by a visual analogue scale and a ranking scale . Patients trained for an average of 25 min two to three times a week , with an average intensity of 50 % of maximal oxygen uptake ( VO2max ) . Unlike the control group , the training group exhibited a decrease in heart rate and VO2 and an increase in respiratory quotient during submaximal workload . Maximal performance capacity and VO2max remained unchanged , whereas the wattpulse ( watt/heart rate ) improved at maximal workload . Pain parameters remained unchanged in the control group , but in the training group the mean number of positive tender points ( 15.4/12.7 ) , the mean pain threshold of the gluteal tender point ( 2.89 kp/3.50 kp ) and the painful body surface ( 18%/15 % body surface ) decreased significantly . Subjective general pain condition deteriorated in two patients but improved in 17 . Our results suggest a positive effect of aerobic endurance exercise on fitness and well-being in patients with FM",
"OBJECTIVE The efficacy of an integrated , psychological treatment program was tested in a controlled study involving 27 patients with chronic musculoskeletal pain ( fibromyalgia ) . DESIGN The experimental treatment program consisted of instruction in various self-help techniques ( e.g. , cognitive behavioral strategies , relaxation , physical exercises ) as well as information on chronic pain . Control groups were instructed only in autogenic training . Measures of pain , daily activities , general symptoms , and psychological functioning were assessed before and after treatment , as well as at 4 months after termination of therapy ( follow-up ) . RESULTS At the end of treatment , 7 patients from the experimental group and 2 from the control group showed significant clinical improvement in 3 of 6 parameters ( NS ) . At follow-up , the improvement was still present in 5 experimental cases but in none of the controls ( p = 0.024 ) . Successful patients had been sick for a shorter period of time and were less impaired by their condition . CONCLUSIONS Psychological interventions in combination with physiotherapy can be effective in treating fibromyalgia patients , especially if applied early",
"Objective : To evaluate the effects of a community patient education -exercise programme , using a cognitive-behavioural approach , for people with fibromyalgia . Design : A r and omized , parallel group trial with assessment s at 0 , 4 and 8 months . Setting : Community leisure centres . Subjects : People with fibromyalgia ( n=183 ) attending a rheumatology outpatient department at a large district general hospital . Interventions : Participants were r and omized to a patient education-exercise group ( n=97 ) or relaxation ( attention control ) group ( n=86 ) . Main measures : The Fibromyalgia Impact Question naire ( 0 - 80 ; lower score means better health ) . Secondary outcomes included : the Arthritis Self-Efficacy Scale(pain and other symptoms subscales : 1 -10 scale ; higher scores mean greater self-efficacy ) and self-reported improvement . Results : Fifty participants withdrew or were unable to attend and 133 completed and returned baseline question naires : patient education group ( n=71 ) ; relaxation group ( n=62 ) ; 120/133 participants were women . Average age was 48 . 53 ( SD 10.89 ) years . Follow-up ranged between 73 and 82 % of question naires returned . At four months , there was a difference in average changes in total Fibromyalgia Impact Question naire scores between the two groups : patient education group -3.38 ( SD 9.35 ) ; relaxation group 0.3 ( SD 8.85 ) ; P=0.02 . Arthritis Self-Efficacy Scale scores were significantly higher in the patient education group : pain 0.59 ( SD 1.45)compared to the relaxation group ’s -0.12 ( SD 1.22 ) ; P=0.003 ; other symptoms ( patient education group 0.72 ( SD 1.33 ) ; relaxation group 0.03 ( SD 1.16 ) ; P=0.002 ) . At eight months these differences were no longer apparent . Forty-seven per cent in the patient education group self-reported improvement compared with 13 % in the relaxation group ( ϰ=13.65 ; P=0.0001 ) . Conclusion : Short-term improvements result ed from the education -exercise programme but were not sustained . Appropriate selection may improve efficacy"
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BACKGROUND Exp and ing public health insurance seeks to attain several desirable objectives , including increasing access to healthcare services , reducing the risk of catastrophic healthcare expenditures , and improving health outcomes . The extent to which these objectives are met in a real-world policy context remains an empirical question of increasing research and policy interest in recent years . METHODS We review ed systematic ally empirical studies published from July 2010 to September 2016 using Medline , Embase , Econlit , CINAHL Plus via EBSCO , and Web of Science and grey literature data bases . No language restrictions were applied . Our focus was on both r and omised and observational studies , particularly those including explicitly attempts to tackle selection bias in estimating the treatment effect of health insurance . The main outcomes are : ( 1 ) utilisation of health services , ( 2 ) financial protection for the target population , and ( 3 ) changes in health status . FINDINGS 8755 abstract s and 118 full-text articles were assessed . Sixty-eight studies met the inclusion criteria including six r and omised studies , reflecting a substantial increase in the quantity and quality of research output compared to the time period before 2010 . Overall , health insurance schemes in low- and middle-income countries ( LMICs ) have been found to improve access to health care as measured by increased utilisation of health care facilities ( 32 out of 40 studies ) . There also appeared to be a favourable effect on financial protection ( 26 out of 46 studies ) , although several studies indicated otherwise . There is moderate evidence that health insurance schemes improve the health of the insured ( 9 out of 12 studies ) . INTERPRETATION Increased health insurance coverage generally appears to increase access to health care facilities , improve financial protection and improve health status , although findings are not totally consistent . Underst and ing the drivers of differences in the outcomes of insurance reforms is critical to inform future implementations of publicly funded health insurance to achieve the broader goal of universal health coverage
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"IMPORTANCE Hypertension is a major public health problem in sub-Saharan Africa , but the lack of affordable treatment and the poor quality of health care compromise antihypertensive treatment coverage and outcomes . OBJECTIVE To report the effect of a community-based health insurance ( CBHI ) program on blood pressure in adults with hypertension in rural Nigeria . DESIGN , SETTING , AND PARTICIPANTS We compared changes in outcomes from baseline ( 2009 ) between the CBHI program area and a control area in 2011 through consecutive household surveys . Households were selected from a stratified r and om sample of geographic areas . Among 3023 community-dwelling adults , all nonpregnant adults ( aged ≥18 years ) with hypertension at baseline were eligible for this study . INTERVENTION Voluntary CBHI covering primary and secondary health care and quality improvement of health care facilities . MAIN OUTCOMES AND MEASURES The difference in change in blood pressure from baseline between the program and the control areas in 2011 , which was estimated using difference-in-differences regression analysis . RESULTS Of 1500 eligible households , 1450 ( 96.7 % ) participated , including 564 adults with hypertension at baseline ( 313 in the program area and 251 in the control area ) . Longitudinal data were available for 413 adults ( 73.2 % ) ( 237 in the program area and 176 in the control area ) . Baseline blood pressure in respondents with hypertension who had incomplete data did not differ between areas . Insurance coverage in the hypertensive population increased from 0 % to 40.1 % in the program area ( n = 237 ) and remained less than 1 % in the control area ( n = 176 ) from 2009 to 2011 . Systolic blood pressure decreased by 10.41 ( 95 % CI , -13.28 to -7.54 ) mm Hg in the program area , constituting a 5.24 ( -9.46 to -1.02)-mm Hg greater reduction compared with the control area ( P = .02 ) , where systolic blood pressure decreased by 5.17 ( -8.29 to -2.05 ) mm Hg . Diastolic blood pressure decreased by 4.27 ( 95 % CI , -5.74 to -2.80 ) mm Hg in the program area , a 2.16 ( -4.27 to -0.05)-mm Hg greater reduction compared with the control area , where diastolic blood pressure decreased by 2.11 ( -3.80 to -0.42 ) mm Hg ( P = .04 ) . CONCLUSIONS AND RELEVANCE Increased access to and improved quality of health care through a CBHI program was associated with a significant decrease in blood pressure in a hypertensive population in rural Nigeria . Community-based health insurance programs should be included in strategies to combat cardiovascular disease in sub-Saharan Africa",
"Using household panel data from Vietnam , this paper compares out-of-pocket health expenditures on outpatient care at a health facility between insured and uninsured patients as well as across various providers . In the r and om effects model , the estimated coefficient of the insurance status variable suggests that insurance reduces out-of-pocket spending by 24 % for those with the compulsory and voluntary coverage and by about 15 % for those with the health insurance for the poor coverage . However , the modest financial protection of the compulsory and voluntary schemes disappears once we control for time-invariant unobserved individual effects using the fixed effects model . Additional analysis of the interaction terms involving the type of insurance and health facility suggests that the overall insignificant reduction in out-of-pocket expenditures as a result of the insurance schemes masks wide variations in the reduction in out-of-pocket sending across various providers . Insurance reduces out-of-pocket expenditures more for those enrollees using district and higher level public health facilities than those using commune health centers . Compared to the uninsured patients using district hospitals , compulsory and voluntary insurance schemes reduce out-of-pocket expenditures by 40 and 32 % , respectively . However , for contacts at the commune health centers , both the compulsory health scheme and the voluntary health insurance scheme schemes have little influence on out-of-pocket spending while the health insurance scheme for the poor reduces out-of-pocket spending by about 15 %",
"Since the 1990s , community-based health insurance ( CBHI ) schemes have been proposed to reduce the financial consequences of illness and enhance access to healthcare in developing countries . Convincing evidence on the ability of such schemes to meet their objectives is scarce . This paper uses r and omized control trials conducted in rural Uttar Pradesh and Bihar ( India ) to evaluate the effects of three CBHI schemes on healthcare utilization and expenditure . We find that the schemes have no effect on these outcomes . The results suggest that CBHI schemes of the type examined in this paper are unlikely to have a substantial impact on access and financial protection in developing countries . Copyright © 2015 John Wiley & Sons ,",
"In this paper , we present evidence on the health effects of a health insurance intervention targeted to poor children using data from a r and omized policy experiment known as the Quality Improvement Demonstration Study . Among study participants , using a difference-in-difference regression model , we estimated a 9 - 12 and 4 - 9 percentage point reduction in the likelihood of wasting and having an infection , respectively , as measured by a common biomarker C-reactive Protein . Interestingly , these benefits were not apparent at the time of discharge ; the beneficial health effects were manifest several weeks after release from the hospital",
"From 2004 to 2006 , a community-based health insurance ( CBI ) scheme was rolled out in Nouna District , Burkina Faso , with the objective of improving access to health services and population health . We explore the r and om timing of the insurance rollout generated by the stepped wedge cluster-r and omized design to evaluate the welfare and health impact of the insurance program . Our results suggest that the insurance had limited effects on average out-of-pocket expenditures in the target areas , but substantially reduced the likelihood of catastrophic health expenditure . The introduction of the insurance scheme did not have any effect on health outcomes for children and young adults , but appears to have increased mortality among individuals aged 65 and older . The negative health effects of the program appear to be primarily driven by the adverse provider incentives generated by the scheme and the result ing decline in the quality of care received by patients",
"In 2004 , a community-based health insurance ( CBI ) scheme was introduced in Nouna district , Burkina Faso , with the primary objective of improving access to facility-based health services . In order to overcome self- selection issues in the analysis of the behavioral effects of insurance , we combine four waves of the Nouna Health District Household Survey into a panel data set , and use the r and omized timing of insurance rollout to estimate the causal effect of insurance coverage on health-seeking behavior . While we find a generally positive association between CBI affiliation and treatment seeking , we can not reject the None that the introduction of health insurance does not have any effect on treatment seeking in general , and utilization of facility-based professional care , in particular . Low levels of health care provider satisfaction , poor perceived quality of care by enrollees , and ambiguity in the coverage level of the CBI benefit package appear to have contributed to these weak results . Our findings imply that the basic notion of insurance mechanically increasing facility-based professional care is not necessarily true empirically , and likely contingent on a large number of context ual factors affecting health-seeking behavior within households and communities",
"OBJECTIVE To evaluate whether community-based health insurance ( CBHI ) protects household assets in rural Burkina Faso , Africa . DATA SOURCES Data were used from a household panel survey that collected primary data from r and omly selected households , covering 41 villages and one town , during 2004 - 2007(n = 890 ) . STUDY DESIGN The study area was divided into 33 clusters and CBHI was r and omly offered to these clusters during 2004 - 2006 . We applied different strategies to control for selection bias-ordinary least squares with covariates , two-stage least squares with instrumental variable , and fixed-effects models . DATA COLLECTION Household members were interviewed in their local language every year , and information was collected on demographic and socio-economic indicators including ownership of assets , and on self-reported morbidity . PRINCIPAL FINDINGS Fixed-effects and ordinary least squares models showed that CBHI protected household assets during 2004 - 2007 . The two-stage least squares with instrumental variable model showed that CBHI increased household assets during 2004 - 2005 . CONCLUSIONS In this study , we found that CBHI has the potential to not only protect household assets but also increase household assets . However , similar studies from developing countries that evaluate the impact of health insurance on household economic indicators are needed to benchmark these results with other setting"
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4117e9e8-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE Type 2 diabetes is a major public health problem . The Dietary Approaches to Stop Hypertension ( DASH ) eating pattern may contribute to managing risk factors of type 2 diabetes . The objective of this study was to conduct a systematic review and meta- analysis on r and omized controlled trials ( RCTs ) that examine the effects of DASH diet consumption on the indices of glycemic control such as fasting blood glucose ( FBG ) , serum fasting insulin level , and Homeostatic Model Assessment insulin resistance ( HOMA-IR ) . METHODS We search ed Pubmed , EMBASE , Science direct , ISI web of science , and Google Scholar for RCTs until July 2012 . In total we found 20 articles that examine the effect of DASH diet on FBG ( n = 9 ) , fasting insulin ( n = 7 ) and HOMA-IR ( n = 4 ) met the inclusion criteria , respectively . RESULTS Meta- analysis showed that the DASH diet can significantly reduce fasting insulin concentration ( mean difference -0.15 ; 95 % confidence interval [ CI ] , -0.22 to -0.08 ; P fasting insulin levels when prescribed for more than 16 wk ( mean difference -0.16 ; 95 % CI , -0.23 to -0.08 ; P FBG ( mean difference -0.26 ; 95 % CI , -0.56 to 0.05 ; P = 0.1 ) , and HOMA-IR ( mean difference -0.26 ; 95 % CI , -0.56 to 0.05 ; P = 0.1 ) . CONCLUSIONS The DASH dietary pattern may lead to an improvement in insulin sensitivity independent of weight loss . The DASH diet may play an important role in glycemic control in long- term interventions . Additional prospect i ve studies regarding the association between DASH diet and risks for type 2 diabetes are necessary
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[
"BACKGROUND Certain dietary components may play a role in the prevention of type 2 diabetes . OBJECTIVE We examined prospect ively the associations between whole- and refined-grain intake and the risk of type 2 diabetes in a large cohort of men . DESIGN Men from the Health Professionals Follow-up Study without a history of diabetes or cardiovascular disease in 1986 ( n = 42898 ) were followed for whole and refined grains , measured every 4 y by use of food-frequency question naires , were used to predict subsequent type 2 diabetes risk through multivariate analysis . RESULTS We ascertained 1197 cases of incident type 2 diabetes . After adjustment for age ; physical activity ; cigarette smoking ; alcohol consumption ; family history of diabetes ; and fruit , vegetable , and energy intakes , the relative risk of type 2 diabetes was 0.58 ( 95 % CI : 0.47 , 0.70 ; P for trend risk of type 2 diabetes . After further adjustment for magnesium intake , cereal fiber intake , and glycemic load , the association between whole grains and type 2 diabetes was attenuated and the trend no longer significant . CONCLUSIONS In men , a diet high in whole grains is associated with a reduced risk of type 2 diabetes in men that may be mediated by cereal fiber . Efforts should be made to replace refined-grain with whole-grain foods",
"We demonstrated similar plasma concentrations and urinary losses but lower erythrocyte magnesium concentrations ( 2.18 + /- 0.04 vs 1.86 + /- 0.03 mmol/L , P less than 0.01 ) in twelve aged ( 77.8 + /- 2.1 y ) vs 25 young ( 36.1 + /- 0.4 y ) , nonobese subjects . Subsequently , aged subjects were enrolled in a double-blind , r and omized , crossover study in which placebo ( for 4 wk ) and chronic magnesium administration ( CMA ) ( 4.5 g/d for 4 wk ) were provided . At the end of each treatment period an intravenous glucose tolerance test ( 0.33 g/kg body wt ) and a euglycemic glucose clamp with simultaneous [D-3H]glucose infusion and indirect calorimetry were performed . CMA vs placebo significantly increased erythrocyte magnesium concentration and improved insulin response and action . Net increase in erythrocyte magnesium significantly and positively correlated with the decrease in erythrocyte membrane microviscosity and with the net increase in both insulin secretion and action . In aged patients , correction of a low erythrocyte magnesium concentration may allow an improvement of glucose h and ling",
"This study examined the effects of the Dietary Approaches to Stop Hypertension ( DASH ) diet on insulin sensitivity and lipids . In a r and omized control trial , 144 overweight ( body mass index : 25 to 40 ) men ( n=47 ) and women ( n=97 ) with high blood pressure ( 130 to 159/85 to 99 mm Hg ) were r and omly assigned to one of the following groups : ( 1 ) DASH diet alone ; ( 2 ) DASH diet with aerobic exercise and caloric restriction ; or ( 3 ) usual diet controls ( UC ) . Body composition , fitness , insulin sensitivity , and fasting lipids were measured before and after 4 months of treatment . Insulin sensitivity was estimated on the basis of glucose and insulin levels in the fasting state and after an oral glucose load . Participants in the DASH diet with aerobic exercise and caloric restriction condition lost weight ( −8.7 kg [ 95 % CI : −2.0 to −9.7 kg ] ) and exhibited a significant increase in aerobic capacity , whereas the DASH diet alone and UC participants maintained their weight ( −0.3 kg [ 95 % CI : −1.2 to 0.5 kg ] and + 0.9 kg [ 95 % CI : 0.0 to 1.7 kg ] , respectively ) and had no improvement in exercise capacity . DASH diet with aerobic exercise and caloric restriction demonstrated lower glucose levels after the oral glucose load , improved insulin sensitivity , and lower total cholesterol and triglycerides compared with both DASH diet alone and UC , as well as lower fasting glucose and low-density lipoprotein cholesterol compared with UC . DASH diet alone participants generally did not differ from UC in these measures . Combining the DASH diet with exercise and weight loss result ed in significant improvements in insulin sensitivity and lipids . Despite clinical ly significant reductions in blood pressure , the DASH diet alone , without caloric restriction or exercise , result ed in minimal improvements in insulin sensitivity or lipids ",
"OBJECTIVE To determine the effects of the Dietary Approaches to Stop Hypertension ( DASH ) eating pattern on cardiometabolic risks in type 2 diabetic patients . RESEARCH DESIGN AND METHODS A r and omized crossover clinical trial was undertaken in 31 type 2 diabetic patients . For 8 weeks , participants were r and omly assigned to a control diet or the DASH eating pattern . RESULTS After following the DASH eating pattern , body weight ( P = 0.007 ) and waist circumference ( P = 0.002 ) reduced significantly . Fasting blood glucose levels and A1C decreased after adoption of the DASH diet ( −29.4 ± 6.3 mg/dl ; P = 0.04 and −1.7 ± 0.1 % ; P = 0.04 , respectively ) . After the DASH diet , the mean change for HDL cholesterol levels was higher ( 4.3 ± 0.9 mg/dl ; P = 0.001 ) and LDL cholesterol was reduced ( −17.2 ± 3.5 mg/dl ; P = 0.02 ) . Additionally , DASH had beneficial effects on systolic ( −13.6 ± 3.5 vs. −3.1 ± 2.7 mmHg ; P = 0.02 ) and diastolic blood pressure ( −9.5 ± 2.6 vs. −0.7 ± 3.3 mmHg ; P = 0.04 ) . CONCLUSIONS Among diabetic patients , the DASH diet had beneficial effects on cardiometabolic risks",
"Abstract — Evidence suggests that obesity may raise blood pressure ( BP ) through oxidative stress – sensitive mechanisms and that the Dietary Approaches to Stop Hypertension combination diet ( DASH-CD ) may decrease BP by enhancing antioxidant capacity . To address this question , 12 obese patients with high-normal – to – stage 1 hypertension ( hypertensives ) and 12 lean normotensives were studied on their usual diets and after following the DASH-CD and a low-antioxidant diet in r and om sequence for 4 weeks each . Acute oxidative stress was induced by a 4-hour infusion of intralipid and heparin . Ferric-reducing activity of plasma ( FRAP ) and plasma F2-isoprostanes were measured as biomarkers of antioxidant capacity and oxidative stress , respectively . BP was lower in obese hypertensives on the DASH-CD than on the usual and low-antioxidant diets ( −8.1±1.5/−7.4±1.6 mm Hg , P ) . BP did not change significantly in lean normotensives after 4 weeks on the DASH-CD but tended to rise on the low-antioxidant diet . FRAP on usual diets was higher in lean subjects than in obese subjects . FRAP increased in obese but not lean volunteers on the DASH-CD compared with usual diet , and the group difference disappeared . F2-isoprostanes increased from baseline during intralipid and heparin in both groups on the low-antioxidant diet but not in obese hypertensives on the DASH-CD . Among free-living obese hypertensives , the DASH-CD raises antioxidant capacity , lowers BP , and reduces oxidative stress induced by acute hyperlipidemia . The findings are consistent with evidence that elevated BP in obese subjects may reflect an imbalance between antioxidant capacity and oxidative stress that is improved by the DASH-CD ",
"The mechanism underlying blood pressure ( BP ) reduction in the high fruits and vegetables arm of the Dietary Approaches to Stop Hypertension ( DASH ) study is unknown but may include potassium , magnesium and fibre . This study was design ed to separate minerals and fibre from other components of DASH on BP in abdominally obese individuals with metabolic syndrome with pre-hypertension to stage 1 hypertension ( obese hypertensives ) . A total of 15 obese hypertensives and 15 lean normotensives were studied on a st and ardized usual diet , r and omized to DASH or usual diet supplemented with potassium , magnesium and fibre to match DASH , then crossed over to the complementary diet . All diets were 3 weeks long , isocaloric and matched for sodium and calcium . In obese hypertensives , BP was lower after 3 weeks on DASH than usual diet ( −7.6±1.4/−5.3±1.4 mm Hg , P ) , whereas BP was not significantly different on usual and supplemented diets . BP values were not different among the three diets in lean normotensives . Small artery elasticity was lower in obese hypertensives than in lean normotensives on the usual and supplemented diets ( P . This index of endothelial function improved in obese hypertensives ( P0.50 ) . DASH is more effective than potassium , magnesium and fibre supplements for lowering BP in obese hypertensives , which suggest that high fruits and vegetables DASH lowers BP and improves endothelial function in this group by nutritional factors in addition to potassium , magnesium and fibre",
"We evaluated the effect of oral calcium supplementation on blood pressure , calcium metabolism , and insulin resistance in essential hypertension . After receiving a st and ard diet with 500 mg of calcium per day during a 4-week period , 20 nondiabetic , essential hypertensive patients were r and omized in a double-blind fashion to receive oral calcium supplementation ( 1500 mg of calcium per day ) or placebo for 8 weeks . At the end of the 4-week period of low-calcium diet and after the 8-week period of intervention , we measured blood pressure ( by both office and 24-hour ambulatory blood pressure monitoring ) , calcium-regulating hormones [ urinary hydroxyproline and serum osteocalcin , parathormone , and 1,25(OH)2-vitamin D3 ] , intraplatelet free calcium concentration , fasting plasma glucose and insulin levels , and the insulin-sensitivity index ( euglycemic-hyperinsulinemic clamp ) . Compared with patients maintained at low calcium intake , essential hypertensive patients under oral calcium supplementation significantly reduced serum osteocalcin ( from 22.2 + /- 1.9 to 17.9 + /- 2.0 micrograms/L ; P = .0015 ) , parathormone ( from 4.20 + /- 0.38 to 3.30 + /- 0.36 pmol/L ; P = .0003 ) , and 1,25(OH)2-vitamin D3 ( from 98.0 + /- 11.0 to 61.6 + /- 5.7 pmol/L ; P = .0062 ) . Likewise , we found a significant reduction in intraplatelet free calcium concentration ( from 35.9 + /- 1.2 to 26.5 + /- 0.8 nmol/L ; P = .0005 ) and fasting plasma insulin levels ( from 71.8 + /- 5.9 to 64.6 + /- 6.2 pmol/L ; P = .05 ) and a significant increase in the insulin-sensitivity index ( from 2.89 + /- 0.77 to 4.00 + /- 0.95 mg.kg-1.min-1 ; P = .0007 ) . None of these parameters were significantly modified in patients maintained at low calcium intake . Office and 24-hour mean values of systolic and diastolic blood pressure did not change after 8 weeks of oral calcium supplementation or placebo",
"BACKGROUND It is known that obesity , sodium intake , and alcohol consumption factors influence blood pressure . In this clinical trial , Dietary Approaches to Stop Hypertension , we assessed the effects of dietary patterns on blood pressure . METHODS We enrolled 459 adults with systolic blood pressures of less than 160 mm Hg and diastolic blood pressures of 80 to 95 mm Hg . For three weeks , the subjects were fed a control diet that was low in fruits , vegetables , and dairy products , with a fat content typical of the average diet in the United States . They were then r and omly assigned to receive for eight weeks the control diet , a diet rich in fruits and vegetables , or a \" combination \" diet rich in fruits , vegetables , and low-fat dairy products and with reduced saturated and total fat . Sodium intake and body weight were maintained at constant levels . RESULTS At base line , the mean ( + /-SD ) systolic and diastolic blood pressures were 131.3+/-10.8 mm Hg and 84.7+/-4.7 mm Hg , respectively . The combination diet reduced systolic and diastolic blood pressure by 5.5 and 3.0 mm Hg more , respectively , than the control diet ( P systolic blood pressure by 2.8 mm Hg more ( P diastolic blood pressure by 1.1 mm Hg more than the control diet ( P=0.07 ) . Among the 133 subjects with hypertension ( systolic pressure , > or = 140 mm Hg ; diastolic pressure , > or = 90 mm Hg ; or both ) , the combination diet reduced systolic and diastolic blood pressure by 11.4 and 5.5 mm Hg more , respectively , than the control diet ( P 326 subjects without hypertension , the corresponding reductions were 3.5 mm Hg ( P blood pressure . This diet offers an additional nutritional approach to preventing and treating hypertension",
"Salt induces oxidative stress in salt-sensitive ( SS ) animals and man . It is not known whether in SS subjects the low-sodium dietary approaches to stop hypertension ( LS-DASH ) reduces oxidative stress more than DASH , which is high in antioxidants . To assess the effects of DASH and LS-DASH on oxidative stress , 19 volunteers were studied after 3 weeks of a st and ardized usual low fruits and vegetables diet ( ULFV ) , followed by 3 weeks on DASH ( both diets ∼120 mmol Na+ per day ) , then 3 weeks on LS-DASH ( 60 mmol Na+ per day ) . SS was defined as systolic blood pressure ⩾5 mm Hg lower on LS-DASH than DASH . In SS subjects ( N=9 ) , systolic blood pressure was lower on LS-DASH ( 111.0±2.0 mm Hg ) than DASH ( 118.0±2.2 , P ) . In salt-resistant ( SR ) volunteers ( N=10 ) , systolic blood pressure was lower on DASH ( 113.0±1.6 ) than ULFV ( 119.0±1.8 , P ) . Urine F2-isoprostanes , a marker of oxidative stress , were lower in SS subjects on LS-DASH ( 1.69±0.24 ) than ULFV ( 3.09±0.50 , P P were not different among the three diets in SR volunteers ( 2.18±0.29 , 2.06±0.29 , 2.27±0.53 , respectively ) . Aortic augmentation index , a measure of vascular stiffness , was lower in SS subjects on LS-DASH than either DASH or ULFV , and lower on DASH than ULFV in SR volunteers . In SS but not SR subjects , LS-DASH is associated with lower values for F2-isoprostanes and the aortic augmentation index . The results suggest that LS-DASH decreases oxidative stress , improves vascular function and lowers blood pressure in SS but not SR volunteers",
"BACKGROUND Diet and lifestyle modifications can substantially reduce the risk of type 2 diabetes . While a strong inverse association has been reported between dairy consumption and the insulin resistance syndrome among young obese adults , the relation between dairy intake and type 2 diabetes is unknown . METHODS We prospect ively examined the relation between dairy intake and incident cases of type 2 diabetes in 41,254 male participants with no history of diabetes , cardiovascular disease , and cancer at baseline in the Health Professionals Follow-up Study . RESULTS During 12 years of follow-up , we documented 1243 incident cases of type 2 diabetes . Dairy intake was associated with a modestly lower risk of type 2 diabetes . After adjusting for potential confounders , including body mass index , physical activity , and dietary factors , the relative risk for type 2 diabetes in men in the top quintile of dairy intake was 0.77 ( 95 % confidence interval [ CI ] , 0.62 - 0.95 ; P for trend , .003 ) compared with those in the lowest quintile . Each serving-per-day increase in total dairy intake was associated with a 9 % lower risk for type 2 diabetes ( multivariate relative risk , 0.91 ; 95 % CI , 0.85 - 0.97 ) . The corresponding relative risk was 0.88 ( 95 % CI , 0.81 - 0.94 ) for low-fat dairy intake and 0.99 ( 95 % CI , 0.91 - 1.07 ) for high-fat dairy intake . The association did not vary significantly according to body mass index ( or = 25 kg/m(2 ) ; P for interaction , .57 ) . CONCLUSION Dietary patterns characterized by higher dairy intake , especially low-fat dairy intake , may lower the risk of type 2 diabetes in men",
"OBJECTIVE —The excess risk of macrovascular disease and death associated with diabetes seems higher in women than in men . The pathogenesis for this risk difference has not been fully eluci date d. We investigated whether female sex was associated with macrovascular disease and death , independently of known risk factors related to type 2 diabetes , nephropathy , or retinopathy in normotensive patients with type 2 diabetes and microalbuminuria . RESEARCH DESIGN AND METHODS —We conducted a prospect i ve , prolonged follow-up study of a subgroup of 67 diabetic patients ( 46 men and 21 women ) without established cardiovascular disease who participated in a larger clinical trial . Data were collected on current and past health , medication use , blood pressure , renal function , and HbA1c during the follow-up period of 4.7 ± 0.8 ( means ± SE ) years . The end point was a composite of death , cardiovascular disease , cerebrovascular events , and peripheral artery disease . RESULTS —Of the women , eight ( 38.1 % ) met the end point compared with six ( 13.4 % ) of the men ( P = 0.02 for difference in event-free survival ) . The hazard ratio of women relative to men was 3.19 ( 95 % CI 1.11–9.21 ) , which further increased after adjusting for age , systolic blood pressure , BMI , smoking , total-to-HDL cholesterol ratio , urinary albumin excretion , and retinopathy . CONCLUSIONS —In our study population of normotensive patients with type 2 diabetes and microalbuminuria , female sex was associated with increased risk of fatal and nonfatal cardiovascular disease , independent of the classical cardiovascular risk factors , the severity of nephropathy or presence of retinopathy , or health care utilization",
"BACKGROUND Type 2 diabetes mellitus is increasingly common , primarily because of increases in the prevalence of a sedentary lifestyle and obesity . Whether type 2 diabetes can be prevented by interventions that affect the lifestyles of subjects at high risk for the disease is not known . METHODS We r and omly assigned 522 middle-aged , overweight subjects ( 172 men and 350 women ; mean age , 55 years ; mean body-mass index [ weight in kilograms divided by the square of the height in meters ] , 31 ) with impaired glucose tolerance to either the intervention group or the control group . Each subject in the intervention group received individualized counseling aim ed at reducing weight , total intake of fat , and intake of saturated fat and increasing intake of fiber and physical activity . An oral glucose-tolerance test was performed annually ; the diagnosis of diabetes was confirmed by a second test . The mean duration of follow-up was 3.2 years . RESULTS The mean ( + /-SD ) amount of weight lost between base line and the end of year 1 was 4.2+/-5.1 kg in the intervention group and 0.8+/-3.7 kg in the control group ; the net loss by the end of year 2 was 3.5+/-5.5 kg in the intervention group and 0.8+/-4.4 kg in the control group ( P cumulative incidence of diabetes after four years was 11 percent ( 95 percent confidence interval , 6 to 15 percent ) in the intervention group and 23 percent ( 95 percent confidence interval , 17 to 29 percent ) in the control group . During the trial , the risk of diabetes was reduced by 58 percent ( P the incidence of diabetes was directly associated with changes in lifestyle . CONCLUSIONS Type 2 diabetes can be prevented by changes in the lifestyles of high-risk subjects",
"To investigate the role of potassium deficiency in the development of glucose intolerance during caloric deprivation , potassium balance was maintained within normality with oral potassium supplementation in a group of obese subjects who underwent protein-modified fast and the results of the study of carbohydrate metabolism ( oral glucose test , insulin receptors on monocytes and peripheral glucose utilization as assessed by euglycaemic clamp ) were compared with those obtained in a group of obese subjects admitted to protein-modified fast without potassium supplementation . Caloric deprivation without oral potassium supplementation was followed by a negative potassium balance and a decrease of serum potassium levels ; a decrease of the peripheral levels of insulin along with an increase in insulin receptors and a striking reduction of peripheral glucose utilization were also observed . The maintenance of normal potassium balance and normal serum potassium levels with oral potassium-chloride supplementation was associated with higher peripheral levels of insulin ( P less than 0.01 ) and improvement of peripheral glucose utilization ( P less than 0.01 ) whereas the binding of insulin to monocytes was unchanged . The data suggest that potassium depletion during protein-modified fast causes a decrease of the peripheral levels of insulin and a resistance to insulin action at the postreceptors sites which is reversed by potassium supply",
"We tested whether lowering of blood pressure ( BP ) on the dietary approaches to stop hypertension ( DASH ) diet was associated with changes in peripheral vascular function : endothelial function , assessed by flow-mediated vasodilatation ( FMD ) of the brachial artery , and subcutaneous adipose tissue blood flow ( ATBF ) . We also assessed effects on heart rate variability ( HRV ) as a measure of autonomic control of the heart . We allocated 27 men and women to DASH diet and control groups . We measured FMD , ATBF and HRV on fasting and after ingestion of 75 g glucose , before and after 30 days on dietary intervention , aim ing for weight maintenance . The control group did not change their diet . The DASH-diet group complied with the diet as shown by significant reductions in systolic ( P and diastolic ( P=0.005 ) BP , and in plasma C-reactive protein ( P LDL-cholesterol ( P apolipoprotein B ( P=0.001 ) , a novel finding . Body weight changed by FMD , or in ATBF , in the DASH-diet group , although heart rate fell ( P Glucose and insulin concentrations did not change . In this small-scale study , the DASH diet lowered BP independently of peripheral mechanisms",
"The aim of the study was to investigate the effects of two hypocaloric ( 800-kcal ) diets on body weight reduction and composition , insulin sensitivity , and proteolysis in 25 normal glucose-tolerant obese women . The two diets had the following composition : 45 % protein , 35 % carbohydrate ( CHO ) , and 20 % fat ( HP diet , 10 subjects ) , and 60 % CHO , 20 % protein , and 20 % fat ( HC diet , 15 subjects ) ; both lasted 21 days . A euglycemic hyperinsulinemic ( 25 mU/kg/h ) clamp lasting 150 minutes combined with indirect calorimetry was performed before and after the diet . Both diets induced a similar decrease in body weight and fat mass ( FM ) , whereas fat-free mass ( FFM ) decreased only after the HC diet . 3-Methylhistidine ( 3-CH3-HIS ) excretion was reduced by 48 % after the HP diet and remained unchanged after the HC diet ( P changes in FFM and in 3-CH3-HIS excretion after the diet ( rs = .50 , P Blood glucose remained unchanged , while insulin decreased in both diets . Free fatty acids ( FFA ) significantly increased only after the HC diet ( P glucose disposal and glucose oxidation significantly increased after the HP diet and significantly decreased after the HC diet . Opposite results were found when measuring lipid oxidation . In conclusion , our experience suggests that ( 1 ) a hypocaloric diet providing a high percentage of natural protein can improve insulin sensitivity ; and ( 2 ) conversely , a hypocaloric high-polysaccharide-CHO diet decreases insulin sensitivity and is unable to spare muscle tissue",
"Few studies exist regarding the effects of the Dietary Approaches to Stop Hypertension ( DASH ) diet on novel cardiovascular risk factors among type 2 diabetic patients . We evaluated the effects of the DASH eating pattern on C-reactive protein ( CRP ) level , coagulation abnormalities , and hepatic function tests in type 2 diabetic patients . In this r and omized , crossover clinical trial , 31 type 2 diabetic patients consumed a control diet or the DASH diet for 8 wk . The DASH diet was rich in fruits , vegetables , whole grains , and low-fat dairy products and low in saturated fat , total fat , cholesterol , refined grains , and sweets , with a total of 2400 mg/d sodium . The control diet was a st and ard diet for diabetic patients . There was a 4-wk washout between the 2 trial phases . The main outcome measures were CRP level , coagulation indices , and hepatic function tests . The mean percent change for plasma CRP level was -26.9 ± 3.5 % after the DASH diet period and -5.1 ± 3.8 % after the control diet period ( P = 0.02 ) . Decreases in both alanine aminotransferase and aspartate aminotransferase levels were greater after consuming the DASH diet compared with the control diet ( -14.8 ± 3.0 % vs -6.6 ± 3.4 % ; P = 0.001 ; -29.4 ± 3.7 % vs -5.9 ± 1.4 % ; P = 0.001 , respectively ) . The decrease in the plasma fibrinogen level during the DASH diet period ( -11.4 ± 3.6 % ) was greater than that during the control diet ( 0.5 ± 3.4 % ) ( P = 0.03 ) . Among diabetic patients , the DASH diet can play an important role in reducing inflammation , plasma levels of fibrinogen , and liver aminotransferases . Future longer term studies are recommended"
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4117ea24-06ff-11f0-808a-c43d1ab1c353
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Controversy exists regarding the clinical and radiological differences in outcomes between fixed-bearing ( FB ) and mobile-bearing ( MB ) total knee arthroplasties ( TKAs ) at the mid- or long-term follow-up . We therefore conducted a meta- analysis and systematic review of r and omized controlled trials ( RCTs ) that have evaluated FB and MB TKAs . We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) in the Cochrane Library , Medline and Embase . The data , including demographic information , method ological quality , duration of follow-up , clinical and radiographical outcomes , patient preferences and complications , were extracted . The method ological quality of the studies was assessed in accordance with the guidelines presented in the Cochrane H and book for Systematic Review s of Interventions . Nine trials , study ing 1,821 knees , were eligible for data extraction and meta- analysis . The Knee Society score and the maximum knee flexion demonstrated no difference between the FB and MB groups ( P=0.47 and P=0.72 , respectively ) . Similarly , no difference was revealed between the groups for radiological outcomes or general health results . An increased number of high- quality RCTs with long-term follow-ups are required to vali date the results
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"Purpose This study was design ed to compare clinical , radiological , and general health results of two prostheses ( mobile vs. fixed weight-bearing devices ) that are used in total knee arthroplasty with a 5-year follow-up . Methods This r and omized controlled study was conducted from 2004 to 2010 in the Department of Orthopedic Surgery at two university hospitals in Isfahan , Iran . Three hundred patients with expected primary total knee arthroplasty ( TKA ) without severe deformity ( a fixed varus or valgus deformity greater than 20 ° ) received fixed weight-bearing ( n = 150 ) or mobile weight-bearing ( n = 150 ) devices . Clinical , radiological , and quality of life outcomes were compared between the two groups at six-month intervals for the first year , after which the comparisons were made annually for the next 4 years . Results Both groups had similar baseline characteristics . Although there was significant improvement in both groups , there was no significant difference between the groups with regard to the means of the Knee Society Scores , which were 92 ( SD : 12.1 ) for the fixed weight-bearing device and 93 ( SD : 14.2 ) for the mobile weight-bearing device ( n.s . ) at the final follow-up point . Radiographs showed that there was no significant difference in prosthetic alignment and no evidence of loosening . After TKA , the SF-36 score increased in both groups , but there was no statistical difference between the groups in quality of life at the final follow-up ( 62 ( 12.2 ) vs. 64 ( 14.3 ) , n.s . ) . There was no revision after 5 years . Conclusions In terms of clinical , radiological or general health outcomes for people who underwent TKA , the results of this study showed no clear advantage of mobile weight-bearing over the fixed weight-bearing prosthesis at the five-year follow-up . Level of evidence",
"A prospect i ve study was performed to compare the clinical and radiological results of mobile- and fixed-bearing total knee arthroplasty with specific attention to rotational alignment and range of motion . Sixty-one knees were assigned to total knee arthroplasty with either the NexGen LPS Flex fixed-bearing or with the NexGen LPS Flex mobile-bearing prosthesis . Postoperatively , knees were compared with regard to range of motion , clinical score , and radiographic findings . Rotational alignment of the femoral and tibial components was evaluated by computed tomography . The median follow-up period was 5.9 years ( range 2.1–8.8 years ) . Median postoperative Knee Society scores were 99 points ( 68–100 ) for the fixed-bearing group and 100 points ( 66–100 ) for the mobile-bearing group ( n.s . ) . The median postoperative flexion angles of 120 ° ( 90 ° –150 ° ) for the fixed-bearing group and 125 ° ( 90 ° –145 ° ) for the mobile-bearing group were not significantly different from each other ( n.s . ) . No knee required revision surgery due to wear of polyethylene or loosening of the component in either group . Computed tomography showed that 11 knees had rotational mismatches of more than 10 ° between the femoral and tibial components , but no significant difference was found in the postoperative extension and flexion angles or in the clinical score between the two treatment groups . Using the identical design for both fixed- and mobile-bearing prostheses , this prospect i ve , r and omized study did not show any clinical advantages of the mobile-bearing knee . Analysis of rotational alignment by CT scan did not reveal a particular advantage of the self-aligning mechanism of mobile-bearing implants",
"Background : The mobile bearing design s have not yet been shown to improve clinical outcome of total knee arthroplasty ( TKA ) . In this prospect i ve r and omized study , we compared the short-term clinical results of a mobile bearing implant with those of the fixed bearing version of the same implant . Methods : We r and omized 100 knees into two double-blind groups who received either the fixed ( FB , 52 knees ) or the mobile bearing ( MB , 48 knees ) version of the same implant . We used navigation to st and ardize the surgical technique . For up to one year , we recorded the Knee Society ( KSS ) and Oxford ( OXF ) scores . We performed an exploratory analysis of variance ( ANOVA ) to determine the influence of baseline scores as covariate and the extent of improvement in clinical outcome over time . Results : After one year , we did not detect any statistically significant difference between the two groups . The KSS scores differed by 2 points , the OXF scores by 1.1 points . Conclusion : Even with identical geometry of implant surfaces and a navigated surgical technique , first-year results do not support a preference for either a fixed or a mobile design",
"The aim of this study was to determine whether there is a difference in functional outcome between the PFC Sigma fixed-bearing and rotating-platform total knee replacement systems . One hundred twenty patients were r and omised to receive either a fixed-bearing or rotating-platform PFC Sigma total knee replacement . Range of movement ( ROM ) , Oxford knee score ( OKS ) and Knee Society score ( KSS ) were assessed independently before and one year after surgery . Weight-bearing X-rays were taken immediately and one year post surgery to determine the incidence of osteolysis and loosening . At a mean follow-up of 13.4 months there was no statistically significant difference in mean ROM , OKS and KSS between the two groups . There was no evidence of osteolysis or loosening in either of the groups and no revision for infection or implant failure . This study shows that there is no statistically significant difference in functional outcome between the two types of implants at short-term follow-up",
"Purpose The primary goal of this study was to assess the difference in active flexion between patients with a mobile versus a fixed bearing , cruciate retaining , and total knee arthroplasty . The study was design ed as a r and omised controlled multi-centre trial . Methods Participants were assigned to interventions by using block-stratified , r and om allocation . Outcome parameters were active flexion , passive flexion , and Knee Society Score ( KSS ) . Outcome parameters were assessed preoperatively and at 3 , 6 , and 12 months postoperatively by an independent nurse . Results Ninety-two patients from one centre were included , 46 in each group . Active flexion was comparable for the two groups , 99.9 ° for the mobile bearing group and 101 ° for the fixed bearing group with a baseline controlled difference of 1.0 ( 95 % CI −3.9 to 5.8 , n.s . ) . The Clinical KSS was comparable between the two bearing groups ( Mobile 90.0 vs. fixed 92.4 , n.s . ) . The functional KSS showed a difference that was attributable to the stair climbing subscore , which showed a difference in favour of the fixed bearing design between preoperative and 3 months ( 7.3 point difference ; 95 % CI 2.3–12.5 ; P = 0.005 ) as well as 12 months ( 4.8 point difference ; 95 % CI 0.1–9.6 ; P = 0.045 ) . Conclusions There were no short-term differences in active flexion between fixed bearing and mobile bearing total knee arthroplasty . Level of evidence",
"INTRODUCTION Total knee prostheses with a mobile-bearing insert were developed to provide nonconstrained joint range of motion while reducing friction forces . The purpose of this study was , based on weightbearing X-rays , to evaluate the mobility of the polyethylene tibial insert in relation to the femoral and tibial components . We studied the results of a cementless total knee arthroplasty ( TKA ) retaining the posterior cruciate ligament ( PCL ) , with a mobile-bearing platform in rotation and anteroposterior translation ( Innex Anterior-Posterior Glide , Zimmer ) with a mean 23-month follow-up duration after surgery . HYPOTHESIS Both anterior-posterior tibiofemoral translation and intraprosthetic axial rotation occur between the mobile polyethylene insert and the tibial endplate . MATERIAL AND METHOD In a series of 51 primary TKA , the three-dimensional ( 3D ) kinematics of the femoral , tibial , and mobile insert components were determined using a computerized matching system between the prosthetic 3D models and the radiographic images of the implants on three lateral follow-up weightbearing knee X-rays : films were taken in full extension , at 45 degrees flexion , and at maximum flexion . RESULTS There was a statistically significant increase in the internal rotation of the mobile tray with flexion , ( up to a mean -3+/-3 degrees between the femoral box and the mobile tray [ p mobile tray did not translate in relation to the tibial endplate from extension to 45 degrees flexion ( 0+/-2 mm [ range : -5 to 6 mm ] ) . However , from 45 degrees to maximum flexion , a statistically significant mean 1+/-2 mm ( range : -2 to 9 mm ) of anterior translation ( p retaining TKA with a mobile-bearing platform , the mobile-bearing platform showed a progressive increase in internal rotation during flexion . Most of this rotational mobility occurred between the mobile platform and the tibial endplate , confirming our hypothesis . However , with flexion , the femoral component increased its mobility relatively to the platform . During flexion , an anterior-posterior translation occurred between the femoral implant and the tibial insert , and between the tibial insert and the tibial endplate , but the direction of the mobile tibial insert translation remained unpredictable with this nonconstrained implant design used . LEVEL OF EVIDENCE Level IV . Prospect i ve non-controlled therapeutic study",
"Introduction In a prospect i ve r and omized study , we compared the results after implantation of the mobile bearing high flex TKA with a fixed bearing posterior stabilized TKA in 60 patients ( 30 patients each group ) . Method We evaluated the hospital for special surgery-score ( HSS ) and different radiological parameters preoperatively , as well as 3 months , 3 and 5 years postoperatively . Result Three months postoperatively , the high flex group showed better results in scores for pain , ROM ( 122.5 ° vs. 107.33 ° ) , as well as in the overall HSS ( 87.21 vs. 82.68 points ) . Three and 5 years postoperatively , there were no differences between both the groups in all scores , but the HSS is still increasing . Conclusion The theoretical advantages of the mobile bearing knee prostheses were reflected in the clinical results , only partly and temporarily",
"Purpose The purpose of this study was to determine whether the floating platforms ( FP ) were superior to rotating platforms ( RP ) in computer-navigated total knee arthroplasty ( TKA ) comparing the range of motion ( ROM ) as well as clinical and subjective function of the knee . Methods This retrospective non-r and omized single-centre cohort study includes 255 patients with a primary implanted computer-navigated e.motion ™ ( Aesculap B. Braun ) TKA system , implanted because of clinical and radiological verified gonarthrosis . In 129 patients , the FP platform was implanted , and in 126 patients , the RP platform . As statistical procedures for differences between inlay type RP/FP in ROM and Knee Society Score ( KSS ) after 3- and 24-month follow-up , an analysis of covariance ( with risk factors gender , age , BMI , preoperative ROM and preoperative KSS ) was performed . Results Although preoperative ROM and knee society function score ( KSS partII ) were significantly higher in the FP group before surgery , there was no significant difference between RP and FP in ROM and KSS at 3- and 24-month follow-up . Conclusion The FP platform design did not have an advantage in ROM as well as in clinical and subjective knee function compared with the RP platform in computer-navigated TKA neither in early follow-up examinations at 3 months postoperatively nor at long-time follow-up at 24 months postoperatively . Level of evidence Therapeutic study , Level III",
"BACKGROUND For some surgeons , rotating-platform total knee design s are an intellectually appealing option to use for total knee arthroplasty because of the contention that they can self-align and accommo date small mismatches in the rotational position of the tibial and femoral components . We carried out a r and omized clinical trial to determine if a posterior-stabilized , rotating-platform knee design provided better maximum knee flexion , better function , or better durability at five years of follow-up when compared with a fixed-bearing design . METHODS This r and omized clinical trial of 240 primary total knee arthroplasties involved a single type of distal femoral implant ( posterior-stabilized ) and three different types of tibial implant ( all-polyethylene fixed-bearing , modular-metal-backed fixed-bearing , and rotating-platform ) . The three tibial implant groups were balanced dynamically with a computerized r and omization process that accounted for patient age , sex , and body mass index ; surgeon ; and implant type . Patients returned for examination and radiographs at three months , one year , two years , and five years postoperatively . RESULTS Knee range of motion was not significantly different among the all-polyethylene , modular-metal-backed , and rotating-platform tibial component groups at two years ( mean , 111 ° , 111 ° , and 110 ° , respectively ) or five years ( mean , 110 ° , 109 ° , and 109 ° , respectively ) . Function , as measured with Knee Society scores , was not significantly different among the all-polyethylene , modular-metal-backed , and rotating-platform groups at two years ( mean , 90 , 91 , and 91 points , respectively ) or five years ( mean , 88 , 89 , and 88 points , respectively ) . Stair-climbing scores were not significantly different among the three groups at two years ( mean , 39 , 40 , and 39 points , respectively ) or five years ( mean , 37 , 40 , and 36 points , respectively ) . There were four revisions : one in the all-polyethylene group ( patellar fracture ) , two in the modular-metal-backed group ( aseptic loosening ) , and one in the rotating-platform group ( deep infection ) . CONCLUSIONS In this r and omized clinical trial , the rotating-platform total knee design was reliable and durable but did not provide better maximum knee flexion , better function , or better durability at five years postoperatively when compared with a posterior-stabilized , fixed-bearing design incorporating either an all-polyethylene or a modular-metal-backed tibial component",
"Background Mobile bearing ( MB ) total knee design has been advocated as a means to enhance the functional characteristics and decrease the wear rates of condylar total knee arthroplasty ( TKA ) . However , it is unclear if these design s achieve these goals . Questions / purpose sWe asked whether function of patients or survivorship would be greater or complications would be lesser in groups of patients with MB compared with fixed bearing ( FB ) TKA . We also sought to describe retrieval findings . Methods We r and omized 507 primary TKAs in 416 eligible patients to receive MB ( n = 252 ) or FB ( n = 255 ) devices from November 2001 to August 2007 ( Investigational Device Exemption G000180 , Clinical Trials.gov registration number NCT00946075 ) . Patients were blinded to treatment allocation . WOMAC Index , SF-12 Health Survey , knee range of motion , and Knee Society scores were collected and compared preoperatively and at 6 , 12 , and 24 months postoperatively . We recorded device failures and complications until October 2009 . Kaplan-Meier survivorship was compared using the log rank test . Twelve retrieved MB devices underwent pathologic analysis . The minimum postoperative time was 2.2 years ( mean , 5.9 years ; range , 2.2–7.9 years ) . Results We found no differences in mean clinical assessment scores or mean score changes from baseline at any postoperative interval through 2 postoperative years . Nineteen of the 252 MB and 13 of the 255 FB knees had undergone revision of any component . Estimated survival at 6 postoperative years was similar for the two devices : 90.1 % ( 95 % confidence interval [ CI ] , 84.1–93.9 ) for MB and 94.2 % ( 95 % CI , 90.1–96.6 ) for FB . Two MB and no FB tibial components were revised for loosening . There was one case of MB insert dislocation . Retrieved MB devices demonstrated no unexpected wear or mechanical device failures . Conclusion We found no evidence of functional advantage of the MB design . Survivorship was similar , although the study is limited by short duration of followup . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"The purpose of this r and omized , single-blind clinical trial was to compare a rotating platform ( RP ) total knee arthroplasty to a fixed-bearing ( FB ) total knee arthroplasty . Ninety-five knees in 69 patients were implanted by 2 surgeons . There were no significant differences in the preoperative demographics . At a minimum of 2-year follow-up , clinical outcomes and complication rates were similar , with the exception that the RP group had significantly better stair-climbing scores ( P = .04 ) . Postoperative range of motion was equally good in both groups ( FB knees , 1 ° -125 ° ; RP knees , 1 - 126 ° ) . There were no bearing dislocations in the RP group . In conclusion , this RP design performs at least as well as the FB version , and the RP patients reported better stair-climbing ability . Enthusiasm for this finding should be tempered by the relatively small sample size",
"The objective of this study was to investigate the range of motion ( ROM ) of the knee before and four years after total knee arthroplasty ( TKA ) with a mobile or fixed type of platform and to prospect ively evaluate whether there was a difference in ligament balance between the platform types . The subjects were 68 patients involving 76 joints . The mobile type was used in 31 joints and fixed type in 45 joints by employing a prospect i ve r and omised method . The passive maximum ROM was measured using a goniometer before and four years after surgery . Also , the intraoperative knee ligament balance was measured . The postoperative extension ROM was significantly improved after TKA using a mobile bearing type compared with that employing a fixed bearing type . In TKA using the former , the intraoperative gap difference was not related to the postoperative flexion angle of the knee . However , they were related in TKA using a fixed bearing type , with a positive correlation regarding the flexion gap",
"The purpose of the current study was to directly compare the results of fixed-bearing and mobile-bearing total knee arthroplasties in the same patient who had bilateral simultaneous total knee replacements . A fixed-bearing total knee prosthesis ( AMK ) was implanted in one knee and a mobile-bearing total knee prosthesis ( LCS ) was implanted in the other knee in 116 patients . The average age of the patients was 65 years ( range , 33–70 years ) . The average followup was 7.4 years ( range , 6–8 years ) . Clinical and radiographic followup was done using Knee Society and Hospital for Special Surgery knee rating systems at 6 weeks , 3 months , 6 months , 1 year after surgery , and yearly thereafter . Total knee score , pain score , mean functional score , and range of motion were comparable in both groups . Two knee replacements ( 2 % ) in one patient with AMK prostheses were revised because of complete wear of tibial bearing polyethylene . One knee replacement ( 1 % ) in one patient with an LCS prosthesis was revised because of dislocation of the medial tibial bearing polyethylene and one knee replacement ( 1 % ) in one patient with an LCS prosthesis was revised because of complete wear of the medial tibial bearing polyethylene . No knee had aseptic loosening or osteolysis in either group . After a minimum followup of 6 years , the results of fixed- and mobile-bearing total knee prostheses in the current series are favorable . However , there is no evidence to prove the superiority of the mobile-bearing total knee design",
"PURPOSE OF THE STUDY Mobile-bearing total knee arthroplasty has become increasingly popular over the last few years since this option presents several theoretical advantages compared with the fixed-bearing models . The clinical advantage remains to be demonstrated . We therefore conducted a prospect i ve r and omized trial to ascertain the potential benefits . MATERIAL AND METHODS This study included patients treated by three senior orthopedic surgeons . Each group included 52 prostheses in 52 patients in the fixed-bearing group and 50 patients in the mobile-bearing group . The per- and postoperative protocol s were the same for both groups . Implants were cemented in all cases and patellae were resurfaced . The SF-12 , the Knee Society Score ( KSS ) , the Hospital of Special Surgery score ( HSS ) and pain and joint motion were noted before and after surgery . RESULTS Among the 104 prostheses implanted , 100 were review ed at mean follow-up of 36 months ( range 24 - 41 ) . One patient in the fixed-bearing group died six months after surgery from an unrelated cause . Three patients were lost to follow-up : one in the fixed-bearing group and two in the mobile-bearing group . There was no difference between groups for the SF-12 , KSS , HSS , pain and joint motion measured postoperatively . Postoperative femorotibial alignment was one degree varus on average in the fixed-bearing group and zero degree in the mobile-bearing group . At last follow-up , there were no radiological signs of prosthesis loosening . One patient in the fixed-bearing group developed a deep venous thrombosis , complicated by pulmonary embolism . Two of the mobile-bearing prostheses were revised , one for patellar fracture caused by a bicycle accident and one for prosthesis infection in a patient with endocarditis 1.5 years after implantation . DISCUSSION The clinical results were similar for the two groups in terms of function , pain , general status and complications . The outcome at 36 months was considered excellent or good in 90 % of the fixed-bearing group and 88 % in the mobile-bearing group . This study did not reveal any difference between the two groups regarding maximal flexion and anterior knee pain , two parameters which would theoretically show short-term improvement with the mobile bearing . Mid- and long-term follow will be required to confirm these findings and to determine the survival of these two types of implants",
"Mobile-bearing ( MB ) total knee arthroplasty ( TKA ) was developed as an alternative to the established fixed-bearing ( FB ) design because of theoretical advantages . Short-term studies comparing these design s have not shown any differences in clinical and radiographic results . We compared the results at 7 years of a r and omised study of patients undergoing TKA using either a FB or a MB variant of the same prosthesis . Fifty-two patients ( 52 knees ) with an average age of 70 years received a FB posterior-stabilized prosthesis , and 50 patients ( 52 knees ) with an average age of 72 years , a MB prosthesis . All implants were cemented and the patella was routinely resurfaced . Preoperatively , there were no differences between the two groups , and surgical procedure and postoperative protocol were the same for both . At an average follow-up of 7.1 years , no significant differences of FB over MB design could be demonstrated with respect to the American Knee Society score ( AKSS ) , pain score , a question naire of general health ( SF-12 score ) , range of motion ( ROM ) , or complication rates . Radiographs showed no significant difference in prosthetic alignment or evidence of loosening . Two knees with a MB design required reoperation , one for persistent joint stiffness and another to treat septic loosening . One patient with a MB prosthesis with signs of tibial component loosening was asymptomatic . We conclude that at mid-term follow-up there is no evidence to prove the superiority of MB over FB TKA with regard to the clinical and radiographic results",
"The purpose of this prospect i ve , r and omized study was to compare the early clinical and functional results of primary total knee arthroplasty using a fixed-bearing ( FB ) and a rotating-platform ( RP ) prosthesis . Outcomes including range of motion ( ROM ) , Knee Society Score , Western Ontario MacMaster ( WOMAC ) , and Short Form-36 ( SF-36 ) were measured preoperatively and at 6 weeks , 3 months , 6 months , 1 year , and 2 years . Radiographic analysis was performed . There were 72 FB and 68 RP knees . The RP group had a greater ROM at 6 weeks and 1 year . This difference was not statistically significant at 2 years . There were no differences in the ROM at any other period . There were no significant differences in Knee Society Score , Short Form-36 , or Western Ontario MacMaster scores at any period . No clinical ly significant differences were noted in the radiographic analysis . The use of a FB or RP design did not affect the early functional outcomes after total knee arthroplasty",
"This study compared the outcome of total knee replacement ( TKR ) in adult patients with fixed- and mobile-bearing prostheses during the first post-operative year and at five years ' follow-up , using gait parameters as a new objective measure . This double-blind r and omised controlled clinical trial included 55 patients with mobile-bearing ( n = 26 ) and fixed-bearing ( n = 29 ) prostheses of the same design , evaluated pre-operatively and post-operatively at six weeks , three months , six months , one year and five years . Each participant undertook two walking trials of 30 m and completed the EuroQol question naire , Western Ontario and McMaster Universities osteoarthritis index , Knee Society score , and visual analogue scales for pain and stiffness . Gait analysis was performed using five miniature angular rate sensors mounted on the trunk ( sacrum ) , each thigh and calf . The study population was divided into two groups according to age ( ≤ 70 years versus > 70 years ) . Improvements in most gait parameters at five years ' follow-up were greater for fixed-bearing TKRs in older patients ( > 70 years ) , and greater for mobile-bearing TKRs in younger patients ( ≤ 70 years ) . These findings should be confirmed by an extended age controlled study , as the ideal choice of prosthesis might depend on the age of the patient at the time of surgery",
"After the introduction of mobile-bearing knee arthroplasty in the late 1970s , he benefits were discussed in comparison to the well-established modular fixed-bearing systems . The hypothetical advantages of mobile-bearing design s are the ability of axial rotation and a greater articular conformity , which reduces significantly fatigue failure of the polyethylene . Biomechanical analyses showed for each system characteristic features , which are not concordant with the aim of restoring normal knee kinematics . In both groups the long-term clinical results were excellent with 10-year survival rates of 95 - 98 % . Ligamentous stability and a perfect operative technique are key factors in mobile-bearing knee arthroplasty . Prospect i ve r and omized clinical trials are necessary to find answers concerning backside and volumetric polyethylene wear and the detrimental effects of wear particle size . Before this is accomplished , the indication for a mobile-bearing knee arthroplasty , especially in young patients , should be carefully considered in each case"
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BACKGROUND Several drugs are approved for the treatment of lower urinary tract symptoms ( LUTS ) in men , but these are mostly used by clinicians as monotherapies . The combination of different compounds , each of which targets a different aspect of LUTS , seems appealing . However , only few clinical trials have evaluated the effects of combination therapies . OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male LUTS . EVIDENCE ACQUISITION PubMed and Cochrane data bases were used to identify clinical trials and meta-analyses on male LUTS combination therapy . The search was restricted to studies of level of evidence ≥ 1b . A total of 49 papers published between January 1988 and March 2012 were identified . EVIDENCE SYNTHESIS The α1-adrenoceptor antagonist (α1-blocker)/5α-reductase inhibitor ( 5-ARI ) combination provides the most data . This combination seems to be more efficacious in terms of several outcome variables in patients whose prostate volume is between 30 ml and 40 ml when treatment is maintained for > 1 yr ; when given for , α1-blockers alone are just as effective . The combination of α1-blocker/5-ARI shows a slightly increased rate of adverse events . It remains unknown whether its safety and superiority over either drug as monotherapy are sustained after > 6 yr . The α1-blocker/muscarinic receptor antagonist ( antimuscarinic ) combination was most frequently assessed as an add-on therapy to already existing α1-blocker therapy . Inconsistent data derive from heterogeneous study population s and different study design s. Currently , the α1-blocker/antimuscarinic combination appears to be a second-line add-on for patients with insufficient symptom relief after monotherapy . The combination seems to be safe in men with postvoid residual 4 mo concerning safety and efficacy of this combination . The α1-blocker/phosphodiesterase type 5 inhibitor combination is a new treatment option with only preliminary reports . More studies are needed before definitive conclusions can be drawn . CONCLUSIONS An α1-blocker/5-ARI combination is beneficial for patients whose prostate volume is between 30 ml and 40 ml when medical treatment is intended for > 1 yr . Based on short-term follow-up studies , add-on of antimuscarinics to α1-blockers is an option when postvoid residual is < 200 ml
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"OBJECTIVE To evaluate the efficacy and tolerability of extended-release oxybutynin in combination with the alpha1-blocker tamsulosin in reducing lower urinary tract symptoms in men . PATIENTS AND METHODS In this multicenter , double-blind trial performed between March 29 , 2004 , and June 22 , 2005 , 420 men aged 45 years or older with a total International Prostate Symptom Score ( IPSS ) of 13 or more and IPSS for storage of 8 or more were r and omized to receive tamsulosin ( 0.4 mg/d ) with either extended-release oxybutynin ( 10 mg/d ) or placebo for 12 weeks . Eligibility requirements included a maximum flow rate of 8 mL/s or more with voided volume of 125 mL or more and a postvoid residual volume of 150 mL or less on 2 occasions . Postvoid residual volume and peak flow rates at weeks 4 , 8 , and 12 were measured . The primary end point was change from baseline in total IPSS after 12 weeks of treatment . Secondary outcomes included change in IPSSs for storage and quality of life . RESULTS Tamsulosin combined with extended-release oxybutynin result ed in significantly greater improvement in total IPSS compared with tamsulosin and placebo after 8 ( P=.03 ) and 12 ( P=.006 ) weeks of treatment , and improved IPSS for storage and quality of life at all assessment points ( P postvoid residual volume higher than 300 mL was 2.9 % ( 6/209 ) in patients receiving combination therapy compared with 0.5 % ( 1/209 ) in patients receiving tamsulosin alone ( P=.12 ) . Occurrence of peak flow rates below 5 mL/s was 3.8 % ( 8/209 ) for combination therapy and 5.7 % ( 12/209 ) for tamsulosin alone ( P=.49 ) . CONCLUSION In men with substantial storage symptoms , combination therapy with tamsulosin and extended-release oxybutynin demonstrated greater efficacy than and comparable safety and tolerability to tamsulosin monotherapy",
"BACKGROUND Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) and prostatic enlargement . OBJECTIVE To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention ( AUR ) , BPH-related surgery , and BPH clinical progression over 4 yr in men at increased risk of progression . DESIGN , SETTING , AND PARTICIPANTS The Combination of Avodart and Tamsulosin ( CombAT ) study was a 4-yr , multicenter , r and omised , double-blind , parallel-group study in 4844 men > or = 50 yr of age with a clinical diagnosis of BPH , International Prostate Symptom Score > or = 12 , prostate volume > or = 30 cm(3 ) , prostate-specific antigen 1.5 - 10 ng/ml , and maximum urinary flow rate ( Q(max ) ) > 5 and or = 125 ml . INTERVENTION Oral daily tamsulosin , 0.4 mg ; dutasteride , 0.5 mg ; or a combination of both . MEASUREMENTS The 4-yr primary end point was time to first AUR or BPH-related surgery . Secondary end points included BPH clinical progression , symptoms , Q(max ) , prostate volume , safety , and tolerability . RESULTS AND LIMITATIONS Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery . Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression . Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr . Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies , with the exception of an imbalance in the composite term of cardiac failure among the three study arms . The lack of placebo control is a study limitation . CONCLUSIONS The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement . CLINICAL TRIALS.GOV IDENTIFIER : NCT00090103 ( http://www . clinical trials.gov/ct2/show/NCT00090103 )",
"This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction ( ED ) and lower urinary tract symptoms secondary to benign prostatic hyperplasia ( BPH/LUTS ) . The trial was conducted in hospitals in Beijing , Shanghai , Changsha , Wuhan and Guangzhou , five major cities in China . A total of 250 patients diagnosed with ED and BPH/LUTS aged 50 - 75 years , and who had International Index of Erection Function-5 ( IIEF-5 ) scores ≤21 and International Prostate Symptom Score ( IPSS ) ≥10 points , were enrolled and r and omly divided into Group A ( 168 cases ; doxazosin GITS 4 mg once daily plus sildenafil 25 - 100 mg on dem and ) and Group B ( 82 cases ; sildenafil 25 - 100 mg on dem and ) . Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life ( QoL ) question naire , and adverse effects were evaluated during the treatment period . There were no statistically significant differences in mean age , and IIEF-5 , IPSS and QoL scores pre-treatment between the two groups . After treatment , IIEF-5 , IPSS and QoL scores were significantly improved in Group A , while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment . There were no significant differences in side effects between the two groups . The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy",
"OBJECTIVES To assess the pharmacodynamic effects of coadministered vardenafil and tamsulosin in patients with benign prostatic hyperplasia ( BPH ) undergoing stable tamsulosin therapy . METHODS In this Phase 1 , placebo-controlled , two-stage , two-way , crossover study , 22 patients undergoing stable ( longer than 4 weeks ) tamsulosin therapy for BPH ( 18 using 0.4 mg and 4 using 0.8 mg tamsulosin daily ) received vardenafil 10 mg ( or placebo ) , followed by vardenafil 20 mg ( or placebo ) , simultaneously with tamsulosin . The mean maximal change from baseline with vardenafil use versus placebo was evaluated for supine and st and ing blood pressure and heart rate for up to 6 hours after dosing . RESULTS In patients receiving vardenafil 10 mg , the mean maximal change from baseline versus placebo in supine systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , and heart rate was -4.5 mm Hg ( 95 % confidence interval [ CI ] -8.2 to -0.8 ) , -2.3 mm Hg ( 95 % CI -4.9 to 0.4 ) , and 3.7 beats per minute ( 95 % CI 1.1 to 6.3 ) , respectively . In patients receiving vardenafil 20 mg , the mean maximal change from baseline versus placebo in supine SBP , DBP , and heart rate was -4.0 mm Hg ( 95 % CI -6.3 to -1.8 ) , -2.9 mm Hg ( 95 % CI -5.6 to -0.2 ) , and 0.8 beats per minute ( 95 % CI -1.2 to 2.9 ) , respectively . These hemodynamic changes were similar to those obtained in the st and ing position . Two placebo patients and 1 vardenafil 10-mg patient had a drop of 20 mm Hg or more in st and ing DBP ; 1 vardenafil 10-mg patient had a st and ing SBP drop of 30 mm Hg or more . No patient exhibited symptomatic hypotension ( SBP less than 85 mm Hg with dizziness ) . Three patients receiving vardenafil 20 mg/tamsulosin 0.4 mg reported dizziness , but never had an SBP of less than 95 mm Hg . No serious adverse events were reported . CONCLUSIONS In this study , no evidence was found that coadministered vardenafil and tamsulosin induced clinical ly significant hypotension in patients with BPH",
"INTRODUCTION The high incidence of erectile dysfunction ( ED ) and lower urinary tract symptoms ( LUTS ) in aging men and the same pathophysiology make probable to treat both disorders with the same treatment . Numerous authors evaluated the actions of PDE5i in improving the LUTS/(benign prostate hyperplasia ) BPH . AIM To assess the efficacy and safety of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day in patients with LUTS in a crossover design study . MAIN OUTCOMES MEASURES International Prostate Symptoms Score ( IPSS ) , IPSS Quality of Life ( IPSS-QOL ) , maximum flow rate ( Qmax ) , post-void residual volume ( PVR ) , International Index of Erectile Function-Erectile Function Domain ( IIEF-EF ) , Global Assessment Quality ( GAQ ) . For the statistical analysis , a Tukey-Kramer multicomparison test was used . METHODS A r and omized , double-blind , crossover study was conducted from September 2007 to February 2008 in one center . Thirty men , older than 50 years old , with a history of LUTS/BPH of at least 6 months , were r and omized into two groups to receive tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day for 45 days , and then switched to the other treatment mode for other 45 days . RESULTS Twenty-seven patients completed the study . Improvements of IPSS score and IPSS-QOL were significant with both treatments but greater with the drug combination . Both regimens similarly improved the Qmax and decreased the PVR volume from baseline ( P tamsulosin alone vs. tamsulosin and tadalafil ( P > 0.05 ) . The IIEF improved with tamsulosin plus tadalafil ( P tamsulosin alone ( P > 0.05 ) . The GAQ showed that all patients preferred the combination scheme . Both treatments were well tolerated . CONCLUSION ; Tamsulosin 0.4 mg/day plus tadalafil 20 mg/day was more effective than tamsulosin 0.4 mg/day alone to improve LUTS and erectile dysfunction and was also well tolerated . Large-scale , r and omized , placebo-controlled studies are needed to further assess the long-term safety and effectiveness of these agents in treating LUTS/BPH with or without ED",
"BACKGROUND We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer , as detected on biopsy , among men who are at increased risk for the disease . METHODS In this 4-year , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study , we compared dutasteride , at a dose of 0.5 mg daily , with placebo . Men were eligible for inclusion in the study if they were 50 to 75 years of age , had a prostate-specific antigen ( PSA ) level of 2.5 to 10.0 ng per milliliter , and had had one negative prostate biopsy ( 6 to 12 cores ) within 6 months before enrollment . Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years . RESULTS Among 6729 men who underwent a biopsy or prostate surgery , cancer was detected in 659 of the 3305 men in the dutasteride group , as compared with 858 of the 3424 men in the placebo group , representing a relative risk reduction with dutasteride of 22.8 % ( 95 % confidence interval , 15.2 to 29.8 ) over the 4-year study period ( P dutasteride group and 233 among 3407 men in the placebo group ( P=0.81 ) . During years 3 and 4 , there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group , as compared with only 1 in the placebo group ( P=0.003 ) . Dutasteride therapy , as compared with placebo , result ed in a reduction in the rate of acute urinary retention ( 1.6 % vs. 6.7 % , a 77.3 % relative reduction ) . The incidence of adverse events was similar to that in studies of dutasteride therapy for benign prostatic hyperplasia , except that in our study , as compared with previous studies , the relative incidence of the composite category of cardiac failure was higher in the dutasteride group than in the placebo group ( 0.7 % [ 30 men ] vs. 0.4 % [ 16 men ] , P=0.03 ) . CONCLUSIONS Over the course of the 4-year study period , dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia . ( Clinical Trials.gov number , NCT00056407 .",
"Purpose Comparison of efficacy of propiverine extended release ( ER ) 30 mg o.d . in the treatment of male OAB administered as monotherapy ( MT ) or add-on to α-blockers ( combination treatment , CT ) in relation to maximum urinary flow ( Qmax ) in a non-interventional study . Methods Men ≥40 years with OAB symptoms , Qmax ≥10 ml/s , prostate volume . OAB symptoms , IPSS , and PVR were recorded before and after 12 weeks of treatment . Participants were stratified by Qmax ( group A ≥15 ml/s , group B CT vs. MT . Safety parameters were monitored . Results A total of 2,219 men participated and were involved in safety analysis ; 1,849 men ( mean age 66 years ) fulfilled the inclusion criteria and were involved in efficacy analysis . In group A , 291 men received MT and 479 CT ; in group B , 184 men received MT and 895 CT . OAB symptoms improved significantly in all groups throughout the study without differences between MT and CT . IPSS improvement in group B was less with MT than with CT ( −3.9 vs. −5.2 ; P ) , whereas IPSS improvement was similar in group A ( −4.6 vs. −5.1 ) . Mean PVR change was not clinical ly relevant , but two men ( 0.1 % ) experienced urinary retention . Conclusions Under real-life conditions , treatment of OAB symptoms with propiverine ER is equally effective in men with MT or CT regardless of baseline Qmax . In men with reduced Qmax , IPSS improvement is significantly smaller with MT . The incidence of urinary retention during propiverine ER treatment is low",
"OBJECTIVE In the treatment of the symptoms of benign prostatic hyperplasia ( BPH ) , a French guideline opposes the use of drugs in conjunction , in the absence of proven utility . The OCOS trial therefore compared one of the possible drug combinations ( tamsulosin and Serenoa repens ) with tamsulosin alone , to see if there was any difference in effectiveness and to evaluate the clinical tolerance of each in patients with symptoms of BPH . MATERIAL AND METHODS In this double-blind , r and omised trial , patients had to have an IPSS ( International Prostate Symptom Score ) > or = 13 and a Qmax between 7 and 15 mL/s . Tamsulosin ( 0.4 mg ) was to be administered once a day for 52 weeks , with , twice daily , a placebo ( TAM ) or Serenoa repens 160 mg ( TAM + SR ) . RESULTS 352 patients were recruited by 47 centres ; 329 ( average age 65 ) were r and omised : 161 into the TAM group and 168 into the TAM + SR group . No statistically significant difference was found between the two groups , neither for the major end-point [ change in total IPSS between the baseline value and the final evaluation ( TAM : -5.2 ; TAM + SR : -6.0 ; p = 0.286 ) ] , nor for the secondary end-points [ changes in the voiding scores ( p = 0.239 ) and in filling scores ( p = 0.475 ) of the IPSS , Qmax ( p = 0.564 ) , percentage of respondents according to the IPSS ( p = 0.361 ) , improvement in quality of life ( IPSS-QoL : p = 0.091 ; UROLIFE BPH QoL : p = 0.442 ) , safety ] . CONCLUSION The addition of Serenoa repens to tamsulosin did not provide any significant benefit to the patients : the OCOS trial does not cast doubt on the guideline applicable to the treatment of BPH",
"PURPOSE VICTOR was a 12-week , double-blind , placebo controlled trial assessing the safety and tolerability of solifenacin plus tamsulosin in men with residual overactive bladder symptoms after tamsulosin monotherapy . Efficacy of solifenacin plus tamsulosin vs placebo plus tamsulosin was also evaluated . MATERIAL S AND METHODS A total of 398 men 45 years old or older were r and omized to 12 weeks of solifenacin plus tamsulosin or placebo plus tamsulosin once daily . The study population had 8 or more micturitions per 24 hours and 1 or more urgency episode per 24 hours after taking tamsulosin for 4 or more weeks , a total International Prostate Symptom Score of 13 or greater , a Patient Perception of Bladder Condition score of 3 or greater , a post-void residual of 200 ml or less and a peak flow rate of 5 ml per second or greater . Adverse events were monitored throughout the study . The primary efficacy end point was mean change from baseline to week 12 in micturitions per 24 hours . Secondary measures included mean change in urgency episodes per 24 hours , and changes in Patient Perception of Bladder Condition , Urgency Perception Scale and total International Prostate Symptom Scores . RESULTS The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth ( 7 % and 3 % , respectively ) and dizziness ( 3 % and 2 % , respectively ) . Of the patients on solifenacin plus tamsulosin 7 ( 3 % ) reported retention and 3 required catheterization . No patients on placebo plus tamsulosin reported retention . Patients on solifenacin plus tamsulosin vs placebo plus tamsulosin showed larger reductions in frequency but not of statistical significance ( -1.05 vs -0.67 , p = 0.135 ) . However , patients on solifenacin plus tamsulosin vs placebo plus tamsulosin did show statistically significant reductions in urgency ( -2.18 vs -1.10 , p Solifenacin plus tamsulosin was well tolerated . There was a low incidence of urinary retention requiring catheterization . At week 12 solifenacin plus tamsulosin decreased daily micturitions and urgency episodes . Only urgency reached statistical significance vs placebo plus tamsulosin ",
"OBJECTIVES This pilot study was undertaken to assess the efficacy and safety of the alpha(1)-blocker alfuzosin 10 mg once daily ( OD ) , the PDE-5 inhibitor sildenafil 25 mg OD , and the combination of both on lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) and erectile dysfunction ( ED ) . MATERIAL AND METHODS Men aged 50 - 76 yr with previously untreated LUTS and ED were r and omized to receive alfuzosin ( n=20 ) , sildenafil ( n=21 ) , or the combination of both ( n=21 ) for 12 wk . Changes from baseline in International Prostate Symptom Score ( IPSS ) , voiding diary , maximum urinary flow rate ( Qmax ) , postvoid residual urine ( PVRU ) volume , and erectile function domain of the International Index of Erectile Function ( IIEF ) were assessed at week 12 . RESULTS Improvement of IPSS was significant with the three treatments but greatest with the combination ( -24.1 % ) compared with alfuzosin ( -15.6 % ) and sildenafil ( -11.8 % ) [ corrected ] alone ( p Frequency , nocturia , PVR , and Qmax were significantly improved with alfuzosin only and the combination . Improvement in IIEF was slight with alfuzosin ( 16.7 % ) , marked with sildenafil ( 49.7 % ) , and greatest with the combination ( 58.6 % ) . Likewise , increases in the frequency of penetration ( Q3 ) and of maintained erection ( Q4 ) were greater with the combination therapy ( 65.2 % and 68.2 % , respectively ) than with sildenafil ( 41.7 % and 59.1 % , respectively ) and alfuzosin ( 27.3 % and 33.3 % , respectively ) alone . All three treatments were well tolerated . CONCLUSIONS In this pilot study , the combination of alfuzosin 10 mg OD and sildenafil 25 mg OD is safe and more effective than monotherapy with either agent to improve both voiding and sexual dysfunction in men with LUTS suggestive of BPH",
"PURPOSE We evaluated the efficacy and safety of a therapeutic modality involving propiverine combined with doxazosin in patients with overactive bladder ( OAB ) and benign prostatic obstruction . MATERIAL S AND METHODS Men 50 years or older with OAB symptoms and urodynamically proven bladder outlet obstruction ( Abrams-Griffith score greater than 20 ) were r and omized ( 1:2 ) into 2 groups , namely group 1-doxazosin controlled release gastrointestinal therapeutic system formulation ( 4 mg once daily ) only and group 2-propiverine hydrochloride ( 20 mg once daily ) plus doxazosin controlled release gastrointestinal therapeutic system formulation for an 8-week treatment regimen . RESULTS A total of 211 men , including 69 in group 1 and 142 in group 2 , were treated and 198 ( 93.8 % ) completed the 8 weeks of treatment . Significant improvements were noted in each group after treatment in urinary frequency , maximum flow rate , average micturition volume and International Prostate Symptom Score . Compared with group 1 improvement rates with regard to urinary frequency ( 23.5 % vs 14.3 % , p = 0.004 ) , average micturition volume ( 32.3 % vs 19.2 % , p = 0.004 ) , and storage ( 41.3 % vs 32.6 % , p = 0.029 ) and urgency ( p = 0.019 ) International Prostate Symptom Score symptoms were more significant in group 2 . Post-void residual urine was found to be significantly increased only in group 2 but this was not accompanied by urinary retention . Patient satisfaction rates were found to be significantly higher in group 2 than in group 1 ( p = 0.002 ) . Overall adverse event rates were higher in group 2 ( p = 0.002 ) , although discontinuation rates and discontinuation rates due to adverse events were not different between the 2 groups . CONCLUSIONS This study reveals that combination therapy consisting of alpha1-adrenoceptor antagonists with antimuscarinics represents an effective and relatively safe treatment modality in select patients with OAB coexisting with benign prostatic obstruction",
"Although ethnicity-based differences in prostate size and physiology have been reported , results of benign prostatic hyperplasia ( BPH ) treatment trials in predominantly Caucasian patients are assumed to be applicable to non-Caucasian population s. This post hoc analysis investigated whether an Asian sub population of men with moderate-to-severe BPH in the CombAT study achieves treatment responses in line with those of the overall study population . In this double-blind , r and omized , parallel-group trial , 325 Asian men were assigned to treatment with 0.5 mg dutasteride once daily , 0.4 mg tamsulosin once daily or the combination . Decrease in international prostate symptom score ( IPSS ) at month 24 from baseline ( the primary endpoint ) was significantly greater with combination treatment compared with tamsulosin ( P with dutasteride . Mean IPSS was reduced from baseline by 7.5 ( ±0.84 ) in the combination group , by 6.3 ( ±0.86 ) in the dutasteride group and by 4.5 ( ±0.78 ) in the tamsulosin group , result ing in respective mean IPSS at months 24 of 11.4 ( ±0.60 ) , 12.7 ( ±0.70 ) and 14.3 ( ±0.74 ) . The adverse event profile was similar to that observed in the overall CombAT population , and drug-related adverse events were more common with combination therapy ( 26 % ) than with tamsulosin ( 15 % ) or dutasteride ( 9 % ) . No unexpected adverse events emerged . In conclusion , in Asian men with moderate-to-severe lower urinary tract symptoms and an enlarged prostate , combination therapy achieved significantly greater improvements from baseline BPH symptoms , flow rate , quality of life , reduced prostate volume and improved treatment satisfaction compared with tamsulosin monotherapy ",
"PURPOSE We evaluated the effectiveness of single or combination drug therapy on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 3,047 men with lower urinary tract symptoms/benign prostatic hyperplasia enrolled in the Medical Therapy of Prostatic Symptoms trial were r and omly assigned to receive doxazosin alone , finasteride alone , combination therapy or placebo . Treatment effectiveness was assessed according to intent to treat by mean reduction in self-reported nightly nocturia at 1 and 4 years . A subgroup analysis by age ( younger than 70 vs 70 years old or older ) was also performed . RESULTS Of the men 2,583 reported 1 or more episodes of nocturia and finished 12 or more months of the trial . Mean nocturia was similar in all groups at baseline . Mean nocturia was reduced at 1 year by 0.35 , 0.40 , 0.54 and 0.58 in the placebo , finasteride , doxazosin and combination groups , respectively . Reductions with doxazosin and combination therapy were statistically greater than with placebo ( p nocturia was also significantly reduced in patients treated with doxazosin and combination therapy ( p ) . In men older than 70 years ( 495 ) all drugs significantly reduced nocturia at 1 year ( finasteride 0.29 , doxazosin 0.46 and combination 0.42 ) compared to placebo ( 0.11 , p Doxazosin and combination therapy reduced nocturia more than placebo , but the net benefit of active drug compared to placebo was often modest with a net difference of less than 0.20 fewer nightly nocturia episodes at 1 and 4 years . Findings in men 70 years old or older were similar , with an even smaller effect observed for finasteride",
"PURPOSE We evaluated the efficacy of tolterodine extended release and /or tamsulosin on micturition related urgency episodes , urgency severity and patient reported outcomes in men who met entry criteria for prostatic enlargement and overactive bladder trials . MATERIAL S AND METHODS Men 40 years old or older with an International Prostate Symptom Score of 12 or greater , frequency ( 8 or more voids per 24 hours ) and urgency ( 3 or more episodes per 24 hours ) with or without urgency urinary incontinence were r and omized to placebo , 4 mg tolterodine extended release , 0.4 mg tamsulosin or tolterodine extended release plus tamsulosin for 12 weeks . Subjects completed 5-day diaries ; the Patient Perception of Bladder Condition and Urgency Perception Scale at baseline , and weeks 1 , 6 and 12 ; Overactive Bladder Question naire at baseline , and weeks 6 and 12 ; Perception of Treatment Satisfaction question at weeks 1 , 6 and 12 ; and Willingness to Continue question at week 12 . Subjects rated the urgency associated with each micturition on a 5-point scale and micturition related urgency episodes were those rated 3 or greater . Urgency severity was measured using frequency-urgency sum , defined as the sum of urgency ratings for all micturitions . RESULTS Compared with placebo , tolterodine extended release plus tamsulosin significantly reduced daytime and nocturnal micturition related urgency episodes as well as frequency-urgency sum at weeks 1 , 6 and 12 . It also improved Patient Perception of Bladder Condition scores at weeks 1 , 6 and 12 ; improved Urgency Perception Scale and Overactive Bladder Question naire , Symptom Bother and Health Related Quality of Life scores at weeks 6 and 12 ; and increased the percentage of subjects who reported treatment satisfaction at weeks 6 and 12 , and willingness to continue at week 12 . CONCLUSIONS Treatment with tolterodine extended release plus tamsulosin significantly improved urgency variables and patient reported outcomes in men meeting entry criteria for overactive bladder and prostatic enlargement trials ",
"PURPOSE We examined data from the Medical Therapy of Prostatic Symptoms trial to determine the relationship between baseline TPV and the effect of medical therapy in men with LUTS secondary to BPH . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to placebo , 4 to 8 mg doxazosin , 5 mg finasteride or the combination of doxazosin and finasteride . Average treatment duration was 4.5 years The primary outcome was time to overall clinical progression of BPH , defined as a confirmed 4 point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency or recurrent urinary tract infection . Secondary outcomes were the need for invasive therapy for BPH , and changes in AUA SS and the maximum urinary flow rate with time . TPV was measured by transrectal ultrasound at baseline and study end . RESULTS In patients with a small prostate ( baseline TPV less than 25 ml ) combination therapy was no better than doxazosin alone for decreasing the risk of clinical progression of BPH and need for invasive therapy as well as improving AUA SS and the maximum urinary flow rate . However , in patients with moderate size ( 25 to less than 40 ml ) or enlarged ( 40 ml or greater ) gl and s combination therapy led to a clinical benefit in these outcomes that was superior to that of doxazosin or finasteride . CONCLUSIONS Combination therapy with doxazosin and finasteride led to a greater decrease in the risk of clinical progression of BPH than either drug alone in patients with LUTS with a baseline TPV of 25 ml or greater",
"OBJECTIVES TAABO was a r and omized , controlled trial to evaluate the efficacy and safety of combination therapy of tamsulosin ( TAM ) with propiverine ( PROP ) in men with both benign prostatic hyperplasia and overactive bladder . METHODS It enrolled men 50 years or older who had an international prostate symptom score ( IPSS ) of 8 or higher , an urgency item score of 1 or higher , and a quality of life ( QOL ) score of 2 or higher . After 8 weeks of TAM 0.2 mg/day , patients who met the inclusion criteria ( 8 micturitions per 24 h and 1 urgency per 24 h , evaluated by bladder diary ) and were eligible for 12-weeks of continued Treatment II . Five hundred and fifteen patients were enrolled . Thereafter , 214 patients were assigned r and omly to receive either TAM alone ( n = 67 ) , TAM plus PROP 10 mg ( n = 72 ) , or TAM plus PROP 20 mg ( n = 75 ) in Treatment II . The primary efficacy end point was a change in micturitions per 24 h documented in the bladder diary . The change from baseline in urgency episodes per 24 h , IPSS , IPSS/QOL subscore , urinary flow rate and postvoid residual volume were assessed as secondary efficacy measures . RESULTS A total of 141 men ( 47 TAM , 49 TAM plus PROP 10 mg , and 45 TAM plus PROP 20 mg patients ) were assessed by week 12 . Compared with the TAM , TAM plus PROP 10 mg patients experienced significantly fewer micturitions ( P = 0.0261 ) , urgencies ( P = 0.0093 ) per 24 h , lower IPSS storage ( P = 0.0465 ) , and IPSS urgency ( P = 0.0252 ) subscores . CONCLUSIONS These results suggest that combining TAM and 10 mg of PROP for 12 weeks provides added benefit for men with both benign prostatic hyperplasia and overactive bladder",
"Objectives : To assess the additive benefit of combining an α1-blocker and a 5α-reductase inhibitor . Methods : This European , r and omized , double-blind , multicenter trial involved 1.051 patients with lower urinary tract symptoms related to benign prostatic hyperplasia . Patients received sustained release ( SR ) alfuzosin ( n = 358 ) , a selective α1-blocker given at a dose of 5 mg twice daily without dose titration ; finasteride ( n = 344 ) , 5 mg once daily , or both drugs ( n = 349 ) , for 6 months . Primary efficacy criteria were symptomatic improvement ( International Prostate Symptom Score : I-PSS ) and maximum flow rate ( Qmax ) . Safety was assessed by monitoring adverse events . Results : Symptomatic improvement was significantly higher from the 1st month of treatment with SR alfuzosin , alone or in combination ; mean changes in I-PSS versus baseline at end-point were –6.3 and –6.1 , respectively , compared with –5.2 with finasteride alone ( SR alfuzosin vs. finasteride , p = 0.01 ; combination vs. finasteride , p = 0.03 ) . The percentages of patients with a decrease in I-PSS of at least 50 % were 43 , 42 and 33 % for SR alfuzosin , the combination and finasteride , respectively ( SR alfuzosin vs. finasteride , p = 0.008 ; combination vs. finasteride , p = 0.009 ) . In the overall population , increases in Qmax were greater with SR alfuzosin and the combination , compared with finasteride alone after 1 month of therapy , but changes at end-point were similar in the three treatment groups . In those 47 % of patients likely to be obstructed ( baseline Qmax however , mean increases in Qmax were significantly higher with SR alfuzosin , alone or in combination , whatever the visit . Finasteride , alone or in combination , significantly impaired sexual function . The incidence of postural symptoms was low and similar in the three treatment groups . Conclusion : In this 6-month trial , SR alfuzosin was more effective than finasteride , with no additional benefit in combining both drugs",
"OBJECTIVE To investigate the effect of combination therapy with dutasteride plus tamsulosin compared with each monotherapy on patient-reported health outcomes over 4 years in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) because of benign prostatic hyperplasia ( BPH ) . METHODS CombAT was a 4-year international , double-blind , r and omised , parallel-group trial in men ( n = 4844 ) with moderate-to-severe symptoms of BPH and at increased risk of disease progression [ age > or = 50 years , International Prostate Symptom Score ( IPSS ) > or = 12 , prostate volume > or = 30 cc , serum prostate-specific antigen > or = 1.5 ng/ml to or = 125 ml ] . Subjects were r and omised to receive 0.5 mg dutasteride , 0.4 mg tamsulosin or the combination once daily for 4 years . The primary endpoint at 4 years was the time to event and proportion of subjects with acute urinary retention or undergoing BPH-related prostate surgery . Secondary endpoints included the health- outcomes measures , BPH Impact Index ( BII ) , IPSS question 8 ( IPSS Q8 ) and the Patient Perception of Study Medication ( PPSM ) question naire . RESULTS At 4 years , combination therapy result ed in significantly superior improvements from baseline in BII and IPSS Q8 than either monotherapy ; these benefits were observed from 3 months onwards compared with dutasteride and from 9 months ( BII ) or 12 months ( IPSS Q8 ) onwards compared with tamsulosin . Also at 4 years , the PPSM question naire showed that a significantly higher proportion of patients was satisfied with , and would request treatment with , combination therapy compared with either monotherapy . CONCLUSIONS Combination therapy ( dutasteride plus tamsulosin ) provides significantly superior improvements in patient-reported quality of life and treatment satisfaction than either monotherapy at 4 years in men with moderate-to-severe BPH symptoms",
"The recent introduction of selective alpha-adrenoceptor blockers adds a further therapeutic option for the treatment of benign prostatic hyperplasia ( BPH ) . Tamsulosin , a selective alpha 1-blocker , has proved effective in relieving irritative and obstructive symptoms caused by BPH . To investigate whether the combination of tamsulosin with the anti- and rogenic drug chlormadinone is of further therapeutic benefit , 80 patients r and omly received tamsulosin 0.2 mg daily , chlormadinone 50 mg daily or a combination of tamsulosin 0.2 mg and chlormadinone 50 mg daily for 16 weeks . Greater improvement in subjective symptoms of BPH was obtained with either tamsulosin alone or in combination with chlormadinone than with chlormadinone alone . However , the greatest improvement in objective uroflowmetric data was obtained with chlormadinone in combination with tamsulosin . Thus , the combination of tamsulosin with chlormadinone appears to be more beneficial than either of these agents used as monotherapy . Further investigation is required to fully evaluate the therapeutic effects of this combination . After the trial period one-third of the chlormadinone and tamsulosin/chlormadinone-treated patients needed no further treatment due to the satisfactory relief of symptoms . At 12 months follow-up , however , one-fourth of the patients had undergone transurethral resection of the prostate ( TUR-P ) regardless of medication . This suggests a limitation of the medical treatment of BPH",
"PURPOSE We measured the detailed hemodynamic effects of tamsulosin and sildenafil separately and together in patients with benign prostatic enlargement . MATERIAL S AND METHODS The supine effects of and responses to passive orthostasis ( 60 degrees for 8 minutes ) were measured in 16 patients with benign prostatic enlargement with the finger blood pressure method and whole-body impedance cardiography . The medications , 100 mg sildenafil ( single doses ) and 0.4 mg tamsulosin ( once daily for up to 14 days ) , were administered in a r and omized , double-blind , crossover fashion . RESULTS Supine systolic arterial pressure decreased with sildenafil ( mean + /- SEM -11 + /- 2 mm Hg ) and sildenafil plus tamsulosin ( -14 + /- 2 mm Hg ) more than with placebo ( -2 + /- 4 mm Hg , p placebo sildenafil plus tamsulosin decreased the systemic vascular resistance index ( 328 + /- 129 vs -241 + /- 134 dyn.sec/cm.m , p = 0.01 ) . Tamsulosin alone did not cause any significant changes in comparison to placebo . Heart rate , diastolic arterial pressure , stroke index , cardiac index and arterial pulse wave velocity were not affected to a statistically significant degree by any of the treatments compared to placebo . Upon head-up tilt the drugs caused only 1 significant change in that diastolic arterial pressure was significantly higher ( -2.7 vs -8.0 mm Hg , p = 0.04 ) in the placebo group than in the tamsulosin plus sildenafil group . CONCLUSIONS Tamsulosin does not disturb hemodynamics in patients with benign prostatic enlargement . Sildenafil decreases blood pressure with the patient supine but not during head-up tilt . The combination treatment also decreases the systemic vascular resistance index in the supine position",
"OBJECTIVE To compare the efficacy and safety of a combination therapy , doxazosin plus tenoxicam , and doxazosin alone for lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) , as various combination therapies increase the efficacy of medical therapy . Alpha blocker agents have been widely used for the treatment of LUTS secondary to BPH . METHOD Fifty-seven patients complaining of LUTS secondary to BPH were enrolled in this clinical trial . Patients were r and omly assigned to receive doxazosin 4 mg or doxazosin 4 mg plus tenoxicam 20 mg treatment . Patients were evaluated for BPH according to the European Association of Urology and American Urological Association clinical guidelines . In addition , patients were assessed with Overactive Bladder Symptom Score ( OABSS ) and International Index of Erectile Function ( IIEF ) . Patients were reevaluated after a 6-week treatment course . The International Prostatic Symptom Score ( IPSS ) , IPSS- Quality of Life ( IPSS-QoL ) , maximal urinary flow rates ( Q(max ) ) , and average urinary flow rates ( AFR ) were determined at baseline and again at 6 weeks as efficacy parameters . RESULTS The total IPSS , IPSS-QoL , and OABSS decreased significantly in both tenoxicam plus doxazosin group and doxazosin alone group compared with baseline ( P Q(max ) and AFR significantly improved in both groups ( P IPSS , IPSS-QoL , and OABSS were significantly better in patients treated with combination therapy ( P < .05 ) . CONCLUSIONS COX-2 inhibitors in combination with an alpha blocker may increase the effectiveness of the therapy for LUTS secondary to BPH without significant effects on side effect profile",
"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 To evaluate the efficacy and tolerability of the selective alpha(1)-adrenergic antagonist doxazosin and the 5-alpha-reductase inhibitor finasteride , alone and in combination , for the symptomatic treatment of benign prostatic hyperplasia . METHODS In a prospect i ve , double-blind , placebo-controlled trial , 1095 men aged 50 to 80 years were r and omized to treatment for 52 weeks with doxazosin , finasteride , the combination of doxazosin and finasteride , or placebo . The dose of finasteride ( or its matched placebo ) was 5 mg/day . Doxazosin ( or its matched placebo ) was initiated at 1 mg/day , and titrated up to a maximum of 8 mg/day over approximately 10 weeks according to the response of the maximal urinary flow rate ( Qmax ) and International Prostate Symptom Score ( IPSS ) . The IPSS and Qmax were assessed at baseline and at weeks 10 , 14 , 26 , 39 , and 52 or at the endpoint . RESULTS An intent-to-treat analysis of 1007 men showed doxazosin and doxazosin plus finasteride combination therapy produced statistically significant improvements in total IPSS and Qmax compared with placebo and finasteride alone ( P total IPSS and Qmax . All treatments were generally well tolerated . CONCLUSIONS Doxazosin was effective in improving urinary symptoms and urinary flow rate in men with benign prostatic hyperplasia , and was more effective than finasteride alone or placebo . The addition of finasteride did not provide further benefit to that achieved with doxazosin alone",
"BACKGROUND Some men receiving alpha-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder ( OAB ) . OBJECTIVE To evaluate the efficacy of tolterodine extended release ( ER ) in men on alpha-blocker therapy . DESIGN , SETTING , AND PARTICIPANTS This double-blind trial included men aged > or = 40 yr with frequency , urgency , and at least moderate problems reported on the Patient Perception of Bladder Condition ( PPBC ) , despite being on a stable dose of alpha-blocker for > or = 1 mo . INTERVENTIONS Subjects were r and omized to tolterodine ER 4 mg per day or placebo for 12 wk while continuing their prescribed alpha-blocker therapy . MEASUREMENTS At baseline and week 12 , subjects completed the PPBC , International Prostate Symptom Score ( IPSS ) , Overactive Bladder Question naire ( OAB-q ) , and 5-d bladder diaries using the five-point Urinary Sensation Scale ( USS ) . Frequency-urgency sum was defined as the sum of USS ratings for all micturitions . RESULTS AND LIMITATIONS PPBC improvement from baseline to week 12 was reported by 63.6 % and 61.6 % of subjects receiving tolterodine ER plus alpha-blocker and placebo plus alpha-blocker , respectively ; this treatment difference , which was the primary end point , was not statistically significant ( p>0.6699 ) . At week 12 , subjects receiving tolterodine ER plus alpha-blocker had significantly greater improvements versus placebo plus alpha-blocker in 24-h micturitions ( -1.8 vs -1.2 ; p=0.0079 ) and daytime micturitions ( -1.3 vs -0.8 ; p=0.0123 ) ; 24-h urgency episodes ( -2.9 vs -1.8 ; p=0.0010 ) , daytime urgency episodes ( -2.2 vs -1.4 ; p=0.0017 ) , and nocturnal urgency episodes ( -0.5 vs -0.3 ; p=0.0378 ) ; frequency-urgency sum ( -7.8 vs -5.1 ; p=0.0065 ) ; IPSS storage subscale ( -2.6 vs -2.1 ; p=0.0370 ) ; and OAB-q symptom bother scale ( -17.9 vs -14.4 ; p=0.0086 ) and coping domain ( 15.4 vs 12.4 ; p=0.0491 ) . Acute urinary retention requiring catheterization occurred in residual volume or maximum urinary flow rate . CONCLUSIONS Men with bothersome OAB symptoms despite continued alpha-blocker therapy showed significantly greater improvements in diary variables , IPSS Storage scores , and symptom bother when receiving additional tolterodine ER versus placebo plus alpha-blocker",
"OBJECTIVE Estimate the prevalence of urinary incontinence ( UI ) , overactive bladder ( OAB ) , and other lower urinary tract symptoms ( LUTS ) among men and women in five countries using the 2002 International Continence Society ( ICS ) definitions . METHODS This population -based , cross-sectional survey was conducted between April and December 2005 in Canada , Germany , Italy , Sweden , and the United Kingdom using computer-assisted telephone interviews . A r and om sample of men and women aged > /= 18 yr residing in the five countries and who were representative of the general population s in these countries was selected . Using 2002 ICS definitions , the prevalence estimates of storage , voiding , and postmicturition LUTS were calculated . Data were stratified by country , age cohort , and gender . RESULTS A total of 19,165 individuals agreed to participate ; 64.3 % reported at least one LUTS . Nocturia was the most prevalent LUTS ( men , 48.6 % ; women , 54.5 % ) . The prevalence of storage LUTS ( men , 51.3 % ; women , 59.2 % ) was greater than that for voiding ( men , 25.7 % ; women , 19.5 % ) and postmicturition ( men , 16.9 % ; women , 14.2 % ) symptoms combined . The overall prevalence of OAB was 11.8 % ; rates were similar in men and women and increased with age . OAB was more prevalent than all types of UI combined ( 9.4 % ) . CONCLUSIONS The EPIC study is the largest population -based survey to assess prevalence rates of OAB , UI , and other LUTS in five countries . To date , this is the first study to evaluate these symptoms simultaneously using the 2002 ICS definitions . The results indicate that these symptoms are highly prevalent in the countries surveyed",
"PURPOSE We evaluate the efficacy of medical therapy on nocturia in men with benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS We performed a secondary analysis of data from the VA Cooperative Study Program Trial in which 1,229 men with BPH 45 to 80 years old were r and omly assigned to receive terazosin , finasteride , combination or placebo . RESULTS The 1,078 men who completed 12 months of the trial are included in this study . Of those men 1,040 ( 96.5 % ) had at least 1 episode of nocturia at baseline and 38 ( 3.5 % ) had less than 1 episode ( baseline nocturia is an average of 2 measures ) . Of those 1,040 men 788 ( 75.8 % ) had 2 or more nocturia episodes . Overall , nocturia decreased from a baseline mean of 2.5 to 1.8 , 2.1 , 2.0 and 2.1 episodes in the terazosin , finasteride , combination and placebo groups , respectively . Of men with 2 or more episodes of nocturia 50 % reduction in nocturia was seen in 39 % , 25 % , 32 % and 22 % in the terazosin , finasteride , combination and placebo groups , respectively . Changes in nocturia were correlated with changes in reported bother from nocturia ( Pearson correlation 0.48 ) , BPH impact index ( 0.32 ) and overall satisfaction with urinary symptoms ( 0.33 ) . CONCLUSIONS Terazosin and combination therapy reduced nocturia in men with BPH , yet the net advantage of terazosin over placebo was a net reduction of 0.3 nocturia episode . For a person to reach a 50 % or greater reduction in nocturia , the advantage of terazosin over placebo was 17 percentage points . Changes in nocturia had a moderate impact on symptom specific quality of life measures",
" This article reports the results of a post hoc analysis of the multicenter , r and omized , double-blind Combination of Avodart and Tamsulosin ( CombAT ) study , which aim ed to investigate the effects of dutasteride ( 0.5 mg ) , tamsulosin ( 0.4 mg ) , and their combination on storage and voiding symptoms in 4844 men aged ⩾50 years with moderate-to-severe lower urinary tract symptoms ( International Prostate Symptom Score ⩾12 ) , prostate volume ( PV ) ⩾30 cm3 and PSA 1.5–10 ng ml−1 . After 24 months , combination treatment achieved significantly greater mean reductions in both voiding and storage symptoms than either monotherapy , in each of the three baseline PV tertiles ( 30 to ) . Dutasteride was as effective as tamsulosin for control of storage symptoms , but provided significantly greater relief of voiding symptoms than tamsulosin",
"Purpose To evaluate the efficacy of sildenafil citrate only , 25 mg . Four times/week , tamsulosin only , 0.4 mg once daily , and the combination of both on lower urinary tract symptoms ( LUTS ) suggestive of benign prostate hyperplasia ( BPH ) and erectile dysfunction . Methods A total of 60 men with BPH-related LUTS were r and omized to receive sildenafil citrate only ( n = 20 ) , tamsulosin only ( n = 20 ) , and the combination of both ( n = 20 ) for 8 weeks . Changes from baseline in International Prostate Symptom Score ( IPSS ) , maximum urinary flow rate ( Qmax ) , post voiding residual urine volume ( PRV ) , Sexual Health Inventory for Male ( SHIM ) score , 3rd and 4th questions of International Index of Erectile Function ( IIEF ) were assessed at the end of the treatment . Results The mean age was 58 years . IPSS , Qmax , PRV , SHIM scores , and 3rd and 4th questions in IIEF significantly improved in each group . Improvement of IPSS was more remarkable in combination ( 40.1 % ) and tamsulosin only ( 36.2 % ) groups in comparison with sildenafil citrate only group ( 28.2 % ; p of Qmax and PRV were greater in tamsulosin only and combination than sildenafil citrate only group . SHIM scores significantly improved in sildenafil citrate only ( 65 % ) and combination ( 67.4 % ) than tamsulosin only ( 12.4 % ; p the 3rd and 4th questions of IIEF were greater in sildenafil only and combination than tamsulosin only ( p combination of tamsulosin only and sildenafil citrate only was not superior to tamsulosin only to enhance voiding symptoms . Also , sexual function improvement was similar for both the combination and sildenafil citrate only treatments",
"Study Type – Symptom prevalence ( prospect i ve cohort",
"PURPOSE Tadalafil , a phosphodiesterase type 5 inhibitor , is effective therapy for erectile dysfunction ( ED ) . Men with ED have a high incidence of comorbid conditions including cardiovascular disease , diabetes mellitus and benign prostatic hyperplasia . Although phosphodiesterase type 5 inhibitors are safe when administered with most medications , sildenafil given with doxazosin and vardenafil given with terazosin evoke orthostatic hypotension in some patients . We examined the hemodynamic interactions of tadalafil with the alpha-blockers doxazosin and tamsulosin . MATERIAL S AND METHODS In separate double-blind , placebo controlled , r and omized crossover studies ( 18 patients in each study ) we evaluated the hemodynamic effects of doxazosin 8 mg with tadalafil 20 mg , and tamsulosin 0.4 mg with tadalafil 10 and 20 mg . Blood pressure ( BP ) and heart rate were recorded before dosing and for 24 hours after dosing . RESULTS Tadalafil 20 mg augmented the hypotensive effect of doxazosin by producing a mean maximal decrease in st and ing systolic BP ( SBP ) that was significantly greater than placebo ( a mean difference of 9.8 mm Hg ) . Analysis of BP outliers showed that the number of subjects with a st and ing SBP of less than 85 mm Hg was greater after doxazosin plus tadalafil ( 28 % ) versus doxazosin plus placebo ( 6 % ) . In subjects on tamsulosin , tadalafil 10 and 20 mg produced mean maximal decreases in st and ing SBP that were similar to placebo ( mean difference of 1.7 and 2.3 mm Hg , respectively ) . No subject taking tamsulosin had a decrease in st and ing SBP less than 85 mm Hg . CONCLUSIONS Tadalafil augmented the hypotensive effects of doxazosin but had little hemodynamic interaction with tamsulosin . In patients taking tadalafil for ED , tamsulosin 0.4 mg may be given for the treatment of benign prostatic hyperplasia ",
"OBJECTIVES To assess the efficacy and safety of solifenacin add-on therapy to tamsulosin in lower urinary tract symptoms ( LUTS ) men with residual overactive bladder ( OAB ) symptoms despite tamsulosin monotherapy . METHODS In this r and omized , multicenter , double-blind study , male LUTS patients aged≥50 years with urgency episodes/24 hours≥2 and micturitions/24 hours≥8 were r and omized to 3 groups : 12-weeks tamsulosin plus placebo ( TAM+PBO ) , tamsulosin plus solifenacin 2.5 mg ( TAM+SOL ) , and tamsulosin plus solifenacin 5 mg ( TAM+SOL ) . Changes from baseline to end of treatment in the number of urgency episodes/24 hours ( primary endpoint ) , micturitions , nocturia , urgency incontinence episodes , International Prostate Symptom Scores ( IPSS ) , and Overactive Bladder Symptom Score ( OABSS ) were compared between the TAM+SOL groups and TAM+PBO . Safety was assessed on adverse events , postvoid residual volume , and maximal urinary flow rate ( Qmax . ) . RESULTS Six-hundred thirty-eight men were r and omized . Urgency was reduced by 2.2 and 2.4 episodes in the TAM+SOL 2.5 and 5 mg groups , respectively . The TAM+SOL 5 mg group showed significant improvement compared with TAM+PBO ( -2.4 vs -1.9 , P=.049 ) . The number of micturitions in both TAM+SOL groups were significantly reduced compared with TAM+PBO ( both P significantly improved in both TAM+SOL groups compared with TAM+PBO . Changes in IPSS voiding symptom score and Qmax . were similar in all groups . Four patients ( 1.9 % ) in the TAM+SOL 5 mg group had urinary retention , but all recovered after catheterization . CONCLUSIONS In male LUTS patients with residual OAB symptoms despite tamsulosin monotherapy , TAM+SOL showed efficacy on urgency , which represents OAB symptoms and was well tolerated",
"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",
"PURPOSE We investigated whether combination therapy with dutasteride and tamsulosin is more effective than either monotherapy alone for improving symptoms and long-term outcomes in men with moderate to severe lower urinary tract symptoms and prostatic enlargement ( 30 cc or greater ) . We report preplanned 2-year analyses . MATERIAL S AND METHODS The CombAT study is an ongoing , multicenter , r and omized , double-blind , parallel group study . Men 50 years or older with a clinical diagnosis of benign prostatic hyperplasia , International Prostate Symptom Score 12 points or greater , prostate volume 30 cc or greater , total serum prostate specific antigen 1.5 ng/ml or greater to 10 ng/ml or less and peak urinary flow greater than 5 to 15 ml per second or less with a minimum voided volume of 125 ml or greater were r and omized to 0.5 mg dutasteride , 0.4 mg tamsulosin or the combination once daily for 4 years . Symptoms were assessed every 3 months and peak urinary flow was assessed every 6 months . The primary end point at 2 years was the change in International Prostate Symptom Score from baseline . RESULTS Combination therapy result ed in significantly greater improvements in symptoms vs dutasteride from month 3 and tamsulosin from month 9 , and in benign prostatic hyperplasia related health status from months 3 and 12 , respectively . There was a significantly greater improvement from baseline in peak urinary flow for combination therapy vs dutasteride and tamsulosin monotherapies from month 6 . There was a significant increase in drug related adverse events with combination therapy vs monotherapies , although most did not result in the cessation of therapy . CONCLUSIONS In men with moderate to severe lower urinary tract symptoms and prostate enlargement ( 30 cc or greater ) combination therapy provides a significantly greater degree of benefit than tamsulosin or dutasteride monotherapy",
"OBJECTIVES The Symptom Management After Reducing Therapy ( SMART-1 ) study examined the combination of the dual action 5alpha-reductase inhibitor ( 5ARI ) dutasteride , and alpha(1)-blocker tamsulosin , followed by withdrawal of tamsulosin in men with symptomatic BPH . METHODS 327 BPH patients were r and omised to 0.5 mg dutasteride and 0.4 mg tamsulosin for 36 weeks ( DT36 ) or 0.5 mg dutasteride and 0.4 mg tamsulosin for 24 weeks followed by dutasteride and tamsulosin matched placebo for the remaining 12 weeks ( DT24+D12 ) . Patients ' assessment of their symptoms , IPSS at weeks 24 , 30 , and drug safety were evaluated . RESULTS 77 % of DT24+D12 patients felt the same/better at week 30 compared with week 24 ( changes in IPSS were consistent with this finding ) . Of those subjects with an IPSS dutasteride monotherapy at week 24 , 84 % switched without a noticeable deterioration in their symptoms . In the 27 % of men with severe baseline symptoms ( IPSS > or=20 ) who had withdrawal of tamsulosin therapy at week 24 , 42.5 % reported a worsening of their symptoms compared with 14 % in the DT36 group . The regimens were well tolerated . CONCLUSIONS Dutasteride can be used in a 24-week combination with tamsulosin , to achieve rapid onset of symptom relief in patients at risk of underlying disease progression . This symptom relief is maintained in the majority of patients after the alpha(1)-blocker is removed from the combination . Patients with severe symptoms may benefit from longer-term combination therapy",
"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 investigate the therapeutic efficacy and safety of Amlodipine alone or in combination with terazosin for the presence of lower urinary tract symptoms ( LUTS ) and hypertension . LUTS and hypertension often coexist in elderly men . METHODS A total of 355 patients with Stage 1 or 2 hypertension and LUTS ( as defined by an International Prostate Symptom Score of > or = 10 ) were r and omly assigned to receive 2 mg of terazosin ( n = 117 ) , 5 mg of Amlodipine ( n = 119 ) , or 5 mg of Amlodipine plus 2 mg of terazosin ( n = 119 ) once daily for a total of 28 days . The primary outcomes were a reduction in the total and subscores of the International Prostate Symptom Score and blood pressure . Analyses were performed by intention to treat . This trial is registered with Clinical Trials.gov ( No. NCT00693199 ) . RESULTS At day 28 of the trial , the Amlodipine plus terazosin group demonstrated comparable efficacy in lowering the total International Prostate Symptom Score and significant improvement in the presence of overactive bladder compared with the terazosin group ( P quality of life compared with the Amlodipine group ( P Amlodipine plus terazosin group also achieved the greatest blood pressure control compared with either the terazosin group ( P tolerated by the study patients . CONCLUSIONS The results of this 4-week , double-blind , r and omized trial have demonstrated that in Chinese male hypertensive patients with LUTS , low-dose Amlodipine plus terazosin therapy appears to be a safe and effective combination therapy to control both conditions , especially for those with predominant overactive bladder symptoms",
"BACKGROUND And rogens are involved in the development of prostate cancer . Finasteride , an inhibitor of 5alpha-reductase , inhibits the conversion of testosterone to dihydrotestosterone , the primary and rogen in the prostate , and may reduce the risk of prostate cancer . METHODS In the Prostate Cancer Prevention Trial , we r and omly assigned 18,882 men 55 years of age or older with a normal digital rectal examination and a prostate-specific antigen ( PSA ) level of 3.0 ng per milliliter or lower to treatment with finasteride ( 5 mg per day ) or placebo for seven years . Prostate biopsy was recommended if the annual PSA level , adjusted for the effect of finasteride , exceeded 4.0 ng per milliliter or if the digital rectal examination was abnormal . It was anticipated that 60 percent of participants would have prostate cancer diagnosed during the study or would undergo biopsy at the end of the study . The primary end point was the prevalence of prostate cancer during the seven years of the study . RESULTS Prostate cancer was detected in 803 of the 4368 men in the finasteride group who had data for the final analysis ( 18.4 percent ) and 1147 of the 4692 men in the placebo group who had such data ( 24.4 percent ) , for a 24.8 percent reduction in prevalence over the seven-year period ( 95 percent confidence interval , 18.6 to 30.6 percent ; P Tumors of Gleason grade 7 , 8 , 9 , or 10 were more common in the finasteride group ( 280 of 757 tumors [ 37.0 percent ] , or 6.4 percent of the 4368 men included in the final analysis ) than in the placebo group ( 237 of 1068 tumors [ 22.2 percent ] , P Sexual side effects were more common in finasteride-treated men , whereas urinary symptoms were more common in men receiving placebo . CONCLUSIONS Finasteride prevents or delays the appearance of prostate cancer , but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high- grade prostate cancer",
"Objectives : A prospect i ve study was conducted in a community hospital in order to evaluate the therapeutic effect of dibenyline , finasteride , and a combination of the two drugs for symptomatic benign prostatic hyperplasia ( BPH ) . Methods : 190 men suffering from severe prostatism entered this study . They were assessed by IPSS symptom score , digital rectal examination , transrectal sonography of the prostate , uroflowmetry and residual urine . The patients were r and omly selected for medical treatment with dibenyline 10 mg b.i.d . ( n = 71 ) , finasteride 5 mg q.d . ( n = 54 ) , and a combination ( n = 65 ) . Clinical assessment s were carried out before treatment and 3 and 6 months after starting treatment . Patients who could not complete the treatment and those with prostatic cancer were excluded from the final statistics . The quality of life after 6 months of treatment and side effects were also assessed . Results : A total of 172 patients completed the treatment course and 153 patients completed the periodic clinical assessment s. Improvement in IPSS was noted in all 3 groups of patients both at 3 and 6 months . The prostatic volume was found to decrease in the finasteride group and the combination group at 6 months by 24.3 and 10.5 % , respectively . Maximal flow rate ( Qmax ) was significantly improved in the dibenyline and combination groups but not in the finasteride group at 3 months . At 6 months a significant increase in Qmax was noted in all groups with a mean increase of 1.4–1.8 ml/s . The quality of life after treatment was satisfactory in 71.9 % of the dibenyline group , 70.4 % of the finasteride group and 83.1 % of the combination group . Side effects were higher in the dibenyline than the finasteride or combination group . The dropout rate was higher in the dibenyline group ( 15.5 % ) than in the finasteride ( 7.5 % ) and combination ( 4.6 % ) groups . After 6 months of treatment , some of the patients discontinued medication and symptom relapse was noted in 92.6 % of the dibenyline group , 57.6 % of the finasteride group , and 71 % of the combination group . Conclusions : Medical treatment is effective in treating symptomatic BPH . Combination dibenyline and finasteride provides a weak synergistic clinical effect without additive side effects",
"OBJECTIVES To evaluate the efficacy of tolterodine extended release ( ER ) , tamsulosin , and tolterodine ER plus tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen ( PSA ) level . METHODS We performed a post hoc analysis of data from men > or=40 years old with frequency and urgency ( with or without urge urinary incontinence ) , postvoid residual urine volume 5 mL/s , International Prostate Symptom Score ( IPSS ) of > or=12 , and quality -of-life score of > or=3 . They had been r and omized to placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER plus tamsulosin for 12 weeks . The men were stratified by the median baseline PSA level ( > or=1.3 vs bladder diary variables and IPSSs . The men rated the urgency level of each micturition , and the frequency-urgency sum was defined as the total of these ratings . RESULTS The PSA level correlated significantly with prostate size . Men with a PSA level of > or=1.3 ng/mL receiving tolterodine ER plus tamsulosin showed significantly greater improvements in 24-hour frequency , daytime frequency , the frequency-urgency sum , total IPSS , and IPSS storage score compared with those receiving placebo . Tamsulosin significantly improved the IPSS voiding scores , but tolterodine ER was ineffective . In men with a PSA level , tolterodine ER alone and tolterodine ER plus tamsulosin significantly improved the 24-hour frequency , daytime frequency , frequency-urgency sum , and IPSS storage scores compared with those receiving placebo ; tamsulosin alone was ineffective . No significant changes were found in the postvoid residual urine volume or maximal urinary flow rate in any group , and the acute urinary retention rates were low . CONCLUSIONS The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms , including overactive bladder , who had lower PSA levels ( ",
"PURPOSE We investigated the effect of the combination of the doxazosin gastrointestinal therapeutic system and 10 mg vardenafil on the hemodynamic status of patients with benign prostatic hyperplasia and erectile dysfunction . MATERIAL S AND METHODS This was a double-blinded , r and omized , placebo controlled crossover trial . Patients with benign prostatic hyperplasia and erectile dysfunction treated with the doxazosin gastrointestinal therapeutic system on a regular basis , with no other antihypertensive events , were recruited . Subjects took 10 mg vardenafil or placebo in a r and omized crossover fashion with a washout period of at least 7 days between each treatment . The supine and st and ing blood pressure of the subjects was recorded from 1 hour before to 6 hours after the administration of vardenafil or placebo . The primary outcome of the study was the maximal change in st and ing systolic blood pressure of the subjects from 1 half hour before to 6 hours after the administration of drugs . RESULTS A total of 37 patients , 25 ( 67.6 % ) and 12 ( 32.4 % ) on the doxazosin gastrointestinal therapeutic system at 4 mg and 8 mg , respectively , completed the trial . The combination drug therapy result ed in a maximal decrease in st and ing systolic blood pressure of 6.18 mm Hg ( 95 % CI -12.02 , -0.33 ; p = 0.039 ) . Only 1 patient had an asymptomatic st and ing systolic blood pressure of less than 85 mm Hg . Otherwise no symptomatic hypotension or clinical ly significant adverse cardiovascular event was observed during the study . CONCLUSIONS In patients on the doxazosin gastrointestinal therapeutic system for benign prostatic hyperplasia a single 10 mg dose of vardenafil had no symptomatic hemodynamic effects",
"BACKGROUND Knowledge of baseline factors that influence outcomes for men with benign prostatic hyperplasia ( BPH ) receiving medical therapy may help to improve outcomes and cost effectiveness . OBJECTIVES To examine the influence of baseline parameters on changes in International Prostate Symptom Score ( IPSS ) and maximum urinary flow rate ( Q(max ) ) in men with BPH receiving dutasteride , tamsulosin , or a combination of the two using 2-yr Combination of Avodart and Tamsulosin ( CombAT ) study data . DESIGN , SETTING , AND PARTICIPANTS CombAT is an ongoing , 4-yr , multicentre , r and omised , double-blind study in 4844 men aged > or=50 yr with clinical diagnosis of BPH , IPSS > or=12 , prostate volume > or=30 cm(3 ) , prostate-specific antigen ( PSA ) 1.5 - 10 ng/ml , and Q(max ) > 5 and or=125 ml . INTERVENTION Daily tamsulosin 0.4 mg , dutasteride 0.5 mg , or the combination . MEASUREMENTS Post hoc analyses of mean IPSS and Q(max ) changes from baseline by treatment group and by baseline prostate volume , PSA , age , body mass index ( BMI ) , IPSS , IPSS quality of life ( QoL ) score , BPH Impact Index score , Q(max ) , and previous BPH medical therapy . RESULTS AND LIMITATIONS Combination therapy was more effective than either monotherapy after 24 mo in improving IPSS in all baseline subgroups , with benefit onset varying by baseline prostate volume . Combination therapy was also more effective in improving Q(max ) versus tamsulosin in all subgroups and versus dutasteride in 10 of 18 subgroups . At 24 mo , dutasteride monotherapy result ed in significantly greater IPSS improvements versus tamsulosin in men with lower age , worse symptoms , worse QoL , less bother , higher BMI , greater Q(max ) , higher prostate volume , and higher PSA at baseline . Post hoc analyses , the lack of placebo control , and the exclusion of men with unsuccessful medical BPH treatment are study limitations . CONCLUSIONS Combination therapy with tamsulosin and dutasteride affords the greatest and the most rapid symptomatic benefit among men with higher baseline prostate volume and is effective regardless of previous BPH medical therapy . Dutasteride monotherapy is more effective than tamsulosin in men with higher baseline prostate volume or PSA and worse symptoms",
"BACKGROUND Some men with lower urinary tract symptoms ( LUTS ) including overactive bladder ( OAB ) symptoms may benefit from antimuscarinic therapy , with or without an alpha-adrenergic antagonist . OBJECTIVES To evaluate the safety and efficacy of tolterodine extended release ( ER ) , tamsulosin , or tolterodine ER+tamsulosin in men meeting symptom entry criteria for OAB and prostatic enlargement trials , stratified by prostate size . DESIGN , SETTING , AND PARTICIPANTS Subjects with an International Prostate Symptom Score ( IPSS ) > or=12 ; frequency and urgency , with or without urgency urinary incontinence ; postvoid residual volume ( PVR ) 5 mL/s were r and omized to receive placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER+tamsulosin for 12 wk . Data were stratified by median baseline prostate volume ( or=29 mL ) . MEASUREMENTS Endpoints included week 12 changes in bladder diary variables , IPSS scores , and safety variables . RESULTS AND LIMITATIONS Among men with larger prostates , tolterodine ER+tamsulosin significantly improved frequency ( p=0.001 ) ; urgency ( p=0.006 ) ; and IPSS total ( p=0.001 ) , storage ( p voiding scores ( p Tamsulosin significantly improved IPSS voiding scores ( p=0.030 ) . Among men with smaller prostates , tolterodine ER significantly improved frequency ( p=0.016 ) , UUI episodes ( p=0.036 ) , and IPSS storage scores ( p=0.005 ) . Tolterodine ER+tamsulosin significantly improved frequency ( p=0.001 ) and IPSS storage scores ( p=0.018 ) . Tamsulosin significantly improved nocturnal frequency ( p=0.038 ) and IPSS voiding ( p=0.036 ) and total scores ( p=0.044 ) . There were no clinical ly or statistically significant changes in Q(max ) or PVR ; incidence of acute urinary retention ( AUR ) was low in all groups ( Men with smaller prostates and moderate-to-severe LUTS including OAB symptoms benefited from tolterodine ER . Therapy with tolterodine ER+tamsulosin was effective regardless of prostate size . Tolterodine ER , with or without tamsulosin , was well tolerated and not associated with increased incidence of AUR"
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4117ea9c-06ff-11f0-808a-c43d1ab1c353
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Atrial fibrillation ( AF ) is a well-established risk factor of thromboembolism ( TE ) . Thromboembolism is one of the most common complications in patients supported by continuous-flow left ventricular assisted devices ( CF-LVADs ) . However , the association between AF and TE complications in this population is controversial . We conducted a systematic review and meta- analysis to assess the association between AF and overall TE , stroke , and device thrombosis events in CF-LVAD patients . We performed a comprehensive literature search through September 2017 in the data bases of MEDLINE and EMBASE . Included studies were prospect i ve or retrospective cohort studies that compared the risk of developing overall TE , stroke , and device thrombosis events in CF-LVAD patients with AF and those without AF . We calculated pooled relative risk ( RR ) with 95 % confidence intervals ( CI ) and I statistic using the r and om-effects model . Eleven studies were included involving 6,351 patients who underwent CF-LVAD implantation . Overall , TE outcome was available in four studies involving 1,106 AF and 3,556 non-AF patients . Stroke outcome was available in seven studies ( 1,455 AF and 4,037 non-AF patients ) . Device thrombosis outcome was available in three studies ( 1,010 AF and 3,327 non-AF patients ) . There was no association between AF and TE events ( RR = 0.95 ; 95 % CI : 0.57 - 1.59 , I = 79 % , p = 0.85 ) , stroke ( RR = 1.10 ; 95 % CI : 0.74 - 1.64 , I = 73 % , p = 0.65 ) , and device thrombosis ( RR = 0.97 ; 95 % CI : 0.56 - 1.67 , I = 42 % , p = 0.91 ) . AF in CF-LVAD patients was not associated with overall TE , stroke , or device thrombosis events . These findings might be explained by the highly thrombogenic property of CF-LVADs that exceeds the thromboembolic risk driven by AF
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[
"AIMS To correlate the dynamics of platelet activation with the development of thromboembolic events in patients with continuous-flow left ventricular assist device ( cf-LVAD ) . METHODS AND RESULTS The platelet activity state ( PAS ) assay was utilized to evaluate platelet activation in 68 cf-LVAD patients implanted with the HeartMate II ( n = 15 , 22 % ) , HeartMate 3 ( n = 15 , 22 % ) , or HeartWare HVAD ( n = 38 , 56 % ) . PAS was measured preoperatively , early post-implant , and at long-term follow-up ( 1 , 3 , 6 , 12 , 18 , and 24 months post-implant ) . PAS was also measured at the occurrence of adverse events in patients who developed thrombotic complications . Data on patient demographics , medical history , antithrombotic therapy , and coagulation parameters were also analysed . Over a median follow-up of 602 ( 234 - 942 ) days , PAS values did not increase over time in the overall population ( P = 0.15 ) . However , PAS measured at event was 15-fold higher in the six patients ( 9 % ) who suffered pump thrombosis ( n = 2 ) or ischaemic stroke ( n = 4 ) vs. the rest of the population [ 6.67 % ( 5.59%-11.98 % ) vs. 0.45 % ( 0.33%-0.75 % ) ; P = 0.012 ] , despite comparable coagulation profile . Pre-implant PAS values were 4.5-fold higher in these patients [ 1.90 % ( 1.24%-3.17 % ) vs. 0.42 % ( 0.32%-0.72 % ) ; P = 0.006 ] . Neither preoperative variables nor the type of the pump or the antiplatelet strategy were associated with a higher risk of complications . CONCLUSIONS Thrombotic events are associated with altered PAS values . Moreover , baseline elevated PAS values in patients who developed thrombotic events suggest patient-specific tendency to post-implant thromboembolic complications . Prospect ively , systematic monitoring of PAS might guide the development of refined patient-tailored antithrombotic strategies and the technological improvement of LVAD design",
"Background Mechanical circulatory support with a left ventricular assist device ( LVAD ) is an established treatment for patients with advanced heart failure . We compared a newer LVAD design ( a small intrapericardial centrifugal‐flow device ) against existing technology ( a commercially available axial‐flow device ) in patients with advanced heart failure who were ineligible for heart transplantation . Methods We conducted a multicenter r and omized trial involving 446 patients who were assigned , in a 2:1 ratio , to the study ( centrifugal‐flow ) device or the control ( axial‐flow ) device . Adults who met contemporary criteria for LVAD implantation for permanent use were eligible to participate in the trial . The primary end point was survival at 2 years free from disabling stroke or device removal for malfunction or failure . The trial was powered to show noninferiority with a margin of 15 percentage points . Results The intention‐to treat‐ population included 297 participants assigned to the study device and 148 participants assigned to the control device . The primary end point was achieved in 164 patients in the study group and 85 patients in the control group . The analysis of the primary end point showed noninferiority of the study device relative to the control device ( estimated success rates , 55.4 % and 59.1 % , respectively , calculated by the Weibull model ; absolute difference , 3.7 percentage points ; 95 % upper confidence limit , 12.56 percentage points ; P=0.01 for noninferiority ) . More patients in the control group than in the study group had device malfunction or device failure requiring replacement ( 16.2 % vs. 8.8 % ) , and more patients in the study group had strokes ( 29.7 % vs. 12.1 % ) . Quality of life and functional capacity improved to a similar degree in the two groups . Conclusions In this trial involving patients with advanced heart failure who were ineligible for heart transplantation , a small , intrapericardial , centrifugal‐flow LVAD was found to be noninferior to an axial‐flow LVAD with respect to survival free from disabling stroke or device removal for malfunction or failure . ( Funded by HeartWare ; ENDURANCE Clinical Trials.gov number , NCT01166347 .",
"BACKGROUND The HeartWare Ventricular Assist System ( HeartWare Inc , Framingmam , MA ) is a miniaturized implantable , centrifugal design , continuous-flow blood pump . The pivotal bridge to transplant and continued access protocol s trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication . METHODS The primary outcome , success , was defined as survival on the originally implanted device , transplant , or explant for ventricular recovery at 180 days . Secondary outcomes included an evaluation of survival , functional and quality of life outcomes , and adverse events . RESULTS A total of 332 patients in the pivotal bridge to transplant and continued access protocol s trial have completed their 180-day primary end-point assessment . Survival in patients receiving the HeartWare pump was 91 % at 180 days and 84 % at 360 days . Quality of life scores improved significantly , and adverse event rates remain low . CONCLUSIONS The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant . Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials , despite longer exposure times due to longer survival and lower transplant rates"
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4117ead8-06ff-11f0-808a-c43d1ab1c353
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Background It remains uncertain which diet is best for people with type 2 diabetes ( T2D ) . Objective We compared the effects of dietary carbohydrate restriction with fat restriction on markers of metabolic syndrome and quality of life in people with T2D . Design This systematic review of r and omized controlled trials ( RCTs ) and controlled clinical trials ( CCTs ) compares the effects of a low-carbohydrate [ ≤40 % of energy ( % ) ] diet with those of a low-fat ( ≤30 % ) diet over a period of ≥4 wk in patients with T2D . Two investigators independently selected studies , extracted data , and assessed risk of bias . The GRADE ( Grading of Recommendations Assessment , Development , and Evaluation ) approach was used to assess the certainty of evidence . Pooled mean differences ( MDs ) and 95 % CIs were calculated with the use of a r and om-effects model . Results Thirty-three RCTs and 3 CCTs ( n = 2161 ) were included . Glycated hemoglobin declined more in people who consumed low-carbohydrate food than in those who consumed low-fat food in the short term ( MD : -1.38 % ; 95 % CI : -2.64 % , -0.11 % ; very-low-certainty evidence ) . At 1 y , the MD was reduced to -0.36 % ( 95 % CI : -0.58 % , -0.14 % ; low-certainty evidence ) ; at 2 y , the difference had disappeared . There is low to high ( majority moderate ) certainty for small improvements of unclear clinical importance in plasma glucose , triglycerides , and HDL concentrations favoring low-carbohydrate food at half of the prespecified time points . There was little to no difference in LDL concentration or any of the secondary outcomes ( body weight , waist circumference , blood pressure , quality of life ) in response to either of the diets ( very-low- to high-certainty evidence ) . Conclusions Currently available data provide low- to moderate-certainty evidence that dietary carbohydrate restriction to a maximum of 40 % yields slightly better metabolic control of uncertain clinical importance than reduction in fat to a maximum of 30 % in people with T2D . This systematic review is registered at http://www.crd.york.ac.uk/ PROSPERO /display_record.php?ID = CRD42017052467 as CRD42017052467
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"OBJECTIVE To test whether a weight loss program promotes greater weight loss , glycemic control , and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake . RESEARCH DESIGN AND METHODS This r and omized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling , with prepackaged foods in a planned menu during the initial phase , or to usual care ( UC ; two weight loss counseling sessions and monthly contacts ) . RESULTS Relative weight loss was 7.4 % ( 95 % CI 5.7–9.2 % ) , 9.0 % ( 7.1–10.9 % ) , and 2.5 % ( 1.3–3.8 % ) for the lower fat , lower carbohydrate , and UC groups ( P . Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year ( fasting glucose 141 [ 95 % CI 133–149 ] vs. 159 [ 144–174 ] mg/dL , P = 0.023 ; hemoglobin A1c 6.9 % [ 6.6–7.1 % ] vs. 7.5 % [ 7.1–7.9 % ] or 52 [ 49–54 ] vs. 58 [ 54–63 ] mmol/mol , P = 0.001 ; triglycerides 148 [ 134–163 ] vs. 204 [ 173–234 ] mg/dL , P lower hemoglobin A1c ( 6.6 % [ 95 % CI 6.3–6.8 % ] vs. 7.2 % [ 6.8–7.5 % ] or 49 [ 45–51 ] vs. 55 [ 51–58 ] mmol/mol ) at 1 year ( P = 0.008 ) . CONCLUSIONS The weight loss program result ed in greater weight loss and improved glycemic control in type 2 diabetes",
"Aims /hypothesisThe study aim ed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance . Methods This was a prospect i ve r and omised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and r and omised by drawing ballots . Patients that did not speak Swedish could not be recruited . The primary outcomes in this non-blinded study were weight and HbA1c . Patients on the LFD aim ed for 55–60 energy per cent ( E% ) and those on LCD for 20 E% from carbohydrate . Results The mean BMI and HbA1c of the participants were 32.7 ± 5.4 kg/m2 and 57.0 ± 9.2 mmol/mol , respectively . No patients were lost to follow-up . Weight loss did not differ between groups and was maximal at 6 months : LFD −3.99 ± 4.1 kg ( n = 31 ) ; LCD −4.31 ± 3.6 kg ( n = 30 ) ; p 0.020 within groups , respectively ) . HbA1c fell in the LCD group only ( LCD at 6 months −4.8 ± 8.3 mmol/mol , p = 0.004 , at 12 months −2.2 ± 7.7 mmol/mol , p = 0.12 ; LFD at 6 months −0.9 ± 8.8 mmol/mol , p = 0.56 ) . At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups . Insulin doses were reduced in the LCD group ( 0 months , LCD 42 ± 65 E , LFD 39 ± 51 E ; 6 months , LCD 30 ± 47 E , LFD 38 ± 48 E ; p = 0.046 for between-group change ) . Conclusions /interpretationWeight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good . Thus , aim ing for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative . Trial registration : Clinical Trials.gov NCT01005498 Funding : University Hospital of Linköping Research Funds , Linköping University , the County Council of Östergötl and , and the Diabetes Research Centre of Linköping",
"AIMS To compare the effects of lifestyle modification programs that prescribe low-glycemic load ( GL ) vs. low-fat diets in a r and omized trial . METHODS Seventy-nine obese adults with type 2 diabetes received low-fat or low-GL dietary instruction , delivered in 40-week lifestyle modification programs with identical goals for calorie intake and physical activity . Changes in weight , HbA(1c ) , and other metabolic parameters were compared at weeks 20 and 40 . RESULTS Weight loss did not differ between groups at week 20 ( low-fat : -5.7±3.7 % ; low-GL : -6.7±4.4 % , p=.26 ) or week 40 ( low-fat : -4.5±7.5 % ; low-GL : -6.4±8.2 % , p=.28 ) . Adjusting for changes in antidiabetic medications , subjects on the low-GL diet had larger reductions in HbA(1c ) than those on the low-fat diet at week 20 ( low-fat : -0.3±0.6 % ; low-GL : -0.7±0.6 % , p=.01 ) , and week 40 ( low-fat : -0.1±1.2 % ; low-GL : -0.8±1.3 % ; p=.01 ) . Groups did not differ significantly on any other metabolic outcomes ( p≥.06 ) . CONCLUSIONS Results suggest that targeting GL , rather than dietary fat , in a low-calorie diet can significantly enhance the effect of weight loss on HbA(1c ) in patients with type 2 diabetes",
"BACKGROUND & AIMS The usefulness of low-carbohydrate diet ( LCD ) for Japanese patients with type 2 diabetes mellitus ( T2DM ) has not been fully investigated . Therefore , we compared the effectiveness and safety of LCD with calorie restricted diet ( CRD ) . METHODS This prospect i ve , r and omized , open-label , comparative study included 66 T2DM patients with HbA1c > 7.5 % even after receiving repeated education programs on CRD . They were r and omly allocated to either the 130g/day LCD group ( n = 33 ) or CRD group ( n = 33 ) . Patients received personal nutrition education of CRD or LCD for 30 min at baseline , 1 , 2 , 4 , and 6 months . Patients of the CRD group were advised to maintain the intake of calories and balance of macronutrients ( 28 × ideal body weight calories per day ) . Patients of the LCD group were advised to maintain the intake of 130 g/day carbohydrate without other specific restrictions . Several parameters were assessed at baseline and 6 months after each intervention . The primary endpoint was a change in HbA1c level from baseline to the end of the study . RESULTS At baseline , BMI and HbA1c were 26.5 ( 24.6 - 30.1 ) and 8.3 ( 8.0 - 9.3 ) , and 26.7 ( 25.0 - 30.0 ) kg/m2 and 8.0 ( 7.6 - 8.9 ) % , in the CRD and LCD , respectively . At the end of the study , HbA1c decreased by -0.65 ( -1.53 to -0.10 ) % in the LCD group , compared with 0.00 ( -0.68 to 0.40 ) % in the CRD group ( p decrease in BMI in the LCD group [ -0.58 ( -1.51 to -0.16 ) kg/m2 ] exceeded that observed in the CRD group ( p = 0.03 ) . CONCLUSIONS Our study demonstrated that 6-month 130 g/day LCD reduced HbA1c and BMI in poorly controlled Japanese patients with T2DM . LCD is a potentially useful nutrition therapy for Japanese patients who can not adhere to CRD . This trial was registered at http://www.umin.ac.jp/english/ ( University Hospital Medical Information Network : study ID number 000010663 )",
"BACKGROUND The appropriate dietary intervention for overweight persons with type 2 diabetes mellitus ( DM2 ) is unclear . Trials comparing the effectiveness of diets are frequently limited by short follow-up times and high dropout rates . AIM The effects of a low carbohydrate Mediterranean ( LCM ) , a traditional Mediterranean ( TM ) , and the 2003 American Diabetic Association ( ADA ) diet were compared , on health parameters during a 12-month period . METHODS In this 12-month trial , 259 overweight diabetic patients ( mean age 55 years , mean body mass index 31.4 kg/m(2 ) ) were r and omly assigned to one of the three diets . The primary end-points were reduction of fasting plasma glucose , HbA1c and triglyceride ( TG ) levels . RESULTS 194 patients out of 259 ( 74.9 % ) completed follow-up . After 12 months , the mean weight loss for all patients was 8.3 kg : 7.7 kg for ADA , 7.4 kg for TM and 10.1 kg for LCM diets . The reduction in HbA1c was significantly greater in the LCM diet than in the ADA diet ( -2.0 and -1.6 % , respectively , p HDL cholesterol increased ( 0.1 mmol/l + /- 0.02 ) only on the LCM ( p reduction in serum TG was greater in the LCM ( -1.3 mmol/l ) and TM ( -1.5 mmol/l ) than in the ADA ( -0.7 mmol/l ) , p = 0.001 . CONCLUSIONS An intensive 12-month dietary intervention in a community-based setting was effective in improving most modifiable cardiovascular risk factors in all the dietary groups . Only the LCM improved HDL levels and was superior to both the ADA and TM in improving glycaemic control",
"BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study . An analysis including all subjects , with the last observation carried forward for those who dropped out , showed that subjects on the low-carbohydrate diet lost more weight than those on the low-fat diet ( mean [ + /-SD ] , -5.8+/-8.6 kg vs. -1.9+/-4.2 kg ; P=0.002 ) and had greater decreases in triglyceride levels ( mean , -20+/-43 percent vs. -4+/-31 percent ; P=0.001 ) , irrespective of the use or nonuse of hypoglycemic or lipid-lowering medications . Insulin sensitivity , measured only in subjects without diabetes , also improved more among subjects on the low-carbohydrate diet ( 6+/-9 percent vs. -3+/-8 percent , P=0.01 ) . The amount of weight lost ( P triglyceride levels and insulin sensitivity . CONCLUSIONS Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie- and fat-restricted diet , with a relative improvement in insulin sensitivity and triglyceride levels , even after adjustment for the amount of weight lost . This finding should be interpreted with caution , given the small magnitude of overall and between-group differences in weight loss in these markedly obese subjects and the short duration of the study . Future studies evaluating long-term cardiovascular outcomes are needed before a carbohydrate-restricted diet can be endorsed",
"BACKGROUND In the United States , obesity is a major clinical and public health problem causing diabetes , dyslipidemia , and hypertension , as well as increasing cardiovascular and total mortality . Dietary restrictions of calories and saturated fat are beneficial . However , it remains unclear whether replacement of saturated fat with carbohydrates ( as in the US National Cholesterol Education Program [ NCEP ] diet ) or protein and monounsaturated fat ( as in our isocaloric modified low-carbohydrate [ MLC ] diet , which is lower in total carbohydrates but higher in protein , monounsaturated fat , and complex carbohydrates ) is optimal . METHODS We r and omized 60 participants ( 29 women and 31 men ) to the NCEP or the MLC diet and evaluated them every 2 weeks for 12 weeks . They were aged 28 to 71 years ( mean age , 44 years in the NCEP and 46 years in the MLC group ) . A total of 36 % of participants from the NCEP group and 35 % from the MLC group had a body mass index ( calculated as weight in kilograms divided by the square of height in meters ) greater than 27 . The primary end point was weight loss , and secondary end points were blood lipid levels and waist-to-hip ratio . RESULTS Weight loss was significantly greater in the MLC ( 13.6 lb ) than in the NCEP group ( 7.5 lb ) , a difference of 6.1 lb ( P = .02 ) . There were no significant differences between the groups for total , low density , and high-density lipoprotein cholesterol , triglycerides , or the proportion of small , dense low-density lipoprotein particles . There were significantly favorable changes in all lipid levels within the MLC but not within the NCEP group . Waist-to-hip ratio was not significantly reduced between the groups ( P = .27 ) , but it significantly decreased within the MLC group ( P = .009 ) . CONCLUSIONS Compared with the NCEP diet , the MLC diet , which is lower in total carbohydrates but higher in complex carbohydrates , protein , and monounsaturated fat , caused significantly greater weight loss over 12 weeks . There were no significant differences between the groups in blood lipid levels , but favorable changes were observed within the MLC diet group",
"OBJECTIVE —The purpose of this study was to compare the effects of high – monounsaturated fatty acid ( MUFA ) and high-carbohydrate ( CHO ) diets on body weight and glycemic control in men and women with type 2 diabetes . RESEARCH DESIGN AND METHODS —Overweight/obese participants with type 2 diabetes ( n = 124 , age = 56.5 ± 0.8 years , BMI = 35.9 ± 0.3 kg/m2 , and A1C = 7.3 ± 0.1 % ) were r and omly assigned to 1 year of a high-MUFA or high-CHO diet . Anthropometric and metabolic parameters were assessed at baseline and after 4 , 8 , and 12 months of dieting . RESULTS —Baseline characteristics were similar between the treatment groups . The overall retention rate for 1 year was 77 % ( 69 % for the high-MUFA group and 84 % for the high-CHO group ; P = 0.06 ) . Based on food records , both groups had similar energy intake but a significant difference in MUFA intake . Both groups had similar weight loss over 1 year ( −4.0 ± 0.8 vs. −3.8 ± 0.6 kg ) and comparable improvement in body fat , waist circumference , diastolic blood pressure , HDL cholesterol , A1C , and fasting glucose and insulin . There were no differences in these parameters between the groups . A follow-up assessment of a subset of participants ( n = 36 ) was conducted 18 months after completion of the 52-week diet . These participants maintained their weight loss and A1C during the follow-up period . CONCLUSIONS —In individuals with type 2 diabetes , high-MUFA diets are an alternative to conventional lower-fat , high-CHO diets with comparable beneficial effects on body weight , body composition , cardiovascular risk factors , and glycemic control",
"BACKGROUND & AIMS We determined the effects of acute and chronic calorie restriction with either a low-fat , high-carbohydrate ( HC ) diet or a low-carbohydrate ( LC ) diet on hepatic and skeletal muscle insulin sensitivity . METHODS Twenty-two obese subjects ( body mass index , 36.5 + /- 0.8 kg/m2 ) were r and omized to an HC ( > 180 g/day ) or LC ( A euglycemic-hyperinsulinemic clamp , muscle biopsy specimens , and magnetic resonance spectroscopy were used to determine insulin action , cellular insulin signaling , and intrahepatic triglyceride ( IHTG ) content before , after 48 hours , and after approximately 11 weeks ( 7 % weight loss ) of diet therapy . RESULTS At 48 hours , IHTG content decreased more in the LC than the HC diet group ( 29.6 % + /- 4.8 % vs 8.9 % + /- 1.4 % ; P ( LC diet , 38.0 % + /- 4.5 % ; HC diet , 44.5 % + /- 13.5 % ) . Basal glucose production rate decreased more in the LC than the HC diet group at 48 hours ( 23.4 % + /- 2.2 % vs 7.2 % + /- 1.4 % ; P Insulin-mediated glucose uptake did not change at 48 hours but increased similarly in both groups after 7 % weight loss ( 48.4 % + /- 14.3 % ; P insulin-stimulated phosphorylation of c-Jun-N-terminal kinase decreased by 29 % + /- 13 % and phosphorylation of Akt and insulin receptor substrate 1 increased by 35 % + /- 9 % and 36 % + /- 9 % , respectively , after 7 % weight loss ( all P < .05 ) . CONCLUSIONS Moderate calorie restriction causes temporal changes in liver and skeletal muscle metabolism ; 48 hours of calorie restriction affects the liver ( IHTG content , hepatic insulin sensitivity , and glucose production ) , whereas moderate weight loss affects muscle ( insulin-mediated glucose uptake and insulin signaling )",
"Background We assessed the long-term effects of a Mediterranean diet on circulating levels of endothelial progenitor cells ( EPCs ) and the carotid intima-media thickness ( CIMT ) in patients with type 2 diabetes . Design This was a parallel , two-arm , single-centre trial . Methods Two hundred and fifteen men and women with newly diagnosed type 2 diabetes were r and omized to a Mediterranean diet ( n = 108 ) or a low-fat diet ( n = 107 ) . The primary outcome measures were changes in the EPC count and the CIMT of the common carotid artery after the treatment period defined as the end of trial ( EOT ) . Results At the EOT , both the CD34+KDR+ and CD34+KDR+CD133 + counts had increased with the Mediterranean diet compared with the low-fat diet ( p the rate of regression in the CIMT was higher in the Mediterranean diet group ( 51 vs. 26 % ) , whereas the rate of progression was lower ( 25 vs. 50 % ) ( p = 0.032 for both ) . Changes in the CIMT were inversely correlated with the changes in EPC levels ( CD34+KDR+ , r = −0.24 , p = 0.020 ; CD34+KDR+CD133 + , r = −0.28 , p = 0.014 ) . At the EOT , changes in levels of HbA1c , HOMA , total cholesterol , high-density lipoprotein cholesterol and systolic blood pressure were significantly greater with the Mediterranean diet than with the low-fat diet . Conclusion Compared with a low-fat diet , a long-term trial with Mediterranean diet was associated with an increase in circulating EPCs levels and prevention of the progression of sub clinical atherosclerosis in patients with newly diagnosed type 2 diabetes",
"Abstract Purpose To test the effect of three diets in their ability to sustain weight loss and improve type 2 diabetes ( T2D ) and cardiovascular disease ( CVD ) risk markers after 18-month intervention . Methods Following a ≥8 % weight loss , 131 healthy , overweight/obese ( BMI ± SD 31.5 ± 2.6 kg/m2 ) men ( n = 55 ) and women ( n = 76 ) aged 28.2 ± 4.8 years were r and omized to either 1 . Moderate fat ( 40 E% ) with 20 E% MUFA and low in glycemic index ( GI ) ( MUFA , n = 54 ) , 2 . Low fat ( 25 E% ) and medium in GI ( LF , n = 51 ) or 3 . Control ( 35 E% fat ) and high in GI ( CTR , n = 26 ) all with similar protein content , and all provided ad libitum . First 6-month intervention with 100 % food provision ( previously reported ) following 12 months of moderately intensive intervention with 20 % food provision now reported . Results Attrition rate was higher in MUFA ( 63 % ) than in LF ( 37 % , P = 0.019 ) and CTR ( 42 % , P = 0.09 ) group . Weight regain in completers was not different between groups ( mean ± SEM ) , MUFA 7.1 ± 2.1 % versus LF 5.6 ± 1.3 % versus CTR 7.2 ± 1.5 % , nor was body fat regain , MUFA 4.8 ± 1.0 % versus LF 4.7 ± 0.8 % versus CTR 5.7 ± 0.6 % . The MUFA group reduced LDL/HDL ratio by −0.47 ± 0.09 compared with −0.23 ± 0.11 in LF ( P groups . Conclusions Weight regain or body composition did not differ between diets over 18 months . No effects on risk markers for T2D or CVD were found , with the exception of an improvement in the LDL/HDL ratio by the MUFA diet compared to the CTR diet . The LF diet was generally more satisfactory and the MUFA diet seemed more difficult to follow",
"Background Type 2 diabetes is a prevalent , chronic disease for which diet is an integral aspect of treatment . In our previous trial , we found that recommendations to follow a very low-carbohydrate ketogenic diet and to change lifestyle factors ( physical activity , sleep , positive affect , mindfulness ) helped overweight people with type 2 diabetes or prediabetes improve glycemic control and lose weight . This was an in-person intervention , which could be a barrier for people without the time , flexibility , transportation , social support , and /or financial re sources to attend . Objective The aim was to determine whether an online intervention based on our previous recommendations ( an ad libitum very low-carbohydrate ketogenic diet with lifestyle factors ; “ intervention ” ) or an online diet program based on the American Diabetes Associations ’ “ Create Your Plate ” diet ( “ control ” ) would improve glycemic control and other health outcomes among overweight individuals with type 2 diabetes . Methods In this pilot feasibility study , we r and omized overweight adults ( body mass index ≥25 ) with type 2 diabetes ( glycated hemoglobin [ HbA1c ] 6.5%-9.0 % ) to a 32-week online intervention based on our previous recommendations ( n=12 ) or an online diet program based around a plate method diet ( n=13 ) to assess the impact of each intervention on glycemic control and other health outcomes . Primary and secondary outcomes were analyzed by mixed-effects linear regression to compare outcomes by group . Results At 32 weeks , participants in the intervention group reduced their HbA1c levels more ( estimated marginal mean [ EMM ] –0.8 % , 95 % CI –1.1 % to –0.6 % ) than participants in the control group ( EMM –0.3 % , 95 % CI –0.6 % to 0.0 % ; P=.002 ) . More than half of the participants in the intervention group ( 6/11 , 55 % ) lowered their HbA1c to less than 6.5 % versus 0 % ( 0/8 ) in the control group ( P=.02 ) . Participants in the intervention group lost more weight ( EMM –12.7 kg , 95 % CI –16.1 to –9.2 kg ) than participants in the control group ( EMM –3.0 kg , 95 % CI –7.3 to 1.3 kg ; P participants lost at least 5 % of their body weight in the intervention ( 10/11 , 90 % ) versus the control group ( 2/8 , 29 % ; P=.01 ) . Participants in the intervention group lowered their triglyceride levels ( EMM –60.1 mg/dL , 95 % CI –91.3 to –28.9 mg/dL ) more than participants in the control group ( EMM –6.2 mg/dL , 95 % CI –46.0 to 33.6 mg/dL ; P=.01 ) . Dropout was 8 % ( 1/12 ) and 46 % ( 6/13 ) for the intervention and control groups , respectively ( P=.07 ) . Conclusions Individuals with type 2 diabetes improved their glycemic control and lost more weight after being r and omized to a very low-carbohydrate ketogenic diet and lifestyle online program rather than a conventional , low-fat diabetes diet online program . Thus , the online delivery of these very low-carbohydrate ketogenic diet and lifestyle recommendations may allow them to have a wider reach in the successful self-management of type 2 diabetes . Trial Registration Clinical Trials.gov NCT01967992 ; https:// clinical trials.gov/ct2/show/NCT01967992 ( Archived by WebCite at http://www.webcitation.org/6o0fI9Mkq",
"BACKGROUND In single-meal studies , dietary protein does not result in an increase in glucose concentrations in persons with or without type 2 diabetes , even though the result ing amino acids can be used for gluconeogenesis . OBJECTIVE The metabolic effects of a high-protein diet were compared with those of the prototypical healthy ( control ) diet , which is currently recommended by several scientific organizations . DESIGN The metabolic effects of both diets , consumed for 5 wk each ( separated by a 2 - 5-wk washout period ) , were studied in 12 subjects with untreated type 2 diabetes . The ratio of protein to carbohydrate to fat was 30:40:30 in the high-protein diet and 15:55:30 in the control diet . The subjects remained weight-stable during the study . RESULTS With the fasting glucose concentration used as a baseline from which to determine the area under the curve , the high-protein diet result ed in a 40 % decrease in the mean 24-h integrated glucose area response . Glycated hemoglobin decreased 0.8 % and 0.3 % after 5 wk of the high-protein and control diets , respectively ; the difference was significant ( P rate of change over time was also significantly greater after the high-protein diet than after the control diet ( P Fasting triacylglycerol was significantly lower after the high-protein diet than after the control diet . Insulin , C-peptide , and free fatty acid concentrations were not significantly different after the 2 diets . CONCLUSION A high-protein diet lowers blood glucose postpr and ially in persons with type 2 diabetes and improves overall glucose control . However , longer-term studies are necessary to determine the total magnitude of response , possible adverse effects , and the long-term acceptability of the diet",
"To determine the mechanisms of increase in plasma triacylglycerol concentrations after high dietary intakes of carbohydrates , 10 men with non-insulin-dependent diabetes mellitus ( NIDDM ) were fed an isoenergetic high-carbohydrate diet ( 55 % of energy as carbohydrate and 30 % as fat ) and a high-monounsaturated-fat diet ( 45 % of energy as fat and 40 % as carbohydrates ) for 6 wk in a r and omized , crossover manner . The high-carbohydrate diet raised fasting plasma triacylglycerol concentrations by 26 % ( P = 0.007 ) but did not affect postheparin lipoprotein lipase ( P = 0.2 ) or hepatic lipase activities ( P = 0.9 ) . The oral-fat-tolerance test labeled with retinyl palmitate also revealed no differences in postpr and ial plasma triacylglycerol ( P = 0.37 ) or retinyl palmitate clearances ( P = 0.34 ) between the two diets . We conclude that the increase in plasma triacylglycerol concentrations with high-carbohydrate diets in men with NIDDM is not due to reduced lipolysis or diminished postpr and ial clearance of triacylglycerol-rich lipoproteins but is primarily due to increased hepatic secretion of very-low-density-lipoprotein triacylglycerols",
"BACKGROUND The optimal source and amount of dietary carbohydrate for managing type 2 diabetes ( T2DM ) are unknown . OBJECTIVE We aim ed to compare the effects of altering the glycemic index or the amount of carbohydrate on glycated hemoglobin ( HbA1c ) , plasma glucose , lipids , and C-reactive protein ( CRP ) in T2DM patients . DESIGN Subjects with T2DM managed by diet alone ( n=162 ) were r and omly assigned to receive high-carbohydrate , high-glycemic-index ( high-GI ) , high-carbohydrate , low-glycemic-index ( low-GI ) , or low-carbohydrate , high-monounsaturated-fat ( low-CHO ) diets for 1 y. RESULTS The high-GI , low-GI , and low-CHO diets contained , respectively , 47 % , 52 % , and 39 % of energy as carbohydrate and 31 % , 27 % , and 40 % of energy as fat ; they had GIs of 63 , 55 , and 59 , respectively . Body weight and HbA1c did not differ significantly between diets . Fasting glucose was higher ( P=0.041 ) , but 2-h postload glucose was lower ( P=0.010 ) after 12 mo of the low-GI diet . With the low-GI diet , overall mean triacylglycerol was 12 % higher and HDL cholesterol 4 % lower than with the low-CHO diet ( P ratio of total to HDL cholesterol disappeared by 6 mo ( time x diet interaction , P=0.044 ) . Overall mean CRP with the low-GI diet , 1.95 mg/L , was 30 % less than that with the high-GI diet , 2.75 mg/L ( P=0.0078 ) ; the concentration with the low-CHO diet , 2.35 mg/L , was intermediate . CONCLUSIONS In subjects with T2DM managed by diet alone with optimal glycemic control , long-term HbA1c was not affected by altering the GI or the amount of dietary carbohydrate . Differences in total : HDL cholesterol among diets had disappeared by 6 mo . However , because of sustained reductions in postpr and ial glucose and CRP , a low-GI diet may be preferred for the dietary management of T2DM",
"BACKGROUND An important therapeutic goal for patients with type 2 diabetes is weight loss , which improves metabolic abnormalities . Ad libitum low-fat diets cause weight loss in nondiabetic population s. Compared with diets higher in monounsaturated fat , however , eucaloric low-fat diets may increase plasma triacylglycerol concentrations and worsen glycemic control in persons with type 2 diabetes . OBJECTIVE We investigated whether , in type 2 diabetes patients , an ad libitum low-fat diet would cause greater weight loss than would a high-monounsaturated fat diet and would do this without increasing plasma triacylglycerol concentrations or worsening glycemic control . DESIGN Eleven patients with type 2 diabetes were r and omly assigned to receive an ad libitum low-fat , high-carbohydrate diet or a high-monounsaturated fat diet , each for 6 wk . The diets offered contained 125 % of the estimated energy requirement to allow self- selection of food quantity . The response variables were body weight ; fasting plasma lipid , lipoprotein , glucose , glycated hemoglobin A(1c ) , and fructosamine concentrations ; insulin sensitivity ; and glucose disposal . RESULTS Body weight decreased significantly ( 1.53 kg ; P diet . Plasma total , LDL- , and HDL-cholesterol concentrations tended to decrease during both diets . There were no interaction effects between diet and the lipid profile response over time . Plasma triacylglycerol concentrations , glycemic control , and insulin sensitivity did not differ significantly between the 2 diets . CONCLUSION Contrary to expectations , the ad libitum , low-fat , high-fiber diet promoted weight loss in patients with type 2 diabetes without causing unfavorable alterations in plasma lipids or glycemic control",
" Two groups of patients with non-insulin-dependent diabetes mellitus ( NIDDM ) , with dietary advice r and omized between a low-carbohydrate ( LC ) diet and a modified-fat ( MF ) diet , were followed to determine the effect of diet on phospholipid fatty acid composition of platelets and on development of retinopathy in the 7 years following diagnosis . There was a tendency for retinopathy to occur more frequently in those r and omized to the LC diet . This difference was not statistically significant , and fatty acid composition of platelets did not differ significantly in those with and without retinopathy . Linoleic acid values from platelet phospholipid fatty acids were significantly higher in NIDDM on an MF diet compared with an LC diet . There was no difference between the two dietary subgroups with respect to platelet arachidonic acid , but this was lower in the whole diabetic population when compared with non-diabetics . The arachidonic acid values correlated with neither glycosylated haemoglobin nor mean glycaemia . Significant correlation between the fatty acid values for platelets and plasma cholesterol esters was found only for 16:0",
"Brackground : The safety and tolerability of very low-calorie-ketogenic ( VLCK ) diets are a current concern in the treatment of obese type 2 diabetes mellitus ( T2DM ) patients . Objective : Evaluating the short-term safety and tolerability of a VLCK diet ( lifestyle and behavioral modification support ( Diaprokal Method ) in subjects with T2DM . Methods : Eighty-nine men and women , aged between 30 and 65 years , with T2DM and body mass index between 30 and 35 kg m−2 participated in this prospect i ve , open-label , multi-centric r and omized clinical trial with a duration of 4 months . Forty-five subjects were r and omly assigned to the interventional weight loss ( VLCK diet ) , and 44 to the st and ard low-calorie diet . Results : No significant differences in the laboratory safety parameters were found between the two study groups . Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group . Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups . Weight loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects ( both P The decline in HbA1c and glycemic control was larger in the VLCK diet group ( P ) . No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up . Conclusions : The interventional weight loss program based on a VLCK diet is most effective in reducing body weight and improvement of glycemic control than a st and ard hypocaloric diet with safety and good tolerance for T2DM patients",
"To compare blood pressure , glucose and fat metabolism after a high-fat diet rich in monounsaturated fat reduced day time systolic ( 131 + /- 3 vs. 137 + /- 3 mmHg , p 24-hour systolic blood pressure ( 126 + /- 8 vs. 130 + /- 10 mmHg , p day time diastolic ( 78 + /- 2 vs. 84 + /- 52 mmHg , p diurnal diastolic blood pressure ( 75 + /- 6 vs. 78 + /- 5 mmHg , p high-carbohydrate diet . Evidence of improved glucose tolerance on the high-monounsaturated diet compared with the high-carbohydrate diet were found with lower fasting blood glucose ( 6.1 + /- 0.3 vs. 6.8 + /- 0.5 mM , p average blood glucose levels ( 7.4 + /- 0.5 vs. 8.2 + /- 0.6 mmol/l , p peak blood glucose responses ( 9.9 + /- 0.6 vs. 11.3 + /- 0.7 mmol/l , p fasting triglyceride , total cholesterol , LDL- and HDL cholesterol were found after the two diets",
"OBJECTIVE Although caloric restriction is a widely used intervention to reduce body weight and insulin resistance , many patients are unable to comply with such dietary therapy for long periods . The clinical effectiveness of low-carbohydrate diets was recently described in a position statement of Diabetes UK and a scientific review conducted by the American Diabetes Association . However , r and omised trials of dietary interventions in Japanese patients with type 2 diabetes are scarce . Therefore , the aim of this study was to examine the effects of a non-calorie-restricted , low-carbohydrate diet in Japanese patients unable to adhere to a calorie-restricted diet . METHODS The enrolled patients were r and omly allocated to receive a conventional calorie-restricted diet or low-carbohydrate diet . The patients received consultations every two months from a registered dietician for six months . We compared the effects of the two dietary interventions on glycaemic control and metabolic profiles . RESULTS The HbA1c levels decreased significantly from baseline to six months in the low-carbohydrate diet group ( baseline 7.6±0.4 % , six months 7.0±0.7 % , p=0.03 ) but not in the calorie-restricted group ( baseline 7.7±0.6 % , six months 7.5±1.0 % , n.s . ) , ( between-group comparison , p=0.03 ) . The patients in the former group also experienced improvements in their triglyceride levels , without experiencing any major adverse effects or a decline in the quality of life . CONCLUSION Our findings suggest that a low-carbohydrate diet is effective in lowering the HbA1c and triglyceride levels in patients with type 2 diabetes who are unable to adhere to a calorie-restricted diet",
"BACKGROUND Glucose-dependent insulinotropic polypeptide [ also known as gastric inhibitory polypeptide ( GIP ) ] and its receptor ( GIPR ) may link overnutrition to obesity , insulin resistance , and type 2 diabetes . A GIPR variant rs2287019 was recently associated with obesity and glucose metabolism . OBJECTIVE We aim ed to examine whether weight-loss diets that vary in fat content may modify the effect of this variant on changes in body weight , fasting glucose , and insulin resistance in the Preventing Overweight Using Novel Dietary Strategies ( POUNDS LOST ) trial . DESIGN We genotyped the GIPR rs2287019 in 737 overweight adults who were r and omly assigned to 1 of 4 weight-loss diets that varied in macronutrient contents for 2 y. We assessed the percentage changes in body weight , fasting glucose , and insulin resistance ( HOMA-IR ) across genotypes by the low-fat and high-fat diets . RESULTS At 6 mo of diet intervention , the T allele of rs2287019 was associated with greater weight loss ( β ± SE : -1.05 ± 0.56 % ; P = 0.06 ) and greater decreases in fasting glucose ( β ± SE : -2.33 ± 0.86 % ; P = 0.006 ) , fasting insulin ( β ± SE : -8.76 ± 4.13 % ; P = 0.03 ) , and HOMA-IR ( β ± SE : -10.52 ± 4.39 % ; P = 0.01 ) in participants who were assigned to low-fat diets , whereas there was no significant genotype effect on changes in these traits in the group assigned to the high-fat diet ( all P > 0.44 ; P-interaction = 0.08 , 0.04 , 0.10 , and 0.07 , respectively ) . After correction for multiple tests ( significant P = 0.008 ) , the genotype effect on changes in fasting glucose remained significant . Sensitivity analysis in white participants showed that the interactions were more evident on changes in insulin and HOMA-IR ( P-interaction improvement of glucose homeostasis in individuals who choose a low-fat , high-carbohydrate , and high-fiber diet . The POUNDS LOST trial was registered at clinical trials.gov as NCT00072995",
"Abstract Aims /hypothesisThe aim of the study was to determine whether basal insulin resistance ( IR ) phenotype ( muscle and /or liver ) determines the effect of long-term consumption of a Mediterranean diet or a low-fat diet on tissue-specific IR and beta cell function . Methods The study was performed in 642 patients included in The effect of an olive oil rich Mediterranean diet on type 2 diabetes mellitus risk and incidence study ( CORDIOPREV-DIAB ) . A total of 327 patients were r and omised to a Mediterranean diet ( 35 % fat ; 22 % from monounsaturated fatty acids ) and 315 to a low-fat diet ( . At baseline , the patients were classified into four phenotypes according to the type of IR : ( 1 ) no IR ; ( 2 ) muscle IR ; ( 3 ) liver IR ; ( 4 ) muscle + liver IR . The hepatic insulin resistance index ( HIRI ) , muscular insulin sensitivity index ( MISI ) and disposition index were analysed at baseline and after 2 years of follow-up . Results At baseline , 322 patients presented no IR , 106 presented muscle IR , 109 presented liver IR , and 105 presented muscle + liver IR . With both dietary interventions , HIRI decreased in all patients ( p MISI increased in muscle IR and muscle + liver IR patients ( p the Mediterranean diet increased the disposition index and insulinogenic index in the muscle IR patients ( p = 0.042 and p = 0.044 , respectively ) and the disposition index in the muscle + liver IR patients ( p = 0.048 ) , whereas the low-fat diet increased the disposition index in the liver IR patients ( p = 0.017 ) . Conclusions /interpretationAlthough both diets improve insulin sensitivity , there are differences based on basal IR phenotypes . Moreover , according to insulinogenic and disposition index data , a low-fat diet might be more beneficial to patients with liver IR , whereas patients with muscle IR and muscle + liver IR might benefit more from a Mediterranean diet . Trial registration Clinical Trials.gov NCT00924937 Funding The study was supported by the Ministerio de Economia y Competitividad ( AGL2012/39615 ) and by the Ministerio de Ciencia e Innovacion ( PIE14/00005 and PI13/00023",
"OBJECTIVE To assess the long-term effects of dietary interventions on glycemic control , need for diabetes medications , and remission of type 2 diabetes . RESEARCH DESIGN AND METHODS Originally , in a two-arm trial design , overweight , middle-aged men and women with newly diagnosed type 2 diabetes were r and omized to a low-carbohydrate Mediterranean diet ( LCMD ; n = 108 ) or a low-fat diet ( n = 107 ) . After 4 years , participants who were still free of diabetes medications were further followed up until the primary end point ( need of a diabetic drug ) ; remission of diabetes ( partial or complete ) and changes in weight , glycemic control , and cardiovascular risk factors were also evaluated . RESULTS The primary end point was reached in all participants after a total follow-up of 6.1 years in the low-fat group and 8.1 years in the LCMD group ; median survival time was 2.8 years ( 95 % CI 2.4–3.2 ) and 4.8 years ( 4.3–5.2 ) , respectively . The unadjusted hazard ratio for the overall follow-up was 0.68 ( 0.50–0.89 ; P LCMD participants were more likely to experience any remission ( partial or complete ) , with a prevalence of 14.7 % ( 13.0–16.5 % ) during the first year and 5.0 % ( 4.4–5.6 % ) during year 6 compared with 4.1 % ( 3.1–5.0 % ) at year 1 and 0 % at year 6 in the low-fat diet group . CONCLUSIONS In patients with newly diagnosed type 2 diabetes , an LCMD result ed in a greater reduction of HbA1c levels , higher rate of diabetes remission , and delayed need for diabetes medication compared with a low-fat diet",
"OBJECTIVE To determine whether the lipoprotein response to weight loss in obese patients with type 2 diabetes can be improved by modifying the macronutrient composition of the commonly prescribed low-fat , high-carbohydrate ( CHO ) hypocaloric diet . RESEARCH DESIGN AND METHODS Nine obese patients with type 2 diabetes were treated with a monounsaturated fatty acid (MUFA)-enriched weight-reducing formula diet and compared with eight obese patients with type 2 diabetes treated with a low-fat , high-CHO weight-reducing formula diet . Weight loss ensued for 6 weeks , followed by 4 weeks of refeeding using isocaloric formulas enriched with MUFA or CHO , respectively . Fasting blood sample s were obtained to measure plasma lipoproteins and LDL susceptibility to oxidation ( measured as lag time : time required to induce in vitro formation of conjugated dienes ) . RESULTS At baseline , there were no differences between the groups in plasma lipids , lipoproteins , or LDL susceptibility to oxidation . Weight loss was similar between the groups . Dieting result ed in decreases in total plasma cholesterol , LDL , HDL , triglycerides , and apolipoproteins A and B ( P total cholesterol , triglycerides , and apolipoprotein B and a smaller decrease in HDL and apolipoprotein A than the CHO group ( P lag time was prolonged in the MUFA group ( 208 ± 10 min ) compared with the CHO group ( 146 ± 11 min ; P 0.05 ) . Lag time was prolonged further during refeeding in the MUFA group ( 221 ± 13 min , P = 0.10 ) , while the CHO group remained unchanged ( 152 ± 9 min , P 0.05 ) . Lag time correlated strongly with the oleic acid content of LDL after dieting and refeeding ( r = 0.74 and r = 0.93 , respectively ; both P obese patients with type 2 diabetes . MUFA-enriched hypocaloric diets potentiate the beneficial effects of weight loss to ameliorate cardiovascular risk factors in obese patients with type 2 diabetes",
"BACKGROUND Current dietary guidelines recommend the replacement of saturated fatty acids ( SAFAs ) with carbohydrates or monounsaturated fatty acids ( MUFAs ) based on evidence on lipid profile alone , the chronic effects of the mentioned replacements on insulin secretion and insulin sensitivity are however unclear . OBJECTIVE To assess the chronic effects of the substitution of refined carbohydrate or MUFA for SAFA on insulin secretion and insulin sensitivity in central ly obese subjects . METHODS Using a crossover design , r and omized controlled trial in abdominally overweight men and women , we compared the effects of substitution of 7 % energy as carbohydrate or MUFA for SAFA for a period of 6 weeks each . Fasting and postpr and ial blood sample s in response to corresponding SAFA , carbohydrate , or MUFA-enriched meal-challenges were collected after 6 weeks on each diet treatment for the assessment of outcomes . RESULTS As expected , postpr and ial nonesterified fatty acid suppression and elevation of C-peptide , insulin and glucose secretion were the greatest with high-carbohydrate ( CARB ) meal . Interestingly , CARB meal attenuated postpr and ial insulin secretion corrected for glucose response ; however , the insulin sensitivity and disposition index were not affected . SAFA and MUFA had similar effects on all markers except for fasting glucose-dependent insulinotropic peptide concentrations , which increased after MUFA but not SAFA when compared with CARB . CONCLUSION In conclusion , a 6-week lower-fat/higher-carbohydrate ( increased by 7 % refined carbohydrate ) diet may have greater adverse effect on insulin secretion corrected for glucose compared with isocaloric higher-fat diets . In contrast , exchanging MUFA for SAFA at 7 % energy had no appreciable adverse impact on insulin secretion",
"Objective : To compare effects of a high carbohydrate ( high-CHO ) and a monounsaturated fat diet ( high-MUFA ) on body fat distribution and sex hormones in post-menopausal women with Type 2 diabetes . Design : R and omised cross-over with no washout . Setting : Geelong Hospital outpatient . Subjects : Thirty four women were recruited , 30 completed the study , and data are presented for 21 women compliant to the high-CHO diet . Interventions : Women followed a high-CHO diet ( 20 % energy ( % E ) from fat , 60%E from carbohydrate and a high-MUFA diet ( 40%E from fat , half as monounsaturated fat , 40%E from carbohydrate ) in r and om order for 12 weeks each . Main outcome measures : Dietary compliance was measured by change in linoleic acid ( C18:2 , ω-6 ) in plasma cholesteryl esters . Body composition was measured by dual-energy X-ray absorptiometry . Fasting concentrations of glucose and insulin were measured in plasma . Steroid hormones and sex hormone binding globulin ( SHBG ) were measured in serum . Results : On the high-CHO diet C18:2 , ω-6 in plasma cholesteryl esters declined by 5.4 % ( 95 % confidence intervals ( CI ) , −2.5 % to −8.4 % , P=0.0015 ) . Fat was lost mainly from the lower body ( lower body loss −0.71 kg , 95 % CI , −0.43 to −1.00 kg , P=0.001 ; upper body loss −0.15 kg , 95 % CI , −0.76 to + 0.46 kg , P=0.6 ) . Yet on the high-MUFA diet , lower body fat loss was minimal ( −0.22 kg , 95%CI , + 0.11 to −0.55 kg , P=0.2 ) . By general linear modelling ( GLM ) , differences in lower body fat loss were significantly related to diet ( P=0.04 ) . After adjustment for age , dehydroepi and rosterone sulphate ( DHEAS ) concentrations after the high-CHO diet were related to levels of lower body fat ( r=0.394 , P=0.04 ) . Conclusions : In women with Type 2 diabetes following a high-CHO diet for 12 weeks the disproportionate loss of lower body fat is related to a decline in DHEAS.Sponsorship : Supported by grant 950921 from the National Health and Medical Research Council of Australia",
"Objective : High-carbohydrate (HC)–high-fibre diets are recommended for weight loss and for treating and preventing diseases such as diabetes and cardiovascular disease . We report a r and omised trial comparing high-fat ( HF ) and high-protein ( HP ) diets with the conventional approach . Research design and methods : A total of 93 overweight insulin-resistant women received advice following r and omisation to HF , HP or HC dietary regimes , to achieve weight loss followed by weight maintenance over 12 months . Weight , body composition and measures of carbohydrate and lipid metabolism were investigated . Results : Retention rates were 93 % for HP and 75 % for HC and HF . Features of the metabolic syndrome improved in all groups during the first 6 months , to a greater extent on HF and HP than an HC . During the second 6 months the HF group had increases in waist circumference ( mean difference 4.4 cm ( 95 % CI 3.0 , 5.8 ) ) , fat mass ( 2.3 kg ( 1.5 , 3.1 ) ) , triglycerides ( 0.28 mmol/l ( 0.09 , 0.46 ) ) and 2 h glucose ( 0.70 mmol/l ( 0.22 , 1.18 ) ) . Overall there was substantial sustained improvement in waist circumference , triglycerides and insulin in the HP group and sustained but more modest changes on HC . Dietary compliance at 12 months was poor in all groups . Conclusions : HP and HC approaches appear to be appropriate options for insulin-resistant individuals . When recommending HP diets appropriate composition of dietary fat must be ensured . HC diet recommendations must include advice regarding appropriate high-fibre , low glycaemic index foods",
"The adequate composition of carbohydrate and fat in low calorie diets for type 2 diabetes mellitus patients with obesity is not fully established . The aim of this study was to investigate the effects of low carbohydrate diet on glucose and lipid metabolism , especially on visceral fat accumulation , and comparing that of a high carbohydrate diet . Obese subjects with type 2 diabetes mellitus were r and omly assigned to take a low calorie and low carbohydrate diet ( n = 11 , 1000 kcal per day , protein : carbohydrate : fat = 25:40:35 ) or a low calorie and high carbohydrate diet ( n = 11 , 1000 kcal per day , protein : carbohydrate : fat = 25:65:10 ) for 4 weeks . Similar decreases in body weight and serum glucose levels were observed in both groups . Fasting serum insulin levels were reduced in the low carbohydrate diet group compared to the high carbohydrate diet group ( -30 % versus -10 % , P Total serum cholesterol and triglyceride levels decreased in both groups , but were not significantly different from each other . High-density lipoprotein-cholesterol ( HDL-C ) increased in the low carbohydrate diet group but not in the high carbohydrate diet group ( + 15 % versus 0 % , P visceral fat area measured by computed tomography in the low carbohydrate diet group compared to the high carbohydrate diet group ( -40 cm(2 ) versus -10 cm(2 ) , P ratio of visceral fat area to subcutaneous fat area did not change in the high carbohydrate diet group ( from 0.70 to 0.68 ) , but it decreased significantly in the low carbohydrate diet group ( from 0.69 to 0.47 , P low calorie/low carbohydrate diet might be more effective treatment for a reduction of visceral fat , improved insulin sensitivity and increased in HDL-C levels than low calorie/high carbohydrate diet in obese subjects with type 2 diabetes mellitus",
"OBJECTIVE To compare three sets of dietary guidelines for the treatment of non-insulin-dependent diabetes ( NIDDM ) in free-living individuals and to observe the effects on metabolic control over an 18-month period . RESEARCH DESIGN AND METHODS Seventy volunteer subjects with NIDDM were r and omly assigned to one of three diets , a weight-management diet , a high-carbohydrate/fiber diet , or a modified-lipid diet and followed for 18 months . Nutrient intakes , weight , blood lipids , and glycemic control were measured . RESULTS In all diet groups , glycated hemoglobin ( HbA1 ) fell significantly before diet intervention began , remaining lower throughout the study and at follow-up 9 months later . Low-density lipoprotein ( LDL ) cholesterol showed a sustained fall in all groups after diet intervention . Apart from transient changes in high-density lipoprotein ( HDL ) cholesterol and triglyceride ( TG ) in the diet groups with the higher carbohydrate intake , no lasting differences were found between the three diet groups . CONCLUSIONS In the long term , there were few differences in the outcome of the three dietary prescriptions . Even with intensive instruction , participants found it difficult to meet recommended nutrient intakes ; however , specific dietary advice did result in an improvement in LDL cholesterol . Adverse changes in HDL cholesterol and TG because of diet intervention were transient . The significant improvement in glycemic control during the recruitment phase may have been the result of particpants ' previous dietary knowledge and the increased attention that they received during the intervention",
"Background Low-carbohydrate diets have been shown to effectively improve the metabolic status of patients with type 2 diabetes mellitus . However , patients may find it challenging to maintain a strict low-carbohydrate diet . The objective of this study was to determine if a one-meal , low-carbohydrate diet is as effective in improving metabolic status as a conventional , energy-restricted diet among patients with type 2 diabetes mellitus . Methods In this 12-week r and omized controlled study , the primary endpoint was differences in the changes of plasma glycosylated hemoglobin ( HbA1c ) levels between the two experimental groups . Since the two groups had differences in body weight , body mass index , and waist circumference , propensity score matching was used to assess HbA1c outcomes via cohort pairs according to age , sex , body weight , HbA1c level , and waist circumference . Results There were no differences in the changes in HbA1c between the two groups ( P = 0.95 ) . In addition , there were no differences in the changes in glycated albumin , 1,5-anhydroglucitol , lipid profile , body weight , waist circumference , and fat mass between the two groups . The mini low-carbohydrate diet group had an increased protein intake ( P = 0.0085 ) , as compared with the control group . However , neither group showed changes in their Diabetes Treatment Satisfaction Question naire score . Conclusion Either diet would be effective for improving the metabolic status of this study population",
"Elevated postpr and ial blood glucose levels constitute a global epidemic and a major risk factor for prediabetes and type II diabetes , but existing dietary methods for controlling them have limited efficacy . Here , we continuously monitored week-long glucose levels in an 800-person cohort , measured responses to 46,898 meals , and found high variability in the response to identical meals , suggesting that universal dietary recommendations may have limited utility . We devised a machine-learning algorithm that integrates blood parameters , dietary habits , anthropometrics , physical activity , and gut microbiota measured in this cohort and showed that it accurately predicts personalized postpr and ial glycemic response to real-life meals . We vali date d these predictions in an independent 100-person cohort . Finally , a blinded r and omized controlled dietary intervention based on this algorithm result ed in significantly lower postpr and ial responses and consistent alterations to gut microbiota configuration . Together , our results suggest that personalized diets may successfully modify elevated postpr and ial blood glucose and its metabolic consequences . VIDEO ABSTRACT",
"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 To evaluate the effects of qualitative dietary changes and the interaction with aerobic exercise training on liver fat content independent of weight loss in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS With use of a factorial 2 × 2 r and omized parallel-group design , 37 men and 8 women , aged 35–70 years , with type 2 diabetes in satisfactory blood glucose control on diet or diet plus metformin treatment were assigned to one of the following groups for an 8-week period : 1 ) high-carbohydrate/high-fiber/low – glycemic index diet ( CHO/fiber group ) , 2 ) high-MUFA diet ( MUFA group ) , 3 ) high-carbohydrate/high-fiber/low – glycemic index diet plus physical activity program ( CHO/fiber+Ex group ) , and 4 ) high-MUFA diet plus physical activity program ( MUFA+Ex group ) . Before and after intervention , hepatic fat content was measured by 1H NMR . RESULTS Dietary compliance was optimal and body weight remained stable in all groups . Liver fat content decreased more in MUFA ( −29 % ) and MUFA+Ex ( −25 % ) groups than in CHO/fiber ( −4 % ) and CHO/fiber+Ex groups ( −6 % ) . Two-way repeated- measures ANOVA , including baseline values as covariate , showed a significant effect on liver fat content for diet ( P = 0.006 ) , with no effects for exercise training ( P = 0.789 ) or diet-exercise interaction ( P = 0.712 ) . CONCLUSIONS An isocaloric diet enriched in MUFA compared with a diet higher in carbohydrate and fiber was associated with a clinical ly relevant reduction of hepatic fat content in type 2 diabetic patients independent of an aerobic training program and should be considered for the nutritional management of hepatic steatosis in people with type 2 diabetes",
"Objective Dietary carbohydrate is the major determinant of postpr and ial glucose levels , and several clinical studies have shown that low-carbohydrate diets improve glycemic control . In this study , we tested the hypothesis that a diet lower in carbohydrate would lead to greater improvement in glycemic control over a 24-week period in patients with obesity and type 2 diabetes mellitus . Research design and methods Eighty-four community volunteers with obesity and type 2 diabetes were r and omized to either a low-carbohydrate , ketogenic diet ( LCKD ) or a low-glycemic , reduced-calorie diet ( 500 kcal/day deficit from weight maintenance diet ; LGID ) . Both groups received group meetings , nutritional supplementation , and an exercise recommendation . The main outcome was glycemic control , measured by hemoglobin A1c . Results Forty-nine ( 58.3 % ) participants completed the study . Both interventions led to improvements in hemoglobin A1c , fasting glucose , fasting insulin , and weight loss . The LCKD group had greater improvements in hemoglobin A1c ( -1.5 % vs. -0.5 % , p = 0.03 ) , body weight ( -11.1 kg vs. -6.9 kg , p = 0.008 ) , and high density lipoprotein cholesterol ( + 5.6 mg/dL vs. 0 mg/dL , p Diabetes medications were reduced or eliminated in 95.2 % of LCKD vs. 62 % of LGID participants ( p Dietary modification led to improvements in glycemic control and medication reduction/elimination in motivated volunteers with type 2 diabetes . The diet lower in carbohydrate led to greater improvements in glycemic control , and more frequent medication reduction/elimination than the low glycemic index diet . Lifestyle modification using low carbohydrate interventions is effective for improving and reversing type 2 diabetes",
"OBJECTIVE To compare the effects of a 1-year intervention with a low-carbohydrate and a low-fat diet on weight loss and glycemic control in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS This study is a r and omized clinical trial of 105 overweight adults with type 2 diabetes . Primary outcomes were weight and A1C . Secondary outcomes included blood pressure and lipids . Outcome measures were obtained at 3 , 6 , and 12 months . RESULTS The greatest reduction in weight and A1C occurred within the first 3 months . Weight loss occurred faster in the low-carbohydrate group than in the low-fat group ( P = 0.005 ) , but at 1 year a similar 3.4 % weight reduction was seen in both dietary groups . There was no significant change in A1C in either group at 1 year . There was no change in blood pressure , but a greater increase in HDL was observed in the low-carbohydrate group ( P = 0.002 ) . CONCLUSIONS Among patients with type 2 diabetes , after 1 year a low-carbohydrate diet had effects on weight and A1C similar to those seen with a low-fat diet . There was no significant effect on blood pressure , but the low-carbohydrate diet produced a greater increase in HDL cholesterol",
"Fifteen non-insulin-dependent diabetic patients with persistently elevated blood glucoses despite high doses of oral hypoglycaemic agents , were r and omly allocated to a high carbohydrate-high fibre diet ( HC ) or a reinforced low carbohydrate diet ( LC ) . After six weeks the diets were reversed for a similar period . Immediately preceding the study and at the end of each dietary period 24-h biochemical profiles were performed . In the 11 patients who completed the study , fasting and prepr and ial glucose , percentage glycosylated haemoglobin , VLDL cholesterol and mean 24-h triglycerides were significantly lower on HC than on LC or during the initial profile on their usual diet . There was no significant difference in any of the measurements on LC compared with the usual diet . Previous studies of high carbohydrate-high fibre diets in diabetes have been carried out in relatively well-controlled patients . These data show that poorly controlled non-insulin-dependent patients have an even more striking response",
"Our aims were 1 ) to examine the effects of a high-carbohydrate low-fat diet on fasting and postpr and ial plasma lipids , apolipoproteins ( apo ) , and lipoprotein composition in noninsulin-dependent diabetes mellitus , and 2 ) to determine whether postpr and ial shift of apo between triglyceride-rich lipoproteins ( TRLP ) and high density lipoproteins ( HDL ) is affected by diet . A cross-over study , of 4 weeks duration , of a high-carbohydrate ( 60 % carbohydrate , 20 % fat ) and a high-fat ( 40 % carbohydrate , 40 % fat ) diet was performed in seven subjects with noninsulin-dependent diabetes mellitus . TRLP , low density lipoproteins ( LDL ) , and HDL were separated by fast protein liquid chromatography . The high-carbohydrate diet result ed in a decrease of fasting total , HDL , and LDL cholesterol and a trend toward an increase in plasma triglycerides . The apo composition of fasting TRLP and HDL was similar on both diets . TRLP apo CII , CIII , and E increased whereas HDL apo CII , CIII , and E decreased postpr and ially on both diets . In contrast , TRLP apo CI increased , and HDL apo CI decreased only after the high-carbohydrate diet . We conclude that 1 ) a high carbohydrate diet results in a decrease in total , LDL , and HDL cholesterol and a trend toward an increase in plasma triglycerides ; 2 ) fasting TRLP and HDL apo composition was similar on a high-carbohydrate or a high-fat diet ; and 3 ) on both diets , apo CII , CIII , and E transfer from HDL to TRLP postpr and ially . However , only the high-carbohydrate diet induced postpr and ial transfer of apo CI from HDL to TRLP . This may explain in part the changes in lipoproteins observed with this diet",
"OBJECTIVE To examine the effects of a high-carbohydrate low-fat ( HCLF ) and a modified-fat ( MF ) diet on body weight and metabolic control in subjects with non-insulin-dependent diabetes mellitus ( NIDDM ) living at home . RESEARCH DESIGN AND METHODS Twenty-four NIDDM patients followed HCLF and MF diets alternately and in r and om order for a 3-month period while at home , with a 1-month baseline and washout between diets . Before and after each diet , fasting glucose and lipids , HbAlc , blood pressure , and body weight were measured . Dietary preferences were assessed by question naire . RESULTS Subjects consumed 50 % of energy as carbohydrate and 23 % as fat on the HCLF diet and 40 % of energy as carbohydrate and 36 % as fat ( over half of which was monounsaturated fat ) on the MF diet . Subjects lost weight on both HCLF and MF diets ( mean loss 0.7 and 1.3 kg , respectively ) . Although the MF diet result ed in a small decrease in fasting glucose levels , there was no significant change in HbA1c . Similarly , there was no significant difference between the diets in changes in blood pressure or fasting blood lipids . Most subjects ( 65 % ) preferred the MF diet . CONCLUSIONS Although the MF diet is not a low-fat diet , it did not appear to facilitate weight gain in subjects with NIDDM living at home . The MF diet provides an alternative for individuals unable to comply with HCLF diets",
"OBJECTIVE To underst and why low-fat high-carbohydrate ( CHO ) diets lead to higher fasting and postpr and ial concentrations of triglyceride (TG)-rich lipoproteins in patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . RESEARCH DESIGN AND METHODS Patients with NIDDM were placed r and omly on diets containing either 55 % CHO , 30 % fat , and 15 % protein or 40 % CHO , 45 % fat , and 15 % protein for 6 weeks , followed by crossover to the other diet . Test meals at the end of each diet period were consumed at 8:00 A.M. and 12:00 P.M. ( noon ) and contained 20 and 40 % of daily calories , respectively . Vitamin A was also given at noon , and TG-rich lipoproteins of intestinal origin were identified by the presence of vitamin A esters . Frequent measurements were made throughout the 24-h study period of plasma glucose , insulin , and TG concentrations . Plasma sample s obtained from 12:00 P.M. ( noon ) until 12 A.M. ( midnight ) were subjected to ultracentrifugation , and measurements were made of TG and vitamin A ester concentrations in plasma and in both the Svedberg flotation constant ( Sf ) > 400 ( chylomicron ) and Sf 20 - 400 ( chylomicron remnant ) lipoprotein fractions . In addition , very-low-density lipoprotein (VLDL)-TG turnover rate was estimated by following the decay of [3H]VLDL-TG . Finally , postheparin lipoprotein lipase and hepatic lipase activities were measured at the end of each dietary period . RESULTS Mean ± SE hourly concentrations of glucose ( 8.0 ± 0.8 vs. 7.5 ± 0.7 mmol/1 ) , insulin ( 184 ± 26 vs. 158 ± 19 pmol/1 ) , and TG ( 2.8 ± 0.2 vs. 2.1 ± 0.2 mmol/1 ) were higher ( P after the 55 % CHO diet . The 55 % CHO diet also led to an increase ( P the mean ± SE hourly concentrations of vitamin A esters in plasma ( 2.3 ± 0.3 vs. 1.6 ±0.1 μmol/l ) and in both the chylomicron ( 2.0 ± 0.3 vs. 1.4 ±0.1 μmol/l ) and chylomicron remnant fractions ( 0.36 ± 0.04 vs. 0.14 ± 0.03 μmol;/l ) . In addition , the VLDL-TG production rate was higher ( 17.2 ± 1.4 vs. 12.8 ± 1.0 mg · kg−1 · h−1 , P the VLDL-TG fractional catabolic rate lower ( 0.22 ± 0.02 to 0.28 ± 0.02 l/h , P % CHO diet . Finally , there was an increase in lipoprotein lipase activity ( 7.0 ± 0.8 to 8.1 ± 0.7 μmol free fatty acids released · ml−1 · h−1 , P the CHO-enriched diet . CONCLUSIONS A low-fat high-CHO diet in patients with NIDDM led to 1 ) higher day-long plasma glucose , insulin , and TG concentrations ; 2 ) postpr and ial accumulation of TG-rich lipoproteins of intestinal origin ; 3 ) increased production of VLDL-TG ; and 4 ) increased postheparin lipoprotein lipase activity . These data provide a mechanism for the hypertriglycer-idemic effect of CHO-enriched diets in patients with NIDDM and demonstrate that multiple risk factors for coronary heart disease are accentuated when these individuals consume diets recommended to reduce this risk",
"We compared a high-carbohydrate diet with a high-fat diet ( specifically , a diet high in monounsaturated fatty acids ) for effects on glycemic control and plasma lipoproteins in 10 patients with non-insulin-dependent diabetes mellitus ( NIDDM ) receiving insulin therapy . The patients were r and omly assigned to receive first one diet and then the other , each for 28 days , in a metabolic ward . In the high-carbohydrate diet , 25 percent of the energy was in the form of fat and 60 percent in the form of carbohydrates ( 47 percent of the total energy was in the form of complex carbohydrates ) ; the high-monounsaturated-fat diet was 50 percent fat ( 33 percent of the total energy in the form of monounsaturated fatty acids ) and 35 percent carbohydrates . The two diets had the same amounts of simple carbohydrates and fiber . As compared with the high-carbohydrate diet , the high-monounsaturated-fat diet result ed in lower mean plasma glucose levels and reduced insulin requirements , lower levels of plasma triglycerides and very-low-density lipoprotein cholesterol ( lower by 25 and 35 percent , respectively ; P less than 0.01 ) , and higher levels of high-density lipoprotein ( HDL ) cholesterol ( higher by 13 percent ; P less than 0.005 ) . Levels of total cholesterol and low-density lipoprotein ( LDL ) cholesterol did not differ significantly in patients on the two diets . These preliminary results suggest that partial replacement of complex carbohydrates with monounsaturated fatty acids in the diets of patients with NIDDM does not increase the level of LDL cholesterol and may improve glycemic control and the levels of plasma triglycerides and HDL cholesterol",
"BACKGROUND For many people , maintenance of weight loss is elusive . Whereas high-protein ( HP ) diets have been found to be superior to high-carbohydrate ( HC ) diets for weight loss in the short term , their benefits long term are unclear , particularly for weight maintenance . Furthermore , the literature lacks consensus on the long-term effects of an HP diet on cardiovascular disease risk factors . OBJECTIVE The objective was to investigate whether macronutrient dietary composition plays a role in weight maintenance and in improvement of cardiovascular disease risk factors . DESIGN The study comprised 2 phases . Phase 1 featured a very-low-energy diet for 3 mo . In phase 2 , the subjects were r and omly assigned to an HP or an HC diet for 12 mo . The diets were isocaloric , tightly controlled , and individually prescribed for weight maintenance . The subjects were overweight or obese but otherwise healthy men and women . RESULTS The subjects lost an average of 16.5 kg during phase 1 and maintained a mean ( + /-SEM ) weight loss of 14.5 + /- 1.2 kg ( P systolic blood pressure were 14.3 + /- 2.4 mm Hg for the HP group and 7.7 + /- 2.2 mm Hg for the HC group ( P . Forty-seven percent of the 180 subjects who began the study completed both phases . CONCLUSIONS The results indicate that the protein or carbohydrate content of the diet has no effect on successful weight-loss maintenance . A general linear model analysis indicated that dietary treatment ( HP or HC ) was a significant factor in systolic blood pressure change and in favor of the HP diet . This trial was registered at www . clinical trials.gov as NCT 00625236",
"OBJECTIVE To study effects of variation in carbohydrate content of diet on glycemia and plasma lipoproteins in patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . DESIGN A four-center r and omized crossover trial . SETTING Outpatient and inpatient evaluation in metabolic units . PATIENTS Forty-two NIDDM patients receiving glipizide therapy . INTERVENTIONS A high-carbohydrate diet containing 55 % of the total energy as carbohydrates and 30 % as fats was compared with a high-monounsaturated-fat diet containing 40 % carbohydrates and 45 % fats . The amounts of saturated fats , polyunsaturated fats , cholesterol , sucrose , and protein were similar . The study diets , prepared in metabolic kitchens , were provided as the sole nutrients to subjects for 6 weeks each . To assess longer-term effects , a subgroup of 21 patients continued the diet they received second for an additional 8 weeks . MAIN OUTCOME MEASURES Fasting plasma glucose , insulin , lipoproteins , and glycosylated hemoglobin concentrations . Twenty-four-hour profiles of glucose , insulin , and triglyceride levels . RESULTS The site of study as well as the diet order did not affect the results . Compared with the high-monounsaturated-fat diet , the high-carbohydrate diet increased fasting plasma triglyceride levels and very low-density lipoprotein cholesterol levels by 24 % ( P daylong plasma triglyceride , glucose , and insulin values by 10 % ( P = .03 ) , 12 % ( P Plasma total cholesterol , low-density lipoprotein cholesterol , and high-density lipoprotein cholesterol levels remained unchanged . The effects of both diets on plasma glucose , insulin , and triglyceride levels persisted for 14 weeks . CONCLUSIONS In NIDDM patients , high-carbohydrate diets compared with high-monounsaturated-fat diets caused persistent deterioration of glycemic control and accentuation of hyperinsulinemia , as well as increased plasma triglyceride and very-low-density lipoprotein cholesterol levels , which may not be desirable",
"OBJECTIVE We compared the effects of a low glycemic index ( GI ) diet with the American Diabetes Association ( ADA ) diet on glycosylated hemoglobin ( HbA1c ) among individuals with type 2 diabetes . METHODS Forty individuals with poorly controlled type 2 diabetes were r and omized to a low-GI or an ADA diet . The intervention , consisting of eight educational sessions ( monthly for the first 6 mo and then at months 8 and 10 ) , focused on a low-GI or an ADA diet . Data on demographics , diet , physical activity , psychosocial factors , and diabetes medication use were assessed at baseline and 6 and 12 mo . Generalized linear mixed models were used to compare the two groups on HbA1c , diabetic medication use , blood lipids , weight , diet , and physical activity . RESULTS Participants ( 53 % female , mean age 53.5 y ) were predominantly white with a mean body mass index of 35.8 kg/m(2 ) . Although both interventions achieved similar reductions in mean HbA1c at 6 mo and 12 mo , the low-GI diet group was less likely to add or increase dosage of diabetic medications ( odds ratio 0.26 , P = 0.01 ) . Improvements in high-density lipoprotein cholesterol , triacylglycerols , and weight loss were similar between groups . CONCLUSION Compared with the ADA diet , the low-GI diet achieved equivalent control of HbA1c using less diabetic medication . Despite its limited size , this trial suggests that a low-GI diet is a viable alternative to the ADA diet . Findings should be evaluated in a larger r and omized controlled trial",
"Summary Type 2 ( insulin independent ) diabetic women were r and omly allocated to receive advice for low fat diets or low carbohydrate diets . By 24 h weighed dietary intakes before and after a mean interval of six months , patients in the low fat group had reduced their fat intake from 41 % to 31 % of total energy , while carbohydrate percentage of total energy intake increased from 38 % to 46 % . Percentage energy intake from fat and carbohydrate in the control group remained unchanged . Body weight fell in both groups , especially for patients in the low fat group who were obese ( weight/height2 ⩾ 28 kg/m2 ) . Mean plasma glucose , HbA1 , and triglycerides were unchanged . Mean plasma total cholesterol fell significantly in the low fat group compared with the controls ( p reduction of high density lipoprotein cholesterol observed in both groups . Thus , adherence to low fat diets occurred without deterioration of diabetes and with benefit for weight and total cholesterol ",
"OBJECTIVE To investigate whether blood pressure is different in type 2 diabetic patients on a diet rich in carbohydrates versus a diet rich in cis-monounsaturated fatty acids . Data on the dietary effects on these diets ' glucose and lipid metabolism have been previously published . RESEARCH DESIGN AND METHODS The study compared the effect of feeding 42 type 2 diabetic patients a carefully controlled isoenergic high-carbohydrate ( high-carb ; 55 % energy as carbohydrate , 30 % as fat , and 10 % as monounsaturated fat ) and high-monounsaturated fat ( high-mono ; 45 % energy as fat , 25 % as monounsaturated fat , and 40 % as carbohydrate ) diet for 6 weeks each in a four-center , r and omized , cross-over study on blood pressure . Twenty-one patients continued the diet they received during the second phase for an additional 8 weeks . RESULTS According to repeated- measures ANOVA , blood pressure during the last 3 days of each phase was similar after 6 weeks of the high-carb and high-mono diets ( systolic blood pressure : 128 + /- 16 vs. 127 + /- 15 mmHg , P = 0.9 ; diastolic blood pressure : 75 + /- 7 vs. 75 + /- 8 mmHg , P = 0.7 ) . However , after 14 weeks of the high-carb diet ( n = 13 ) , there was a significant increase in blood pressure compared with 6 weeks of the high-mono diet ( systolic blood pressure : 132 + /- 13 vs. 126 + /- 11 mmHg , P = 0.04 ; diastolic blood pressure : 83 + /- 6 vs. 76 + /- 7 mmHg , P = 0.002 ) . After 14 weeks of the high-mono diet ( n = 8) , the reduction in blood pressure was not significant compared with 6 weeks of the high-carb diet ( systolic blood pressure : 118 + /- 14 vs. 121 + /- 16 mmHg , P = 0.4 ; diastolic blood pressure : 71 + /- 8 vs. 75 + /- 10 mmHg , P = 0.3 ) . CONCLUSION Although the exchange of carbohydrates with monounsaturated fats may not affect blood pressure in the short term , long-term consumption of a high-carbohydrate diet may modestly raise blood pressure in type 2 diabetic patients",
"1 . A prospect i ve r and omized study of two dietary regimens has been started in newly-diagnosed diabetics to determine their effect on circulating metabolites and on diabetic complications . 2 . During the first year of treatment the fasting plasma glucose concentrations on both the low-carbohydrate diet and the high-carbohydrate , modified-fat ( MF ) diet showed a similar decrease . 3 . Plasma cholesterol showed a sustained decrease only in patients recommended a MF diet . Transient changes in plasma triglyceride concentrations occurred in patients on both dietary regimens . 4 . Increased plasma cholesterol levels are associated with atheromatous disease which is common in diabetics in Europe and North America . A MF diet may therefore have an advantage in that it lowers the plasma cholesterol as well as being effective in lowering the plasma glucose",
" A group of non-insulin dependent diabetics taking oral hypoglycaemic therapy were studied to determine the effect of improved diabetic control on the platelet levels of the prostagl and in precursor fatty acids . The patients were r and omised to receive either a low carbohydrate diet ( 35 % of total energy ) for six weeks or a high carbohydrate diet ( 55 % of total energy ) , high fibre diet for six weeks and the diets were then reversed . At the end of the high carbohydrate , high fibre diet the mean fasting blood glucose ( 6.6 mmol section 1 ) and mean percentage glycosylated haemoglobin ( 8.2 % ) were significantly lower than after the low carbohydrate diet ( 7.8 . mmol/l , p less than 0.05 : 9.9 % , p less than 0.01 ) . Mean platelet phospholipid arachidonic acid percentage was significantly higher after the high carbohydrate , high fibre diet ( 24.2 % ) than after the low carbohydrate diet ( 19.9 % , p less than 0.01 ) . There were no significant changes in the other platelet fatty acids",
"Although low-fat high-carbohydrate diets are recommended for patients with non-insulin-dependent diabetes mellitus ( NIDDM ) in an effort to reduce the risk of coronary artery disease ( CAD ) , the results of short-term studies have shown that these diets can lead to changes in carbohydrate and lipid metabolism associated with an increased risk of CAD . This study has extended these earlier observations by determining the metabolic effects of such diets over a longer period in these patients . The comparison diets contained either 40 or 60 % of the total calories as carbohydrates , with reciprocal changes in fat content from 40 to 20 % consumed in r and om order for 6 wk in a crossover experimental design . The ratio of polyunsaturated to saturated fat and the total cholesterol intake were held constant in the two diets . Plasma glucose and insulin concentrations were significantly ( P carbohydrate diet , and 24-h urinary glucose excretion more than doubled ( 0.8 vs. 1.8 mol/24 h ) . Fasting plasma total and very-low-density lipoprotein ( VLDL ) triglyceride ( TG ) concentrations increased by 30 % ( P % carbohydrate diet , and the magnitude of carbohydrate-induced hypertriglyceridemia persisted unchanged throughout the 6-wk study period . Total plasma cholesterol concentrations were similar after both diets . However , VLDL cholesterol ( VLDL-chol ) was significantly increased , whereas both low-density lipoprotein ( LDL- ) and high-density lipoprotein ( HDL- ) chol concentrations were significantly decreasedafter consumption of the 60 % carbohydrate diet . Consequently , neither total-chol-to-HDL-chol nor LDL-chol-to-HDL-chol ratios changed . The results of this study indicate that high-carbohydrate diets lead to several changes in carbohydrate and lipid metabolism in patients with NIDDM that could lead to an increased risk of CAD , and these effects persist for > 6 wk . Given these results , it seems reasonable to suggest that the routine recommendation of low-fat high-carbohydrate diets for patients with NIDDM be reconsidered",
"OBJECTIVE To determine the optimal diet for improving glucose and lipid profiles in obese patients with type 2 diabetes during moderate energy restriction . RESEARCH DESIGN AND METHODS A total of 35 free-living obese patients with type 2 diabetes were assigned to one of three 1,600 kcal/day diets for 12 weeks . The diets were high carbohydrate ( 10 % fat , 4 % saturated ) , high monounsaturated fat ( MUFA ) ( 32 % fat , 7 % saturated ) , or high saturated fat ( SFA ) ( 32 % fat , 17 % saturated ) . RESULTS Diet composition did not affect the magnitude of weight loss , with subjects losing an average of 6.6 + /- 0.9 kg . Energy restriction and weight loss result ed in reductions in fasting plasma glucose ( -14 % ) , insulin ( -27 % ) , GHb ( -14 % ) , and systolic ( -7 % ) and diastolic blood pressure ( -10 % ) levels and the glucose response area ( -17 % ) independent of diet composition . Diet composition did affect the lipoprotein profile . LDL was 10 % and 17 % lower with the high-carbohydrate and high-MUFA diets , respectively , whereas no change was observed with the high-SFA diet ( P HDL was transiently reduced on the high-carbohydrate diet at weeks 1 , 4 , and 8 , whereas higher fat consumption maintained these levels . The total cholesterol : HDL ratio , although significantly reduced on the high-MUFA diet ( P glycemic control ; however , reducing SFA intake by replacing SFA with carbohydrate or MUFA reduces LDL maximally during weight loss and to a greater degree than has been shown in weight-stable studies",
"In comparison to a traditional low carbohydrate diet ( LC ) , the effect of an isocaloric high carbohydrate , high fibre diet ( HC ) upon the insulin binding to mononuclear blood cells of seven non-insulin-dependent diabetics was examined . Each subject , in r and om order , took both diets for 6 weeks each . There was no significant difference in weight during either dietary period , but a significant ( P less than 0.05 ) increase in the monocyte insulin binding activity on the HD diet ( tracer specific binding : 4.2 % HC ; 3.5 % LC ) . This was accompanied by a significantly ( P less than 0.02 ) lower fasting plasma glucose concentration ( LC = 7.1 mmol/l ; HC = 6.1 ) without a significant change in the fasting plasma insulin level . In contrast to the usual low carbohydrate diet , a high carbohydrate diet tends to correct the lowered insulin receptor status observed in maturity-onset diabetics",
"In a r and omised cross-over study 18 nondependent ( NIDDM ) and 9 insulin-dependent ( IDDM ) diabetics were put on to a high carbohydrate diet containing leguminous fibre ( HL ) for 6 weeks , and also a st and ard low carbohydrate diet ( LC ) for 6 weeks . During two identical 24 h metabolic profiles mean prepr and ial and mean 2 hour postpr and ial blood glucoses were significantly lower on HL in both groups , as were also several overall measures of diabetic control , including the degree of glycosuria . Total cholesterol was reduced significantly on HL in both groups , and the HDL/LDL cholesterol ratio increased significantly on HL in the NIDDM group . A diet high in complex carbohydrate and leguminous fibre improves all aspects of diabetic control , and continued use of a low carbohydrate diet no longer appears justified",
"OBJECTIVE This study sought to examine the effects of a 3-month programme of dietary advice to restrict carbohydrate intake compared with reduced-portion , low-fat advice in obese subjects with poorly controlled Type 2 diabetes . RESEARCH DESIGN AND METHODS One hundred and two patients with Type 2 diabetes were recruited across three centres and r and omly allocated to receive group education and individual dietary advice . Weight , glycaemic control , lipids and blood pressure were assessed at baseline and 3 months . Dietary quality was assessed at the end of study . RESULTS Weight loss was greater in the low-carbohydrate ( LC ) group ( -3.55 + /- 0.63 , mean + /- sem ) vs. -0.92 + /- 0.40 kg , P = 0.001 ) and cholesterol : high-density lipoprotein ( HDL ) ratio improved ( -0.48 + /- 0.11 vs. -0.10 + /- 0.10 , P = 0.01 ) . However , relative saturated fat intake was greater ( 13.9 + /- 0.71 vs. 11.0 + /- 0.47 % of dietary intake , P short-term weight loss compared with st and ard advice , but this was at the expense of an increase in relative saturated fat intake",
"Approximately 80 % of patients with type 2 diabetes are overweight/obese ( 1 ) , and weight loss is the mainstay of treatment for these individuals . However , there is growing controversy as to whether reduced-fat or reduced-carbohydrate diets are best suited for this purpose , and results ( 2–8 ) in nondiabetic subjects suggest that lower carbohydrate diets are similarly or more efficacious in improving weight , triglycerides , and HDL cholesterol . There are no published r and omized studies evaluating the role of dietary macronutrients with respect to weight loss and cardiovascular risk improvement in patients with type 2 diabetes . Thus , we r and omized diet-treated patients with type 2 diabetes to hypocaloric diets , moderately restricted in either carbohydrate or fat , to determine whether weight loss or metabolic improvement differed as a function of macronutrient composition . A total of 29 patients with diet-treated type 2 diabetes were recruited from the San Francisco Bay area . All subjects gave written informed consent . Inclusion criteria included BMI 27–36 kg/m2 , fasting plasma glucose concentration 7.2–8.3 mmol/l , no use of antihyperglycemic medications , and stable weight for 3 months . Subjects on anti-hypertensive or cholesterol-lowering drugs or aspirin were allowed to continue their medications . Insulin-mediated glucose uptake was quantified by a modification ( 9 ) of the insulin suppression test as originally described ( 10 ) and vali date d ( 11 ) . In this test , a 180-min infusion of somatostatin ( 0.27 μg/m2 per min ) , insulin ( 25 mU/m2 per min ) ,",
"High-density lipoprotein ( HDL ) plays an important role in the process of reverse cholesterol transport , which may become suboptimal with increasing body fatness . HDL cholesterol that is reduced in obese subjects paradoxically decreases during weight reduction . To determine how weight reduction affects HDL subclasses that are involved in reverse cholesterol transport , we studied HDL from obese diabetic subjects before and after energy restriction within background diets high in either carbohydrate or monounsaturated fatty acids ( MUFAs ) . Body weight , blood glucose , total cholesterol , and LDL cholesterol decreased after 8 and 12 weeks of weight reduction . With the very-low-fat diet , HDL cholesterol decreased significantly at 8 weeks , but recovered to initial levels after 12 weeks as body weight began to stabilize . Plasma apolipoprotein A-I ( apo A-I ) decreased substantially and significantly at 8 and 12 weeks with both diets , and was reflected in the reduction of apo A-I in HDL subclasses alpha1 , alpha2 , pre-beta1 , and pre-beta2 + pre-beta3 . The calculation of the percentage distribution of apo A-I among HDL species showed that only the proportion of pre-beta1-HDL decreased , whereas alpha2-HDL increased . This led to a significant increase in the alpha1 + alpha2/pre-beta ratio , ie , the ratio of the large cholesterol \" storage \" or \" sink \" HDL to the HDL \" shuttle \" fraction considered to be the initial acceptor of cell cholesterol . These data suggest that despite the reduction in HDL cholesterol and apo A-I , the redistribution of apo A-I in pre-beta1-HDL and alpha-HDL observed with weight reduction appears to revert to the pattern that we have previously reported in lean as opposed to overweight subjects",
"OBJECTIVE To evaluate whether plasma fibrinogen concentration is correlated with the level of physical activity and aerobic power in patients with newly diagnosed non-insulin-dependent diabetes mellitus ( NIDDM ) . RESEARCH DESIGN AND METHODS We studied 78 middle-aged ( 54 ± 6 years , mean ± SD ) , obese ( body mass index [ BMI ] 32 ± 5 kg/m2 ) patients ( 45 men and 33 women ) before and after a 12-month treatment period consisting of either conventional treatment given by community health centers or intensified dietary and exercise education given by a university outpatient clinic . Plasma fibrinogen concentration was measured by using a coagulometer . Physical activity was assessed by a question naire , and the patients were classified into a sedentary group or moderately or intensively exercising groups . Aerobic power ( maximum oxygen uptake [ ] , anaerobic threshold [ ] ) was measured by direct breath-by-breath technique . RESULTS At baseline , the sedentary patients had higher fibrinogen concentration than those with moderate or high physical activities ( 3.8 ± 0.8 vs. 3.3 ± 0.7 g/I , P with fibrinogen ( r = -0.38 , P analysis , BMI , Vo2 max ( ml/min ) , and smoking were the only significant independent factors explaining 23 % of the variance in fibrinogen concentration . In sedentary patients , poor glycemie control was related with high fibrinogen concentration . During the follow-up period , patients maintained , on the average , good to moderate glycemie control . The originally sedentary group showed a decrease in fibrinogen concentration ( to 3.3 ± 0.7 g/I , P improved glycemie control , but not with any of the other assessed factors , including fatty acid composition of serum lipids reflecting dietary intake of fats . CONCLUSIONS In addition to BMI and smoking , low reported physical activity and low aerobic power are independently associated with high plasma fibrinogen concentration in newly diagnosed NIDDM",
"AIMS To compare the effects of a high-carbohydrate ( CHO ) diet and a high-monounsaturated fatty acid ( MUFA ) diet on LDL oxidative resistance in free-living individuals with Type 2 diabetes mellitus . METHODS Twenty-two men and women out- patients with Type 2 diabetes , with mean age 61 years and in fair metabolic control ( HbA1c , were enrolled at a university hospital lipid clinic in a r and omized , crossover feeding trial comparing two isocaloric diets for 6 weeks each : CHO ( fat , 28 % energy ) and MUFA ( fat , 40 % energy ) based on virgin olive oil . Outcome measurements were changes in LDL susceptibility to oxidation , body weight , glycaemic control , and lipoprotein profiles . RESULTS Planned and observed diets were well matched . Participants preferred the MUFA diet over the CHO diet . The lag time of conjugated diene formation during Cu2 + -induced LDL oxidation was similar after the CHO and MUFA diets ( 36.4 + /- 12.2 min and 36.0 + /- 13.7 min , respectively ) . Body weight , glycaemic control , total triglycerides , and total , LDL- and HDL-cholesterol levels also were similar after the two diets . Compared with the CHO diet , the MUFA diet lowered VLDL-cholesterol by 35 % ( P=0.023 ) and VLDL triglyceride by 16 % ( P=0.016 ) . CONCLUSIONS Natural food-based high-CHO and high-MUFA diets have similar effects on LDL oxidative resistance and metabolic control in subjects with Type 2 diabetes . A MUFA diet is a good alternative to high-CHO diets for nutrition therapy of diabetes because it also has a beneficial effect on the lipid profile and superior patient acceptance",
" In two groups of obese patients with type 2 diabetes the effects of 2 different diet compositions were tested with regard to glycaemic control and bodyweight . A group of 16 obese patients with type 2 diabetes was advised on a low-carbohydrate diet , 1800 kcal for men and 1600 kcal for women , distributed as 20 % carbohydrates , 30 % protein and 50 % fat . Fifteen obese diabetes patients on a high-carbohydrate diet were control group . Their diet , 1600 - 1800 kcal for men and 1400 - 1600 kcal for women , consisted of approximately 60 % carbohydrates , 15 % protein and 25 % fat . Positive effects on the glucose levels were seen very soon . After 6 months a marked reduction in bodyweight of patients in the low-carbohydrate diet group was observed , and this remained one year later . After 6 months the mean changes in the low-carbohydrate group and the control group respectively were ( + /-SD ) : fasting blood glucose ( f-BG ) : -3.4 + /- 2.9 and -0.6 + /- 2.9 mmol/l ; HBA1c : -1.4 + /- 1.1 % and -0.6 + /- 1.4 % ; Body Weight : -11.4 + /- 4 kg and -1.8 + /- 3.8 kg ; BMI : -4.1 + /- 1.3 kg/m _ and -0.7 + /- 1.3 kg/m_. Large changes in blood glucose levels were seen immediately . A low-carbohydrate diet is an effective tool in the treatment of obese patients with type 2 diabetes",
"Low-carbohydrate diets have been associated with significant reductions in weight and HbA(1c ) in obese , diabetic participants who received high-intensity lifestyle modification for 6 or 12 months . This investigation sought to determine whether comparable results to those of short-term , intensive interventions could be achieved over a 24-month study period using a low-intensity intervention that approximates what is feasible in outpatient practice . A total of 144 obese , diabetic participants were r and omly assigned to a low-carbohydrate diet ( a low fat diet ( . Participants were provided weekly group nutrition education sessions for the first month , and monthly sessions thereafter through the end of 24 months . Weight , HbA(1c ) , glucose , and lipids were measured at baseline and 6 , 12 , and 24 months . Of the 144 enrolled participants , 68 returned for the month 24 assessment visit . Weights were retrieved from electronic medical records for an additional 57 participants ( total , 125 participants ) at month 24 . All participants with a baseline measurement and at least one of the three other measurements were included in the mixed-model analyses ( n = 138 ) . The low-intensity intervention result ed in modest weight loss in both groups at month 24 . At this time , participants in the low-carbohydrate group lost 1.5 kg , compared to 0.2 kg in the low-fat group ( P = 0.147 ) . Lipids , glycemic indexes , and dietary intake did not differ between groups at month 24 ( or at months 6 or 12 ) ( Clinical Trials.gov number , NCT00108459 )",
"BACKGROUND Low-carbohydrate diets are effective for weight reduction in people without diabetes , but there is limited evidence for people with Type 2 diabetes . Aims To assess the impact of a low-carbohydrate diet on body weight , glycated haemoglobin ( HbA(1c ) ) , ketone and lipid levels in diabetic and non-diabetic subjects . METHODS Thirteen Type 2 diabetic subjects ( on diet or metformin ) and 13 non-diabetic subjects were r and omly allocated to either a low-carbohydrate diet ( or = 40 g carbohydrate/day ) or a healthy-eating diet following Diabetes UK nutritional recommendations and were seen monthly for 3 months . Subjects ( 25 % male ) were ( mean + /- sd ) age 52 + /- 9 years , weight 96.3 + /- 16.6 kg , body mass index 35.1 kg/m(2 ) , HbA(1c ) 6.6 + /- 1.1 % , total cholesterol 5.1 + /- 1.1 mmol/l , high-density lipoprotein cholesterol 1.3 + /- 0.4 mmol/l , low-density lipoprotein cholesterol 3.1 + /- 0.9 mmol/l , triglycerides ( geometric mean ) 1.55 ( 1.10 , 2.35 ) mmol/l and ketones range 0.0 - 0.2 mmol/l . RESULTS Analysis was by intention to treat with last observation carried forward . Twenty-two of the participants ( 85 % ) completed the study . Weight loss was greater ( 6.9 vs. 2.1 kg , P = 0.003 ) in the low-carbohydrate group , with no difference in changes in HbA(1c ) , ketone or lipid levels . CONCLUSIONS The diet was equally effective in those with and without diabetes",
"OBJECTIVE To comprehensively compare the effects of a very low-carbohydrate , high – unsaturated/low – saturated fat diet ( LC ) with those of a high – unrefined carbohydrate , low-fat diet ( HC ) on glycemic control and cardiovascular disease ( CVD ) risk factors in type 2 diabetes ( T2DM ) . RESEARCH DESIGN AND METHODS Obese adults ( n = 115 , BMI 34.4 ± 4.2 kg/m2 , age 58 ± 7 years ) with T2DM were r and omized to a hypocaloric LC diet ( 14 % carbohydrate [ or an energy-matched HC diet ( 53 % carbohydrate , 17 % protein , and 30 % fat [ for 24 weeks . The outcomes measured were as follows : glycosylated hemoglobin ( HbA1c ) , glycemic variability ( GV ; assessed by 48-h continuous glucose monitoring ) , antiglycemic medication changes ( antiglycemic medication effects score [ MES ] ) , and blood lipids and pressure . RESULTS A total of 93 participants completed 24 weeks . Both groups achieved similar completion rates ( LC 79 % , HC 82 % ) and weight loss ( LC −12.0 ± 6.3 kg , HC −11.5 ± 5.5 kg ) ; P ≥ 0.50 . Blood pressure ( −9.8/−7.3 ± 11.6/6.8 mmHg ) , fasting blood glucose ( −1.4 ± 2.3 mmol/L ) , and LDL cholesterol ( −0.3 ± 0.6 mmol/L ) decreased , with no diet effect ( P ≥ 0.10 ) . LC achieved greater reductions in triglycerides ( −0.5 ± 0.5 vs. −0.1 ± 0.5 mmol/L ) , MES ( −0.5 ± 0.5 vs. −0.2 ± 0.5 ) , and GV indices ; P ≤ 0.03 . LC induced greater HbA1c reductions ( −2.6 ± 1.0 % [ −28.4 ± 10.9 mmol/mol ] vs. −1.9 ± 1.2 % [ −20.8 ± 13.1 mmol/mol ] ; P = 0.002 ) and HDL cholesterol ( HDL-C ) increases ( 0.2 ± 0.3 vs. 0.05 ± 0.2 mmol/L ; P = 0.007 ) in participants with the respective baseline values HbA1c > 7.8 % ( 62 mmol/mol ) and HDL-C improvements for several clinical glycemic control and CVD risk markers . These improvements and reductions in GV and antiglycemic medication requirements were greatest with the LC compared with HC . This suggests an LC diet with low saturated fat may be an effective dietary approach for T2DM management if effects are sustained beyond 24 weeks",
"Over the past decades , we have observed an increase of prevalence of diabetes in many countries along with significant differences in prevalence trends between countries worldwide ( 1 ) . In Europe and other Western countries , the prevalence rate reaches a plateau or has slowed down on the level of ∼8–10 % . In Asia , a continuous rise in prevalence has been monitored , similar to that in Africa , and an explosion of diabetes prevalence can be observed in the Arabic region . Surprisingly , in each of the countries , there is a significant number of people who do not develop diabetes during their lives despite living unhealthy lifestyles in similar environments — in Europe , an estimated 10 % of the population ( 2 ) . These people might be the secret answer to successful individual diabetes prevention , but we still do not underst and the detailed mechanisms of why some people develop diabetes— and why others do not . What we can do is observe individual lifestyle and environment as determinants for the development or prevention of diabetes and the respective risk factors including genetic susceptibility . The interplay between these determinants , influencing the probability of the individual staying healthy or how a person learns or chooses a healthy lifestyle , will define success in diabetes prevention ( 3 ) . Innovative actions are needed to slow down the progression of type 2 diabetes . The purpose of this article is to offer innovative policy and environmental strategic activities design ed to enable sustainable diabetes prevention with scalability on national level . # # # Why Do We Need Environmental and Policy Changes in Diabetes Prevention ? Diabetes prevention is a success story , but it generates new challenges . Throughout the past 15 years , a number of r and omized controlled trials have sought to test various interventions to prevent diabetes ( 4 ) . The results are overwhelmingly positive on an individual level , with a significant relative diabetes risk reduction attributed to lifestyle and pharmacological intervention ( 5",
"Five quantitative measures of diabetic control [ HbA1c determinations , mean 24-h plasma glucose values , mean amplitude of glycemic excursions ( MAGE ) , mean 24-h urinary loss of glucose , and daily exogenous insulin requirement ] were compared in 20 pregnant women who were r and omly assigned to either a high-carbohydrate , high-fiber diet ( HCF ) that was low in fat or to a control diet commonly prescribed for pregnancy . Eleven women followed the HCF diet and nine subjects , the control diet , from baseline entry into the study until delivery . Dietary compliance was excellent , with 78 % of the women in each group rated good or acceptable . HbA1c values were similar in both groups at baseline ( HCF : 11.0 ± 0.5 % versus control : 10.2 ± 0.6 % ) , with no different predelivery values ( 8.6 ± 0.4 % ) . Mean 24-h plasma glucose levels improved in patients on both diets , with lower values noted in the HCF group at predelivery . MAGE values and st and ard deviations did not differ significantly in the two groups . Glycosuria decreased markedly in both dietary groups , but differences between groups were not significant . Improved control of diabetes on the HCF diet was achieved with significantly lower increments in insulin dose during gestation ( HCF baseline : 32 ± 8 U/24 h to 66 ± 10 U/24 h versus control baseline : 27 ± 9 U/24 h to 108 ± 12 U/24 h , P 0.03 ) . Outcome of pregnancy did not differ in the two groups of patients , but women on the HCF diet gained less weight than those on the control diet ( 26 ± 3 lb versus 35 ± 5 lb , P was similar in the two groups ( HCF : 37.2 ± 0.7 wk versus control : 36.5 ± 0.7 wk ) . Mean birth weight in infants of HCF mothers ± was 3809 ± 248 g versus 3313 ± 278 g in infants of control mothers ( P on the HCF diet achieved better control of diabetes with significantly lower increments in exogenous insulin"
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INTRODUCTION Evaluation of the long-term performance of implants used in trauma surgery relies on post-marked clinical studies since no registry based implant assessment exists . The purpose of this study was to evaluate the evidence of performance of implants currently used for treating proximal femoral fractures ( PFF ) in Denmark . METHOD PubMed was search ed for clinical studies on primary PFF with follow-up ≥12 months , reporting implant-related failure and evaluating one of following : DHS , CHS , HipLoc , Gamma3 , IMHS , InterTan , PFN , PFNA or PTN . LIMITS English language and publication date after 1st of January 1990 . RESULTS All studies were evidence level II or III . 30 publications for SHS were found : 13 of CHS , 15 of DHS and 2 of HipLoc . In total CHS was evaluated in 1110 patients ( 900 prospect ively ) , DHS in 2486 ( 567 prospect ively ) and HipLoc in 251 ( all prospect ively ) . Fifty-four publications for nails were found : 13 of Gamma3 , 7 of IMHS , 5 of InterTan , 10 of PFN , 24 of PFNA and 0 of PTN . In total Gamma3 was evaluated in 1088 patients ( 829 prospect ively ) , IMHS in 1543 ( 210 prospect ively ) , InterTan in 595 ( 585 prospect ively ) , PFN in 716 ( 557 prospect ively ) , PFNA in 1762 ( 1018 prospect ively ) and PTN in 0 . CONCLUSIONS The clinical evidence behind the current implants used for proximal femoral fractures is weak considering the number of implants used worldwide . Sporadic evaluation is not sufficient to identify long term problems . A systematic post market surveillance of implants used for fracture treatment , preferable by a national register , is necessary in the future
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"INTRODUCTION The Danish Fracture Data base ( DFDB ) was established in 2011 to establish nationwide prospect i ve quality assessment of all fracture-related surgery . In this paper , we describe the DFDB 's setup , present preliminary data from the first annual report and discuss its future potential . MATERIAL AND METHODS The DFDB collaboration includes 13 hospitals and covers a population of 3.7 million . Data registration is performed online by the surgeon following surgery , and it includes patient- , trauma- and surgery-related data . Primary procedures , reoperations and planned secondary procedures are registered . Indication for reoperation is also recorded . The reoperation rate and the one-year mortality are the primary indicators of quality . RESULTS Approximately 10,000 fracture-related surgical procedures were registered in the data base at the time of presentation of the first annual DFDB report ( currently 15,000 ) . 85 % of all procedures were performed on adult fractures and 15 % on paediatric fractures . Proximal femur ( 33 % ) , distal radius ( 15 % ) and malleolar fractures ( 12 % ) were the three most common primary adult fractures . Pain and discomfort from orthopaedic hardware , infection and failure of osteo synthesis were the three most common indications for reoperation and accounted for 34 % , 14 % and 13 % , respectively . CONCLUSION The DFDB is an online data base for registration of fracture-related surgery that allows for basic quality assessment of surgical fracture treatment and large-scale observational research by registering primary surgery , reoperations and planned secondary procedures . FUNDING not relevant . TRIAL REGISTRATION not relevant",
"Purpose The purpose of this prospect i ve r and omised trial was to assess whether an intramedullary nail is superior to a sliding hip screw in the treatment of multifragmentary intertrochanteric fractures Methods Eighty patients with a 31-A2.2 or A2.3 Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association ( AO/OTA ) intertrochanteric fracture were r and omly allocated to fixation with either the Gamma nail or the AMBI sliding hip screw device . Results All patients were followed up at one , three , six and 12 months postoperatively , except for nine who died . There was no statistical difference in Parker mobility score between groups . The Gamma nail group had significantly higher Barthel Index and EuroQol-5D ( EQ-5D ) scores than the AMBI group at 12 months . At the same time , the EQ-5D score had returned to its pre-operative values in the Gamma nail group but not in the AMBI group . There were no differences in mortality , radiation time and hospital stay . Duration of the operation , incision length and hip pain occurrence were significantly less in the Gamma nail group . Conclusions Few failures occur when unstable 31-A2.2 and A2.3 AO/OTA fractures are fixed with a sliding hip screw . Nevertheless , an intramedullary nail seems superior in reconstituting patients to their pre-operative state",
"Background The treatment and management of hip fracture poses a great challenge for clinicians in osteology and surgery . The aim of this study is to compare the clinical effectiveness of the percutaneous compression plate ( PCCP ) versus proximal femoral nail anti-rotation ( PFNA ) in the treatment of intertrochanteric fractures in elderly patients . Methods A prospect i ve r and omized study was carried out from January 2008 to October 2011 involving 90 elderly patients with intertrochanteric fractures ( 90 hips ) who underwent minimally invasive surgery using the PCCP or PFNA . Evaluation variables , including operation time , intra- and perioperative blood loss , duration of hospital stay , incidence of postoperative complications , and final clinical outcomes by the end of follow-up , were used to compare the benefits of these two implants . Results Among 90 subjects , 45 received PCCPs and 45 received PFNAs . The baseline characteristics of the two groups were comparable . The median follow-up time was 16.9 months ( 12–24 months ) . In the PCCP group , the mean operative time was 53 min ( 40–75 min ) , and the mean intra- and perioperative blood losses were 100.7 ml ( 60–150 ml ) and 916 ml ( 433–1339 ml ) , respectively , which were significantly lower than those in the PFNA group . Nevertheless , there was no statistical difference in the incidence of postoperative complications and final clinical outcomes including pain complaints , range of motion of the hip , postoperative hip function at 12 months , and the recovery of walking ability to pre-injury status between these two implants . Conclusions Overall , the PCCP and PFNA appear to have similar clinical effects in treating elderly patients with intertrochanteric fractures , although the PCCP provided shorter operation times and less blood loss than PFNA . Both implants discussed were demonstrated to be ideal for the treatment of femoral intertrochanteric fractures in elderly patients",
"Background Trochanteric fractures are common fractures in the elderly . Due to characteristic demographic changes , the incidence of these injuries is rapidly increasing . Treatment of these fractures is associated with high rates of complications . In addition , the long-term results remain poor , with high morbidity , declines in function , and high mortality . Therefore , in this study , complication rates and patients ’ outcomes were evaluated after fixation of geriatric trochanteric fractures using the Gamma3 ™ nail . Methods Patients aged 60 years old or older , with pertrochanteric and subtrochanteric femoral fractures , were included . Patients with polytrauma or pathological fractures were excluded . Age , sex , and fracture type were collected on admission . In addition , data were recorded concerning the surgeon ( resident vs. consultant ) , time of operation , and local or systemic perioperative complications . Complications were also collected at the 6- and 12-month follow-ups after trauma . Barthel Index , IADL , and EQ-5D measurements were evaluated retrospectively on admission , as well as at discharge and during the follow-up . Results Ninety patients were prospect ively included between April 2009 and September 2010 . The patients ’ average age was 81 years old , and their average ASA score was 3 . The incision/suture time was 53 min ( 95 % CI 46–60 min ) . Hospital mortality was 4 % , and overall mortality was 22 % at the 12-month follow-up . Eight local complications occurred ( 4 haematomas , 1 deep infection , 1 cutting out , 1 irritation of the iliotibial tract , 1 periosteosynthetic fracture ) . The incidence of relevant systemic complications was 6 % . Forty-two percent of the patients were operated on by residents in training , without significant differences in duration of surgery , complication rate , or mortality rate . The Barthel Index ( 82 to 71 , p , IADL ( 4.5 to 4.3 , p = .0195 ) and EQ-5-D ( 0.75 to 0.66 , p = .068 ) values did not reach pre-fracture levels during the follow-up period of 12 months . Conclusion The results showed a relatively low complication rate using the Gamma3 ™ nail , even if the nailing was performed by residents in training . The high mortality , declines in function , and low quality of life could probably be attributed to pre-existing conditions , such as physical status . In summary , the Gamma3 ™ nail seems to be a useful implant for the nailing of trochanteric fractures , although further studies are necessary comparing different currently available devices",
"This study is a r and omized prospect i ve study comparing two fracture fixation implants , the extramedullary sliding hip screw ( SHS ) and the dual lag screw cephalomedullary nail , in the treatment of intertrochanteric femoral fractures in the elderly . One hundred and sixty-five patients with low-energy intertrochanteric fractures , classified as AO/OTA 31A , were prospect ively included during a 2-year period ( 2005–2006 ) . Patients were r and omized into two groups : group A included 79 hip fractures managed with sliding hip screws and group B included 86 fractures treated with cephalomedullary nails . Delay to surgery , duration of surgery , time of fluoroscopy , total hospital stay , implant-related complications , transfusion requirements , re-operation details , functional recovery , and mortality were recorded . The mean follow-up was 36 months ( 24–56 months ) . The mean surgical time was statistically significantly shorter and fluoroscopy time longer for the group B. No intraoperative femoral shaft fractures occurred . There was no statistically significant difference in the functional recovery score , reoperation , and mortality rates between the 2 groups . A new type of complication , the so-called Z-effect phenomenon , was noticed in the cephalomedullary nail group . There are no statistically significant differences between the two techniques in terms of type and rate of complications , functional outcome , reoperation and mortality rates when comparing the SHS and the cephalomedullary nail for low-energy AO/OTA 31A intertrochanteric fractures . Our data do not support recommendations for the use of one implant over the other",
"We analysed the time-dependent mean changes in the femoral neck length , neck-shaft angle and hip offset in a r and omised study comprising 48 patients who were treated with the dynamic hip screw ( DHS ) or the proximal femoral nail ( PFN ) for an unstable intertrochanteric femoral fracture . As a consequence of fracture compression , the mean post-operative neck length was significantly shorter in patients treated with the DHS . During the first 6 weeks after the operation , a mean decrease of 4.6 ° was observed in the neck-shaft angle , but there was not a significant difference between the treatment groups . The radiographic measures remained virtually unaffected during the interval from 6 weeks to 4 months in both groups . When the operated hip was compared to the opposite hip , patients who had received the DHS showed significantly greater medialisation of the femoral shaft at 4 months than those treated with the PFN . We thus recommend that unstable intertrochanteric fractures should be initially reduced in a slight valgus position in order to achieve an outcome after healing that is as normal as possible . As a result of differences in operative technique and implant stability , the PFN may be superior to the DHS in retaining the anatomical relations in the hip region in unstable intertrochanteric fractures . RésuméNous avons analysé les modifications , en fonction du temps , des valeurs moyennes de la longueur du col fémoral , de l’angle cervico-diaphysaire et du bras de levier de la hanche dans une étude r and omisée qui comprenait 48 malades traités avec une Vis Dynamique ( DHS ) ou un Clou Fémoral Proximal ( PFN ) aprés une fracture intertrochantérienne instable . Par suite de la compression de la fracture , la longueur du col était nettement plus courte chez les malades traités avec une DHS . Pendant les premières six semaines après l’opération , une baisse moyenne de 4.6 ° de l’angle cervico-diaphysaire a été observée mais il n’y avait pas de différence notable entre les groupes de traitement . Les mesures radiographiques sont restées pratiquement non affectées pendant l’intervalle de six semaines à quatre mois dans les deux groupes . Comparé à la hanche opposée , les malades qui avaient reçu une DHS ont montré à 4 mois une nettement plus gr and e médialisation de la diaphyse que ceux traités avec le PFN . Nous recomm and ons que ces fractures intertrochantériennes instables soient réduites en léger valgus pour avoir une situation aussi normale que possible après consolidation . Par suite de différences dans la technique opératoire et dans la stabilité de l’implant , le PFN semble supérieur au DHS pour rétablir l’anatomie de la région de la hanche dans les fractures intertrochantériennes instables",
"The purpose of our study was to compare the proximal femoral nail antirotation ( PFNA ; Synthes , Paoli , Pennsylvania ) with a reconstruction nail ( Recon ; Zimmer , Warsaw , Indiana ) in the treatment of comminuted proximal femoral fractures . Between 2003 and 2010 , twenty-three consecutive patients with AO/Orthopaedic Trauma Association 31-A3 fractures combined with proximal 32 fractures who had a minimum 18-month follow-up were evaluated retrospectively . There were 10 patients ( age range , 18 - 74 years ) in the Recon nail group and 13 patients ( age range , 22 - 90 years ) in the PFNA nail group . Patients treated with Recon nails experienced a longer operation time ( P=.006 ) and more blood loss ( P=.012 ) than patients treated with the PFNA nail . On postoperative radiographs , the change in the neck-shaft angle was 8.8 ° in the Recon nail group and 4.7 ° in the PFNA nail group ( P=.048 ) . The fracture union time averaged 31.8 weeks in the Recon nail group and 21.5 weeks in the PFNA nail group ( P=.148 ) . More patients in the Recon nail group underwent major or minor reoperation ( P=.038 ) compared with the PFNA nail group . No implant failure occurred in either group . The functional results were similar in the 2 groups . For the treatment of comminuted proximal femoral fractures , use of either the PFNA and Recon nail is clinical ly effective . However , the PFNA nail provides a shorter operation time , less blood loss , and better realignment ability and reduces the incidence of reoperation . Therefore , the PFNA nail can be considered a better device than the Recon nail",
"ObjectTo compare the Sliding with Non-sliding lag screw of a gamma nail in the treatment of A1 and A2 AO-OTA intertrochanteric fractures . Material s and methods 80 patients were prospect ively collected . In each group , AO/OTA 31-A were classified into group A. AO/OTA 31-A2.1 was classified as group B. We classified the A2.2 and A2.3 as group C. According to the set-screw locking formation of Gamma-III , the cases were r and omly allocated to Sliding subgroup and Non-sliding subgroup in A , B and C groups . Follow-ups were performed 1 , 3 , 6 and 12 months postoperatively . Results In the Sliding group , the bone healing rate 3 , 6 , 12 months postoperatively reached 85.00 % , 97.50 % , 100 % in group A , B and C. Meanwhile , in Non-sliding group , postoperatively , bone healing rate were 90.00 % , 95.00 % and 97.50 % in group A , B and C , respectively . Both differences were not significant . Lower limb discrepancy between Sliding and Non-sliding pattern was significantly different in group C which represent fracture types of AO/OTA 31-A2.2 and A2.3 ( 0.573 ± 0.019 mm in Non-sliding group , 0.955 mm ± 0.024 mm in Sliding group , P Difference of sliding distance among the three groups was significant among group A , B and C : 0.48 mm ± 0.04 mm , 0.62 mm ± 0.07 mm and 0.92 mm ± 0.04 mm ( P 0.001 ) . Differences in average healing time and Harris scores also presented no significance in the three groups . Conclusions As a result , we can conclude that the sliding distance is minimal in Gamma nails and it is related to the comminuted extent of the intertrochanteric area in A1 and A2 AO-OTA intertrochanteric fractures . For treating these kinds of fractures , the sliding of the lag screw of an Gamma nail does not improve any clinical results and in certain cases , such as highly comminuted A1 and A2 fractures , can therefore even benefit from a locked lag screw by tightening the set-screw",
"BACKGROUND We hypothesized that undergoing surgery as soon as possible reduces early mortality in patients with a proximal femoral fracture . Our aim was to evaluate the association between surgical delay and early mortality in these patients . METHODS We performed a retrospective analysis of prospect ively collected data from the Danish Fracture Data base and the Civil Registration System on patients who were fifty years of age or older and had undergone surgery for a proximal femoral fracture . Femoral head fracture ( classified as OTA/AO 31C per the OTA/AO classification system ) , high-energy trauma , pathological fractures , multiple fractures , and surgeries performed with implants not commonly used were excluded . End points were adjusted odds ratios for thirty-day and ninety-day mortality . RESULTS For the 3517 surgeries included in this study , the median patient age was 82.0 years ( range , fifty-one to 107 years ) , 2458 patients ( 70 % ) were female , and 1720 surgeries ( 49 % ) were performed because of a trochanteric fracture . Within twelve hours , 722 of the surgeries ( 21 % ) had been performed ; within twenty-four hours , 2482 surgeries ( 71 % ) ; within thirty-six hours , 3024 surgeries ( 86 % ) ; within forty-eight hours , 3242 surgeries ( 92 % ) ; and within seventy-two hours , 3353 surgeries ( 95 % ) . Unsupervised surgeons with an education level below that of an attending surgeon performed the surgery in 1807 ( 51 % ) of all cases . The thirty-day mortality was 380 ( 10.8 % ) and the ninety-day mortality was 612 ( 17.4 % ) . The risk of thirty-day mortality increased with a surgical delay of more than twelve hours ( odds ratio , 1.45 ; p = 0.02 ) , more than twenty-four hours ( odds ratio , 1.34 ; p = 0.02 ) , and more than forty-eight hours ( odds ratio , 1.56 ; p = 0.02 ) ; the risk of ninety-day mortality increased with a surgical delay of more than twenty-four hours ( odds ratio , 1.23 ; p = 0.04 ) . An education level of the surgeon below that of an attending surgeon increased the risk of thirty-day mortality ( odds ratio , 1.28 ; p = 0.035 ) and ninety-day mortality ( odds ratio , 1.26 ; p = 0.016 ) . Increasing American Society of Anesthesiologists score and male sex significantly increased both thirty-day and ninety-day mortality . CONCLUSIONS In this study , a surgical delay of more than twelve hours significantly increased the adjusted risk of thirty-day mortality and a surgical delay of more than twenty-four hours significantly increased the adjusted risk of ninety-day mortality . The adjusted risk of both thirty-day and ninety-day mortality increased significantly when the education level of the surgeon was below that of an attending surgeon . The study findings challenge orthopaedic departments to facilitate fast surgical treatment supported by attending orthopaedic surgeons",
"As health care costs increase , evaluating treatment methods in femoral neck fractures to determine the most effective treatment paradigm will become increasingly important . The current study compared two methods of treatment in similar cohorts of displaced femoral neck fractures . One hundred and twenty two patients were r and omly assigned to two groups : In Group A , 62 patients were treated with a hemiarthroplasty . In group B , 60 patients were treated with dynamic screw fixation . Patients were evaluated at a minimum 3 year follow-up . Using the Matta functional hip score , 42 % of group A and 70 % of group B had good to excellent results . This difference was significant ( p = 0.004 ) . A significant agreement between physician assessment using the Matta score , and patient perception of outcome using the SF-36 scale was demonstrated ( r = 0.64 ) . No statistical difference between groups for revision surgery existed . Both physician based and patient based outcome scores favour retention and internal fixation of the femoral head in this cohort of patients at a short-term follow-up",
"Background Technical advancements have produced many challenges to intramedullary implants for unstable pertrochanteric fractures . Helical blade fixation of the femoral head has the theoretical advantages of higher rotational stability and cutout resistance and should have a lower rate of reoperation than a locked plating technique . Questions / purpose sWe asked whether ( 1 ) helical blade nailing reduces the rate of reoperation within 24 months compared with locked plating and ( 2 ) any of various preoperative , intraoperative , or postoperative factors predicted failure in these two groups . Methods We prospect ively enrolled 108 patients with unstable pertrochanteric fractures in a surgeon-allocated study between November 2005 and November 2008 : 54 with percutaneous compression plates ( PCCP ) and 54 with proximal femoral nail antirotation ( PFNA ) . We evaluated patients regarding reoperation , mortality , and function . Seventy-four patients had a minimum followup of 24 months ( mean , 26 months ; range , 24–30 months ) . Results We found no differences in the number of reoperations attributable to mechanical problems in the two groups : PCCP = six and PFNA = five . Despite a greater incidence of postoperative lateral wall fractures with helical blade nailing , only postoperative varisation of the neck-shaft angle and tip-apex distance ( 33 mm versus 28 mm ) predicted reoperation . Mortality and function were similar in the two groups . Conclusions Our data suggest unstable pertrochanteric fractures may be fixed either with locked extramedullary small-diameter screw systems to avoid lateral wall fractures or with the new intramedullary systems to avoid potential mechanical complications of a broken lateral wall . Tip-apex distance and preservation of the preoperative femoral neck-shaft angle are the key technical factors for prevention of reoperation . Level of Evidence Level III , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence",
"Introduction : In this study , we initiated a prospect i ve , r and omised , clinical trial comparing the AMBI , TGN and PFN operations used for treatment of unstable fractures , for differences in intra-operative use , consolidation , complications and functional outcome . Material s and methods : We have compared the pre- , intra- and post-operating variables of AMBI , TGN and PFN operations that were used for treatment of unstable trochanteric fractures , of 120 patients all above 60 years old diagnosed with extracapsular hip fractures classified as AO Type 31-A2 or Type 31-A3 . Results : According to our results the three methods are comparable in the treatment of unstable trochanteric fractures of patients above 60 years old . Conclusion : The AMBI remains the gold st and ard for the fractures of trochanteric region . TGN has an easier and faster procedure , facilitates early weight bearing and had minor late complications . An improper use of the PFN system was the reason for the most complications and the longer operation time of the device . PFN is also an accepted minimally invasive implant for unstable proximal femoral fractures but future modification of the implant to avoid Z-effect phenomenon , careful surgical technique and selection of the patients should reduce its high complication rate",
"Objective . To compare two internal fixation devices clinical ly in stabilisation of intertrochanteric femur fractures . Methods . Eighty-seven patients were r and omised upon their admission to the hospital using a sealed envelope method . Forty-five were treated with proximal femur nail antirotation ( PFNA ) and 42 with reverse less invasive stabilisation system ( LISS ) . The perioperative data were recorded and compared in relation to fracture type . Results . In each type of fractures , no significant differences were found with respect to the blood loss , the quality of reduction , the time to bony healing , and the Harris hip score between the 2 groups . The mean duration of surgery was significantly longer in reverse LISS group than in PFNA group . Conclusion . Both the PFNA and the reversed LISS are effective in the treatment of different types of intertrochanteric femur fractures . PFNA is superior to reverse LISS in terms of surgical time , weight-bearing , and perhaps fluoroscopy time",
"There is an urgent need for the introduction of new implant technology in orthopedic surgery to be conducted in a more controlled manner than in the past . Inadequate regulation and lack of effective post-market surveillance have meant that patients have not been protected from potentially harmful implants and procedures . Compounding the problem is a lack of question ing , a lack of critical appraisal , and lack of a requirement for clinical evidence by both surgeons and manufacturers before large-scale introduction of new technology to the market . There is a long and growing history of failed innovation , demonstrated by the failure or recall of individual products such as Boneloc ( bone cement ) , The Capital Hip ( total hip arthroplasty ) , and the ASR hip system ( total hip arthroplasty ) among others , as well as whole classes of devices such as large-head metal-on-metal bearings . This demonstrates simple , yet severe flaws in the mechanisms that should protect patients from increased risk associated with introduction of new technology . Insufficient or inadequate pre clinical data , a lack of clinical data from timely RSA ( radiostereometric analysis ) studies , and limited larger , multicenter cohort studies prior to general release all increase the risk to patients . The 510k process , where the majority of so-called innovative new design s have been cleared or approved by FDA - or CE-notified bodies for clinical use , is based on similarities to previously used implants . In the 510k process , there is no requirement for specific clinical evidence , so manufactures have not obtained clinical data . Registry post-market surveillance has proven to be a powerful method for detection of increased risk of implant failure , but this is not available in all countries . When registries do identify poor-performing devices , regulators and manufacturers are often slow to respond . The main problem with the current approach to the introduction of new technology is the inability to identify unanticipated failures before wider release ( Bauer 1992 ) . It is 20 years since the stepwise introduction of new implants was first described ( Malchau 1995 ) . The basic concept of this approach is that the smallest possible numbers of patients ( after sufficient pre clinical testing ) are exposed to the implant prior to general release . Stepwise introduction uses a combination of ( 1 ) outcome measurements with high-precision metrics in small cohorts , such as RSA , and ( 2 ) limited clinical introduction in a larger cohort , prospect ively monitoring outcomes and revisions . Adoption of this concept would certainly have reduced the large number of poor-performing new implants introduced in recent years . The concept has , however , never been implemented due to lack of support from surgeons , manufacturers , and regulatory authorities . Now trends have changed , with increasing focus on implementing an effective approach to pre-release clinical assessment . The ongoing work and discussion s in the International Society of Arthroplasty Registries ( ISAR ) , the reports from the Australian Orthopaedic Association total joint registry , and the actions taken in the UK to put a “ beyond compliance ” program into action will facilitate a more cautious market introduction . In addition , the Arthroplastywatch project ( www.arthroplastywatch.com ) is in action : data are collected on the web through a specially developed search routine . Based on examination in several steps using medical and statistical expertise , a caution could be warranted or a warning declared . These combined initiatives say one thing : that close monitoring of new implants by well-established registries during a phase of controlled introduction must be a universal requirement . We propose a structured model for clinical trials involving 4 levels : ( 1 ) a pure observational study using reoperation data from multiple registries , as shown in several papers by the Nordic Arthroplasty Register Association ( NARA ) ; ( 2 ) patient-reported outcome measures , either from national implant registries or from other registries for specific studies ; ( 3 ) radiographic data plus other parameters such as blood levels of metal ions , based on specific needs for a new technology ; and ( 4 ) options for r and omized studies with use of , for example , RSA in the evaluation . The cornerstone in this structural model should be the exp and ed use of existing and future registries with a high degree of coverage and completeness . While registries have a strong tradition in arthroplasty surgery , this is not as well developed in other areas of orthopedic surgery . It is the responsibility of orthopedic surgeons and their professional bodies to support and implement registries where they can be of benefit . The arthroplasty registry experience has shown that it is possible to use registries to effectively monitor the introduction of new technology . Without this registry-based surveillance , identification of many of the failed innovations would have been delayed or might even have gone unrecognized . It is encouraging that registries in fracture surgery are now emerging , where implants are inserted in large and increasing numbers . Finally , implant performance is potentially confounded by the technical difficulty of inserting the implant , the knowledge and abilities of the surgeon inserting them , and the complexity of the cases . Many registries monitor performance at the surgeon level . This together with continuous education and training in how to use new implants should be an integral part of the process of a more cautious market introduction . If training is linked in with the stepwise introduction , it will be possible to identify the need for and the extent of training . Our proposed regulatory change to require registry-based monitoring of new implants during the phase of limited introduction must be accompanied by a change in the way we think and act as orthopedic surgeons . In the training of future orthopedic surgeons , emphasis must be placed on developing a healthy skepticism to innovation , on recognizing the need for evidence -based introduction , and on building a culture holding the view that reporting to a registry is imperative . The registries will then be able to offer back data to enable surgeons to choose the best clinical practice . To increase innovation and to ensure that innovation is effective and beneficial , the role of registries should be exp and ed . The registries should not undertake the role of a regulatory authority , but in compliance with the industry and the orthopedic community they should ensure that a more cautious approach is used when new technology is introduced . This could lead to a better balance between the inborn conservatism that a registry represents and the continuous need for innovation . The independence , infrastructure , and expertise of the registries can be used more fully to optimize how new implants are introduced . All stakeholders need to join to ensure that first and foremost , we do no harm",
"Background Trochanteric fractures ( TF ) have become a major source of morbidity and mortality in elderly . We conducted this study to compare the outcomes of unstable trochanteric fractures treated with the InterTan nail and Gamma3 nail . Methods Between January 2008 and May 2013 , patients aged 60 years or older with a diagnosis of unstable TF treated with InterTan nail or Gamma3 nail were included . Patients treated with InterTan nail were pair-matched to patients treated with Gamma3 nail in a 1:2 ratio . Radiographs were obtained at 1 , 3 , 6 , and 12 months follow-up , and all implant position changes , complications , fixation failures and functional scores were recorded . Results Eighty-seven patients were included in the InterTan nail group , and 174 pair-matched patients were included in the Gamma3 nail group . Preoperative scores were similar between the 2 groups . There are significant improvements postoperatively in both groups . The incidence of cut-out and femoral shaft fracture were significantly higher in the Gamma3 nail group than the InterTan nail group ( P = 0.024 and P = 0.044 , respectively ) . Patients treated with the InterTan nail experienced longer fluoroscopy and operative times . Conclusions The InterTan nail may have a tendency in better outcomes for patients with unstable TF . However , the limited period of follow-up and inherent defects of nonr and omized trials indicate that better- design ed r and omized controlled trials will be required . Virtual SlidesThe virtual slide(s ) for this article can be found here :",
"We compared the outcome of patients treated for an intertrochanteric fracture of the femoral neck with a locked , long intramedullary nail with those treated with a dynamic hip screw ( DHS ) in a prospect i ve r and omised study . Each patient who presented with an extra-capsular hip fracture was r and omised to operative stabilisation with either a long intramedullary Holl and nail or a DHS . We treated 92 patients with a Holl and nail and 98 with a DHS . Pre-operative variables included the Mini Mental test score , patient mobility , fracture pattern and American Society of Anesthesiologists grading . Peri-operative variables were anaesthetic time , operating time , radiation time and blood loss . Post-operative variables were time to mobilising with a frame , wound infection , time to discharge , time to fracture union , and mortality . We found no significant difference in the pre-operative variables . The mean anaesthetic and operation times were shorter in the DHS group than in the Holl and nail group ( 29.7 vs 40.4 minutes , p mean blood loss within the DHS group versus the Holl and nail group ( 160 ml vs 78 ml , respectively , p mean time to mobilisation with a frame was shorter in the Holl and nail group ( DHS 4.3 days , Holl and nail 3.6 days , p = 0.012 ) . More patients needed a post-operative blood transfusion in the DHS group ( 23 vs seven , p = 0.003 ) and the mean radiation time was shorter in this group ( DHS 0.9 minutes vs Holl and nail 1.56 minutes , p Holl and nail . There were no revisions in the Holl and nail group . All fractures in both groups were united when followed up after one year . We conclude that the DHS can be implanted more quickly and with less exposure to radiation than the Holl and nail . However , the result ant blood loss and need for transfusion is greater . The Holl and nail allows patients to mobilise faster and to a greater extent . We have therefore adopted the Holl and nail as our preferred method of treating intertrochanteric fractures of the hip",
"Background Intertrochanteric fractures are surgically treated by using different methods and implants . The optional type of surgical stabilization is still under debate . However , between devices with the same philosophy , different design characteristics may substantially influence fracture healing . This is a prospect i ve study comparing the complication and final functional outcome of two intramedullary devices , the intramedullary hip screw ( IMHS ) and the ENDOVIS nail . Material s and methods Two hundred fifteen patients were r and omized on admission in two treatment groups . Epidemiology features and functional status was similar between two treatment groups . Fracture stability was assessed according to the Evan 's classification . One hundred ten patients were treated with IMHS and 105 with ENDOVIS nail . Results There were no significant statistical differences between the two groups regarding blood loss , transfusion requirements and mortality rate . In contrast , the number of total complications was significantly higher in the ENDOVIS nail group . Moreover , the overall functional and walking competence was superior in the patients treated with the IMHS nail . Conclusions These results indicate that the choice of the proper implant plays probably an important role in the final outcome of surgical treatment of intertrochanteric fractures . IMHS nail allows for accurate surgical technique , for both static and dynamic compression and high rotational stability . IMHS nail proved more reliable in our study regarding nail insertion and overall uncomplicated outcome",
"BACKGROUND Both intramedullary nails and sliding hip screws are used with good results in the treatment of intertrochanteric and subtrochanteric fractures . The aim of our study was to assess whether use of the TRIGEN INTERTAN nail , as compared with a sliding hip screw , result ed in less postoperative pain , improved functional mobility , and reduced surgical complication rates for patients with an intertrochanteric or subtrochanteric fracture . METHODS In a prospect i ve , r and omized multicenter study , 684 elderly patients were treated with the INTERTAN nail or with a sliding hip screw with or without a trochanteric stabilizing plate . The patients were assessed during their hospital stay and at three and twelve months postoperatively . A visual analogue scale ( VAS ) pain score was recorded at all time points , and functional mobility was assessed with use of the timed Up & Go test . The Harris hip score ( HHS ) was used to assess hip function more specifically . Quality of life was measured with the EuroQol-5D ( EQ-5D ) . Radiographic findings as well as intraoperative and postoperative complications were recorded and analyzed . RESULTS Patients treated with an INTERTAN nail had slightly less pain at the time of early postoperative mobilization ( VAS score , 48 versus 52 ; p = 0.042 ) , although this did not influence the length of the hospital stay and there was no difference at three or twelve months . Regardless of the fracture and implant type , functional mobility , hip function , patient satisfaction , and quality -of-life assessment s were comparable between the groups at three and twelve months . The numbers of patients with surgical complications were similar for the two groups ( twenty-nine in the sliding-hip-screw group and thirty-two in the INTERTAN group , p = 0.67 ) . CONCLUSIONS INTERTAN nails and sliding hip screws are similar in terms of pain , function , and reoperation rates twelve months after treatment of intertrochanteric and subtrochanteric fractures",
"Aim Our objective was to compare the results of PCCP ( Percutaneous Compression Plate ) device and Gamma 3 nail for the treatment of stable trochanteric hip fractures and to demonstrate that PCCP device is a minimally invasive system . Method Prospect i ve , r and omized trial . Eighty patients aged 60 and over with stable trochanteric fracture were selected and then r and omized using a table of r and omized numbers . Length of time of operative procedure , hemoglobin levels at 6 and 48 h after surgery , packed cells units administered , and hospital stay were recorded . In addition , the postoperative complications in the first year after the surgery was collected . Results No differences were found in hospital stay , surgical time , blood loss , functional outcome at 1-year follow-up , neck-shaft angle , fracture collapse , and mortality . Conclusions PCCP and Gamma 3 have not presented significant differences in any measured parameter for treatment of stable trochanteric fractures . Therefore , the PCCP system is shown to be as minimally invasive as the Gamma 3",
"Background : Intertrochanteric fractures are composed of different anatomic patterns that vary in their degree of stability following open reduction and internal fixation . A particularly unstable group is classified as AO/OTA 31-A3 , with the fracture pattern described as reverse oblique or transverse . The purpose of this study was to compare the results of intramedullary fixation with those of plate fixation for these intertrochanteric fractures in elderly patients . Methods : Thirty-nine elderly patients with AO/OTA 31-A3 intertrochanteric fractures of the femur were r and omized into two treatment groups and were followed for a minimum of one year . The nineteen patients in Group I were treated with a 95 ° fixed-angle screw-plate ( Dynamic Condylar Screw ) , and the twenty patients in Group II were treated with an intramedullary nail ( Proximal Femoral Nail ) . The treatment groups were comparable with regard to all demographic and injury variables . Results : Patients treated with an intramedullary nail had shorter operative times , fewer blood transfusions , and shorter hospital stays compared with those treated with a 95 ° screw-plate . Implant failure and /or nonunion was noted in seven of the nineteen patients who had been treated with the 95 ° screw-plate . Only one of the twenty fractures that had been treated with an intramedullary nail did not heal . Conclusion : The results of our study support the use of an intramedullary nail rather than a 95 ° screw-plate for the fixation of reverse oblique and transverse intertrochanteric fractures in elderly patients",
"We report the results of a prospect i ve r and omized clinical trial comparing the Gamma 3 nail with the ACE trochanteric nail for the treatment of pertrochanteric femoral fractures . One hundred and twelve consecutive patients were enrolled in the study : 61 patients were treated with the Gamma 3 nail , 51 with the ACE trochanteric nail . The two groups were matched for age , fracture type and preoperative Merle d'Aubigné hip score . All patients were followed up clinical ly and radiographically on a regular basis between 6 weeks and one year postoperatively . Twenty-six patients ( 23 % ) died within the first postoperative year . Six patients were lost to follow-up . In each group , two patients were revised due to mechanical failure . Nonunion did not occur . The mean postoperative hip scores in the Gamma 3 and the ACE group were 14.19 and 14.12 respectively , with no significant difference ( p = 0.92 ) . Walking ability was adequately restored in approximately 80 % of the patients . Both implants appeared as safe and effective methods of treatment for intertrochanteric hip fractures",
"This prospect i ve r and omized study compared the outcome of elderly patients with an unstable pertrochanteric fracture , treated with a proximal femoral nail antirotation device ( PFNA ; n = 51 ) or a dynamic hip screw ( DHS ; n = 55 ) . All patients in the DHS group and nine in the PFNA group had open reductions . Incisions were significantly shorter for the PFNA than the DHS group . Blood loss and the number of patients requiring postoperative blood transfusions were significantly greater , but operation and fluoroscopy times were significantly shorter , for the DHS versus the PFNA group . Time to mobilization with a frame was significantly shorter in the PFNA group , and post-operative complications were more common in the DHS group . Poor fracture reduction led to three revisions . All fractures in both groups united during follow-up . The PFNA allowed earlier mobilization and faster recovery than the DHS . The PFNA is a highly acceptable , minimally invasive implant for unstable fractures",
"We compared fixation with hook pins or sliding screw plate in a prospect i ve r and omized study of 222 patients with a cervical hip fracture . Radiographic evidence of early redisplacement , nonunion , or late segmental collapse was found in 43 of 122 patients operated on with two hook pins and in 40 of 100 patients operated on with the sliding screw plate . According to the actuarial method , the failure rate after 2 years was 38 % with hook pins and 46 % with screw plates , which not is a significant difference . Due to early redisplacement , reoperation with an endoprosthesis was performed within 0.5 ( 2 ) years in 11 ( 22 ) patients in the hook-pin group and in 4 ( 17 ) patients in the sliding-screw plate group",
"We report a r and omised , prospect i ve study comparing a st and ard sliding hip screw and the intramedullary hip screw for the treatment of unstable intertrochanteric fractures in the elderly . One hundred and two patients were r and omised on admission to two treatment groups . Fifty-two patients were treated with a compression hip screw ( CHS ) , and fifty had intramedullary fixation with an intramedullary hip screw ( IMHS ) . Patients were followed for 1 year and had a clinical and radiological review at 3 , 6 and 12 months . The mean duration of operation and fluoroscopy screening time was significantly greater for insertion of the intramedullary hip screw . There was no difference between the groups with regard to transfusion requirements or time to mobilise after surgery . There were two technical complications in the CHS group and three in the IMHS group . There was no significant difference between the two groups in radiological or functional outcome at 12 months . It remains to be shown whether the theoretical advantages of intramedullary fixation of extracapsular hip fractures bring a significant improvement in eventual outcome",
"In this prospect i ve r and omised trial we compare the mortality , morbidity and functional results of patients following each of the three principal methods of treatment for displaced subcapital fractures of the femur . Two hundred and ninety patients over the age of 65 years were included and r and omly allocated to undergo closed reduction and internal fixation with a sliding compression screw plate or uncemented Austin Moore hemiarthroplasty or cemented Howse II total hip arthroplasty ( THA ) . Nineteen patients were subsequently excluded . The 13 year results show that there was no statistical difference in the mortality between the three groups ( 81 , 85 and 91 % respectively ) . Internal fixation and hemiarthroplasty groups fared poorly with a revision rate of 33 and 24 % , respectively , compared with 6.75 % in the THA group . The dislocation rate was 13 % following hemiarthroplasty and 20 % following THA . Average Harris hip scores were 62 , 55 and 80 , respectively , for the internal fixation , hemiarthroplasty and THA groups . In the long term , both internal fixation and hemiarthroplasty result ed in a poor outcome with respect to pain and mobility . Despite high early complications , THA result ed in least pain and most mobility both in the short and long-term and was encouraging with a revision rate of only 6.25 % . THA should be seriously considered in physiologically active patients with a displaced subcapital fracture of the femur",
"The objective of this study comparing the proximal femoral nails Targon PF ( Aesculap , Tuttlingen , Germany ) and Proximal Femoral Nail Antirotation ( PFNA ; Synthes . Oberdorf , Switzerl and ) was to observe the complications and postoperative results following pertrochanteric femoral fracture fixation , with special attention devoted to the dynamic properties of both implants under physiological load in vivo . The survey was design ed as a r and omized , prospect i ve study of 80 patients who had sustained a pertrochanteric femoral fracture ( AO type 31.A2 ) . Postoperative radiological and clinical examinations were conducted over a period of 12 months on 40 respective patients treated with a PFNA or a Targon PF nail . Average operative time was 66.2 minutes and average fluoroscopy time was 103.6 seconds in the PFNA group , which was significantly lower than in the Targon PF group ( 84.7 minutes and 164.5 seconds , respectively ) . No significant difference was found between the 2 groups in terms of range of motion ( P=.26 ) or Harris Hip Score ( P=.83 ) . The femoral neck components of the Targon PF showed a significantly higher sliding ability ( 14.5 mm ; P=.04 ) than the PFNA ( 11.1 mm).Both implants are suited to treat pertrochanteric femoral fractures and display comparable clinical results . The Targon PF demonstrates better dynamic properties than the PFNA under physiological load in vivo . A disadvantage of the Targon PF , however , is the more complicated surgical technique and the longer operative time",
"Abstract . The aim of the present paper is to compare the results obtained using two osteo synthesis systems developed for the surgical treatment of fractures of the trochanteric region of the femur , based on the principles of closed intramedullary nailing : the Gamma nail and the proximal femoral nail ( PFN ) . A prospect i ve study is presented of 125 trochanteric fractures of the femur treated with PFN and 125 treated with the Gamma nail in our service between the years 1997 and 2000 , with the prerequisite of a minimum follow-up of 1 year . Fractures were classified according to the AO system , the most commonly recorded subtype encountered being the A2 . Clinical and radiographic controls were performed upon admission and in the post-operative follow-up at 1 , 3 , 6 , and 12 months , the corresponding assessment protocol being completed on each occasion . Of the 250 patients , 179 were women and the rest men . The average age was 78.9 years . Both systems enabled early mobilisation and walking in most of our patients . There were no significant differences in the use of either nail in terms of the recovery of previous functional capacity , nor in terms of the time required for fracture healing ( 12 weeks on average ) . With regard to the more significant technical complications recorded , shaft fractures and the cutting-out phenomenon were more common with the use of the Gamma nail , while secondary varus occurred at a greater rate when using the PFN.Résumé . Nous comparons les résultats obtenus avec deux systèmes d'ostéosynthèse des fractures de la région trochantérienne du fémur , basés sur le principe de l'enclouage médullaire à foyer fermé : le clou Gamma et le P.F.N ( Proximal Femoral Nail ) . Une étude prospect i ve est présentée de 125 fractures trochantériennes traitées avec P.F.N. et 125 avec le clou Gamma dans notre service entre les années 1997 et 2000 , avec un suivi minimum de une année . Les fractures ont été classées d'après le système AO , la plus fréquemment rencontrée étant la sous-classe A2 . Des contrôles cliniques et radiologiques ont été fait à l'admission et dans les suites opératoires à 1 , 3 , 6 , et 12 mois . 179 des 250 cas étaient des femmes et l'âge moyen était 78.9 années . Les deux systèmes ont permis une mobilisation précoce et la marche pour la plupart de nos patients . Il n'y avait pas de différences notables dans l'usage de l'un et l'autre clou quant à la récupération de la capacité fonctionnelle antérieure , ni quant au temps nécessaire pour la consolidation de la fracture ( 12 semaines sur moyenne ) . Quant aux complications techniques enregistrées , les fractures diaphysaires ont été plus fréquentes avec l'usage du clou Gamma , t and is que les varisations secondaires se sont produits à un plus gr and taux avec le",
"The aim of this prospect i ve matched-pair ( age , sex , fracture type , residential status , and walking ability at fracture ) study was to analyse the short-term outcome after Gamma nail ( GN ) and dynamic hip screw ( DHS ) fixation , focusing especially on functional aspects ( St and ardised Audit of Hip Fractures in Europe [ SAHFE ] hip fracture follow-up forms ) , reoperations , and mortality . Both groups consisted of 134 patients . DHS and GN groups did not differ significantly with respect to location of residence at 4 months or returning to the prefracture dwelling ( 78 % vs. 73 % , P = 0.224 ) . The change in walking ability at 4 months compared to prefracture situation was better in the DHS group ( p = 0.042 ) , although there was no difference in the change of use of walking aids . The frequency of reoperations during the first year was somewhat lower in the DHS group ( 8.2 % vs. 12.7 % , p = 0.318 ) . Mortality was lower in the DHS group both at 4 months ( 6.0 % vs. 13.4 % , p = 0.061 ) and 12 months ( 14.9 % vs. 23.9 % , p = 0.044 ) . Although walking ability was better and mortality lower in the DHS group , both methods are useful in the treatment of trochanteric femoral fractures . RésuméLe but de cette étude prospect i ve est de comparer et d’analyser le devenir à long terme des fractures du col fémoral traitées par clou Gamma ( GN ) ou par le vis plaque ( DHS ) , notamment en ce qui concerne leurs aspects fonctionnels , les ré interventions et la mortalité . Deux groupes de 134 patients ont été comparés . Il n’y a pas de différence significative entre ces deux groupes à 4 mois en ce qui concerne le retour aux activités pré-opératoires ( 78 % vs. 73 % , P = 0.224 ) entre DHS et GN . Néanmoins , la marche à 4 mois est bien meilleure dans le groupe DHS ( p = 0.042 ) , il n’y a pas de différence en ce qui concerne l’utilisation d’aide à la marche , moins de ré interventions dans le groupe DHS ( 8,2 % vs. 12,7 % , p = 0.318 ) , de même en ce qui concerne la mortalité ( 6,0 % vs. 13,4 % , p = 0.061 ) et à 12 mois ( 14,9 % vs 23,9 % , p = 0.044 ) . Ces deux méthodes sont utiles dans le traitement des fractures cervico trochantériennes , néanmoins , l’amélioration de la marche et la mortalité sont bien meilleures dans le groupe GHS que dans le groupe clou gamma",
"One hundred elderly patients who had an intertrochanteric femoral fracture were r and omized to treatment with a compression hip-screw with a plate ( fifty patients ) or a new intramedullary device , the intramedullary hip-screw ( fifty patients ) . All patients were followed prospect ively for one year or until death . A detailed assessment of the functional status and the plain radiographs of the hip was performed one , three , six , and twelve months postoperatively . The two treatment groups were strictly comparable . The operative time needed to insert the intramedullary hip-screw was significantly greater than that needed to insert the compression hip-screw with the plate ( p = 0.02 ) , but use of the intramedullary hip-screw was associated with less estimated intraoperative blood loss ( p = 0.011 ) . The prevalence of perioperative complications , such as bronchopneumonia , cardiac failure , and urinary tract infection , was comparable in the two treatment groups . There were one intraoperative fracture of the femoral shaft and two intraoperative fractures of the greater trochanter in the group managed with the intramedullary hip-screw . One patient had pulling-out of the compression hip-screw on the seventh postoperative day . Four patients had a trochanteric wound hematoma , without infection , after insertion of an intramedullary hip-screw . All but one of the fractures healed . The one non-union , which was in a patient who had a compression hip-screw , was treated with a hemiarthroplasty . The mortality rate was similar in the two treatment groups . The patients who had an intramedullary hip-screw had , on the average , significantly better mobility at one ( p intramedullary hip-screw still had significantly better walking ability outside the home at those time-periods ( p = 0.05 ) . The compression hip-screw was removed from two patients because of pain in the mid-portion of the thigh , which had begun after consolidation of the fracture . Fourteen patients who had an intramedullary hip-screw had cortical hypertrophy at the level of the tip of the nail at twelve months postoperatively . Cortical hypertrophy was significantly related to the use of two interlocking screws ( p = 0.02 ) . Six of these patients also had pain in the mid-portion of the thigh , and the nail had been locked with two screws in five of them . Three of the six patients had the hardware removed because of the pain , and the symptoms resolved . A seventh patient had pain without cortical hypertrophy . The intramedullary hip-screw device was associated with significantly less sliding of the lag-screw and subsequent shortening of the limb in the region of the thigh ( p = 0.012 and 0.019 , respectively ) ; these differences were more pronounced when the unstable fractures in the two treatment groups were compared ( p < 0.001 )",
"Objective : To compare outcome between the proximal femoral nail ( PFN ) and the Medoff sliding plate ( MSP ) in patients with unstable trochanteric or subtrochanteric fractures . Methods : This was a consecutive prospect i ve r and omized clinical study . In all , 203 patients admitted to two university hospitals with an unstable trochanteric or a subtrochanteric fracture type were included . Surgery was performed with a short intramedullary nail or a dual-sliding plate device . Follow up visits occurred at 6 weeks , 4 months , and 12 months . Functional outcome was measured by walking ability , rising from a chair , curb test , and additional assessment s of abductor strength , pain , living conditions , and complications . Results : The ability to walk 15 m at 6 weeks was significantly better in the PFN group compared to the MSP group with an odds ratio 2.2 ( P = 0.04 , 95 % confidence limits 1.03 - 4.67 ) . No statistical difference in walking ability could be found between trochanteric and subtrochanteric fractures . The major complication rate ( 8 % in the PFN group and 4 % in the MSP group ) did not differ statistically ( P = 0.50 ) but reoperations were more frequent in the PFN group ( 9 % ) compared to the MSP group ( 1 % ; P functional outcome or major complications between the treatment groups . Reasons other than the operated fracture seem to be equally important in determining the long-term functional ability of the patients in our study . An advantage with the MSP was the lower reoperation rate",
"We review ed 155 consecutive patients who were treated with a proximal femoral nail from 1997 to 2001 to determine the rate of implant specific complications . Results were stratified according to fracture type and surgeon experience to determine which problems occurred in these groups . One year postoperative followup was available for 129 of 132 surviving patients ( 98 % ) . Failure of fixation occurred in three patients ( 2 % ) , and a femoral shaft fracture occurred in one patient ( 0.7 % ) . Fixation failures included one cutout , one delayed fracture healing , and one lateral displacement of the antirotation screw . The total reoperation rate was high ( 12 % ) mainly because of hardware removals , which occurred in 13 patients ( 8.6 % ) . Stratification of results showed that hematomas and iliotibial tract irritation occurred more commonly with lesser surgical experience . General complications and intraoperative problems were seen more often with subtrochanteric fractures . Because the high reoperation rate with the proximal femoral nail is a concern , extramedullary devices continue to be the preferred implants for treatment of stable trochanteric fractures . The low rates of femoral shaft fractures and failure of fixation suggest the proximal femoral nail is useful for treatment of unstable trochanteric and subtrochanteric fractures . Level of Evidence : Therapeutic study , Level IV ( case series ) . See the Guidelines for Authors for a complete description of levels of evidence",
"The aim of this study was design ed to assess the risk factors of lag-screw cutout in the treatment of intertrochanteric fracture with a dynamic hip screw ( DHS ) . From 2003 to 2007 , 1,150 patients who had acute unilateral intertrochanteric fractures of the femur were enrolled to the study . All fractures were managed by closed reduction and internal fixation with 135 ° DHS devices . Patient demographics , fracture patterns , reduction and fixation and perioperative course parameters were all recorded . The follow-up period was 38 months on average ( range 16–60 months ) . Finally , 937 patients were available for evaluation of final results in which we focused on lag-screw cutout . Excluding complications not related to screw position , 64 patients ( 6.8 % ) with screw cutout were encountered , and the remaining 873 patients had uneventful union , with the average union time of 17.5 weeks ( range15–24 weeks ) . Upon analysis with logistic regression , the tip−apex distance ( TAD ) was shown to be the most important predictive factor for cutout , followed by screw position , fracture pattern , reduction and patient age . In order to decrease the risk of lag-screw cutout , it is important to ensure good fracture reduction and to place the lag screw in either the middle/middle or inferior/middle position with appropriate TAD",
"Objectives To compare the results between a sliding compression hip screw and an intramedullary nail in the treatment of pertrochanteric fractures . Design Prospect i ve computer-generated r and omization of 206 patients into two study groups : those treated by sliding compression hip screw ( Group 1;n = 106 ) and those treated by intramedullary nailing ( Group 2;n = 100 ) . Setting University Level I trauma center . Patients All patients over the age of fifty-five years presenting with fractures of the trochanteric region caused by a low-energy injury , classified as AO/OTA Type 31-A1 and A2 . Intervention Treatment with a sliding compression hip screw ( Dynamic Hip Screw ; Synthes-Stratec , Oberdorf , Switzerl and ) or an intramedullary nail ( Proximal Femoral Nail ; Synthes-Stratec , Oberdorf , Switzerl and ) . Main Outcome Measurements Intraoperative : operative and fluoroscopy times , the difficulty of the operation , intraoperative complications , and blood loss . Radiologic : fracture healing and failure of fixation . Clinical : pain , social functioning score , and mobility score . Results The minimum follow-up was one year . We did not find any statistically significant difference , intraoperatively , radiologically , or clinical ly , between the two groups of patients . Conclusions There is no advantage to an intramedullary nail versus a sliding compression hip screw for low-energy pertrochanteric fractures AO/OTA 31-A1 and A2 , specifically with its increased cost and lack of evidence to show decreased complications or improved patient outcome",
"Objective : To evaluate the outcome and efficacy of LISS ( Less Invasive Stabilization System ; Synthes USA , Paoli , PA ) for the treatment of proximal femoral fractures to find another appropriate minimally invasive surgery for these fractures in which intramedullary nailing may be difficult . Design : A consecutive prospect i ve r and omized clinical study . Setting : University teaching hospital . Patients : Between May 2006 and March 2008 , 64 consecutive patients who had a proximal femoral fracture were r and omized to be treated with fixation with either LISS or PFNA ( Proximal Femoral Nail Anti-rotation ; Synthes USA ) . Intervention : LISS or PFNA fixation of proximal femoral fractures . Main Outcome Measurements : Intraoperative time , intraoperative blood loss , length of hospitalization , hip function ( Harris score ) , general complications , fracture complications . Results : Fifty-nine patients were evaluated with a mean follow-up time of 26.8 months ( range , 21–36 months ) . No statistical differences in general complications , intraoperative blood loss , length of hospitalization , or hip function could be found between the two groups . The average operative time was longer in the LISS group ( 98.25 minutes ) compared with the PFNA group ( 65.36 minutes ) ( P intrapelvic penetration of the helical blade ; two LISS cases had breakage of the screws . Conclusion : There were no major differences in outcome or complications between the treatment groups . LISS can be used effectively in treating proximal femoral fractures , especially for complex fractures patterns in which intramedullary nailing may be difficult . Level of Evidence : Therapeutic Level II . See page 128 for a complete description of levels of evidence",
"The purpose of this study was to compare the clinical results and the complication rates of a new generation of two intramedullary fixation devices : Proximal Femoral Nail Antirotation ® ( PFNA ) and Gamma3 ® . We conducted a prospect i ve r and omised multicentre trial of 61 patients who underwent a PFNA fixation treatment ( 31 patients ) or a Gamma3 nail ( 30 patients ) . We documented the fixation failure complications as well as data of the surgical procedure , the clinical and functional outcomes ( the EuroQoL5 question naire , the Katz index score , the Short Form 36 ( SF-36 ) , and the Harris Hip Score ) and the plain radiographic parameters at 3,6 and 12 months follow up . The PFNA and Gamma3 fixation devices were similar in terms of complication rates . The risk for experiencing a postoperative complication after Gamma3 nailing was 40 % versus 45 % after PFNA fixation . At the 6-month and 1-year follow-up evaluations , there were no significant differences in terms of range of motion , clinical scores and radiological outcomes",
"Objectives To compare the surgical complications and functional outcome of the Gamma nail intramedullary fixation device versus the Richards sliding hip screw and plate device in intertrochanteric femoral fractures . Design A prospect i ve , r and omised controlled clinical trial with observer blinding . Setting A regional teaching hospital in the United Kingdom . Patients All patients admitted from the local population with intertrochanteric fractured femurs were included . There were 400 patients entered into the study and 399 followed-up to one year or death . Intervention The devices were assigned by r and omization to either a short-type Gamma nail ( 203 patients ) or a Richard's-type sliding hip screw and plate ( 197 patients ) . Main Outcome Measurements The main surgical outcome measurements were fixation failure and reoperation . A functional outcome of pain , mobility status , and range of movement were assessed until one year . Results The requirement for revision in the Gamma nail group was twelve ( 6 % ) ; for Richard 's group , eight ( 4 % ) . This was not statistically different ( p = 0.29 ; odds ratio , 1.48 [ 0.59–3.7 ] ) . A subcapital femoral fracture occurred in the Richard 's group . Femoral shaft fractures occurred with four in the Gamma nail group ( 2 % ) and none in the Richard 's group ( p = 0.13 ) . Three required revision to another implant . Lag-screw cut-out occurred in eight patients in the gamma nail group ( 4 % ) and four in the Richard 's group ( 2 % ) . This was not statistically significant ( p = 0.37 ; odds ratio , 2.29 [ 0.6–9.0 ] ) . The development of other postoperative complications was the same in both groups . There was no difference between the two groups in terms of early or long-term functional status at one year . Conclusions The use of an intramedullary device in the treatment of intertrochanteric femoral fractures is still associated with a higher but nonsignificant risk of postoperative complications . Routine use of the Gamma nail in this type of fracture can not be recommended over the current st and ard treatment of dynamic hip screw and plate",
"Objectives : Reoperations are common after surgical treatment of hip fractures but may be reduced by optimal choice of implant based on fracture classification . We hypothesized that implementing a surgical treatment algorithm was possible in our hospital and would result in a reduced reoperation rate . Design : Retrospective comparative study . Setting : Provincial level III trauma center . Patients : The evidence -based “ Hvidovre Algorithm ” for treatment of hip fractures was adopted and implemented at our provincial institution in September 2008 . Three hundred eighty-six consecutive patients older than 50 years admitted with a hip fracture in the first year after implementation were prospect ively included and compared with 417 retrospectively included similar patients admitted within the last year before implementation . Intervention : Implementation of an evidence -based treatment algorithm for hip fracture surgery . Results : Eighty-five percent ( 330 of 386 ) patients were operated according to the algorithm after implementation , compared with 67 % ( 280 of 417 ) of procedures before implementation ( P overall reoperation rate showed a tendency toward a reduction to 8 % ( 32 of 386 ) from 12 % ( 48 of 417 ) ( P = 0.1 ) . Among all the 803 included patients , the reoperation rate was lower if procedures had been performed according to the algorithm recommendations : 9 % ( 53 of 610 ) versus 14 % ( 27 of 193 ) ( P = 0.009 ) . Conclusions : The algorithm for hip fracture surgery was easily implemented , and our results support that using it facilitates a low reoperation rate . The reoperation rate may be further reduced with higher adherence to algorithm recommendation . Level of Evidence : Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence",
"OBJECTIVE To evaluate whether the implantation of the modular trochanter stabilizing plate ( TSP ) in addition to the dynamic hip screw ( DHS ) prevents excessive telescoping and limb shortening in four-part and selected three-part trochanteric fractures . DESIGN Prospect i ve clinical study . SETTING The study was conducted at the trauma unit of the Surgical Department of the University of Basel , Switzerl and . PATIENTS Forty-six consecutive patients with unstable intertrochanteric fractures were treated with an additional TSP super-imposed on the regular DHS at our institution between July 1991 and July 1993 . Five patients died before the first follow-up , one patient was lost to follow-up , and another patient refused follow-up . Thus , thirty-nine patients were followed for at least twelve months ( mean 14 months , range 12 to 20 months ) . INTERVENTION The fractures treated were classified according to the OTA classification , which is based on the AO classification . Seventeen were 31-A2.2 , seven were 31-A2.3 , and fourteen were 31-A3.3 fractures . RESULTS Lateralization of the greater trochanter was successfully prevented in all fractures . Limited fracture impaction was found in 90 percent ( n = 35 ) of the patients with telescoping of 9.5 millimeters ( range 0 to 30 millimeters ) , result ing in mean limb shortening of 5.37 millimeters ( range 0 to 14.9 millimeters ) . Four patients suffered limb shortening exceeding fifteen millimeters ( range 15.6 to 21.3 millimeters ) . Functional results were excellent and good in 87 percent of patients and fair in 13 percent according to the Salvati-Wilson score . All fractures had healed six months after the operation . Three complications required a secondary procedure : one from not inserting a second screw parallel to the gliding hip screw to prevent rotation of the head-neck fragment ( \" antirotation screw \" ) , one because of deep infection , and one because of a refracture after premature implant removal . CONCLUSION In unstable pertrochanteric fractures with small or missing lateral cortical buttress , the addition of a TSP to the DHS effectively supports the unstable greater trochanter fragment and can prevent rotation of the head-neck fragment . Excessive fracture impaction and consecutive limb shortening was prevented by this additional implant in 90 percent of these patients",
"This prospect i ve , r and omized study compared the functional outcome and complications associated with a proximal femoral nail antirotation ( PFNA ) device with those of a traditional extramedullary device , the dynamic hip screw ( DHS ) , in patients with trochanteric fracture . A total of 121 patients were r and omized to the PFNA group ( n = 58 ) or the DHS group ( n = 63 ) . Perioperative information and complications were recorded , and assessment s of functional outcome were made . The DHS group required a longer operative time and was associated with greater blood loss than the PFNA group . The re-operation rate was lower in the PFNA group compared with the DHS group , especially in patients with unstable fractures , although there was no statistically significant difference in the overall complication rate between the two groups . There were no significant differences in functional outcome between the PFNA and the DHS groups . In conclusion , the PFNA device is useful in the treatment of trochanteric fractures",
"Objective : The aim of this study was to report the long-term outcome for patients with stable trochanteric fractures , especially regarding the health-related quality of life ( HRQoL ) . Design : A prospect i ve cohort study with a 2-year follow-up . Setting : Four university hospitals . Patients : One hundred forty-eight consecutive patients with stable trochanteric fractures , that is , a 2-part fracture ( J-M 1 and 2 ) according to the Jensen-Michaelsen classification , treated with a sliding hip screw . Main Outcome Measurements : Mortality rate , reoperation rate , pain at the hip , walking ability , activities of daily living ( ADL ) function , and HRQoL assessed with the EuroQol-5D ( EQ-5Dindex score ) . Results : The 2-year mortality rate was 29 % . The reoperation rate was 3 % . At the final follow-up , 81 % of the patients reported no or only limited pain at the hip , 55 % had regained their prefracture walking ability , and 66 % their prefracture level of ADL function . The EQ-5Dindex score decreased from 0.69 before the fracture to 0.57 at 4 months , 0.59 at 12 months , and 0.66 at 24 months . Conclusions : Besides the expected mortality rate , the results of the study confirm a low reoperation rate and a good outcome regarding pain at the hip and only limited deterioration in HRQoL after a stable trochanteric fracture . However , a considerable number of the patients experienced deterioration in their walking ability and ADL function . The data on HRQoL obtained in this study can be used in future healthcare evaluations and to calculate quality -adjusted life years",
"A consecutive clinical series of 33 patients with either an undisplaced ( Garden I ) or minimally displaced ( Garden II ) femoral neck fracture was r and omly divided into two operative protocol s. Half of the fractures were treated with three cannulated cancellous bone screws , while the other half were treated with a st and ard screw-angle plate device . After a mean follow-up of 2 years , 4 patients had died , while 20 of the remaining 29 hips showed excellent or good , 3 fair and 6 poor functional results . The three-screw fixation seemed to yield more technical complications as compared to the screw-angle plate fixation . However , the differences in functional end- results were of no clear statistical significance . We conclude that the screw-angle plate device gives acceptable results in this group of fractures . The use of cannulated hip screws may be more advantageous in the treatment of dislocated femoral neck fractures , where the torsional strength of fracture fixation and femoral head viability are more critical",
"In this issue of Spine , a novel method for managing chronic discogenic low back pain with a thermal intradiscal catheter is reported . This study raises some general questions regarding the introduction of new treatment techniques and devices . Decisions about medical treatment should be based on a careful appraisal of the best evidence available . A step-wise introduction is necessary to increase the use of evidence -based decision making in the implementation of new surgical techniques and implants while exposing as few patients as possible to the potential risk of failure . The development of the total hip arthroplasty procedure , for example , could have been different if the introduction of new devices and techniques had been done more carefully and performed in a step-wise manner . Inferior properties could have been revealed earlier , thus reducing the number of failures and allowing for necessary improvements . It is also desirable , therefore , that members of this profession agree on a st and ardized way to introduce new surgical techniques and implants in the field of spinal disorders . Based on the results of Swedish reports and practice , the following schedule for step-wise clinical introduction of new implants is suggested ( Figure 1 ) : The initial step is a pre clinical testing and is beyond the scope of this discussion . The first clinical step is the open prospect i ve and preferably r and omized trial that includes a minimum of patients but yields a relevant evaluation . The strict rules of prospect i ve , r and omized trials should be adhered to . In this first clinical phase , methods associated with high accuracy , such as radiostereometric analysis ( RSA ) , are required . Within 6 to 24 months , this method has the potential to identify implants/ methods that provide inferior fixation and increased polyethylene wear . Results from this first step determine whether further clinical evaluation is worthwhile . It should be noted and stressed that all types of complications can not be predicted and that further follow-up study is necessary . If favorable results are obtained in the first step , the second step , a multicenter trial exposing the new procedure to a broader aspect in the orthopedic community , can be initiated . In the first step , there is a risk for susceptibility and performance bias because the inventors themselves often perform this introductory investigation . The protocol in the multicenter trial must be prepared carefully and agreed on by all participating inventors . A sufficient number of patients should be included to allow adequate statistical analysis . The ultimate goal for step two is to make even the multicenter trial r and omized by using well-documented methods /implants as the gold st and ard . The final step in the evaluation , step three , is to include a continuous control group by using register studies based on large cohorts to reveal early or unusual and potential clinical catastrophic complications . In a rather small and closed community such as Sweden , the register should be nationwide and include all units in a specific field . When applying the principles for step-wise introduction to the investigation of chronic discogenic low back pain with a thermal intradiscalcatheterbySaal and Saal , oneobserves that the current study falls between the pre clinical step and step one . The lack of r and omization toward either conservative or surgical intervention is a definite limitation of the study , and before this method is introduced to a larger study group , a r and omized trial must be considered . A multicenter trial exposing the new procedure to a broader aspect of the orthopedic community is recommended before using it in general orthopedic practice . The length of the follow-up period was very short in this study , and no long-term clinical conclusions can be drawn based on the results",
"Limited access surgery is thought to reduce post-operative morbidity and provide faster recovery of function . The percutaneous compression plate ( PCCP ) is a recently introduced device for the fixation of intertrochanteric fractures with minimal exposure . It has several potential mechanical advantages over the conventional compression hip screw ( CHS ) . Our aim in this prospect i ve , r and omised , controlled study was to compare the outcome of patients operated on using these two devices . We r and omised 104 patients with intertrochanteric fractures ( AO/OTA 31.A1-A2 ) to surgical treatment with either the PCCP or CHS and followed them for one year postoperatively . The mean operating blood loss was 161.0 ml ( 8 to 450 ) in the PCCP group and 374.0 ml ( 11 to 980 ) in the CHS group ( Student 's t-test , p pain score and ability to bear weight were significantly better in the PCCP group at six weeks post-operatively . Analysis of the radiographs in a proportion of the patients revealed a reduced amount of medial displacement in the PCCP group ( two patients , 4 % ) compared with the CHS group ( 10 patients , 18.9 % ) ; Fisher 's exact test , p PCCP device was associated with reduced intra-operative blood loss , less postoperative pain and a reduced incidence of collapse of the fracture",
"A prospect i ve , r and omized study comparing the Dynamic Hip screws and the Gouffon screws in the treatment of femoral neck fractures was terminated before the planned number of patients had been admitted , owing to a preponderance of early failure of the Gouffon screws ( P 0.014 ) ; thus only 73 patients entered the study . After three years ' follow-up , 25/38 Gouffon screws and 12/35 Dynamic Hip screws had failed . Six patients treated with Gouffon screws and 14 treated with Dynamic Hip screws had died . The outcome still favoured the use of Dynamic Hip screws ( P 0.02 )",
"In a prospect i ve study we assessed the causes of mechanical failure in a series of 230 intertrochanteric femoral fractures which had been internally fixed with either a sliding hip screw or a Küntscher Y-nail . The overall rate of mechanical failure was 16.5 % ; cutting-out of the implant from the femoral head was the cause in three-quarters of the instances . Implants placed posteriorly in the femoral head cut out more often ( 27 % ) than those placed central ly ( 7 % ) . The cut-out rate was also determined by the quality of the fracture reduction , but age , walking ability and bone density ( assessed by the Singh grade and metacarpal indices ) had no significant influence . We conclude that these fractures should be reduced as accurately as possible and it is imperative that the implant is placed central ly within the femoral head",
"Objective : A new device for the treatment of intertrochanteric fractures that uses 2 cephalocervical screws in an integrated mechanism allowing linear intraoperative compression and rotational stability of the head/neck fragment has been developed . The aim of this study was to describe the results using this device for the treatment of stable and unstable intertrochanteric fractures . Design : Prospect i ve , consecutive . Setting : Academic Trauma Center . Methods : Between March 1 , 2005 , and July 31 , 2006 , 100 consecutive patients with an intertrochanteric fracture were treated with a new trochanteric ante grade nail ( InterTan ; Smith-Nephew , Memphis , TN ) . All living patients were followed up for a minimum of 1 year postoperatively ( range 12 - 27 months ) . Clinical and radiographic examinations were performed until healing and at the 1-year anniversary of the index procedure . Healing , pain with ambulation , return to activities of daily living , the modified Harris hip score , and Barthel Index were used to evaluate outcomes . Results : The mean age of the patients was 81.2 ( ±11.3 ) years . Thirty-seven patients died , 12 were too infirmed for follow-up , and 3 could not be located , leaving 48 patients available for final evaluation . The average surgical time was 41 minutes ( 13 - 95 minutes ) . This rose significantly with the complexity of the fracture ( OTA/AO classification : A1 versus A3 , P = 0.016 ) . All fractures healed within 16 weeks ( range 10 - 16 weeks ) . Radiographic analysis at healing revealed no loss of reduction , no uncontrolled collapse of the neck , no nonunions , no femoral shaft fractures , and no implant failures . Two cases in the series were poorly reduced and settled into varus malalignment . There was no varus malposition seen in the remaining 46 fractures . The mean prefracture Harris hip score ( 75.1 ± 13.4 ) was significantly reduced at the time of follow-up ( 70.3 ± 14.5 , P = 0.003 ) ; 58 % of the patients recovered their prefracture status . No significant difference was seen for the Barthel Index . Conclusions : The InterTan device appears to be a reliable implant for the treatment of intertrochanteric femoral fractures . Its design provides for stability against rotation and minimizes neck malunions ( shortening ) through linear intraoperative compression of the head/neck segment to the shaft . As a result of the negligible complication rate and improved clinical outcomes , this implant is now the st and ard treatment for all intertrochanteric fractures at our institution",
"Background Reverse obliquity fractures of the proximal femur have biomechanical characteristics distinct from other intertrochanteric fractures and high implant failure rate when treated with sliding hip screws . Intramedullary hip nailing for these fractures reportedly has less potential for cut-out of the lag screw because of their loadbearing capacity when compared with extramedullary implants . However , it is unclear whether nail length influences healing . Questions / purpose sWe compared st and ard and long types of intramedullary hip nails in terms of ( 1 ) reoperation ( fixation failure ) , ( 2 ) 1-year mortality rate , ( 3 ) function and mobility , and ( 4 ) union rate . Methods We conducted a pilot prospect i ve r and omized controlled trial comparing st and ard versus long ( ≥ 34 cm ) intramedullary hip nails for reverse obliquity fractures of the proximal femur from January 2009 to December 2009 . There were 15 patients with st and ard nails and 18 with long nails . Mean age was 79 years ( range , 67–95 years ) . We determined 1-year mortality rates , reoperation rates , Parker-Palmer mobility and Harris hip scores , and radiographic findings ( fracture union , blade cut-out , tip-apex distance , implant failure ) . Minimum followup was 12 months ( mean , 14 months ; range , 12–20 months ) . Results We found no difference in reoperation rates between groups . Two patients ( both from the long-nail group ) underwent revision surgery because of implant failure in one and deep infection in the other . There was no difference between the st and ard- and long-nail groups in mortality rate ( 17 % versus 18 % ) , Parker-Palmer mobility score ( five versus six ) , Harris hip score ( 74 versus 79 ) , union rate ( 100 % in both groups ) , blade cut-out ( zero versus one ) , and tip-apex distance ( 22 versus 24 mm ) . Conclusions Our preliminary data suggest reverse obliquity fractures of the trochanteric region of the femur can be treated with either st and ard or long intramedullary nails . Level of Evidence Level II , therapeutic study . See Instructions for Authors for a complete description of levels of evidence"
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An increasing number of original studies suggest that sedentary behavior is associated with the risk of dementia , but the results remain inconsistent and inconclusive . In this meta- analysis , we analyzed available observational epidemiological evidence to identify the association between sedentary behavior and the risk of dementia . We search ed PubMed and Embase from their inception to March 2019 to identify observational studies examining the association between sedentary behavior and risk of dementia . Two authors independently extracted data and assessed study quality using predefined criteria . The Q statistics and I² methods were used to test for heterogeneity . The publication bias of the included studies was also estimated using Begg ’s and Egger ’s tests . We identified 18 relevant cohort studies involving 250,063 participants and 2269 patients with dementia . Pooled result showed that sedentary behavior was significantly associated with increased risk of dementia ( RR = 1.30 ; 95 % CI : 1.12–1.51 ) . In addition , subgroup analyses by state , and controlling for the concomitant effects of age , sex , education were conducted for the increase of dementia risk , relating to sedentary , respectively . In general , these subgroup analyses showed no statistically significant differences . The results of our meta- analysis suggested that sedentary behavior was independently associated with a significantly increased risk of dementia , which might have important implication s in conducting etiological studies for dementia and developing strategies for dementia prevention
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"Background The primary objective of this trial is to investigate the effects of a short-term exercise program on neuropsychiatric signs and symptoms in acute hospital dementia care . Methods Within a hospital-based r and omized controlled trial , the intervention group conducted a 2-week exercise program with four 20-min exercise sessions on 3 days per week . The control group conducted a social stimulation program . Effects on neuropsychiatric signs and symptoms were measured via the Alzheimer ’s Disease Cooperative Study - Clinical Global Impression of Change , the Neuropsychiatric Inventory , and the Cohen-Mansfield Agitation Inventory . The antipsychotic and sedative dosage was quantified by olanzapine and diazepam equivalents . Results Eighty-five patients were r and omized via minimization to an intervention group ( IG ) and a control group ( CG ) . Seventy patients ( 82 % ) ( mean age 80 years , 33 females , mean Mini Mental State Examination score 18.3 points ) completed the trial . As compared to the CG ( n = 35 ) , the IG ( n = 35 ) showed significantly reduced neuropsychiatric signs and symptoms . Especially , agitated behavior and lability improved . There were no between-group differences concerning antipsychotic and benzodiazepine medication . Conclusions This exercise program is easily applicable in hospital dementia care and significantly reduces neuropsychiatric signs and symptoms in patients suffering from predominantly moderate stages of dementia . Trial registration German Clinical Trial Register DRKS00006740 . Registered 28 October 2014",
"We investigated the long-term influence of physical activity on the risk of dementia in an elderly Japanese population . A total of 803 community-dwelling elderly Japanese individuals without dementia aged ≥65 years were followed prospect ively for 17 years . Physically active status was defined as engaging in exercise at least one or more times per week during leisure time , and participants were divided into an active group and an inactive group by the presence or absence of such physical activity . The risk estimates of physical activity on the development of all-cause dementia and its subtypes were computed using a Cox proportional hazards model . During the follow-up , 291 participants developed all-cause dementia . Of these , 165 had Alzheimer ’s disease ( AD ) , 93 had vascular dementia ( VaD ) , and 47 had other dementia . Compared with the inactive group , the active group showed significantly lower crude incidence of AD ( 21.8 vs. 14.2 per 1000 person-years , p = 0.01 ) , but no significant differences were observed for all-cause dementia ( 35.6 vs. 30.5 , p = 0.17 ) , VaD ( 11.3 vs. 9.8 , p = 049 ) , and other dementia ( 4.6 vs. 7.1 , p = 0.15 ) . After adjusting for potential confounders , the relationship between physical activity and risk of AD remained significant ( adjusted hazard ratio 0.59 , 95 % confidence interval 0.41–0.84 , p = 0.003 ) . Our findings suggest that physical activity reduces the long-term risk of dementia , especially AD , in the general Japanese population",
"OBJECTIVES To determine whether adhering to a healthy lifestyle in midlife may reduce the risk of dementia . DESIGN Case-control study nested in a prospect i ve cohort . SETTING The Honolulu-Asia Aging Study , Oahu , Hawaii . PARTICIPANTS Three thous and four hundred sixty-eight Japanese-American men ( mean age 52 in 1965 - 1968 ) examined for dementia 25 years later . MEASUREMENTS Men at low risk were defined as those with the following midlife characteristics : nonsmoking , body mass index ( BMI ) less than 25.0 kg/m(2 ) , physically active , and having a healthy diet ( based on alcohol , dairy , meat , fish , fruits , vegetables , cereals , and ratio of monounsaturated to saturated fat ) . Logistic regression was used to calculate odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) for developing overall dementia , Alzheimer 's disease ( AD ) , and vascular dementia ( VaD ) , adjusting for potential confounders . RESULTS Dementia was diagnosed in 6.4 % of men ( 52.5 % with AD , 35.0 % with VaD ) . Examining the risk factors individually , BMI was most strongly associated with greater risk of overall dementia ( OR = 1.87 , 95 % CI = 1.26 - 2.77 ; BMI > 25.0 vs diet score were significantly associated with VaD , whereas none were significantly associated with AD alone . Men with all four low-risk characteristics ( 7.2 % of the cohort ) had the lowest OR for overall dementia ( OR = 0.36 , 95 % CI = 0.15 - 0.84 ) . There were no significant associations between the combined low-risk characteristics and the risk of AD alone . CONCLUSION Among Japanese-American men , having a healthy lifestyle in midlife is associated with a lower risk of dementia in late life",
"Background and Purpose — We aim ed to study if physical activity could interfere with progression for cognitive impairment and dementia in older people with white matter changes living independently . Methods — The LADIS ( Leukoaraiosis and Disability ) prospect i ve multinational European study evaluates the impact of white matter changes on the transition of independent elderly subjects into disability . Subjects were evaluated yearly during 3 years with a comprehensive clinical protocol and cognitive assessment with classification of cognitive impairment and dementia according to usual clinical criteria . Physical activity was recorded during the clinical interview . MRI was performed at entry and at the end of the study . Results — Six hundred thirty-nine subjects were included ( 74.1±5 years old , 55 % women , 9.6±3.8 years of schooling , 64 % physically active ) . At the end of follow-up , 90 patients had dementia ( vascular dementia , 54 ; Alzheimer disease with vascular component , 34 ; frontotemporal dementia , 2 ) , and 147 had cognitive impairment not dementia . Using Cox regression analysis , physical activity reduced the risk of cognitive impairment ( dementia and not dementia : & bgr;=−0.45 , P=0.002 ; hazard ratio , 0.64 ; 95 % CI , 0.48–0.85 ) , dementia ( & bgr;=−0.49 , P=0.043 ; hazard ratio , 0.61 ; 95 % CI , 0.38–0.98 ) , and vascular dementia ( & bgr;=−0.86 , P=0.008 ; hazard ratio , 0.42 ; 95 % CI , 0.22–0.80 ) , independent of age , education , white matter change severity , medial temporal atrophy , previous and incident stroke , and diabetes . Conclusions — Physical activity reduces the risk of cognitive impairment , mainly vascular dementia , in older people living independently",
"BACKGROUND As physical activity may modify the effect of the apolipoprotein E ( APOE ) ε4 allele on the risk of dementia and Alzheimer 's disease ( AD ) dementia , we tested for such a gene-environment interaction in a sample of general practice patients aged ⩾75 years . METHOD Data were derived from follow-up waves I-IV of the longitudinal German study on Ageing , Cognition and Dementia in Primary Care Patients ( AgeCoDe ) . The Kaplan-Meier survival method was used to estimate dementia- and AD-free survival times . Multivariable Cox regression was used to assess individual associations of APOE ε4 and physical activity with risk for dementia and AD , controlling for covariates . We tested for gene-environment interaction by calculating three indices of additive interaction . RESULTS Among the r and omly selected sample of 6619 patients , 3327 ( 50.3 % ) individuals participated in the study at baseline and 2810 ( 42.5 % ) at follow-up I. Of the 2492 patients without dementia included at follow-up I , 278 developed dementia ( 184 AD ) over the subsequent follow-up interval of 4.5 years . The presence of the APOE ε4 allele significantly increased and higher physical activity significantly decreased risk for dementia and AD . The co-presence of APOE ε4 with low physical activity was associated with higher risk for dementia and AD and shorter dementia- and AD-free survival time than the presence of APOE ε4 or low physical activity alone . Indices of interaction indicated no significant interaction between low physical activity and the APOE ε4 allele for general dementia risk , but a possible additive interaction for AD risk . CONCLUSIONS Physical activity even in late life may be effective in reducing conversion to dementia and AD or in delaying the onset of clinical manifestations . APOE ε4 carriers may particularly benefit from increasing physical activity with regard to their risk for AD",
"The risk of dementia and Alzheimer 's disease ( AD ) probably results from an interaction between genetic and environmental factors . The aim of this study was to investigate the effects and putative interactions between the apoE ε4 allele and lifestyle related risk factors for dementia and AD . Participants of the Cardiovascular Risk Factors , Aging , and Dementia ( CAIDE ) study were derived from r and om , population -based sample s previously studied in 1972 , 1977 , 1982 or 1987 . After an average follow-up of 21 years , 1449 individuals ( 72.5 % ) aged 65–79 years were re-examined in 1998 . The apoE ε4 allele was an independent risk factor for dementia/AD even after adjustments for sociodemographic , lifestyle and vascular factors ( odds ratio [OR]= 2.83 , 95 % confidence interval [CI]ε1.61–4.97 ) . Physical inactivity , alcohol drinking and smoking increased the risk of dementia/AD particularly among the apoE ε4 carriers . Furthermore , low – moderate intake of polyunsaturated , and moderate – high intake of saturated fats were associated with an increased risk of dementia/AD more pronouncedly among apoE ε4 carriers . Composite effect of the lifestyle factors was particularly seen among the ε4 carriers ( OR = 11.42 , 95 % CI = 1.94–67.07 in the 4th quartile ) . Physical inactivity , dietary fat intake , alcohol drinking and smoking at midlife are associated with the risk of dementia and AD , especially among the apoE ε4 carriers . The apoE ε4 carriers may be more vulnerable to environmental factors , and thus , lifestyle interventions may greatly modify dementia risk particularly among the genetically susceptible individuals",
"Even when adults meet physical activity guidelines , sitting for prolonged periods can compromise metabolic health . Television ( TV ) time and objective measurement studies show deleterious associations , and breaking up sedentary time is beneficial . Sitting time , TV time , and time sitting in automobiles increase premature mortality risk . Further evidence from prospect i ve studies , intervention trials , and population -based behavioral studies is required",
"BACKGROUND The Philippines is experiencing rapid demographic aging and with it , the dementia epidemic . Prevalence of dementia and associated risk factors have not been studied in the Philippines . OBJECTIVES The study aim ed to provide a reliable estimate of dementia prevalence and identify associated risk factors in the Filipino population . METHODS 1460 participants 60 years and older were r and omly selected from the Marikina City 's senior registry . A multidisciplinary team ( nurse , psychologist , and neurologist ) administered a comprehensive assessment to the study population : health history , neurological examination , Geriatric Depression Scale , Neuropsychiatric Inventory , Disability Assessment for Dementia , Alzheimer 's Disease 8 , and Clinical Dementia Rating Scale . The neurologist analyzed all clinical data to diagnose dementia based on the DSM-IV criteria , Alzheimer 's Disease ( AD ) on the NINCDS-ADRDA criteria , vascular dementia ( VaD ) on the Hachinski Ischemic Scale , cognitive impairment no dementia ( CIND ) on a CDR score of 0.5 and not fulfilling DSM-IV criteria for dementia . Risk factors were correlated with dementia prevalence using multivariate binary logistic regression . RESULTS 1460 persons were r and omly selected . 1367 agreed to participate and underwent all assessment s. The response rate was 93.6 % . Dementia prevalence was found to be 10.6 % ( 95 % CI 9.0 to 12.4 ) with the breakdown 85.5 % AD , 11.7 % VaD , and 2.7 % other dementias . In this population , 82.0 % of men and 70.4 % of women had at least one cardiovascular risk factor ( hypertension , diabetes , dyslipidemia , smoking ) , which was associated with VaD prevalence but not AD . CONCLUSION The prevalence of dementia , CIND , and cardiovascular risk factors are high in the Philippines",
"CONTEXT Dementia is common , costly , and highly age related . Little attention has been paid to the identification of modifiable lifestyle habits for its prevention . OBJECTIVE To explore the association between physical activity and the risk of cognitive impairment and dementia . DESIGN , SETTING , AND SUBJECTS Data come from a community sample of 9008 r and omly selected men and women 65 years or older , who were evaluated in the 1991 - 1992 Canadian Study of Health and Aging , a prospect i ve cohort study of dementia . Of the 6434 eligible subjects who were cognitively normal at baseline , 4615 completed a 5-year follow-up . Screening and clinical evaluations were done at both waves of the study . In 1996 - 1997 , 3894 remained without cognitive impairment , 436 were diagnosed as having cognitive impairment-no dementia , and 285 were diagnosed as having dementia . MAIN OUTCOME MEASURE Incident cognitive impairment and dementia by levels of physical activity at baseline . RESULTS Compared with no exercise , physical activity was associated with lower risks of cognitive impairment , Alzheimer disease , and dementia of any type . Significant trends for increased protection with greater physical activity were observed . High levels of physical activity were associated with reduced risks of cognitive impairment ( age- , sex- , and education-adjusted odds ratio , 0.58 ; 95 % confidence interval , 0.41 - 0.83 ) , Alzheimer disease ( odds ratio , 0.50 ; 95 % confidence interval , 0.28 - 0.90 ) , and dementia of any type ( odds ratio , 0.63 ; 95 % confidence interval , 0.40 - 0.98 ) . CONCLUSION Regular physical activity could represent an important and potent protective factor for cognitive decline and dementia in elderly persons",
"Background Epidemiological studies suggest that excessive sitting time is associated with increased health risk , independent of the performance of exercise . We hypothesized that a daily bout of exercise can not compensate the negative effects of inactivity during the rest of the day on insulin sensitivity and plasma lipids . Methodology /Principal Findings Eighteen healthy subjects , age 21±2 year , BMI 22.6±2.6 kgm−2 followed r and omly three physical activity regimes for four days . Participants were instructed to sit 14 hr/day ( sitting regime ) ; to sit 13 hr/day and to substitute 1 hr of sitting with vigorous exercise 1 hr ( exercise regime ) ; to substitute 6 hrs sitting with 4 hr walking and 2 hr st and ing ( minimal intensity physical activity ( PA ) regime ) . The sitting and exercise regime had comparable numbers of sitting hours ; the exercise and minimal intensity PA regime had the same daily energy expenditure . PA was assessed continuously by an activity monitor ( ActivPAL ) and a diary . Measurements of insulin sensitivity ( oral glucose tolerance test , OGTT ) and plasma lipids were performed in the fasting state , the morning after the 4 days of each regime . In the sitting regime , daily energy expenditure was about 500 kcal lower than in both other regimes . Area under the curve for insulin during OGTT was significantly lower after the minimal intensity PA regime compared to both sitting and exercise regimes 6727.3±4329.4 vs 7752.0±3014.4 and 8320.4±5383.7 mU•min/ml , respectively . Triglycerides , non-HDL cholesterol and apolipoprotein B plasma levels improved significantly in the minimal intensity PA regime compared to sitting and showed non-significant trends for improvement compared to exercise . Conclusions One hour of daily physical exercise can not compensate the negative effects of inactivity on insulin level and plasma lipids if the rest of the day is spent sitting . Reducing inactivity by increasing the time spent walking/st and ing is more effective than one hour of physical exercise , when energy expenditure is kept constant",
"BACKGROUND Identification of subjects with a progressive disease phenotype is an urgent need in the pharmaceutical industry where most of the recent clinical trials in Alzheimer 's disease have failed . OBJECTIVES The objective of this study was to identify subgroups of individuals with objective cognitive impairment ( OCI ) , who were most likely to progress to dementia and to identify the risk factors associated with progression . DESIGN Prospect i ve cohort study . SETTING Population -based . PARTICIPANTS 5,380 elderly women from Denmark . MEASUREMENTS The Short Blessed Test and a category fluency test with animal naming , was used to assess cognitive function , and to classify them into different groups of OCI . RESULTS OCI was identified in 852 subjects at baseline . The risk of dementia was elevated for OCI subjects as compared to subjects with normal cognition ( HR 1.46[1.19 - 1.79 ] ) . The courses of OCI were studied in a sub-cohort who completed the cognitive assessment at both the baseline and the follow-up visit ( n = 1,933 ) . Of these subjects 203 had OCI at baseline . The multi-domain subtypes of OCI were associated with progressive OCI . Subjects most likely to progress were older , physically inactive , had a higher level of total cholesterol ( > 6.5 mmol/L ) and had a history of depression as compared to subjects with a non-progressive course of OCI . CONCLUSIONS In this cohort we identified a risk profile associated with progression from OCI in older women . The degree of impairment at baseline was an important predictor of conversion to dementia , additionally several modifiable risk factors were associated with progression",
"Several studies have associated physical activity with the risk of dementia , but mostly did so during short follow-up . It remains unclear whether physical activity also affects dementia during longer follow-up . We examined the association between physical activity and risk of dementia during a follow-up period up to 14 years . From 1997 to 1999 , physical activity was assessed using a vali date d question naire in 4,406 elderly persons ( age range 61–97 ) from the prospect i ve , population -based Rotterdam Study . Follow-up for dementia was complete until January 1 , 2011 . We used Cox proportional hazards models to assess the association between physical activity and incident dementia . Next , we stratified follow-up time using a cut-off of 4 years . We separately investigated dementia due to Alzheimer disease . During 38,631 person-years , 583 participants developed dementia . When adjusting for age and sex , we found a borderline significant association between higher physical activity and lower risk of dementia ( HR 0.95 ; 95 % CI 0.87–1.04 ) . This association was confined to follow-up up to 4 years ( HR 0.82 ; 95 % CI 0.71–0.95 ) , and not to follow-up of at least 4 years ( HR 1.04 ; 95 % CI 0.93–1.16 ) . Additional adjustments only slightly attenuated the associations . A similar pattern was present for Alzheimer disease . We found a higher level of physical activity to be associated with a lower risk of dementia . This association was confined to follow-up for up to 4 years and not to longer follow-up , suggesting either a role for reverse causality or only a short term effect of late-life physical activity in an elderly population",
"BACKGROUND Physical activity may help maintain cognitive function and decrease dementia risk , but epidemiological findings remain controversial . The aim of our study was to investigate the association between leisure-time physical activity at midlife and the subsequent development of dementia and Alzheimer 's disease ( AD ) . METHODS Participants were r and omly selected from the survivors of a population -based cohort previously surveyed in 1972 , 1977 , 1982 , or 1987 . 1449 persons ( 72.5 % ) age 65 - 79 years participated in the re-examination in 1998 ( mean follow-up , 21 years ) . 117 persons had dementia and 76 had AD . Multiple logistic regression methods were used to analyse the association between leisure-time physical activity and dementia or AD . FINDINGS Leisure-time physical activity at midlife at least twice a week was associated with a reduced risk of dementia and AD ( odds ratio [ OR ] 0.48 [ 95 % CI 0.25 - 0.91 ] and 0.38 [ 0.17 - 0.85 ] , respectively ) , even after adjustments for age , sex , education , follow-up time , locomotor disorders , APOE genotype , vascular disorders , smoking , and alcohol drinking . The associations were more pronounced among the APOE epsilon4 carriers . INTERPRETATION Leisure-time physical activity at midlife is associated with a decreased risk of dementia and AD later in life . Regular physical activity may reduce the risk or delay the onset of dementia and AD , especially among genetically susceptible individuals",
"QUESTION Does physical exercise training improve physical function and quality of life in people with cognitive impairment and dementia ? Which training protocol s improve physical function and quality of life ? How do cognitive impairment and other patient characteristics influence the outcomes of exercise training ? DESIGN Systematic review with meta- analysis of r and omised trials . PARTICIPANTS People with mild cognitive impairment or dementia as the primary diagnosis . INTERVENTION Physical exercise . OUTCOME MEASURES Strength , flexibility , gait , balance , mobility , walking endurance , dual-task ability , activities of daily living , quality of life , and falls . RESULTS Forty-three clinical trials ( n=3988 ) were included . According to the Grade s of Recommendation , Assessment , Development and Evaluation ( GRADE ) system , the meta-analyses revealed strong evidence in support of using supervised exercise training to improve the results of 30-second sit-to-st and test ( MD 2.1 repetitions , 95 % CI 0.3 to 3.9 ) , step length ( MD 5 cm , 95 % CI 2 to 8) , Berg Balance Scale ( MD 3.6 points , 95 % CI 0.3 to 7.0 ) , functional reach ( 3.9 cm , 95 % CI 2.2 to 5.5 ) , Timed Up and Go test ( -1second , 95 % CI -2 to 0 ) , walking speed ( 0.13 m/s , 95 % CI 0.03 to 0.24 ) , and 6-minute walk test ( 50 m , 95 % CI 18 to 81 ) in individuals with mild cognitive impairment or dementia . Weak evidence supported the use of exercise in improving flexibility and Barthel Index performance . Weak evidence suggested that non-specific exercise did not improve dual-tasking ability or activity level . Strong evidence indicated that exercise did not improve quality of life in this population . The effect of exercise on falls remained inconclusive . Poorer physical function was a determinant of better response to exercise training , but cognitive performance did not have an impact . CONCLUSION People with various levels of cognitive impairment can benefit from supervised multi-modal exercise for about 60minutes a day , 2 to 3days a week to improve physical function . [ Lam FMH , Huang MZ , Liao LR , Chung RCK , Kwok TCY , Pang MYC ( 2018 ) Physical exercise improves strength , balance , mobility , and endurance in people with cognitive impairment and dementia : a systematic review . Journal of Physiotherapy 64 : 4 - 15 ]",
"Objective To examine the relationship between socioeconomic factors and APOE carrier status on the development of dementia . Methods Subjects were derived from r and om , population -based sample s previously studied in surveys carried out in 1972 , 1977 , 1982 , and 1987 . After an average follow-up of 21 years , 1449 ( 73 % ) subjects aged 65 to 79 years were re-examined in 1998 . The diagnosis of dementia among the non participants was derived from patient records of the local hospitals and primary health care clinics . Results Low income level at old age was related to dementia , but low income level at midlife was not a risk factor for dementia . Dementia was also associated with decreasing income level , from midlife to old age 21 years later , when dementia was diagnosed . A sedentary occupation ( office , service , or intellectual work ) was associated with a decreased risk for dementia among participants ; however , when the non participants were included in the analysis , the associations were no longer significant . Low educational level and the APOE & egr;4 allele independently increased the risk for dementia . Conclusions Reduction in income level during follow-up and low income level at old age might be the consequence of a dementing process rather than being associated with risk evolution of dementia",
"The objective was to evaluate the effects of a multicomponent dyadic intervention on the cognitive functioning of people with dementia living at home in a r and omized controlled trial . People with dementia and their family caregivers ( n = 111 ) were r and omly assigned to 8 home-based sessions including physical exercise and support or a minimal intervention consisting of monthly written information bulletins and monthly phone calls . Memory , executive functioning ( EF ) , and attention were assessed at baseline , and after 3 ( postmeasurement ) and 6 months ( follow-up ) . Data were analyzed by using generalized estimating equations ( GEE ) . A small , significant effect was found on attention . No effects were found on memory and EF . Finding only a small significant effect might be explained by the ineffectiveness of the intervention , but also by moderate treatment adherence or a lack of room for improvement because half of the people with dementia were already receiving care in a day care facility",
"Objective : To assess whether the risk of incidence of Alzheimer disease ( AD ) varies over time . The increase in numbers of people at the oldest ages in the population will bring an increase in the number of people with AD . Projections of the size of the increase assume the risk of AD is constant . Methods : All persons age 65 or older in a biracial , geographically defined area were invited to participate in a home interview every 3 years . From the approximately 10,000 participants , stratified r and om sample s were selected for detailed clinical evaluation . At each cycle , individuals determined free of AD in a previous cycle , either by examination or by high score on cognitive function tests , were sample d in the subsequent cycle for evaluation for incident AD . The evaluations for disease were structured and uniform across time . These analyses include 1,695 subjects evaluated for incident disease from 1997 through 2008 . Results : AD developed in 360 participants . Change over time in risk of incident disease was assessed in logistic regression analyses including evaluation date and controlling for age , gender , education , race , interval from disease-free design ation to evaluation for incident disease , and sample design . The time variable ( in years ) was not significant ( odds ratio = 0.970 , 95 % confidence interval = 0.902 to 1.044 ) . Conclusions : The None relation of evaluation date to disease incidence suggests no recent change in risk of AD over time , and supports this assumption for projections of AD"
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Background : Concerns have been raised about the concurrent temporal trend between simple sugar intakes , especially of fructose or high-fructose corn syrup ( HFCS ) , and rates of nonalcoholic fatty liver disease ( NAFLD ) in the United States . Objective : We examined the effect of different amounts and forms of dietary fructose on the incidence or prevalence of NAFLD and indexes of liver health in humans . Design : We conducted a systematic review of English- language , human studies of any design in children and adults with low to no alcohol intake and that reported at least one predetermined measure of liver health . The strength of the evidence was evaluated by considering risk of bias , consistency , directness , and precision . Results : Six observational studies and 21 intervention studies met the inclusion criteria . The overall strength of evidence for observational studies was rated insufficient because of high risk of biases and inconsistent study findings . Of 21 intervention studies , 19 studies were in adults without NAFLD ( predominantly healthy , young men ) and 1 study each in adults or children with NAFLD . We found a low level of evidence that a hypercaloric fructose diet ( supplemented by pure fructose ) increases liver fat and aspartate aminotransferase ( AST ) concentrations in healthy men compared with the consumption of a weight-maintenance diet . In addition , there was a low level of evidence that hypercaloric fructose and glucose diets have similar effects on liver fat and liver enzymes in healthy adults . There was insufficient evidence to draw a conclusion for effects of HFCS or sucrose on NAFLD . Conclusions : On the basis of indirect comparisons across study findings , the apparent association between indexes of liver health ( ie , liver fat , hepatic de novo lipogenesis , alanine aminotransferase , AST , and γ-glutamyl transpeptase ) and fructose or sucrose intake appear to be confounded by excessive energy intake . Overall , the available evidence is not sufficiently robust to draw conclusions regarding effects of fructose , HFCS , or sucrose consumption on NAFLD
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"BACKGROUND & AIMS Diets high in fructose have been proposed to contribute to nonalcoholic fatty liver disease . We compared the effects of high-fructose and matched glucose intake on hepatic triacylglycerol ( TAG ) concentration and other liver parameters . DESIGN In a double-blind study , we r and omly assigned 32 healthy but central ly overweight men to groups that received either a high-fructose or high-glucose diet ( 25 % energy ) . These diets were provided during an initial isocaloric period of 2 weeks , followed by a 6-week washout period , and then again during a hypercaloric 2-week period . The primary outcome measure was hepatic level of TAG , with additional assessment s of TAG levels in serum and soleus muscle , hepatic levels of adenosine triphosphate , and systemic and hepatic insulin resistance . RESULTS During the isocaloric period of the study , both groups had stable body weights and concentrations of TAG in liver , serum , and soleus muscle . The high-fructose diet produced an increase of 22 ± 52 μmol/L in the serum level of uric acid , whereas the high-glucose diet led to a reduction of 23 ± 25 μmol/L ( P high-fructose diet also produced an increase of 0.8 ± 0.9 in the homeostasis model assessment of insulin resistance , whereas the high-glucose diet produced an increase of only 0.1 ± 0.7 ( P = .03 ) . During the hypercaloric period , participants in the high-fructose and high-glucose groups had similar increases in weight ( 1.0 ± 1.4 vs 0.6 ± 1.0 kg ; P = .29 ) and absolute concentration of TAG in liver ( 1.70 % ± 2.6 % vs 2.05 % ± 2.9 % ; P = .73 ) and serum ( 0.36 ± 0.75 vs 0.33 ± 0.38 mmol/L ; P = .91 ) , and similar results in biochemical assays of liver function . Body weight changes were associated with changes in liver biochemistry and concentration of TAGs . CONCLUSIONS In the isocaloric period , overweight men who were on a high-fructose or a high-glucose diet did not develop any significant changes in hepatic concentration of TAGs or serum levels of liver enzymes . However , in the hypercaloric period , both high-fructose and high-glucose diets produced significant increases in these parameters without any significant difference between the 2 groups . This indicates an energy-mediated , rather than a specific macronutrient-mediated , effect . Clinical trials.gov no : NCT01050140",
"Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged",
"Background Prospect i ve studies in humans examining the effects of fructose consumption on biological markers associated with the development of metabolic syndrome are lacking . Therefore we investigated the relative effects of 10 wks of fructose or glucose consumption on plasma uric acid and RBP-4 concentrations , as well as liver enzyme ( AST , ALT , and GGT ) activities in men and women . Methods As part of a parallel arm study , older ( age 40–72 ) , overweight and obese male and female subjects ( BMI 25–35 kg/m2 ) consumed glucose- or fructose-sweetened beverages providing 25 % of energy requirements for 10 wks . Fasting and 24-h blood collection s were performed at baseline and following 10 wks of intervention and plasma concentrations of uric acid , RBP-4 and liver enzyme activities were measured . Results Consumption of fructose , but not glucose , led to significant increases of 24-h uric acid profiles ( P and RBP-4 concentrations ( P = 0.012 ) , as well as plasma GGT activity ( P = 0.04 ) . Fasting plasma uric acid concentrations increased in both groups ; however , the response was significantly greater in subjects consuming fructose ( P = 0.002 for effect of sugar ) . Within the fructose group male subjects exhibited larger increases of RBP-4 levels than women ( P = 0.024 ) . Conclusions These findings suggest that consumption of fructose at 25 % of energy requirements for 10 wks , compared with isocaloric consumption of glucose , may contribute to the development of components of the metabolic syndrome by increasing circulating uric acid , GGT activity , suggesting alteration of hepatic function , and the production of RBP-4",
"BACKGROUND A high dietary protein intake has been shown to blunt the deposition of intrahepatic lipids in high-fat- and high-carbohydrate-fed rodents and humans . OBJECTIVE The aim of this study was to evaluate the effect of essential amino acid supplementation on the increase in hepatic fat content induced by a high-fructose diet in healthy subjects . DESIGN Nine healthy male volunteers were studied on 3 occasions in a r and omized , crossover design after 6 d of dietary intervention . Dietary conditions consisted of a weight-maintenance balanced diet ( control ) or the same balanced diet supplemented with 3 g fructose · kg(-1 ) · d(-1 ) and 6.77 g of a mixture of 5 essential amino acids 3 times/d ( leucine , isoleucine , valine , lysine , and threonine ) ( HFrAA ) or with 3 g fructose · kg(-1 ) · d(-1 ) and a maltodextrin placebo 3 times/d ( HFr ) ; there was a washout period of 4 to 10 wk between each condition . For each condition , the intrahepatocellular lipid ( IHCL ) concentration , VLDL-triglyceride concentration , and VLDL-[(13)C]palmitate production were measured after oral loading with [(13)C]fructose . RESULTS HFr increased the IHCL content ( 1.27 ± 0.31 compared with 2.74 ± 0.55 vol % ; P and VLDL-triglyceride ( 0.55 ± 0.06 compared with 1.40 ± 0.15 mmol/L ; P also enhanced VLDL-[(13)C]palmitate production . HFrAA significantly decreased IHCL compared with HFr ( to 2.30 ± 0.43 vol% ; P change VLDL-triglyceride concentrations or VLDL-[(13)C]palmitate production . CONCLUSIONS Supplementation with essential amino acids blunts the fructose-induced increase in IHCL but not hypertriglyceridemia . This is not because of inhibition of VLDL-[(13)C]palmitate production . This trial was registered at www . clinical trials.gov as NCT01119989",
"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",
"Despite the increasing prevalence of nonalcoholic fatty liver disease ( NAFLD ) , the criteria used to diagnose the disorder remain poorly defined . Localized proton magnetic resonance spectroscopy ( MRS ) accurately measures hepatic triglyceride content ( HTGC ) but has been used only in small research studies . Here , MRS was used to analyze the distribution of HTGC in 2,349 participants from the Dallas Heart Study ( DHS ) . The reproducibility of the procedure was vali date d by showing that duplicate HTGC measurements were high correlated ( r = 0.99 , P high-fat meal did not significantly affect the measurements , and values were similar when measurements were made from the right and left hepatic lobes . To determine the \" upper limit of normal \" for HTGC , the distribution of HTGC was examined in the 345 subjects from the DHS who had no identifiable risk factors for hepatic steatosis ( nonobese , nondiabetic subjects with minimal alcohol consumption , normal liver function tests , and no known liver disease ) . The 95th percentile of HTGC in these subjects was 5.56 % , which corresponds to a hepatic triglyceride level of 55.6 mg/g . With this value as a cutoff , the prevalence of hepatic steatosis in Dallas County was estimated to be 33.6 % . Thus MRS provides a sensitive , quantitative , noninvasive method to measure HTGC and , when applied to a large urban US population , revealed a strikingly high prevalence of hepatic steatosis",
"Objective To evaluate the association between non-alcoholic fatty liver disease and all cause and cause specific mortality in a representative sample of the US general population . Design Prospect i ve cohort study . Setting US Third National Health and Nutrition Examination Survey ( NHANES III : 1988 - 94 ) with follow-up of mortality to 2006 . Participants 11 371 adults aged 20 - 74 participating in the Third National Health and Nutrition Examination Survey , with assessment of hepatic steatosis . Main outcome measure Mortality from all causes , cardiovascular disease , cancer , and liver disease ( up to 18 years of follow-up ) . Results The prevalence of non-alcoholic fatty liver disease with and without increased levels of liver enzymes in the population was 3.1 % and 16.4 % , respectively . Compared with participants without steatosis , those with non-alcoholic fatty liver disease but normal liver enzyme levels had multivariate adjusted hazard ratios for deaths from all causes of 0.92 ( 95 % confidence interval 0.78 to 1.09 ) , from cardiovascular disease of 0.86 ( 0.67 to 1.12 ) , from cancer of 0.92 ( 0.67 to 1.27 ) , and from liver disease of 0.64 ( 0.12 to 3.59 ) . Compared with participants without steatosis , those with non-alcoholic fatty liver disease and increased liver enzyme levels had adjusted hazard ratios for deaths from all causes of 0.80 ( 0.52 to 1.22 ) , from cardiovascular disease of 0.59 ( 0.29 to 1.20 ) , from cancer of 0.53 ( 0.26 to 1.10 ) , and from liver disease of 1.17 ( 0.15 to 8.93 ) . Conclusions Non-alcoholic fatty liver disease was not associated with an increased risk of death from all causes , cardiovascular disease , cancer , or liver disease",
"Non-alcoholic fatty liver disease ( NAFLD ) is closely associated with insulin resistance and obesity . Hence , carbohydrate quality could be of relevance to the risk of NAFLD , but prospect i ve data are lacking . The aim of the present study was to investigate longitudinal associations between carbohydrate quality ( including dietary glycaemic index ( GI ) and intakes of sugar , starch and fibre ) and markers of liver function in an older Australian population . The analysis was based on 866 participants ( ≥ 49 years ) of the Blue Mountains Eye Study with fasting blood specimens and dietary intake data at baseline and 5-year follow-up . Multi-level mixed regression analysis was used to relate dietary GI and sugar , starch and fibre intake to the liver enzymes alanine aminotransferase ( ALT ) and γ-glutamyltransferase ( GGT ) , as well as fasting TAG and HDL-cholesterol ( HDL-C ) . After adjustment for potential confounding factors , a lower fibre intake was cross-sectionally related to higher GGT ( P= 0.02 ) and fasting TAG ( P= 0.002 ) levels , with fruit fibre being the most relevant fibre source ( P= 0.095 for GGT ; P= 0.003 for TAG ) . A higher dietary GI was associated with lower HDL-C ( P= 0.046 ) . Changes in carbohydrate quality during 5 years were not related to changes in ALT , GGT , TAG or HDL-C ( P≥ 0.08 ) . In conclusion , the absence of longitudinal associations between carbohydrate quality and liver enzymes and serum lipids in this older population does not support a major role of carbohydrate nutrition in liver function among the elderly",
"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 & AIMS Prevalence of nonalcoholic fatty liver disease ( NAFLD ) has not been well established . The purpose of this study was to prospect ively define the prevalence of both NAFLD and nonalcoholic steatohepatitis ( NASH ) . METHODS Out patients 18 to 70 years old were recruited from Brooke Army Medical Center . All patients completed a baseline question naire and ultrasound . If fatty liver was identified , then laboratory data and a liver biopsy were obtained . RESULTS Four hundred patients were enrolled . Three hundred and twenty-eight patients completed the question naire and ultrasound . Mean age ( range , 28 - 70 years ) was 54.6 years ( 7.35 ) ; 62.5 % Caucasian , 22 % Hispanic , and 11.3 % African American ; 50.9 % female ; mean body mass index ( BMI ) ( calculated as kg/m(2 ) ) was 29.8 ( 5.64 ) ; and diabetes and hypertension prevalence 16.5 % and 49.7 % , respectively . Prevalence of NAFLD was 46 % . NASH was confirmed in 40 patients ( 12.2 % of total cohort , 29.9 % of ultrasound positive patients ) . Hispanics had the highest prevalence of NAFLD ( 58.3 % ) , then Caucasians ( 44.4 % ) and African Americans ( 35.1 % ) . NAFLD patients were more likely to be male ( 58.9 % ) , older ( P = .004 ) , hypertensive ( P higher BMI ( P ate fast food more often ( P = .049 ) , and exercised less ( P = 0.02 ) than their non-NAFLD counterparts . Hispanics had a higher prevalence of NASH compared with Caucasians ( 19.4 % vs 9.8 % ; P = .03 ) . Alanine aminotransferase , aspartate aminotransferase , BMI , insulin , Quantitative Insulin-Sensitivity Check Index , and cytokeratin-18 correlated with NASH . Among the 54 diabetic patients , NAFLD was found in 74 % and NASH in 22.2 % . CONCLUSION Prevalence of NAFLD and NASH is higher than estimated previously . Hispanics and patients with diabetes are at greatest risk for both NAFLD and NASH",
"Consumption of simple carbohydrates has markedly increased over the past decades , and may be involved in the increased prevalence in metabolic diseases . Whether an increased intake of fructose is specifically related to a dysregulation of glucose and lipid metabolism remains controversial . We therefore compared the effects of hypercaloric diets enriched with fructose ( HFrD ) or glucose ( HGlcD ) in healthy men . Eleven subjects were studied in a r and omised order after 7 d of the following diets : ( 1 ) weight maintenance , control diet ; ( 2 ) HFrD ( 3.5 g fructose/kg fat-free mass ( ffm ) per d , + 35 % energy intake ) ; ( 3 ) HGlcD ( 3.5 g glucose/kg ffm per d , + 35 % energy intake ) . Fasting hepatic glucose output ( HGO ) was measured with 6,6 - 2H2-glucose . Intrahepatocellular lipids ( IHCL ) and intramyocellular lipids ( IMCL ) were measured by 1H magnetic resonance spectroscopy . Both fructose and glucose increased fasting VLDL-TAG ( HFrD : + 59 % , P IHCL ( HFrD : + 52 % , P HGO increased after both diets ( HFrD : + 5 % , P fasting glycaemia , insulin and alanine aminotransferase concentrations . IMCL increased significantly only after the HGlcD ( HFrD : + 24 % , NS ; HGlcD : + 59 % , P IHCL and VLDL-TAG were not different between hypercaloric HFrD and HGlcD , but were increased compared to values observed with a weight maintenance diet . However , glucose led to a higher increase in IMCL than fructose",
"OBJECTIVES The aim of this study was to investigate the effects of thymosin alpha(1 ) ( Talpha(1 ) ) in rats having fructose-induced steatosis . Fructose leads to experimental steatosis in the liver by exerting its effect on some components of the oxidant/antioxidant system , and on several cytokines ( interleukin-1beta , -2 , and -6 ) in blood . METHODS Twenty-four rats at r and om were divided into three groups ( each group containing eight animals ) ; the control group ( C ) , which received a purified diet ; the high-fructose-fed group ( F ) ; and the high-fructose-fed and Talpha(1 ) injected group ( F + T ) . After the experimental period of 10 days , liver lipid peroxidation and antioxidant status , and blood IL-1beta , IL-2 , and IL-6 levels were quantified . RESULTS In comparison with the C group , the F group had a higher nitric oxide ( NO ) level , xanthine oxidase ( XO ) activity , and lipid peroxidation , as indicated by concentrations of thiobarbituric acid reactive substances ( TBARS ) , and lower superoxide dismutase ( SOD ) and glutathione peroxidase ( GSH-Px ) activities in the liver . In the F + T group , these markers were near the values of the control group . In addition , increased IL-1beta and IL-6 levels were kept at near to normal levels with treatment of Talpha(1 ) , but not IL-2 levels . In the F group , the most consistent findings in the histologic sections of liver tissues were the macrovesicular and microvesicular steatosis . Talpha(1 ) treatment protected the majority of the liver cells , while minimal macrovesicular and microvesicular steatosis was observed in the remaining cells . CONCLUSIONS These results show that a high-fructose diet in rats leads to hepatic steatosis and a defect in the free radical defense system , and that treatment of Talpha(1 ) may improve these biochemical and morphologic changes in the fructose-fed rat livers",
"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 diet upon liver function tests and serum lipids within the restricted environment of a Phase I unit . METHODS An open r and omized three-way crossover study was design ed with subjects consuming three types of diet . The diets comprised , a balanced normal calorie diet , a high-carbohydrate high-calorie diet and a high-fat high-calorie diet . Each diet was consumed in a r and omized sequence over 8 days with a recovery period of 14 days between periods . The blood concentrations of various laboratory parameters were measured at intervals throughout each dietary period and during the recovery periods . RESULTS Blood transaminase activity and triglyceride concentrations increased significantly whilst subjects consumed a high-carbohydrate high-calorie diet but not when fed either a high-fat high-calorie diet or a balanced normal calorie diet . CONCLUSIONS The rises in transaminases and triglycerides were caused by the carbohydrate content of the diet rather than its calorific value . Sucrose rather than starch was the carbohydrate which caused the rise in transaminases and triglycerides . The importance of controlling diet in Phase I studies is stressed",
"An increasing amount of fructose in the diet is suggested to play a causal role in the pathogenesis of the metabolic syndrome , type 2 diabetes and fatty liver . Our aim was to investigate and compare the effects of very high fructose and very high glucose in hyperenergetic diets on glucose and lipid metabolism and on fat depots in healthy humans . We conducted an exploratory , prospect i ve , r and omised , single-blinded , intervention trial . Participants in addition to a balanced weight-maintaining diet received 150 g of fructose or glucose/d for 4 weeks . Insulin sensitivity was estimated from oral glucose tolerance tests . Visceral and subcutaneous abdominal fat was determined with MRI . Liver fat and intramyocellular lipids of the tibialis anterior muscle were measured with (1)H magnetic resonance spectroscopy . A total of twenty healthy subjects ( fructose group n 10 and glucose group n 10 ; twelve males and eight females ) completed the study . They had a mean age of 30·5 ( SEM 2·0 ) years and a mean BMI of 25·9 ( SEM 0·5 ) kg/m(2 ) . Insulin sensitivity appeared to decrease both in the fructose and glucose groups . TAG markedly increased in the fructose group . No strong alterations or treatment effects were found for liver fat , visceral fat , subcutaneous abdominal fat and intramyocellular lipids of the tibialis anterior muscle . In conclusion , the effects of very high fructose and very high glucose in hyperenergetic diets on glucose metabolism and body fat composition were not different in the healthy participants of the present study . However , elevation of plasma TAG seemed to be fructose-specific",
"BACKGROUND Both nutritional and genetic factors are involved in the pathogenesis of nonalcoholic fatty liver disease and insulin resistance . OBJECTIVE The aim was to assess the effects of fructose , a potent stimulator of hepatic de novo lipogenesis , on intrahepatocellular lipids ( IHCLs ) and insulin sensitivity in healthy offspring of patients with type 2 diabetes (OffT2D)--a subgroup of individuals prone to metabolic disorders . DESIGN Sixteen male OffT2D and 8 control subjects were studied in a crossover design after either a 7-d isocaloric diet or a hypercaloric high-fructose diet ( 3.5 g x kg FFM(-1 ) x d(-1 ) , + 35 % energy intake ) . Hepatic and whole-body insulin sensitivity were assessed with a 2-step hyperinsulinemic euglycemic clamp ( 0.3 and 1.0 mU x kg(-1 ) x min(-1 ) ) , together with 6,6-[2H2]glucose . IHCLs and intramyocellular lipids ( IMCLs ) were measured by 1H-magnetic resonance spectroscopy . RESULTS The OffT2D group had significantly ( P IHCLs ( + 94 % ) , total triacylglycerols ( + 35 % ) , and lower whole-body insulin sensitivity ( -27 % ) than did the control group . The high-fructose diet significantly increased IHCLs ( control : + 76 % ; OffT2D : + 79 % ) , IMCLs ( control : + 47 % ; OffT2D : + 24 % ) , VLDL-triacylglycerols ( control : + 51 % ; OffT2D : + 110 % ) , and fasting hepatic glucose output ( control : + 4 % ; OffT2D : + 5 % ) . Furthermore , the effects of fructose on VLDL-triacylglycerols were higher in the OffT2D group ( group x diet interaction : P 7-d high-fructose diet increased ectopic lipid deposition in liver and muscle and fasting VLDL-triacylglycerols and decreased hepatic insulin sensitivity . Fructose-induced alterations in VLDL-triacylglycerols appeared to be of greater magnitude in the OffT2D group , which suggests that these individuals may be more prone to developing dyslipidemia when challenged by high fructose intakes . This trial was registered at clinical trials.gov as NCT00523562"
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OBJECTIVE Interproximal enamel reduction is a part of orthodontic treatment for gaining a modest amount of space in the treatment of crowding . Today interproximal enamel reduction has become a viable alternative to the extraction of permanent teeth , and helps to adjust the Bolton Index discrepancy . The aim of the study is to evaluate various interproximal enamel reduction techniques , its indications , contraindications and complications presented in recent scientific studies . MATERIAL AND METHODS Papers published in English language between 2003 and 2012 were search ed in PubMed , ScienceDirect and The Cochrane Library data bases , as well as the Web search Google Scholar . Initial search es were made to find peer- review ed systematic review s , meta-analyses , literature review s , clinical trials , which analysed at least one interproximal enamel reduction method . 31 published data fulfilled the inclusion criteria . RESULTS According to the study , abrasive metal strips , diamond-coated stripping disks , and air-rotor stripping are the main interproximal enamel reduction techniques . Indications for use are mild or moderate crowding in dental arches , Bolton Index discrepancy , changes in tooth shape and dental esthetics within the enamel , enhancement of retention and stability after orthodontic treatment , normalization of gingival contour , elimination of black gingival triangles , and correction of the Curve of Spee . Complications of interproximal enamel reduction are hypersensitivity , irreversible damage of dental pulp , increased formation of plaque , the risk of caries in the stripped enamel areas and periodontal diseases . CONCLUSION Interproximal enamel reduction is an important part of orthodontic treatment for gaining space in the dental arch , and for the correction of the Bolton index discrepancy
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"OBJECTIVE The effect of total arch distalization using orthodontic mini-implants ( OMIs ) combined with interproximal stripping ( IPS ) and second premolar extraction was investigated in Class I malocclusion patients . MATERIAL S AND METHODS A total of 66 consecutively treated Class I malocclusion ( Class I molar relationship ; 0 mm in this study . Pre- and posttreatment lateral cephalograms and dental casts were measured and compared statistically . RESULTS In the distalization with IPS group , 3.6 mm and 3.8 mm of crowding in the upper and lower arches , respectively , were resolved , and 3.8 mm and 3.2 mm of upper and lower incisor retraction , respectively , were achieved simultaneously by the treatment . As a result of the second premolar extraction treatment , 3.9 mm and 3.6 mm of crowding in the upper and lower arches , respectively , were resolved , and 3.3 mm and 3.2 mm of incisor retraction , respectively , were achieved during treatment . There was no statistically significant difference in the amount of crowding and incisor retraction between the two groups . CONCLUSIONS Total arch distalization using an OMI with IPS did not yield a significantly different treatment result compared to second premolar extraction treatment",
"OBJECTIVE To evaluate the influence of attachments and interproximal reduction on canines undergoing rotational movement with Invisalign . MATERIAL S AND METHODS In this prospect i ve clinical study , 53 canines ( 33 maxillary and 20 m and ibular ) were measured from the virtual TREAT models of 31 participants treated with anterior Invisalign . The pretreatment virtual model of the predicted final tooth position was superimposed on the posttreatment virtual model using ToothMeasure , Invisalign 's proprietary measurement software . A one-way analysis of variance ( ANOVA ) ( P attachments only ( AO ) , interproximal reduction only ( IO ) , and neither attachments nor interproximal reduction ( N ) . Student 's t-tests ( P mean accuracy of canine rotation between arches . RESULTS The mean accuracy of canine rotation with Invisalign was 35.8 % ( SD = 26.3 ) . Statistical analyses indicated that there was no significant difference in accuracy between groups AO , IO , and N ( P = .343 ) . There was no statistically significant difference ( P = .888 ) in rotational accuracy for maxillary and m and ibular canines for any of the treatment groups . The most commonly prescribed attachment shape was the vertical-ellipsoid ( 70.5 % ) . CONCLUSIONS Vertical-ellipsoid attachments and interproximal reduction do not significantly improve the accuracy of canine rotation with the Invisalign system",
"OBJECTIVE To assess the surface roughness result ing after application of currently available interproximal polishing . MATERIAL S AND METHODS The analysis was carried out by means of digital subtraction radiography , profilometry , and scanning electron microscopy . The roughness of natural untreated enamel served as the reference . Five enamel reduction methods were tested ( Profin , New Metal Strips , O-Drive D30 , Air Rotor , and the Ortho-Strips ) and were applied in accordance with their manufacturers ' recommendations . Fifty-five teeth were treated by r and omly chosen methods , all of which were applied by one person . One proximal surface was only ground and left unpolished while the other received the finishing and polish recommended by the manufacturer . RESULTS Loss of tooth substance , as measured by subtraction radiography , was significantly lower ( P Ortho-Strips . Profilometric analysis of enamel roughness showed that the use of Ortho-Strips , O-Drive D30 , and New Metal Strips in the grinding mode produced equally rough surfaces ( P > .05 ) . The Air Rotor and Profin system in the grinding mode produced the significantly ( P roughest surfaces . A significant ( P mean roughness values was registered in all groups when treatment was followed by polishing . The Profin system and Ortho-Strips achieved the significantly smoothest surfaces ( P < .05 ) with polishing . CONCLUSIONS In general , interproximal enamel reduction should be followed by thorough polishing . Furthermore , oscillating systems seem to be advantageous",
"INTRODUCTION Air-rotor stripping ( ARS ) is a commonly used method to alleviate crowding in the permanent dentition . Its widespread acceptance , however , has been limited by the potential increase in caries risk of the abraded enamel surface . The aim of this study was to compare the susceptibility of ARS-treated enamel surfaces with intact surfaces in patients undergoing fixed orthodontic therapy . METHODS Forty patients treated with ARS were examined clinical ly and radiographically for caries 1 to 6 years after interproximal enamel reduction . All patients were seen by their dentists for prophylaxis at 6-month intervals during active orthodontic treatment and were exposed to fluori date d water and toothpaste . Topical fluoride agents or sealants were not applied on the abraded surface after any ARS session . Caries incidence was compared between ARS-treated and unaltered surfaces within subjects . The decayed , missing , filled tooth ( DMFT ) and surface ( DMFS ) scores were used to evaluate the subjects ' overall caries risk . RESULTS Totals of 376 test and 376 control surfaces were examined . The number of interproximal lesions detected was found to be low with no statistically significant difference detected between the groups ( test = 3 ; control = 6 ; P = .33 ] . The DMFT and DMFS scores increased significantly during the study period , indicating that these patients were clearly at risk of tooth decay ( P risk of caries is not affected by ARS . Furthermore , our data show that the application of topical fluoride on the enamel surfaces immediately after ARS in patients exposed to fluori date d water and fluoride-containing toothpaste may not provide any additional benefit",
"INTRODUCTION A prospect i ve r and omized study was design ed to compare the skeletal , dental , and soft-tissue profile changes in Class I borderline patients treated with extraction and non extraction by means of the air-rotor stripping ( ARS ) technique and to compare the treatment times . METHODS Twenty-six borderline patients with balanced and orthognathic facial profiles were r and omly divided into 2 groups . In the first group , 13 subjects with a mean age of 18.1 + /- 3.7 years and mean maxillary and m and ibular crowding of 5.7 + /- 1.5 and 5.9 + /- 1.4 mm , respectively , were treated by removal of 4 premolars with minimum anchorage . In the second group , 13 subjects with a mean age of 17.8 + /- 2.4 years and mean maxillary and m and ibular crowding of 5.0 + /- 1.3 and 5.9 + /- 1.3 mm , respectively , were treated with ARS . Lateral cephalometric radiographs and dental models taken before and after treatment were evaluated . RESULTS The initial skeletal , dental , and profile characteristics of both groups were similar . In the first group , the maxillary and m and ibular incisors were slightly retracted , whereas lip positions did not change . In the non extraction group , maintenance of maxillary incisor position , slight protrusion of the m and ibular incisors and the upper and lower lips were observed at the end of treatment . The nasolabial angle decreased significantly . Because of postpubertal growth of the nose and the chin , the lips appeared slightly retrusive after extraction therapy , whereas lip protrusion was compensated in the non extraction group . The main soft-tissue profile differences between the 2 groups were 1 to 1.5 mm more retruded upper and lower lip positions in the extraction patients , but both groups had well-balanced and desirable facial esthetics with all profile measurements within normal limits . Non extraction therapy with ARS reduced treatment time by 8 months . CONCLUSIONS Both extraction and ARS combined with non extraction therapies are effective treatment alternatives for Class I borderline patients with good facial profile and moderate dental crowding",
"AIM The purpose of this study was to evaluate the ultramorphology and surface roughness of permanent tooth enamel after various post-stripping polishing methods . METHODS Sixty extracted , permanent lower incisors were r and omly assigned to two groups ( Group A and Group B ) . Group A was morphologically assessed by a scanning electron microscopy ( SEM ) and Group B was assessed by a stylus profilometer which applied a surface roughness test . Each group was divided into five subgroups of six incisors . Four of the subgroups were subjected to interpoximal enamel reduction , followed by various polishing methods ; the fifth subgroup served as a control . The polishing methods comprised ; Subgroup 1 , diamond disk followed by a fine Sof-lex disc ; Subgroup 2 , diamond disk and fine diamond bur ; Subgroup 3 , diamond disk and fine tungsten carbide bur ; Subgroup 4 , diamond disk and chemical stripping using 37 % orthophosphoric acid in conjunction with a fine 3 M finishing strip and Subgroup 5 ( control ) , no stripping nor polishing . Qualitative ( scanning electron microscopy ) and quantitative ( surface roughness test ) assessment s were performed . Surface roughness values ( Ra ) for permanent enamel were evaluated using the Welch analysis of variance ( ANOVA ) . RESULTS Subgroup 1 ( diamond disk and fine Sof-lex disc ) produced the smoothest enamel surface and Subgroup 4 ( chemical stripping ) produced the roughest enamel surface . CONCLUSIONS All proximal stripping and polishing methods significantly roughened the enamel surfaces . The best results were obtained when the stripped enamel surfaces were polished and finished with fine Sof-lex discs"
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4117ec18-06ff-11f0-808a-c43d1ab1c353
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Assessment s of gait , balance , and transfer in elderly people play a valuable role in maintaining healthy aging and preventing a decline in mobility . Several evaluation tools have been proposed ; however , clinicians should select the most accurate ones wisely , based on numerous criteria . This systematic review aims to identify all applicable elderly mobility assessment tests and show their measurement properties with as much detail as possible . Initially , a broad search was performed . Articles were screened based on their titles and abstract s , and only studies published in English were considered . Based on our inclusion and exclusion criteria , 31 assessment tests evaluating the mobility of healthy elderly people were found . Then , further search es were completed to identify the measurement properties of each test . These characteristics include the origin and year of establishment , several practicality factors , and validity . The analysis of our outcomes illustrates the similarities and differences between the identified tests
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[
"BACKGROUND AND PURPOSE Walk tests provide essential outcome information when assessing ambulation of individuals with lower-limb amputation and a prosthetic device . Existing tests have limitations such as ceiling effects or insufficient challenge . The objective of this study was to assess the reliability and validity of data for a clinical measure of basic mobility , the L Test of Functional Mobility ( L Test ) . SUBJECTS For this method ological study , 93 people with unilateral amputations ( 74 % transtibial , 26 % transfemoral ; 78 % male , 22 % female ; mean age=55.9 years ) were consecutively recruited from an outpatient clinic . Twenty-seven subjects returned for retesting . METHODS To assess concurrent validity , subjects completed the L Test , Timed \" Up & Go \" Test ( TUG ) , 10-Meter Walk Test , and 2-Minute Walk Test , followed by the Activities-specific Balance Confidence scale , Frenchay Activities Index ( FAI ) , and mobility subscale of the Prosthetic Evaluation Question naire ( PEQ-MS ) . Amputation cause and level , walking aid use , automatic stepping , and age variables were used to assess discriminant validity . RESULTS Intraclass correlation coefficients were .96 for interrater reliability and .97 for intrarater reliability , and minimal bias existed upon retesting . The magnitude of concurrent validity correlations ( r ) was very high between the L Test data and data for other walk tests and fair to moderate between the L Test data and data for self-report measures . The L Test discriminated between all groups as hypothesized . DISCUSSION AND CONCLUSION The L Test is a 20-m test of basic mobility skills that includes 2 transfers and 4 turns . It demonstrated excellent measurement properties in this study",
"Background The newly developed Brief – Balance Evaluation System Test ( Brief-BESTest ) may be useful for measuring balance and predicting falls in individuals with Parkinson disease ( PD ) . Objectives The purpose s of this study were : ( 1 ) to describe the balance performance of those with PD using the Brief-BESTest , ( 2 ) to determine the relationships among the scores derived from the 3 versions of the BESTest ( ie , full BESTest , Mini-BESTest , and Brief-BESTest ) , and ( 3 ) to compare the accuracy of the Brief-BESTest with that of the Mini-BESTest and BESTest in identifying recurrent fallers among people with PD . Design This was a prospect i ve cohort study . Methods Eighty participants with PD completed a baseline balance assessment . All participants reported a fall history during the previous 6 months . Fall history was again collected 6 months ( n=51 ) and 12 months ( n=40 ) later . Results At baseline , participants had varying levels of balance impairment , and Brief-BESTest scores were significantly correlated with Mini-BESTest ( r=.94 , P BESTest ( r=.95 , P Six-month retrospective fall prediction accuracy of the Brief-BESTest was moderately high ( area under the curve [AUC]=0.82 , sensitivity=0.76 , and specificity=0.84 ) . Prospect i ve fall prediction accuracy over 6 months was similarly accurate ( AUC=0.88 , sensitivity=0.71 , and specificity=0.87 ) , but was less sensitive over 12 months ( AUC=0.76 , sensitivity=0.53 , and specificity=0.93 ) . Limitations The sample included primarily individuals with mild to moderate PD . Also , there was a moderate dropout rate at 6 and 12 months . Conclusions All versions of the BESTest were reasonably accurate in identifying future recurrent fallers , especially during the 6 months following assessment . Clinicians can reasonably rely on the Brief-BESTest for predicting falls , particularly when time and equipment constraints are of concern",
"Background Falling is a common problem in the fast-growing elderly population . Multitasking or engaging in two or more activities at the same time is common in daily living . Objective To determine the usefulness of the trail-walking test ( TWT ) for predicting a fall in community-dwelling elderly individuals . Methods This was a prospect i ve study in which the TWT was used to evaluate the risk of falling among a group of community-dwelling elderly individuals ( n = 171 ) with a mean age of 80.5 ± 5.6 years . The following tests were conducted : TWT , trail-making test ( TMT ) , timed-up- and -go test ( TUG ) , functional reach ( FR ) test , one-leg st and ing ( OLS ) test , and 10-m walking time test . Test – retest reliability was assessed by repeating the TWT within 2 weeks of the first trial , and there was a 1-year follow-up . Stepwise logistic regression analysis was used to analyze whether the TWT , TMT , TUG , FR , OLS , or 10-m walking tests predicted falling . Results The test – retest reliability of TWT was high ( intraclass correlation coefficient 0.945 , p Fifty-nine participants ( 34.5 % ) had reported a fall during the year preceding the 1-year follow-up . The stepwise logistic regression analysis revealed that only the TWT was significantly related to falling ( odds ratio 1.160 , 95 % confidence interval 1.107–1.214 ; p the TWT was most useful test of those evaluated for assessing the risk of fall among our elderly cohort",
"Over the ensuing seven months she had three more clinical relapses , each accompanied by reappearance in the stools of either the organism or its cytotoxin , or both . Each improvement after vancomycin ( eight to 14-daycourses ) was accompanied by disappearance of the organism . At one point she was given cholestyramine , but she was unable to tolerate it . Her illness was punctuated by malnutrition and episodes of heart failure . She was given no other antibiotics . After the sixth relapse maintenance treatment with oral vancomycin 125 mg eight-hourly was begun . With this regimen diarrhoea was controlled and stools over the next 10 weeks remained negative for C difficile and its cytotoxin . There was no adverse reaction to vancomycin throughout",
"Background and Purpose — The modified Emory Functional Ambulation Profile ( mEFAP ) is an easily administered test that measures the time to ambulate through 5 common environmental terrains with or without an assistive device or manual assistance . The mEFAP was evaluated for its interrater reliability , test-retest reliability , concurrent validity , and sensitivity to change during outpatient rehabilitation for poststroke gait dysfunction . Methods — Twenty-six poststroke patients were followed up prospect ively in a rehabilitation day-treatment program . The mEFAP , Berg Balance Test ( BBT ) , and 7-item mobility subsection of the Functional Independence Measure + Functional Assessment Measure ( FAMm ) were completed at admission and discharge . Results — mEFAP interrater reliability ( intraclass coefficient [ ICC ] 0.999 ) and test-retest reliability ( ICC 0.998 ) were high . The BBT demonstrated high interrater ( ICC 0.992 ) but poor test-retest ( ICC 0.605 ) reliability . Initial and final scores comparing the mEFAP with the BBT ( r = −0.735 , r = −0.703 ) and the mEFAP with the FAMm ( r = 0.685 , r = −0.775 ) were strongly correlated . Improvement on the mEFAP correlated with improved BBT performance ( r = −0.524 ) . There was no correlation between overall change observed on the FAMm and change on the mEFAP ( r = −0.145 ) . Total mEFAP and all mEFAP subtask scores improved over time ( P patients with stroke and is sensitive to change in ambulation speed",
"BACKGROUND numerous tests have been suggested as fall risk indicators . However , the validity of these assessment s has not been demonstrated in large representative sample s of community-dwelling older people . OBJECTIVE the objective of this study was to examine the comparative ability and clinical utility of eight mobility tests for predicting multiple falls in older community-dwelling people . METHODS design -- prospect i ve cohort study ; subjects--362 subjects aged 74 - 98 years ; measurements --the sit-to-st and test with one and five repetitions , the pick-up-weight test , the half-turn test , the alternate-step test ( AST ) , the six-metre-walk test ( SMWT ) and stair ascent and descent tasks . Falls were monitored for 1 year with fall calendars . RESULTS in the 12-month follow-up period , 80 subjects ( 22.1 % ) suffered two or more falls . Multiple fallers performed significantly worse than non-multiple fallers in the sit-to-st and test with five repetitions ( STS-5 ) , the AST , the half-turn test , the SMWT and the stair-descent test . When dichotomised using cut-off points from receiver-operated characteristics ( ROC ) curve analyses , these tests demonstrated reasonable sensitivity and specificity in identifying multiple fallers . A principal components analysis identified only one factor underlying the mobility tests . Poor performances in two mobility tests , however , increased the risk of multiple falls more than poor performance in one test alone ( ORs = 3.66 , 95 % CI = 1.44 , 9.27 and 1.61 , 95 % CI = 0.62 , 4.16 respectively ) . CONCLUSIONS the mobility tests appear to be measuring a similar ' mobility ' construct . Based on feasibility and predictive validity , the AST , STS-5 and SMWTs were the best tests",
"Background : With the increasing incidence of Alzheimer disease ( AD ) , determining the validity and reliability of outcome measures for people with this disease is necessary . Objective : The goals of this study were to assess test-retest reliability of data for the Timed “ Up & Go ” Test ( TUG ) , the Six-Minute Walk Test ( 6MWT ) , and gait speed and to calculate minimal detectable change ( MDC ) scores for each outcome measure . Performance differences between groups with mild to moderate AD and moderately severe to severe AD ( as determined by the Functional Assessment Staging [ FAST ] scale ) were studied . Design : This was a prospect i ve , nonexperimental , descriptive method ological study . Methods : Background data collected for 51 people with AD included : use of an assistive device , Mini-Mental Status Examination scores , and FAST scale scores . Each participant engaged in 2 test sessions , separated by a 30- to 60-minute rest period , which included 2 TUG trials , 1 6MWT trial , and 2 gait speed trials using a computerized gait assessment system . A specific cuing protocol was followed to achieve optimal performance during test sessions . Results : Test-retest reliability values for the TUG , the 6MWT , and gait speed were high for all participants together and for the mild to moderate AD and moderately severe to severe AD groups separately ( intraclass correlation coefficients ≥.973 ) ; however , individual variability of performance also was high . Calculated MDC scores at the 90 % confidence interval were : TUG=4.09 seconds , 6MWT=33.5 m ( 110 ft ) , and gait speed=9.4 cm/s . The 2 groups were significantly different in performance of clinical tests , with the participants who were more cognitively impaired being more physically and functionally impaired . Limitations : A single research er for data collection limited sample numbers and prohibited blinding to dementia level . Conclusions : The TUG , the 6MWT , and gait speed are reliable outcome measures for use with people with AD , recognizing that individual variability of performance is high . Minimal detectable change scores at the 90 % confidence interval can be used to assess change in performance over time and the impact of treatment",
"Background : The ‘ timed up and go ’ test ( TUG ) is a simple , quick and widely used clinical performance-based measure of lower extremity function , mobility and fall risk . We speculated that its properties may be different from other performance-based tests and assessed whether cognitive function may contribute to the differences among these tests in a cohort of healthy older adults . Objective : To evaluate psychometric properties of the TUG in healthy older adults in comparison to the Berg balance test ( BBT ) and the Dynamic Gait Index ( DGI ) . Methods : The TUG , DGI and BBT were assessed in 265 healthy older adults ( 76.4 ± 4.3 years ; 58.3 % women ) who participated in a 3-year prospect i ve study . The Mini-Mental State Examination , digit span and verbal fluency measured cognitive function . The one- sample Kolmogorov-Smirnov test evaluated deviations from a normal distribution and Pearson ’s correlation coefficients quantified associations . Results : The mean scores of the BBT , DGI and TUG were : 54.0 ± 2.4 , 22.8 ± 1.5 , 9.5 ± 1.7 s , respectively . The BBT and the DGI were not normally distributed ( p with digit span and verbal fluency and were related to future falls , while the BBT and the DGI were not . Conclusions : The TUG appears to be an appropriate tool for clinical assessment of functional mobility even in healthy older adults . It does not suffer from ceiling effect limitations , is normally distributed and is apparently related to executive function . The BBT and the DGI do not share these beneficial properties . Perhaps the transferring and turning components of the TUG help to convert this relatively simple motor task into a more complex measure that also depends on cognitive re sources",
"BACKGROUND AND PURPOSE The Performance-Oriented Mobility Assessment ( POMA ) is a widely used instrument that provides an evaluation of balance and gait . It is used clinical ly to determine the mobility status of older adults or to evaluate changes over time . To support the use of the POMA for these purpose s , the clinimetric properties ( in particular , responsiveness ) were determined . SUBJECTS Participants ( 78 % female ; mean age=84.9 years ) were living in either self-care or nursing-care residences . Concurrent and discriminant validity were assessed with the total group ( N=245 ) , whereas reliability and responsiveness were determined with a sub sample ( n=30 ) . Fall-related predictive validity was assessed with a sub sample of 72 participants . METHODS In addition to the POMA , several reference performance tests were administered . The POMA was assessed on 2 consecutive days by 2 raters ( observers ) . The analyses included the calculation of Spearman rank correlation coefficients ( R ) , limits of agreement ( LOA ) with Bl and -Altman plots , minimal detectable changes at the 95 % confidence level ( MDC(95 ) ) , and sensitivity and specificity with regard to predicting falls . When possible , findings for the total scale ( POMA-T ) were complemented by findings for its balance subscale ( POMA-B ) and its gait subscale ( POMA-G ) . RESULTS The interrater and test-retest reliability for the POMA-T and the POMA-B were good ( R=.74-.93 ) , whereas for the POMA-G , the reliability values , although high as well , were systematic ally slightly lower ( R=.72-.89 ) . The Spearman correlations with the reference performance tests ( R=|.64|- |.68| ) indicated satisfactory concurrent validity for the POMA-T and the POMA-B , but the corresponding findings for the POMA-G ( R=|.52|- |.56| ) were less convincing . The discriminant validity values of the 3 scales were about the same . The LOA for the POMA-T were on the order of -4.0 to 4.0 for test-retest agreement and -3.0 to 3.0 for interrater agreement . On the basis of the MDC(95 ) values , it was concluded that changes in POMA-T scores at the individual level should be at least 5 points and that those at the group level ( n=30 ) should be at least 0.8 point to be considered reliable . Even when optimal cutoff points were used , sensitivity and specificity values ( varying between 62.5 % and 66.1 % ) for the POMA-T as well as for its 2 subscales indicated poor accuracy in predicting falls . DISCUSSION AND CONCLUSION The POMA-T and its subscale POMA-B have adequate reliability and validity for assessing mobility in older adults . The POMA-T is useful for demonstrating intervention effects at the group level . Changes within subjects , however , should be at least 5 points before being interpreted as reliable changes . The accuracy of the POMA-T in predicting falls is poor",
"BACKGROUND AND PURPOSE The University of Alabama at Birmingham ( UAB ) Study of Aging Life-Space Assessment ( LSA ) is a relatively new instrument to measure mobility . The purpose of this report is to describe the relationships between LSA and traditional measures of physical function , sociodemographic characteristics , depression , and cognitive status . SUBJECTS Subjects were a stratified r and om sample of 998 Medicare beneficiaries aged > or = 65 years . The sample was 50 % African American , 50 % male , and 50 % from rural ( versus urban ) counties . METHODS In-home interviews were conducted . Mobility was measured using the LSA , which documents where and how often subjects travel and any assistance needed during the 4 weeks prior to the assessment . Basic activities of daily living ( ADL ) and instrumental activities of daily living ( IADL ) , cognitive status , income level , presence of depressive symptoms , and transportation re sources were determined . The Short Physical Performance Battery ( SPPB ) was used to assess physical performance . RESULTS Simple bivariate correlations indicated a significant relationship between LSA and all variables except residence ( rural versus urban ) . In a regression model , physical function ( ADL , IADL ) and physical performance ( SPPB ) accounted for 45.5 % of the variance in LSA scores . An additional 12.7 % of the variance was explained by sociodemographic variables , and less than 1 % was explained by cognition and depressive symptoms . DISCUSSION AND CONCLUSION The LSA can be used to document patients ' mobility within their home and community . The LSA scores are associated with a person 's physical capacity and other factors that may limit mobility . These scores can be used in combination with other tests and measures to generate clinical hypotheses to explain mobility deficits and to plan appropriate interventions to address these deficits",
"A previously reported functional obstacle course ( FOC ) developed to assess elderly persons with and without balance and mobility impairment was used in a hospital-based study of 237 participants . A new modified version of the FOC was developed for use in a community-based study , by placing some obstacles next to walls instead of between parallel bars . These modifications eliminate the need for parallel bars or for extra personnel to interchange the obstacles . We were concerned that the modifications could affect performance scores , because touching or holding onto the now eliminated parallel bars could influence FOC scores under the original scoring system . To determine the effect of these modifications on FOC performance , we tested 36 volunteers , ( 18 fallers [ falls within last year ] and 18 non-fallers ) , on the modified parts of the old and new versions of the FOC . R and om testing order and inter-trial rests were used . For both the old and new FOC versions , we summed quality and task completion time scores from the six modified obstacles ( artificial turf , carpet , pine bark , s and , up ramp and down ramp ) to create scores for quality and time . Our hypothesis was that there would be no performance difference between the original and modified obstacle course . Using a two-factor repeated- measures analysis of variance , we found no difference in quality scores between the two FOC versions and no effect of an interaction between faller status and the course versions . We did find that the time was approximately 2 seconds longer for the new version ; however , the time increase was the same for fallers and non-fallers . These data show that fallers and non-fallers have comparable performance on both versions of the FOC ; however , to compare the two obstacle courses we recommend an adjustment of 2 seconds in time scores . The obstacle course modifications will facilitate more extensive and efficient use of the obstacle course as a research tool to assess balance and mobility"
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4117ec54-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To review , in conformance with the Preferred Reporting Items for Systematic Review s and Meta-Analyses guidelines , the totality of evidence for the use of neuromuscular electrical stimulation ( NMES ) in the critical care setting , when compared with usual care , under all domains of the World Health Organisation , International Classification of Functioning , Disability and Health ( ICF ) framework . DATA SOURCE Six electronic data bases were search ed : PubMed , Embase , Web of Knowledge , Cumulative Index to Nursing and Allied Health Literature , The Cochrane Library and the Physiotherapy Evidence Data base ( PEDro ) ( 1945 - 2014 ) . Limits of the English language and human studies were applied . STUDY SELECTION Trials investigating the effect of NMES in critical care adult patients were included . One review er excluded articles by title . Two review ers excluded remaining articles by abstract and full text . One review er extracted data under a st and ardised form . Two review ers assessed method ological quality using the Cochrane Risk of Bias Tool and the Newcastle Ottawa Scale . RESULTS Twelve full-text articles , eleven r and omised controlled trials ( RCTs ) and one case-control trial indicated the potential of NMES to preserve muscle mass and joint range of motion , improve outcomes of ventilation , and reduce activity limitations . Meta- analysis from three RCTs supported NMES to preserve muscle strength using a fixed-effects model [ n = 146 ; st and ardised mean difference 0.93 ( 0.51 , 1.35 ) P = 0.0002 ] ; however , significant heterogeneity was recorded . No outcomes evaluated the effect on participation restrictions . CONCLUSION NMES , as an adjunct to current rehabilitation practice s in critically ill patients , may maintain muscle strength . However , high- quality studies with longer follow-up periods and st and ardised outcome measures across all domains of the ICF framework are required
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"Introduction Critically ill patients are characterized by increased loss of muscle mass , partially attributed to sepsis and multiple organ failure , as well as immobilization . Recent studies have shown that electrical muscle stimulation ( EMS ) may be an alternative to active exercise in chronic obstructive pulmonary disease ( COPD ) and chronic heart failure ( CHF ) patients with myopathy . The aim of our study was to investigate the EMS effects on muscle mass preservation of critically ill patients with the use of ultrasonography ( US ) . Methods Forty-nine critically ill patients ( age : 59 ± 21 years ) with an APACHE II admission score ≥13 were r and omly assigned after stratification upon admission to receive daily EMS sessions of both lower extremities ( EMS-group ) or to the control group ( control group ) . Muscle mass was evaluated with US , by measuring the cross sectional diameter ( CSD ) of the vastus intermedius and the rectus femoris of the quadriceps muscle . Results Twenty-six patients were finally evaluated . Right rectus femoris and right vastus intermedius CSD decreased in both groups ( EMS group : from 1.42 ± 0.48 to 1.31 ± 0.45 cm , P = 0.001 control group : from 1.59 ± 0.53 to 1.37 ± 0.5 cm , P = 0.002 ; EMS group : from 0.91 ± 0.39 to 0.81 ± 0.38 cm , P = 0.001 control group : from 1.40 ± 0.64 to 1.11 ± 0.56 cm , P = 0.004 , respectively ) . However , the CSD of the right rectus femoris decreased significantly less in the EMS group ( -0.11 ± 0.06 cm , -8 ± 3.9 % ) as compared to the control group ( -0.21 ± 0.10 cm , -13.9 ± 6.4 % ; P of the right vastus intermedius decreased significantly less in the EMS group ( -0.10 ± 0.05 cm , -12.5 ± 7.4 % ) as compared to the control group ( -0.29 ± 0.28 cm , -21.5 ± 15.3 % ; P Conclusions EMS is well tolerated and seems to preserve the muscle mass of critically ill patients . The potential use of EMS as a preventive and rehabilitation tool in ICU patients with polyneuromyopathy needs to be further investigated . Trial Registration clinical trials.gov :",
"Muscle dysfunction is a major problem in chronic obstructive pulmonary disease ( COPD ) , particularly after exacerbations . We thus asked whether neuromuscular electrostimulation ( NMES ) might be directly useful following an acute exacerbation and if such a therapy decreases muscular oxidative stress and /or alters muscle fibre distribution . A pilot r and omised controlled study of NMES lasting 6 weeks was carried out in 15 in- patients ( n=9 NMES ; n=6 sham ) following a COPD exacerbation . Stimulation was delivered to the quadriceps and hamstring muscles ( 35 Hz ) . Primary outcomes were quadriceps force and muscle oxidative stress . At the end of the study , quadriceps force improvement was statistically different between groups ( p=0.02 ) , with a significant increase only in the NMES group ( median ( interquartile range ) 10 ( 4.7–11.5 ) kg ; p=0.01 ) . Changes in the 6-min walking distance were statistically different between groups ( p=0.008 ) , with a significant increase in the NMES group ( 165 ( 125–203 ) m ; p=0.003 ) . NMES did not lead to higher muscle oxidative stress , as indicated by the decrease in total protein carbonylation ( p=0.02 ) and myosin heavy chain carbonylation ( p=0.01 ) levels . Finally , we observed a significant increase in type I fibre proportion in the NMES group . Our study shows that following COPD exacerbation , NMES is effective in counteracting muscle dysfunction and decreases muscle oxidative stress",
"Introduction Critical illness polyneuromyopathy ( CIPNM ) is a common complication of critical illness presenting with muscle weakness and is associated with increased duration of mechanical ventilation and weaning period . No preventive tool and no specific treatment have been proposed so far for CIPNM . Electrical muscle stimulation ( EMS ) has been shown to be beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary disease . Aim of our study was to assess the efficacy of EMS in preventing CIPNM in critically ill patients . Methods One hundred and forty consecutive critically ill patients with an APACHE II score ≥ 13 were r and omly assigned after stratification to the EMS group ( n = 68 ) ( age:61 ± 19 years ) ( APACHE II:18 ± 4 , SOFA:9 ± 3 ) or to the control group ( n = 72 ) ( age:58 ± 18 years ) ( APACHE II:18 ± 5 , SOFA:9 ± 3 ) . Patients of the EMS group received daily EMS sessions . CIPNM was diagnosed clinical ly with the medical research council ( MRC ) scale for muscle strength ( maximum score 60 , . Duration of weaning from mechanical ventilation and intensive care unit ( ICU ) stay were recorded . Results Fifty two patients could be finally evaluated with MRC ; 24 in the EMS group and 28 in the control group . CIPNM was diagnosed in 3 patients in the EMS group as compared to 11 patients in the control group ( OR = 0.22 ; CI : 0.05 to 0.92 , P = 0.04 ) . The MRC score was significantly higher in patients of the EMS group as compared to the control group [ 58 ( 33 to 60 ) vs. 52 ( 2 to 60 ) respectively , median ( range ) , P = 0.04 ) . The weaning period was statistically significantly shorter in patients of the EMS group vs. the control group [ 1 ( 0 to 10 ) days vs. 3 ( 0 to 44 ) days , respectively , median ( range ) , P = 0.003 ] . Conclusions This study suggests that daily EMS sessions prevent the development of CIPNM in critically ill patients and also result in shorter duration of weaning . Further studies should evaluate which patients benefit more from EMS and explore the EMS characteristics most appropriate for preventing CIPNM.Trial Registration Number Clinical Trials.gov",
"Purpose . This is a secondary analysis of previously published data to investigate the effects of electrical muscle stimulation ( EMS ) on strength of various muscle groups in critically ill patients . Methods . One hundred forty-two consecutive patients , with APACHE II score ≥ 13 , were r and omly assigned to the EMS or the control group . EMS sessions were applied daily on vastus lateralis , vastus medialis , and peroneus longus of both lower extremities . Various muscle groups were evaluated with the Medical Research Council ( MRC ) scale for muscle strength . H and grip strength assessment was also employed . Results . Twenty four patients in the EMS group and 28 patients in the control group were finally evaluated . EMS patients achieved higher MRC scores than controls ( P ≤ 0.05 ) in wrist flexion , hip flexion , knee extension , and ankle dorsiflexion . Collectively , the EMS group performed higher ( P 0.01 ) in the legs and overall . H and grip strength correlated ( P ≤ 0.01 ) with the upper and lower extremities ' muscle strength and the overall MRC scores . Conclusions . EMS has beneficial effects on the strength of critically ill patients mainly affecting muscle groups stimulated , while it may also affect muscle groups not involved presenting itself as a potential effective means of muscle strength preservation and early mobilization in this patient population",
"OBJECTIVE It is known that patients in the intensive care unit show an enormous loss of muscle mass . Neuromuscular electrical stimulation is effective in enhancing strength and endurance in immobilized patients . The aim of this study was to evaluate the effects of neuromuscular electrical stimulation on muscle layer thickness of knee extensor muscles in intensive care unit patients . DESIGN R and omized , controlled , double-blind , pilot trial . PATIENTS Thirty-three patients , male to female ratio 26:7 , mean age 55 years ( st and ard deviation 15 ) . METHODS After enrolment in the study , intensive care unit patients ( main diagnoses : polytrauma , cardiovascular diseases , transplantation , pneumonia , cancer ) were stratified ( based on the length of their stay in hospital ) into 2 groups : 17 acute patients ( 14 days ) . Both groups were r and omized to a stimulation group or a sham-stimulation group . Neuromuscular electrical stimulation was applied to knee extensor muscles for a period of 4 weeks ( session time 30 - 60 minutes , 5 days/week ) . Ultrasound measurements were performed before and after the stimulation period to quantify muscle layer thickness of knee extensor muscles . RESULTS Only stimulated long-term patients ( + 4.9 % ) showed a significant ( p = 0.013 ) increase in muscle layer thickness compared with sham-stimulated patients ( -3.2 % ) . CONCLUSION Neuromuscular electrical stimulation appears to be a useful adjunct to revert muscle wasting in intensive care unit long-term patients ; however , larger studies with a larger sample size are needed to confirm these promising , but preliminary , results",
"Abstract Background : Electrical muscle stimulation ( EMS ) is applied to critically ill patients in order to improve their muscle strength , thereby preventing hypotrophy and promoting functional recovery . Objective : To assess the effects of early EMS on the range of movement of the ankle joint , and on thigh and leg circumference in critically ill patients . Methods : This is a prospect i ve r and omized clinical trial comprising 11 patients undergoing mechanical ventilation . Before and after EMS the thigh and leg circumference in both lower limbs and the goniometry of the tibiotarsal joint were measured . The angle of 90 ° on the goniometer was taken as the st and ard neutral position ( NP ) , with the arm fixed on the lateral malleolus of the ankle joint . Other measurements , namely dorsiflexion and plantar flexion , referred to as mobile arm , were taken from the NP . These recordings were obtained following an active contraction of the patients ’ muscles . Results : Compared with the electrostimulated limb , a difference in dorsiflexion of the control limb was observed ( 96.2 ± 24.9 versus 119.9 ± 14.1 ° ; p = 0.01 ) . A girth of 10 cm of the leg was found in limb reduction when compared to the electrostimulated one ( 24.7 ± 3.1 versus 26.4 ± 4.0 cm ; p = 0.03 ) . Conclusions : EMS used at low current intensity and for a short duration failed to prevent muscle atrophy in critically ill patients . However , we did find a significant improvement in active dorsiflexion of the ankle joint suggesting that it could help to prevent against stance plantar flexion in these patients",
"STUDY OBJECTIVE To compare the effects of active limb mobilization ( ALM ) with or without electrical stimulation ( ES ) on muscle strength , respiratory rate ( RR ) , heart rate , oxygen saturation , and time needed to transfer from bed to chair in two groups of patients with COPD . DESIGN R and omized , controlled study . SETTING Respiratory high-dependency care unit . PATIENTS Twenty-four bed-bound patients with chronic hypercapnic respiratory failure due to COPD who were receiving mechanical ventilation , with marked peripheral muscle hypotonia and atrophy . METHODS Patients were r and omly assigned either to ALM alone or to ALM plus ES ( ALM/ES ) . ES was applied using square-wave alternate , symmetric , and compensated impulses for 30 min bid . The duration of treatment was 28 days for all patients . RESULTS Muscle strength improved significantly in the overall group of patients ( from 1.75 + /- 0.73 to 3.44 + /- 0.65 , p ALM/ES significantly improved muscle strength ( 2.16 + /- 1.02 vs 1.25 + /- 0.75 , p = 0.02 ) and RR ( - 1.91 + /- 1.72 vs 0.41 + /- 1.88 , p = 0.004 ) , and decreased the number of days needed to transfer from bed to chair ( 10.75 + /- 2.41 days vs 14.33 + /- 2.53 days , p = 0.001 ) . CONCLUSION In bed-bound patients with COPD receiving mechanical ventilation , with marked peripheral muscle hypotonia and atrophy , application of ES in addition to classical ALM significantly improved muscle strength and decreased the number of days needed to transfer from bed to chair",
"BACKGROUND : The functional status and outcomes in patients with prolonged mechanical ventilation ( PMV ) are often limited by poor endurance and pulmonary mechanics , which result from the primary diseases or prolonged time bedridden . We evaluate the impact of exercise training on pulmonary mechanics , physical functional status , and hospitalization outcomes in PMV patients . METHODS : Twenty-seven subjects with PMV in our respiratory care center ( RCC ) were divided r and omly into an exercise training group ( n = 12 ) and a control group ( n = 15 ) . The exercise program comprised 10 sessions of exercise training . The measurement of pulmonary mechanics and physical functional status ( Functional Independence Measurement and Barthel index ) were performed pre- study and post- study . The hospitalization outcomes included : days of mechanical ventilation , hospitalization days , and weaning and mortality rates during RCC stay . RESULTS : The training group had significant improvement in tidal volume ( 143.6 mL vs 192.5 mL , P = .02 ) and rapid shallow breathing index after training ( 162.2 vs 110.6 , P = .009 ) . No significant change was found in the control group except respiratory rate . Both groups had significant improvement in functional status during the study . However , the training group had greater changes in FIM score than the control group ( 44.6 vs 34.2 , P = .024 ) . The training group also had shorter RCC stay and higher weaning and survival rates than the control group , although no statistical difference was found . CONCLUSIONS : Subjects with PMV in our RCC demonstrated significant improvement in pulmonary mechanics and functional status after exercise training . The application of exercise training may be helpful for PMV patients to improve hospitalization outcomes",
"The effect of percutaneous electrical stimulation in preventing immobilisation-induced muscle atrophy was determined from measurements of quadriceps mass , composition , and rate of protein synthesis in seven men who had a fracture of one tibia immobilised in a long-leg cast for 6 weeks . These features were compared with those of fourteen men with similar injuries who did not use an electrical stimulator . In men who did not use the stimulator , quadriceps cross-sectional area ( CSA ) at midthigh , measured by ultrasonography , fell by a mean ( SD ) 17 (10)% and the rate of muscle protein synthesis was 23 (10)% lower on the immobilised than on the control side ( 0.037 [ 0.016 ] vs 0.048 [0.02]%/h ) . In contrast , in those who used the stimulator , quadriceps CSA ( 55.5 [ 7.3 ] ) cm2 control leg , 50.9 [ 9.0 ] cm2 immobilised leg ) and the rate of muscle protein synthesis ( 0.053 [ 0.009 ] % /h control leg , 0.059 [ 0.012 ] % /h immobilised leg ) were similar on the two sides . The results suggest that brief periods of low-voltage percutaneous electrical stimulation will reduce quadriceps atrophy secondary to knee immobilisation , and that the mechanism includes prevention of the fall in muscle protein synthesis that usually occurs on immobilisation",
"Objective : Immobilization and subsequent weakness are consequences of critical illness . Despite the theoretical advantages of physical therapy to address this problem , it has not been shown that physical therapy initiated in the intensive care unit offers benefit . Design and Setting : Prospect i ve cohort study in a university medical intensive care unit that assessed whether a mobility protocol increased the proportion of intensive care unit patients receiving physical therapy vs. usual care . Patients : Medical intensive care unit patients with acute respiratory failure requiring mechanical ventilation on admission : Protocol , n = 165 ; Usual Care , n = 165 . Interventions : An intensive care unit Mobility Team ( critical care nurse , nursing assistant , physical therapist ) initiated the protocol within 48 hrs of mechanical ventilation . Measurements and Main Results : The primary outcome was the proportion of patients receiving physical therapy in patients surviving to hospital discharge . Baseline characteristics were similar between groups . Outcome data are reflective of survivors . More Protocol patients received at least one physical therapy session than did Usual Care ( 80 % vs. 47 % , p ≤ .001 ) . Protocol patients were out of bed earlier ( 5 vs. 11 days , p ≤ .001 ) , had therapy initiated more frequently in the intensive care unit ( 91 % vs. 13 % , p ≤ .001 ) , and had similar low complication rates compared with Usual Care . For Protocol patients , intensive care unit length of stay was 5.5 vs. 6.9 days for Usual Care ( p = .025 ) ; hospital length of stay for Protocol patients was 11.2 vs. 14.5 days for Usual Care ( p = .006 ) ( intensive care unit/hospital length of stay adjusted for body mass index , Acute Physiology and Chronic Health Evaluation II , vasopressor ) . There were no untoward events during an intensive care unit Mobility session and no cost difference ( survivors + nonsurvivors ) between the two arms , including Mobility Team costs . Conclusions : A Mobility Team using a mobility protocol initiated earlier physical therapy that was feasible , safe , did not increase costs , and was associated with decreased intensive care unit and hospital length of stay in survivors who received physical therapy during intensive care unit treatment compared with patients who received usual care",
"BACKGROUND Approaches to removal of sedation and mechanical ventilation for critically ill patients vary widely . Our aim was to assess a protocol that paired spontaneous awakening trials (SATs)-ie , daily interruption of sedatives-with spontaneous breathing trials ( SBTs ) . METHODS In four tertiary-care hospitals , we r and omly assigned 336 mechanically ventilated patients in intensive care to management with a daily SAT followed by an SBT ( intervention group ; n=168 ) or with sedation per usual care plus a daily SBT ( control group ; n=168 ) . The primary endpoint was time breathing without assistance . Data were analysed by intention to treat . This study is registered with Clinical Trials.gov , number NCT00097630 . FINDINGS One patient in the intervention group did not begin their assigned treatment protocol because of withdrawal of consent and thus was excluded from analyses and lost to follow-up . Seven patients in the control group discontinued their assigned protocol , and two of these patients were lost to follow-up . Patients in the intervention group spent more days breathing without assistance during the 28-day study period than did those in the control group ( 14.7 days vs 11.6 days ; mean difference 3.1 days , 95 % CI 0.7 to 5.6 ; p=0.02 ) and were discharged from intensive care ( median time in intensive care 9.1 days vs 12.9 days ; p=0.01 ) and the hospital earlier ( median time in the hospital 14.9 days vs 19.2 days ; p=0.04 ) . More patients in the intervention group self-extubated than in the control group ( 16 patients vs six patients ; 6.0 % difference , 95 % CI 0.6 % to 11.8 % ; p=0.03 ) , but the number of patients who required reintubation after self-extubation was similar ( five patients vs three patients ; 1.2 % difference , 95 % CI -5.2 % to 2.5 % ; p=0.47 ) , as were total reintubation rates ( 13.8%vs 12.5 % ; 1.3 % difference , 95 % CI -8.6 % to 6.1 % ; p=0.73 ) . At any instant during the year after enrolment , patients in the intervention group were less likely to die than were patients in the control group ( HR 0.68 , 95 % CI 0.50 to 0.92 ; p=0.01 ) . For every seven patients treated with the intervention , one life was saved ( number needed to treat was 7.4 , 95 % CI 4.2 to 35.5 ) . INTERPRETATION Our results suggest that a wake up and breathe protocol that pairs daily spontaneous awakening trials ( ie , interruption of sedatives ) with daily spontaneous breathing trials results in better outcomes for mechanically ventilated patients in intensive care than current st and ard approaches and should become routine practice",
"Objective : Intensive care unit admission is associated with muscle wasting and impaired physical function . We investigated the effect of early transcutaneous electrical muscle stimulation on quadriceps muscle volume in patients with septic shock . Design : R and omized interventional study using a single-legged exercise design with the contralateral leg serving as a paired control . Setting : A mixed 18-bed intensive care unit at a tertiary care university hospital . Patients : Eight adult male intensive care unit patients with septic shock included within 72 hrs of diagnosis . Interventions : After r and omization of the quadriceps muscles , transcutaneous electrical muscle stimulation was applied on the intervention side for 7 consecutive days and for 60 mins per day . All patients underwent computed tomographic scans of both thighs immediately before and after the 7-day treatment period . The quadriceps muscle was manually delineated on the computed tomography slices , and muscle volumes were calculated after three-dimensional reconstruction . Measurements and Main Results : Median age and Acute Physiology and Chronic Health Evaluation II score were 67 years ( interquartile range , 64–72 years ) and 25 ( interquartile range , 20–29 ) , respectively . During the 7-day study period , the volume of the quadriceps muscle on the control thigh decreased by 16 % ( 4–21 % , p = .03 ) corresponding to a rate of 2.3 % per day . The volume of the stimulated muscle decreased by 20 % ( 3–25 % , p = .04 ) corresponding to a rate of 2.9 % per day ( p = .12 for the difference in decrease ) . There was no difference in muscle volume between the stimulated and nonstimulated thigh at baseline ( p = .10 ) or at day 7 ( p = .12 ) . The charge delivered to the muscle tissue per training session ( 0.82 [ 0.66–1.18 ] coulomb ) correlated with the maximum sequential organ failure assessment score . Conclusions : We observed a marked decrease in quadriceps volume within the first week of intensive care for septic shock . This loss of muscle mass was unaffected by transcutaneous electrical muscle stimulation applied for 60 mins per day for 7 days",
"Quittan M , Wiesinger GF , Sturm B , Puig S , Mayr W , Sochor A , Paternostro T , Resch KL , Pacher R , Fialka-Moser V : Improvement of thigh muscles by neuromuscular electrical stimulation in patients with refractory heart failure : a single-blind , r and omized , controlled trial . Am J Phys Med Rehabil 2001;80:206–214 . Objective To determine the impact of an 8-wk neuromuscular stimulation program of thigh muscles on strength and cross-sectional area in patients with refractory heart failure listed for transplantation . Design Forty-two patients with a stable disease course were assigned r and omly to a stimulation group ( SG ) or a control group ( CG ) . The stimulation protocol consisted of biphasic symmetric impulses with a frequency of 50 Hz and an on/off regime of 2/6 sec. Results Primary outcome measures were isometric and isokinetic thigh muscle strength and muscle cross-sectional area . Our results showed an increase of muscle strength by mean 22.7 for knee extensor and by 35.4 for knee flexor muscles . The CG remained unchanged or decreased by −8.4 in extensor strength . Cross-sectional area increased in the SG by 15.5 and in the CG by 1.7 . Conclusions Activities of daily living as well as quality of life increased in the SG but not in the CG . Subscales of the SF-36 increased significantly in the SG , especially concerning physical functioning by + 7.5 ( 1.3–30.0 ) , emotional role by + 33.3 ( 0–66.6 ) , and social functioning by + 18.8 ( 0–46.9 ) , all P Neuromuscular electrical stimulation of thigh muscles in patients with refractory heart failure is effective in increasing muscle strength and bulk and positively affects the perception of quality of life and activities of daily living",
"CONTEXT Although electrophysiologic and histologic neuromuscular abnormalities are common in intensive care unit ( ICU ) patients , the clinical incidence of ICU-acquired neuromuscular disorders in patients recovering from severe illness remains unknown . OBJECTIVES To assess the clinical incidence , risk factors , and outcomes of ICU-acquired paresis ( ICUAP ) during recovery from critical illness in the ICU and to determine the electrophysiologic and histologic patterns in patients with ICUAP . DESIGN Prospect i ve cohort study conducted from March 1999 to June 2000 . SETTING Three medical and 2 surgical ICUs in 4 hospitals in France . PARTICIPANTS All consecutive ICU patients without preexisting neuromuscular disease who underwent mechanical ventilation for 7 or more days were screened daily for awakening . The first day a patient was considered awake was day 1 . Patients with severe muscle weakness on day 7 were considered to have ICUAP . MAIN OUTCOME MEASURES Incidence and duration of ICUAP , risk factors for ICUAP , and comparative duration of mechanical ventilation between ICUAP and control patients . RESULTS Among the 95 patients who achieved satisfactory awakening , the incidence of ICUAP was 25.3 % ( 95 % confidence interval [ CI ] , 16.9%-35.2 % ) . All ICUAP patients had a sensorimotor axonopathy , and all patients who underwent a muscle biopsy had specific muscle involvement not related to nerve involvement . The median duration of ICUAP after day 1 was 21 days . Mean ( SD ) duration of mechanical ventilation after day 1 was significantly longer in patients with ICUAP compared with those without ( 18.2 [ 36.3 ] vs 7.6 [ 19.2 ] days ; P = .03 ) . Independent predictors of ICUAP were female sex ( odds ratio [ OR ] , 4.66 ; 95 % CI , 1.19 - 18.30 ) , the number of days with dysfunction of 2 or more organs ( OR , 1.28 ; 95 % CI , 1.11 - 1.49 ) , duration of mechanical ventilation ( OR , 1.10 ; 95 % CI , 1.00 - 1.22 ) , and administration of corticosteroids ( OR , 14.90 ; 95 % CI , 3.20 - 69.80 ) before day 1 . CONCLUSIONS Identified using simple bedside clinical criteria , ICUAP was frequent during recovery from critical illness and was associated with a prolonged duration of mechanical ventilation . Our findings suggest an important role of corticosteroids in the development of ICUAP",
"PURPOSE The aim of this study was to describe the frequency , physiologic effects , safety , and patient outcomes associated with traditional rehabilitation therapy in patients who require mechanical ventilation . MATERIAL S AND METHODS Prospect i ve observational report of consecutive patients ventilated 4 or more days and eligible for rehabilitation in a single medical intensive care unit ( ICU ) during a 13-week period was conducted . RESULTS Of the 32 patients who met the inclusion criteria , only 21 ( 66 % ) received physician orders for evaluation by rehabilitation services ( physical and /or occupational therapy ) . Fifty rehabilitation treatments were provided to 19 patients on a median of 12 % of medical ICU days per patient , with deep sedation and unavailability of rehabilitation staff representing major barriers to treatment . Physiologic changes during rehabilitation therapy were minimal . Joint contractures were frequent in the lower extremities and did not improve during hospitalization . In 53 % and 79 % of initial ICU assessment s , muscle weakness was present in upper and lower extremities , respectively , with a decreased prevalence of 19 % and 43 % at hospital discharge , respectively . New impairments in physical function were common at hospital discharge . CONCLUSIONS This pilot project illustrated important barriers to providing rehabilitation to mechanically ventilated patients in an ICU and impairments in strength , range of motion , and functional outcomes at hospital discharge",
"IMPORTANCE Survivors of critical illness demonstrate skeletal muscle wasting with associated functional impairment . OBJECTIVE To perform a comprehensive prospect i ve characterization of skeletal muscle wasting , defining the pathogenic roles of altered protein synthesis and breakdown . DESIGN , SETTING , AND PARTICIPANTS Sixty-three critically ill patients ( 59 % male ; mean age : 54.7 years [ 95 % CI , 50.0 - 59.6 years ] ) with an Acute Physiology and Chronic Health Evaluation II score of 23.5 ( 95 % CI , 21.9 - 25.2 ) were prospect ively recruited within 24 hours following intensive care unit ( ICU ) admission from August 2009 to April 2011 at a university teaching and a community hospital in Engl and . Patients were recruited if older than 18 years and were anticipated to be intubated for longer than 48 hours , to spend more than 7 days in critical care , and to survive ICU stay . MAIN OUTCOMES AND MEASURES Muscle loss was determined through serial ultrasound measurement of the rectus femoris cross-sectional area ( CSA ) on days 1 , 3 , 7 , and 10 . In a subset of patients , the fiber CSA area was quantified along with the ratio of protein to DNA on days 1 and 7 . Histopathological analysis was performed . In addition , muscle protein synthesis , breakdown rates , and respective signaling pathways were characterized . RESULTS There were significant reductions in the rectus femoris CSA observed at day 10 ( −17.7 % [ 95 % CI , −25.9 % to 8.1 % ] ; P the rectus femoris CSA decreased by 10.3 % ( 95 % CI , 6.1 % to 14.5 % ) , the fiber CSA by 17.5 % ( 95 % CI , 5.8 % to 29.3 % ) , and the ratio of protein to DNA by 29.5 % ( 95 % CI , 13.4 % to 45.6 % ) . Decrease in the rectus femoris CSA was greater in patients who experienced multiorgan failure by day 7 ( −15.7 % ; 95 % CI , −27.7 % to 11.4 % ) compared with single organ failure ( −3.0 % ; 95 % CI , −5.3 % to 2.1 % ) ( P ; P = .03 ) . Myofiber necrosis occurred in 20 of 37 patients ( 54.1 % ) . Protein synthesis measured by the muscle protein fractional synthetic rate was depressed in patients on day 1 ( 0.035%/hour ; 95 % CI , 0.023 % to 0.047%/hour ) compared with rates observed in fasted healthy controls ( 0.039%/hour ; 95 % CI , 0.029 % to 0.048%/hour ) ( P = .57 ) and increased by day 7 ( 0.076 % [ 95 % CI , 0.032%-0.120%/hour ] ; P = .03 ) to rates associated with fed controls ( 0.065%/hour [ 95 % CI , 0.049 % to 0.080%/hour ] ; P = .30 ) , independent of nutritional load . Leg protein breakdown remained elevated throughout the study ( 8.5 [ 95 % CI , 4.7 to 12.3 ] to 10.6 [ 95 % CI , 6.8 to 14.4 ] μmol of phenylalanine/min/ideal body weight × 100 ; P = .40 ) . The pattern of intracellular signaling supported increased breakdown ( n = 9 , r = −0.83 , P = .005 ) and decreased synthesis ( n = 9 , r = −0.69 , P = .04 ) . CONCLUSIONS AND RELEVANCE Among these critically ill patients , muscle wasting occurred early and rapidly during the first week of critical illness and was more severe among those with multiorgan failure compared with single organ failure . These findings may provide insights into skeletal muscle wasting in critical illness",
"RATIONALE ICU-acquired paresis ( ICUAP ) is common in survivors of critical illness . There is significant associated morbidity , including prolonged time on the ventilator and longer hospital stay . However , it is unclear whether ICUAP is independently associated with mortality , as sicker patients are more prone and existing studies have not adjusted for this . OBJECTIVES To test the hypothesis that ICUAP is independently associated with increased mortality . Secondarily , to determine if h and grip dynamometry is a concise measure of global strength and is independently associated with mortality . METHODS A prospect i ve multicenter cohort study was conducted in intensive care units ( ICU ) of five academic medical centers . Adults requiring at least 5 days of mechanical ventilation without evidence of preexisting neuromuscular disease were followed until awakening and were then examined for strength . MEASUREMENTS AND MAIN RESULTS We measured global strength and h and grip dynamometry . The primary outcome was in-hospital mortality and secondary outcomes were hospital and ICU-free days , ICU readmission , and recurrent respiratory failure . Subjects with ICUAP ( average MRC score of hospital stays and required mechanical ventilation longer . H and grip strength was lower in subjects with ICUAP and had good test performance for diagnosing ICUAP . After adjustment for severity of illness , ICUAP was independently associated with hospital mortality ( odds ratio [ OR ] , 7.8 ; 95 % confidence interval [ CI ] , 2.4 - 25.3 ; P = 0.001 ) . Separately , h and grip strength was independently associated with hospital mortality ( OR , 4.5 ; 95 % CI , 1.5 - 13.6 ; P = 0.007 ) . CONCLUSIONS ICUAP is independently associated with increased hospital mortality . H and grip strength is also independently associated with poor hospital outcome and may serve as a simple test to identify ICUAP . Clinical trial registered with www . clinical trials.gov ( NCT00106665 )"
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BACKGROUND Increasing active travel ( primarily walking and cycling ) has been widely advocated for reducing obesity levels and achieving other population health benefits . However , the strength of evidence underpinning this strategy is unclear . This study aim ed to assess the evidence that active travel has significant health benefits . METHODS The study design was a systematic review of ( i ) non-r and omised and r and omised controlled trials , and ( ii ) prospect i ve observational studies examining either ( a ) the effects of interventions to promote active travel or ( b ) the association between active travel and health outcomes . Reports of studies were identified by search ing 11 electronic data bases , websites , reference lists and papers identified by experts in the field . Prospect i ve observational and intervention studies measuring any health outcome of active travel in the general population were included . Studies of patient groups were excluded . RESULTS Twenty-four studies from 12 countries were included , of which six were studies conducted with children . Five studies evaluated active travel interventions . Nineteen were prospect i ve cohort studies which did not evaluate the impact of a specific intervention . No studies were identified with obesity as an outcome in adults ; one of five prospect i ve cohort studies in children found an association between obesity and active travel . Small positive effects on other health outcomes were found in five intervention studies , but these were all at risk of selection bias . Modest benefits for other health outcomes were identified in five prospect i ve studies . There is suggestive evidence that active travel may have a positive effect on diabetes prevention , which may be an important area for future research . CONCLUSIONS Active travel may have positive effects on health outcomes , but there is little robust evidence to date of the effectiveness of active transport interventions for reducing obesity . Future evaluations of such interventions should include an assessment of their impacts on obesity and other health outcomes
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"Background and Purpose — The role of physical activity , especially that of occupational and commuting physical activity , in the prediction of stroke risk is not properly established . We assessed the relationship of different types of physical activity with total and type-specific stroke risk . Methods — We prospect ively followed 47 721 Finnish subjects 25 to 64 years of age without a history of coronary heart disease , stroke , or cancer at baseline . Hazard ratios ( HRs ) for incident stroke were estimated for different levels of leisure time , occupational , and commuting physical activity . Results — During a mean follow-up of 19.0 years , 2863 incident stroke events were ascertained . The multivariate-adjusted ( age , sex , area , study year , body mass index , systolic blood pressure , cholesterol , education , smoking , alcohol consumption , diabetes , and other 2 types of physical activity ) HRs associated with low , moderate , and high leisure time physical activity were 1.00 , 0.86 , and 0.74 ( Ptrend respectively . Occupational activity had a modest association with ischemic stroke in the multivariate analysis ( Ptrend=0.046 ) . Conclusion — A high level of leisure time physical activity reduces the risk of all subtypes of stroke . Daily active commuting also reduces the risk of ischemic stroke",
"In the 1970s Archie Cochrane noted that many healthcare procedures and forms of organisation lacked evidence of effectiveness and efficiency , and argued for improved methods of evaluation , moving from clinical opinion and observation to r and omised controlled trials ( RCTs ) . His arguments gradually became accepted in medicine , but there has been considerable resistance among policymakers and research ers to their application to social and public health interventions . This essay argues that opposition to RCTs in public health is often based on a false distinction between healthcare and community setting s , and sometimes on a misunderst and ing of the principles of RCTs in health care . It suggests that just as in medicine , good intentions and received wisdom are not a sufficient basis for making public policy and allocating public funds for social or health improvement",
"Study objective : To determine if a self help intervention , delivered via written interactive material s ( the “ Walk in to Work Out ” pack ) , could increase active commuting behaviour ( walking and cycling ) . Design : R and omised controlled trial . The intervention group received the “ Walk in to Work Out ” pack , which contained written interactive material s based on the transtheoretical model of behaviour change , local information about distances and routes , and safety information . The control group received the pack six months later . Focus groups were also conducted after six months . Setting : Three workplaces in the city of Glasgow , Scotl and , UK . Participants : 295 employees who had been identified as thinking about , or doing some irregular , walking or cycling to work . Main results : The intervention group was almost twice as likely to increase walking to work as the control group at six months ( odds ratio of 1.93 , 95 % confidence intervals 1.06 to 3.52 ) . The intervention was not successful at increasing cycling . There were no distance travelled to work , gender , or age influences on the results . Twenty five per cent ( 95 % confidence intervals 17 % to 32 % ) of the intervention group , who received the pack at baseline , were regularly actively commuting at the 12 month follow up . Conclusion : The “ Walk in to Work Out ” pack was successful in increasing walking but not cycling . The environment for cycling must be improved before cycling will become a popular option",
"Reports of studies relating physical activity to stroke and cancer sub-types indicate inconsistent findings . Some are hampered by low statistical power , owing to a low number of events , and a failure to adjust for potential confounding variables . The purpose of this study was to relate physical activity to 12 mortality endpoints in a prospect i ve cohort study of 11,663 men aged 40–64 years who responded to an enquiry about travel activity during a baseline medical examination conducted between 1967 and 1969 . During 25 years of follow-up there were 4672 deaths . Travel activity was inversely related to mortality attributable to all-causes , coronary heart disease , respiratory disease and lung cancer , whereas the association with stroke was positive . There was evidence for attenuation of some of these associations on adjustment for potentially confounding variables . Our simplistic measure of physical activity may , in part , explain the weak associations seen",
"There is good evidence that physical activity reduces the risk for cardiovascular disease ( 1 - 6 ) , possibly in part by lowering blood pressure ( 7 ) . Although mild or moderate physical activity , such as brisk walking , is a recommended part of the treatment protocol for persons with hypertension ( 8 , 9 ) , it is not known whether mild physical activity , especially walking , reduces the risk for hypertension . With few exceptions , epidemiologic studies of physical activity and hypertension have been cross-sectional rather than prospect i ve . Physical activity was inversely related to blood pressure in cross-sectional and controlled studies ( 7 ) , and in two prospect i ve studies ( 10 , 11 ) , vigorous exercise was inversely related to the subsequent risk for hypertension . Physicians in Japan usually advise their patients to walk to work as often as they can , and indeed , for middle-aged working Japanese men , the journey to and from work seems to be the main source of exercise . We prospect ively examined the relation of mild physical activity , especially walking to work , and leisure-time physical activity to the risk for hypertension during 6 to 16 years of observation . Methods The Osaka Health Survey The Osaka Health Survey is an ongoing cohort study of risk factors for chronic diseases , including hypertension and diabetes . Study participants are male employees of a gas company in Osaka , Japan . Japanese law requires all employers to conduct annual health screenings for all employees . For the purpose s of the Osaka Health Survey , in addition to these annual screenings , all employees 35 years of age or older undergo more detailed biennial clinical examinations and complete question naires on health-related behaviors , including exercise . Study Sample Between 1981 and 1990 , 7979 Japanese men 35 to 63 years of age at entry who had sedentary occupations were enrolled in the study . We excluded 1875 men because they had physician-diagnosed hypertension , borderline hypertension ( systolic blood pressure 140 and glucose tolerance ( fasting plasma glucose level 6.1 mmol/L [ 110 mg/dL ] and Data Collection and Measurements The biennial clinical examination consisted of a medical history ; a physical examination ; blood pressure measurement ; anthropometric measurements ; measurement of the fasting plasma glucose level ; and surveys of health-related behaviors , such as physical activity , smoking , and daily alcohol consumption . Trained nurses took all measurements . Participants were asked to fast for 12 hours and to avoid smoking and heavy physical activity for more than 2 hours before the examination . After a 5-minute rest in a quiet room , a st and ard mercury sphygmomanometer was used to measure systolic and diastolic blood pressures in the right arm while the participant was seated . Pressure was measured twice , at an interval of a few minutes . Anthropometric measurements included height and body weight , which were measured while the participant was wearing light clothing without shoes . Body mass index was calculated as the weight in kilograms divided by the height in meters squared . The question naire completed by each participant elicited information on leisure-time physical activity , the duration of the walk to work , the nature of the participant 's occupation , and the level of activity involved . Leisure-time physical activity was defined as physical activity unrelated to the participant 's work . Questions about leisure-time physical activity were as follows : Do you engage in any regular physical exercise , such as jogging , bicycling , swimming , and tennis , long enough to work up a sweat ( lasting 30 minutes or more ) ? If yes , how many times per week ? What exercise is this ? The questions about regular physical exercise have been vali date d as a measure of physical exercise ( 12 - 15 ) . In the analysis , participants were classified as engaging in regular physical exercise at least once per week or less than once per week . They were also classified into one of three categories of exercise frequency : 0 ( less than once per week ) , once per week , or two or more times per week . The question about the duration of the walk to work was How long does it take you to walk to this office ? Occupational activity was scored as 1 if the participant 's work was mostly sedentary and 2 if he worked outside or if the job required a lot of lifting and walking . In the present study , we excluded all participants who reported a score of 2 for their occupational activities . Questions about alcohol intake included items about the type of alcoholic beverage , the weekly frequency of alcohol consumption , and the usual amount consumed daily . Alcohol intake was converted to total alcohol consumption ( in milliliters of ethanol per day ) by using st and ard Japanese tables . Current and past smoking habits were classified according to the type and quantity of cigarettes smoked daily . Participants were classified as current smokers , past smokers , or nonsmokers . Hypertension was also diagnosed during the biennial study clinical examinations . All participants underwent medical screening by a physician at least once annually , and hypertension was also diagnosed by the physicians . Hypertension was defined by using World Health Organization criteria as physician-diagnosed hypertension ( systolic blood pressure 160 mm Hg , diastolic blood pressure 95 mm Hg , or both ) or use of antihypertensive medication ( 16 ) . Statistical Analysis Age-adjusted mean values and relevant population characteristics were computed for the duration of the walk to work by using analysis of covariance for continuous variables and the direct method for categorical variables . For each participant , person-years of follow-up were counted from the date at study entry to the date of diagnosis of hypertension or 1 April 1997 , whichever came first . The rate of follow-up was 94 % of the total potential person-years of follow-up . Multivariate Cox proportional-hazards regression models were used to evaluate the simultaneous effects of the duration of the walk to work , the frequency of leisure-time physical activity , age , body mass index , daily alcohol consumption , smoking status , and fasting plasma glucose level . Baseline systolic and diastolic blood pressure were not included in our primary analyses because they could presumably be in the causal pathway between the exposures ( such as physical activity , age , body mass index , and alcohol consumption ) and risk for hypertension . However , we included systolic and diastolic blood pressure in further models to assess the effect of physical activity on the risk for hypertension independent of their effects on systolic and diastolic blood pressure . The linear trends in risks were evaluated by entering indicators for each categorical level of exposure or by using the median value for each category . As a reference category , we used men with the lowest level of physical activity . To address the potential misclassification of leisure-time physical activity over time , additional analyses were performed on the basis of the data at both study entry ( 1981 to 1990 ) and the examination done 4 years after ( 1985 to 1994 ) each participant was enrolled . We also performed analyses that excluded participants who developed hypertension between study entry ( 1981 to 1990 ) and the third examination done 4 years later ( 1985 to 1994 ) . We calculated the 95 % CI for each relative risk ( 17 ) , and all P values are two-tailed . Statistical analyses were performed by using the SPSS 7.5J software package ( SPSS , Inc. , Chicago , Illinois ) . We estimated the number needed to walk , a value analogous to the number needed to treat . The number needed to treat for a given therapy is the reciprocal of the absolute risk reduction for that treatment ( 18 ) . A 95 % CI for the number needed to treat is obtained simply by taking reciprocals of the values defining the 95 % CI of the absolute risk reduction ( 19 ) . In our study , the number needed to walk was defined as the number of men who would have to adopt walking to avoid a single case of hypertension . The number needed to treat must always be based on an outcome for a specific period of time ( 20 ) ; thus , in estimating the number needed to walk , we chose an observation period of 10 years between study entry ( 1981 to 1986 ) and the examination done 10 years after ( 1991 to 1996 ) each participant was enrolled . Role of the Funding Source The funding agencies did not participate in the collection , analysis , or interpretation of data presented in this report or in the decision to su bmi t the manuscript for publication . Results Of the 6104 men eligible for this study between 1981 and 1990 , we excluded 87 men who did not undergo medical check-ups during the follow-up period . The study sample for analysis consisted of 6017 men . During the 59 784 person-years of follow-up between 1981 and 1997 , 626 men developed hypertension . As the duration of the walk to work increased , body weight and the body mass index decreased ( P for trend=0.037 and 0.035 , respectively ) ( Table 1 ) . We identified no significant relation between the duration of the walk to work and the levels of leisure-time physical activity ( P for trend=0.062 ) . Table 1 . Baseline Characteristics according to Duration of the Walk to Work Duration of the Walk to Work The duration of the walk to work was associated with a decreased risk for incident hypertension ( Table 2 ) . After adjustment for age , body mass index , daily alcohol consumption , smoking status , frequency of leisure-time physical activity , systolic blood pressure , diastolic blood pressure , and fasting plasma glucose level , the relative risk for hypertension was 0.71 ( 95 % CI , 0.52 to 0.97 ) in men whose walk to work lasted 21 minutes or more compared with those",
"BACKGROUND Physical activity is associated with low mortality in men , but little is known about the association in women , different age groups , and everyday activity . OBJECTIVE To evaluate the relationship between levels of physical activity during work , leisure time , cycling to work , and sports participation and all-cause mortality . DESIGN Prospect i ve study to assess different types of physical activity associated with risk of mortality during follow-up after the subsequent examination . Mean follow-up from examination was 14.5 years . SETTING Copenhagen University Hospital , Copenhagen , Denmark . PARTICIPANTS Participants were 13,375 women and 17,265 men , 20 to 93 years of age , who were r and omly selected . Physical activity was assessed by self-report , and health status , including blood pressure , total cholesterol level , triglyceride levels , body mass index , smoking , and educational level , was evaluated . MAIN OUTCOME MEASURE All-cause mortality . RESULTS A total of 2,881 women and 5,668 men died . Compared with the sedentary , age- and sex-adjusted mortality rates in leisure time physical activity groups 2 to 4 were 0.68 ( 95 % confidence interval , 0.64 - 0.71 ) , 0.61 ( 95 % confidence interval , 0.57 - 0.66 ) , and 0.53 ( 95 % confidence interval , 0.41 - 0.68 ) , respectively , with no difference between sexes and age groups . Within the moderately and highly active persons , sports participants experienced only half the mortality of non participants . Bicycling to work decreased risk of mortality in approximately 40 % after multivariate adjustment , including leisure time physical activity . CONCLUSIONS Leisure time physical activity was inversely associated with all-cause mortality in both men and women in all age groups . Benefit was found from moderate leisure time physical activity , with further benefit from sports activity and bicycling as transportation",
"Background Walking and cycling to school are one source of regular physical activity . The aim of this two years observational study in pre-pubertal children was to evaluate if walking and cycling to school was associated with higher total amount of physical activity and larger gain in bone mineral content ( BMC ) and bone width than when going by car or bus . Methods 133 boys and 99 girls aged 7 - 9 years were recruited to the Malmö Prospect i ve Paediatric Osteoporosis Prevention ( POP ) study . BMC ( g ) was measured by dual X-ray absorptiometry ( DXA ) in total body , lumbar spine ( L2-L4 ) and femoral neck ( FN ) at baseline and after 24 months . Bone width was measured in L2-L4 and FN . Skeletal changes in the 57 boys and 48 girls who consistently walked or cycled to school were compared with the 24 boys and 17 girls who consistently went by bus or car . All children remained in Tanner stage I. Level of everyday physical activity was estimated by accelerometers worn for four consecutive days and question naires . Comparisons were made by independent student 's t-tests between means and Fisher 's exact tests . Analysis of covariance ( ANCOVA ) was used to adjust for group differences in age at baseline , duration of organized physical activity , annual changes in length and BMC or bone width if there were differences in these traits at baseline . Results After the adjustments , there were no differences in the annual changes in BMC or bone width when comparing girls or boys who walked or cycled to school with those who went by car or bus . Furthermore , there were no differences in the levels of everyday physical activity objective ly measured by accelerometers and all children reached above the by the United Kingdom Expert Consensus Group recommended level of 60 minutes moderate to vigorous physical activity per day . Conclusion A physical active transportation to school for two years is in pre-pubertal children not associated with a higher accrual of BMC or bone width than a passive mode of transportation , possibly due to the fact that the everyday physical activity in these pre-pubertal children , independent of the mode of school transportation , was high",
"OBJECTIVE To prospect ively examine potential benefits of active commuting to school on measures of weight status and physical activity in a sample of youth . RESEARCH METHODS AND PROCEDURES A cohort of students from seven elementary schools was measured four times -- in the fall and spring of fourth grade ( N = 1083 ) and fifth grade ( N = 924 ) . Participants were classified as active ( walking , biking , or skateboarding to school almost every day for baseline analyses or at least 2 d/wk for analyses of consistent active commuting ) or non-active commuters to school . Accelerometers were used to measure physical activity . Height , weight , and skinfolds were objective ly assessed . RESULTS Boys who actively commuted to school had lower BMI ( p skinfolds ( p BMI change or overweight status . DISCUSSION Walking and cycling to school may contribute to preventing excessive weight gain , or leaner children may walk or cycle to school",
"Aim /hypothesisLeisure-time physical activity can reduce the risk of Type 2 diabetes , but the potential effect of different types of physical activity is still uncertain . This study is to examine the relationship of occupational , commuting and leisure-time physical activity with the incidence of Type 2 diabetes . Methods We prospect ively followed 6898 Finnish men and 7392 women of 35 to 64 years of age without a history of stroke , coronary heart disease , or diabetes at baseline . Hazards ratios of incidence of Type 2 diabetes were estimated by levels of occupational , commuting , and leisure-time physical activity . Results During a mean follow-up of 12 years , there were 373 incident cases of Type 2 diabetes . In both men and women combined , the hazards ratios of diabetes associated with light , moderate and active work were 1.00 , 0.70 and 0.74 ( p=0.020 for trend ) after adjustment for confounding factors ( age , study year , sex , systolic blood pressure , smoking , education , the two other types of physical activity and BMI ) . The multivariate-adjusted hazards ratios of diabetes with none , 1 to 29 , and more than 30 min of walking or cycling to and from work were 1.00 , 0.96 , and 0.64 ( p=0.048 for trend ) . The multivariate-adjusted hazards ratios of diabetes for low , moderate , high levels of leisure-time physical activity were 1.00 , 0.67 , and 0.61 ( p=0.001 for trend ) ; after additional adjustment for BMI , the hazards ratio was no longer significant . Conclusions /interpretationModerate and high occupational , commuting or leisure-time physical activity independently and significantly reduces risk of Type 2 diabetes among the middle-aged general population",
"Background : In epidemiological studies abundant physical activity has been related to decreased breast cancer risk , though the results have been inconsistent . The purpose of this paper was to study the association of physical activity at leisure and commuting to work and incidence of breast cancer . Methods : The study cohort consisted of 30,548 female participants of the Finnish adult health behaviour survey , based on annual r and om sample s of Finns aged 15–64 , collected in 1978–1993 . By the end of 1995 , 332 breast cancer cases had been diagnosed in the cohort . Relative risks of breast cancer were adjusted for age at survey , body mass index ( BMI ) , education , length of follow-up , parity and age at first birth using Poisson regression models . Results : Compared to women exercising less than once a week , the adjusted relative risk of breast cancer for women exercising once a week was 0.80 ( 95 % confidence interval ( CI ) : 0.58–1.10 ) , for women exercising 2–3 times per week 0.92 ( 95 % CI : 0.78–1.22 ) and for women exercising daily 1.01 ( 95 % CI : 0.72–1.42 ) . Women who reported commuting , walking or bicycling to work 30 min or more daily had slightly lower adjusted risk of breast cancer ( RR : 0.87 , 95 % CI : 0.62–1.24 ) than women working at home , being unemployed or driving a car to working place . Conclusion : Although a small protective effect of regular physical activity for breast cancer incidence was found in physical activity when commuting to work , the role of the physical activity in breast cancer prevention is still an open question",
"AIMS To investigate separately for men and women whether moderate or high leisure time physical activity , occupational physical activity , and commuting activity are associated with a reduced cardiovascular disease ( CVD ) and all-cause mortality , independent of CVD risk factors and other forms of physical activity . METHODS AND RESULTS Prospect i ve follow-up of 15,853 men and 16,824 women aged 30 - 59 years living in eastern and south-western Finl and ( median follow-up time 20 years ) . CVD and all-cause mortality were lower ( 9 - 21 % ) in men and women ( 2 - 17 % ) who were moderately or highly physically active during leisure time . Moderate and high levels of occupational physical activity decreased CVD and all-cause mortality by 21 - 27 % in both sexes . Women spending daily 15 min or more in walking or cycling to and from work had a reduced CVD and all-cause mortality before adjustment for occupational and leisure time physical activity . Commuting activity was not associated with CVD or all-cause mortality in men . CONCLUSION Moderate and high levels of leisure time and occupational physical activity are associated with a reduced CVD and all-cause mortality among both sexes . Promoting already moderate levels of leisure time and occupational physical activity are essential to prevent premature CVD and all-cause mortality",
"A large body of epidemiological evidence suggests an inverse relationship between physical activity and risk of fractures . However , it is unclear how this association varies according to the domain of life in which the activity is undertaken . In this analysis of the European Prospect i ve Investigation of Cancer-Norfolk study , we assessed total and domain-specific physical activity using a vali date d question naire ( EPAQ2 ) in 14,903 participants ( 6514 men , mean age 62 year ) who also underwent quantitative ultrasound of the heel . After a median follow-up of 7.5 years , there were 504 fractures of which 164 were hip fractures . In multivariable linear regression analysis , broadb and ultrasound attenuation ( BUA ) was positively associated with total and leisure-time activities while showing no association with transportation and work activities . Home activities were associated with a lower BUA among younger participants . In multivariable Cox proportional-hazards models , moderate activities at home and in leisure time were associated with lower hip fracture risk among women ( hazard ratios [ HR ] 0.51 and 0.55 , p value 0.02 and 0.03 , respectively ) . Among men , leisure-time activities were associated with lower risk of hip fracture ( HR=0.58 ; p for trend risk of any fracture ( HR=1.25 ; p for trend=0.008 ) . Walking for leisure or transport was associated with lower risk of fracture in both men and women . Multivariable fractional polynomial modelling showed a U-shaped association between home activities and fracture risk especially among women . This study suggests that different domains of physical activity may relate differently to fracture risk and these relationships may vary by sex",
"Background —The influence of physical activity on the incidence of angina pectoris and hard coronary events ( myocardial infa rct ion and coronary deaths ) was examined in Northern Irel and and France at contrasting risk for coronary heart disease ( CHD ) and with different physical activity patterns . Methods and Results — Participants of the Prospect i ve Epidemiological Study of Myocardial Infa rct ion ( PRIME ) ( n=9758 ; age , 50 to 59 years ) , free of CHD at baseline , were followed up for 5 years : 167 hard CHD and 154 angina events were recorded . Net energy expenditure ( EE ) as the result of physical activity was assessed by means of the MONICA Optional Study of Physical Activity Question naire ( MOSPA-Q ) . Leisure-time physical activity EE was calculated ; subjects were also categorized as to whether they performed high-intensity leisure-time activities or walked or cycled to work . After multivariate adjustment , leisure-time physical activity EE was associated with a lower risk of hard CHD events ( P walking or cycling to work was not independently related to hard CHD events . No interaction by country was found . The beneficial effect of leisure-time physical activity was also present among subjects who did not report high-intensity activities ( P leisure-time physical activity was associated with a higher risk of angina in both countries . Conclusions —These data indicate a beneficial effect of leisure-time physical activity EE on hard CHD incidence in middle-aged men , which could partly explain the unfavorable rate of CHD in Northern Irel and . The higher level of leisure-time activities in France could , in part , explain its lower rate of CHD",
"Previous epidemiological studies have shown that vigorous physical activity reduces the development of type 2 diabetes ( 1–3 ) . A recommendation from the Centers for Disease Control and Prevention reported that individuals should engage in ≥30 min of moderate-intensity physical activity , such as brisk walking , on most days of the week for health promotion and disease prevention ( 4 ) ; however , it is unclear whether mild physical activity ( i.e. , walking to walk ) reduces the risk for type 2 diabetes . In the present study , we examined the relationship between walking to work and the development of type 2 diabetes during a 4-year observational period . The Kansai Healthcare Study is an ongoing cohort investigation design ed to clarify the risk factors for cardiometabolic diseases . Between April 2000 and March 2001 , 12,647 male employees of a company in the area of Kansai , Japan , who were aged 40–55 years at entry and considered to be involved in sedentary jobs were enrolled in this study . All employees aged ≥40 years underwent annual detailed medical check-ups . The protocol for this research was review ed by the Human Subjects Review Committee at Osaka City University . For current analysis , study participants consisted of 11,073 Japanese men aged 40–55 years at entry with a fasting plasma glucose ( FPG ) A 4-year follow-up examination after baseline was conducted between April 2004 and March 2005 . We excluded 53 men because of death and 2,016 men because of",
"Objective To determine whether low leisure-time physical activity , occupational physical activity and commuting activity independently increase the risk of hypertension when adjusted for most risk factors for hypertension and for different forms of physical activity . Design Population -based prospect i ve cohort study . Setting Eastern and south-western Finl and . Participants Men ( n = 5935 ) and women ( n = 6227 ) aged 25 - 64 years . Main outcome measure Initiation of free-of-charge medication for hypertension during a mean follow-up time of 11.3 years . Results Men with high leisure-time physical activity had a reduced risk of hypertension when adjustment had been made for age , area and year of survey , education , smoking , alcohol intake , baseline systolic blood pressure ( SBP ) , body mass index ( BMI ) , commuting activity and occupational physical activity [ hazard ratio ( HR ) 0.79 ; 95 % confidence interval ( CI ) 0.63 to 0.99 ] . Women with high leisure-time physical activity had a reduced risk of hypertension when adjusted for age , area and time of survey ( HR 0.65 ; 95 % CI 0.46 to 0.91 ) . This association was no longer significant when further adjustments were made for other covariates ( HR 0.73 ; 95 % CI 0.52 to 1.03 ) . High occupational physical activity reduced the risk of hypertension only among men and women combined when adjustment was made for age , area and time of survey , education , smoking and alcohol intake , in addition to baseline SBP , BMI , commuting activity and leisure-time physical activity ( HR 0.83 ; 95 % CI 0.72 to 0.96 ) . Commuting activity was not associated with risk of hypertension in multivariate models . Conclusion High levels of leisure-time physical activity are associated with a reduced risk of hypertension , independently of most common risk factors for hypertension , occupational physical activity and commuting activity . Promoting leisure-time physical activity is essential to prevent hypertension",
"BACKGROUND This study examined predictors of adoption and maintenance of vigorous physical activity over time in a sample of 1,719 r and omly selected women and men . METHODS Based on reported frequency of vigorous exercise in a mail survey at baseline , subjects were classified as sedentary ( zero sessions per week ) , intermediate ( one to two sessions per week ) , or active ( three or more sessions per week ) . RESULTS On the same survey subjects reported on 25 potential determinants of physical activity based on a comprehensive learning model . Twenty-four months later , 85 % of subjects were resurveyed , and their physical activity levels were classified . Within each baseline category and gender subgroup , predictors of follow-up physical activity were identified . In multivariate analyses , adoption of vigorous exercise by sedentary men was predicted by self-efficacy , age ( inverse ) , and neighborhood environment ( inverse ) . Adoption by sedentary women was predicted by education , self-efficacy , and friend and family support for exercise . Maintenance of vigorous physical activity was predicted by self-efficacy and age ( inverse ) for initially active men and by education for initially active women . CONCLUSION These results suggest that factors influencing adoption are different for men and women , and there may be different factors influencing adoption versus maintenance of vigorous physical activity",
"Active commuting to school ( e.g. walking or bicycling ) has been suggested as a strategy to increase children ’s physical activity 1 , 2 and a number of walk-to-school websites now exist . 3–5 Several observational studies have found positive associations between walking to school and physical activity 6–9 but they are unable to determine the causal direction . Adult-chaperoned walks to school ( i.e. , walking school bus1 , 5 ) have been evaluated 10–12 but no research was found that assessed objective ly measured changes in physical activity from walking to school . Walk-to-school programs can be a component of comprehensive school health plans , have particular relevance for school nurse/health staff and physical education faculty and can be adapted to suit the schools ’ physical and social environment . Therefore , we completed a small , short-term pilot and feasibility r and omized control trial to 1 ) test the feasibility of the walking school bus as an intervention strategy and 2 ) to identify any changes in physical activity from walking to school . A r and omized controlled trial design was used with all participants completing one week of baseline automobile commuting . Students were then r and omized , for the second week , to either a control group that continued to be driven to school or an intervention group that participated in the walking school bus . Families were recruited from one elementary school ( Menlo Park , CA ) . Eighteen families responded and met the inclusion criteria : 1 ) student in 3rd–5th grade and 2 ) currently being driven to school at least four days/week . Six families declined to participate , due to time constraints ( n=4 ) , shared custody ( n=1 ) , and general concern ( n=1 ) . Therefore , 12 students were r and omized to a control ( CON , n=6 ) or intervention ( WALK , n=6 ) group . All students completed the study protocol as design ed . One student in the WALK group was excluded from analysis due to activity monitor malfunction , leaving five WALK and six CON students in the analysis sample . This study was approved by the Stanford University Administrative Panel on Human Subjects in Medical Research . This study was conducted during March and April of 2005 . The ActiGraph physical activity monitor was used to measure physical activity . 13–15 One-minute data collection time intervals ( epochs ) were used for this study . An elastic belt with an attached monitor was fit to each student on the first day of the study ( always a weekend ) . Students were instructed to wear the monitor at all times for 14 consecutive days except when swimming , bathing , or sleeping . All students were instructed to maintain their normal activities during the baseline week . On the fifth day , families were notified of their group r and omization and , for the WALK group , the planned route and schedule . The morning commute for the CON group was not altered . A walking school bus , led by one study personnel , followed the safest route to school based on the location of the students ’ homes relative to each other and the school . Students walked at their normal pace but were encouraged to stay together as a group . A wagon , pulled by the study personnel , was used to transport backpacks and instruments . If a student lived more than 1.6 Km from the school , the parent/guardian dropped the student off at one of the other student ’s homes ( 1.1 Km from school ) and he/she walked the remainder of the trip . Raw accelerometer data were reduced to summary variables using a custom software program . 9 For analysis , accelerometer data were summarized for the total week and weekdays . Each weekday was also divided into four time blocks ; before- , during- , and after-school and evening . Average monitor counts·min−1 and the average percent of time spent in moderate-tovigorous physical activity ( % MVPA ) were calculated for each student using age-specific count cutoffs 16 and change scores ( intervention – baseline ) calculated . Between group comparisons used non-parametric Wilcoxon Rank Sum tests with a two-tailed alpha=0.05 . CON ( n=6 ) and WALK ( n=5 ) students were ( mean±SD ) 9.5±1.02 and 9.7±0.90 years old . The CON group had four boys ( all Caucasian ) and two girls ( 1 Caucasian , 1 Chinese ) . The WALK group had two boys and three girls ( all Caucasian ) . On average , CON and WALK students lived 1.3±0.68 and 0.9±0.46 Km from school . The time required to walk to school for the WALK students ranged from 10–36 minutes and was proportional to the distance traveled 0.4–1.1 Km ( mean , 0.8 Km ) ( Spearman r=0.95 ) . Compared to students in the CON group , WALK students significantly increased their counts·min-1 and % MVPA ( p≤0.02 ) before school ( Table 1 ) . This difference was even more pronounced when only looking at the General Commute Time ( GCT ) , defined as the 45 minutes before school ( p Average counts·min-1 and percent of time spent in MVPA by group by weekday time blocks , all days , and weekdays To our knowledge , this is the first experimental study to investigate the effect of walking to school on physical activity . The walking school bus did prove feasible in this small sample . Compared to students that were driven to school , those that walked to school increased their MVPA during the GCT by 14 minutes per day . Qualitative data collected at the end of the intervention indicated that the walking school bus was well liked . Parents noted that it was a , “ less stressful start to the day ” and another mentioned , “ She can do it ! And she enjoys walking . She even wanted to walk home ” . Students indicated that they enjoyed walking with others and one student noted that he , “ Did n't feel as tired in the morning compared to when I am driven to school ” . Two students indicated they did not like getting up earlier and none of the students liked the “ loud , embarrassing wagon ” . Five of the six students in the WALK group said they would continue to walk to school . In this experimental study we found no significant group differences for total daily or weekday physical activity or percent of time spent in MVPA . This was likely due to insufficient power to detect such differences , given the high variability of physical activity behavior and measurement error . The 14 minute increase in MVPA during the general commute time for the WALK students represents approximately 25 % of the recommended 60-minutes of MVPA per day . The promising results of this small experimental study justify larger walk to school experiments to examine whether walk to school interventions can impact total daily physical activity and MVPA , as well as other health and behavior outcomes . Additional community level benefits include less car congestion and emissions and improved neighborhood safety via more frequent social interactions with neighbors and greater community cohesion . Since walking to school will likely take longer than being driven , the morning routine may change to accommo date this . The child may need to get up earlier , potentially reducing the amount of time for sleeping and eating breakfast . Therefore , quality and quantity of sleep , consumption of breakfast and overall dietary behavior of students that walk to school should be considered . Lastly , such school- and community-based efforts should seek to engage school personnel and parent and community volunteers as walking school bus chaperones.17 The experiences from such programs can be incorporated into physical education and science curriculums as experiential learning opportunities ( e.g. , walkability audits ; car , bike , and pedestrian counts ; step or distance goals for active commuting , etc … ) "
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Background The mortality of coronary heart disease can be largely reduced by modifying unhealthy lifestyles . However , the long-term effectiveness of interventions for modifying unhealthy diet and physical inactivity of patients with coronary heart disease remain unsatisfactory worldwide . This study aims to systematic ally design a set of theory-based and evidence -based , individualized , and intelligent interventions for promoting the adoption and maintenance of a healthy diet and physical activity level in patients with coronary heart disease . Methods The interventions will be delivered by a mobile health care system called Individualized , Intelligent and Integrated Cardiovascular Application for Risk Elimination . Three steps of the intervention mapping framework were used to systematic ally develop the interventions . Step 1 : needs assessment , which was carried out by a literature review , in-depth interviews and focus group discussion s. Step 2 : development of objective matrix for diet and physical activity changes , based on the intersection of objectives and determinants from the Contemplation-Action-Maintenance behavior change model . Step 3 : formulation of evidence -based methods and strategies , and practical applications , through a systematic review of existing literature , research team discussion s , and consultation with multidisciplinary expert panels . Results Three needs relevant to content of the intervention , one need relevant to presentation modes of the intervention , and four needs relevant to functional features of the application were identified . The objective matrix includes three performance objectives , and 24 proximal performance objectives . The evidence -based and theory-based interventions include 31 strategies , 61 evidence -based methods , and 393 practical applications . Conclusions This article describes the development of theory-based and evidence -based interventions of the mobile health care system for promoting the adoption and maintenance of a healthy diet and physical activity level in a structured format . The results will provide a theoretical and method ological basis to explore the application of intervention mapping in developing effective behavioral mobile health interventions for patients with coronary heart disease . Trial registration Chinese Clinical Trial Registry : ChiCTR-INR-16010242 . Registered 24 December 2016 .
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"BACKGROUND The association between intake of fruits , vegetables , and legumes with cardiovascular disease and deaths has been investigated extensively in Europe , the USA , Japan , and China , but little or no data are available from the Middle East , South America , Africa , or south Asia . METHODS We did a prospect i ve cohort study ( Prospect i ve Urban Rural Epidemiology [ PURE ] in 135 335 individuals aged 35 to 70 years without cardiovascular disease from 613 communities in 18 low-income , middle-income , and high-income countries in seven geographical regions : North America and Europe , South America , the Middle East , south Asia , China , southeast Asia , and Africa . We documented their diet using country-specific food frequency question naires at baseline . St and ardised question naires were used to collect information about demographic factors , socioeconomic status ( education , income , and employment ) , lifestyle ( smoking , physical activity , and alcohol intake ) , health history and medication use , and family history of cardiovascular disease . The follow-up period varied based on the date when recruitment began at each site or country . The main clinical outcomes were major cardiovascular disease ( defined as death from cardiovascular causes and non-fatal myocardial infa rct ion , stroke , and heart failure ) , fatal and non-fatal myocardial infa rct ion , fatal and non-fatal strokes , cardiovascular mortality , non-cardiovascular mortality , and total mortality . Cox frailty models with r and om effects were used to assess associations between fruit , vegetable , and legume consumption with risk of cardiovascular disease events and mortality . FINDINGS Participants were enrolled into the study between Jan 1 , 2003 , and March 31 , 2013 . For the current analysis , we included all unrefuted outcome events in the PURE study data base through March 31 , 2017 . Overall , combined mean fruit , vegetable and legume intake was 3·91 ( SD 2·77 ) servings per day . During a median 7·4 years ( 5·5 - 9·3 ) of follow-up , 4784 major cardiovascular disease events , 1649 cardiovascular deaths , and 5796 total deaths were documented . Higher total fruit , vegetable , and legume intake was inversely associated with major cardiovascular disease , myocardial infa rct ion , cardiovascular mortality , non-cardiovascular mortality , and total mortality in the models adjusted for age , sex , and centre ( r and om effect ) . The estimates were substantially attenuated in the multivariable adjusted models for major cardiovascular disease ( hazard ratio [ HR ] 0·90 , 95 % CI 0·74 - 1·10 , ptrend=0·1301 ) , myocardial infa rct ion ( 0·99 , 0·74 - 1·31 ; ptrend=0·2033 ) , stroke ( 0·92 , 0·67 - 1·25 ; ptrend=0·7092 ) , cardiovascular mortality ( 0·73 , 0·53 - 1·02 ; ptrend=0·0568 ) , non-cardiovascular mortality ( 0·84 , 0·68 - 1·04 ; ptrend = 0·0038 ) , and total mortality ( 0·81 , 0·68 - 0·96 ; ptrend ) . The HR for total mortality was lowest for three to four servings per day ( 0·78 , 95 % CI 0·69 - 0·88 ) compared with the reference group , with no further apparent decrease in HR with higher consumption . When examined separately , fruit intake was associated with lower risk of cardiovascular , non-cardiovascular , and total mortality , while legume intake was inversely associated with non-cardiovascular death and total mortality ( in fully adjusted models ) . For vegetables , raw vegetable intake was strongly associated with a lower risk of total mortality , whereas cooked vegetable intake showed a modest benefit against mortality . INTERPRETATION Higher fruit , vegetable , and legume consumption was associated with a lower risk of non-cardiovascular , and total mortality . Benefits appear to be maximum for both non-cardiovascular mortality and total mortality at three to four servings per day ( equivalent to 375 - 500 g/day ) . FUNDING Full funding sources listed at the end of the paper ( see Acknowledgments )",
"Background Coronary heart disease ( CHD ) is the leading cause of cardiovascular mortality worldwide , yet implementation of evidence -based strategies for secondary prevention remains suboptimal . Objective This study aim ed to evaluate the feasibility , specifically the usability and acceptability , and estimate the preliminary effectiveness of a mobile health ( mHealth ) intervention targeting both physicians and patients to improve adherence to evidence -based medications and lifestyle modifications . Methods We conducted a 12-week pre-post interventional pilot study at two sites in Shanghai and Hainan , China . Physicians used the app design ed in this study to prescribe evidence -based medicines and record patient information . Eligible and consenting patients received automatic text messages or voice calls 4 to 5 times per week for 12 weeks on medication adherence and healthy behaviors . Interviews were conducted among 10 physicians and 24 patients at the two sites for their thoughts on medication adherence and feedback on the usability and acceptability . Questions on usability and acceptability were also asked in a patient follow-up survey . With regard to estimating effectiveness , the primary outcome was medication adherence ( as estimated by the Morisky Green Levine Scale ) at 12 weeks . Secondary outcomes included physical activity , smoking status , fruits and vegetables consumption , and facility visit frequency . Results Interview findings and patient survey showed the good usability and acceptability of the intervention . Among 190 patients who completed the intervention , there was a significant increase in medication adherence ( odds ratio [ OR ] 1.80 , 95 % CI 1.14 - 2.85 ) . The study also showed decrease of smokers ’ percentage ( −5 % , P=.05 ) , increase of daily vegetables consumption frequency ( + 0.3/day , P=.01 ) , and community health care center visit frequency ( + 3 in 3 months , P=.04 ) . The following site-specific differences were noted : medication adherence appeared to increase in Hainan ( OR 14.68 , 95 % CI 5.20 - 41.45 ) but not in Shanghai ( OR 0.61 , 95 % CI 0.33 - 1.12 ) . Conclusions Our study demonstrated that the intervention was feasible in both a tertiary care center and an urban community health center in China . Preliminary results from pre-post comparison suggest the possibility that provider and patient-linked mHealth interventions may improve medication adherence and lifestyle modifications among CHD patients , especially in re source -scarce setting s. R and omized controlled trials are needed to verify the findings",
"Background Low adherence to dietary guidelines and a concurrent rise of obesity-related chronic diseases emphasize the need for effective interventions to promote healthy eating . There is growing recognition that behavior change interventions should draw on theories of behavior change . Online interventions grounded in theory lead to increased effectiveness for health behavior change ; however , few theory-driven social media-based health promotion interventions have been described in the literature . Objective The objective of this study was to describe the application of the Intervention Mapping ( IM ) protocol to develop an evidence -informed blog to promote healthy eating among French-Canadian mothers of preschool and school-aged children . Methods The following six steps of the IM protocol were performed . In Step 1 , a preliminary needs assessment included a literature search on theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults ( ie , knowledge , beliefs about capabilities , beliefs about consequences , intention/ goals ) and a qualitative study including focus groups to identify female Internet users ’ perceptions of their use of healthy eating blogs . In Step 2 , two behavioral outcomes were selected ( ie , increase daily intakes of Vegetables and Fruits and Milk and Alternatives of mothers to reach Canadian dietary recommendations ) and subsequently divided into six performance objectives inspired by national and international dietary recommendations such as planning for healthy meals . A matrix of change objectives was then created by crossing performance objectives with theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults . Step 3 consisted of selecting theory-based intervention methods ( eg , modeling and goal setting ) and translating them into practical applications for the context of a dietary intervention delivered through a blog . A 6-month intervention was developed in Step 4 in which we aim ed to address one performance objective per month in weekly blog publications written by a registered dietitian . For Step 5 , we sought to include engagement-promoting methods ( eg , peer and counselor support ) to promote mothers ’ use of the blog and adherence to the intervention . Finally in Step 6 , a r and omized controlled trial has been launched to evaluate the effects of the blog on dietary behaviors of French-Canadian mothers . Results The intervention study is expected to be completed in March 2018 . Conclusions An intervention mapping protocol allowed for effective decision making in the development of a novel knowledge translation tool to increase adherence to dietary recommendations among mothers of preschool and school-aged children",
"Background Cancer and cancer treatment coincide with substantial negative physical , psychological and psychosocial problems . Physical activity ( PA ) can positively affect the negative effects of cancer and cancer treatment and thereby increase quality of life in CPS . Nevertheless , only a minority of CPS meet PA guidelines . We developed the OncoActive ( OncoActief in Dutch ) intervention : a computer-tailored PA program to stimulate PA in prostate and colorectal CPS , because to our knowledge there are only a few PA interventions for these specific cancer types in the Netherl and s Methods The OncoActive intervention was developed through systematic adaptation of a proven effective , evidence -based , computer-tailored PA intervention for adults over fifty , called Active Plus . The Intervention Mapping ( IM ) protocol was used to guide the systematic adaptation . A literature study and interviews with prostate and colorectal CPS and health care professionals revealed that both general and cancer-specific PA determinants are important and should be addressed . Change objectives , theoretical methods and applications and the actual program content were adapted to address the specific needs , beliefs and cancer-related issues of prostate and colorectal CPS . Intervention participants received tailored PA advice three times , on internet and with printed material s , and a pedometer to set goals to improve PA . Pre- and pilot tests showed that the intervention was highly appreciated ( target group ) and regarded safe and feasible ( healthcare professionals ) . The effectiveness of the intervention is being evaluated in a r and omized controlled trial ( RCT ) ( n = 428 ) , consisting of an intervention group and a usual care waiting-list control group , with follow-up measurements at three , six and twelve months . Participants are recruited from seventeen hospitals and with posters , flyers and calls in several media . Discussion Using the Intervention Mapping protocol result ed in a systematic ally adapted , theory and evidence -based intervention providing tailored PA advice to prostate and colorectal CPS . If the intervention turns out to be effective in increasing PA , as evaluated in a RCT , possibilities for nationwide implementation and extension to other cancer types will be explored . Trial registration The study is registered in the Dutch Trial Register ( NTR4296 ) on November 23rd 2013 and can be accessed at http://www.trialregister.nl/trialreg/admin/ rct view.asp?TC=4296",
"Computer-tailored programs may help to prevent overweight and obesity , which are worldwide public health problems . This study investigated ( 1 ) the 12-month effectiveness of a video- and text-based computer-tailored intervention on energy intake , physical activity , and body mass index ( BMI ) , and ( 2 ) the role of educational level in intervention effects . A r and omized controlled trial in The Netherl and s was conducted , in which adults were allocated to a video-based condition , text-based condition , or control condition , with baseline , 6 months , and 12 months follow-up . Outcome variables were self-reported BMI , physical activity , and energy intake . Mixed-effects modelling was used to investigate intervention effects and potential interaction effects . Compared to the control group , the video intervention group was effective regarding energy intake after 6 months ( least squares means ( LSM ) difference = −205.40 , p = 0.00 ) and 12 months ( LSM difference = −128.14 , p = 0.03 ) . Only video intervention result ed in lower average daily energy intake after one year ( d = 0.12 ) . Educational role and BMI did not seem to interact with this effect . No intervention effects on BMI and physical activity were found . The video computer-tailored intervention was effective on energy intake after one year . This effect was not dependent on educational levels or BMI categories , suggesting that video tailoring can be effective for a broad range of risk groups and may be preferred over text tailoring",
"BACKGROUND Obesity , physical inactivity , and reduced physical fitness contribute to the rising burden of chronic diseases in China . We investigated these factors in Chinese adults over a 14-year period ( 2000 - 14 ) using data from r and omised national surveys . METHODS We did four national surveys in 2000 , 2005 , 2010 , and 2014 among Chinese adults aged 20 - 59 years . We used BMI to assess underweight ( 18·5 kg/m(2 ) ) , overweight ( ≥23·0 to 27·5 kg/m(2 ) ) , and obesity ( ≥27·5 kg/m(2 ) ) . Central obesity was defined as a waist circumference greater than 90 cm in men and greater than 85 cm in women . We assessed leisure-time physical activity ( LTPA ) by whether or not participants had completed the recommended minimum 150 min of moderate or 75 min of vigorous exercise per week . Indices for assessment of physical fitness were forced vital capacity , resting heart rate , h and grip strength , sit and reach distance , and time st and ing on one leg . FINDINGS 151 656 ( 78 % ) of 193 440 adults responded to the survey in 2000 , 163 386 ( 84 % ) in 2005 , 154 931 ( 80 % ) in 2010 , and 146 703 ( 76 % ) in 2014 . The prevalence of obesity increased from 8·6 % in 2000 , to 10·3 % in 2005 , 12·2 % in 2010 , and 12·9 % in 2014 ( estimated increase 0·32 % per year , 95 % CI 0·30 - 0·33 ; p for overweight ( estimated increase 0·27 % per year , 95 % CI 0·25 - 0·30 ; p for central obesity ( estimated increase 0·78 % per year , 0·76 - 0·80 ; p ) . The prevalence of overweight , obesity , and central obesity increased with age ( all p in the prevalence of underweight ( estimated decrease of 0·06 % per year , 95 % CI 0·04 - 0·07 ; p ) . The proportion of adults meeting the minimum LTPA recommendation increased over time ( 17·2 % in 2000 , 18·1 % in 2005 , and 22·8 % in 2014 ) , with the estimated prevalence change per year being 0·33 % ( 95 % CI 0·24 - 0·42 ; p over time in all measures of physical fitness in normal-weight adults ( all p apart from resting heart rate ( p=0·69 ) . INTERPRETATION Despite increased participation in LTPA , we noted increases in overweight or obesity and a decrease in physical fitness in Chinese adults . Continued nationwide interventions are needed to promote physical activity and other healthy lifestyle behaviours in China . FUNDING National Physical Fitness Surveillance Center and Ministry of Science and Technology of the People 's Republic of China",
"Background Increasing physical activity ( PA ) among adolescents is an important health promotion goal . PA has numerous positive health effects , but the majority of Dutch adolescents do not meet PA requirements . The present paper describes the systematic development of a theory-based computer-tailored intervention , YouRAction , which targets individual and environmental factors determining PA among adolescents . Design The intervention development was guided by the Intervention Mapping protocol , in order to define clear program objectives , theoretical methods and practical strategies , ensure systematic program planning and pilot-testing , and anticipate on implementation and evaluation . Two versions of YouRAction were developed : one that targets individual determinants and an extended version that also provides feedback on opportunities to be active in the neighbourhood . Key determinants that were targeted included : knowledge and awareness , attitudes , self-efficacy and subjective norms . The extended version also addressed perceived availability of neighbourhood PA facilities . Both versions aim ed to increase levels of moderate-to-vigorous PA among adolescents . The intervention structure was based on self-regulation theory , comprising of five steps in the process of successful goal pursuit . Monitoring of PA behaviour and behavioural and normative feedback were used to increase awareness of PA behaviour ; motivation was enhanced by targeting self-efficacy and attitudes , by means of various interactive strategies , such as web movies ; the perceived environment was targeted by visualizing opportunities to be active in an interactive geographical map of the home environment ; in the goal setting phase , the adolescents were guided in setting a goal and developing an action plan to achieve this goal ; in the phase of active goal pursuit adolescents try to achieve their goal and in the evaluation phase the achievements are evaluated . Based on the results of the evaluation adolescents could revise their goal or choose another behaviour to focus on . The intervention is delivered in a classroom setting in three lessons . YouRAction will be evaluated in a cluster-r and omized trial , with classes as unit of r and omization . Evaluation will focus on PA outcomes , cognitive mediators/moderators and process measures . Discussion The planned development of YouRAction result ed in two computer-tailored interventions aim ed at the promotion of PA in a Dutch secondary school setting .Trial registration",
"IMPORTANCE Little is known about adoption of healthy lifestyle behaviors among individuals with a coronary heart disease ( CHD ) or stroke event in communities across a range of countries worldwide . OBJECTIVE To examine the prevalence of avoidance or cessation of smoking , eating a healthy diet , and undertaking regular physical activities by individuals with a CHD or stroke event . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve Urban Rural Epidemiology ( PURE ) was a large , prospect i ve cohort study that used an epidemiological survey of 153,996 adults , aged 35 to 70 years , from 628 urban and rural communities in 3 high-income countries ( HIC ) , 7 upper-middle-income countries ( UMIC ) , 3 lower-middle-income countries ( LMIC ) , and 4 low-income countries ( LIC ) , who were enrolled between January 2003 and December 2009 . MAIN OUTCOME MEASURES Smoking status ( current , former , never ) , level of exercise ( low , 3000 MET-min/wk ) , and diet ( classified by the Food Frequency Question naire and defined using the Alternative Healthy Eating Index ) . RESULTS Among 7519 individuals with self-reported CHD ( past event : median , 5.0 [ interquartile range { IQR } , 2.0 - 10.0 ] years ago ) or stroke ( past event : median , 4.0 [ IQR , 2.0 - 8.0 ] years ago ) , 18.5 % ( 95 % CI , 17.6%-19.4 % ) continued to smoke ; only 35.1 % ( 95 % CI , 29.6%-41.0 % ) undertook high levels of work- or leisure-related physical activity , and 39.0 % ( 95 % CI , 30.0%-48.7 % ) had healthy diets ; 14.3 % ( 95 % CI , 11.7%-17.3 % ) did not undertake any of the 3 healthy lifestyle behaviors and 4.3 % ( 95 % CI , 3.1%-5.8 % ) had all 3 . Overall , 52.5 % ( 95 % CI , 50.7%-54.3 % ) quit smoking ( by income country classification : 74.9 % [ 95 % CI , 71.1%-78.6 % ] in HIC ; 56.5 % [ 95 % CI , 53.4%-58.6 % ] in UMIC ; 42.6 % [ 95 % CI , 39.6%-45.6 % ] in LMIC ; and 38.1 % [ 95 % CI , 33.1%-43.2 % ] in LIC ) . Levels of physical activity increased with increasing country income but this trend was not statistically significant . The lowest prevalence of eating healthy diets was in LIC ( 25.8 % ; 95 % CI , 13.0%-44.8 % ) compared with LMIC ( 43.2 % ; 95 % CI , 30.0%-57.4 % ) , UMIC ( 45.1 % , 95 % CI , 30.9%-60.1 % ) , and HIC ( 43.4 % , 95 % CI , 21.0%-68.7 % ) . CONCLUSION AND RELEVANCE Among a sample of patients with a CHD or stroke event from countries with varying income levels , the prevalence of healthy lifestyle behaviors was low , with even lower levels in poorer countries",
"Background Cardiovascular disease ( CVD ) is the leading cause of early death worldwide , responsible for an estimated 29 % of all global deaths . Reducing salt intake lowers blood pressure and risk of secondary cardiac events . However , identifying low salt foods can be challenging . SaltSwitch is a simple smartphone application ( app ) that enables shoppers to scan the barcode of packaged foods and receive an immediate , interpretive , traffic light nutrition label on the screen , along with suggestions for healthier lower-salt alternatives . A growing body of evidence suggests mobile technologies can support healthy behaviour change . However , robust evidence for the impact of smartphone interventions is lacking . This manuscript outlines the rationale and methods for a r and omized controlled trial design ed to determine the effectiveness of SaltSwitch in supporting people with CVD to make lower-salt food choices . Design / Methods A 6-week , two-arm , parallel , r and omized controlled trial is being undertaken in New Zeal and ( 2 weeks baseline and 4 weeks intervention ) . Three hundred adults aged 40 years and older with CVD and their main household shoppers are recruited from research lists , cardiac rehabilitation clinics , and communities in Auckl and . Participants are r and omized to receive either the SaltSwitch smartphone app or no intervention ( control ) . R and omisation is stratified by ethnicity and age . The primary outcome is the salt content of household food purchases . Secondary outcomes are the saturated fat and energy content of household food purchases , household food expenditure , use and acceptability of the SaltSwitch app by shoppers , and urinary sodium and blood pressure of participants with CVD . Ambulatory blood pressure and potential longer-term impact ( 12 weeks ) of SaltSwitch will be assessed in sub- studies ( n ~ 40 and n ~ 20 , respectively ) . Household purchases of salt and other nutrients will be assessed using till receipt data electronically linked with br and ed food composition data . Discussion The results of the SaltSwitch trial will determine the effectiveness , use and acceptability of a smartphone application to support lower salt food choices and secondary prevention of CVD.Trial registration ACTRN12614000206628 . Registered 30 March 2014",
"This study provides insight in the effectiveness of a print-delivered and a Web-based physical activity ( PA ) intervention ( with or without additional environmental information on local PA possibilities ) among people aged over 50 . Intervention groups ( print-delivered basic [ PB ; n = 439 ] , print-delivered environmental [ PE ; n = 435 ] , Web-based basic [ WB ; n = 423 ] , Web-based environmental [ WE ; n = 432 ] ) and a control group ( n = 411 ) were studied in a clustered r and omized controlled trial . Participants received three times tailored advice within four months , targeting the psychosocial determinants of PA , and additional environmental information ( in two conditions ) . Outcome measures include weekly minutes and days of sufficient PA 6 months after the start , considering age , gender , educational level , body mass index , the presence of a chronic physical limitation and PA intentions as possible effect moderators . The results showed that the PB ( B = 192.47 ; 95 % CI = 75.24 - 309.71 ; P = 0.003 ) , the PE ( B = 229.31 ; 95 % CI = 108.73 - 349.89 ; P = 0.001 ) and the WB-intervention condition ( B = 214.25 ; 95 % CI 88.65 - 339.85 ; P = 0.002 ) result ed in significantly increased weekly minutes of PA . Only the printed conditions result ed in increased days of sufficient PA ( PB : B = 0.63 ; 95 % CI = 0.35 - 0.92 ; P effective in increasing PA in adults aged over 50",
"Background To assess the short-term impact of a comprehensive , community-based multilevel intervention on knowledge , beliefs and practice s with respect to smoking , physical activity and diet in Hangzhou , China . Methods A non-r and omised , controlled , before-after quasi-experimental trial was conducted in two intervention areas and one comparison area . The intervention built on a socioecological framework and took place across four setting s : neighbourhoods , schools , workplaces and community health centres . Two independent cross-sectional surveys of adults aged 18–64 years at baseline and a subsequent follow-up were conducted in 2008/2009 and 2011 in the intervention and comparison areas . A 2-year intervention programme was begun in mid-2009 and continued until mid-2011 . Results A total of 2016 adults at baseline and 2016 adults at follow-up completed the survey . Over the 2-year intervention period , the intervention areas showed a statistically significant decline ( 25.2 % vs 18.7 % , p prevalence of smoking compared with the comparison area ( 18.0 % vs 16.4 % , p=0.343 ) . The proportion of individuals who had noticed anyone smoking in any of nine locations in the previous 30 days demonstrated a statistically significant decline in the intervention ( 78.9 % vs 66.5 % , p The fruit and vegetable consumption score increased in a statistically significant manner in the intervention ( 24.84 vs 25.97 , p=0.036 ) and comparison ( 24.25 vs 26.67 , p The metabolic equivalent of physical activity increased from 1204 to 1386 ( p=0.023 ) in the intervention areas compared with 918 to 924 in the comparison area ( p=0.201 ) . Conclusions After a 2-year intervention , beneficial changes were noted in the intervention areas with respect to smoking and physical activity but not diet . A community-based multilevel intervention programme is feasible in urban China",
"Summary Background One of the most important risk factors for coronary artery disease is physical inactivity . Health psychological research demonstrates the importance of planning for behaviour change success . Consequently , a health action process approach ( HAPA ) model-based design to support the uptake of physical activity was initiated for the first time in an acute cardiac ward . Methods For impact evaluation , a control group ( CG ) and an intervention group ( IG ) of coronary artery disease patients were compared in a controlled longitudinal study . Baseline assessment included socio-demographic variables , intentions regarding physical activity , and actual physical activity prior to the coronary artery disease event . Follow-up data were collected 2 and 6 months after discharge . Results In total , 193 patients participated in this controlled longitudinal study ( 63 ± 9 years ; CG : N = 78 ; IG : N = 115 ) . The IG reported a higher increase in physical activity ( p 0.05 ) , intentions , and coping planning ( p also in action planning and control ( p increased their physical activity 6 months after discharge to the point of no significant difference ( p = 0.664 ) . Conclusions A HAPA model-based health psychological intervention on an acute cardiac ward is able to increase patients ’ physical activity over the short term . However , integration of follow-up interventions ( preferable in cardiac rehabilitation setting s ) would be necessary to support sustained physical activity",
"Percutaneous coronary intervention ( PCI ) has played an integral role in the therapeutic management strategies for patients who present with either acute coronary syndromes or stable angina pectoris . The COURAGE ( Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation ) trial enrolled patients with chronic stable angina and at least 1 significant ( > or = 70 % ) angiographic coronary stenosis who were r and omly assigned to an initial treatment of either PCI in conjunction with optimal medical therapy or optimal medical therapy alone . Although the initial management strategy of PCI did not reduce the risk of death , myocardial infa rct ion , or other major cardiovascular events , improvement in angina-free status and a reduction in the requirement for subsequent revascularization was observed . An in-depth analysis of the COURAGE trial design and execution is provided",
"Background Prevalent co-occurring poor diet and physical inactivity convey chronic disease risk to the population . Large magnitude behavior change can improve behaviors to recommended levels , but multiple behavior change interventions produce small , poorly maintained effects . Objective The Make Better Choices 2 trial tested whether a multicomponent intervention integrating mHealth , modest incentives , and remote coaching could sustainably improve diet and activity . Methods Between 2012 and 2014 , the 9-month r and omized controlled trial enrolled 212 Chicago area adults with low fruit and vegetable and high saturated fat intakes , low moderate to vigorous physical activity ( MVPA ) and high sedentary leisure screen time . Participants were recruited by advertisements to an open-access website , screened , and r and omly assigned to either of two active interventions targeting MVPA simultaneously with , or sequentially after other diet and activity targets ( N=84 per intervention ) or a stress and sleep contact control intervention ( N=44 ) . They used a smartphone app and accelerometer to track targeted behaviors and received personalized remote coaching from trained paraprofessionals . Perfect behavioral adherence was rewarded with an incentive of US $ 5 per week for 12 weeks . Diet and activity behaviors were measured at baseline , 3 , 6 , and 9 months ; primary outcome was 9-month diet and activity composite improvement . Results Both simultaneous and sequential interventions produced large , sustained improvements exceeding control ( P all diet and activity behaviors to guideline levels . At 9 months , the interventions increased fruits and vegetables by 6.5 servings per day ( 95 % CI 6.1 - 6.8 ) , increased MVPA by 24.7 minutes per day ( 95 % CI 20.0 - 29.5 ) , decreased sedentary leisure by 170.5 minutes per day ( 95 % CI –183.5 to –157.5 ) , and decreased saturated fat intake by 3.6 % ( 95 % CI –4.1 to –3.1 ) . Retention through 9-month follow-up was 82.1 % . Self-monitoring decreased from 96.3 % of days at baseline to 72.3 % at 3 months , 63.5 % at 6 months , and 54.6 % at 9 months ( P in self-monitoring differed across intervention groups . Conclusions Multicomponent mHealth diet and activity intervention involving connected coaching and modest initial performance incentives holds potential to reduce chronic disease risk . Trial Registration Clinical Trials.gov NCT01249989 ; https:// clinical trials.gov/ct2/show/NCT01249989 ( Archived by WebCite at https:// clinical trials.gov/ct2/show/NCT01249989 )",
"BACKGROUND Although proof-of-concept for mobile health ( mHealth ) life-style programs targeting physical inactivity and overweight/obesity has been established in r and omized trials , the feasibility and effect of a globally distributed , large-scale , mass-participation mHealth implementation has not been investigated . OBJECTIVES The purpose of this study was to determine the effect of Stepathlon , an international , low-cost , mass-participation mHealth intervention , on physical activity , sitting , and weight . METHODS We prospect ively collected cohort data from participants completing Stepathlon , an annual 100-day global event in 2012 , 2013 , and 2014 . Participants were organized in worksite-based teams , issued pedometers , and encouraged to increase daily steps and physical activity as part of the team-based race . The program was conducted via an interactive multiplatform application available on mobile devices and the Internet . Analysis was performed according to a pre-specified plan . RESULTS A total of 69,219 subjects participated ( 481 employers , 1,481 cities , 64 countries , all populated continents , age 36 ± 9 years , 23.9 % female , 8.0 % high-income countries , and 92.0 % lower-middle income countries ) . After Stepathlon completion , participants recorded improved step count ( + 3,519 steps/day ; 95 % confidence interval [ CI ] : 3,484 to 3,553 steps/day ; p 0.0001 ) , exercise days ( + 0.89 days ; 95 % CI : 0.87 to 0.92 days ; p ( -0.74 h ; 95 % CI : -0.78 to -0.71 h ; p ) and weight ( -1.45 kg ; 95 % CI : -1.53 to -1.38 kg ; p women and men , in all geographic regions , and in both high and lower-middle income countries , and the results were reproduced in 2012 , 2013 , and 2014 cohorts . Predictors of weight loss included step increase , sitting duration decrease , and increase in exercise days ( all p improvements in physical activity , sitting , and weight . ( Effect of the Stepathlon Pedometer Program on Physical Activity , Weight and Well-Being ; ACTRN12615001310550 )"
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In a 1998 review article , Laurell and colleagues performed a meta- analysis of relevant guided tissue regeneration ( GTR ) articles over the previous 20 years ( 1 ) . The purpose of the present research was to exp and on that work , particularly search ing for trends discriminating between bioabsorbable and non-bioabsorbable barriers , as well as the use of enamel matrix derivative , with respect to interproximal bony defects . The most recent periodontal journals were review ed and a search of PubMed ( National Institutes of Health ) was conducted via the internet covering 1990 to the present . Forty-nine articles were found to be relevant and within established parameters . The data were analyzed using ( a ) a variation of the methods described in Laurell et al. ( 1 ) and ( b ) statistics appropriate for inter-group comparisons . In most respects , all membranes and enamel matrix derivative ( EMD ) delivered better outcomes , in the range of 1 to 2 mm , than open flap debridement . The use of any barrier type or EMD configuration was found to yield more Clinical Attachment Level ( CAL ) gain than any open flap configuration . Other than collagen without grafts versus non-bioabsorbables without grafts , no other comparison between membranes or between membranes and EMD found any significant differences ( P > 0.05 ) . GTR was confirmed to be superior to open flap debridement
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"The objective of this study was to evaluate an allogeneic bone matrix ( ABM ) as a graft material for the treatment of periodontal osseous defects . ABM is allogeneic demineralized freeze-dried human bone which has been processed to eliminate contaminating lipids , serum proteins , and cellular components which , when present , have the potential to reduce the osteoinductive capacity of the graft . ABM is provided in a glycerine delivery suspension which enhances graft stability and ease in placement . Paired osseous defects , ranging in depth from 3 to 12 mm , within 11 patients , were r and omized to receive ABM or demineralized freeze-dried bone allograft ( DFDBA ) . Probing depth , clinical attachment level , bone fill , and defect resolution were determined at baseline and at the 6-month re-entry procedure . St and ardized radiographs and computer-assisted densitometric image analysis ( CADIA ) were used to assess bone density changes . Complete bone defect resolution was seen in 7 of 11 defects receiving ABM , and in 5 of 11 defects with the use of DFDBA . Mean defect fill with ABM was 69 % ( 33 to 100 % ) compared to 77 % ( 66 to 100 % ) with DFDBA . Soft tissue healing without clinical evidence of tissue reaction to ABM was observed . ABM and DFDBA sites exhibited similar probing depth reduction of 4.0 and 4.6 mm , respectively . In sites with initial probing depth of 7 mm or more , probing depths were reduced a mean of 5.8 mm with ABM and 6.7 mm with DFDBA ; both grafts result ed in a mean 4 mm of attachment gain . Results of radiographic analysis suggest similar density changes with each graft . These results demonstrate that both treatments were effective and that ABM may be a useful graft material in the treatment of periodontal osseous defects . J Periodontol 1995;66:1074 - 1079",
"The aim of the present clinical trial was to compare the long-term effect of EMDOGAIN treatment as an adjunct to modified widman flap ( MWF ) surgery with the effect of MWF and placebo treatment . The investigation was a placebo-controlled , r and omized multicenter trial involving 33 subjects with 34 paired test and control sites . The protocol required 2 interproximal sites , appropriately separated , in the same jaw with probing pocket depths > or = 6 mm and an associated intrabony defect with a depth of > or = 4 mm and a width of > or = 2 mm as measured on a radiograph . Only predominantly 1- and 2-wall defects were included . Clinical attachment gain and radiographic bone gain were used as primary outcome variables . Assessment s were made at baseline , 8 , 16 and 36 months . Mean values for clinical attachment level gain in test and control sites at 8 months were 2.1 mm and 1.5 mm , respectively ; at 16 months , 2.3 mm and 1.7 mm , respectively ; and at 36 months 2.2 mm and 1.7 mm , respectively ; and the differences were statistically significantly different at each time point ( p radiographic bone level continued to increase over the 36 months at the EMDOGAIN-treated sites , while it remained close to the baseline level at the control sites . The statistically significant ( p radiographic bone gain at 36 months of 2.6 mm at EMDOGAIN-treated sites corresponded to 36 % gain of initial bone loss or 66 % defect fill . The present trial has demonstrated that topical application of EMDOGAIN onto diseased root surfaces associated with intrabony defects during MWF periodontal surgery will promote an increased gain of radiographic bone and clinical attachment compared to control ( placebo application ) surgery in the same patient . There was no evidence to indicate any clinical adverse effects from application of EMDOGAIN conjunction with periodontal surgery",
"BACKGROUND It has been shown that clinical improvement of intrabony periodontal defects can be achieved with the use of enamel matrix proteins ( EMPs ) or by grafting with bovine porous bone mineral ( BPBM ) . There is no report on the potential synergistic effect of EMPs and BPBM in periodontal regenerative therapy . The purpose of this study was to compare the clinical effectiveness of EMPs used alone or in combination with BPBM in the treatment of periodontal intrabony defects in humans . METHODS Twenty-one paired intrabony defects were surgically treated using a split-mouth design . Intrabony defects were treated either with enamel matrix proteins ( EMP group ) or with enamel matrix proteins combined with bovine porous bone mineral ( EMP/BPBM group ) . Re-entry surgeries were performed at 6 months . RESULTS Preoperative probing depths , attachment levels , and transoperative bone measurements were similar for the EMP and EMP/BPBM groups . Postsurgical measurements taken at 6 months revealed a significantly greater reduction in probing depth in the EMP/BPBM group ( 3.43 + /- 1.32 mm on buccal sites and 3.36 + /- 1.35 mm on lingual sites ) when compared to the EMP group ( 1.91 + /- 1.42 mm on buccal sites and 1.85 + /- 1.38 mm on lingual sites ) . The EMP/BPBM group also presented with significantly more attachment gain ( 3.13 + /- 1.41 mm on buccal sites and 3.11 + /- 1.39 mm on lingual sites ) than the EMP group ( 1.72 + /- 1.33 mm on buccal sites and 1.75 + /- 1.37 mm on lingual sites ) . Surgical re-entry of the treated defects revealed a significantly greater amount of defect fill in favor of the EMP/BPBM group ( 3.82 + /- 1.43 mm on buccal sites and 3.74 + /- 1.38 mm on lingual sites ) as compared to the EMP group ( 1.33 + /1.17 mm on buccal sites and 1.41 + /- 1.19 mm on lingual sites ) . CONCLUSIONS The results of this study indicate that BPBM has the ability to augment the effects of EMPs in reducing probing depth , improving clinical attachment levels , and promoting defect fill when compared to presurgical levels",
"As observed in previous case reports , dental rubber dam ( DRD ) can be utilized as a barrier membrane in the guided tissue regeneration ( GTR ) technique for the treatment of periodontal intrabony defects . The purpose of the present study was ( 1 ) to confirm the validity of DRD as a suitable material in regenerative procedures and ( 2 ) to compare , in a split-mouth clinical trial , the effectiveness of DRD-made membranes in the treatment of periodontal intrabony defects versus that of exp and ed polytetrafluoroethylene ( e-PTFE ) barriers . 22 systemically healthy non-smoker adult periodontitis patients ( 7 male , 15 female ) aged between 35 to 58 years were selected for the study . In each patient , a couple of 2 - 3 wall intrabony defects , located in different quadrants , were treated by a GTR technique using DRD ( test sites ) and e-PTFE ( control sites ) , respectively . Performing a strict control of the oral hygiene level and of the marginal gingival health during the whole period of study , clinical ( pocket probing depth , PPD ; probing attachment level , PAL ; gingival recession , GR ) and intrasurgical ( depth of the defect 's intraosseous component , IOC ; level of the alveolar crest , ACL ) parameters were recorded at baseline and at the 1-year re-entry procedure in each experimental site . Furthermore , the coronal level of the newly formed tissue from the base of the defect ( NFTL ) and the vertical bone gain ( VBG ) were calculated at the time of membrane removal and after the re-entry procedure respectively . Membranes were removed from both test and control sites after 5 weeks ; however , exposure of the membrane always occurred in test sites whereas it was observed in only 6 out of 22 control sites , this fact leading to an incomplete coverage of the regenerated tissue by the gingival flap in 18 out of 22 test sites . In both test and control sites , a statistically significant improvement of clinical and intrasurgical parameters occurred at the end of the study period ; however , a significantly greater improvement was observed in control sites for PAL ( + 4.0 mm versus + 3.0 mm ; p VBG ( 3.9 mm versus 2.9 mm ; p NFTL was similar between the experimental sites ( test : 5.8 ; control : 5.6 ; p>0.05 ) . Conversely , test sites exhibited a statistically significant greater increase in gingival recession ( + 1.9 versus + 1.2 ; p ( -1.1 versus -0.3 , p e-PTFE membranes can provide a greater improvement in PAL and VBG , probably because of the difficulty in completely covering the regenerated tissue due to the fact that the gingival tissues have undergone a consistent recession in DRD-treated sites . Further studies are needed to demonstrate if an adequate coverage of the regenerated tissue in DRD-treated sites can eliminate these differences",
"The aim of the present study was to evaluate clinical ly and histologically the treatment of intrabony periodontal defects with a bioresorbable membrane barrier . Fifty-two intrabony periodontal defects were treated according to the principles of guided tissue regeneration ( GTR ) with a bioresorbable membrane . Results were evaluated by assessing probing pocket depth , recession of the gingival margin , and clinical attachment level at baseline and at 1 and 2 years after therapy . Bone level changes were evaluated radiographically . The postoperative phase was uneventful in all cases . There was a mean probing pocket depth reduction from 8.4 to 3.6 mm , a mean increase of gingival margin recession from 1.5 to 3.0 mm , and a mean clinical attachment level change from 9.9 to 6.5 mm . Mean attachment gain was 3.4 mm . Two teeth scheduled for extraction were also treated with the same bioresorbable membrane . The histologic analysis 6 months after treatment revealed the formation of new connective tissue attachment and new alveolar bone in both cases . Based on the histologic findings it can be concluded that the clinical improvements following GTR with this type of bioresorbable membrane may represent , at least in part , true periodontal regeneration",
"BACKGROUND Treatment with enamel matrix proteins ( EMD ) and guided tissue regeneration ( GTR ) with bioabsorbable membranes has been shown to promote periodontal regeneration ; however , until now , there were only limited data on the long-term clinical results following these regenerative techniques . Therefore , the aim of the present study was to present the 4-year results following treatment of intrabony defects with EMD or guided tissue regeneration ( GTR ) . METHODS Twelve patients , each displaying one pair of intrabony defects located contralaterally in the same jaw , were r and omly treated with EMD or with GTR by means of bioabsorbable membranes . The following clinical parameters were evaluated at baseline , at 1 year , and at 4 years after treatment : plaque index ( P1 ) , gingival index ( G1 ) , bleeding on probing ( BOP ) , probing depth ( PD ) , gingival recession ( GR ) , and clinical attachment level ( CAL ) . The primary outcome variable was CAL . No statistically significant differences between the groups were found at baseline . Power analysis to determine superiority of EMD treatment showed that the available sample size would yield 70 % power to detect a 1 mm difference . RESULTS The sites treated with EMD demonstrated mean CAL change from 9.8 + /- 2.0 mm to 6.4 + /- 1.6 mm ( P CAL mean at 1 and 4 years postoperatively . The sites treated with GTR showed a mean CAL change from 9.8 + /- 2.3 mm to 6.6 + /- 1.7 mm ( P CAL change between I and 4 years did not present statistically significant differences . No statistically significant differences in any of the investigated parameters were observed at 1 and 4 years between the treatment groups . CONCLUSIONS It was concluded that the CAL gain obtained following treatment with EMD or GTR can be maintained over a 4-year period",
"AIM The purpose of the present multicenter clinical trial was to compare the efficacy of two different procedures in the treatment of infrabony defects : guided tissue regeneration ( GTR ) with nonresorbable membranes and enamel matrix derivative ( EMD ) . MATERIAL AND METHODS Six centers participated in this study . Ninety-eight patients with an interproximal infrabony defect were selected . All patients were treated with an initial phase of scaling and root planing , and at the study 's baseline the selected defects presented a value of probing depth ( PD ) > or = 6 mm with an infrabony component > or = 4 mm . Forty-nine patients were treated with GTR procedures ( using ePTFE membranes ( Gore-Tex W.L. Gore and Associates , Flagstaff , AZ , USA ) ) and forty-nine with EMDs ( Emdogain ( U Biora AB Malm , Sweden ) ) . The efficacy of each treatment modality was investigated through covariance analysis . RESULTS The patients were reevaluated at one year postop . Probing attachment level ( PAL ) gain and PD reduction were analyzed . In the Emdogain group the PAL before surgery ( PAL 0 ) and the PD before surgery ( PD 0 ) were respectively 9.9+/-1.4 and 8.5+/-1.6 mm . The PAL gain and the PD reduction at 1 year postsurgery were respectively 4.1+/-1.8 and 5.3+/-1.9 mm . The group of patients treated with membranes showed that PAL 0 and PD 0 were respectively 8.9+/-1.9 and 8.1+/-1.9 . The PAL gain was 4.3+/-1.9 mm and the PD reduction was 5.6+/-1.5 mm . The mean PAL gain expressed by percentage ( PAL gain/PAL 0 ) for the group treated with EMD was 41 % , while it was 48 % for the group treated with GTR . Results from our analysis suggest that there is no statistically significant difference between GTR and EMD treatments in terms of PAL gain , PD reduction and recession variation . Applying the regression model to a group of patients with a PAL 0 > or = 8 mm , we observed a better clinical outcome in terms of PAL gain ( difference of 0.3 mm ) in patients treated with the GTR procedure compared to those treated with EMD . Covariance analysis showed a strong correlation in both groups of patients between PAL gain and full mouth bleeding score , and between PAL gain and defect morphology and depth",
"AIM The purpose of the present study was to compare clinical ly the treatment of deep intrabony defects with a combination of an enamel matrix protein derivative ( EMD ) and a bioactive glass ( BG ) to EMD alone . METHODS Thirty patients ( 16 females and 14 males ) suffering from advanced marginal periodontitis were included in this prospect i ve , controlled parallel design multicenter study . In each of the patients , one intrabony defect was r and omly treated with either EMD+BG ( test ) or with EMD alone ( control ) . Clinical measurements were recorded at baseline and at 1 year following therapy . RESULTS No differences in any of the investigated parameters were observed at baseline between the two groups . Healing was uneventful in all patients . At 1 year after therapy , the test group showed a reduction in mean probing depth ( PD ) from 8.5+/-1.1 to 4.4+/-1.2 mm ( p mean clinical attachment level ( CAL ) from 10.4+/-1.5 to 7.1+/-1.5 mm ( p mean PD was reduced from 8.5+/-1.5 to 4.0+/-1.6 mm ( p mean CAL changed from 10.2+/-2.1 to 6.3+/-2.2 mm ( p CAL , whereas in the control group a CAL gain of 3 mm or more was measured at 13 sites ( 87 % ) . No statistically significant differences in terms of PD reduction and CAL gain were found between the test and the control treatment . CONCLUSIONS Within the limits of the present study it can be concluded that : ( i ) at 1 year after surgery , both therapies result ed in significant PD reductions and CAL gains , and ( ii ) the combination of EMD+BG does not seem to additionally improve the clinical results",
"This study clinical ly evaluates the use of exp and ed polytetrafluoroethylene ( ePTFE ) membranes with or without the addition of decalcified freezedried bone allograft ( DFDBA ) in the treatment of interproximal intraosseous defects . 25 patients ( 26 paired defects ) diagnosed with advanced periodontitis and having at least 2 bilateral interproximal probing depths of > or = 6 mm participated in the study . After the hygiene phase , measurements were made to determine soft tissue recession , pocket depth , and clinical attachment levels . Defects from each pair were r and omly treated with either ePTFE alone ( control ) , or ePTFE+DFDBA ( experimental ) . Measurements were made during the surgery to determine crestal resorption , defect resolution and defect fill . Membranes were removed at 4 to 6 weeks . At 6 months , the soft and hard tissue measurements ( surgical reentry ) were repeated . Both groups showed statistically significant improvement when compared to baseline ( p defect resolution changes were also similar between control and experimental groups , respectively ( 80 % , 74 % ) . For this short-term study , it was concluded that either technique was beneficial for the treatment of intraosseous defects . Other studies are needed to assess the long-term stability of the improvements rendered by these treatments",
"BACKGROUND Various clinical studies have demonstrated that applying commercially available enamel matrix proteins ( EMP ) on the instrumented root surface during access flap surgery promotes clinical ly significant gains of clinical attachment and bone in intrabony defects . The aim of the present controlled clinical trial was to evaluate the adjunctive effect of filling the intrabony lesion with bovine porous bone mineral ( BPBM ) to a simplified papilla preservation ( SPP ) flap and EMP surgical procedure . METHODS Sixty deep interproximal intrabony lesions in 60 patients with chronic periodontitis were treated with the SPP flap and EMP . In the 30 test defects , the intrabony component was filled with BPBM particles previously reconstituted with the EMP gel . A stringent infection control program was adopted for 1 year . The clinical and radiographical reevaluation was made 1 year after surgery . RESULTS Both techniques result ed in clinical ly and statistically significant improvements between baseline and 1 year , in terms of clinical attachment level ( CAL ) gain , probing depth ( PD ) reduction , and radiographic bone fill ; however , the BPBM test treatment showed statistically significantly greater CAL ( 5.8 + /- 1.1 versus 4.9 + /- 1.0 ) and radiographic bone ( DEPTH ) level gains ( 5.3 + /- 1.1 versus 4.3 + /- 1.5 ) , and less increase in gingival recession ( 0.4 + /- 0.6 versus 0.9 + /- 0.5 ) than the control surgical procedure . CONCLUSION The present study data supported the hypothesis that the adjunctive use of BPBM in grafting intrabony defects has the ability to improve clinical and radiographical outcomes achievable with EMP alone",
"This clinical and radiological study evaluated the healing of 3 + 2 + 1 wall-combined intrabony defects treated using the guided tissue regeneration technique ( GTR ) with and without hydroxyapatite-collagen alloplastic graft material s ( HAC ) , in comparison to that of HAC alone and conventional flap surgery ( CF ) . 40 interproximal defects with probing depth > 6 mm were treated in 18 adult periodontitis patients of ages 35 - 60 years . After non-surgical therapy , the defects were r and omly grouped into 4 groups of 10 defects each . These groups were design ated : ( 1 ) exp and ed polytetrafluoroethylene membrane ( e-PTFE ) , ( 2 ) e-PTFE + HAC , ( 3 ) HAC alone and ( 4 ) CF . At 6 months , the following changes in parameters were recorded . Mean PPD reduction for each group was 5.83 , 5.85 , 3.80 and 3.17 mm respectively . PPD reduced very significantly in all groups ( p PPD being for the e-PTFE + HAC and CF group respectively . Comparison between the 4 groups showed higher PPD reduction in both membrane groups than in either of the non membrane groups ( p Mean attachment gain for the 4 groups was 3.70 , 3.80 , 2.60 and 2.1 mm , respectively . Similarly attachment gain for all groups was very significant ( p attachment gains were for the e-PTFE + HAC and CF group respectively . Both membrane groups showed significantly more attachment gain than the CF group ( p Change in probing bone level ( BL ) for the 4 groups was 1.60 , 1.90 , 1.0 and 0.65 mm respectively . Again the highest changes in BL were recorded for the e-PTFE + HAC group . Significant differences were found between both membrane groups and the CF group ( p in radiographic bone level at the deepest point of the defect on the radiograph to be 1.50 , 1.55 , 0.85 and 0.60 mm , respectively and this was significantly higher in both membrane groups than in the CF group ( p e-PTFE membranes both alone and when combined with HAC to lead to more attachment gain and bone fill than did HAC alone or CF . It found HAC combined with e-PTFE to perform better although not significantly better than e-PTFE alone",
"UNLABELLED The aim of the present study was to assess the predictability of probing attachment gain and probing pocket depth reduction following Emdogain treatment at sites with deep angular bone defects . MATERIAL AND METHODS 108 consecutively-treated periodontal patients ( mean age 55.8 years ) were included . Each subject exhibited at least 1 deep interproximal intrabony defect that could be identified as an experimental site based on the inclusion criteria : ( i ) probing pocket depth > or = 5 mm , ( ii ) probing attachment loss > or = 6 mm , ( iii ) radiographic evidence of an interproximal bone defect with a > or = 3 mm intrabony component . A total of 145 defects met the criteria for inclusion . All subjects received non-surgical periodontal therapy . This included subgingival instrumentation in all parts of the dentition . At least 6 months after the completion of this treatment , a baseline examination was performed to characterise the experimental site . Reconstructive therapy was subsequently performed . Full-thickness periodontal flaps were elevated , and the root surface scaled and planed . No bone recontouring was performed . A gel containing 24 % EDTA was applied on the exposed root and was kept in place for 2 min . A preparation of enamel matrix proteins was applied to the root surface and adjacent defect space . The flaps were replaced and closed with sutures . The experimental sites were re-examined 12 months after reconstructive surgery . RESULTS The re-examination demonstrated that a treatment including the application of enamel matrix proteins at periodontal sites with angular defects result ed in a mean probing attachment level gain of 4.6 mm and a probing pocket depth reduction of 5.2 mm . 87 % of all sites treated exhibited a probing attachment gain of > 2 mm . One site suffered probing attachment loss . The radiographic assessment s revealed that the bone defect had been reduced in depth by 2.9 mm on average . The reduction in defect size corresponded to an average bone fill of 69 % of the original defect . In 43 % of the defects , the bone fill amounted to > or = 80 % . CONCLUSION The overall probing pocket depth reduction , probing attachment level gain , and soft tissue recession , that results following Emdogain therapy , is similar to the corresponding outcome variables following GTR",
"The purpose of this controlled clinical trial was to compare the clinical efficacy of 3 treatment modalities in the treatment of deep interproximal intrabony defects . Thirty-six ( 36 ) defects in 36 patients were r and omly assigned to 1 of 3 treatment groups by blocking to prognostic variables . The test was treated with bioresorbable membranes positioned coronal to the interproximal bone crest ; the second group ( membrane control ) was treated with conventional non-resorbable ( ePTFE ) barrier membranes applied coronal to the alveolar crest ; the third group ( flap Control ) was treated with an access flap procedure ( MWF ) . No differences were observed in terms of baseline oral hygiene and defect characteristics among the 3 groups , indicating that the blocking approach was effective . A stringent infection control program was enforced for 1 year . The results indicated that : 1 ) at 1 year all treatment modalities result ed in clinical ly significant improvements in clinical attachment levels ( CAL ) and reductions in probing depths ; 2 ) a statistically significant treatment effect ( P CAL gain ; 3 ) differences in terms of CAL gain between the test ( bioresorbable ) and the membrane control ( ePTFE ) groups were not statistically significant ( P = 0.19 , t-test ) ; 4 ) both the test and the membrane control groups gained significantly more CAL at 1 year than the MWF group ( P CAL gains > or = 4 mm were observed in 83.3 % of cases in both GTR groups , while CAL gains of this magnitude were not detected in the MWF group . We concluded that clinical ly significant CAL gains can be obtained with GTR procedures using both bioresorbable and non-resorbable membranes . Patients ' morbidity , however , was lower in the group treated with bioresorbable membranes",
"BACKGROUND The use of barrier membranes in the treatment of periodontal defects is well documented . There has been an increase in the use of bioabsorbable material s which do not require a second surgical procedure for removal . However , there are little data evaluating the efficacy of bioabsorbable membranes in the treatment of intrabony defects . The purpose of this investigation was to evaluate the regenerative potential of 2 bioabsorbable barrier membranes without the use of grafting material s in the treatment of interdental intrabony defects . METHODS Twenty-three 2- or 3-walled intrabony defects were treated in 19 patients with a mean age of 50.4 years . All had completed nonsurgical treatment and a period of supportive periodontal therapy . The sites were r and omly chosen to receive a barrier membrane composed of type I bovine collagen ( 11 ) or a copolymer of polylactic acid ( PGA/PLA;12 ) . A pressure sensitive disc probe was used to evaluate the following criteria at baseline and re-entry : 1 ) occlusal surface to the apical depth of probe penetration ( OS-DP ) ; 2 ) occlusal surface to the gingival margin ( OS-GM ) ; 3 ) occlusal surface to the alveolar crest ( OS-AC ) ; and 4 ) occlusal surface to the base of the osseous defect ( OS-BD ) . Full thickness mucoperiosteal flaps were reflected to expose the surgical sites . The defects were debrided of the granulomatous tissue , the root surfaces instrumented and conditioned with 4 one-minute applications of 50 mg/ml of tetracycline . The barrier membranes were adapted to cover the defects and the flaps replaced . The postsurgical healing was uneventful and similar in both treatment modalities . RESULTS Twenty-three sites were surgically re-entered 6 months from the time of the initial surgery . The deepest probe depth for each site was used for statistical analysis . There was a mean relative attachment gain of 2.58+/-1.90 mm for the collagen , and 2.77+/-2.13 mm for the copolymer . There was a decrease in probing depth of 3.27+/-1.91 mm and 0.69+/-1.35 mm of recession for the collagen . The PGA/PLA copolymer had 3.55+/-2.47 mm reduction in probe depth and 0.78+/-1.14 mm of recession . CONCLUSIONS The data indicated the bioabsorbable collagen and copolymer membranes result ed in comparable results . A larger sample size would be necessary to determine if one membrane was superior to the other",
"BACKGROUND , AIMS The purpose of the present study was to compare the efficacy of 3 different surgical procedures in the treatment of infrabony defects : guided tissue regeneration ( GTR ) with non-resorbable membranes , Widman modified flap ( WMF ) and enamel matrix derivative ( EMD ) . METHOD 30 patients with an infrabony component > or = 4 mm were selected . 10 were treated with exp and ed polytetrafluorethylene ( ePTFE ( Gore - Tex W. L. Gore and Associates , Flagstaff , AZ , USA ) ) membranes , 10 with WMF and 10 with enamel matrix derivatives ( Emdogain ( U Biora AB Malm , Sweden ) ) . The efficacy of each treatment modality was investigated through regression analysis . Probing attachment level ( PAL ) gain , probing depth ( PD ) reduction and gingival recession ( REC ) variation were analyzed . RESULTS Both Emdogain ( enamel matrix derivative ) and ePTFE treatment show significant better results as compared to the WMF procedure in which there were no significant changes in PAL gain and PD reduction at baseline and 1 year after surgery . CONCLUSIONS Results from our analysis suggest that there is no statistically significant difference in PAL gain between GTR and EMD . The clinical outcomes of this pilot study may be of little significance , considering the small number of patients , but it has provided an important base for a controlled clinical trial ( with a larger number of patients ) which is currently in progress",
"BACKGROUND The purpose of the present study was to compare the treatment of deep intrabony defects with a combination of an enamel matrix protein derivative ( EMD ) and a bioactive glass ( BG ) to BG alone . METHODS Twenty-eight patients with chronic periodontitis , each of whom displayed 1 intrabony defect , were r and omly treated with a combination of EMD and BG or with BG alone . Soft tissue measurements were made at baseline and at 1 year following therapy . RESULTS No differences in any of the investigated parameters were observed at baseline between the 2 groups . Healing was uneventful in all patients . At 1 year after therapy , the sites treated with EMD and BG showed a reduction in mean probing depth ( PD ) from 8.07 + /- 1.14 mm to 3.92 + /- 0.73 mm and a change in mean clinical attachment level ( CAL ) from 9.64 + /- 1.59 mm to 6.42 + /- 1.08 mm ( P mean PD was reduced from 8.07 + /- 1.32 mm to 3.85 + /- 0.66 mm and the mean CAL changed from 9.78 + /- 1.71 mm to 6.71 + /- 1.89 mm ( P enamel matrix derivative and bioactive glass does not seem to additionally improve the clinical outcome of the therapy",
"BACKGROUND Several studies have documented the clinical efficacy of guided tissue regeneration ( GTR ) with non-resorbable exp and ed polytetrafluoroethylene ( ePTFE ) membranes and enamel matrix proteins ( EMP ) in the treatment of infrabony defects . The objective of this controlled clinical study was to compare the clinical outcomes of 3 surgical modalities in the treatment of deep interproximal infrabony defects . METHODS Ninety ( 90 ) defects in 90 healthy subjects affected by chronic periodontitis were assigned to 1 of 3 treatment groups by blocking to prognostic variables . The test group was treated with the application of EMP and the simplified papilla preservation ( SPP ) technique ; the second group was treated with titanium-reinforced ePFTE membranes and the SPP technique ; and the third group was treated with the SPP technique used as access flap control procedure . No differences were observed in terms of baseline oral hygiene and defect characteristics among the 3 groups , indicating that the blocking approach was effective . A stringent infection control program was adopted for 1 year . RESULTS The 1-year results indicated that : 1 ) all treatment modalities result ed in clinical ly significant improvements in clinical attachment levels ( CAL ) and reduction in probing depth ( PD ) ; 2 ) a statistically significant treatment effect was demonstrated comparing the EMP test , the membrane control , and the flap control groups in terms of CAL gains ; 3 ) both the EMP test and the membrane control groups showed significant CAL gains compared to the flap control group ; 4 ) a statistically significantly greater amount of CAL gain was demonstrated in GTR-treated compared to EMP-treated patients ; 5 ) deeper residual probing depths but smaller increases in gingival recession were demonstrated following EMP therapy ; and 6 ) smoking habits reduced the clinical outcomes of both regenerative procedures . CONCLUSIONS The use of a regenerative procedure is indicated in the treatment of deep vertical bony defects since both the regenerative techniques ( GTR and EMD ) in the present study result ed in clinical ly and statistically significant improvements in clinical parameters compared to the access flap procedure . The use of EMP can be helpful in esthetically-sensitive sites and in reducing patient morbidity",
"AIM This prospect i ve multicenter r and omized controlled clinical trial was design ed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of a guided tissue regeneration (GTR)/bone replacement material . MATERIAL S AND METHODS One hundred and twenty-four patients with advanced chronic periodontitis were recruited in 10 centers in seven countries . All patients had at least one intrabony defect of > or = 3 mm . The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure . After debridement , the regenerative material was applied in the test subjects , and omitted in the controls . At baseline and 1 year following the interventions , clinical attachment levels ( CALs ) , probing pocket depths ( PPDs ) , recession , full-mouth plaque scores and full-mouth bleeding scores ( FMBS ) were assessed . RESULTS One year after treatment , the test defects gained 3.3 + /- 1.7 mm of CAL , while the control defects yielded a significantly lower CAL gain of 2.5 + /- 1.5 mm . Pocket reduction was also significantly higher in the test group ( 3.7 + /- 1.8 mm ) when compared with the controls ( 3.2 + /- 1.5 mm ) . A multivariate analysis indicated that the treatment , the clinical centers , baseline PPD and baseline FMBS significantly influenced CAL gains . Odds ratios ( ORs ) of achieving above-median CAL gains were significantly improved by the test procedure ( OR = 2.6 , 95 % CI 1.2 - 5.4 ) and by starting with deeper PPD ( OR = 1.7 , 1.3 - 2.2 ) but were decreased by receiving treatment at the worst-performing clinical center ( OR = 0.9 , 0.76 - 0.99 ) . CONCLUSIONS The results of this trial indicated that regenerative periodontal surgery with a GTR/bone replacement material offers an additional benefit in terms of CAL gains , PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone",
"OBJECTIVES Application of the guided tissue regeneration ( GTR ) principle and utilization of enamel matrix derivative ( EMD ) have both been shown to result in periodontal regeneration . While clinical investigations have demonstrated that the use of a microsurgical concept in combination with the GTR technique positively affects the percentage of primary closure and the amount of tissue preservation , no such information is available for EMD-treated periodontal defects . It was the aim of the present investigation to assess the clinical effect of the microsurgical access flap and EMD treatment with an emphasis on the evaluation of early wound healing . MATERIAL AND METHODS Eleven patients displaying at least one pair of intrabony periodontal defects with an intrabony component of > or =3 mm participated in the study . At baseline and at 6 and 12 months after surgery , the following clinical parameters were assessed by a blinded examiner : oral hygiene status ( API ) , gingival inflammation ( BOP ) , probing pocket depth ( PPD ) , clinical attachment level ( CAL ) and gingival recession ( GR ) . Defects were r and omly assigned to test or control treatment , which both consisted of a microsurgical access flap procedure design ed for maximum tissue preservation . The exposed root surfaces of the test sites were conditioned with a 24 % EDTA gel followed by EMD ( Emdogain(R ) ) application . Primary flap closure was achieved by a 2-layered suturing technique . Postoperative healing was evaluated by a newly introduced early wound-healing index ( EHI ) at 1 and 2 weeks after surgery . RESULTS Both test and control treatment result ed in a statistically significant mean CAL gain of 2.8 and 2.0 mm at 6 months , and 3.6 and 1.7 mm at 12 months , respectively ( p CAL gain between the two treatment modalities were statistically significant at both time points ( p GR values after 12 months averaged 0.3 and 0.4 mm for test and control sites , respectively , and did not reach statistical significance ( p > or = 0.05 ) . Two weeks after surgery , primary closure was maintained in 89 % of the test sites and in 96 % of the control sites . CONCLUSION Both treatment modalities using the microsurgical flap procedure result ed in a high percentage of primary flap closure and maximum tissue preservation . In terms of PPD reduction and CAL gain , the combination with EMD application appeared to be superior to the microsurgical access flap alone",
"BACKGROUND The aim of the present controlled clinical study was to compare platelet-rich plasma ( PRP ) combined with a biodegradable ceramic , porous hydroxyapatite ( HA ) with a mixture of HA and saline in the treatment of human intrabony defects . METHODS Seventy interproximal intrabony osseous defects in 70 healthy , non-smoking subjects diagnosed with chronic periodontitis were included in this study . Thirty-five subjects each were r and omly assigned to either the test group ( PRP and HA ) or control group ( HA with saline ) . Clinical and radiographic measurements were determined at baseline and the 12-month evaluation . RESULTS When compared to baseline , the 12-month results indicated that , while both treatment modalities result ed in significant changes in all clinical parameters ( gingival index , bleeding on probing , probing depth , clinical attachment level , and intrabony defect fill ; P probing depth reduction : 4.7 + /- 1.6 mm versus 3.7 + /- 2.0 mm ( P clinical attachment gain : 3.4 + /- 1.7 mm versus 2.0 + /- 1.2 mm ( P vertical relative attachment gain : 70.3 % + /- 23.4 % versus 45.5 % + /- 29.4 % ( P PRP and HA compared to HA with saline led to a significantly more favorable clinical improvement in intrabony periodontal defects",
"BACKGROUND Previous studies have demonstrated that enamel matrix derivative ( EMD ) has the ability to improve clinical parameters when used to treat intraosseous defects . The purpose of the present study was to compare at 12 months postsurgery sites treated with open flap debridement ( OFD ) alone to those treated with OFD and EMD . METHODS Twenty-three subjects with at least 2 intrabony defects were chosen . Fifty-three defects received EMD in conjunction with OFD . Thirty-one defects in these same 23 subjects were treated with OFD alone . Stents were fabricated to serve as fixed reference points . Re-entries were performed at least 1 year after initial surgery . Soft tissue measurements were recorded prior to initial surgery and prior to re-entry for gingival ( GI ) and plaque ( PI ) indices , probing depth ( PD ) , gingival margin position , and clinical attachment level ( CAL ) . Hard tissue measurements were recorded during the initial and re-entry surgery for level of crestal bone and depth of defect . Statistical analysis was conducted using the method of generalized estimating equations to determine changes in GI , PI , PD , CAL , fill of the osseous defect , and crestal resorption . Percent of defect fill was also calculated . RESULTS In all categories , treatment with EMD ( test ) was superior to treatment without EMD ( control ) . Average PI and GI were not significantly different either initially or prior to re-entry . The average PD reduction was 2.7 mm greater with EMD than controls . The average CAL gains were 1.5 mm greater , and the average fill of osseous defect 2.4 mm greater with EMD than controls . The average percent of defect fill after adjusting for crestal bone loss was more than 3 times greater for EMD versus control-treated sites ( 74 % defect fill with EMD versus 23 % defect fill for control sites ) . CONCLUSIONS This study indicates that treatment of periodontal intraosseous defects with EMD is clinical ly superior to treatment without EMD ( open flap debridement ) in every parameter evaluated . Re-entry data demonstrate that percent fill of osseous defects treated with EMD compares favorably with the treatment results utilizing bone grafts or membrane barriers , according to published literature",
"BACKGROUND There is limited information available from clinical trials regarding the performance of enamel matrix derivative ( EMD ) in the treatment of periodontal intrabony defects . This r and omized , double-blind , placebo-controlled , split-mouth study was design ed to compare the clinical and radiographical effects of EMD treatment to that of placebo-controlled treatment for intrabony defects . METHODS Sixteen patients were included , each of whom had 1 or 2 pairs of intrabony defects located contralaterally in the same arch . Thirty-six intrabony defects were r and omly assigned treatment with flap surgery plus EMD or flap surgery plus placebo . At baseline and at the 12-month follow-up evaluation visit , clinical and radiographic measurements were determined . Data were statistically analyzed using the Wilcoxon-signed rank test ( alpha = 0.05 ) . RESULTS At the 12-month visit , bleeding on probing for the EMD group was 0.11 + /- 0.32 compared to the placebo group , 0.61 + /- 0.50 ( P Probing depth reduction was greater in the EMD group ( 3.00 + /- 0.97 mm ) compared to the placebo group ( 2.22 + /- 0.81 mm ) ( P Mean values for clinical attachment gain in the EMD and the placebo groups were 1.72 + /- 1.07 mm and 0.83 + /- 0.86 mm , respectively ( P Vertical relative attachment gain was 38.5 + /- 22.6 % in the EMD group and 21.4 + /- 25.2 % in the placebo group ( P Radiographic bone density gain was greater in the EMD ( 20.2 + /- 16.6 % ) compared to the placebo group ( -3.94 + /- 23.3 % ) ( P EMD , compared to flap surgery with placebo , produced a significantly more favorable clinical improvement in intrabony periodontal defects",
"BACKGROUND Infection after a periodontal surgical site has been prepared for guided tissue regeneration ( GTR ) is one of the common complications that can compromise healing . The purpose of this study was to assess the effect of repeated local antimicrobial therapy following GTR for improving clinical attachment gains , and to histologically evaluate the various cell population s and bacterial contamination of the retrieved exp and ed polytetrafluoroethylene membrane ( ePTFE ) . METHODS Forty periodontal intrabony defects in 40 patients were treated by a flap procedure that included the use of ePTFE membranes to allow GTR . Patients were r and omly assigned to 2 treatment groups : 20 patients were treated with the ePTFE alone ( control group ) , and the other 20 were treated with the ePTFE combined with the administration of a weekly repeated local application of minocycline ointment for 8 weeks after membrane placement ( test group ) . The membranes were retrieved 6 weeks after the initial surgery and sectioned serially in a coronal-apical plane . The sections were then divided into 9 fields and examined by light microscopy for the presence of inflammatory cells and oral bacteria . Clinical measurements were taken at the time of baseline examination and at a 6-month follow-up examination after removal of the ePTFE . RESULTS At the 6-month follow-up examination , control and test groups showed significant improvement ; i.e. , reduction in the probing depth and increased clinical attachment gain compared with the values at the baseline examination . However , the mean clinical attachment gain of the test group ( 3.0+/-0.3 mm ) was significantly ( P = 0.03 ) greater than that of the control group ( 2.0+/-0.5 mm ) . Histologically , the total number of the cells of both groups was similar . In both groups , mononuclear cells were dominant and fibroblasts , neutrophils , and plasma cells were rarely encountered . There was a tendency for the number of macrophages to be somewhat higher in the control group . The total number of bacteria in the test group was significantly less than that in the control group . The number of bacteria in both control and test groups decreased toward the apical portion . CONCLUSIONS In the present study , clinical attachment gain of intrabony defects following GTR was favorable with repeated local administration of minocycline ointment . However , a complete microbial eradication was not achieved",
"AIM The purpose of this study was to evaluate the clinical effectiveness of a bovine porous bone mineral used in combination with a porcine derived collagen membrane as a barrier in promoting periodontal regeneration in intrabony defects in humans . MATERIAL AND METHODS The study employed a split-mouth design . 22 paired intrabony defects were treated and surgically re-entered 6 months after treatment . Experimental sites were grafted with bovine porous bone mineral and received a collagen membrane for guided tissue regeneration . Control sites were treated with an open flap debridement . RESULTS Preoperative pocket depths , attachment levels and trans-operative bone measurements were similar for control and experimental sites . Post surgical measurements revealed a significantly greater reduction in pocket depth ( differences of 1.89 + /- 0.31 mm on buccal 0.88 + /- 0.27 mm on lingual measurements ) and more gain in clinical attachment ( differences of 1.51 + /- 0.33 mm on buccal and 1.50 + /- 0.35 mm on lingual measurements ) in experimental sites . Surgical reentry of the treated defects revealed a significantly greater amount of defect fill in favor of experimental sites ( differences of 2.67 + /- 0.91 mm on buccal and 2.54 + /- 0.87 mm on lingual measurements ) . CONCLUSIONS The results of this study indicate that clinical resolution of intrabony defects can be achieved using a combination of bovine porous bone mineral and an absorbable , porcine derived collagen membrane when employing a technique based on the principles of guided tissue regeneration . The nature of the attachment between the newly regenerated tissue and the root surfaces needs to be evaluated histologically to confirm the presence of new attachment",
"BACKGROUND Bacterial contamination of membrane material negatively affects healing after guided tissue regeneration ( GTR ) procedures ; conversely , flap connective tissue integration on barrier material improves the clinical outcomes . The objective of this study was to evaluate the effect of topical application of antibiotics on : 1 ) clinical outcomes of GTR surgical procedures using titanium reinforced exp and ed polytetrafluoroethylene ( ePTFE ) periodontal membrane ; 2 ) bacterial colonization of membrane material ; and 3 ) flap connective tissue-membrane integration . METHODS Fifty-six deep interproximal bony defects were treated with GTR surgical procedures using titanium reinforced ePTFE periodontal membranes . Patients were r and omly assigned to 1 of the 2 antimicrobial treatment groups : the test group received weekly topical application of 25 % metronidazole gel and the control group received systemic antibiotics ( amoxicillin plus clavulanic acid 1 g/day for 14 days ) . Clinical outcomes were assessed at 1 year ; the amount of bacterial contamination and connective tissue integration on membrane material was evaluated at time of membrane removal by means of a morphological ( SEM ) method . RESULTS No statistically significant difference was found between test and control groups in terms of clinical attachment ( CAL ) gain ( baseline CAL - 12 months CAL ; P = 0.2 ) and probing depth ( PD ) reduction ( baseline PD - 12 months PD ; P = 0.6 ) . A greater increase in gingival recession ( REC ) ( 12 months REC - baseline REC ) was found in the test group compared to the control group ( P = 0.003 ) . The SEM analysis revealed no statistically significant ( t test ) difference between test and control groups in the number of fields positive to integrated connective tissue ( P = 0.82 ) , while the number of fields positive to bacteria was statistically higher ( P < 0.001 ) in the control group . CONCLUSIONS Local antibiotic administration is more effective than systemic use in preventing membrane contamination , but it does not improve clinical outcomes due to an interference of the vehicle ( gel ) with gingival tissues which may reduce the potential benefits derived from better control of the bacterial load",
"BACKGROUND Utilisation of enamel matrix proteins ( EMD ) and application of the guided tissue regeneration principle ( GTR ) are treatment modalities which both have been shown to result in periodontal regeneration . However , it is yet unknown whether the combination of EMD and GTR may additionally favor the regeneration process . AIM The aim of the present controlled study was to evaluate clinical ly the treatment effect of EMD , GTR , combination of EMD and GTR , and flap surgery ( control ) on intrabony defects . MATERIAL AND METHODS 56 patients each of whom displaying one intrabony defect of a depth of at least 6 mm were r and omly treated with one of the treatment modalities . Prior to surgery and at one year after , the following parameters were evaluated by a blinded examiner : Plaque index ( PlI ) , gingival index ( GI ) , bleeding on probing ( BOP ) , probing pocket depth ( PPD ) , gingival recession ( GR ) and clinical attachment level ( CAL ) . No statistical significant differences between the four groups were observed at baseline for any of the investigated parameters . RESULTS At 1 year after therapy , the sites treated with EMD demonstrated a mean PPD reduction of 4.1 + /- 1.7 mm and a mean CAL gain of 3.4 + /- 1.5 mm ( p GTR showed a mean PPD reduction of 4.2 + /- 1.9 mm and a mean CAL gain of 3.1 + /- 1.5 mm ( p mean PPD reduction of 4.3 + /- 1.4 mm and a mean CAL gain of 3.4 + /- 1.1 mm ( p mean PPD reduction was 3.7 + /- 1.4 mm ( p CAL gain measured 1.7 + /- 1.5 mm ( p PPD reduction and CAL gain . All three regenerative treatments led to higher CAL gain than the control treatment ( p PPD reduction and CAL gain were observed between the three regenerative treatments . CONCLUSION It may be concluded that ( a ) all 3 regenerative treatment modalities may lead to higher CAL gain than the control one , and ( b ) the combined treatment does not seem to improve the outcome of the regenerative procedure",
"BACKGROUND The purpose of this study was to evaluate the effectiveness of a combination of enamel matrix proteins ( EMP ) , bovine porous bone mineral ( BPBM ) , and a bioabsorbable membrane for guided tissue regeneration ( GTR ) as regenerative therapy for intrabony defects in humans and compare it to an open flap debridement ( OFD ) technique . METHODS Using a split-mouth design , 18 pairs of intrabony defects were treated and surgically reentered 6 months after the initial surgery . Experimental sites were treated with EMP , grafted with BPBM , and received a collagen/polylactic acid membrane for GTR . Control sites were treated with OFD . The primary outcomes evaluated in the study included probing depth resolution , clinical attachment gain , and bony defect fill . RESULTS Preoperative probing depths , attachment levels , and intraoperative bone measurements were similar for the experimental and control groups . Postsurgical measurements taken at 6 months revealed a significantly greater reduction in probing depth in the experimental group ( 4.95+/-1.52 mm on buccal sites and 4.74+/-1.47 mm on lingual sites ) when compared to the control group ( 2.83+/-0.83 mm on buccal sites and 2.90+/-0.91 mm on lingual sites ) . The experimental sites also presented with significantly more attachment gain ( 3.89+/-1.16 mm on buccal sites and 3.78+/-1.14 mm on lingual sites ) than the control sites ( 1.52+/-0.83 mm on buccal sites and 1.48+/-0.78 mm on lingual sites ) . Surgical reentry of the treated defects revealed a significantly greater amount of defect fill in favor of the experimental group ( 4.76+/-1.36 mm on buccal sites and 4.81+/-1.37 mm on lingual sites ) as compared to the control group ( 1.78+/-0.92 mm on buccal sites and 1.67+/-0.90 mm on lingual sites ) . CONCLUSIONS The results of this study indicate that a combination technique including BPBM , EMP , and GTR results in better clinical resolution of intrabony defects than treatment with OFD . Differences observed were both statistically and clinical ly significant . The exact role of each of the 3 technique components in achieving the clinical improvement observed in this study remains to be determined",
"BACKGROUND The various methods for regeneration of periodontal tissue that have been developed can be classified into guided tissue regeneration and bone implantation . Since the implantation material s have shown both deficiencies and merits , dentists have begun exploring the bioactive glass first used in plastic surgery . This paper examines the effectiveness of this new material on periodontal intrabony defects . METHODS Clinical effects of bioactive glass implantation in intrabony periodontal defects were evaluated 6 months after surgery in 38 intrabony defects from 38 patients with chronic periodontitis . Twenty-one experimental defects received bioactive glass implantation ( test group ) , while 17 control defects were treated with a flap procedure only ( control group ) . The criteria for comparative observation were preoperative and postoperative probing depth ( PD ) , clinical attachment level ( CAL ) , bone probing depth ( BPD ) , and gingival recession . RESULTS Reductions in PD were observed in both groups ( P reduction in PD was significantly greater in the test group when preoperative PD exceeded 7 mm ( P Improvements in CAL were also observed in both groups ( P Reduction in BPD was observed in both groups , with the test group showing significantly greater reduction ( P difference in BPD change , however , when preoperative BPD was reduction of BPD in the test group was observed when intrabony defect depth was > 4 mm ( P PD , CAL , and BPD were noted in the test group when the crestal involvement exceeded 100 degrees . Correlation test between various clinical parameters indicated that greater changes in PD and CAL in the test group were observed when preoperative CAL was large ( P changes in PD ( P CAL ( P BPD ( P crestal involvement and CAL change was noted only in the control group ( P PD changes and CAL changes and between CAL changes and BPD changes in both groups . CONCLUSIONS Use of a bone substitute in a flap operation result ed in significantly greater improvements in CAL and BPD over flap operation alone and seemed to have positive effects in postoperative PD , CAL , and BPD in those cases with more severe preoperative CAL and BPD",
"BACKGROUND The combination of bone replacement graft material s has been suggested for the treatment of periodontal osseous defects . The purpose of this study was to evaluate the effectiveness of enamel matrix derivative ( EMD ) combined with a bovine-derived xenograft ( BDX ) as compared to EMD alone in the treatment of intraosseous defects in patients with moderate to advanced periodontitis . METHODS Sixteen adult patients with at least 2 intrabony defects were entered in this split-mouth design study . Defects were treated with EMD alone or EMD + BDX . Reentries were performed 6 to 8 months after initial surgery . The following soft and hard tissue measurements were recorded prior to initial surgery and at reentry : probing depth ( PD ) , gingival margin location , clinical attachment level ( CAL ) , depth of defect , and crestal bone level . Statistical analyses were performed to determine changes in PD , CAL , fill of osseous defect , and crestal resorption . Percentages of bone fill ( % BF ) and defect resolution ( % DR ) were also calculated . RESULTS The most significant results were that gingival recession was greater for the group treated with EMD alone ( 0.8 + /- 0.8 mm ) compared to EMD + BDX ( 0.3 + /- 0.6 mm ) ( P = 0.04 ) and bone fill was greater for EMD + BDX ( 4.0 + /- 0.8 mm ) compared to EMD alone ( 3.1 + /- 1.0 mm ) ( P = 0.02 ) . The measures for PD reduction , attachment level gain , crestal resorption , % BF , and % DR did not present a statistically significant difference ( P > 0.10 ) . CONCLUSIONS This study evaluated the performance of EMD + BDX and EMD alone . The results demonstrated that a significant improvement in clinical parameters was observed . When comparing both modalities , a statistically significant difference was only found for gingival recession and bone fill , yielding a more favorable outcome towards the combined approach",
"BACKGROUND Current literature shows that calcium sulfate can be used in guided tissue regeneration . Its biocompatibility and resorbability give it significant advantages in the treatment of periodontal and endodontic defects . Clinical ly guided tissue regeneration procedures have demonstrated significant positive clinical change , beyond that achieved with debridement alone , in treating intraosseous defects . The aim of the present investigation was to evaluate the clinical results obtained with autologous bone plus calcium sulfate , and to compare them with the results obtained using autologous bone plus membrane . METHODS A total of 12 patients were treated in the present investigation . A split-mouth design was utilized . Twelve 3-wall periodontal defects were treated with calcium sulfate plus autologous bone graft ( test ) and compared with 12 contra-lateral defects treated with a bioabsorbable membrane plus autologous bone graft ( control ) . Before the surgical procedure , patients were instructed about oral hygiene and scaling and root planing ( SRP ) was completed . Probing depth ( PD ) , clinical attachment level ( CAL ) , and bleeding on probing ( BOP ) were recorded at baseline and 6 months . RESULTS There were no statistical differences between test and control defects at baseline . BOP was 58 % and 50 % for control and test defects , respectively . Mean PD was 7.75+/-0.96 mm ( control ) and 8.0+/-1.28 mm ( test ) . Mean CAL was 8.58+/-1.31 mm ( control ) and 8.83+/-0.91 mm ( test ) . At 6 months , mean PD was 3.41+/-0.51 ( P = 0.0022 ) for control defects and 3.58+/-0.51 ( P = 0.0022 ) for test defects . CAL showed a mean gain of 5+/-0.85 for controls ( P = 0.0022 ) and 5.25+/-0.75 for test defects ( P = 0.0022 ) . Thus , there was a mean reduction of PD of 4.33 mm ( 56 % ) for control sites and 4.42 mm ( 55 % ) for test sites . The mean clinical attachment gain was 3.57 mm for control sites and 3.58 mm for test sites . As there were no sham-operated controls , it is not clear that the healing of these test or control-treated sites was any better than similar 3-walled defects sham operated . CONCLUSIONS Both therapies led to short-term improvement of the measured parameters ; neither was superior to the other",
"The purpose was to evaluate the use of demineralized freeze-dried bone allograft reconstituted with 50 mg/ml tetracycline hydrochloride in the treatment of intrabony periodontal defects . Fifteen systemically healthy patients ( 12 females , 3 males ; aged 35 to 61 ) with moderate-advanced periodontitis were treated . Patients had 3 osseous defects with probing depths ( PD ) > 5 mm after initial therapy . Each site in each subject was r and omly assigned to one of the following groups : 1 ) demineralized freeze-dried bone allograft reconstituted with 50 mg/ml tetracycline ( DFDBA + TCN ) ; 2 ) demineralized freeze-dried bone allograft alone ( DFDBA ) ; or 3 ) debridement only ( D ) . Clinical measurements were taken the day of surgery , 6 months , and 1 year . St and ardized radiographs were taken at baseline and 1 year and were evaluated by computer assisted densitometric image analysis ( CADIA ) . Clinical measurements included gingival recession , PD , clinical attachment level , and mobility . Osseous defect measurements were taken at baseline and at the 1 year reentry . No adverse healing responses occurred . The results showed that all patients had a statistically significant improvement in probing depth and attachment level at 1 year . Osseous measurements showed bone fill of 2.27 mm ( 51.6 % ) for the DFDBA + TCN group , 2.20 mm ( 52.4 % ) for the DFDBA group , and 1.27 mm ( 32.8 % ) for the D group . Defect resolution was 77.3 % for the DFDBA + TCN group , 77.9 % for the DFDBA group , and 63.8 % for the D group . The mean CADIA values were 5.04 for the DFDBA + TCN group , 6.79 for the DFDBA group and 2.78 for the D group . The CADIA values did not correlate with the clinical parameters . Although the grafted groups showed greater bone fill and defect resolution , there was no statistically significant difference in any of the clinical parameters between the treatment groups . This study suggests that there is no significant benefit from reconstituting the allograft with 50 mg/ml of tetracycline hydrochloride",
"THIS R AND OMIZED , CONTROLLED , CLINICAL STUDY was design ed to evaluate outcome following surgical implantation of an allogeneic , freeze-dried , demineralized bone matrix-calcium sulfate ( DBM+CS ) composite with a CS barrier in intrabony periodontal defects . Twenty-six patients contributing 26 deep intrabony defects completed the study . Thirteen patients received the DBM+CS implant . Thirteen patients received gingival flap surgery alone ( GFS ; control ) . Clinical outcome was assessed at 6 and 12 months postsurgery . At 12 months postsurgery , probing depth ( PD ) reduction ( mean + /-SD ) for the DBM+CS and GFS group was to 4.3+/-0.5 and 3.0+/-1.3 mm ; clinical attachment gain was to 2.9+/-0.8 and 1.7+/-1.5 mm ; and probing bone level gain was to 2.9+/-1.4 and 1.2+/-1.2 mm , respectively . There were no apparent differences between evaluations at 6 and 12 months postsurgery . Clinical improvements were significantly different from presurgery for both groups at both observation intervals ( P PD reduction and clinical attachment gain . Probing bone level gain was significantly greater in the DBM+CS group compared to controls ( P implantation of DBM+CS with a CS barrier result ed in reduced PD and improved attachment levels comparable to that achieved by gingival flap surgery alone . However , gain in probing bone levels in deep intrabony periodontal pockets assessed by clinical parameters was greater than that observed by gingival flap surgery alone . These changes were noted at both 6 and 12 months after surgery . This regenerative technique needs further biologic evaluation before being generally accepted",
"The aim of the present study was to evaluate histologically in humans the healing of advanced intrabony defects following treatment with enamel matrix proteins ( EMD ) or guided tissue regeneration ( GTR ) . Fourteen patients , each of them displaying 1 advanced intrabony defect around teeth scheduled for extraction were included in the study . The defects were treated r and omly either with an enamel matrix protein derivative ( Emdogain , BIORA AB , Malmö , Sweden ) or with a bioabsorbable membrane ( Resolut , Regenerative Material , W.L. Gore & Assoc . , Flagstaff , Arizona , USA ) . At baseline the mean probing pocket depth ( PPD ) in the EMD group was 11.3 + /- 1.8 mm and the mean clinical attachment level ( CAL ) 12.1 + /- 2.0 mm , whereas in the GTR group the mean PPD was 11.4 + /- 2.2 mm and the mean CAL 13.3 + /- 2.3 mm . Healing was uneventful in all cases . Neither allergic reactions against EMD or the bioabsorbable membrane , nor suppuration or abscesses were observed . The clinical results revealed at 6 months in the EMD group a mean PPD of 5.6 + /- 1.3 mm and a mean CAL of 9.1 + /- 1.5 mm . In the GTR group the mean PPD was 5.6 + /- 1.3 mm and the mean CAL 10.1 + /- 1.5 mm . The histological analysis showed in the EMD group a mean 2.6 + /- 1.0 mm of new attachment ( i.e. new cementum with inserting collagen fibers ) and a mean 0.9 + /- 1.0 mm of new bone . In this group , the formation of new attachment was not always followed by bone regeneration . In the GTR group , the mean new attachment was 2.4 + /- 1.0 mm and the mean new bone 2.1 + /- 1.0 mm . In every case treated with GTR , the formation of new attachment was followed by a varying amount of new bone . After both types of regenerative treatment the newly formed cementum displayed a predominantly cellular character . The findings of the present study indicate that the treatment of intrabony defects with enamel matrix proteins or with bioabsorbable membranes enhances the formation of a new connective tissue attachment in humans",
"BACKGROUND The purpose of this study was to compare the clinical and radiographic parameters with the histometric findings following 2 different regenerative procedures in humans . METHODS Fourteen advanced intrabony defects at teeth scheduled for extraction were r and omly treated as follows : 8 with guided tissue regeneration ( GTR ) using bioabsorbable barriers and 6 with an enamel matrix protein derivative ( EMD ) . St and ardized radiographs , probing depths ( PD ) , and attachment levels ( CAL ) at baseline and 6 months after therapy were evaluated and compared to the histometric measurements made following the removal of teeth and surrounding tissues 6 months after the surgery . RESULTS Significant PD reductions ( GTR : -5.62 mm ; EMD : -5.00 mm ) and CAL gains ( GTR : 3.87 mm ; EMD : 2.67 mm ) were observed in both groups . Six months after surgery , minor resorptions of the alveolar crest ( AC ) ( GTR : 0.40 mm ; EMD : 0.33 mm ) and bony gain at the bottom of the defects ( GTR : 0.47 mm ; EMD : 1.05 mm ) were observed radiographically . No statistically significant differences in the change of clinical and radiographic parameters between the GTR and EMD groups were found . Histometrically , significant amounts of new connective tissue attachment ( i.e. , cementum with inserting collagen fibers ) were observed in both groups ( GTR : 2.29 mm ; EMD : 1.81 mm ) . Bone regeneration was found to be significant only in the GTR group ( GTR : 1.93 mm ; EMD : 0.78 mm ) . However , the study lacked statistical power for determining equivalence between the groups . CONCLUSIONS Within the limitations of the present study , it may be concluded that at 6 months after GTR or enamel matrix protein derivative therapy , formation of new cementum and bone may be histometrically demonstrated . Except for the formation of new bone , no statistically significant differences between both therapies could be seen for clinical , radiographic , and histometric results 6 months after surgery",
"The aim of this study was to compare the clinical regenerative capacity of collagen membrane with and without demineralized freeze-dried bone allografts ( DFDBA ) in treating periodontal intrabony defects . Ten systemically healthy patients with similar bilateral periodontal defects were scheduled for surgery . Each patient had at least > or = 6 mm clinical probing depth and loss of attachment at selected sites . Baseline measurements included gingival index ( GI ) , plaque index ( PI ) , gingival recession ( GR ) , clinical attachment level ( CAL ) , probing depth ( PD ) , and mobility . At the time of surgery , the defects were r and omly assigned to either test ( collagen membrane plus DFDBA ) or control group ( collagen membrane only ) . Stent to base of the defects , stent to crest bone , crest of bone to base of the defect , and width of the defects were recorded at the time of surgery and reentry . Eight patients returned after 6 months for reentry surgery . Statistical analysis with a paired t test was used to evaluate the treatment effect and comparison between test and control groups . In addition , a McNemar test was used to analyze the significance of GI , PI , and mobility at different times . The result of this study indicated that both the collagen plus DFDBA and the collagen alone treatment groups had a significant decrease of PD ( 3.4 + /- 0.4 and 3.2 + /- 0.4 mm ) , gain of CAL ( 2.3 + /- 0.5 and 2.0 + /- 0.4 mm ) , and defect fill ( 1.7 + /- 0.3 and 1.9 + /- 0.9 mm ) ( P PD , AL , GR , defect fill , crestal bone resorption , GI , PI , or mobility between the test group and control group . No adverse tissue reaction , infection , or delayed wound healing was noted throughout the treatment in either group . This study suggests that the collagen membrane is well tolerated by the human tissues . Both treatments , either collagen membrane plus DFDBA or collagen membrane alone , promoted significant resolution of periodontal intrabony defects . The addition of a bone graft ( DFDBA ) with a collagen membrane appears to add no extra benefit to the collagen membrane treatment",
"BACKGROUND Combined regenerative approaches have been used for treating advanced osseous lesions around teeth . The aim of combining treatments is to enhance both clinical predictability and regenerative outcome compared to a monotherapeutic approach . This case series from a private practice reports on the clinical efficacy of an enamel matrix derivative ( EMD ) combined with either demineralized freeze-dried bone allograft ( DFDBA ) or freeze-dried bone allograft ( FDBA ) in the treatment of advanced infrabony lesions . The advanced lesions were veneered by a rapidly formed absorbable polymer barrier of poly(DL-lactide ) to enhance graft containment . METHODS A total of 22 consecutive patients , each contributing one infrabony lesion , are reported . After patients completed presurgical preparation , the infrabony lesions were surgically treated with a combined approach that included root surface treatment with citric acid . The two groups differed in their composite graft ; one received DFDBA-EMD ( n = 10 ) and the other received FDBA-EMD ( n = 12 ) . Patients followed a stringent postoperative protocol and were evaluated 6 months postsurgery . Clinical outcomes were assessed by changes in clinical attachment level ( CAL ) and probing depth ( PD ) from pretreatment . Surgical re-entry of several sites was possible in each group . RESULTS CAL at pretreatment measured 9.2 + /- 1.3 mm and 9.1 + /- 1.9 mm for DFDBA-EMD and FDBA-EMD groups , respectively , with corresponding PD of 8.4 + /- 1.6 mm and 8.9 + /- 2.0 mm for each group . At 6 months post-treatment , CALs were reduced to 4.7 + /- 1.3 mm and 3.8 + /- 1.0 mm for DFDBA-EMD and FDBA-EMD groups , respectively ; with corresponding PD decreased to 3.0 + /- 0.8 mm and 3.2 + /- 1.0 mm . Relative improvements in CAL for the DFDBA-EMD and DFDBA-EMD groups were 49.1 % + /- 11.0 % and 57.3 % + /- 9.4 % , respectively ( P mediator ( EMD ) was combined with either DFDBA or FDBA . In this limited case series , a trend was observed towards greater improvement in clinical attachment level gain in advanced infrabony defects when EMD was combined with FDBA as compared to DFDBA . Larger prospect i ve controlled clinical trials are needed to determine if differences exist in the relative efficacy of DFDBA versus FDBA in combination with EMD",
"BACKGROUND Demineralized bone matrix ( DBX ) paste and putty are particulate demineralized bone matrices in a 2 % or 4 % hyaluronate carrier , respectively . The purpose of this study was to determine the effectiveness of DBX paste and putty compared to demineralized freeze-dried bone allograft ( DFDBA ) in the treatment of human intraosseous periodontal defects . METHODS Sixty systemically healthy individuals between the ages of 31 and 71 years with at least one intraosseous periodontal defect of > or = 3 mm in depth and radiographic evidence of at least 40 % to 50 % vertical bone loss were accrued . Following initial non-surgical periodontal therapy , sites were r and omly selected to receive either DBX paste , DBX putty , or DFDBA ( control ) . Baseline and 6-month reentry soft and hard tissue parameter measurements were made by calibrated examiners . Data were analyzed within and between groups utilizing analysis of variance ( ANOVA ) and paired and unpaired Student t tests . RESULTS Probing depth reductions were significantly improved in all treatment groups with DFDBA , DBX paste , and putty patients demonstrating 2.8 mm , 3.6 mm , and 2.3 mm , respectively . Attachment level gains were significantly improved from baseline for all treatment groups with DFDBA , DBX paste , and putty , respectively , demonstrating 2.4 mm , 2.9 mm , and 1.6 mm . Bone fill was similar between all groups with DBX paste , putty , and DFDBA control groups demonstrating 2.0 mm , 2.4 mm , and 2.2 mm , respectively . All groups yielded significant improvements in percent bone fill with DFDBA , DBX paste and putty , respectively , achieving 37 % , 42.1 % , and 50 % with no significant differences between the groups . CONCLUSION In summary , demineralized bone matrix paste , demineralized bone matrix putty , and demineralized freeze-dried bone allograft all demonstrated similar favorable improvements in soft and hard tissue parameters in the treatment of human intraosseous defects",
"BACKGROUND The regenerative therapy of non-contained intrabony defects achieves better results when bioabsorbable membranes are combined with a filling material . The purpose of the present study was to analyze clinical and radiographic effectiveness of a space-making bioabsorbable membrane in the treatment of wide and shallow intrabony defects characterized by a relevant 1-wall component . METHODS Eighteen pairs of angular bone defects were selected in 18 healthy , non-smoking patients ( age range 30 to 66 years ) . Prior to the surgical phase , patients were enrolled in a strict periodontal program including oral hygiene instructions and scaling and root planing ( presurgical full-mouth plaque score guided tissue regeneration ( GTR ) using a bioabsorbable membrane ( test group ) and 18 to receive open flap debridement alone ( control group ) . Clinical treatment outcome was evaluated 12 months postoperatively for changes in probing depth ( PD ) , clinical attachment level ( CAL ) , and position of gingival margin ( REC ) and radiographically for bone changes . RESULTS Open flap debridement and GTR yielded statistically significant ( P PD reduction ( 2.39+/- 0.92 mm and 3.44+/- 0.78 mm ) , CAL gain ( 1.50+/- 0.99 mm and 2.89 + /- 0.90 mm ) , increased REC ( -0.89 + /- 0.58 mm and -0.56 + /- 0.92 mm ) and bone fill ( 1.05+/- 0.94 mm and 2.13+/- 1.21 mm ) when 12-month data were compared to baseline . The differences between test and control groups were statistically significant for all parameters ( P REC ( P=0.25 ) . CONCLUSION The use of this bioabsorbable membrane would seem to be effective in the treatment of intrabony defects with unfavorable architecture without the use of filling material",
"BACKGROUND Medical- grade calcium sulfate ( CS ) is a biocompatible , bioabsorbable , and clinical ly versatile ceramic for use in bone repair . This study compared the clinical efficacy of a combination of calcium sulfate dihydrate , as a binder and barrier , and demineralized freeze-dried bone allograft ( DFDBA ) to polytetrafluoroethylene ( ePTFE ) and DFDBA for the treatment of human periodontal defects . METHODS Two intrabony defects were compared in each of 19 patients with chronic periodontitis . After initial preparation , full-thickness mucoperiosteal flaps were elevated , osseous defects debrided , and the roots prepared ( ultrasonic , h and curets , and tetracycline conditioning ) . Defects were r and omly treated with either a combination graft of DFDBA with CS ( 4:1 ) covered by a CS barrier or with DFDBA and fitted with an ePTFE barrier . Flaps were coronally positioned to obtain primary closure . Clinical soft tissue measurements were recorded at 6 months , and all study sites were surgically reentered for evaluation . RESULTS The mean presurgical measurements for defects r and omized to the CS and ePTFE treatments , respectively , were similar for attachment level ( AL ; 6.2 + /- 1.8 mm and 6.1 + /- 1.7 mm ) , probing depth ( PD ; 6.3 + /- 1.1 mm and 6.2 + /- 1.1 mm ) , and gingival recession ( 0.1 + /- 1.9 mm and 0.2 + /- 1.4 mm ) . Defects treated with CS or ePTFE demonstrated statistically significant ( P mean PD ( 2.7 + /- 1.4 mm and 3.4 + /- 1.3 mm , respectively ) and gains in mean AL ( 1.8 + /- 1.5 mm and 1.7 + /- 1.4 mm , respectively ) . Recession increased by 0.8 + /- 1.4 mm at CS sites and 1.6 + /- 1.7 mm at ePTFE-treated sites ( P mean defect depths were 4.1 + /- 1.0 mm and 3.7 + /- 1.0 mm for CS and ePTFE sites , respectively . Reentry evaluations revealed a mean defect fill of 2.7 + /- 1.5 mm and 2.5 + /- 0.9 mm for the CS and ePTFE sites , respectively , with a corresponding mean defect resolution of 80.3 + /- 18.7 % and 76.7 + /- 18.5 % . The CS and ePTFE sites did not differ significantly in mean defect fill or defect resolution . CONCLUSIONS The results of this study indicate that calcium sulfate , when used as a binder and barrier in combination with DFDBA , supports significant clinical improvement in intrabony defects , as evidence d by reductions in probing depth , gains in clinical attachment level , and defect fill and resolution . Calcium sulfate represents an important alternative to non-resorbable ePTFE barriers in combination with DFDBA for the treatment of intrabony defects",
"Abstract s on this page have been chosen and edited by Dr Trevor Watts Abstract Results were similar for both methods of regenerative periodontal treatment .",
"BACKGROUND A recent study suggests that the addition of enamel matrix derivative to demineralized freeze-dried bone allograft may enhance osseoinduction . The purpose of this study was to evaluate the use of demineralized freeze-dried bone allograft ( DFDBA ) in combination with enamel matrix derivative ( EMD + DFDBA ) compared to enamel matrix derivative ( EMD ) alone in the treatment of human intrabony periodontal defects . METHODS Forty patients with a total of 67 sites ( intrabony defect > or = 3 mm deep ) were selected to participate in this single-masked , parallel design , r and omized , controlled clinical trial . Each subject received either EMD alone ( 34 sites ) or in combination with DFDBA ( 33 sites ) . Soft tissue measurements included probing depth ( PD ) , clinical attachment level ( CAL ) , and recession . Hard tissue measurements included defect depth , alveolar crestal resorption , and defect morphology . Following 6 months of healing , all soft tissue measurements were repeated . Forty-nine sites ( EMD + DFDBA = 26 sites , EMD alone = 23 sites ) were surgically reentered . Statistical analyses were performed using unpaired and paired Student t tests . RESULTS Analyses showed a significant improvement in soft tissue parameters for both treatment groups ( P probing depth reduction ( PDR ) for the EMD + DFDBA was 3.6 + /- 0.2 mm , while the EMD alone had a PDR of 4.0 + /- 0.3 mm . The CAL gain for the EMD + DFDBA group was 3.0 + /- 0.3 mm and 3.2 + /- 0.3 mm for the EMD alone group . The mean value for bone fill in the EMD + DFDBA group was 3.7 + /- 0.2 mm ( 74.9 % ) , while the EMD alone group demonstrated a mean bone fill of 2.6 + /- 0.4 mm ( 55.3 % ) . While there were no significant differences between the two treatments with regards to soft tissue measurements , the combination of EMD + DFDBA therapy yielded statistically significant improvements in bone fill , crestal resorption , and percentage of sites gaining greater than 50 % and 90 % bone fill when compared to EMD alone ( P enamel matrix derivative is added to demineralized freeze-dried bone allograft",
"AIM This prospect i ve multicentre r and omized controlled clinical trial was design ed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of enamel matrix proteins ( EMD ) . MATERIAL AND METHODS 172 patients with advanced chronic periodontitis were recruited in 12 centers in 7 countries . All patients had at least one intrabony defect of > or = 3 mm . Heavy smokers ( > or = 20 cigarettes/day ) were excluded . The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure . After debridement , roots were conditioned for 2 min with a gel containing 24 % EDTA . EMD was applied in the test subjects , and omitted in the controls . Postsurgically , a strict plaque control protocol was followed . At baseline and 1 year following the interventions , clinical attachment levels ( CAL ) , pocket probing depths ( PPD ) , recession ( REC ) , full-mouth plaque scores and full-mouth bleeding scores were assessed . A total of 166 patients were available for the 1-year follow-up . RESULTS At baseline , 86 test and 86 control patients presented with similar subject and defect characteristics . On average , the test defects gained 3.1+/-1.5 mm of CAL , while the control defects yielded a significantly lower CAL gain of 2.5+/-1.5 mm . Pocket reduction was also significantly higher in the test group ( 3.9+/-1.7 mm ) when compared to the controls ( 3.3+/-1.7 mm ) . A multivariate analysis indicated that the treatment , the clinical centers , cigarette smoking , baseline PPD , and defect corticalisation significantly influenced CAL gains . A frequency distribution analysis of the studied outcomes indicated that EMD increased the predictability of clinical ly significant results ( CAL gains > or = 4 mm ) and decreased the probability of obtaining negligible or no gains in CAL ( CAL gains EMD offers an additional benefit in terms of CAL gains , PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone",
"This study clinical ly evaluates the use of decalcified freeze-dried bone allograft ( DFDBA ) in conjunction with an exp and ed polytetrafluoroethylene ( ePTFE ) membrane specifically design ed for the treatment of interproximal intraosseous defects . It also examines by SEM , plaque contaminated membranes retrieved from patients . 15 advanced periodontitis patients with two bilateral interproximal probing depths of > or = 6 mm participated . After hygiene phase , measurements were made to determined soft tissue recession , pocket depth , clinical attachment levels and amount of keratinized tissue . Defects from each pair were r and omly treated with ePTFE plus DFDBA ( experimental ) or DFDBA alone ( control ) . Measurements were made during the surgery to determine crestal resorption , defect resolution and defect fill . Membranes were removed at 4 to 6 weeks and analyzed by SEM . Each site was surgically reentered and measurements repeated at six months . Both groups showed clinical and statistically significant changes when compared to baseline ( P soft tissue recession vs control group , 0.9 versus 0.4 mm , and loss of keratinized tissue 1.6 versus 0.1 mm ( P bone fill while experimental sites had 70 % bone fill . There were no clear patterns of microbial colonization or cell adherences in either side of the membrane . It was concluded that the presence of plaque on the membranes did not compromise the initial clinical healing during the first 4 - 6 weeks . Results suggest a beneficial effect with the use of either technique for the treatment of intraosseous defects",
"Identification and control of significant factors determining clinical outcomes is of paramount importance to improve expected results of a variety of therapeutic procedures . The aim of this investigation was to identify , with a multivariate approach , factors associated with healing outcomes of 3 periodontal surgical procedures in deep intrabony defects . 45 patients with evidence of deep intrabony defects were r and omly assigned to 3 treatment groups : access flap ( group C ) , conventional guided tissue regeneration ( GTR ) with non-resorbable exp and ed polytetrafluoroethilene ( ePTFE ) membranes ( group B ) , and GTR with self supporting membranes combined with the modified papilla preservation technique ( group A ) . In both GTR procedures , membranes were positioned coronal to the interproxymal alveolar crest . Primary outcome variables ( i.e. , probing attachment level gains at 1 year and the amount of newly formed tissue present at membrane removal ) were explained in terms of a series of patient , defect morphology and surgical factors , using a multivariate approach . Highly significant treatment effects were observed , indicating that the 3 tested therapeutic modalities result ed in significant differences in primary outcome variables . Detailed analysis assessing the significance of the tested factors in determining the healing outcomes following each procedure was performed with a stepwise elimination approach of non-significant factors . The results indicated that : ( i ) the need to create and maintain space should be a key objective of regenerative approaches based upon the principles of guided tissue regeneration ; ( ii ) control of patient 's oral hygiene and residual periodontal infection in the oral cavity are strongly associated with clinical outcomes of both regenerative and conventional surgical procedures and should receive proper attention",
"The purpose of this prospect i ve multi-center study was to evaluate a resorbable barrier membrane design ed for periodontal regeneration . Thirty-one Class II furcations and 30 two- and three-wall intrabony defects were treated by flap debridement and bioabsorbable barrier membrane augmentation . The efficacy of treatment was evaluated in terms of changes in vertical probing depth ( PD ) , horizontal probing depth ( HPD ) , clinical attachment levels ( CAL ) , and recession . Five centers participated in the study . Changes in clinical parameters are reported by individual center and by the average of the centers . All patients had either one molar with a Class II furcation or an intrabony defect . Baseline data were taken on the day of surgery . Post-treatment data were collected at 6 months and 1 year . This report is based on the 1-year findings . The average initial PD for Class II furcations was 6.1 mm . At 1 year the average PD was reduced to 3.6 mm , a 2.5 mm change . These differences were clinical ly and statistically significant ( P gain of 2.1 mm of clinical attachment ( P recession ( P HPD ( P average PD reduction of 4.1 mm ( P mean gain of CAL of 2.9 mm ( P recession was 0.9 mm which was statistically significant . When treatment outcomes were compared between centers there were no differences for either group of treated defects . There were differences between centers when baseline PD for furcations and intrabony sites were compared . The results of this study indicate that clinical ly and statistically significant improvements in PD , CAL , and HPD occurred after treatment of Class II furcations and 2- to 3-wall intrabony defects with the bioabsorbable periodontal membrane",
"The purpose of this controlled clinical trial was to compare the clinical efficacy of 3 treatment modalities in the treatment of deep interproximal intrabony defects . Forty-five ( 45 ) defects in 45 patients were r and omly assigned to 1 of 3 treatment groups by blocking to prognostic variables . The test group was treated with titanium reinforced membranes positioned just apical to the cemento-enamel junction and the modified papilla preservation technique ; the second group received conventional exp and ed polytetrafluoroethylene ( ePTFE ) barrier membranes applied at the alveolar crest ; the third group was treated with an access flap procedure . The groups were well balanced with respect to all prognostic variables . During the 1-year observation period , patients were subjected to a stringent infection control program including : professional tooth cleaning every week for the first 6 weeks ( all groups ) and in the 4 weeks following membrane removal ( guided tissue regeneration groups ) , then at monthly intervals ( all groups ) . The results indicated that : 1 ) all treatment modalities result ed in clinical and statistically significant improvements in clinical attachment level ( CAL ) and probing depths ( PD ) at 1 year ; 2 ) a significantly greater amount of CAL gain ( P = 0.0003 , analysis of variance ) was observed in the test group ( 5.3 + /- 2.2 mm ) with respect to both the ePTFE group ( 4.1 + /- 1.8 mm ) and the flap control group 2.5 + /- 0.8 ; 3 ) in the test group the 1 year CAL ( 4.7 + /- 1.8 mm ) was located more coronally than the baseline position of the interproximal alveolar crest ( 5.9 + /- 2 mm ; P = 0.003 , t test ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The aim of the study was to evaluate the clinical , radiographical and microbiological outcome after using guided tissue regeneration ( GTR ) with a bioabsorbable membrane , Resolut . Subjects with bilateral infrabony defects at single rooted teeth were selected . A total of 22 teeth , 2 in each 1 of 7 patients and 4 in 2 patients , with probing pocket depth > or = 5 mm , 3 months after scaling , participated . At baseline , assessment s of plaque and gingival indices , bleeding on probing , probing pocket depth and probing attachment level were recorded and reproducible radiographs for computer-based bone level measurements were taken . Bacterial sample s were collected to investigate the presence of periodontitis-associated bacteria , e.g. , Porphyromonas/Prevotella- and Fusobactrium-like micro-organisms . One tooth was r and omly treated with GTR and the contralateral with an open debridement procedure as a control . Clinical , radiographical and microbiological examinations were repeated 6 and 12 months postoperatively . Both procedures demonstrated a statistically significant improvement of gingival conditions , reduction of pocket depths and gain of attachment . When evaluating the differences between test and control teeth , none of the clinical parameters yielded statistical difference . Computer-based bone-level measurements showed only small differences in the majority of both test and control sites . The differences were not significant . Periodontitis-associated bacteria were present at baseline , but the appearance was not related to any specific site or patient and did not demonstrate any unwanted change in the 6- and 12-month sample s. The findings suggest that the clinical , radiographical and microbiological improvements were not significantly enhanced with the GTR therapy",
"This study clinical ly evaluated a bioabsorbable barrier membrane design ed for periodontal regeneration . Ten Class II furcations and 12 interproximal infrabony defects were treated by flap debridement and placement of a bioabsorbable barrier membrane using the principles of guided tissue regeneration . Treatment was evaluated in terms of changes in vertical probing depth , horizontal attachment level , clinical attachment level , and recession . Baseline data were collected on the day of surgery , and outcome measurements were performed at the 1-year appointment . The mean initial probing depth for Class II furcations was 6.5 mm . At 1 year , the mean probing depth was reduced to 2.9 mm , a 3.6 mm change . These differences were clinical ly and statistically significant ( P gain of 2.4 mm in clinical attachment level ( P change in horizontal attachment level ( P Recession increased 1.2 mm . For interproximal infrabony defects , there was a mean probing depth reduction of 5.0 mm ( P gain of clinical attachment level of 3.8 mm ( P in recession ( P membrane and guided tissue regeneration",
"BACKGROUND A growing flow of recent evidence indicates enamel matrix derivative ( EMD , Emdogain ) as a useful tool for the regeneration of periodontal tissues . This prospect i ve clinical study aim ed to evaluate the efficacy of EMD combined with surgical treatment of periodontal intra-bony defects , as compared with surgery alone , up to 24 months of follow-up . METHODS Twenty-four intra-bony defects were treated in 24 patients in a single clinical centre . Each defect had intra-bony depth ( IBD ) > or = 4 mm and probing pocket depth ( PPD ) > or = 6 mm . Patients were r and omly assigned to either test or control group . Plaque index ( PI ) , gingival index ( GI ) , PPD and periodontal attachment level ( PAL ) were assessed at baseline pre-surgical examination at the site to be treated . Full mouth plaque score ( FMPS ) and full mouth bleeding score ( FMBS ) were also evaluated . Twelve patients were treated by simplified papilla preservation flap technique ( control group ) , while 12 patients were treated with the same surgical technique plus EMD after ethylenediamine tetraacetic acid root conditioning ( test group ) . Any probing at the involved sites was avoided in the first year post-surgery . Radiographs were taken at baseline , 12 and 24 months after surgery using customized bite blocks . Intra-bony defect depth ( IBD ) and angle ( IBA ) were measured from X-rays by a computer-aided technique . At 12 and 24 months post-surgery , FMPS , FMBS , PI , GI , PPD , PAL and radiographic IBD and IBA were assessed . The difference between each follow-up and baseline , and between groups at each follow-up was evaluated for the above parameters by st and ard statistical methods . RESULTS In both groups , clinical and radiographic parameters were improved at either 12 or 24 months when compared with baseline . The test group displayed better outcomes when compared with the control group for IBD , PPD , and PAL gain at 12 months , and only for PAL and IBD gain at 24 months . No adverse event related to the use of EMD was reported . CONCLUSIONS The surgical procedure used in the present study , aim ing for maximum preservation of the regenerative potential of periodontal tissues , showed per se excellent results . The use of EMD as an adjunct to periodontal surgery in the treatment of angular defects possibly enhances periodontal regeneration rate",
"UNLABELLED In the present prospect i ve clinical trial , the effect of various regenerative procedures performed at sites with angular bone defects were evaluated . The main outcome variable was probing attachment alteration . MATERIAL AND METHODS 40 subjects , aged 32 - 61 years participated . They met the following inclusion criteria : ( i ) presence of generalized , advanced periodontal tissue destruction ; ( ii ) presence of 2 similar , contralateral , angular bone defects ( experimental sites ) located in either the maxilla or the m and ible ; ( iii ) the defect site must exhibit a probing pocket depth ( PPD ) of > or = 6 mm , a probing attachment level ( PAL ) of > or = 7 mm , and a depth of the intrabony component of > or = 3 mm . All subjects had a good oral hygiene st and ard , were in good general health and did not use any medication . Prior to the start of the study , all subjects received non-surgical treatment for periodontal disease . Baseline clinical measurements ( plaque , gingivitis , PPD , PAL and soft tissue recession ) of the selected experimental sites were obtained 6 months after the completion of basic therapy . The 40 subjects were r and omly divided into 4 treatment groups including 10 subjects each : 3 membrane groups and one Emdogain group . 1 h before surgery , the patients were given 3 g of Amoxicillin . No other antibiotics were prescribed . The test and control sites were treated during the same surgical session . Full thickness flaps were elevated and the exposed root surfaces were planed . Membrane placement : The root surface was rinsed with saline . A barrier membrane ( Guidor or Resolut or Periodontal ( e-PTFE ) material ) was positioned to cover the defect and the adjacent 2 - 3 mm of bone tissue . The control treatment was identical to the test treatment with the exception of barrier placement . Emdogain placement : The exposed root surfaces at both the test and control sites were , during a 2-min period , conditioned with a 24 % EDTA gel . Emdogain was applied to the exposed root surface of the test site . In the control site , the vehicle , the PGA gel , was used as placebo control . The flaps were closed and sutured to obtain a complete coverage of the intrabony defect . RESULTS Re-examinations , which were performed 12 months after surgery , disclosed that regenerative therapy , including either the use of barrier membranes or application of enamel matrix proteins to an instrumented root surface in an angular , intrabony defect , enhanced outcome variables such as probing pocket depth and probing attachment gain . It was furthermore demonstrated that clinical improvements were better at sites with deep , than at sites with shallow , intrabony defects . CONCLUSION The 4 regenerative modalities tested appeared to be equally effective in terms of PPD reduction and PAL gain , and superior to open flap curettage alone",
"The purpose of this study was to compare the clinical results of guided periodontal tissue regeneration ( GPTR ) using a resorbable barrier manufactured from a copolymer of polylactic and polyglycolic acids ( Resolut Regenerative Material ) with those of non-resorbable e-PTFE barrier ( Gore-Tex Periodontal Material ) . 12 subjects participated , 6 with similarly paired class II furcations and 6 with 2 similar 2 , 3-wall periodontal lesions . The resorbable and non-resorbable barriers were r and omly assigned to 1 defect in each subject . Non-resorbable barriers were removed in six weeks . Plaque index ( PlI ) , gingival index ( GI ) , probing depth ( PD ) , clinical attachment level ( CAL ) and gingival recession ( R ) were recorded at baseline , ( i.e. , immediately prior to surgery ) and at 12 months postsurgically . The clinical healing was similar and uneventful in both groups . Intrabony pockets depicted significant changes from baseline ( p probing depth reduction and gain in clinical attachment levels . No differences were found between treatments . Class II furcations showed significant improvements from baseline ( p probing depth reduction and clinical attachment gain . No differences were detected between treatments . It is concluded that the resorbable barrier tested is as effective as the nonresorbable e-PTFE barrier for the treatment of class II furcations and intrabony defects",
"AIM The purpose of the present study was to compare clinical ly the treatment of deep intra-bony defects with a combination of a composite bovine-derived xenograft ( BDX Coll ) and a bioresorbable collagen membrane [ guided tissue regeneration ( GTR ) ] to access flap surgery only . METHODS Thirty-two patients , each of whom displayed one intra-bony defect , were treated either with BDX Coll+GTR ( test ) or with access flap surgery ( control ) . The results were evaluated at 1 year following therapy . RESULTS No differences in any of the investigated parameters were observed at baseline between the two groups . Healing was uneventful in all patients . At 1 year after therapy , the test group showed a reduction in the mean probing depth ( PD ) from 8.3+/-1.5 to 2.9+/-1.3 mm ( p mean clinical attachment level ( CAL ) from 9.4+/-1.3 to 5.3+/-1.5 mm ( p mean PD was reduced from 8.0+/-1.2 to 4.4+/-1.7 mm ( p CAL changed from 9.6+/-1.3 to 7.9+/-1.6 mm ( p PD reductions ( p CAL gains ( p CAL . In this group , a CAL gain of 3 or 4 mm was measured at 10 sites ( 62 % ) , whereas at six sites ( 38 % ) , the CAL gain was 5 or 6 mm . In the control group , no CAL gain occurred at three sites ( 19 % ) , whereas at 10 sites ( 62 % ) , the CAL gain was only 1 or 2 mm . A CAL gain of 3 mm was measured in three defects ( 19 % ) . CONCLUSIONS Within the limits of the present study , it can be concluded that the combination of BDX Coll+GTR result ed in significantly higher CAL gains than treatment with access flap surgery alone , and thus appears to be a suitable alternative for treating intra-bony periodontal defects",
"Abstract s on this page have been chosen and edited by Dr Trevor Watts",
"AIM Comparison of two bioabsorbable barriers ( collagen and polylactic acid ( PLA ) membranes ) combined with a bovine bone mineral ( BBM ) graft , with an access flap procedure ( AFP ) alone for treating intrabony defects . MATERIAL AND METHODS Thirty-four subjects participated in this prospect i ve , controlled clinical trial . Baseline clinical examination ( probing depth ( PD ) , clinical attachment level ( CAL ) ) of selected sites was performed 2 months after completion of conservative treatment in conjunction with hard-tissue measurements to ascertain the depth of the defect ( cementoenamel junction to the bottom of the defects ) . After r and omly dividing patients into three groups ( two membrane groups , one control group ) , full thickness flaps were elevated and exposed root surfaces planed before filling defects with bone graft and positioning a barrier membrane covering the defect . The control group was treated identically except for the barrier and bone graft placement . Clinical treatment outcomes were finally evaluated 12 months after surgery for changes of PD and CAL . Radiographs at baseline and 12 months were compared using non-st and ardized digital radiography . RESULTS A mean reduction in PD value of 5.08 mm and mean CAL gain of 4.39 mm occurred in the collagen-BBM group . Corresponding values for the PLA-BBM group were 4.72 and 3.71 mm , while access flap procedure ( AFP ) sites produced values of 2.50 and 2.43 mm . All improvements in clinical parameters were statistically significant ( p PD reduction and CAL gain compared with AFP treatment ( p probing pocket depth reduction ( p=0.56 ) or in CAL gain ( p=0.34 ) . CONCLUSION Placement of the two barrier membranes used in the present study in combination with BBM graft significantly improved clinical and radiographic parameters of deep intrabony pockets and proved superior to access flap alone"
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BACKGROUND Muscle weakness in old age , is associated with physical disability and an increased risk of falls . Progressive resistance strength ( PRT ) training exercises ( i.e. movements performed against a specific external force that is regularly increased during training ) are design ed to increase strength in older people . OBJECTIVES To assess the effect of PRT on measures of physical disability , functional limitation and impairment in older people , and identify adverse events . SEARCH STRATEGY We search ed the Cochrane Musculoskeletal Injuries Group specialized register ( to August 2002 ) , CENTRAL /CCTR ( The Cochrane Library Issue 2 , 2002 ) , MEDLINE ( 1966 to February 1 , 2002 ) , EMBASE ( 1980 to February 1 , 2002 ) , CINAHL ( 1982 to February 1 , 2002 ) , Sports Discus ( 1948 to February 1 , 2002 ) , PEDro - The Physiotherapy Evidence Data base ( accessed February 1 , 2002 ) and Digital Dissertations ( accessed February 1 , 2002 ) . We also search ed reference lists of articles , review ed conference abstract s and contacted authors . SELECTION CRITERIA R and omised trials of PRT alone for older people ( i.e. mean age of 60 or over ) were included . DATA COLLECTION AND ANALYSIS Two review ers independently assessed trial quality and extracted data . Weighted mean differences ( WMD ) were obtained using fixed or r and om effect models as appropriate . When measures with different units were pooled , st and ardised mean differences ( SMD ) were calculated . Relative risks were calculated for dichotomous outcomes . MAIN RESULTS Sixty-six trials with 3783 participants were included . Most studies were small and of poor quality . PRT had a large positive effect on strength ( 41 trials , 1955 participants ) , but there was statistical heterogeneity that was not explained by differences in study quality , participant characteristics or the exercise program . Some functional limitation measures showed modest improvements ( i.e. gait speed , 14 trials , 798 participants , WMD 0.07 m/s , 95 % CI 0.04 to 0.09 ) . However , there was no evidence that PRT had an effect on physical disability when activity measures or health related quality of life measures ( HRQOL ) were assessed ( 10 trials , 798 participants , SMD 0.01 , 95 % CI -0.14 to 0.16 ) . Adverse events were poorly recorded , but musculoskeletal injuries were detected in most of the studies that prospect ively defined and monitored these events . REVIEW ER 'S CONCLUSIONS PRT appears to be an effective intervention to increase strength in older people and has a positive effect on some functional limitations . However , the effect of this intervention on more substantive outcomes such as measures of disability or HRQOL remains unclear . It is difficult to determine the balance of risks and benefits of PRT because adverse events have generally been poorly collected and recorded
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"OBJECTIVE To test the efficacy of high-velocity training in healthy older persons . DESIGN A 12-week r and omized trial , with subjects blocked for gender and residence , comparing high-velocity resistance training with a self-paced walking program . SETTING Retirement community . PARTICIPANTS Forty-three volunteers over the age of 70 years . INTERVENTION Power group : high-velocity leg exercises 3 times weekly with weekly increases in resistance combined with 45 minutes of moderate , nonresistance exercise weekly . Walking group : moderate intensity exercise 30 minutes daily , 6 days weekly . MAIN OUTCOME MEASURES Variables measured included leg press peak power and leg extensor strength . Functional performance outcomes included : 6-minute walk distance , Short Physical Performance Battery , Physical Performance Test , and Medical Outcomes Study Short-Form Health Survey . RESULTS Peak power improved 22 % ( p = .004 ) in the power group ( 3.7 + /- 1.0 W/kg to 4.5 + /- 1.4 W/kg ) but did not change in the walking group ( 3.99 + /-.76 W/kg to 3.65 + /-.94 W/kg ) . Leg extensor power at resistance of 50 % , 60 % , and 70 % of body weight increased 50 % , 77 % , and 141 % , respectively , in the power group ( p Strength improved 22 % in the power-trained individuals and 12 % in the walkers ( p functional task performance in either group . One subject developed a radiculopathy during training . CONCLUSIONS Resistance training focusing on speed of movement improved leg power and maximal strength substantially , but did not improve functional performance in healthy high-functioning older volunteers",
"Changes in strength , speed and size of the quadriceps muscle have been investigated in elderly men and women after 6 months of isometric strength training . We have also indirectly investigated the role of metabolites as a stimulus for muscle hypertrophy by study ing two training protocol s. One thigh was trained using short , intermittent contractions ( IC ) , while the other trained using long , continuous contractions ( CC ) . This meant that there should be a greater metabolite change in the muscle performing CC , as the blood flow is occluded for longer . Nine subjects [ eight women , mean ( SE ) age , 71.8 ( 2.9 ) years ] were measured for contractile properties and strength before and after training , and compared to nine age-matched controls [ 71.5 ( 2.1 ) years ] . The training group increased quadriceps strength by 48.7 (9.1)% ( P muscle strength in the controls . Both muscles showed significant slowing after training as measured by the relaxation times and the force-frequency ratio . There were non-significant decreases in muscle fatigability after training . The control group also showed some significant decreases in fatigability and muscle speed . The training group showed significant increases in muscle ( and bone ) cross-sectional area of 4.0 (1.7)% and 4.9 (1.3)% following the CC and IC protocol s , respectively . These increases were significantly different from the decrease observed in the control group . These findings suggest that people over the age of 55 still have the capacity to increase muscle strength and size , and that the training causes slowing of the muscle . Muscle hypertrophy does not seem to be strongly influenced by metabolite changes in this age group , as there were no differences in measurements observed between protocol",
"OBJECTIVE To use two different exercise programs over a 2-year period to reduce falls and their sequelae among residents of two long-term care facilities . DESIGN R and omized , controlled trial . SETTING The study took place at two long-term care facilities with services ranging from independent living to skilled nursing . PARTICIPANTS One hundred and ten participants whose average age was 84 and who were capable of ambulating with or without assistive devices and could follow simple directions . INTERVENTION Participants were r and omized to one of two exercise groups ( resistance/endurance plus basic enhanced programming or tai chi plus basic enhanced programming ) or to a control group ( basic enhanced programming only ) . Exercise classes were held three times per week throughout the study . MEASUREMENTS Participants were evaluated for cognitive and physical functioning at baseline and 6 , 12 , and 24 months . Falls were determined from incident reports filed by the nursing staffs at the facilities . RESULTS Time to first fall , time to death , number of days hospitalized , and incidence of falls did not differ among the treatment and control groups ( P>.05 ) . Among all participants , those who fell had significantly lower baseline Folstein Mini-Mental State Examination and instrumental activities of daily living scores and experienced significantly greater declines in these measures over the 2-year program . CONCLUSION There were no significant differences in falls among the two exercise groups and the control group . Lack of treatment differences and low adherence rates suggest that residents of long-term care facilities may require individualized exercise interventions that can be adapted to their changing needs",
"OBJECTIVE To determine the effect of frequency of resistive training on gain in muscle strength and neuromuscular performance in healthy older adults . DESIGN A r and omized controlled trial with subjects assigned either to high-intensity resistance training 1 ( EX1 ) , 2 ( EX2 ) , or 3 ( EX3 ) days per week for 24 weeks or to a control group ( CO ) . SETTING An exercise facility at an academic medical center . SUBJECTS Forty-six community-dwelling healthy men ( n = 29 ) and women ( n = 17 ) aged 65 to 79 years . INTERVENTION Progressive resistance training consisting of three sets of eight exercises targeting major muscle groups of the upper and lower body , at 80 % of one-repetition maximum ( 1-RM ) for eight repetitions , either 1 , 2 , or 3 days per week . MEASURES Dynamic muscle strength ( 1-RM ) using isotonic equipment every 4 weeks , bone mineral density and body composition by dual energy X-ray absorptiometry ( DXA ) , and neuromuscular performance by timed chair rise and 6-meter backward t and em walk . RESULTS For each of the eight exercises , muscle strength increased in the exercise groups relative to CO ( P change averaged 3.9 + /- 2.4 ( CO ) , 37.0 + /- 15.2 ( EX1 ) , 41.9 + /- 18.2 ( EX2 ) , and 39.7 + /- 9.8 ( EX3 ) . The time to rise successfully from the chair 5 times decreased significantly ( P 6-meter backward t and em walk approached significance ( P = .10 ) in the three exercise groups compared with CO . Changes in chair rise ability were correlated to percent changes in quadriceps strength ( r = -0.40 , P lean mass ( r = -0.40 , P resistance exercise achieves muscle strength gains similar to 3 days per week training in older adults and is associated with improved neuromuscular performance . Such improvement could potentially reduce the risk of falls and fracture in older adults",
"BACKGROUND In patients with intermittent claudication , a supervised walking exercise program increases peak exercise performance and community-based functional status . Patients with peripheral arterial disease also have muscle weakness in the affected extremity that may contribute to the walking impairment . However , the potential benefits of training modalities other than walking exercise , such as strength training , have not been critically evaluated in this patient population . The present study tested the hypothesis that a strength training program would be as effective as treadmill walking exercise and that combinations of strengthening and walking exercise would be more effective than either alone in improving exercise performance . METHODS AND RESULTS Twenty-nine patients with disabling claudication were r and omized to 12 weeks of supervised walking exercise on a treadmill ( 3 h/wk at a work intensity sufficient to produce claudication ) , strength training ( 3 h/wk of resistive training of five muscle groups of each leg ) , or a nonexercising control group . Grade d treadmill testing was performed to maximally tolerated claudication pain to define changes in peak exercise performance . After 12 weeks , patients in the treadmill training program had a 74 + /- 58 % increase in peak walking time as well as improvements in peak oxygen consumption ( VO2 ) and the onset of claudication pain . Patients in the strength-trained group had a 36 + /- 48 % increase in peak walking time but no change in peak VO2 or claudication onset time . Control subjects had no changes in any of these measures over the 12-week period . After the first 12 weeks , patients in the initial walking exercise group continued for 12 more weeks of supervised treadmill training . This result ed in an additional 49 + /- 53 % increase in peak walking time ( total of 128 + /- 99 % increase over the 24 weeks ) . After the initial 12 weeks , patients in the strength-trained group began 12 weeks of supervised treadmill training , and patients in the control group participated in a 12-week combined program of strengthening and treadmill walking exercise . The combined strength and treadmill training program and treadmill training after 12 weeks of strength training result ed in increases in peak exercise performance similar to those observed with 12 weeks of treadmill training alone . CONCLUSIONS A supervised treadmill walking exercise program is an effective means to improve exercise performance in patients with intermittent claudication , with continued improvement over 24 weeks of training . In contrast , 12 weeks of strength training was less effective than 12 weeks of supervised treadmill walking exercise . Finally , strength training , whether sequential or concomitant , did not augment the response to a walking exercise program",
"OBJECTIVE We evaluated the effects of exercise on neurobehavioral function in healthy older people more than 75 years of age . DESIGN A r and omized controlled trial with 6-month follow-up was conducted . SETTING The study was performed in the rural town of Kahoku , Japan , the population of which is considered representative of the older population of Japan . PARTICIPANTS We studied 42 healthy volunteers ( 18 men and 24 women ; mean age , 79 years ( range 75 to 87 years ) ) who were r and omly assigned to one of two groups , exercise or control . INTERVENTION Subjects assigned to the exercise group were instructed to exercise for 60 minutes twice a week for 6 months . Subjects in the control group were not instructed to engage in an specific exercise regimen . MEASUREMENTS The following measurements were recorded for both groups at baseline and at 6-month follow-up : ( 1 ) Neurobehavioral function as determined by the following tests : Mini-Mental State Exam ( MMSE ) , Hasegawa Dementia Scale Revised ( HDSR ) , Visuospatial Cognitive Performance Test ( VCP-test ) , Button score , Up & Go test , and Functional Reach ; and ( 2 ) Body mass index and blood pressure . RESULTS The effects of exercise were shown in the Up & Go test , and Functional Reach ( ANOVA with repeated measures ) . CONCLUSION This study demonstrates the acceptability and effectiveness of exercise on neurobehavioral function , even in older people more than 75 years of age",
"OBJECTIVES This r and omized controlled trial studied the effects of a low- to moderate-intensity group exercise program on strength , endurance , mobility , and fall rates in fall-prone elderly men with chronic impairments . METHODS Fifty-nine community-living men ( mean age = 74 years ) with specific fall risk factors ( i.e. , leg weakness , impaired gait or balance , previous falls ) were r and omly assigned to a control group ( n = 28 ) or to a 12-week group exercise program ( n = 31 ) . Exercise sessions ( 90 minutes , three times per week ) focused on increasing strength and endurance and improving mobility and balance . Outcome measures included isokinetic strength and endurance , five physical performance measures , and self-reported physical functioning , health perception , activity level , and falls . RESULTS Exercisers showed significant improvement in measures of endurance and gait . Isokinetic endurance increased 21 % for right knee flexion and 26 % for extension . Exercisers had a 10 % increase ( p distance walked in six minutes , and improved ( p observational gait scale . Isokinetic strength improved only for right knee flexion . Exercise achieved no significant effect on hip or ankle strength , balance , self-reported physical functioning , or number of falls . Activity level increased within the exercise group . When fall rates were adjusted for activity level , the exercisers had a lower 3-month fall rate than controls ( 6 falls/1000 hours of activity vs 16.2 falls/1000 hours , p exercise can improve endurance , strength , gait , and function in chronically impaired , fall-prone elderly persons . In addition , increased physical activity was associated with reduced fall rates when adjusted for level of activity",
"OBJECTIVE To determine the effects of 12 weeks of progressive resistance strength training on the isometric strength , explosive power , and selected functional abilities of healthy women aged 75 and over . DESIGN Subjects were matched for age and habitual physical activity and then r and omly assigned into either a control or an exercise group . SETTING The Muscle Function Laboratory , Royal Free Hospital School of Medicine , London . PARTICIPANTS Fifty-two healthy women were recruited through local and national newspapers . Five dropped out before and seven ( 4 exercisers and 3 controls ) during the study . Pre- and posttraining measurements were obtained from 20 exercisers ( median age 79.5 , range 76 to 93 years ) and 20 controls ( median age 79.5 , range 75 to 90 years ) . INTERVENTIONS Training comprised one supervised session ( 1 hour ) at the Medical School and two unsupervised home sessions ( supported by an exercise tape and booklet ) per week for 12 weeks . The training stimulus was three sets of four to eight repetitions of each exercise , using rice bags ( 1 - 1.5 kg ) or elastic tubing for resistance . The exercises were intended specifically to strengthen the muscles considered relevant for the functional tasks , but were not to mimic the functional measurements . No intervention was prescribed for the controls . MEASUREMENTS Pre- and posttraining measurements were made for isometric knee extensor strength ( IKES ) , isometric elbow flexor strength ( IEFS ) , h and grip strength ( HGS ) , leg extensor power ( LEP ) , and anthropometric indices ( Body impedance analysis , arm muscle circumference , and body weight ) . Functional ability tests were chair rise , kneel rise , rise from lying on the floor , 118-m self-paced corridor walk , stair climbing , functional reach , stepping up , stepping down , and lifting weights onto a shelf . Pre- and posttraining comparisons were made using analysis of variance or analysis of covariance ( using weight as a covariate ) for normally distributed continuous data and one-sided Fishers exact test ( 2 x 2 table ) for discontinuous data . RESULTS Improvements in IKES ( mean change 27 % , P = .03 ) , IEFS ( 22 % , P = .05 ) , HGS ( 4 % , P = .05 ) , LEP/kg ( 18 % , P = .05 ) were associated with training , but the improvement in LEP ( 18 % , P = .11 ) did not reach statistical significance . There was an association between training and a reduction in normal pace kneel rise time ( median change 21 % , P = .02 ) and a small improvement in step up height ( median 5 % , P = .005 ) . The other functional tests did not improve . CONCLUSIONS Progressive resistance exercise can produce substantial increases in muscle strength and in power st and ardized for body weight in healthy , very old women . However , isolated increases in strength and LEP/kg may confer only limited functional benefit in healthy , independent , very old women",
"OBJECTIVE To determine the effects of stopping and restarting two types of exercise programs in older adults . DESIGN A controlled , longitudinal study that utilized r and om assignment of volunteers . Treatments were exercise programs design ed to improve cardiovascular or neuromuscular fitness . MEASUREMENTS Dependent variables measured before and after implementation of treatments were : maximum oxygen consumption , oxygen pulse , treadmill and cycle training workloads , quadriceps isokinetic peak torque , quadriceps isokinetic total work , and quadriceps training workload . MAIN RESULTS Exercise training was highly effective in improving cardiovascular endurance or muscular strength . Ten weeks of exercise detraining result ed in small losses in newly gained cardiovascular capacity but more noticeable losses in muscular strength . Exercise retraining was accomplished easily using cardiovascular or resistive exercises . The functional benefits of restarting a cardiovascular exercise program appeared additive despite a 10-week intervening period of exercise detraining . In this age group , cardiovascular exercise produced limited improvements in muscular strength , and resistive exercise training positively influenced cardiovascular exercise performance . CONCLUSIONS Older adults are fairly resilient to 10 weeks of cardiovascular detraining and retain newly gained muscular strength for at least 5 weeks , despite an interruption of formal exercise . An occasional missed exercise session or temporary cessation of habitual exercise should not be a cause for distress in exercising older adults . Instead , they should realize the case with which they may restart their exercise program and also appreciate the generalized fitness benefits that can be ascribed to becoming more active",
"BACKGROUND The purpose of this study was to evaluate how weight training or nursing-based rehabilitative care programs in nursing homes impact on resident performance of Activities of Daily Living ( ADL ) and objectives tests of physical performance . METHODS This study involved a quasi-experimental control , longitudinal comparison of functional status over a 10-month period , where baseline status was adjusted through a weighting procedure based on functional status , cognitive status , and age . All residents from six residential care nursing home facilities were eligible except those with a terminal prognosis , a projected stay of less than 90 days , or with health complications that prohibited contact . Homes were placed into matched triplets based on patient characteristics : two members of each triplet were r and omly design ated to be experimental sites , the third became the control site . Baseline data were available for 468 subjects , follow-up for 392 . ADL self-performance measures derived from the Minimum Data Set , including indicators of early loss ADL , locomotion , and late loss ADL ; a number of objective functional tests ( including measures of balance , power , and endurance ) ; and mood state as measured by the Geriatric Depression Scale . RESULTS Mean ADL values in the two experimental groups declined at a significantly lower rate than did rates for the controls . Functional decline was also lower in more specific measures : locomotion , early loss ADL , and late loss ADL . CONCLUSIONS With both interventions , facilities were able to implement a broad-based intervention that result ed in a significant reduction in ADL decline rates . A facility-wide nursing rehabilitation program can play a useful role in reversing functional decline , helping residents to maintain their involvement in a broad spectrum of ADL activities",
"A r and omized controlled trial examined the growth and form of multidimensional self-esteem over a 12-month period ( 6-month exercise intervention and 6-month follow-up ) in 174 older adults engaged in either a walking or stretching/toning program . The extent to which changes in physical fitness parameters and physical self-efficacy were related to changes in perceptions of attractive body , strength , physical conditioning , and physical self-worth was also determined . Latent growth curve analyses showed a curvilinear pattern of growth in esteem with significant increases at all levels of self-esteem upon completion of the intervention followed by significant declines at 6 months poistintervention in both groups . Frequency of activity and changes in physical fitness , body fat , and self-efficacy were related to improvements in esteem perceptions relative to attractive body , strength , and physical condition . Model fitting procedures suggested that the best fit of the data was to a model in which the influence of changes in efficacy and physical parameters on physical self-worth were mediated by perceptions of attractive body and physical conditions",
"Body composition changes and loss of functionality in the elderly are related to subst and ard diets and progressive sedentariness . The aim of this study was to assess the impact of an 18-mo nutritional supplementation and resistance training program on health functioning of elders . Healthy elders aged > or = 70 y were studied . Half of the subjects received a nutritional supplement . Half of the supplemented and nonsupplemented subjects were r and omly assigned to a resistance exercise training program . Every 6 mo , a full assessment was performed . A total of 149 subjects were considered eligible for the study and 98 ( 31 supplemented and trained , 26 supplemented , 16 trained and 25 without supplementation or training ) completed 18 mo of follow-up . Compliance with the supplement was 48 % , and trained subjects attended 56 % of programmed sessions . Activities of daily living remained constant in the supplemented subjects and decreased in the other groups . Body weight and fat-free mass did not change . Fat mass increased from 22.2 + /- 7.6 to 24.1 + /- 7.7 kg in all groups . Bone mineral density decreased less in both supplemented groups than in the nonsupplemented groups ( ANOVA , P Serum cholesterol remained constant in both supplemented groups and in the trained groups , but it increased in the control group ( ANOVA , P Upper and lower limb strength , walking capacity and maximal inspiratory pressure increased in trained subjects . In conclusion , patients who were receiving nutritional supplementation and resistance training maintained functionality , bone mineral density and serum cholesterol levels and improved their muscle strength",
"Physical exercise is expected to improve and maintain physical function in older people , thus promoting health and preventing or postponing the onset of disability in later life . The Sendai Silver Center Trial ( SSCT ) was a r and omized controlled trial design ed to evaluate the efficacy of exercise training among healthy free-living older people . Sixty-five eligible participants , aged from 60 to 81 years , were r and omly allocated to an exercise group or a control group . The subjects in the exercise group were asked to attend training classes at the Sendai Silver Center , a municipal health and welfare facility in the center of Sendai City , at least twice a week for 25 weeks . Each training class , lasting two hours , started with a warm-up session , followed by an endurance session with a bicycle ergometer , and a resistance exercise training session using rubber films , and ended with a cool-down session . The subjects in the control group were asked to attend recreational classes at the Center twice a month . There were no drop-outs or accidents during the intervention . Comparison of maximum oxygen consumption ( VO2max ) before and after the 25-week intervention revealed a significant increase in the exercise group ( 2.1 ml/kg/min ) but no significant change in the control group . Our result is equivalent to the participants becoming younger in aerobic capacity by five years after six months of exercise training",
"BACKGROUND Physical activity programs in nursing homes typically consist of seated , range of motion ( ROM ) exercises , regardless of resident abilities . The Functional Fitness for Long-Term Care ( FFLTC ) Program was design ed not only to maintain ROM , but also to improve strength , balance , flexibility , mobility , and function . In addition , it was tailored to meet the needs of both high and low mobility residents . METHODS The feasibility and efficacy of the FFLTC Program were evaluated with 68 residents ( mean age 80 ) from five institutions . Persons were classified as low or high mobility and r and omized into either the FFLTC program or a seated ROM program . Classes were conducted in groups of 4 to 10 residents by trained facility staff for 45 minutes , three times per week . Assessment s at baseline and 4 months consisted of mobility , balance , gait , flexibility , functional capacity , and several upper and lower extremity strength measures . RESULTS Attendance averaged 86 % for the FFLTC and 79 % for the ROM classes . Four months of exercise led to significant improvements in mobility ( 16 % ) , balance ( 9 % ) , flexibility ( 36 % ) , knee ( 55 % ) , and hip ( 12 % ) strength for the FFLTC group . Shoulder strength was the only improvement found for the ROM group . The ROM group significantly deteriorated in some areas , particularly hip strength , mobility , and functional ability . CONCLUSIONS Institutionalized seniors , even those who are physically frail , incontinent and /or have mild dementia , can respond positively to a challenging exercise program . The FFLTC program demonstrated clear benefits over typical , seated ROM exercises . Moreover , with minimal training , the program can be safely delivered at low cost by institutional staff and volunteers",
"To assess muscle remodeling and functional adaptation to exercise and diet interventions , 26 men and women aged 72 - 98 yr underwent a vastus lateralis biopsy before and after placebo control condition , and progressive resistance training , multinutrient supplementation , or both . Type II atrophy , Z b and , and myofibril damage were present at baseline . Combined weight lifting and nutritional supplementation increased strength by 257 + /- 62 % ( P = 0.0001 ) and type II fiber area by 10.1 + /- 9.0 % ( P = 0.033 ) , with a similar trend for type I fiber area ( + 12.8 + /- 22.2 % ) . Exercise was associated with a 2 . 5-fold increase in neonatal myosin staining ( P = 0.0009 ) and an increase of 491 + /- 137 % ( P IGF-I staining . Ultrastructural damage increased by 141 + /- 59 % after exercise training ( P = 0.034 ) . Strength increases were largest in those with the greatest increases in myosin , IGF-I , damage , and caloric intake during the trial . Age-related sarcopenia appears largely confined to type II muscle fibers . Frail elders respond robustly to resistance training with musculoskeletal remodeling , and significant increases in muscle area are possible with resistance training in combination with adequate energy intakes",
"BACKGROUND To study the effects of resistance training on muscle strength and size in older people , we enrolled 8 men and 17 women ( mean age 68.2 + /- 1 SEM ) into a one-year exercise trial . METHODS Subjects were r and omly assigned to exercise or control groups . Muscle biopsies were obtained from 11 subjects ( 8 exercisers/3 controls ) at baseline and after 15 weeks ; exercisers underwent another biopsy at 30 weeks . After testing maximum strength using the 1-RM method , the exercisers began a 12-exercise circuit ( 3 sets of 8 repetitions at 75 % of 1-RM ) , 3 times a week . The controls repeated the strength testing every 15 weeks . They were asked to continue usual activities and not to start any exercise program . RESULTS With exercise , muscle strength increased , average increases ranging from 30 % ( hip extensors ) to 97 % ( hip flexors ) . Strength increased rapidly over 3 months , then plateaued for the duration of the experiment . No strength changes were observed in sedentary controls . Cross-sectional area of type 1 muscle fibers increased in exercisers by 15 weeks ( 29.4 + /- 1 % , p Type 2 fiber area did not change at 15 weeks , but increased by 30 weeks of training ( 66.6 + /- 9.5 % , p moderate to high intensity resistance training may be carried out by healthy older adults with reasonable compliance , and that such training leads to sustained increases in muscle strength . These improvements are rapidly achieved and are accompanied by hypertrophy of both type 1 and type 2 muscle fibers",
"BACKGROUND PATIENTS : with chronic airflow obstruction are often limited by muscle fatigue and weakness . As exercise rehabilitation programmes have produced modest improvements at best a study was design ed to determine whether specific muscle training techniques are helpful . METHODS : Thirty four patients with chronic airflow limitation ( forced expiratory volume in one second ( FEV1 ) 38 % of predicted values ) were stratified for FEV1 to vital capacity ( VC ) ratio less than 40 % and arterial oxygen desaturation during exercise and r and omised to a control or weightlifting training group . In the experimental group training was prescribed for upper and lower limb muscles as a percentage of the maximum weight that could be lifted once only . It was carried out three times a week for eight weeks . RESULTS : Three subjects dropped out of each group ; results in the remaining 14 patients in each group were analysed . Adherence in the training group was 90 % . In the trained subjects muscle strength and endurance time during cycling at 80 % of maximum power output increased by 73 % from 518 ( SE69 ) to 898 ( 95 ) s , with control subjects showing no change ( 506 ( 86 ) s before training and 479 ( 89 ) s after training ) . No significant changes in maximum cycle ergometer exercise capacity or distance walked in six minutes were found in either group . Responses to a chronic respiratory question naire showed significant improvements in dyspnoea and mastery of daily living activities in the trained group . CONCLUSIONS : Weightlifting training may be successfully used in patients with chronic airflow limitation , with benefits in muscle strength , exercise endurance , and subjective responses to some of the dem and s of daily living",
"This study determined the cellular energetic and structural adaptations of elderly muscle to exercise training . Forty male and female subjects ( 69.2 + /- 0.6 yr ) were assigned to a control group or 6 mo of endurance ( ET ) or resistance training ( RT ) . We used magnetic resonance spectroscopy and imaging to characterize energetic properties and size of the quadriceps femoris muscle . The phosphocreatine and pH changes during exercise yielded the muscle oxidative properties , glycolytic ATP synthesis , and contractile ATP dem and . Muscle biopsies taken from the same site as the magnetic resonance measurements were used to determine myosin heavy chain isoforms , metabolite concentrations , and mitochondrial volume densities . The ET group showed changes in all energetic pathways : oxidative capacity ( + 31 % ) , contractile ATP dem and ( -21 % ) , and glycolytic ATP supply ( -56 % ) . The RT group had a large increase in oxidative capacity ( 57 % ) . Only the RT group exhibited change in structural properties : a rise in mitochondrial volume density ( 31 % ) and muscle size ( 10 % ) . These results demonstrate large energetic , but smaller structural , adaptations by elderly muscle with exercise training . The rise in oxidative properties with both ET and RT suggests that the aerobic pathway is particularly sensitive to exercise training in elderly muscle . Thus elderly muscle remains adaptable to chronic exercise , with large energetic changes accompanying both ET and RT",
"OBJECTIVES To examine the effects of 18-month aerobic walking and strength training programs on static postural stability among older adults with knee osteoarthritis . DESIGN R and omized , single-blind , clinical trial of therapeutic exercise . SETTING Both center-based ( university ) and home-based . PARTICIPANTS A cohort of 103 older adults ( age = 60 years ) with knee osteoarthritis who were participants in a large ( n = 439 ) clinical trial and who were r and omly assigned to undergo biomechanical testing . INTERVENTION An 18-month center- ( 3 months ) and home-based ( 15 months ) therapeutic exercise program . The subjects were r and omized to one of three treatment arms : ( 1 ) aerobic walking ; ( 2 ) health education control ; or ( 3 ) weight training . MEASUREMENTS Force platform static balance measures of average length ( Rm ) of the center of pressure ( COP ) , average velocity ( Vel ) of the COP , elliptical area ( Ae ) of the COP , and balance time ( T ) . Measures were made under four conditions : eyes open , double- and single-leg stances and eyes closed , double- and single-leg stances . RESULTS In the eyes closed , double-leg stance condition , both the aerobic and weight training groups demonstrated significantly better sway measures relative to the health education group . The aerobic group also demonstrated better balance in the eyes open , single-leg stance condition . CONCLUSIONS Our results suggest that long-term weight training and aerobic walking programs significantly improve postural sway in older , osteoarthritic adults , thereby decreasing the likelihood of larger postural sway disturbances relative to a control group",
"Objective : Comparison of two flooring types – carpet and vinyl – in the bed areas , and two modes of physiotherapy – conventional therapy and additional leg strengthening exercises – in avoiding falls . Design : R and omized 2 × 2 controlled trial . Setting : Elderly care rehabilitation ward in a community hospital . Subjects : Fifty-four consecutive patients referred for rehabilitation . Outcome measures : The incidence of falls , and the change in strength . Results : There were 10 falls on carpet , and only a single fall on vinyl floor covering ( relative risk 8.3 , 95 % confidence interval 0.95–73 , p = 0.05 ) . There were four falls in those receiving additional exercise , and seven falls in those receiving only conventional physiotherapy ( relative risk 0.21 , 95 % confidence interval 0.04–1.2 , p = 0.12 ) . Fifty-nine per cent of patients were able to complete strength measurements on admission and discharge . In these , h and grip strength improved more in those given additional exercise than conventional physiotherapy ( 2.1 kg versus – 0.3 kg , p preventing falls on a rehabilitation ward , but within this low-powered study , there was a strong trend towards vinyl being superior ",
"OBJECTIVE To evaluate the effects of isokinetic exercise versus a program of patient education on pain and function in older persons with knee osteoarthritis . DESIGN A r and omized , comparative clinical trial , with interventions lasting 8 weeks and evaluations of 12 weeks . SETTING An outpatient Veterans Affairs Medical Center clinic and an affiliated university hospital . PATIENTS One hundred thirteen men and women between 50 and 80 years old with diagnosed osteoarthritis of the knee ; 98 completed the entire assigned treatment . INTERVENTION Patients received either a regimen of isokinetic exercise of the quadriceps muscle three times weekly over 8 weeks or a series of 4 discussion s and lectures led by health care professionals . MAIN OUTCOME MEASURES Variables studied for change were isokinetic and isometric quadriceps strength , pain and function determined by categorical and visual analog scales , and overall status using physician and patient global evaluations by the Arthritis Impact Scale , version 2 , Western Ontario McMaster 's Arthritis Index , and Medical Outcome Study Short Form 36 . RESULTS Both treatment groups showed significant strength gains ( p pain scores for more of the variables measured than those receiving education . Both groups had positive functional outcomes and slightly improved measures of overall status . CONCLUSIONS Isokinetic exercise is an effective and well-tolerated treatment for knee osteoarthritis , but a much less costly education program also showed some benefits",
"To evaluate the effects of 26 wk of aerobic and resistance training on the incidence of injury and program adherence in 70- to 79-yr-old men and women , 57 healthy volunteers ( 25 males , 32 females ) were r and omly assigned to a walk/jog ( W/J , N = 21 ) , strength ( STREN , N = 23 ) , or control ( CONT , N = 13 ) group . Walk/jog training was for 30 - 45 min , 3 d.wk-1 with intensity equal to 40 - 70 % heart rate max reserve ( HRmax reserve ) during the first 13 wk , and 75 - 85 % HRmax reserve for weeks 14 - 26 . STREN training consisted of one set ( 10 - 12 repetitions ) each of 10 variable resistance exercises performed to volitional fatigue . Forty-nine of the original participants completed the training program . Walk/jog training increased VO2max from 22.5 to 27.1 ml.kg-1.min-1 ( P less than or equal to 0.05 ) while STREN and CONT showed no change . STREN improved significantly in chest press and leg extension strength ( P less than or equal to 0.05 ) while W/J and CONT showed no change . Adherence to training was 20/23 ( 87 % ) and 17/21 ( 81 % ) in STREN and W/J , respectively . One repetition maximum ( 1-RM ) strength testing result ed in 11 injuries in the 57 subjects ( 19.3 % ) while STREN training result ed in only two injuries in 23 subjects ( 8.7 % ) . Walk training during weeks 1 - 13 result ed in one injury in 21 subjects ( 4.8 % ) . Eight of 14 subjects ( 57 % ) who began jogging intervals at week 14 incurred an injury : two of eight ( 25 % ) of the men and all of the women ( 6 of 6 ) . All W/J training injuries were to the lower extremity . ( ABSTRACT TRUNCATED AT 250 WORDS",
"PURPOSE To determine whether isokinetic training can improve the strength of the hemiparetic knee musculature , functional mobility , and physical activity and to evaluate its effect on spasticity in long-term stroke survivors . DESIGN Nonr and omized self-controlled trial . SUBJECTS A volunteer sample of 15 community-dwelling stroke survivors of at least 6 months . INTERVENTION A 6-week ( 3 days/week , 40 minutes/day ) program consisting of warm-up , stretches , reciprocal knee extension and flexion isokinetic strengthening , and cool-down for the paretic limb . MAIN OUTCOME MEASURES Peak isokinetic hamstring and quadriceps torque , quadriceps spasticity , gait velocity , timed Up and Go , timed stair climb , and the Human Activity Profile ( HAP ) scores were recorded at baseline , after training , and 4 weeks after training cessation ( follow-up ) . RESULTS Paretic muscle strength improved after training ( p tone remained consistent ( p > .87 ) . Gait velocity increased after training ( p in stair climbing and timed Up and Go were not significant ( p > .37 ; p > .91 ) , although subjects perceived gains in their physical abilities at follow-up ( p strength and gait velocity without concomitant increases in muscle tone are possible after a short-term strengthening program for stroke survivors . The psychological benefit associated with physical activity is significant",
"Abstract . There is evidence that high intensity resistance training promotes bone maintenance in older women , however , the effect of high intensity free weight training has not been investigated in older men or women . Furthermore , little is known about the chronic effect of weight training on serum insulin growth factor-I ( IGF-I ) in this population . We compared the effects of a moderate intensity seated resistance-training program with a high intensity st and ing free weight exercise program on bone mass and serum levels of IGF-I and IGFBP3 in healthy older men and women . Twenty-eight men ( 54.6 ± 3.2 years ) and 26 nonestrogen-replaced women ( 52.8 ± 3.3 years ) served as their own controls for 12 weeks , then were r and omly assigned to a moderate or high intensity training group and trained three times/week for 24 weeks . Prior to and after the control period and at the end of training , bone mass and body composition were assessed by dual energy X-ray absorptiometry ( DXA ) , muscle strength by isokinetic dynamometry , muscular power by Wingate Anaerobic Power Test , and IGF-I by radioimmunoassay ( RIA ) . A repeated measures analysis of covariance ( ANCOVA ) revealed that high intensity training result ed in a gain in spine BMD in men ( 1.9 % ) , P increases in trochanteric BMD ( 1.3 % and 2.0 % , respectively ) and a decrease in femoral BMD ( −1.8 % ) . Neither circulating serum IGF-I nor IGFBP3 were altered by either training regimen , but both training programs result ed in improvements in total body strength ( 37.62 % ) and lean mass ( males 4.1 % , females 3.1 % ) . We conclude that although resistance training of moderate to high intensity produced similar muscle changes in older adults , a higher magnitude is necessary to stimulate osteogenesis at the spine . However , at the spine , intensity was not sufficient to offset low levels of estrogen in early postmenopausal women . Furthermore , bone changes were not accompanied by changes in circulating serum levels of IGF-I or IGFBP3",
" Eighty-six elderly people with limited mobility and dependence in at least one activity of daily living were recruited to a home exercise study . The subjects ( mean age 82 years ) were allocated at r and om to either a strength exercise group , a mobility exercise group or a health education group . Subjects were visited for 30 minutes every 3 - 4 weeks by a physiotherapist who gave both verbal and written instruction . Sixty-nine of the original 86 completed the 6-month study , with five drop-outs from the strength group , ten drop-outs from the mobility group , and two drop-outs from the health education group . By the end of the study , there were no significant differences between the groups with regard to changes in outcome variables . The results showed a trend towards improvement in both the exercise groups in both Sit to St and and Timed Get Up and Go tests , but this failed to attain statistical significance . Further work is required to identify the optimal exercise intervention for this subgroup of the elderly population",
"BACKGROUND This study was undertaken to determine ( a ) whether a program of regular exercise can improve gait patterns in older women , and ( b ) whether any such improvement in gait is mediated by increased lower limb muscle strength . METHOD A 22-week r and omized controlled trial of exercise was conducted as part of the R and wick Falls and Fractures Study in Sydney , Australia . Subjects were 160 women aged 60 - 83 years ( Mean age 71.1 , SD = 5.2 ) who were r and omly recruited from the community . Exercise and control subjects were tested prior to and at the end of the trial . At initial testing , exercisers and controls performed similarly in the strength and gait parameters . They were well matched in terms of age and a number of health and life-style characteristics . RESULTS At the end of the trial , the exercise subjects showed improved strength in five lower limb muscle groups , increased walking speed , cadence , stride length , and shorter stride times as indicated by both reduced swing and stance duration . There were no significant improvements in any of the strength or gait parameters in the controls . Within the exercise group , increased cadence was associated with improved ankle dorsiflexion strength , and increased stride length was associated with improved hip extension strength . Exercise subjects with initial slow walking speed showed greater changes in velocity , stride length , cadence , and stance duration than those with initial fast walking speed . CONCLUSION These findings show that exercise can increase gait velocity and related parameters in older persons , and that part of this increase may be mediated by improved lower limb muscle strength",
"The objectives of this study were to evaluate ( 1 ) the effect of spinal muscle strengthening by loading exercises on the bone mineral density ( BMD ) of the spine , and ( 2 ) the effect of upper extremity loading exercises on the BMD of the midradius and femur in healthy , premenopausal women . The study design was a r and omized , controlled trial of 3 years ' duration . Ninety-six healthy , premenopausal , white women aged 30 - 40 years participated ; 67 completed the study . All subjects were in good health ( normal menses ) and were active , but not athletic ( that is , not involved in a regular sport activity ) . Subjects were r and omized to an exercise or control group . The exercise group performed a supervised , non-strenuous , weight-lifting exercise program . Exercise performance was supervised once a week at the medical facility . In addition , the subjects performed the exercises twice a week on their own . Dietary calcium intake was to be maintained at 1,500 mg/day in both groups . Bone density was measured at the lumbar spine and hip with dual-energy X-ray absorptiometry at 0 , 1 , and 3 years . BMD of the midradius was measured with single photon absorptiometry . Measurements of muscle strength were obtained at baseline and every 3 months for 3 years . Maximal oxygen uptake was measured , and the level of physical activity was recorded . Compliance with the exercise program was excellent during the first year of the study , but decreased thereafter . At the end of 3 years , subject withdrawal was about 34 % from the exercise group and about 22 % from the control group ( total subject withdrawal was about 30 % ) . Muscle strength in the exercise group increased significantly at all involved skeletal sites ( p values all BMD of Ward 's triangle with spinal flexor strength ( r = 0.32 , p = 0.008 ) and with grip strength ( r = 0.38 , p = 0.001 ) . Comparing study groups , we found no significant effect of the loading and nonstrenuous strengthening exercises in the exercise group or free physical activity group ( our control group ) on BMD at the spine , hip , or midradius measurement sites . In active , but not athletic premenopausal women , additional moderate weight-lifting exercises showed no significant effect on BMD",
"Abstract : A r and omised controlled trial was conducted to determine whether a 12–month program of group exercise had beneficial effects on physiological and cognitive functioning and mood in 187 older community – dwelling women . The exercisers ( n= 94 ) and controls ( n= 93 ) were well matched in terms of the test measures and a number of health and life – style assessment s. The mean number of classes attended by the 71 exercise subjects who completed the program was 59.0 ( range 26 to 82 ) . At the end of the trial , the exercisers showed significant improvements in reaction time , strength , memory span and measures of wellbeing when compared with the controls . There was also an indication that anxiety had been reduced in the exercisers . Within the exercise group , improvements in memory span were associated with concomitant improvements in both reaction time and muscle strength . Also , within this group , initial mood measures were significantly inversely associated with improvements at retest , which suggests that the program may have normalised mood states in subjects who had high initial depression , anxiety and stress levels , rather than inducing improvements in all subjects . These findings suggest that group exercise has beneficial effects on physiological and cognitive functioning and wellbeing in older people",
"PURPOSE This investigation examined the effect of 6 months of high- or low-intensity resistance exercise ( REX ) on bone mineral density ( BMD ) and biochemical markers of bone turnover in adults aged 60 - 83 yr . METHODS Sixty-two men and women ( 68.4 + /- 6 yr ) were stratified for strength and r and omly assigned to a control ( CON , N = 16 ) , low-intensity ( LEX , N = 24 ) , or high-intensity ( HEX , N = 22 ) group . Subjects participated in 6 months of progressive REX training . Subjects trained at either 50 % of their one repetition maximum ( 1-RM ) for 13 repetitions ( LEX ) or 80 % of 1-RM for 8 repetitions ( HEX ) 3 times x wk(-1 ) for 24 wk . One set each of 12 exercises was performed . 1-RM was measured for eight exercises . BMD was measured for total body , femoral neck , and lumbar spine by dual energy x-ray absorptiometry ( DXA ) . Serum levels of bone-specific alkaline phosphatase ( BAP ) , osteocalcin ( OC ) , and pyridinoline cross-links ( PYD ) were measured . RESULTS 1-RM significantly increased for all exercises tested for both the HEX and LEX groups ( P increases in total strength ( sum of all eight 1-RMs ) were 17.2 % and 17.8 % for the LEX and HEX groups , respectively . Bone mineral density ( BMD ) of the femoral neck significantly ( P BMD were found . OC increased by 25.1 % and 39.0 % for the LEX and HEX groups , respectively ( P BAP significantly ( P REX training was successful for improving BMD of the femoral neck in healthy elderly subjects . Also , these data suggest REX increased bone turnover , which over time may lead to further changes in BMD",
"PURPOSE This study investigated effects of an 8-wk , low-frequency and low-volume , supervised , progressive strength training program emphasizing free weight , multijoint movements on the muscular power , strength , endurance , and flexibility of African American women 44 to 68 yr of age . METHODS Nineteen sedentary African American women were r and omly assigned to a strength training ( ST ) only group ( N = 12 ; mean age , 51 yr ) or a nonexercise control ( C ) group ( N = 7 ; mean age , 52 yr ) . Maximal power , strength , absolute endurance , and flexibility were assessed before and after training . Subjects trained 2 d x wk(-1 ) using free weight ( barbells and dumbbells ) and machine ( plate loaded ) exercises for two to three sets of 8 to 10 repetitions on both primary and assistance exercises . RESULTS Upper body power ( medicine ball put distance ) significantly increased statistically ( P = 0.002 ) , but gains possibly lacked practical significance because of measurement variation . Lower body power ( peak watts on bicycle ) experienced a small , nonsignificant increase in the ST group . Significant increases ( P = 0.000 ) in 1RM muscle strength occurred in the ST group ( leg press , + 99.8 % ; bench press , + 34.4 % ) . Absolute endurance significantly increased ( P = 0.000 ) in the ST group ( leg press repetitions to failure at 70 % pretest 1RM , + 221 % ; bench press repetitions to failure at 50 % pretest 1RM , + 112 % ) . Significant flexibility gains occurred in the ST group ( sit- and -reach test , + 8.2 % ; P = 0.017 ) . No significant changes occurred in power , strength , absolute endurance , or flexibility in the C group . CONCLUSION This study demonstrates that 8 wk of low-frequency , supervised , progressive strength training emphasizing free weight , multijoint movements can safely cause significant gains in muscle strength , absolute endurance , and flexibility in older African American women",
"It has been shown that high levels of high-density lipoprotein ( HDL ) cholesterol and low levels of low-density lipoprotein ( LDL ) cholesterol are associated with health maintenance in older women , but the few studies that have examined the relationship between exercise and plasma lipoprotein levels in this elderly population have been equivocal . In addition , there are no studies that examine the plasma lipoprotein response of two different types of exercise in a group of active but nonexercising women . Thus , the effects of exercise training on plasma lipoprotein levels in elderly women remain unclear . The purpose of this research was to examine the effects of endurance and resistance exercise on plasma lipoprotein levels in elderly women who were active but nonexercising prior to the study . A total of 45 healthy , active women , aged 70 - 87 years , were r and omly assigned to either an aerobic training ( AT , 76 + /- 5 years , n = 15 ) , resistance training ( RT , 73 + /- 3 years , n = 15 ) , or control ( C , 74 + /- 5 years , n = 15 ) group . The AT group walked 3 days a week at 70 % heart rate reserve . The duration on day 1 was 20 minutes , and it was increased by 5 minutes each day until subjects were walking for 50 minutes ( week 3 ) . The exercise training session for the RT group consisted of one to three sets of eight repetitions of eight different exercises at an eight repetition maximum ; the C group maintained normal activity . Weight and diet were unchanged across groups . The exercise interventions lasted 10 weeks . Blood sample s were obtained from all subjects at week 0 and week 11 . Training result ed in a significant decrease in 1-mile walk times and heart rate at completion of the walk for the AT group and a significant increase in eight repetition maximum of all RT exercises . Both AT and RT groups experienced increased HDL cholesterol and decreased triglycerides at week 11 compared with week 0 . There were no positive changes in control lipoproteins . Both triglycerides and the total cholesterol to HDL ratio increased significantly while total cholesterol , HDL cholesterol , and LDL cholesterol remained unchanged . The RT group also had significantly lower LDL cholesterol and total cholesterol compared with controls at week 11 . Both RT and endurance training result ed in favorable changes to plasma lipoprotein levels for elderly women in only 10 weeks . The fact that this occurred without concurrent changes in weight or diet is an indication that high-intensity exercise alone can be used to modify lipoproteins in population s of healthy elderly women",
"Sullivan DH , Wall PT , Bariola JR , Bopp MM , Frost YM : Progressive resistance muscle strength training of hospitalized frail elderly . Am J Phys Med Rehabil 2001;80:503–509 . Objective To determine whether frail elderly patients recuperating from acute illnesses could safely participate in and gain appreciable improvement in muscle strength from progressive resistance muscle strength training . Design Muscle strength ( one repetition maximum ) , functional abilities ( sit-to-st and maneuver and 20-sec maximal safe gait speed ) , and body composition were measured before and at the conclusion of a 10-wk program of lower limb progressive resistance muscle strength training . The nonr and omized study was conducted in a 30-bed geriatric rehabilitation unit of a university-affiliated Veterans Affairs hospital and a 28-bed transitional care unit of a community nursing home . Participants included 19 recuperating elderly subjects ( 14 male , 5 female ; 13 ambulatory , 6 nonambulatory ) > 64 yr ( mean age , 82.8 ± 7.9 yr ) . Results The one repetition maximum increased an average of 74 % ± 49 % ( median , 70 % ; interquartile range , 38%–95 % , and an average of 20 ± 13 kg ( P = 0.0001 ) . Sit-to-st and maneuver times improved in 15 of 19 cases ( 79 % ) . Maximum safe gait speeds improved in 10 of 19 cases ( 53 % ) . Four of the six nonambulatory subjects progressed to ambulatory status . No subject experienced a complication . Conclusions A carefully monitored program of progressive resistance muscle strength training to regain muscle strength is a safe and possibly effective method for frail elderly recuperating from acute illnesses . A r and omized control study is needed to examine the degree to which progressive resistance muscle strength training offers advantages , if any , over routine posthospital care that includes traditional low-intensity physical therapy",
"OBJECTIVE To determine the effect on balance and strength of 3 months of intensive balance and /or weight training followed by 6 months of low intensity Tai Chi training for maintenance of gains . DESIGN R and omized control intervention . Four groups in 2 x 2 design : Control , Balance , Strength , Balance + Strength , using blinded testers . SETTING Exercise and balance laboratory at University of Connecticut Health Center . PARTICIPANTS Subjects were 110 healthy community dwellers ( mean age 80 ) who were free of dementia , neurological disease , and serious cardiovascular or musculoskeletal conditions . INTERVENTIONS Short-term training ( 3 months ) occurred 3 times/week ( 45 minutes Balance and Strength , 90 minutes Balance + Strength ) . Balance training included equilibrium control exercises of firm and foam surfaces and center-of-pressure biofeedback . Strengthening consisted of lower extremity weight-lifting . All subjects than received long-term group Tai Chi instruction ( 6 months , 1 hour , 1 time/week ) . MEASUREMENTS Losses of balance during Sensory Organization Testing ( LOB ) , single stance time ( SST ) , voluntary limits of stability ( FBOS ) , summed isokinetic torque of eight lower extremity movements ( ISOK ) , and usual gait velocity ( GVU ) . RESULTS AND CONCLUSIONS Balance training meaningfully improved all balance measures by restoring performance to a level analogous to an individual 3 to 10 years younger : LOB = -2.0 + /- 0.3 ( adjusted paired differences , P ISOK by 1.1 + /- 0.1 Nm kg-1 ( P Tai Chi , although there was some decrement",
"Chronic heart failure ( CHF ) is characterized by a skeletal muscle myopathy not optimally addressed by current treatment paradigms or aerobic exercise . Sixteen older women with CHF were compared with 80 age-matched peers without CHF and r and omized to progressive resistance training or control stretching exercises for 10 wk . Women with CHF had significantly lower muscle strength ( P aerobic capacity to women without CHF . Exercise training was well tolerated and result ed in no changes in resting cardiac indexes in CHF patients . Strength improved by an average of 43.4 + /- 8.8 % in resistance trainers vs. -1.7 + /- 2.8 % in controls ( P = 0.001 ) , muscle endurance by 299 + /- 66 % vs. 1 + /- 3 % ( P = 0.001 ) , and 6-min walk distance by 49 + /- 14 m ( 13 % ) vs. -3 + /- 19 m ( -3 % ) ( P = 0.03 ) . Increases in type I fiber area ( 9.5 + /- 16 % ) and citrate synthase activity ( 35 + /- 21 % ) in skeletal muscle were independently predictive of improved 6-min walk distance ( r2 = 0.78 ; P = 0.0024 ) . High-intensity progressive resistance training improves impaired skeletal muscle characteristics and overall exercise performance in older women with CHF . These gains are largely explained by skeletal muscle and not resting cardiac adaptations",
"The purpose of this study was to investigate the efficacy of , and the adherence to , a 12-week home-based progressive resistance training program for older adults utilizing elastic tubing . Sixty-two adults ( mean age , 71.2 years ) qualified to participate in the study . Subjects were r and omly assigned to either the exercise ( E ) ( n=31 ) or non-exercise ( NE ) group ( n=31 ) . Pre- and post-testing included isokinetic ( 1.05 rad · s −1 ) concentric/eccentric knee extension/flexion strength testing and flexibility measures of the hip , knee , and ankle . The E group trained three times per week , performing one to three sets of 10–12 repetitions for each of 12 resistance exercises . The exercises involved muscles of both the lower and upper body . Within the E group , 25 of the 31 subjects ( 80.6 % ) completed the study . Of the E subjects completing the study adherence to the three training sessions per week was 90 % ( range 72%–100 % ) . Training resistances used during workouts increased significantly with the average estimated increase being 82 % ( P P . No other significant changes were observed between E and NE groups . These results suggest that home-based resistance training programs utilizing elastic tubing can serve as a practical and effective means of eliciting strength gains in adults over the age of 65",
"Women aged 67 - 84 yr were r and omly assigned to either resistance exercise ( RE , n = 15 ) or control group ( C , n = 14 ) . RE group completed 10 wk of resistance training , whereas C group maintained normal activity . Blood sample s were obtained from the RE group ( at the same time points as for resting C ) at rest , immediately after resistance exercise , and 2 h after exercise before ( week 0 ) and after ( week 10 ) training . Mononuclear cell ( CD3 + , CD3+CD4 + , CD3+CD8 + , CD19 + , and CD3-CD16+CD56 + ) number , lymphocyte proliferative ( LP ) response to mitogen , natural cell-mediated cytotoxicity ( NCMC ) , and serum cortisol levels were determined . Strength increased significantly in RE subjects ( % change 8-repetition maximum = 148 % ) . No significant group , exercise time , or training effects were found for CD3 + , CD3+CD4 + , or CD3+CD8 + cells , but there was a significant exercise time effect for CD3-CD16+CD56 + cells . LP response was not different between groups , across exercise time , or after training . NCMC was increased immediately after exercise for RE subjects at week 0 and for RE and C groups at week 10 . The week 0 and week 10 NCMC values were above baseline for both RE and C groups 2 h after exercise . In conclusion , acute resistance exercise did not result in postexercise suppression of NCMC or LP , and 10 wk of resistance training did not influence resting immune measures in women aged 67 - 84 yr",
"BACKGROUND Muscle size and strength decrease with aging , and the result ant muscle weakness has been implicated in increased risk of falls in older adults . These falls have large economic and functional costs . METHODS The purpose of this r and omized , controlled study was to determine if an 8-week , 3-day per week intense ( 77.8 + /- 3.4 % of 1-repetition maximum [ 1RM ] ) strength training program could improve functional ability related to the risk of falling in subjects aged 61 - -87 years ( mean 72 , SD 6.3 ) . Twelve strength-training-naive subjects performed two sets of 10 repetitions for six lower body exercises while 12 subjects served as nonintervention controls . Subjects were tested pre- , mid- , and postintervention for strength gain and on three tests of functional ability . RESULTS Postintervention strength was significantly better ( p injuries were reported as a result of either training or 1RM testing . After controlling for preintervention differences , repeated measure analysis of covariance ( ANCOVA ) found a significant difference between experimental and nonintervention control subjects for postintervention maximal walking speed [ F(1,19 ) = 5.03 , p 1-leg blind balance time or 5-repetition sit-to-st and performance [ F(1,19 ) = .082 ; F(1,19 ) = .068 , respectively , p > .05 ] . CONCLUSIONS These findings suggest that strength training alone does not appear to enhance st and ing balance or sit-to-st and performance in active , community-dwelling older adults but that it may improve maximal walking speed . The relationship between strength gain and risk of falls remains unclear . The data do reinforce the notion that intense strength training is a safe and effective way to increase muscle strength in this population",
"BACKGROUND Past studies suggest multidisciplinary interventions that include physical therapy ( PT ) can improve function of nursing home residents . This trial specifically evaluates effects of PT for frail long-stay nursing home residents . DESIGN R and omized , controlled trial . SETTING One academic nursing home and eight community nursing homes . PATIENTS A total of 194 elderly nursing home residents dependent in at least two activities of daily living residing in the nursing home for at least 3 months . INTERVENTIONS Patients were r and omized to individually tailored one-on-one PT sessions or friendly visits ( FVs ) three times a week for 4 months . Physical therapy included range-of-motion , strength , balance , transfer , and mobility exercises . MAIN OUTCOME MEASURES Performance-based physical function assessed by the Physical Disability Index ; self-perceived health status assessed with the Sickness Impact Profile ; observer-reported activities of daily living ; and falls . RESULTS Eighty-nine percent and 92 % of PT and FV sessions , respectively , were attended ; 5 % and 9 % of subjects dropped out in the PT group and FV group , respectively . Compared with the FV group , the PT group experienced no significant improvements in overall Physical Disability Index , Sickness Impact Profile , or activities of daily living scores . A 15.5 % improvement in the mobility subscale of the Physical Disability Index was seen ( 95 % confidence interval [ CI ] , 6.4 % to 24.7 % ) ; no benefits in range-of-motion , strength , or balance subscales were found . Compared with the FV group , the PT group used assistive devices for bed mobility tasks less often ( P = .06 ) and were less likely to use assistive devices and wheelchairs for locomotion ( P group vs 60 falls in the FV group ( P = .11 ) . Charge for the 4-month PT program was $ 1220 per subject ( 95 % CI , $ 412 to $ 1832 ) . CONCLUSION This st and ardized physical therapy program provided modest mobility benefits for very frail long-stay nursing home residents with physical disability due to multiple comorbid conditions",
"OBJECTIVES The objective of this study is to determine if exercise increases joint symptoms in older adults with a history of arthritis or produces symptoms in older adults without such history . In addition , we examine whether joint symptoms explain the large observed variation in strength gain in older adults undergoing vigorous strength training exercise , and report the incidence of musculoskeletal injuries upon initiation of an exercise program . DESIGN A population -based , single blinded , r and omized controlled trial with three exercise groups and one control group . SETTING A large urban health maintenance organization . PARTICIPANTS Older men and women ( N = 105 ) aged 68 to 85 , with leg strength below the 50th percentile for their age , sex , height , and weight and without neuromuscular disease or active cardiovascular disease . INTERVENTIONS Supervised exercise in 1-hour sessions , three times each week , for 24 to 26 weeks . One exercise group did strength training ( ST ) using weight machines ( n = 25 ) ; another group did endurance training ( ET ) using stationary cycles ( n = 25 ) ; and the third group did combined strength training and endurance training ( ST+ET ) ( n = 25 ) . The control group ( n = 30 ) received no intervention . MEASUREMENTS Strength was measured at the ankle , knee , hip , and elbow using an isokinetic dynamometer . Joint symptoms were rated on a 6-point scale ( 0 = none , 5 = severe ) . Arthritis severity was based on self-reported use of arthritis medication . Health status was measured with subscales of the SF-36 and Sickness Impact Profile ( SIP ) . RESULTS Joint symptoms fluctuated over time in all exercise groups , but they did not improve or worsen significantly in any group . The physical dimension of the SIP and SF-36 subscale scores , including Bodily Pain Scores , did not change over time in any group . Subjects with arthritis and joint symptoms gained as much strength with strength training as did subjects without joint symptoms . Adjustment for age , gender , baseline strength , adherence , and exercise group did not affect this finding . The rate of minor musculoskeletal injuries was 2.2 injuries per 1000 exercise hours . CONCLUSIONS Moderate intensity stationary cycle exercise and vigorous intensity strength training do not appear to produce or exacerbate joint symptoms in older adults . Joint symptoms did not explain the large variation in gains in strength in older adults participating in a st and ardized strength training exercise program . Musculoskeletal injuries occurred relatively infrequently , and no major injuries occurred . In evaluating joint pain that occurs in older adults in well regulated exercise programs , clinicians should consider other etiologies before attributing pain to exercise per se",
"PURPOSE The purpose of this study was to compare the effects of high-resistance ( HR ) training , 3 times.wk(-1 ) at 80 % maximum strength ( 1RM ) with 3 times.wk(-1 ) variable-resistance ( VR ) training ( once-weekly training at 80 % , 65 % , and 50 % 1RM ) in older adults . METHODS The study was a 6-month resistance training intervention conducted in the Birmingham Alabama metropolitan area , and included healthy volunteer men and women over the age of 60 . Twenty-eight subjects were assigned r and omly to two training groups . Eight volunteers served as controls . Before and after 25 wk of training , body composition was measured by densitometry ; strength by isometric tests ; and difficulty in performing daily activity tasks ( DAT ) by measuring heart rate , oxygen uptake , electromyography , and perceived exertion . In addition , 1RM strength was measured every 25 d throughout the 6 months of training . Repeated measures ANOVA and paired t-tests with Bonferroni corrections for additive alpha were used to analyze the data . RESULTS The control group did not significantly change in any study parameter . No significant change in body weight occurred for any group . However , the HR and VR groups increased fat free mass ( FFM ) similarly ( 1.8 kg and 1.9 kg , respectively ) . Both training groups increased strength significantly , without significant differences in change . No significant change in oxygen uptake occurred during DAT . However , there was a significant time effect for heart rate and perceived exertion . Greater decrease in normalized integrated electromyography during the carry task was found in the VR group over the HR and control groups . CONCLUSION Despite similar increases in strength and fat free mass , the VR group decreased difficulty of performing the carry task more than the HR group . These data suggest that larger improvements in DAT may be achieved if frequency of high-resistance training is less than 3 times.wk(-1 )",
"BACKGROUND The study tested the effect of strength and endurance training on gait , balance , physical health status , fall risk , and health services use in older adults . METHODS The study was a single-blinded , r and omized controlled trial with intention-to-treat analysis . Adults ( n = 105 ) age 68 - 85 with at least mild deficits in strength and balance were selected from a r and om sample of enrollees in a health maintenance organization . The intervention was supervised exercise ( 1-h sessions , three per week , for 24 - 26 weeks ) , followed by self-supervised exercise . Exercise groups included strength training using weight machines ( n = 25 ) , endurance training using bicycles ( n = 25 ) , and strength and endurance training ( n = 25 ) . Study outcomes included gait tests , balance tests , physical health status measures , self-reported falls ( up to 25 months of follow-up ) , and inpatient and outpatient use and costs . RESULTS There were no effects of exercise on gait , balance , or physical health status . Exercise had a protective effect on risk of falling ( relative hazard = .53 , 95 % CI = .30-.91 ) . Between 7 and 18 months after r and omization , control subjects had more outpatient clinic visits ( p hospital costs over $ 5000 ( p Exercise may have beneficial effects on fall rates and health care use in some subgroups of older adults . In community-living adults with mainly mild impairments in gait , balance , and physical health status , short-term exercise may not have a restorative effect on these impairments",
"OBJECTIVE To determine the safety and efficacy of 3 months of resistive training of multiple lower extremity muscle groups compared with balance training in persons over 75 years . DESIGN R and omized 3-month clinical trial . Subjects ( n = 110 , mean age 80 ) were r and omized to 4 groups in a 2 x 2 design ( control , resistive , balance , combined resistive/balance ) . INTERVENTIONS Resistive training involved knee extension and flexion , hip abduction and extension , and plantar and dorsiflexion using simple resistive machines and s and bags . Balance training consisted of exercises to improve postural control . The control group attended 5 health-related discussion sessions . MEASUREMENTS Summed isokinetic moments ( N m ) of 8 leg movements : hip , knee and ankle flexion/extension , and hip abduction/adduction . Secondary outcomes were gait velocity and chair rise time . MAIN RESULTS Summed peak moment increased in both resistive exercise-trained groups ( 13 % increase in the resistive group and 21 % in the combined training group , P resistance training was significant ( MANOVA F = 21.1 , P strength , and there was no interaction ( positive or negative ) between balance and resistive training . Maximal gait velocity and chair rise time did not improve . Eleven subjects ( 20 % ) had musculoskeletal complaints related to resistive training , but all were able to complete the program with modifications . CONCLUSION Resistive training using simple equipment is an effective and acceptable method to increase overall leg strength in older persons . Resistive or balance training did not improve maximal gait velocity or chair rise time in this sample of relatively healthy older persons",
"OBJECTIVE To determine how multiple risk factors for osteoporotic fractures could be modified by high-intensity strength training exercises in postmenopausal women . DESIGN R and omized controlled trial of 1-year duration . SETTING Exercise laboratory at Tufts University , Boston , Mass. POPULATION Forty postmenopausal white women , 50 to 70 years of age , participated in the study ; 39 women completed the study . The subjects were sedentary and estrogen-deplete . INTERVENTIONS High-intensity strength training exercises 2 days per week using five different exercises ( n = 20 ) vs untreated controls ( n = 19 ) . MAIN OUTCOME MEASURES Dual energy x-ray absorptiometry for bone status , one repetition maximum for muscle strength , 24-hour urinary creatinine for muscle mass , and backward t and em walk for dynamic balance . RESULTS Femoral neck bone mineral density and lumbar spine bone mineral density increased by 0.005 + /- 0.039 g/cm2 ( 0.9 % + /- 4.5 % ) ( mean + /- SD ) and 0.009 + /- 0.033 g/cm2 ( 1.0 % + /- 3.6 % ) , respectively , in the strength-trained women and decreased by -0.022 + /- 0.035 g/cm2 ( -2.5 % + /- 3.8 % ) and -0.019 + /- 0.035 g/cm2 ( -1.8 % + /- 3.5 % ) , respectively , in the controls ( P = .02 and .04 ) . Total body bone mineral content was preserved in the strength-trained women ( + 2.0 + /- 68 g ; 0.0 % + /- 3.0 % ) and tended to decrease in the controls ( -33 + 77 g ; -1.2 % + /- 3.4 % , P = .12 ) . Muscle mass , muscle strength , and dynamic balance increased in the strength-trained women and decreased in the controls ( P = .03 to High-intensity strength training exercises are an effective and feasible means to preserve bone density while improving muscle mass , strength , and balance in postmenopausal women",
"BACKGROUND Functional assessment is an important part of the evaluation of elderly persons . We conducted this study to determine whether objective measures of physical function can predict subsequent disability in older persons . METHODS This prospect i ve cohort study included men and women 71 years of age or older who were living in the community , who reported no disability in the activities of daily living , and who reported that they were able to walk one-half mile ( 0.8 km ) and climb stairs without assistance . The subjects completed a short battery of physical-performance tests and participated in a follow-up interview four years later . The tests included an assessment of st and ing balance , a timed 8-ft ( 2.4-m ) walk at a normal pace , and a timed test of five repetitions of rising from a chair and sitting down . RESULTS Among the 1122 subjects who were not disabled at base line and who participated in the four-year follow-up , lower scores on the base-line performance tests were associated with a statistically significant , graduated increase in the frequency of disability in the activities of daily living and mobility-related disability at follow-up . After adjustment for age , sex , and the presence of chronic disease , those with the lowest scores on the performance tests were 4.2 to 4.9 times as likely to have disability at four years as those with the highest performance scores , and those with intermediate performance scores were 1.6 to 1.8 times as likely to have disability . CONCLUSIONS Among nondisabled older persons living in the community , objective measures of lower-extremity function were highly predictive of subsequent disability . Measures of physical performance may identify older persons with a pre clinical stage of disability who may benefit from interventions to prevent the development of frank disability",
"The purpose of this study was to determine the effects of a 12-month resistance training program , of two different intensities , on bone mineral density ( BMD ) in healthy , older women . Twenty-six Caucasian women ( aged 65 - 79 years ) completed the study . Subjects were r and omly assigned to one of three groups : high-intensity ( HI ; n = 8) , low-intensity ( LI ; n = 7 ) , and control ( CON ; n = 11 ) . The active groups performed 10 exercises , 3 days/week under supervision . Exercise intensity was maintained at 80 % of one-repetition maximum ( 1-RM ) for the HI groups , and at 40 % 1-RM for the LI group . The volume of work was maintained constant between the two groups by assigning the LI group twice as many repetitions for each exercise . Maximal muscular strength and BMD of the lumbar spine and total hip were measured at baseline and at 12 months . Strength was evaluated using the 1-RM method , and BMD was determined by dual-energy X-ray absorptiometry . Exercise session attendance was similar for the two groups ( 81.0 % HI ; 76.8 % LI ) . Muscular strength improved in the exercisers compared with the CON group ( p Percentage change in lumbar spine BMD was 0.7 + /- 1.9 % , 0.5 + /- 2.4 % , and -0.1 + /- 2.3 % for the HI , LI , and CON groups , respectively . Percentage change in total hip BMD was 0.8 + /- 2.3 % ( HI ) , 1.0 + /- 1.7 % ( LI ) , and 0.9 + /- 1.3 % ( CON ) . Group differences in BMD change were not significant ( p > 0.05 ) . These findings suggest that high-intensity and low-intensity resistance training regimens effectively increase muscular strength , but not lumbar spine or total hip BMD , in healthy , older women",
"Abstract Objective : To assess the effectiveness of a home exercise programme of strength and balance retraining exercises in reducing falls and injuries in elderly women . Design : R and omised controlled trial of an individually tailored programme of physical therapy in the home ( exercise group , n=116 ) compared with the usual care and an equal number of social visits ( control group , n=117 ) . Setting : 17 general practice s in Dunedin , New Zeal and . Subjects : Women aged 80 years and older living in the community and registered with a general practice in Dunedin . Main outcome measures : Number of falls and injuries related to falls and time between falls during one year of follow up ; changes in muscle strength and balance measures after six months . Results : After one year there were 152 falls in the control group and 88 falls in the exercise group . The mean ( SD ) rate of falls was lower in the exercise than the control group ( 0.87 ( 1.29 ) v 1.34 ( 1.93 ) falls per year respectively ; difference 0.47 ; 95 % confidence interval 0.04 to 0.90 ) . The relative hazard for the first four falls in the exercise group compared with the control group was 0.68 ( 0.52 to 0.90 ) . The relative hazard for a first fall with injury in the exercise group compared with the control group was 0.61 ( 0.39 to 0.97 ) . After six months , balance had improved in the exercise group ( difference between groups in change in balance score 0.43 ( 0.21 to 0.65 ) . Conclusions : An individual programme of strength and balance retraining exercises improved physical function and was effective in reducing falls and injuries in women 80 years and older . Key messages Modifiable risk factors for falls in elderly people have been well defined ; they include loss of muscle strength and impaired balance A programme to improve strength and balance in women aged 80 years and older can be set up safely with four home visits from a physiotherapist This programme reduced falls and moderate injuries appreciably over the subsequent year in Dunedin , New Zeal and The benefit was most noticeable in elderly people who fell",
"OBJECTIVE To examine the effects of aerobic and resistance exercise on self-efficacy beliefs in older adults with knee osteoarthritis ( OA ) and to determine whether self-efficacy and knee pain mediated the effects of the treatments on stair time performance and health perceptions . METHODS Measures of self-efficacy , knee pain , stair climbing performance , and health perceptions were collected prior to r and omization and again at an 18-month followup in older adults with knee OA who were assigned to 1 of 3 treatment conditions : aerobic exercise , resistance training , or health education control . All analyses were conducted on the intention-to-treat principle . RESULTS Both exercise treatments increased self-efficacy for stair climbing in comparison to the health education control group . Both knee pain and self-efficacy mediated the effect of the treatments on stair climb time , whereas only knee pain mediated health perceptions . CONCLUSIONS The findings suggest that control beliefs and changes in physical symptoms such as knee pain are important outcomes in physical activity programs with patients who have OA of the knee . Moreover , these variables mediate the effects that such programs have on disability and health perceptions",
"Exercise is known to preserve many physiological responses in the healthy elderly , yet those with physical impairments are often discouraged from exercising . The authors studied the effects of a closely supervised exercise program design ed specifically for elders with health problems and functional limitations . Tests , selected for their relevance to clinical patient management , included the Self Evaluation of Life Function question naire , treadmill performance , and tests of autonomic nervous system and neuromotor functions . Ambulatory volunteers , aged 64 to 83 years , with noncardiac health problems , were r and omly assigned to a control group ( CG ; n = 17 ) or a 16-week exercise group ( EG ; 3 hr/wk , n = 18 ) . Nine of the control and 13 of the exercise subjects completed the study . All EG dropouts were due to illness . EG attendance averaged 87 % , and subjects trained at a heart rate ( HR ) of 103 + /- 5 beats/min ( SD ) ( 98 % of prescription HR ) . Though EG test responses showed a tendency to improve , none reached statistical significance . This result was affected by the small number completing the study and the variability inherent in such a sample . Though these impaired elderly subjects enthusiastically and safely participated with high attendance and at an exercise intensity adequate to expect benefit , measurable training effects were not demonstrated",
"OBJECTIVE To determine the short- and long-term effects of resistance training on muscle strength , psychological well-being , control-beliefs , cognitive speed and memory in normally active elderly people . METHODS 46 elderly people ( mean age 73.2 years ; 18 women and 28 men ) , were r and omly assigned to training and control groups ( n=23 each ) . Pre- and post-tests were administered 1 week before and 1 week after the 8-week training intervention . The training sessions , performed once a week , consisted of a 10 min warm-up phase and eight resistance exercises on machines . RESULTS There was a significant increase in maximum dynamic strength in the training group . This training effect was associated with a significant decrease in self-attentiveness , which is known to enhance psychological well-being . No significant changes could be observed in control-beliefs . Modest effects on cognitive functioning occurred with the training procedure : although there were no changes in cognitive speed , significant pre/post-changes could be shown in free recall and recognition in the experimental group . A post-test comparison between the experimental group and control group showed a weak effect for recognition but no significant differences in free recall . Significant long-term effects were found in the training group for muscular strength and memory performance ( free recall ) 1 year later . CONCLUSION An 8-week programme of resistance training lessens anxiety and self-attentiveness and improves muscle strength",
"To evaluate the effect of aerobic and variable resistance exercise training on fractionated reaction time ( RT ) and speed of movement ( SM ) in elderly individuals , premotor time ( PMT ) , motor time ( MT ) , total RT , and SM were measured in 49 healthy , untrained men and women , 70 to 79 years of age , before and after 6 months of training . Subjects were r and omized into either a walk/jog ( n = 17 ) , a strength training ( n = 20 ) , or a control group ( n = 12 ) . Improvements in aerobic capacity were only weakly related to reduced total RT ( r = 0.30 , p less than .05 ) . Analysis of covariance revealed that there were no differences ( p greater than .05 ) among the three groups after training with respect to PMT , MT , total RT , and SM . These findings indicate that 6 months of aerobic and strength training did not induce significant changes in RT or SM in this group",
"BACKGROUND Decreased muscle strength impedes elders ' functional performance in daily activities such as gait . The mechanisms whereby increased strength improves gait are unknown . METHODS A prospect i ve , blinded , r and omized trial of moderate intensity strength exercise was conducted and its impact was measured on functional mobility during gait in 132 functionally limited elders . Lower extremity strength was measured , including hip abductor , hip extensor , and knee extensor strength . Of the 132 subjects , 120 subjects ( mean age , 75.1 yrs ) completed 6 months of elastic b and resistance training at least 3 times a week or served as no-exercise controls . RESULTS Subjects increased their lower extremity strength in the exercise and control groups , by 17.6 % and 7.3 % ( p Gait stability improved significantly more in the exercise group than in the control group ( p forward gait velocity were not significantly different between groups . Peak mediolateral velocity and base of support improved in the exercise group , but not in the control group . Change in lower extremity strength correlated significantly but weakly with many of the gait variables . CONCLUSIONS Gait stability , especially mediolateral steadiness , improved in the exercise group but not in the control group . These results show that even moderate strength gains benefit gait performance in elders and thus provide a sound basis for encouraging low-intensity strength training for elders with functional limitations",
"Resistance training ( RT ) has gained popularity as an effective form of exercise for older adults . However , the effects of RT on left ventricular ( LV ) morphology and systolic function in older persons is not well known . The purpose of this study was to assess the effects of 16 weeks of RT on LV morphology and systolic function in healthy older men . Subjects were r and omly assigned into a RT group ( n = 10 ; mean+/- SD age , 68 + /- 3 years ) or a nonexercise control group ( n = 10 ; age 68 + /- 4 years ) . RT was performed 3 times per week for 16 weeks at a mean intensity between 60 % and 80 % of 1 repetition maximum . Leg and bench press 1 repetition maximum and 2-dimensional echocardiography were performed at baseline and after 4 , 8 , 12 , and 16 weeks of training in the RT group . Sixteen weeks of RT was associated with an increase in leg press maximal strength ( baseline , 285 + /- 48 kg ; after 16 weeks , 367 + /- 47 kg ; p bench press maximal strength ( baseline , 59 + /- 11 kg ; after 16 weeks , 69 + /- 11 kg ; p leg press maximal strength ( baseline , 291 + /- 59 kg ; after 16 weeks , 290 + /- 53 kg ; p > 0.05 ) or bench press maximal strength ( baseline , 60 + /- 9 kg ; after 16 weeks , 61 + /- 13 kg ; p > .05 ) was found in control subjects during the same time . RT was not associated with changes in LV cavity size , wall thickness , mass , or systolic function after 4 , 8 , 12 , and 16 weeks of exercise . Thus , 16 weeks of RT was sufficient to increase leg press and bench press maximal strength but did not alter the size or systolic function of the senescent left ventricle",
"Regular exercise is widely advocated for the young and middle-aged , but less is heard about its relevance to elderly people . This study reports the findings of a controlled trial of seated exercise in residents of local authority homes for the elderly . Forty-nine residents aged 64 - 91 years volunteered for the 7-month project , and participated in either twice-weekly exercise or reminiscence sessions . Primary outcome measures were postural sway , flexibility of the spine and knees , h and -grip strength and functional capacity . The average ( range of ) attendance at the exercise sessions was 91 % ( 64 - 100 % ) , and at the reminiscence sessions was 86 % ( 46 - 100 % ) . By the end of the project , the change observed in the exercise group was significantly different from that of the reminiscence group in terms of grip strength ( p spinal flexion ( p chair-to-st and time ( p activities of daily living ( p self-rating of depression ( p very elderly residents of old peoples homes can benefit from participation in regular seated exercise and improve their functional capacity",
"The purpose of this study was to evaluate whether strength training is a useful addition to aerobic training in patients with chronic obstructive pulmonary disease ( COPD ) . Forty-five patients with moderate to severe COPD were r and omized to 12 wk of aerobic training alone ( AERO ) or combined with strength training ( AERO + ST ) . The AERO regimen consisted of three weekly 30-min exercise sessions on a calibrated ergocycle , and the ST regimen included three series of eight to 10 repetitions of four weight lifting exercises . Measurements of peripheral muscle strength , thigh muscle cross-sectional area ( MCSA ) by computed tomographic scanning , maximal exercise capacity , 6-min walking distance ( 6MWD ) , and quality of life with the chronic respiratory question naire were obtained at baseline and after training . Thirty-six patients completed the program and constituted the study group . The strength of the quadriceps femoris increased significantly in both groups ( p thigh MCSA and strength of the pectoralis major muscle increased in the AERO + ST group by 8 + /- 13 % and 15 + /- 9 % , respectively ( p 0.05 ) . These changes were significantly different in the two study groups ( p increase in strength of the latissimus dorsi muscle after training was modest and of similar magnitude for both groups . The changes in peak exercise work rate , 6MWD , and quality of life were comparable in the two groups . In conclusion , the addition of strength training to aerobic training in patients with COPD is associated with significantly greater increases in muscle strength and mass , but does not provide additional improvement in exercise capacity or quality of life",
"The short- and long-term effects of heavy-resistance training ( 85 % of one-repetition maximum ( RM ) ) on elbow flexion and knee extension dynamic and isokinetic strength and on morphology in the biceps brachii and vastus lateralis muscles were evaluated during 1 year in 35 Sc and inavian men and women , aged 70 - 77 years , 12 of whom formed a control group . After the first 11 weeks of training ( n = 23 ; 3 times/week ) elbow flexion and knee extension dynamic strength ( 1 RM ) had increased [ mean + /- SD ] 49 % + /- 16 and 163 % + /- 75 , respectively , with no significant difference between men and women . For the following 27 weeks , strength was maintained with one training session per week ( n = 12 ) but dropped without training ( n = 11 ) . After the final 11 weeks of training ( n = 11 ; 3 times/week ) , strength had further increased 32 % + /- 16 in both the arm and the leg . Isokinetic strength measurements ( Cybex II ; 30 degrees/s ) revealed similar but smaller gains than for dynamic strength . Muscle biopsies ( n = 20 ) taken at the start and after the first 11 weeks of training showed a significant increase in the area of both type 1 and type 2 fibers in the biceps brachii muscle and a positive significant correlation between the percentage increase in the proportional area of type 2 fibers in the vastus lateralis muscle and the percentage increase in knee extension dynamic muscle strength . In conclusion , older Sc and inavian men and women have a high capacity both to improve and to maintain muscle strength , some of which is mediated through an adaptation in the muscle fiber type population",
"OBJECTIVE The purpose s of this pilot study were to determine if a combined dietary and exercise intervention would result in significant weight loss in older obese adults with knee osteoarthritis , and to compare the effects of exercise plus dietary therapy with exercise alone on gait , strength , knee pain , biomarkers of cartilage degradation , and physical function . DESIGN Single-blind , two-arm , r and omized clinical trial conducted for 24 weeks . SETTING A university health and exercise science center . PARTICIPANTS Twenty-four community-dwelling obese older adults aged > or = 60 years , body mass index > or = 28 , knee pain , radiographic evidence of knee osteoarthritis , and self-reported physical disability . INTERVENTION R and omization into two groups : exercise and diet ( E&D ) and exercise alone ( E ) . Exercise consisted of a combined weight training and walking program for 1 hour three times per week . The dietary intervention included weekly sessions with a nutritionist utilizing cognitive-behavior modification to change dietary habits to reach a group goal of an average weight loss of 15 lb ( 6.8 kg ) over 6 months . MEASUREMENTS All measurements were conducted at baseline and 3 and 6 months , except for synovial fluid analysis , which was obtained only at baseline and 6 months . In addition , weight was measured weekly in the E&D group . Physical disability and knee pain were measured by self-report and physical performance was measured using the 6-minute walk and stair climb tasks . Biomechanical testing included kinetic and kinematic analysis of gait and isokinetic strength testing . Synovial fluid was analyzed for levels of total proteoglycan , keratan sulfate , and interleukin-1 beta . RESULTS Twenty-one of the 24 participants completed the study , with one dropout in the E&D group and two in the E group . The E&D group lost a mean of 18.8 lb ( 8.5 kg ) at 6 months compared with 4.0 lb ( 1.8 kg ) in the E group ( P = .01 ) . Significant improvements were noted in both groups in self-reported disability and knee pain intensity and frequency as well as in physical performance measures . However , no statistical differences were found between the two groups at 6 months in knee pain scores or self-reported performance measures of physical function . There was no difference in knee strength between the groups , with both groups showing modest improvements from baseline to 6 months . At 6 months , the E&D group had a significantly greater loading rate ( P = .03 ) and maximum braking force ( P = .01 ) during gait . There were no significant between-group differences in the other biomechanical measures . Synovial fluid sample s were obtainable at both baseline and 6 months in eight participants ( four per group ) . The level of keratan sulfate decreased similarly in both groups from an average baseline of 96.8 + /- 37.1 to 71.5 + /- 23 ng/microg total proteoglycan . The level of IL-1 decreased from 25.3 + /- 9.8 at baseline to 8.3 + /- 6.1 pg/mL. The decrease in IL-1 correlated with the change in pain frequency ( r = -0.77 , P = .043 ) . CONCLUSIONS Weight loss can be achieved and sustained over a 6-month period in a cohort of older obese persons with osteoarthritis of the knee through a dietary and exercise intervention . Both exercise and combined weight loss and exercise regimens lead to improvements in pain , disability , and performance . Moreover , the trends in the biomechanical data suggest that exercise combined with diet may have an additional benefit in improved gait compared with exercise alone . A larger study is indicated to determine if weight loss provides additional benefits to exercise alone in this patient population",
"The short-term effects of an accessible exercise intervention on the strength and health-related quality of life ( HRQOL ) among older adult women were evaluated . We conducted an 8-week resistance training intervention utilizing elastic b and s in 62 community-dwelling women with a mean age of 68 years . Participants were r and omly assigned to either an exercise or a control group . Pre- and postintervention assessment s included strength tests and HRQOL . Results revealed significant increases in three major muscles compared to the control group . However , there were no significant changes on either mental or physical health functioning . The elastic b and s provide older adult women with an inexpensive , practical exercise program that effectively increases strength within 8 weeks but may have little effect on self-reported HRQOL",
"Both aerobic training ( AT ) and resistance training ( RT ) may increase aerobic power ( VO2peak ) in the older population ; however , the role of changes in the capillary supply in this response has not been evaluated . Twenty healthy men ( age 65 - 74 yr ) engaged in either 9 wk of lower body RT followed by 9 wk of AT on a cycle ergometer ( RT-->AT group ) or 18 wk of AT on a cycle ergometer ( AT-->AT group ) . RT was performed three times per week and consisted of three sets of four exercises at 6 - 12 repetitions maximum . AT was performed three times per week for 30 min at 60 - 70 % heart rate reserve . VO2peak was increased after both RT and AT ( P number of capillaries per fiber perimeter length was increased after both AT and RT ( P VO2peak , whereas capillary density was increased only after AT ( P change in capillary supply and VO2peak ( r = 0.52 ) , suggest the possibility that similar mechanisms may be involved in the increase of VO2peak after high-intensity RT and AT in the older population",
"OBJECTIVE To determine the effects of structured exercise programs on self-reported disability in older adults with knee osteoarthritis . SETTING AND DESIGN A r and omized , single-blind clinical trial lasting 18 months conducted at 2 academic medical centers . PARTICIPANTS A total of 439 community-dwelling adults , aged 60 years or older , with radiographically evident knee osteoarthritis , pain , and self-reported physical disability . INTERVENTIONS An aerobic exercise program , a resistance exercise program , and a health education program . MAIN OUTCOME MEASURES The primary outcome was self-reported disability score ( range , 1 - 5 ) . The secondary outcomes were knee pain score ( range , 1 - 6 ) , performance measures of physical function , x-ray score , aerobic capacity , and knee muscle strength . RESULTS A total of 365 ( 83 % ) participants completed the trial . Overall compliance with the exercise prescription was 68 % in the aerobic training group and 70 % in the resistance training group . Postr and omization , participants in the aerobic exercise group had a 10 % lower adjusted mean ( + /- SE ) score on the physical disability question naire ( 1.71 + /- 0.03 vs 1.90 + /- 0.04 units ; P knee pain question naire ( 2.1 + /- 0.05 vs 2.4 + /- 0.05 units ; P=.001 ) , and performed better ( mean [ + /- SE ] ) on the 6-minute walk test ( 1507 + /- 16 vs 1349 + /- 16 ft ; P time to climb and descend stairs ( 12.7 + /- 0.4 vs 13.9 + /- 0.4 seconds ; P=.05 ) , time to lift and carry 10 pounds ( 9.1 + /- 0.2 vs 10.0 + /- 0.1 seconds ; P time to get in and out of a car ( 8.7 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P resistance exercise group had an 8 % lower score on the physical disability question naire ( 1.74 + /- 0.04 vs 1.90 + /- 0.03 units ; P=.003 ) , 8 % lower pain score ( 2.2 + /- 0.06 vs 2.4 + /- 0.05 units ; P=.02 ) , greater distance on the 6-minute walk ( 1406 + /- 17 vs 1349 + /- 16 ft ; P=.02 ) , faster times on the lifting and carrying task ( 9.3 + /- 0.1 vs 10.0 + /- 0.16 seconds ; P=.001 ) , and the car task ( 9.0 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P=.003 ) than the health education group . There were no differences in x-ray scores between either exercise group and the health education group . CONCLUSIONS Older disabled persons with osteoarthritis of the knee had modest improvements in measures of disability , physical performance , and pain from participating in either an aerobic or a resistance exercise program . These data suggest that exercise should be prescribed as part of the treatment for knee osteoarthritis",
"OBJECTIVE To determine whether a 12-month program of regular exercise can improve balance , reaction time , neuromuscular control , and muscle strength and reduce the rate of falling in older women . DESIGN A r and omized , controlled trial of 12 months duration . SETTING Conducted as part of the R and wick Falls and Fractures Study in Sydney , Australia . PARTICIPANTS One hundred ninety-seven women aged 60 to 85 years ( mean age 71.6 , SD = 5.4 ) who were r and omly recruited from the community . OUTCOME MEASURES Accidental falls , postural sway , reaction time , neuromuscular control , and lower limb muscle strength . MAIN RESULTS Exercise and control subjects were tested before , midway through , and at the end of the trial . At initial testing , exercisers and controls performed similarly in all tests and were well matched in relevant health and lifestyle factors . The mean number of classes attended for the 75 exercise subjects who completed the program was 60.0 ( range 26 - 82 ) . At the end of the trial , the exercise subjects showed improved performance in all five strength measures , in reaction time , neuromuscular control , body sway on a firm surface with the eyes open , and body sway on a compliant surface with the eyes open and closed . In contrast , there were no significant improvements in any of the test measures in the controls . In one test measure , hip flexion strength , the exercisers showed continued improvement throughout the study year . There was no significant difference in the proportion of fallers between the exercise and control subjects . Interesting trends were evident , however , between falls frequency and adherence to the exercise program . CONCLUSIONS These findings show that exercise can produce long-term benefits with regard to improving sensorimotor function in older persons . The findings also suggest that high compliance to an exercise program may reduce falls frequency , although further studies are required to conclusively demonstrate that exercise offers an effective means of preventing falls",
"BACKGROUND Depression in elderly people may be contributed to by the multiple losses of aging . Exercise has the potential to positively impact many of these losses simultaneously . We tested the hypothesis that progressive resistance training ( PRT ) would reduce depression while improving physiologic capacity , quality of life , morale , function and self-efficacy without adverse events in an older , significantly depressed population . METHODS We conducted a 10-week r and omized controlled trial of volunteers aged 60 and above with major or minor depression or dysthymia . Subjects were r and omized for 10 weeks to either a supervised PRT program three times a week or an attention-control group . RESULTS A total of 32 subjects aged 60 - 84 , mean age 71.3 + /- 1.2 yr , were r and omized and completed the study . No significant adverse events occurred . Median compliance was 95 % . PRT significantly reduced all depression measures ( Beck Depression Inventory in exercisers 21.3 + /- 1.8 to 9.8 + /- 2.4 versus controls 18.4 + /- 1.7 to 13.8 + /- 2 , p = .002 ; Hamilton Rating Scale of Depression in exercisers 12.3 + /- 0.9 to 5.3 + /- 1.3 versus controls 11.4 + /- 1.0 to 8.9 + /- 1.3 , p = .008 ) . Quality of life subscales of bodily pain ( p = .001 ) , vitality ( p = .002 ) , social functioning ( p = .008 ) , and role emotional ( p = .02 ) were all significantly improved by exercise compared to controls . Strength increased a mean of 33 % + /- 4 % in exercisers and decreased 2 % + /- 2 % in controls ( p depression scores ( r2 = .617 , p = .0002 ) . CONCLUSIONS PRT is an effective antidepressant in depressed elders , while also improving strength , morale , and quality of life",
"We evaluated the effect of a strength-training program on the ability of persons with essential tremor to exert steady forces with the index finger . Thirteen subjects with a diagnosis of essential tremor were assigned to three different groups : one group trained with heavy loads , one with light loads , and one did not perform any training . Subjects attempted to generate steady contractions during both postural and constant-force tasks . Steadiness was quantified by the root mean square amplitude of acceleration during postural tasks and the st and ard deviation and coefficient of variation of force during the constant-force tasks . Subjects who performed the training program with heavy loads experienced an increase in steadiness around the target force during the constant-force tasks . Subjects in the other two groups did not exhibit any changes . These findings suggest that strength training can decrease the magnitude of tremor . However , we did not observe any associated improvements in functional abilities",
"We investigated if long-term resistance training would increase insulin-like growth factor-1 ( IGF-1 ) bioavailabilty at rest in older women ( 68+/-1 years ) with low bone mineral density . IGF-1 levels were significantly lower ( P insulin-like growth factor binding proteins -1 and -3 ( IGFBP-1 and IGFBP-3 ) significantly higher than an age-matched healthy normal group . Resistance training result ed in significant ( P repetition maximums across all exercises ( range 41 - 78 % ) . Resting IGF-1 levels were significantly ( P resistance training whereas no significant changes occurred in IGFBP-1 and IGFBP-3 levels . IGFBP-1/IGF-1 and IGFBP-3/IGF-1 ratios were significantly decreased ( approximately - 50 % ) as a result of resistance training ( P IGF-1 bioavailability was increased as a result of resistance training induced increases in IGF-1 levels in older women with low bone mineral density . These alterations in the IGF-1 system may be contributing to the significant strength gain observed with the resistance training in this population",
"PURPOSE In patients with intermittent claudication ( IC ) a structured walking exercise program improves exercise performance . However , few studies have evaluated the effects of exercise training on functional status during daily activities . We hypothesized that a supervised exercise training program would improve functional status in patients with IC , with 24 weeks of training more beneficial than 12 weeks . A secondary aim was to evaluate the effects of strength training and combinations of strength and treadmill training on functional status . METHODS Twenty-nine men with disabling IC were r and omized to 12 weeks of either supervised treadmill training ( 3 hr/wk at a work intensity sufficient to produce claudication ) , strength training ( 3 hr/wk of resistive training of six muscle groups of each leg ) , or to a nonexercising control group . Functional status was assessed by question naires characterizing walking ability ( Walking Impairment Question naire , WIQ ) , habitual physical activity level ( Physical Activity Recall , PAR ) , and physical , social , and role functioning , well-being , and overall health ( Medical Outcomes Study SF-20 , MOS ) . Patients alos had their activity levels monitored with an activity monitor ( Vitalog ) . RESULTS After 12 weeks of treadmill training PAR scores increased by 48 metabolic equivalent hr/wk , the MOS physical functioning score by 24 percentage points , and the number of bouts of walking activity measured by the Vitalog by 4.5 bouts/hr ( all p WIQ scores . After 12 additional weeks of treadmill training improvements initially observed in the PAR , MOS , and Vitalog scores were maintained , and in addition the ability to walk distances ( WIQ ) improved by 31 percentage points , and the IC severity score had improved by 29 percentage points ( both p strength training patients improved their WIQ walking speed , stair climbing scores , and MOS well-being scores with no other changes in functional status . Subjects in the control group did not improve functional status by any measure . Twelve weeks of treadmill training after the strength training program maintained WIQ walking speed scores , and activity level defined by Vitalog improved . Twelve weeks of combined treadmill and strength training after the control period had no effect on functional status . CONCLUSIONS A supervised treadmill training program improved functional status during daily activities , with 24 weeks more effective than 12 . In addition , treadmill training alone was more effective in improving functional status in patients with IC than strength training or combinations of the training modalities",
"Cardiac rehabilitation programs have not consistently been shown to improve the psychological well being of their patients . In our study of 38 cardiac patients ( 29 men and 9 women ) , a variety of quality -of-life parameters were assessed before and after they completed either 12 weeks of high-intensity strength training or flexibility training added to their outpatient cardiac rehabilitation aerobic exercise program . The strength-trained patients increased their self-efficacy scores for lifting ( 29 % vs 4 % , p Mood States dimensions : total mood disturbance ( 123 % vs 18 % , p depression/dejection ( 73 % vs 15 % , p fatigue/inertia ( 42 % vs 3 % p Medical Outcome Survey Short Form 36 role emotional health domain scores were significantly improved in the strength group when compared with the flexibility group ( 64 % vs 0 % , p role limitation scores improved in both groups . Increases in strength were associated with enhanced self efficacy and improved mood and well-being scores ( n = 34 , r = 0.30 to 0.53 , p High-intensity strength training added to a cardiac rehabilitation program of selected patients leads to improvements in quality -of-life parameters . These data , in conjunction with improvements in strength , strongly support the value of adding high-intensity strength training to cardiac rehabilitation programs",
"Physical exercise is often recommended as a therapeutic tool to combat pre- and postmenopausal loss of bone density . However , the relationship between training dosage ( intensity , duration , frequency ) and the effect on bone density still is undergoing discussion . Furthermore , the exercise quantification programs are often described so inadequately that they are neither quantitatively nor qualitatively reproducible . The aim of this investigation was to determine whether a clearly defined training of muscle strength , under defined safety aspects , performed only twice weekly , can counteract bone density loss in women with postmenopausal osteopenia . Data from 16 women in the training group ( age , 63.6 + /- 6.2 yr ) and 15 women in the control group ( age , 67.4 + /-9.7 yr ) , of comparable height and weight , were evaluated . Strength training was performed for 6 mo as continually adapted strength training , providing an intensity of about 70 % of each test person 's one repetition maximum . Bone mineral density of lumbar vertebrae 2 to 4 and the femoral neck was measured by dual-energy x-ray absorptiometry . Maximum performance in watts and parameters of hemodynamics were controlled with a bicycle ergometer test to maximal effort . In addition , metabolic data were assessed . In the lumbar spine and femoral neck , the training group showed no significant changes , whereas the control group demonstrated a significant loss of bone mineral density , especially in the femoral neck ( P strength increase was highly significant in all exercised muscle groups , rising to about 70 % above the pretraining status ( P Heart rate and blood pressure data indicated a slight economization , metabolism was not significantly influenced . Based on these findings , we conclude that continually adapted strength training is an effective , safe , reproducible , and adaptable method of therapeutic strength training , following only two exercise sessions per week",
"BACKGROUND Cardiovascular benefits of resistance training in cardiac patients have been suggested but not studied in a r and omized , controlled trial of circuit weight training ( CWT ) without an aerobic exercise component . The purpose of the current study was to examine the effects of 10 weeks of CWT on muscular strength , peak oxygen consumption ( peak VO2 ) , and myocardial oxygen dem and ( mVO2 ) in men after coronary artery bypass surgery . METHODS Twenty-six , post-coronary bypass male subjects ( mean 19 months after bypass ) , aged 60 + /- 8.5 years , were r and omly allocated to 10 weeks of CWT at 40 to 60 % of maximum voluntary contraction ( n = 12 ) or to a control group ( n = 14 ) . Muscular strength was assessed using a modified one repetition maximum technique . Peak VO2 was recorded during symptom-limited treadmill exercise . Rate pressure product , as an indirect measure of mVO2 , was measured during isometric , isodynamic , and dynamic exercise . RESULTS No ischemic symptoms nor electrocardiographic changes were recorded during testing or training . Strength increased by 18 % ( P peak VO2 . Rate pressure product during isometric and isodynamic exercise decreased from pre- to post-testing ( P Moderate intensity CWT is safe and can improve strength in selected low-risk patients after coronary artery bypass surgery . However , it does not significantly increase peak VO2 nor reduce mVO2 during isometric , isodynamic , and dynamic exercise",
"BACKGROUND Although inactivity is an important contributor to impaired functioning and disability with age , little is known concerning how improvements in physical functioning and well-being in older adults vary with the type of physical activity undertaken . METHODS One hundred three adults age 65 years and older , recruited via population -based methods , were r and omized to 12 months of community-based , moderate-intensity endurance and strengthening exercises ( Fit & Firm ) or stretching and flexibility exercises ( Stretch & Flex ) . A combination of class- and home-based exercise formats was used . Measured and self-rated physical performance along with perceived functioning and well-being were assessed pre- and postintervention . RESULTS Fit & Firm subjects showed greater 12-month improvements in both measured and self-rated endurance and strength compared to Stretch & Flex subjects . Stretch & Flex subjects reported greater improvements in bodily pain , and Stretch & Flex men evidence d greater improvements in flexibility relative to Fit & Firm subjects . Although overall exercise adherence was high in both exercise conditions ( approximately 80 % ) , subjects in both conditions showed better adherence to the home- versus class-based portions of their exercise prescriptions . CONCLUSIONS Community-based programs focusing on moderate-intensity endurance and strengthening exercises or flexibility exercises can be delivered through a combination of formats that result in improvement in important functional and well-being outcomes . This represents one of the first studies to report significant improvements in an important quality of life outcome -bodily pain-with a regular regimen of stretching and flexibility exercises in a community-based sample of older adults",
"BACKGROUND Beneficial training outcomes have been reported in patients with chronic heart failure ( CHF ) following leg exercise training . However , data from more comprehensive training programs are limited . The aim of this study was to test the hypothesis that exercise training applying the concept of comprehensive local muscle training can improve aerobic and functional working capacity as well as quality of life in patients with CHF . METHODS Twenty-four men and women [ age 63+/-9 years ( mean+/-S.D. ) ] with stable , moderate chronic heart failure ( left ventricular ejection fraction 30+/-10 % ) , were investigated in a r and omized controlled study with a training group of 16 patients and a control group of 8 patients . The training was performed as an aerobic resistance training by activating all the main muscle groups , one at a time . The patients exercised for 1 h , three times per week for 8 weeks . RESULTS Patient groups did not differ at baseline . Peak oxygen uptake ( 8 % , P distance walked in a 6-min walking test ( 11 % , P health-related quality of life ( P plasma norepinephrine levels at rest ( 32 % , P peak oxygen uptake ( P quality of life scores ( P comprehensive physical training activating a minor muscle mass at a time markedly improves exercise capacity and quality of life and reduces catecholamine levels , it can be recommended for the rehabilitation of patients with CHF under supervision of a physical therapist",
"The purpose of this study was to determine whether a moderate to high intensity strengthening and aerobic exercise program can improve the strength , exercise capacity , gait and balance of deconditioned male nursing home residents . Ambulatory subjects who scored 30 or less on the modified Tinetti gait and balance assessment scale , who demonstrated less than 80 % of age-matched lower extremity strength on isokinetic muscle testing and who gave informed consent were enrolled . Subjects were r and omized to either an exercise ( n = 8) or a control ( n = 6 ) group . All participants underwent an exercise test to determine maximal oxygen uptake ( Vo2max ) and received quantitative gait and balance measurements . The subjects assigned to the exercise group then completed a 12-wk program of weight training for the lower extremities and stationary cycling . Both the exercise and control groups were then retested . Ten outcome variables were assessed : Tinetti mobility scores , Vo2max , isokinetic-tested lower extremity strength and endurance , stride length , gait velocity , stance time , gait duration , cadence and balance . The exercise group , after completion of the program , demonstrated significant improvements in Tinetti mobility scores ( P combined right and left quadricep muscle strength ( P right and left lower extremity muscular endurance ( P left stride length and gait velocity ( P control group revealed no changes of significance with the exception of improvement of the combined right and left hamstring muscle strength ( P < 0.05 ) . Nevertheless , for those outcome variables that had improved significantly in the exercise group , the changes amounted to only a 5 to 10 % increase over the baseline measurements . These findings showed that an appropriately design ed high intensity exercise program can result in significant although limited improvements for clinical mobility scores , strength , muscular endurance and certain gait parameters",
"BACKGROUND Resistance-training intervention studies have demonstrated meaningful health benefits in older adults ; however , most have used exercises performed at specific intensities on expensive equipment , which limit their widespread applicability . We tested whether two self-paced , less expensive exercise protocol s could be effective and safe for modifying neuromotor performance and functional capacity in community-dwelling adults 65 - 95 years of age . METHODS One hundred and thirty-one subjects were r and omized to a novel resistance training , walking , or control group . Subjects determined their level of resistance or walking intensity ( self-paced ) on a session-by-session basis . Muscle strength , balance , reaction time , stair climbing speed , and a timed pen pickup task were measured before and after the intervention period . Exercisers met three times per week for 10 months . RESULTS Significant improvements in t and em stance and single-legged stance with eyes open times and stair climbing speed were seen in both exercise groups . In addition , resistance trainers improved their muscle strength and ability to pick up an object from the floor and reduced the number of missteps taken during t and em walking , and walkers reduced t and em walking time . Controls showed no significant improvement in any variable . CONCLUSIONS The two self-paced exercise protocol s were effective at improving neuromotor performance and functional capacity in the study sample and show promise as a safe , effective , cost-efficient , acceptable exercise model for primary and secondary prevention in the general population of community-dwelling older adults",
"BACKGROUND AND PURPOSE This prospect i ve clinical investigation examined the effects of a multidimensional exercise program on balance , mobility , and risk for falls in community-dwelling older adults with a history of falling . Factors used to predict adherence and a successful response to exercise were identified . SUBJECTS A total of 105 community-dwelling older adults ( > or = 65 years of age ) with a history of two or more falls in the previous 6 months ( no neurologic diagnosis ) participated . They were classified into ( 1 ) a control group of fallers ( n = 21 ) , ( 2 ) a fully adherent exercise group ( n = 52 ) , and ( 3 ) a partially adherent exercise group ( n = 32 ) . METHODS Following evaluation , each patient received an individualized exercise program addressing the impairments and functional disabilities identified during the assessment . The control group received no intervention . Changes in performance on five clinical tests of balance and mobility and fall risk were compared among groups . RESULTS Both exercise groups scored better than the control group on all measures of balance and mobility . Although both exercise groups showed a reduction in fall risk compared with the control group , the greatest reduction was found in the fully adherent exercise group . Factors associated with successful response to exercise included degree of adherence to exercise program and pretest score on the Tinetti Mobility Assessment . CONCLUSION AND DISCUSSION Exercise can improve balance and mobility function and reduce the likelihood for falls among community-dwelling older adults with a history of falling . The amount of exercise needed to achieve these results , however , could not be determined from this study",
"Chronic renal insufficiency , regardless of cause , generally progresses to end-stage renal disease ( 1 ) . Malnutrition and muscle wasting in chronic uremia often parallel the progression of renal failure ( 2 ) . They also contribute to excess morbidity and mortality in patients with renal disease ( 3 ) . Protein-restricted diets delay the progression of renal disease ( 4 , 5 ) and alleviate uremic symptoms ( 6 ) . Although nutritional status , as assessed by biochemical and anthropometric indicators , may be maintained during protein restriction ( 6 , 7 ) , studies have shown that deterioration of nutritional status is associated with low energy and protein intake in patients with chronic renal insufficiency ( 8) . Resistance training increases nitrogen retention ( 9 ) , protein synthesis ( 10 ) , and expression of insulin-like growth factor I in skeletal muscle ( 11 ) ; ameliorates losses of muscle mass and function ; and enhances quality of life ( 12 ) in both healthy and unwell persons . The anabolic potential of resistance training counteracts the catabolism of HIV infection ( 13 ) and myopathy secondary to corticosteroid use in cardiac transplantation ( 14 ) , the loss of lean tissue during energy restriction for obesity ( 15 ) , and the interleukin-mediated myopathy of chronic heart failure ( 16 ) . However , its utility as an adjunctive treatment off setting the catabolism of a low-protein diet in uremic patients is not known ( 17 ) . We conducted a r and omized , controlled trial to determine whether resistance training would preserve lean body mass , nutritional status , and muscle function through alterations in protein turnover ( synthesis and oxidation ) in patients with moderate chronic renal insufficiency who were consuming a low-protein diet to slow the progression of renal failure . Methods Study Design Patients older than 50 years of age with chronic renal insufficiency were r and omly assigned to a low-protein diet plus resistance training or a low-protein diet plus sham exercises ( referred to as low-protein diet alone ) . Patients were asked to follow a low-protein diet ( 0.6 g/kg of body weight per day ) for 2 to 8 weeks ( run-in period ) before r and omization . They continued the low-protein diet for an additional 12 weeks after r and omization ( intervention period ) ( Figure 1 ) . The Human Investigation Review Committee at Tufts University , Boston , Massachusetts , and collaborating hospitals approved the study , and written informed consent was obtained from all patients . Figure 1 . Flow of patients through the study . * The post office returned letters because addresses were incorrect or persons had relocated . No patients withdrew , experienced ineffective interventions , or were lost to follow-up . One patient in each group had incomplete postintervention measures because of health-related reasons . HNRCA = Jean Mayer U.S. Department of Agriculture Human Nutrition Research Center on Aging . Study Sample Patients were recruited from the nephrology clinic at New Engl and Medical Center , Saint Elizabeth 's and Newton Wellesley Hospitals , and the Lahey Hitchcock Clinic , all in Boston , Massachusetts . Screening procedures took place at the Jean Mayer U.S. Department of Agriculture Human Nutrition Research Center on Aging ( HNRCA ) at Tufts University . These procedures included sociodemographic and health history question naires ; physical examination ; electrocardiography ; blood hematology , chemistry , and urine analyses ; and a treadmill stress test . Eligibility criteria included serum creatinine concentrations between 133 and 442 mol/L ( 1.5 and 5.0 mg/dL ) and physician approval to follow a low-protein diet . A nephrologist confirmed renal diagnosis by review ing renal biochemistry results and clinical records . Exclusion criteria were myocardial infa rct ion ( within the past 6 months ) , any unstable chronic condition , dementia , alcoholism , dialysis or previous renal transplantation , current resistance training , recent involuntary weight change ( 2 kg ) , albumin level less than 30 g/L , proteinuria greater than 10 g/d , or abnormal stress test results at screening ( 18 ) . Reasons for early withdrawal from the study included loss of more than 25 % of initial body weight ; need for dialysis or transplantation ; development of any serious condition requiring hospitalization or precluding exercise ; and signs of malnutrition , such as a decrease in serum transferrin levels to less than 1.5 g/L or a 15 % decrease in hemoglobin or leukocyte count to below baseline levels . Diet Dietary intake of macronutrients and micronutrients and adherence to the low-protein diet were monitored twice per week during the run-in period and weekly during the intervention period by 3-day assisted dietary records ( including week and weekend days ) and regular meetings with the study dietitian , who was not blinded to group assignment . Dietary data were coded and analyzed by using Nutritionist-IV software ( N-Squared Computing , San Bruno , California ) . Patients collected one 24-hour urine specimen for every 3-day dietary record . Protein intake was also estimated by urea nitrogen levels ( 19 ) calculated from urine collection s and was used to assess adherence , which was defined as intake within 15 % of the prescribed low-protein intake ( 0.6 g/kg per day ) . Patients were counseled to reduce their habitual protein intake by eating food sources with less protein or by reducing portion sizes of higher-protein foods . Behavior modification strategies , including tips , recipes , food models , and self-monitoring tools for protein counts , were provided . These strategies were adapted from the Modification of Diet in Renal Disease Study ( 20 ) . Exercise Muscle strength was determined twice before r and omization and once after 12 weeks by measuring one repetition maximum ( 1 RM ) ( 21 ) using Keiser resistance training equipment ( Keiser Sports Health Equipment , Inc. , Fresno , California ) . One repetition maximum is the heaviest load that can be lifted once in good form through the full range of motion . Five machines ( chest and leg press , latissimus pull-down , knee extension , and knee flexion ) were used to include functionally large muscle groups . The better of the two baseline measurements of 1 RM was used in analyses and to set initial training loads for patients r and omly assigned to resistance training . All exercise sessions were performed at the HNRCA three times per week under the supervision of an exercise physiologist . Vital signs and body weight were recorded before each session . Patients who performed resistance training had monthly 1 RM testing on each machine . Workload during training was adjusted to reflect 80 % of the most recent 1 RM . In addition , patients ' workloads were progressively increased as appropriate according to the trainer 's objective perception of patients ' difficulty with workloads at each session . Patients performed three sets of eight repetitions on each machine per session , which lasted about 45 minutes ( 21 ) . Patients assigned to the low-protein diet alone performed five to eight sham exercises ( gentle movements while st and ing , sitting , and bending ) for the upper and lower body . These were design ed not to have a physiologic impact but to provide trainer contact time similar to that of the resistance training group . Study Measures All measures were taken before ( week 0 ) and 12 weeks after r and omization . Observers were blinded to study group assignment at all times , except during assessment s of postintervention muscle strength . Main Outcome Measures Total body potassium is the best single measure of body cell mass closely linked to functional status ( 22 ) , prognosis , and survival ( 23 ) . Body cell mass ( muscle and viscera ) comprises the metabolically active tissues where protein is targeted ( 24 ) . Potassium-40 represents approximately 0.0118 % of total body potassium . Loss of total body potassium occurs in patients following low-protein diets ( 25 ) and in patients with renal disease ( 26 ) , as well as in patients with many other wasting syndromes . Total body potassium was determined in the body composition laboratory at HNRCA , with a coefficient of variation of 5 % ( 24 ) . Regional body composition of the area involving the mid-thigh muscle was determined by computerized tomography of the nondominant thigh . A Siemens DR3 CT Scanner ( Somatom-Siemens , Erlangen , Germany ) was used to obtain an 8-mm scan at the midpoint between the inguinal crease and the proximal pole of the patella . Images were digitized and analyzed to the nearest 0.01 cm2 , as described elsewhere ( coefficient of variation , 0.5 % to 1.5 % ) ( 21 ) . Type I and type II muscle-fiber cross-sectional areas were determined from vastus lateralis muscle biopsies of the nondominant thigh , performed with a 5-mm Bergstrom needle ( 27 ) . Sections were stained with adenosine triphosphatase ( pH , 4.3 ) to visualize type I and type II fibers . A slide preparation was made for each biopsy specimen , and 50 to 150 fibers per patient were analyzed by light microscopy ( coefficient of variation , 3 % ) ( 11 , 27 ) . Anthropometry Body weights were measured to the nearest 0.1 kg on a Toledo Weight-Plate ( Bay State Scale & Systems , Inc. , Burlington , Massachusetts ) . Height was measured once to the nearest 0.25 cm , without shoes , by using a wall-mounted stadiometer . Body mass index was determined from body weight and height as kg/m2 . Biochemical Measures All measurements were collected in the fasting state in a blinded fashion at the nutrition evaluation laboratory at HNRCA ( coefficient of variation , 5 % to 10 % ) . Urea nitrogen and creatinine concentrations in serum and urine and levels of plasma insulin-like growth factor I were determined , as described elsewhere ( 25 , 27 ) . In addition , blood cell count ; hematocrit ; and levels of serum albumin , transferrin , and prealbumin were measured monthly to evaluate nutritional status . Glomerular Filtration Rate Glomerular filtration rate was measured as the renal clearance of 125I-iothalamate ( Glofil , Cypros Pharmaceutical Corp. , Carlsbad , California ) , with a coefficient of",
"This study was design ed to examine the psychological benefits of anaerobic exercise for older adults . Specifically , strength training was employed to examine the effects on mood and anxiety in a group of healthy but sedentary older women . 36 women ( mean age = 68.5 yr . ) were r and omly assigned to groups given high intensity or moderate intensity strength training or to a control group . Strength training was conducted three days a week for 12 weeks . After the training period , both high and moderate strength-training programs produced marked improvements in muscle strength and body composition compared to the control subjects . The average improvements in the high and moderate intensity strength-training groups for muscle strength were 40.5 and 35.5 % , respectively , and for percent body fat 1.52 and 2.50 % , respectively . As for psychological changes , both training groups significantly improved positive mood ( vigor ) , and the moderate intensity group significantly reduced trait anxiety compared to means of the control group . Also , both training groups showed some decrease in tension and state anxiety after the training period . These findings provide evidence for the effectiveness of anaerobic training to enhance perception of psychological well-being in older women . A moderate intensity rather than high intensity of training regimen may be more beneficial for sedentary older women to improve psychological health",
"Experimental evidence indicates that a lower synthesis rate of muscle contractile protein myosin heavy chain ( MHC ) occurs in age-related muscle wasting and weakness . To determine the molecular mechanism of this lower synthesis of MHC , we measured transcript levels of isoforms of MHC ( MHCI , MHCIIa , and MHCIIx ) in muscle biopsy sample s of 7 young ( 20 - 27 yr ) , 12 middle-aged ( 47 - 60 yr ) , and 14 older ( > 65 yr ) people . We further determined the effect of 3 mo of resistance exercise training ( exercise ) vs. nonintervention ( control ) on transcript levels of MHC isoforms on these subjects and the fractional synthesis rate ( FSR ) of MHC in 39 people aged 46 - 79 yr . MHCI mRNA levels did not significantly change with age , but MHCIIa decreased 38 % ( P MHCIIx decreased 84 % ( P FSR of MHC by 47 % ( P muscle protein by 56 % ( P Exercise training results in an increase ( 85 % ) in transcript levels of MHCI and a decrease in the transcript levels of MHCIIa and MHCIIx . In conclusion , an age-related lowering of the transcript levels of MHCIIa and MHCIIx is not reversed by exercise , whereas exercise results in a higher synthesis rate of MHC in association with an increase in MHCI isoform transcript levels",
"The effects of 52 weeks resistance training at one of two exercise intensities on thigh muscle strength , fiber cross-sectional area ( CSA ) , and tissue composition were studied in healthy 65 - 79-year-old women . Subjects were assigned to either a control ( CO ) , high-intensity ( HI ) or low-intensity ( LO ) training group . Exercise regimens consisted of three sets of leg press , knee extension , and knee flexion exercises , 3 days/week , at either 80 % of one-repetition maximum ( 1-RM ) for seven repetitions ( HI ) or 40 % of 1-RM for 14 repetitions ( LO ) . Dynamic muscle strength was evaluated by 1-RM , thigh lean tissue mass ( LTM ) , fat mass , and bone mineral density ( BMD , g/cm2 ) by dual energy X-ray absorptiometry , and fiber CSA of vastus lateralis m. by histomorphometry . Muscle strength increased , on average ( + /- SEM ) , by 59.4 + /- 7.9 % and 41.5 + /- 7.9 % for HI and LO , respectively , compared to 1.3 + /- 4.8 % in CO ( P = 0.0001 ) . Type I fiber CSA increased over time ( P type II area ( HI , P = 0.06 ; LO , P = 0.11 ) . There was no significant effect of either exercise program on thigh tissue composition , except for BMD at the 1/3 site ( middle third of the femur ) , where LO and CO groups experienced a decline ( P thigh muscle strength , which were associated with fiber hypertrophy , although these did not translate into appreciable alterations in thigh tissue composition",
"This study determined the effects of endurance or resistance exercise training on maximal O2 consumption ( VO2max ) and the cardiovascular responses to exercise of 70- to 79-yr-old men and women . Healthy untrained subjects were r and omly assigned to a control group ( n = 12 ) or to an endurance ( n = 16 ) or resistance training group ( n = 19 ) . Training consisted of three sessions per week for 26 wk . Resistance training consisted of one set of 8 - 12 repetitions on 10 Nautilus machines . Endurance training consisted of 40 min at 50 - 70 % VO2max and at 75 - 85 % VO2max for the first and last 13 wk of training , respectively . The endurance training group increased its VO2max by 16 % during the first 13 wk of training and by a total of 22 % after 26 wk of training ; this group also increased its maximal O2 pulse , systolic blood pressure , and ventilation , and decreased its heart rate and perceived exertion during submaximal exercise . The resistance training group did not elicit significant changes in VO2max or in other maximal or submaximal cardiovascular responses despite eliciting 9 and 18 % increases in lower and upper body strength , respectively . Thus healthy men and women in their 70s can respond to prolonged endurance exercise training with adaptations similar to those of younger individuals . Resistance training in older individuals has no effect on cardiovascular responses to submaximal or maximal treadmill exercise",
" Twelve middle-aged men and 12 middle-aged women in the 50-year-old age group ( M50 ; range 44 - 57 years ; W50 ; 43 - 57 ) , and 12 elderly men and 12 elderly women in the 70-year-old age group ( M70 ; 59 - 75 ; W70 ; 62 - 75 ) volunteered as subjects in order to examine effects of 12-week progressive heavy resistance strength training on electromyographic activity ( EMG ) , muscle cross-sectional area ( CSA ) of the quadriceps femoris and maximal concentric force in a one repetition maximum ( 1 RM ) test of the knee extensor muscles . One half of the subjects in each group performed the knee extension ( and flexion ) exercises only bilaterally ( BIL ) , while another half performed the exercises only unilaterally ( UNIL ) . None of the subject groups demonstrated statistically significant changes in any of the 1 RM values during the 2 week control period with no training ( between week -2 and 0 ) preceding the actual experimental training . However , the 12-week training result ed in increases ( P RM values in each group so that the average relative increase of 19 + /- 12 % ( P bilateral 1 RM in all BIL trained subjects was greater ( P relative increases of 17 + /- 11 % ( P 14 + /- 14 % ( P ) in unilateral 1 RM values of the right and left leg in all UNIL trained subjects were greater ( P relative average increase of 19 + /- 19 % ( P in the maximum averaged IEMG of both legs during the bilateral actions in all BIL trained subjects was greater ( P relative increases of 14 + /- 12 % ( P + /- 6 % ( P CSA in all BIL and UNIL trained subjects did not differ significantly from each others . The present findings suggest that progressive heavy resistance strength training leads to great increases in maximal dynamic strength of the trained subjects accompanied by both considerable neural adaptations and muscular hypertrophy not only in middle-aged but also in elderly men and women . Both bilateral and unilateral exercises are effective to produce functional and structural adaptations in the neuromuscular system , although the magnitude of functional strength increase seems to be specific to the type of exercise used , further supporting the principle of specificity in the design of strength programmes",
" Abstract The effects of a short-term strength training programme on resting lymphocyte subsets and stress hormone concentrations were analysed in 32 elderly sedentary subjects . Out of these 32 subjects , 8 women and 8 men [ mean age 70.1 ( SEM 1.0 ) years ] were r and omly assigned to a 8-week strength training programme which consisted of three sets of eight repetitions at 80 % of one repetition maximum , for leg press , bilateral leg extension and seated chest press , 3 days a week . The remaining 8 women and 8 men [ mean age 70.5 ( SEM 0.9 ) years ] served as controls . Absolute counts of lymphocyte subsets ( CD20 + , CD3 + , CD3+CD4 + , CD3+CD8 + , CD3−CD56+CD16 + ) were measured with a new technique combining fluorescent microspheres and flow cytometry . In the trained subjects , substantial increases in strength took place in one repetition maximum during the 8-week training period for leg press [ from means of 20.7 ( SEM 1.0 ) to 23.6 ( SEM 1.0 ) N · kg−1LBM ( lean body mass ) ] , chest press [ from means of 5.4 ( SEM 0.3 ) to 6.2 ( SEM 0.3 ) N · kg−1LBM ] and bilateral leg extension [ from means of 6.3 ( SEM 0.2 ) to 7.4 ( SEM 0.3 ) N · kg−1LBM ] movements . Baseline cortisol concentration ( P 0.01 ) , CD20 + cell count ( P 0.05 ) , CD3 + cell count ( P ) , and CD4 + cell count ( P strength training on resting adrenaline , noradrenaline and cortisol concentrations or distributions of lymphocyte subsets at rest was observed . The main finding of this study was to demonstrate that 8-week is too short a duration for a strength training programme to modify counts of lymphocyte subsets at rest in elderly sedentary adults",
"Strength measurements were administered to 52 men ranging in age from 42 to 83 years , who were then r and omly assigned within their respective age group to either the Isometric-training Group ( ITG ) or to the Control-exercise Group ( CEG ) . At the conclusion of a six-week training program all initial measurements were again administered . No significant differences were found in ( 1 ) strength trainability by age group , and ( 2 ) in strength trainability by muscle group when the upper-extremity-strength ratios were compared with the lower-extremity-strength ratios . When the initial and final strength scores of the ITG were subjected to a t test for correlated sample s , the findings included : ( 1 ) the four age groups of the ITG experienced statistically significant gains in strength for six of the eight strength measurements , and ( 2 ) as age increased , strength trainability appeared to decrease",
"OBJECTIVE To assess how dietary change affects gain in strength and muscle mass during heavy resistance training of elderly men . DESIGN R and omized controlled trial . INTERVENTION During 12 weeks of resistance training of knee extensors and flexors , a daily supplement of 560 + /- 16 kcal/day ( 17 % energy from protein , 43 % from carbohydrate , 40 % from fat ) was r and omly assigned to six men ( S ) while five men ( U ) received no supplement . Food intake , strength , whole body composition , and midthigh composition by CT scan were assessed before training and at 6 and 12 weeks . SETTING The men were out patients but lived in a Metabolic Research Unit during the three assessment s. PARTICIPANTS Eleven healthy men aged 61 to 72 years . RESULTS Densitometry showed no change over time in fat or fat-free mass . However , the S men increased ( P less than 0.05 ) weight , skinfold thickness at six sites , subcutaneous midthigh fat , and creatinine excretion ; in all men , changes in these values and in midthigh muscle were proportional to changes in reported energy intake ( P less than 0.05 ) . There was midthigh muscle hypertrophy in both groups , but it was greater in S than U ( P less than 0.01 ) . Both groups gained strength ( P less than 0.001 ) with no effect of diet . CONCLUSIONS During physical rehabilitation of the elderly , dietary intake may influence the increase in lean as well as adipose tissue without altering strength gain . These preliminary findings should be confirmed by a larger study with sedentary controls",
"Increased gait instability is common in older adults , even in the absence of overt disease . The goal of the present study was to quantitatively investigate the factors that contribute to gait instability and its potential reversibility in functionally impaired older adults . We studied 67 older men and women with functional impairment before and after they participated in a r and omized placebo-controlled , 6-mo multimodal exercise trial . We found that 1 ) gait instability is multifactorial ; 2 ) stride time variability is strongly associated with functional status and performance-based measures of function that have previously been shown to predict significant clinical outcomes such as morbidity and nursing home admission ; 3 ) neuropsychological status and health-related quality of life play important , independent roles in gait instability ; and 4 ) improvement in physiological capacity is associated with reduced gait instability . Although the etiology of gait instability in older persons with mild-moderate functional impairment is multifactorial , interventions design ed to reduce gait instability may be effective in bringing about a more consistent and more stable walking pattern",
"Abstract The effects of 12 weeks of a low-intensity general conditioning programme on maximal instantaneous peak power ( W˙peak ) and maximal oxygen uptake ( V˙O2max ) were examined in 20 elderly women . After medical , familiarisation , and ethical procedures , the subjects were r and omly divided into either a training and or a control group . The training group [ n = 11 ; mean ( SD ) age 63.0 ( 3.1 ) years ] agreed to take part in a 12-week training programme at an exercise intensity kept under 60 % of the heart rate reserve for about 60 min , 3 times a week . The control group [ n = 9 ; mean ( SD ) age 63.5 ( 3.3 ) years ] did not perform any particular physical training . Before and after the training period , all participants underwent anthropometric measures and a maximal cycling test to exhaustion to measure their V˙O2max . In addition , W˙peak was determined 1 week later by the subjects performing a vertical jump from a squatting position on a force platform . Following training , neither the anthropometric characteristics nor the V˙O2max changed in either of the groups . In contrast , W˙peak increased significantly ( P an improved level of neuromuscular activation . Furthermore , it shows that although muscle power declines with age at a faster rate than does aerobic power , its sensitivity to training seems to be higher than that of the aerobic system",
"Knee extension strength , walking speed , quadriceps muscle mass and composition of the muscle compartment were studied in 66 to 85-year-old female athletes and controls . Maximal voluntary knee extension force , force/body mass , extension torque , torque/body mass and walking speed were higher for the athletes than the controls . A muscle index indicating intramuscular fat and connective tissue measured using ultrasonography was lower for the athletes than the controls . There were no differences between the study groups in knee extension force related either to cross-sectional area ( CSA ) or lean tissue area ( CSAL ) of the quadriceps . Within the subgroups , there was no significant correlation between knee extension torque and CSA or CSAL of the same muscle . In the athletes high knee extension torque/body mass was related to a low muscle index and high walking speed to a low relative proportion of fat in the muscle . The muscle index was lower the more kilometers trained during the preceding year . In the controls high knee extension torque/body mass and high walking speed were related to a low relative proportion of fat . Knee extension torque and walking speed were higher the more kilometers walked during the preceding year . The results indicate that elderly female athletes have superior muscle performance compared to their age-peers . Performance in a maximal isometric strength test in elderly women is not clearly related to muscle mass . However , to some extent it is related to the composition of the same muscle , especially the degree to which fat is infiltrated into the muscle",
"OBJECTIVE To determine the effects of resistance training on muscular strength , body composition ( percent fat and lean tissue mass ) , and program adherence in active women over 60 years of age . DESIGN This study was design ed as a stratified , r and omized , non-blinded trial . Subjects were stratified into rank-ordered pairs by level of physical activity according to the Blair Seven-Day Recall , then r and omly assigned into either a weight-training ( WT , n = 18 ) or control ( CON , n = 18 ) group . PARTICIPANTS AND SETTING Thirty-six women over the age of 60 ( 67.1 + /- 1.5 , chi + /- SE ) were recruited from the San Diego community . All subjects had to be engaging in some form of aerobic exercise at least 3 days each week for a minimum of 6 months . MEASUREMENTS AND INTERVENTION : Subjects engaged in isotonic training 3 days/week on Polaris machines at a target intensity of 80 % of the 1 repetition maximum ( 1 RM ) for three sets of seven exercises selected to train major muscle groups of the trunk and upper and lower body . The 1 RM was re-tested every 6 weeks in WT and the workload adjusted to maintain target intensity . The 1 RM was tested at 0 , 12 , and 24 weeks in CON . Body fatness and lean tissue mass , excluding skeletal mass , were assessed at 0 and 24 weeks by dual energy radiography using a total body scan . RESULTS Increases in muscle strength of the weight trainers were significant for all seven exercises ( 5%-65 % ) , with the greatest gains in the shoulder and trunk muscles . Percent body fat of weight trainers decreased significantly ( from 38.8 % to 37.9 % , P lean tissue mass increased by 1.5 kg ( P body composition were observed in control subjects . Overall program adherence was 83 % ( 15 weight trainers and 15 control women completed the study ) . Monthly attendance averaged 86.8 + /- 3.3 % , with no incidence of injury during the training sessions . CONCLUSIONS These data indicate that heavy-resistance weight training is safe and enjoyable for older women and that meaningful gains in muscular strength and body composition can be made even in women who are already highly active",
"Patients with heart failure ( HF ) often have profound activity limitations and diminished quality of life ( QOL ) due to symptoms of dyspnea and fatigue . Although recent studies demonstrate positive physiologic and psychological benefits of low to moderate intensity , supervised , aerobic exercise training performed 3 to 5 days/ week for 20 to 40 minutes ' duration , in a monitored setting , the efficacy of a home-based exercise program combining endurance and resistance exercise on symptoms and QOL , are unknown . This r and omized controlled study examined the efficacy , safety , and adherence rates of a 3-month home-based combined walking and resistance exercise program on symptoms and QOL in 40 women and men aged 30 to 76 years with New York Heart Association class II to III HF . Baseline and 3-month evaluations consisted of a chronic HF question naire to assess symptoms and QOL and exercise capacity by symptom-limited treadmill exercise test with respiratory gas analysis . The exercise intervention improved fatigue ( p = 0.02 ) , emotional function ( p = 0.01 ) , and mastery ( p = 0.04 ) . Overall exercise adherence was excellent ( 90 % ) and there were no reported adverse events . A moderate intensity home-based combined walking and resistance program for patients with class II to III HF is safe and effective in reducing symptoms and improving QOL",
"BACKGROUND AND PURPOSE Loss of lower-extremity strength increases the risk of falls in older persons . The purpose of this study was to test the hypothesis that a vigorous program of lower-extremity strengthening , walking , and postural control exercises would improve the single-stance balance of healthy older women and lower their risk of falls and fall-associated injuries . SUBJECTS From a total of 38 respondents , 21 women were r and omly assigned to either a treatment group ( combined training , n = 12 ) or a control group ( flexibility training , n = 9 ) . The subjects ranged in age from 62 to 75 years ( mean = 68 , SD = 3.5 ) . METHODS A r and omized control trial compared the effects of two exercise programs on static balance . The combined training group exercised three times per week on knee extension and sitting leg press machines , walked briskly for 20 minutes , and performed postural control exercises , which included simple tai chi movements . The flexibility training group performed postural control exercises weekly . Measurements of balance were obtained on a force platform in double and single stance , at baseline and following 6 months of exercise training . RESULTS Double-stance measurements were unchanged after training . The mean displacement of the center of pressure in single stance improved 17 % in the combined training group and did not change in the flexibility training group . A repeated- measures analysis of variance revealed that the difference in improvement between the combined training and flexibility training groups was not significant . DISCUSSION AND CONCLUSION This is the first intervention trial to demonstrate improvements in single-stance postural sway in older women with exercise training . Additional studies with more subjects will be needed to determine whether a combined training program of resistance training , walking , and postural exercises can improve balance more than a program of postural control exercises alone",
"BACKGROUND Age-related loss in physiologic capacities contributes to the decline in physical function in the elderly population . Despite the beneficial effects of exercise interventions on maximal physiologic capacity measures , the functional benefits have not been shown in independently living older adults . The objective of this study was to evaluate exercise in independent older adults for significant and meaningful improvements in physical function , not detected by commonly used measures of physical function . METHODS In a r and omized controlled study , 49 independently living men and women were assigned to either a nonexercise control group ( Control ; n = 26 ) or an exercise training group ( Exercise ; n = 23 ) . Participants ( age = 76+/-4 ) in good general health were recruited from retirement communities or apartments . The combined endurance and strength training was performed at 75 % to 80 % intensity ; the groups met 3 times/week for 6 months of supervised sessions . Outcome measures included physical capacity , health status , and physical function using a newly developed performance test -- the Continuous Scale-Physical Functional Performance test ( CS-PFP ) . RESULTS Compared to the Control group , the Exercise group showed significant increases in maximal oxygen consumption ( 11 % ) and muscle strength ( 33 % ) . No significant differences were found between groups for changes in the Sickness Impact Profile , SF-36 scales , or the 6-minute walk . However , the CS-PFP score improved significantly in the Exercise group ( 14 % , effect size 0.80 ) . CONCLUSIONS Independent older adults gain meaningful functional benefits from several months of exercise training . The public health importance of physical activity may relate not just to its role in preventing decline , but also to its role in enhancing physical function",
"Thirty-nine healthy women ( 59.5 + /- 0.9 yr ) were r and omized to either a control group ( CON ) or a progressive resistance training group ( PRT ) that trained twice weekly for 12 months . PRT trained at 80 % or more ( average of 84 % ) of their most recent one repetition maximum ( 1RM ) on the lateral pull-down ( LPD ) , knee extensor ( KE ) , and double leg press ( DLP ) apparatus . One RM was measured for each exercise once monthly in PRT and at baseline , mid study , and end of study in CON . One RM significantly increased in PRT for all muscle groups trained compared to CON ( P KE , DLP , and LPD in PRT and 12.7 % + /- 8 % , 3.7 % + /- 3 % , and 18.4 % + /- 4 % , respectively , in CON were observed . Approximately 50 % of the gains in KE and LPD and 40 % in the DLP were seen in the first 3 months of the study . In all three exercises , strength gains in PRT continued over the entire 12-month period . These data indicate that high-intensity strength training results in substantial , continual increases in strength in postmenopausal women for at least 12 months , with the greatest gains seen in the first 3 months of training",
"OBJECTIVE Reduced muscle mass and strength are characteristic findings of growth hormone deficiency ( GHD ) and aging . We evaluated measures of muscle strength , muscle fiber type , and cross sectional area in response to treatment with recombinant human growth hormone ( rhGH ) with or without a structured resistance exercise program in frail older subjects . DESIGN Placebo-controlled , r and omized , double blind trial . SETTING Outpatient clinical research center at an urban university-affiliated teaching hospital . PARTICIPANTS Thirty-one consenting older subjects ( mean age 71.3 + /- 4.5 years ) recruited as a subset of a larger project evaluating rhGH and exercise in older people , who underwent 62 quadricep-muscle biopsies . INTERVENTION R and om assignment to a 6-month course of one of four protocol s : rhGH administered subcutaneously daily at bedtime , rhGH and a structured resistance exercise program , structured resistance exercise with placebo injections , or placebo injections only . MEASUREMENTS Muscle biopsy specimens were obtained from the vastus lateralis muscle . Isokinetic dynamometry strength tests were used to monitor individual progress and to adjust the weights used in the exercise program . Serum insulin-like growth factor-I ( IGF-I ) was measured and body composition was measured using a Hologic QDR 1000W dual X-ray densitometer . RESULTS The administration of rhGH result ed in significant increase in circulating IGF-I levels in the individuals receiving rhGH treatment . Muscle strength increased significantly in both the rhGH/exercise ( + 55.6 % , P = .0004 ) as well as the exercise alone ( + 47.8 % , P = .0005 ) groups . There was a significant increase in the proportion of type 2 fibers between baseline and six months in the combined rhGH treated subjects versus those not receiving rhGH ( P = .027 ) . CONCLUSIONS Our results are encouraging in that they suggest an effect of growth hormone on a specific aging-correlated deficit . IGF-I was increased by administrating rhGH and muscle strength was increased by exercise . The administration of rhGH to frail older individuals in this study result ed in significant changes in the proportions of fiber types . Whether changes in fiber cross-sectional area or absolute number occur with long-term growth hormone administration requires further study",
"The purpose of this study was to investigate the effects of a progressive resistance training program on myosin heavy chain isoform expression , fiber type , and capillarization in patients with symptomatic peripheral arterial disease . Patients were r and omized to either a training group ( n = 11 , mean + /- SD , 70 + /- 6 years , 4 men , 7 women ) or a control group ( n = 9 , 66 + /- 6 years , 5 men , 4 women ) . The training sessions were completed 3 times/week , using 2 sets of various exercises , each performed for 8 - 15 repetitions . Muscle biopsies were obtained before and after 24 weeks from the medial gastrocnemius . Following the 24-week training program , the training group had significantly decreased the percentage of myosin heavy chain type IIB . The proportion of type IIB/AB fibers as measured by using myosin adenosine triphosphatase histochemistry decreased significantly in the training group . There were significant increases in type I and type II fiber areas , and capillary density also increased significantly in the training group . There were significant increases in 10 repetition maximum leg press and calf press strengths in the trained subjects . There were no significant changes in any of the measurements in the control group . It is concluded that progressive resistance training results in significant increases in muscle strength and alters skeletal muscle composition of subjects with peripheral arterial disease",
"OBJECTIVE Resistance and endurance training result in gains in fitness in the aged . It is unclear whether the debilitated elderly can perform moderate-intensity training and whether such training results in short-term improvements in strength , endurance , and function in this population . DESIGN R and omized , controlled trial . SETTING S AND PATIENTS Subjects were from a Veterans Affairs nursing home and rehabilitation unit and a community nursing home . They were older than 60 yrs with impairment in at least one physical activity of daily living . Seventy-eight subjects volunteered and 58 ( mean age , 75 yrs ; 9 women , 49 men ) completed the intervention and initial posttest . Only one subject withdrew because of injury or disinterest . INTERVENTION Thrice-weekly resistance training ( using an isokinetic dynamometer ) and twice-weekly endurance training for 4 to 8 weeks . MAIN OUTCOMES Isometric strength in dominant arm and leg , heart rate response to timed endurance test , and activities of daily living score . RESULTS The mean change in isometric strength across the muscle movements tested was 32.8 % in the training group and 10.2 % in the control group ( difference , 22.6 % ; 95 % confidence interval , 6.2 % to 39.0 % ) . No change in heart rate during exercise was seen in the training group . Trained subjects tended to have a greater improvement in functional activity than control subjects , which was statistically significant ( p = .04 ) for those subjects who at enrollment were most dysfunctional ( i.e. , activities of daily living score less than 13 [ maximum score 26 ] ) . CONCLUSION This group of debilitated elderly patients effectively performed resistance training and increased their strength , with the most impaired gaining the most function . Few in the group could effectively perform endurance training",
"We conducted a 2-year ( 42 weeks of consecutive training in each year , separated by 10 weeks of testing and vacation time ) r and omized , controlled trial of weight training in 142 healthy male and female subjects , aged 60 to 80 years . Measurements included dynamic strength , symptom-limited endurance in cycling , treadmill walking and stair climbing , muscle size , and bone mineral density and content of the lumbar spine and whole body . One hundred and thirteen subjects completed the study ( 57 exercise , 56 control ) , with a mean attendance of 85 % among the exercisers . Muscle strength was unchanged in the control subjects but increased ( collapsed across age and gender ) from 32 % ( leg press ) to 90 % ( military press ) in the exercisers . Symptom-limited endurance in cycling , treadmill walking , and stair climbing increased in the exercisers by ( mean + /- SE ) 6.2 + /- 0.8 % , 29.2 + /- 7.3 % , and 57 + /- 12 % , respectively ; the only change in the controls was an unanticipated 33 % increase in stair climbing performance during the first year . These values were unchanged in the controls . Cross-sectional area of the knee extensors increased by 8.7 + /- 0.9 % in the trained subjects and was unchanged in controls . Measures of whole body , lumbar spine bone mineral density , and lumbar spine bone mineral content were unchanged in the exercisers , but whole body bone mineral content decreased by 1 % . In contrast , there were small increases ( bone mineral density among the controls . Long-term weight training proved to be a safe and well-tolerated mode of exercise for the elderly . Increased strength was associated with muscle hypertrophy in each year , and with increased endurance in cycling , walking , and stair climbing . There were no changes in bone mineral density but a small reduction in whole body bone mineral content",
"Previous studies concerning psychological benefits of exercise among the elderly has focused predominantly on the effects of aerobic exercise . In the present study , psychological and behavioral adaptations in response to 12-weeks of strength training were examined in medically healthy but sedentary 42 older adults ( mean age = 68 years ) . The purpose of this study was to evaluate the effects of high and low intensity resistance training intensity on a ) muscular fitness , b ) psychological affect , and c ) neurocognitive functioning . Subjects were r and omly assigned to high intensity/low volume ( EXH : 2 sets of 8 to 10 repetitions for 75 to 85 % of 1 RM ) , low intensity/high volume ( EXL : 2 sets of 14 to 16 repetitions for 55 to 65 % of 1 RM ) , or no exercise control programs . Prior to and following the 12-week program , subjects underwent comprehensive physiological and psychological evaluations . Physiological assessment included measurements of blood pressure , heart rate , arm and leg muscle strength , body composition , and oxygen consumption ( VO2max ) . Psychological measures included evaluations of mood , anxiety , and physical self-efficacy as well as cognitive functioning . The results of this study indicated that both high and low intensity strength programs were associated with marked improvements in physiological fitness and psychological functioning . Specifically , subjects in the strength training programs increased overall muscle strength by 38.6 % and reduced percent body fat by 3.0 % . Favorable psychological changes in the strength-trained subjects included improvements in positive and negative mood , trait anxiety , and perceived confidence for physical capability . The treatment effects of neurocognitive functioning were not significant . In summary , this study demonstrated that participation in 12-weeks of high or low intensity strength training can improve overall physical fitness , mood , and physical self-efficacy in older adults while cognitive functioning remains constant",
"Underst and ing the stress/strain relationship between exercise and bone is critical to underst and ing the potential benefit of exercise in preventing postmenopausal bone loss . This study examined the effect of a 2-year exercise intervention and calcium supplementation ( 600 mg ) on bone mineral density ( BMD ) in 126 postmenopausal women ( mean age , 60 + /- 5 years ) . Assignment was by block r and omization to one of three groups : strength ( S ) , fitness ( F ) , or nonexercise control ( C ) . The two exercise groups completed three sets of the same nine exercises , three times a week . The S group increased the loading , while the F group had additional stationary bicycle riding with minimal increase in loading . Retention at 2 years was 71 % ( 59 % in the S group , 69 % in the F group , and 83 % in the C group ) , while the exercise compliance did not differ between the exercise groups ( S group , 74 + /- 13 % ; F group , 77 + /- 14 % ) . BMD was measured at the hip , lumbar spine , and forearm sites every 6 months using a Hologic 4500 . Whole body BMD also was measured every 6 months on a Hologic 2000 . There was no difference between the groups at the forearm , lumbar spine , or whole body sites . There was a significant effect of the strength program at the total ( 0.9 + /- 2.6 % ; p intertrochanter hip site ( 1.1 + /- 3.0 % ; p strength program in increasing bone density at the clinical ly important hip site . We concluded that a strength program could be recommended as an adjunct lifestyle approach to osteoporosis treatment or used in combination with other therapies",
"OBJECTIVE To study the effect of a home program of physical therapy . DESIGN Nonr and omized control trial . SETTING Home based . PATIENTS Subjects had total hip arthroplasty ( THA ) for hip osteoarthritis ( hip-OA ) without THA failure , or cardiopulmonary , neurological , or cognitive problems . Twenty-three subjects ( mean age 63.4 years ; mean post-THA period 793 days , 6 to 48 months ) were divided into 3 groups matching with age , gender , and postoperative periods . INTERVENTION The 6-week home program included range of motion ( ROM ) exercises , and low resistance isometric and eccentric exercises of hip abductors . Physical therapists prescribed ROM and isometric exercises for group A , all programs for group B , and no programs for the control group . The programs were modified every 2 weeks as necessary . MAIN OUTCOME MEASURE Hip ROM , maximum isometric hip abduction torque measured by Cybex II , gait speed , and cadence were evaluated . RESULTS The practice ratio of the program was about 70 % for both groups . Maximum isometric torque improved in the THA side of group A ( p Gait speed and cadence also improved significantly . No correlation coefficient existed between practice days and the improvement ratio of the maximum torque . CONCLUSION The home program was effective in long-term post-THA",
"The effects of a 16-wk strength-training program on total and regional body composition were assessed by dual-energy X-ray absorptiometry ( DEXA ) , magnetic resonance imaging ( MRI ) , and hydrodensitometry in 13 untrained healthy men [ 60 + /- 4 ( SD ) yr ] . Nine additional men ( 62 + /- 6 yr ) served as inactive controls . The strength-training program result ed in substantial increases in both upper ( 39 + /- 8 % ; P lower ( 42 + /- 14 % ; P body strength . Total fat-free mass ( FFM ) increased by 2 kg ( 62.0 + /- 7.1 to 64.0 + /- 7.2 kg ; P total fat mass decreased by the same amount ( 23.8 + /- 6.7 to 21.8 + /- 6.0 kg ; P FFM ( 61.3 + /- 7.8 to 63.0 + /- 7.6 kg ; P fat mass ( 23.8 + /- 7.9 to 22.1 + /- 7.7 kg ; P FFM was increased in the arms ( 6.045 + /- 0.860 to 6.418 + /- 0.803 kg ; P fat mass was reduced in the arms ( 2.383 + /- 0.830 to 2.128 + /- 0.714 kg ; P < 0.01 ) , legs ( 7.583 + /- 1.675 to 6.945 + /- 1.551 kg ; P < 0.001 ) , and trunk ( 12.216 + /- 4.143 to 11.281 + /- 3.653 kg ; P < 0.01 ) as a result of training . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND Since falling is associated with serious morbidity among elderly people , we investigated whether the risk of falling could be reduced by modifying known risk factors . METHODS We studied 301 men and women living in the community who were at least 70 years of age and who had at least one of the following risk factors for falling : postural hypotension ; use of sedatives ; use of at least four prescription medications ; and impairment in arm or leg strength or range of motion , balance , ability to move safely from bed to chair or to the bathtub or toilet ( transfer skills ) , or gait . These subjects were given either a combination of adjustment in their medications , behavioral instructions , and exercise programs aim ed at modifying their risk factors ( intervention group , 153 subjects ) or usual health care plus social visits ( control group , 148 subjects ) . RESULTS During one year of follow-up , 35 percent of the intervention group fell , as compared with 47 percent of the control group ( P = 0.04 ) . The adjusted incidence-rate ratio for falling in the intervention group as compared with the control group was 0.69 ( 95 percent confidence interval , 0.52 to 0.90 ) . Among the subjects who had a particular risk factor at base line , a smaller percentage of those in the intervention group than of those in the control group still had the risk factor at the time of re assessment , as follows : at least four prescription medications , 63 percent versus 86 percent , P = 0.009 ; balance impairment , 21 percent versus 46 percent , P = 0.001 ; impairment in toilet-transfer skills , 49 percent versus 65 percent , P = 0.05 ; and gait impairment , 45 percent versus 62 percent , P = 0.07 . CONCLUSIONS The multiple-risk-factor intervention strategy result ed in a significant reduction in the risk of falling among elderly persons in the community . In addition , the proportion of persons who had the targeted risk factors for falling was reduced in the intervention group , as compared with the control group . Thus , risk-factor modification may partially explain the reduction in the risk of falling",
"This study was design ed to assess the effects of 18 months of resistance exercise on regional and total bone mineral density ( BMD ) and soft tissue lean mass ( STL ) in premenopausal women aged 28 - 39 r and omly assigned to an exercise or control group . Twenty-two exercise and 34 control subjects completed the 18-month training study . All subjects were previously inactive and untrained women . Initial , 5- , 12- and 18-month assessment s were made of total and regional BMD and total and regional STL using dual energy X-ray absorptiometry . All subjects consumed a 500 mg/day elemental calcium supplement throughout the study . Initial Ca intake without supplement averaged 1,023 mg/day in total sample . Serum levels of bone osteocalcin and dietary assessment s using 12 r and omly assigned days of diet records were also completed . Muscular strength was assessed from both 1 repetition maximum ( RM ) testing of 10 weightlifting exercises and by peak torque for hip abduction/adduction and knee extension/flexion . Training increased strength by 58.1 % based on 1 RM testing and by 33.8 % based on isokinetic testing at 18 months versus baseline . BMD increased significantly above baseline at the lumbar spine for the exercise group at 5 months ( 2.8 % ) , 12 months ( 2.3 % ) , and 18 months ( 1.9 % ) as compared with controls . Femur trochanter BMD increased significantly ( p total BMD , arm BMD , or leg BMD were found . There was a 20 % increase in BGP in the exercise group as compared with controls at 5 months and this difference was maintained throughout the study . For STL , significant increases for total , arm , and leg were found at 5 , 12 , and 18 months for the exercise group versus control ranging from 1 - 6 % over baseline . These results support the use of strength training for increasing STL and muscular strength with smaller but significant regional increases in BMD in the premenopausal population",
"OBJECTIVES Peak power declines more precipitously than strength with advancing age and is a reliable measure of impairment and a strong predictor of functional performance . We tested the hypothesis that a high-velocity resistance-training program ( HI ) would increase muscle power more than a traditional low-velocity resistance-training program ( LO ) . DESIGN R and omized controlled trial . SETTING University-based human physiology laboratory . PARTICIPANTS Thirty women with self-reported dis-ability ( aged 73 + 1 , body mass index 30.1 + 1.1 kg/mn ) . INTERVENTION We conducted a r and omized trial comparing changes in skeletal muscle power and strength after 16 weeks of HI or LO . Training was performed three times per week , and subjects completed three sets ( 8 - 10 repetitions ) of leg press ( LP ) and knee extension ( KE ) exercises at 70 % of the one-repetition maximum ( IRM ) . MEASUREMENTS One-repetition maximum ( 1 RM ) and peak power for KE and LP . RESULTS LP and KE relative training force and total work were similar between groups ( P > .05 ) . However , HI generated significantly higher power during training sessions than LO for LP ( 3.7-fold greater , P LP and KE 1RM muscle strength increased similarly in both groups asa result of the training ( P LP peak power increased significantly more in HI than in LO ( 267 W vs 139 W , P improvement in LP power at 40 % , 50 % , 60%,70 % , 80 % , and 90 % of the 1 RM than did LO ( P 1RM strength similarly and was more effective in improving peak power than was traditional LO in older women . Improvements in lower extremity peak power may exert a greater influence on age-associated reductions in physical functioning than other exercise interventions",
"The present study was design ed to identify prospect ively the individual chronic characteristics associated with falling among elderly persons and to test the hypothesis that risk of falling increases as the number of chronic disabilities increases . Seventy-nine consecutive admissions to three intermediate care facilities were evaluated . Twenty-five of the subjects became recurrent fallers . The nine risk factors included in the fall risk index were mobility score , morale score , mental status score , distant vision , hearing , postural blood pressure , results of back examination , postadmission medications , and admission activities of daily living score . A subject 's fall risk score was the number of index factors present . The proportions of recurrent fallers increased from 0 percent ( 0 of 30 ) in those with 0 to three risk factors , to 31 percent ( 11 of 35 ) in those with four to six factors , to 100 percent ( 14 of 14 ) in those with seven or more factors . Falling , at least among some elderly persons , appears to result from the accumulated effect of multiple specific disabilities . Some of these disabilities may be remediable . The mobility test , the best single predictor of recurrent falling , may be useful clinical ly because it is simple , recreates fall situations , and provides a dynamic , integrated assessment of mobility",
"Objectives —There is a paucity of long term studies on exercise training in elderly women . The purpose of this study was to investigate the effects of one year of progressive resistance exercise ( PRE ) on dynamic muscular strength and the relations to bone mineral density ( BMD ) in elderly women . Methods —Forty four healthy sedentary women ( mean age 68.8 years ) volunteered for this study and were r and omly assigned to either an exercise group or a control group . The exercise group were involved in three one hour sessions a week for 52 weeks of supervised PRE to strengthen the large muscle groups of the body , while the control group were instructed to continue their normal lifestyle . The exercise circuit included three sets of eight repetitions at 75 % of one repetition maximum focused on the large muscle groups . BMD was measured by dual energy x ray absoptiometry ( Lunar DPX ) at the lumbar spine and at three sites in the proximal femur . Other selected parameters of physical fitness were also measured . Results —Statistical analyses ( analysis of covariance ) showed significant strength gains ( p bilateral bench press ( > 29 % ) , bilateral leg press ( > 19 % ) , and unilateral biceps curl ( > 20 % ) . No significant difference between groups was evident in body weight , grip strength , flexibility , waist to hip ratio , or the sum of eight skinfolds . Significant relations ( p dynamic leg strength and the BMD of the femoral neck , Ward 's triangle , and the lumbar spine . Conclusions —Significant strength changes , after one year of PRE , were evident in elderly women , and the muscle increases may parallel changes in BMD ; however , correlation coefficients were moderate",
"PURPOSE The purpose of this study was to determine , in a r and omized clinical trial of 439 individuals with knee osteoarthritis , the incremental cost-effectiveness of aerobic versus weight resistance training , compared with an education control intervention . METHODS Cost estimates of the intervention were based upon the cost of purchasing from the community similar services to provide exercise or health education . Effect at 18 months was measured using several variables , including : self-reported disability score , 6-min walking distance , stair climb , lifting and carrying task , car task , and measures of pain frequency and pain intensity on ambulation and transfer . RESULTS The total cost of the educational intervention was $ 343.98 per participant . The aerobic exercise intervention cost $ 323.55 per participant , and the resistance training intervention cost $ 325.20 per participant . On all but two of the outcome variables , the incremental savings per incremental effect for the resistance exercise group was greater than for the aerobic exercise group . CONCLUSION The data obtained from this study suggest that , compared with an education control , resistance training for seniors with knee osteoarthritis is more economically efficient than aerobic exercise in improving physical function . However , the magnitude of the difference in efficiency between the two approaches is small",
"BACKGROUND Pharmacological treatment of depression in geriatric patients is often difficult . Although unsupervised exercise has been shown to benefit younger depressed patients , there is no evidence that unsupervised exercise can be used as a maintenance treatment for depression in elderly patients . Our aim was to test the feasibility and efficacy of unsupervised exercise as a long-term treatment for clinical depression in elderly patients . METHODS We studied 32 subjects ( 71.3 + /- 1.2 years of age , mean + /- SE ) in a 20-week , r and omized , controlled trial , with follow-up at 26 months . Subjects were community-dwelling patients with major or minor depression or dysthymia . Exercisers engaged in 10 weeks of supervised weight-lifting exercise followed by 10 weeks of unsupervised exercise . Controls attended lectures for 10 weeks . No contact was made with either group after 20 weeks until final follow-up . Blinded assessment was made with the Beck Depression Inventory ( BDI ) , the Philadelphia Geriatric Morale Scale , and Ewart 's Self Efficacy Scale at 20 weeks and with the BDI and physical activity question naire at 26 months . RESULTS Patients r and omized to the exercise condition completed 18 + /- 2 sessions of unsupervised exercise during Weeks 10 to 20 . The BDI was significantly reduced at both 20 weeks and 26 months of follow-up in exercisers compared with controls ( p weight lifting , versus 0 % of controls ( p Unsupervised weight-lifting exercise maintains its antidepressant effectiveness at 20 weeks in depressed elderly patients . Long-term changes in exercise behavior are possible in some patients even without supervision",
"It is considered that skeletal mass in humans may respond to loading or the number of loading cycles . The aim of this study was to examine the effect of a 1 year progressive resistance training program on the bone mass of 56 postmenopausal women . Assignment was by block r and omization to one of two resistance training groups : a strength trained group ( 3 x 8 repetition maximum ) or an endurance group ( 3 x 20 repetition maximum ) . The resistance exercises were selected to stress the ipsilateral forearm and hip region . The exercising side was r and omly assigned with one side exercised while the alternate side acted as the nonexercise control . Bone mineral density ( BMD ) was measured every 3 months at the radial forearm and four hip sites using the Hologic QDR 2000 bone densitometer . A linear regression function was fitted for each individual 's bone density results , and the slope was compared for the exercise and control side using paired t-tests . The bone mass increase with the strength regimen was significantly greater at the trochanteric hip site ( control -0.6 + /- 2.2 % , exercise 1.7 + /- 4.1 % , p increase in BMD with the endurance regimen except at the radius midsite ( control -1.0 + /- 2.3 % , exercise 0.1 + /- 1.4 % , p muscle strength , tested by a one-repetition maximum ( 1RM ) test , increased significantly for all 10 exercises ( p change in BMD and the percentage increase in strength as follows : trochanter with leg press ; intertrochanter with leg press ( p resistance exercise in that although the trochanter and intertrochanter bone density was elevated by the resistance exercises undertaken , there was no effect on the femoral neck value . Postmenopausal bone mass can be significantly increased by a strength regimen that uses high-load low repetitions but not by an endurance regimen that uses low-load high repetitions . We conclude that the peak load is more important than the number of loading cycles in increasing bone mass in early postmenopausal women",
"OBJECTIVES This investigation determined whether an in-home resistance training program achieved health benefits in older adults with disabilities . METHODS A r and omized controlled trial compared the effects of assigning 215 older persons to either a home-based resistance exercise training group or a waiting list control group . Assessment s were conducted at baseline and at 3 and 6 months following r and omization . The program consisted of videotaped exercise routines performed with elastic b and s of varying thickness . RESULTS High rates of exercise adherence were achieved , with 89 % of the recommended exercise sessions performed over 6 months . Relative to controls , subjects who participated in the program achieved statistically significant lower extremity strength improvements of 6 % to 12 % , a 20 % improvement in t and em gait , and a 15 % to 18 % reduction in physical and overall disability at the 6-month follow-up . No adverse health effects were encountered . CONCLUSIONS These findings provide important evidence that home-based resistance exercise programs design ed for older persons with disabilities hold promise as an effective public health strategy",
"Most studies that assess the effects of exercise in the elderly involve subjects who are in good health . The objective of this prospect i ve longitudinal study was to examine the impact of exercise on cardiovascular fitness , flexibility , and strength in an elderly population that included chronically ill individuals . Patients were recruited initially from a population of veterans over 64 years of age who use a VA outpatient clinic as their regular source of care . The exercise intervention consisted of 90 minutes of exercise 3 days per week at 70 % of the patient 's maximal capacity . Activities included stationary cycling , stretching , weight training , and walking . Of 69 patients who began the program , 49 ( 71 % ) reached 4-month follow-up . Most patients completing follow-up ( 76 % ) had at least one chronic disease , such as arthritis , hypertension , or heart disease . Patients who dropped out were more likely to have multiple chronic illnesses than those who remained in the program . Average weekly attendance was 65 % and was stable over time . Improvements in cardiovascular fitness at 4-month follow-up were significant : Metabolic equivalents increased from 7.1 + /- 2.3 to 8.3 + /- 2.6 ( P less than .001 ) , treadmill time increased from 8.5 + /- 3.8 to 11.2 + /- 4.2 minutes ( P less than .001 ) , submaximal heart rate decreased from 123.7 + /- 18.8 to 118.8 + /- 19.4 beats per minute ( P less than .001 ) and resting heart rate decreased from 68.1 + /- 10.6 to 63.3 + /- 11.6 beats per minute ( P = .005 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Skeletal muscle adaptations to high intensity knee extensor strength and /or endurance training in patients with chronic heart failure were investigated . Eleven patients with chronic heart failure were r and omized into two groups and exercised the m. quadriceps femoris 3 days/week for 8 weeks . After training , the maximal exercise intensity tolerated on the ergometer cycle was raised from 99 ( 32 ) to 114 ( 40 ) watts ( W , P Peak dynamic knee extensor work rate showed the greatest increase after endurance training ( 40 % , P Maximal dynamic and isometric strength were elevated by 40 - 45 % ( P strength training . The cross-sectional area of m. quadriceps femoris was increased in the strength-trained legs ( 9 % , P capillary per fibre ratio of m. vastus lateralis was raised by 47 and 58 % in the endurance-trained legs ( P oxidative enzyme activity in m. vastus lateralis was significantly raised above 50 % after endurance training , whereas glycolytic enzyme activity was unaltered . The peripheral skeletal musculature in patients with chronic heart failure adapts fairly quickly to high intensity knee extensor training . This results in a marked rise in local , and a small rise in total work capacity , indicating maintained plasticity of skeletal muscle in chronic heart failure patients",
"OBJECTIVES This investigation examined the effect of 6 months of high- or low-intensity resistance exercise on muscular strength and endurance and stair climbing ability in adults aged 60 to 83 . DESIGN A r and omized controlled trial . SETTING University of Florida Center for Exercise Science . PARTICIPANTS Sixty-two men and women completed the study protocol . Subjects were matched for strength and r and omly assigned to a control ( n = 16 ) , low-intensity ( LEX , n = 24 ) , or high-intensity ( HEX , n = 22 ) group . INTERVENTION Six months of progressive , whole-body resistance training . Subjects trained at 50 % of their one-repetition maximum ( 1RM ) for 13 repetitions ( LEX ) or 80 % of 1RM for eight repetitions ( HEX ) three times per week for 24 weeks using resistance machines . One set each of 12 exercises was performed . MEASUREMENTS One-repetition maximum was measured for eight different exercises . Muscular endurance was measured using leg press and chest press machines . Low back strength was measured using a lumbar extension machine . Stair climbing ability was assessed as the time to ascend one flight of stairs . RESULTS 1RM significantly increased for all exercises tested for the HEX and LEX groups ( P total strength ( sum of all eight 1RMs ) were 17.2 % and 17.8 % for the LEX and HEX groups , respectively . Muscular endurance improved by 79.2 % and 105.0 % for the leg press , and 75.5 % and 68.0 % for the chest press for the LEX and HEX groups , respectively . The time to ascend one flight of stairs significantly decreased for both the LEX and HEX groups ( P Lumbar extension strength increased by 62.6 % and 39.5 % for the LEX and HEX groups , respectively . CONCLUSIONS These data indicate that significant and similar improvements in strength , endurance , and stair climbing time can be obtained in older adults as a consequence of high- or low-intensity resistance exercise training . These findings may have an effect on how resistance exercise is prescribed to older adults",
"OBJECTIVES This paper describes a videotaped , home-based , strength training program , titled Strong-for-Life and reports on its effectiveness in improving muscle strength , psychological well-being , and health status in a sample of older persons . DESIGN AND SETTING We enrolled 102 nondisabled , community-dwelling older people aged 66 to 87 , identified from the Medicare beneficiary list , into a r and omized , controlled trial . MEASUREMENTS Effectiveness was based on change in isokinetic upper and lower extremity muscle strength , psychologic well-being , and health status . RESULTS Results revealed several statistically significant short-term benefits after 12 to 15 weeks of exercise , especially for men . Younger older adults demonstrated a 10 % improvement in knee extensor strength relative to control subjects . Older male exercisers achieved significant differences relative to controls in perceived anger , tension , and overall social functioning . Male exercisers , in general , achieved significant improvement in perceived vigor . Women did not report psychological benefits following participation in the program . CONCLUSION Study results reveal that the Strong for Life program , design ed to be widely disseminated to the nondisabled older population , has many short-term positive benefits",
"Decreases in muscular strength , endurance , and angular velocity have previously been demonstrated in the elderly . Osteoarthritis ( OA ) , especially of the knee , may cause further reductions in these parameters and lead to functional limitations . This study measured the effects of a quantitative progressive exercise muscle rehabilitation program ( QPE ) that was added to a physical therapy ( PT ) program . Forty subjects ( 20 men and 20 women ) with OA of the knees were r and omly selected from a group of volunteers ( N = 437 ) for the 3-month program . Measurements of strength , endurance , angular velocity , and the Jette Functional Status Index were determined before and after 1 , 2 , and 3 months of the program . The QPE program was composed of isometric , isotonic , isotonic with resistance , endurance , and speed contractions prescribed in a progressive sequence . Muscle strength ( 14 % and 29 % ) and endurance ( 38 % and 43 % ) increased significantly ( p walking time and the difficulty and pain experienced during functional activities",
"The effects of 12 wk of progressive resistance strength training on in vivo and in vitro immune parameters were evaluated in a controlled study of eight subjects with rheumatoid arthritis ( RA ) , eight healthy young ( 22 - 30 yr ) , and eight healthy elderly ( 65 - 80 yr ) individuals . Six healthy elderly ( 65 - 80 yr ) nontraining control subjects were also evaluated to account for seasonal and psychosocial effects . Training subjects exercised at 80 % of their one-repetition maximum and performed eight repetitions per set , three sets per session on a twice weekly basis . Peripheral blood mononuclear cell ( P BMC ) sub population s , cytokine and prostagl and in ( PG ) E2 production , proliferative response , and delayed type hypersensitivity ( DTH ) skin response were measured before and after 12 wk of training . Training did not induce changes in P BMC subsets , interleukin (IL)-1 beta , tumor necrosis factor-alpha ( TNF ) , IL-6 , IL-2 , or PGE2 production , lymphocyte proliferation , or DTH response in any of the training groups , compared with control subjects . These data suggest that 12 wk of high-intensity progressive resistance strength training does not affect immune function in young or elderly healthy individuals or subjects with RA",
"OBJECTIVE To determine the effects of heavy resistance strength training ( ST ) on resting blood pressure ( BP ) in older men and women . DESIGN Prospect i ve intervention study . SETTING University of Maryl and Exercise Science Laboratory . PARTICIPANTS Twenty-one sedentary , healthy older men ( 69 + /- 1 year , n = 11 ) and women ( 68 + /- 1 year , n = 10 ) served as subjects for the study . INTERVENTION Six months of progressive whole body ST performed 3 days per week using Keiser K-300 air-powered resistance machines . MEASUREMENTS One-repetition maximum ( 1 RM ) strength was measured for seven different exercises before and after the ST program . Resting BP was measured on six separate occasions before and after ST for each subject . RESULTS Substantial increases in 1 RM strength were observed for upper body ( UB ) and lower body ( LB ) muscle groups for men ( UB : 215 vs 265 kg ; LB : 694 vs 838 kg ; P ST program led to reductions in both systolic ( 131 + /- 2 vs 126 + /- 2 mm Hg , P diastolic ( 79 + /- 2 vs 75 + /- 1 mm Hg , P BP . Systolic BP was reduced significantly in men ( 134 + /- 3 vs 127 + /- 2 mm Hg , P diastolic BP was reduced following training in both men ( 81 + /- 3 vs 77 + /- 1 , mm Hg , P = .054 ) and women ( 78 + /- 2 vs 74 + /- 2 mm Hg , P = .055 ) . CONCLUSIONS Six months of heavy resistance ST may reduce resting BP in older persons . According to the latest guidelines from the Joint National Committee for the Detection , Evaluation , and Treatment of Hypertension , the changes in resting BP noted in the present study represent a shift from the high normal to the normal category",
"OBJECTIVE Muscle strength training is one of the most common therapy methods in physical therapy programs , and the usual goal of this treatment is to improve muscle strength . Little attention has been paid , however , to the effects of strength training on the other components of motor performance . This study examined the effects of a 10-week strength training program on the motor performance of the h and , including reaction time , speed of movement , tapping speed , and coordination in normal healthy volunteers . DESIGN Before-after trial . SUBJECTS AND SETTING Sixteen healthy women volunteers aged 25 to 45 years participated . INTERVENTION Subjects accomplished a 10-week muscle strength training program of the upper extremities . MAIN OUTCOME MEASURES Reaction time , speed of movement , tapping speed , and coordination were measured three times on consecutive days , and muscle strength and electromyographic values of the right upper extremity were recorded once before the training period . After the training period , the same measurements were made as before the training . RESULTS The 10-week strength training decreased choice reaction time by 6 % ( p tapping speed by 3 % ( p coordination by 5 % ( p Speed of movement increased , but this change was not statistically significant . All the measured isometric muscle strengths and electromyographic activations upon maximum isometric contraction increased . CONCLUSIONS A 10-week strength training of the upper extremities increased muscle strength and some motor performance functions of the h and , including choice reaction time , tapping speed , and coordination",
"Physical disability is common among older persons living within the community . The Framingham Disability Study [ 1 , 2 ] reported that , among community-dwelling persons older than 70 years of age , 49 % of women and 27 % of men have substantial mobility or work limitations . More recently , a 4-year prospect i ve trial of healthy elderly persons with no disability at baseline showed that lower-extremity physical performance at baseline was highly predictive for the subsequent development of disability [ 3 ] . Muscle mass , strength , and endurance decrease with age , and a close correlation between short-course walking speed and the size and strength of leg muscles has been shown in institutionalized nonagenarians [ 4 ] . Furthermore , resistance training in this population has been shown to result in increased measures of physical performance and corresponding increases in muscle strength , size , and short-course walking speed [ 4 , 5 ] . Our goal was to determine whether resistance training would improve walking endurance and lower-limb strength in nondisabled , community-dwelling elderly persons . Methods Twenty-four sedentary , healthy persons ( 11 men and 13 women ) were r and omly assigned within sex groups either to a 12-week resistance-training program or to sedentary control status . The mean age of the participants was 70.4 4 years ( range , 65 to 79 years ) , and no differences in mean age were seen between groups ( 69.9 4 years in the resistance-training group ; 70.7 5 years in the control group [ P > 0.2 ] ) . The resistance-training group was composed of 6 men and 6 women ; the control group consisted of 5 men and 7 women . Participants did symptom-limited treadmill stress tests at baseline , and we collected expired gas to determine peak aerobic capacity . We used a Horizon Metabolic Measurement Cart ( Sensormedics , Yorba Linda , California ) to analyze expired air . Participants were excluded if they had angina or electrocardiographic ischemia ( defined as ST-segment depression more than 1 mm ) during the exercise test ( n = 2 ) , if their resting blood pressure was higher than 160/90 mm Hg ( n = 4 ) , or if they had a noncardiopulmonary limitation of exercise capacity , such as claudication , arthritis , or cerebrovascular disease ( n = 1 ) . We tested 29 participants to arrive at the final study sample of 24 persons . No participants were receiving calcium- or -blocking medications or estrogen-replacement therapy , and none had diabetes . We determined body composition by using underwater weighing and correcting for residual volume [ 6 ] . Leg-muscle mass was determined by dual-energy x-ray absorptiometry [ 7 ] . Strength was evaluated on a Universal Gym apparatus ( Universal , Cedar Rapids , Iowa ) by measuring the single repetition maximal lift for leg extension , leg flexion , and bench press . We measured submaximal endurance capacity on the treadmill by first having participants walk for 5 minutes at an intensity of 50 % of their previously determined peak aerobic capacity . Participants then gradually increased their walking intensity to 80 % of peak aerobic capacity by 10 minutes of the continuous protocol and proceeded until exhaustion ( n = 24 ) or 45 minutes , at which time the test was terminated . Because none of the participants had angina , claudication , or exercise-limiting arthritis , exhaustion was defined as a combination of leg fatigue , dyspnea , and overall body fatigue . During endurance testing , heart rate , blood pressure , oxygen uptake , and perceived exertion [ 8 ] were measured at 5-minute intervals until exhaustion . After 12 weeks , variables were measured again , and walking endurance was measured at the same absolute workload as before conditioning . The weight-training regimen consisted of three sets of eight repetitions of seven exercises done using a Universal Gym apparatus 3 days per week . The exercises ( and primary muscles exercised ) were leg extension ( quadriceps ) , leg curl ( hamstrings ) , arm extension ( triceps ) , arm curl ( biceps ) , lateral pull-down ( latissimus dorsi and biceps ) , bench press ( pectoralis major and triceps ) , and squat ( gluteals and quadriceps ) . A rest period of 1 to 2 minutes was taken between sets . The participants began at a resistance of 50 % of their single repetition maximum . The resistance was then increased progressively until participants were exercising at 80 % of their single repetition maximum by week 9 . Strength was retested intermittently , and the training loads were adjusted as required . The participants did not train aerobically . Controls were instructed not to alter their home activity habits . A two-factor analysis of variance was done on baseline measures , with sex and training groups as the factors [ 9 ] . Women differed from men in baseline measures of fitness , strength , and body composition , but no sex-group interactions were seen . Pre- to postconditioning measures were analyzed using repeated-measure analysis of variance with results separated by sex . Data collected during the submaximal endurance study were analyzed for perceived exertion , heart rate , and systolic blood pressure ( excluding rest and exhaustion values ) by repeated-measure analysis of variance . Relations between variables were studied by linear regression analysis . Data are presented as mean SD . Analyses were done using BMDP New System for Windows , Version 1.0 ( BMDP Statistical Software , Los Angeles , California ) . Results After the 12-week resistance-training program , strength increased substantially in the resistance-training group . The single repetition maximums increased by 29 % 24 % for leg extension , 65 % 79 % for leg flexion , and 29 % 15 % for bench press . When results were analyzed separately by sex and compared with results in controls , single repetition maximums for leg extension increased significantly among women ( P single repetition maximums for bench press increased significantly among women ( P single repetition maximums for leg flexion compared with controls ( P control group showed no change in strength measures over the 12-week period , and the strength changes for each of the exercises in the intervention group when sexes were combined were significantly greater than the measures in the controls ( P Resistance-Training and Control Groups at Baseline and 12 Weeks Women in our study had lower measures of peak aerobic capacity at baseline than men ( 21.5 1.1 mL/kg min1 compared with 28.8 1.5 mL/kg min1 ; P = 0.03 ) and lower measures of strength as measured by single repetition maximum for leg extension ( 23.5 1.0 kg compared with 42.8 4 kg ; P = 0.001 ) , leg curl ( 5.3 0.4 kg compared with 14.4 1.5 kg ; P = 0.003 ) , and bench press ( 20.9 1.1 kg compared with 31.3 2.2 kg ; P = 0.008 ) . Neither women nor men showed changes in peak aerobic capacity after resistance training . No participant had significant changes in body weight , percentage of body fat , fat mass , or fat-free mass as measured by underwater weighing ( Table 1 ) . Analysis of regional body composition measured by dual-energy x-ray absorptiometry scanning showed an increased lean mass of the leg with weight training when compared with controls ( P = 0.02 ) ( Table 1 ) . This was due to an increase among women ( P 0.2 ) . Peak aerobic capacity was unaltered in both groups , regardless of sex . The primary outcome variable of interest was walking endurance time . After the resistance-training program , mean walking time until exhaustion for the resistance-training group increased by 38 % , from 25 4 minutes to 34 9 minutes . In contrast , no change was seen in the control group ( 20 5 minutes to 19 10 minutes ; P = 0.005 for comparison between groups ) . The increase in endurance time was due primarily to increases seen among men ( P 0.2 ) . Mean exercise intensity , measured at 10 minutes of the endurance protocol at baseline , was 82 % of peak aerobic capacity in both the training group and the control group ( P > 0.2 between groups ) . Before the study intervention , none of the 24 participants completed the full 45-minute endurance protocol . After conditioning , 3 of the 12 participants who received resistance training and 1 of 12 controls completed the entire protocol . After conditioning , mean scores for perceived exertion for all submaximal data points from 10 minutes until the end of the walking endurance protocol ( not including the exhaustion point ) were lower in the resistance-training group than in the control group ( P = 0.03 ) ( Figure 1 ) . Mean submaximal heart rate and systolic blood pressure measures were lower after conditioning ; however , when groups were compared by repeated-measure analysis of variance , differences between groups were not significant ( Figure 1 ) . Submaximal or peak exercise oxygen consumption did not change during the endurance testing . Figure 1 . Conditioning data in the resistance-training group . For all 24 participants , significant relations were seen between change in walking endurance and change in strength measures for leg extension ( r = 0.48 [ 95 % CI , 0.10 to 0.74 ] ; P = 0.02 ) and leg flexion ( r = 0.46 [ CI , 0.07 to 0.73 ] ; P = 0.03 ) . Baseline peak aerobic capacity ( r = 0.10 [ CI , 0.48 to 0.3 ] ; P > 0.2 ) and baseline endurance time ( r = 0.41 [ CI , 0.22 to 0.73 ] ; P = 0.13 ) were not significantly related to change in endurance capacity in the resistance-training group of 12 participants . Discussion We show that healthy , community-dwelling elders can improve walking endurance and leg strength by participating in a resistance-training program . This finding is relevant to persons at risk for disability because walking endurance and leg strength are important components of physical functioning [ 3 ] . Resistance training improves walking endurance in at",
"OBJECTIVE To investigate the effects of a dynamic , intensive exercise regimen on pain , disease activity , and physical functioning in active rheumatoid arthritis ( RA ) . METHODS 64 patients with RA with a mean age of 60 ( 13 ) years and mean disease duration of 8 ( 8) years , admitted to hospital because of active disease , were r and omly assigned to an intensive exercise programme or to a conservative exercise programme during their period in hospital with a mean length of 30 ( 14 ) days . The intensive exercise programme consisted of knee and shoulder dynamic and isometric muscle strengthening exercises against resistance five times a week and conditioning bicycle training three times a week and was supplemental to the conservative exercise programme of range of motion and isometric exercises . Indices of disease activity , pain , muscle strength , and functional ability were assessed at 0 , 3 , 6 , 12 , and 24 weeks by a blinded observer . RESULTS The medical treatment during the study was the same in both groups . Both groups improved in measures of disease activity , differences between groups were not statistically significant . The mean improvement in disease activity score at 24 weeks in the intensive and conservative exercise group was −1.4 ( 1.5 ) and −0.7 ( 1.4 ) , respectively . Measures of physical functioning improved significantly for patients in the intensive exercise group , and differences between groups were statistically significant for measures of muscle strength . CONCLUSION A short term intensive exercise programme in active RA is more effective in improving muscle strength than a conservative exercise programme and does not have deleterious effects on disease activity",
"OBJECTIVE To examine the effects of a 3-month low-intensity exercise program on physical frailty . DESIGN R and omized clinical trial . SETTING Regional tertiary-care hospital and academic medical center with an outpatient rehabilitation fitness center . PARTICIPANTS Eighty-four physically frail older adults ( mean age , 83 + /- 4 yrs ) . INTERVENTION Three-month low-intensity supervised exercise ( n = 48 ) versus unsupervised home-based flexibility activities ( n = 36 ) . MAIN OUTCOME MEASURES Physical performance test , measures of balance , strength , flexibility , coordination , speed of reaction , peripheral sensation . RESULTS Significant improvement was made by the exercise group on our primary indicator of frailty , a physical performance test ( PPT ) ( 29 + /- 4 vs 31 + /- 4 out of a possible 36 points ) , as well as many of the risk factors previously identified as contributors to frailty ; eg , reductions in flexibility , strength , gait speed , and poor balance . Although the home exercise control group showed increases in range of motion , the improvements in flexibility did not translate into improvements in physical performance capacity as assessed by the PPT . CONCLUSIONS Our results suggest that physical frailty is modifiable with a program of modest activities that can be performed by virtually all older adults . They also indicate that exercise programs consisting primarily of flexibility activities are not likely to reverse or attenuate physical frailty . Although results suggest that frailty is modifiable , it is not likely to be eliminated with exercise , and efforts should be directed toward preventing the condition",
"OBJECTIVES The objectives of this study were to determine the effects of a strength-training program on walking speed and relative muscular stress , as measured by normalized integrated electromyographic ( nIEMG ) activity , while carrying a box of groceries and st and ing from a chair . DESIGN Prospect i ve intervention study . SETTING Volunteer subjects from the community of Birmingham , Alabama . PARTICIPANTS Fourteen healthy women aged 60 to 77 years . INTERVENTION Sixteen weeks of total body strength conditioning . MEASUREMENTS Before and after 16 weeks of strength conditioning , the following variables were evaluated for all subjects : ( 1 ) strength , six isotonic tests and two isometric tests ; ( 2 ) walking velocity ; ( 3 ) nIEMG of the biceps while carrying a box of groceries ; and ( 4 ) nIEMG of the rectus femoris while st and ing from a chair . MAIN RESULTS After the strength training program , subjects ' isotonic strength increased significantly , an average of 52 % on the isotonic tests and 31 % on the isometric tests . Walking velocity also increased significantly ( 18 % ) . nIEMG of the biceps decreased 36 % while carrying a box of groceries . Rectus femoris nIEMG decreased 40 % while st and ing and 47 % while sitting . CONCLUSIONS After strength conditioning , healthy older women showed not only substantially increased strength but also improvements in walking velocity and the ability to carry out daily tasks such as rising from a chair and carrying a box of groceries",
"PURPOSE This r and omized controlled study assessed whether adding a program of high-intensity strength training ( 80 % of maximum ) to an outpatient cardiac rehabilitation program would be a safe and effective means of improving muscle strength and body composition . METHODS Thirty-eight cardiac patient volunteers ( 29 men and 9 women ) were r and omized to either high-intensity strength training or flexibility training added concurrently to a 12-week outpatient cardiac rehabilitation aerobic exercise program . Muscle strength , local muscle endurance , joint flexibility , maximum treadmill tolerance time , and body composition were measured before and after completion of the training . RESULTS The strength-trained patients ( n = 18 ) had greater increases in mean strength ( 90 + /- 19 % versus 9 + /- 4 % , P local muscle endurance ( 20 versus 6 times , P mean perceived exertion for lifting the initial one repetition maximum load ( 11 + /- 1 versus 15 + /- 1 , P body fat ( 2.8 + /- 2.0 versus 1.3 + /- 2.0 kg , P gain more lean tissue ( 1.5 + /- 2.3 versus 0.5 + /- 1.2 kg , P improvements in treadmill time ( 2.3 + /- 1.3 versus 1.2 + /- 1.0 minute , P joint flexibility were similar for each group . None of the subjects had evidence of cardiac ischemia or arrhythmia during the training sessions . CONCLUSIONS Medically supervised high-intensity strength training is well tolerated when added to the aerobic training of cardiac rehabilitation programs and allows patients to aggressively gain the strength and endurance they will need to complete daily living tasks at lower perceived efforts . Strength training also reduces cardiac risk factors by improving body composition and maximum treadmill exercise time",
"OBJECTIVE --To determine the effectiveness of group- vs home-based exercise training of higher and lower intensities among healthy , sedentary older adults . DESIGN --Year-long r and omized , controlled trial comparing ( 1 ) higher-intensity group-based exercise training ; ( 2 ) higher-intensity home-based exercise training ; ( 3 ) lower-intensity home-based exercise training ; or ( 4 ) assessment -only control . SETTING --General community located in northern California . PARTICIPANTS --One hundred sixty women and 197 men 50 to 65 years of age who were sedentary and free of cardiovascular disease . One out of nine persons contacted through a community r and om-digit-dial telephone survey and citywide promotion were r and omized . INTERVENTIONS --For higher-intensity exercise training , three 40-minute endurance training sessions per week were prescribed at 73 % to 88 % of peak treadmill heart rate . For lower-intensity exercise training , five 30-minute endurance training sessions per week were prescribed at 60 % to 73 % of peak treadmill heart rate . MAIN OUTCOME MEASURES --Treadmill exercise test performance , exercise participation rates , and heart disease risk factors . RESULTS --Compared with controls , subjects in all three exercise training conditions showed significant improvements in treadmill exercise test performance at 6 and 12 months ( P less than .03 ) . Lower-intensity exercise training achieved changes comparable with those of higher-intensity exercise training . Twelve-month exercise adherence rates were better for the two home-based exercise training conditions relative to the group-based exercise training condition ( P less than .0005 ) . There were no significant training-induced changes in lipid levels , weight , or blood pressure . CONCLUSIONS --We conclude that ( 1 ) this community-based exercise training program improved fitness but not heart disease risk factors among sedentary , healthy older adults ; ( 2 ) home-based exercise was as effective as group exercise in producing these changes ; ( 3 ) lower-intensity exercise training was as effective as higher-intensity exercise training in the home setting ; and ( 4 ) the exercise programs were relatively safe",
"The purpose of this study was to examine the effects of a 14-week resistance training program on the anile strength training intensity , postural control , and gait velocity of older adults . Forty-two older adults ( mean age = 72 ) , 21 in the resistance and control groups , completed the 14-week project . The resistance training group participated in 14 weeks of resistance training three times per week using elastic b and s ( Therab and ) for resistance . Isokinetic ankle strength , training intensity , postural stability , and gait velocity were measured prior to and following the 14-week intervention . Following the training , the resistance group exhibited improved ankle dorsiflexion , training resistances , and gait velocity , but showed no change in plantar flexion or postural control . The control group also exhibited improvements in dorsiflexion , but these gains were approximately one-half of the gains observed in the resistance training group . Finally , when adjusted for baseline differences , subjects in the resistance training group demonstrated no changes in the dependent measures over the control group",
"OBJECTIVE To assess the effect of a home based exercise programme , design ed to improve quadriceps strength , on knee pain and disability . Methods —191 men and women with knee pain aged 40–80 were recruited from the community and r and omised to exercise ( n=113 ) or no intervention ( n=78 ) . The exercise group performed strengthening exercises daily for six months . The primary outcome measure was change in knee pain ( Western Ontario McMaster Osteoarthritis index ( WOMAC ) ) . Secondary measures included visual analogue scales ( VAS ) for pain on stairs and walking and WOMAC physical function scores . Results —WOMAC pain score reduced by 22.5 % in the exercise group and by 6.2 % in the control group ( between group difference p scores for pain also reduced in the exercise group compared with the control group ( p Physical function scores reduced by 17.4 % in the exercise group and were unchanged in controls ( p home quadriceps exercises can significantly improve self reported knee pain and function",
"OBJECTIVE To determine the effect of a home exercise program on strength , postural control , and mobility following hip fracture . DESIGN R and omized controlled trial of 1 month 's duration . SETTING Daily exercise carried out within the subjects ' home environments . PARTICIPANTS Forty-two people 64 to 94 years of age , 35 of whom were living independently in the community and 7 of whom were residing in institutional care . Subjects were recruited on average 7 months after a fall-related hip fracture and r and omly allocated to either the intervention or the control group ( n = 21 each ) . The groups were well matched in terms of medical conditions , medication use , disability , and activity levels . INTERVENTION A \" home-based \" program of weight-bearing exercise established at a visit by a physiotherapist . MAIN OUTCOME MEASURES Quadriceps strength , postural sway , functional reach , weight-bearing ability , walking velocity , and self-rated fall risk . The subjects undertook these assessment s at the beginning and end of the trial . RESULTS At pretest , exercisers and controls performed similarly in all tests . At the end of the trial , the intervention group showed significantly greater quadriceps strength in the affected ( hip-fractured ) leg and increased walking velocity . The intervention subjects also improved their weight-bearing ability and reported reduced subjective falls risk . In contrast , there were no significant improvements in any of the test measures in the controls . Within the intervention group , improvements in quadriceps strength were significantly associated with improved performances in the weight-bearing test measures and with increased walking velocity . CONCLUSIONS This exercise program improved strength and mobility following hip fracture . Further research is needed to ascertain whether the extent of this improvement in these fall risk factors is sufficient to prevent falls",
"BACKGROUND Strength loss is strongly associated with functional decline and is reversible with exercise . The effect of increased strength on function has not been clearly established . The purpose of this study was to determine whether strength gain is associated with improvement in physical performance and disability . METHODS One hundred functionally impaired community-dwelling men and women ( 77.6 + /- 7.6 yrs ) were tested at baseline and outcome for lower extremity strength , physical performance , and disability . After r and om group assignment , exercise participants received strengthening exercises in their homes three times a week for 10 weeks while control subjects continued their normal activities . Using multiple regression techniques , the relationship between strength gain and improvement in physical performance and disability was assessed , controlling for age , depression , and baseline strength . RESULTS A significant impact of strength gain on mobility skills ( p = .0009 ) was found . The impact of strength gain on chair rise performance was significant in participants who were more impaired ( p = .04 ) . Strength gain was associated with gain in gait speed ( p = .02 ) and in falls efficacy ( p = .05 ) , but not with other balance , endurance , or disability measures . CONCLUSIONS Lower extremity strength gain is associated with gains in chair rise performance , gait speed , and in mobility tasks such as gait , transfers , stooping , and stair climbing , but not with improved endurance , balance , or disability . Strength gain is also associated with improvement in confidence in mobility . Factors that may influence the ability of strength gain to affect function are initial level of frailty and specificity of exercise . These results support the idea that strength training is an intervention that can potentially improve physical health status in many frail elders",
"To investigate the effects of cessation and subsequent resumption of training on muscle strength in elderly men , 11 men ( aged 65 - 77 years ) , just completing a 24-week r and omized controlled trial of recombinant human growth hormone ( rhGH ) and resistance exercise ( rhGH , n = 6 ; placebo , n = 5 ) , detrained for 12 weeks and subsequently retrained for 8 weeks . During the detraining and retraining phase , subjects did not receive rhGH . The resistance programme included three sets of eight repetitions at 75 % of one-repetition maximum ( 1-RM ) , three times per week , for 10 upper and lower body exercises . Dynamic muscle strength was assessed by the 1-RM method every 2 weeks for 44 weeks . Needle biopsies of vastus lateralis muscle were obtained from seven men . Muscle strength increased during initial training by 40.4 + /- 5.5 % ( mean + /- SEM ) , ranging from 26.0 + /- 5.0 to 83.9 + /- 15.6 % , depending on muscle group . Increased strength was accompanied by hypertrophy ( P strength gains , only 29.9 + /- 5.2 % was lost with detraining . However , type I and II fibre cross-sectional area reverted to pretraining values . After 8 weeks of retraining , muscle strength returned to trained values , but without a significant change in fibre morphology . The results indicate that elderly men lose some muscle strength following short-term detraining , but that only a brief period of retraining suffices to regain maximal strength . Reversal of fibre cross-sectional area with detraining , and only modest improvement with retraining , suggests that much of the retention in strength with detraining and reacquisition of lost strength with retraining reflects neural adaptation",
"PURPOSE This study examined the effects of 24 wk of high intensity strength training or low intensity walking on lumbar bone mineral density ( BMD ) , muscular strength , and calcium turnover in Australian women either taking hormone replacement therapy ( HRT ) or not taking HRT . METHODS A subject pool of 64 women between 45 - 65 yr and r and omly allocated into weights ( N = 21 ) , walking ( N = 20 ) , weightsHRT ( N = 14 ) , and walkingHRT ( N = 9 ) groups completed this study . All subjects trained twice weekly in either a 50-min walking or weight-training program ( 60 - 90 % IRM ) . Measurements included maximal isometric knee strength , IRM bench press , IRM squat , isokinetic back strength , lumbar ( L2-L4 ) BMD , serum osteocalcin , and urinary deoxypyridinoline crosslinks ( Dpd ) . RESULTS No significant group differences in BMD were evident at the completion of training . However , a significant ( P BMD decreased 1.3 % below baseline testing . Osteocalcin levels increased significantly ( P Maximal bench press and squat strength improved significantly ( P isokinetic back strength ( 22.2 % ) . CONCLUSION It was concluded that short-term high intensity resistance training provides an effective means for increasing muscular strength in women between 45 and 65 yr . The training effects on lumbar BMD were not apparent in the present study",
"Knowledge of the effects of exercise on bone mass in postmenopausal women is limited and controversial . Animal studies have shown that the response of bone to bending strain is an alteration of bone geometry . We studied 250 postmenopausal women , aged 52 - 72 years , willing to participate in a 6-month exercise program . The first 125 started the program immediately and the remaining 125 served as controls . The training program included exercises design ed to maximize the stress on the wrist . One hundred and eighteen of the active group and 116 of the control group completed the study and were reassessed 6 months later . Bone mineral density ( BMD ) of the femoral neck , lumbar spine , ultradistal and proximal radius was measured by dual-energy X-ray absorptiometry ( DXA ) both before and at the end of the exercise program . The forearm was also evaluated by peripheral quantitative computed tomography , which measures the area , bone mineral content ( BMC ) , and volumetric density for both the cortical and the trabecular component . The results showed that the DXA measurements at the femoral neck , lumbar spine , ultradistal and proximal radius were similar between the two groups . No significant difference was detected after the exercise program at the proximal radius . At the ultradistal radius , the cross-sectional area of cortical bone rose by 2.8 + /- 15.0 % ( SD , p apposition and corticalization of the trabecular tissue . The volumetric density of cortical bone rose by 2 . 2 + /- 15.8 % ( p trabecular bone decreased by 2.6 + /- 10.7 % ( p bone volume and density in the exercise group were associated with marked increase in cortical BMC ( 3.1 + /- 10.7 % , p trabecular BMC ( -3.4 + /- 14.2 % , p bone mass . However , it appears that some exercises may reshape the bone segment under stress by increasing both the cross-sectional area and the density of the cortical component . These structural changes are theoretically associated with increases in the bending strength",
"This study was design ed to determine whether an 8-week isokinetic muscle-strength-training program improved the functional health status of patients with osteoarthritis of the knee joint . Twenty volunteers with osteoarthritis of the knee joint were r and omly assigned to either an experimental ( n=10 ) or control ( n=10 ) group . The experimental group completed six sets of five maximal contractions three times per week for 8 weeks on a Cybex II dynamometer at 90 degrees per second . Both groups were pre- and posttest for extension and flexion strength of the right and left legs , the 50-foot walk time , range of motion at the knee joint , the Osteoarthritis Screening Index ( OASI ) , and the Arthritis Impact Measurement Scale ( AIMS ) . There was a significant decrease in pain and stiffness , and a significant increase in mobility . There was also a significant decline in arthritis activity in the experimental group as measured by the OASI and AIMS . The experimental group significantly increased in all strength measures , while the control group increased in only right leg flexion and left leg extension across the training period",
"BACKGROUND Although disuse of skeletal muscle and undernutrition are often cited as potentially reversible causes of frailty in elderly people , the efficacy of interventions targeted specifically at these deficits has not been carefully studied . METHODS We conducted a r and omized , placebo-controlled trial comparing progressive resistance exercise training , multinutrient supplementation , both interventions , and neither in 100 frail nursing home residents over a 10-week period . RESULTS The mean ( + /- SE ) age of the 63 women and 37 men enrolled in the study was 87.1 + /- 0.6 years ( range , 72 to 98 ) ; 94 percent of the subjects completed the study . Muscle strength increased by 113 + /- 8 percent in the subjects who underwent exercise training , as compared with 3 + /- 9 percent in the nonexercising subjects ( P Gait velocity increased by 11.8 + /- 3.8 percent in the exercisers but declined by 1.0 + /- 3.8 percent in the nonexercisers ( P = 0.02 ) . Stair-climbing power also improved in the exercisers as compared with the nonexercisers ( by 28.4 + /- 6.6 percent vs. 3.6 + /- 6.7 percent , P = 0.01 ) , as did the level of spontaneous physical activity . Cross-sectional thigh-muscle area increased by 2.7 + /- 1.8 percent in the exercisers but declined by 1.8 + /- 2.0 percent in the nonexercisers ( P = 0.11 ) . The nutritional supplement had no effect on any primary outcome measure . Total energy intake was significantly increased only in the exercising subjects who also received nutritional supplementation . CONCLUSIONS High-intensity resistance exercise training is a feasible and effective means of counteracting muscle weakness and physical frailty in very elderly people . In contrast , multi-nutrient supplementation without concomitant exercise does not reduce muscle weakness or physical frailty",
"We examined the effects of 42 weeks of progressive weight-lifting training on dynamic muscle strength , peak power output in cycle ergometry , symptom limited endurance during progressive treadmill walking and stair climbing , knee extensor cross-sectional areas , and bone mineral density and content in healthy males and females aged 60 - 80 years , currently enrolled in a 2-year resistance training program . Subjects were r and omized into either exercise ( EX ) or control ( CON ) groups ( 60 - 70 years : 38 males and 36 females ; 70 - 80 years : 25 males and 43 females ) . EX trained several muscle groups twice per week for 42 weeks at intensities ranging from 50 - 80 % of the load that they could lift once only ( 1 RM ) ; CON did usual daily activities . After the 10 months there was no change in 1 RM strength in CON , but significant gains ( mean increases up to 65 % ) in EX ( no independent age or gender effects ) ; 30 % and 47 % of the increase in 1 RM had occurred by 6 and 12 weeks , respectively . In EX , the 7.1 % increase in peak cycling power output was significantly greater than in CON ( + 1.1 % ) . The 17.8 % improvement in symptom limited treadmill walking endurance was also greater than in CON ( + 3.4 % ) , but the difference between groups during stair climbing was not significant ( EX + 57 % , CON + 33 % ) . The cross-sectional areas of the knee extensors increased significantly by 5.5 % in EX but were unchanged in CON . There were no changes in bone mineral density or content in either group . We conclude that long-term resistance training in older people is feasible and results in increases in dynamic muscle strength , muscle size , and functional capacity",
"The aim of the present study was to evaluate the effects of a 16-week progressive high-intensity strength training ( HIST ) program on peripheral markers of bone turnover ( bone Gla protein , BGP ; bone alkaline phosphatase , B-AP ; N-terminal propeptide of type I procollagen , PINP ; C-terminal cross-linked telopeptide of type I collagen , ICTP ) in healthy , elderly men over 65 yr of age . Thirty healthy men ( aged 65–81 yr ) , performing light to moderate daily physical activity , were r and omly divided into two groups . Group 1 ( no.=16 ) followed a supervised 16-week progressive HIST program , while subjects of group 2 ( no.=14 ) , used as controls , were requested to maintain their habitual level of physical activity for 16 weeks . HIST program consisted of 6 different sets of exercise ( 2 involving the major muscle groups of the lower limb and 4 involving those of the upper limb ) . Three sessions/week , during which 10 repetitions of each exercise set were completed , were performed . Lower limb exercises shifted from 50 to 80 % of the one maximal repetition ( 1MR ) during the first month of the protocol and were thereafter maintained at an intensity of 80 % 1MR throughout the training . Upper limb exercises shifted from 40 to 65 % of 1MR with a similar pattern . All sessions were preceded by 15 min of cycloergometer exercise at 50 % of maximal oxygen uptake and by a warm-up of 15 repetitions at 20 % of 1MR of each exercise set . The HIST program did not significantly change BGP ( mean±SE , before : 15.6±1.2 μg/l vs after : 16.0±1.2 μg/l , NS ) and PINP levels ( before : 44.6±6.7 μg/l vs after : 43.1±6.0 μg/l , NS ) . On the contrary , serum B-AP significantly increased ( before : 50.2±6.1 IU/l vs after : 62.3±7.0 IU/l , p ( before : 4.0±0.3 μg/l vs after : 3.8±0.3 μg/l , p , a significant improvement in this ratio was found in all subjects of group 1 ( before : 12.9±1.3 IU/μg vs after : 17.3±1.5 IU/μg , p 2 . No significant changes of IGF-I levels were observed after the HIST program ( before : 94.9±9.4 μg/l vs after : 89.9±9.7 μg/l ) . No significant changes of BGP , PINP , B-AP , ICTP , B-APICTP ratio and IGF-I levels were observed in controls ( group 2 ) during the 16 weeks of observation . Although the positive effects of a progressive HIST program on B-AP levels and B-AP-ICTP ratio seem promising , the support of bone mass measurement and the determination of other bone markers are requested to better identify exercise protocol ( duration , intensity ) for elderly people",
"PURPOSE The recommendations for exercise training and physical activity for older adults include cardiovascular and resistance training components ( CVT and RT , respectively ) . The purpose of the present investigation was to compare the fitness benefits of concurrent CVT and RT with those attained through an equivalent duration of CVT or RT alone . METHODS Thirty-six participants ( ages 60 - 84 ) were assigned to a control group or to one of three exercise treatment groups . The treatment groups exercised three times per week for 12 wk using RT ( N = 11 ) , CVT ( N = 10 ) , or CVT and RT ( BOTH , N = 9 ) . Pre- and post-training , participants performed a submaximal exercise test ( GXT ) , five repetition-maximum strength tests ( 5RM ) , and the AAHPERD functional fitness test for older adults . RESULTS All exercise treatment groups revealed lower resting heart rate and rate-pressure product ; lower exercise diastolic blood pressure and rating of perceived exertion ; increased GXT duration ; increased leg , back , and shoulder 5RM scores ; and improved AAHPERD flexibility , coordination , and cardiovascular endurance scores . The exercise treatment groups responded differently on the following : RT and BOTH enhanced arm and chest strength more than CVT ; and BOTH enhanced AAHPERD strength and agility scores more than CVT or RT . CONCLUSIONS Concurrent CVT and RT is as effective in eliciting improvements in cardiovascular fitness and 5RM performance as CVT or RT , respectively . Moreover , incorporating both CVT and RT in exercise programs for older adults may be more effective in optimizing aspects of functional fitness than programs that involve only one component",
"This study tested whether a 12-week dynamic resistance strength training program can change gait velocity and improve measures of balance among adults age 65 and older . Fifty-five community-dwelling adults ( mean age = 71.1 ) were r and omized into an exercise ( n = 25 ) or control ( n = 30 ) group . The exercisers were requested to complete three bouts of strength training per week for 12 weeks using elastic tubing . At posttest the exercisers demonstrated slower gait velocity , enhanced balance , and an improved ability to walk backward , although none of these posttest measures was significantly different from the control group",
"Fifty female subjects , aged 72 - 92 ( mean 82 ) years , were enrolled in a 12-week ( 36 classes ) exercise program aim ed at increasing postural stability . Subjects were residents of sheltered apartments , rest homes or nursing homes , well enough and mobile enough to participate in the classes . The subjects were r and omized into an exercise or a control group . Their postural sway , st and ing at rest on a force platform , was measured with eyes open and eyes closed . The groups were well matched in all respects . The results showed no improvement in the postural sway as a result of the exercise program . We hypothesize that increasing postural sway in the elderly represents a deterioration in , for the most part , the nervous system and may at this extreme of life indicate an irreversible loss of function . For this reason no improvement in postural sway may be possible",
"Twenty active elderly subjects ( mean age = 66.4 years , range 51 - 81 ) participated in a 12-week weight-training program to determine the possibility of increasing muscular strength and lean body weight . The training utilized variable resistance weight machines which trained the major muscle groups . The male subjects ( n = 11 ) experienced an average increase of 66.1 % ( SD = 19.39 , p total maximum weight lifted while the females ( n = 9 ) showed an average increase of 72.2 % ( SD = 33.44 , p Lean body weight , which was calculated by skinfold measurements for each group did increase , but was not statistically significant ( males p weight-training regimen can have on an elderly population",
"Left ventricular function and hemodynamic alterations at rest were measured echocardiographically following running or isometric training in 40 healthy elderly . They were r and omly assigned into two groups . Twenty ( 67 + /- 4 years ) were engaged in running and 20 ( 67.8 + /- 3.8 years ) in isometric training programs . All subjects underwent a 12-week program , 3 times a week 30 min each session . The running exercise ( REX ) group had an aerobic exercise conditioning program at 70 % of their VO2max . The program for the isometric exercise ( IEX ) group included weight lifting utilizing large muscle mass at 30 % of their maximal voluntary contraction . After training , the REX group increased significantly ( p less than 0.05 ) their VO2max from 2.08 + /- 0.37 to 2.36 + /- 0.41 liter/min and ejection fraction 56 + /- 5.9 to 62 + /- 6.1 % . They decreased significantly their heart rate , from 73 + /- 7 to 65 + /- 7 beats/min . No change occurred in the IEX group in left ventricular function and hemodynamic parameters . These data suggest that left ventricular responses at rest differ between the two groups following a short-term training with a favorable response after REX training . In addition , this study demonstrated that a controlled aerobic training program is a better way to improve physical capacity than is a weight lifting program for trained healthy elderly"
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OBJECTIVE To demonstrate the application of the modified Ottawa method by establishing the up date need of a systematic review with focus on the caries preventive effect of GIC versus resin pit and fissure sealants ; to answer the question as to whether the existing conclusions of this systematic review are still current ; to establish whether a new up date of this systematic review was needed . METHODS Application of the Modified Ottawa method . Application date : April/May 2012 . RESULTS Four signals aligned with the criteria of the modified Ottawa method were identified . The content of these signals suggest that higher precision of the current systematic review results might be achieved if an up date of the current review were conducted at this point in time . However , these signals further indicate that such systematic review up date , despite its higher precision , would only confirm the existing review conclusion that no statistically significant difference exists in the caries-preventive effect of GIC and resin-based fissure sealants . CONCLUSION In conclusion , this study demonstrated the modified Ottawa method as an effective tool in establishing the up date need of the systematic review . In addition , it was established that the conclusions of the systematic review in relation to the caries preventive effect of GIC versus resin based fissure sealants are still current , and that no up date of this systematic review was warranted at date of application
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"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",
"Background This article constitutes a partial up date of the original systematic review evidence by Yengopal et al. from 15 January 2008 ( published in the Journal of Oral Science in 2009 ) with primary focus on research quality in regard to bias risk in trials . Its aim is to up date the existing systematic review evidence from the English literature as to whether caries occurrence on pits and fissures of teeth sealed with either GIC or resin is the same . Methods In addition to the 12 trials included during the original systematic review , 5 new trials were identified during the data base search ( up to 26 August 2010 ) and 2 further trials were included from a h and search and reference check . Of these , 3 trials were excluded and 16 were accepted for data extraction and quality assessment . The quality of accepted trials was assessed , using up date d quality criteria , and the risk of bias was investigated in more depth than previously reported . In addition , the focus of quantitative synthesis was shifted to single data sets that were extracted from the accepted trials . Results Twenty-six dichotomous and 4 continuous data sets were extracted . Meta- analysis and cumulative meta- analysis were used in combining clinical ly homogenous data sets . The overall outcome of the computed data sets suggest no difference between the caries-preventive effects of GIC- and resin-based fissure sealants . Conclusions This overall outcome is in agreement with the conclusions of the original systematic review . Although the findings of the trials identified in this up date may be considered to be less affected by attrition- and publication bias , their risk of selection - and detection-/performance bias is high . Thus , verification of the currently available results requires further high quality r and omised control trials",
"OBJECTIVES The aim of the present study was to investigate the caries-preventive effect of sealants produced with a high-viscosity glass-ionomer with an elevated powder-liquid ratio ( ART ) , of having energy added to this glass-ionomer , and that of glass-carbomer , in comparison to that of resin composite sealants . METHODS The r and omized controlled trial covered 407 children , with a mean age of 8 years . At a school compound three dentists placed sealants in pits and fissures of high caries-risk children . Evaluation by two independent evaluators was conducted after 0.5 , 1 and 2 years . The Kaplan-Meier survival method , ANOVA and t-test were used in analyzing the data . RESULTS 1352 first permanent molars were sealed . 6.6 % of children and 6.8 % of sealants dropped out within 2 years . 27 re-exposed pits and fissures , 20 in occlusal and 7 in smooth surfaces , in 25 children , developed a dentin carious lesion . The cumulative survival of dentin carious lesion-free pits and fissures in the glass-carbomer sealant group was statistically significantly lower ( 97.4 % ) than those in the high-viscosity glass-ionomer with energy supplied ( 99 % ) and the resin-composite ( 98.9 % ) sealant groups . There was no statistically significant difference in the cumulative survival of dentin carious lesion-free pits and fissures , between the high-viscosity glass-ionomer with ( 99 % ) and without ( 98.3 % ) energy supplied sealant groups , after 2 years . SIGNIFICANCE The survival of dentin carious lesion-free pits and fissures was high in all sealant types . More dentin carious lesions were observed in the glass-carbomer sealant group",
"AIM : To evaluate retention and caries prevention of a glass-ionomer cement ( GIC ) and a resin-based fissure sealant placed by fifth-year undergraduate dental students . METHODS : The study was conducted according to a split-mouth , r and omised clinical trial . Children with at least one pair of caries-free permanent first molars with deep pits and fissures were included in the study . The children were selected from a population that had a high risk for dental caries . Sealant material s were applied by fifth-year undergraduate dental students on 346 fissures of the first permanent molars in 173 children . The ages of the children ranged from 7–15 years ( mean 9.4 ) . Two research ers at the clinics supervised all of the procedures . Intra-examiner reproducibility and inter-examiner reproducibility were 0.90 and 0.86 , respectively , for the clinical assessment of sealant retention and caries evaluation . RESULTS : GIC sealants were completely lost in 31.9 % and resin-based sealants in 16.6 % ( p The total retention rates of GIC sealants and resin-based sealants were 13.8 % and 20.8 % , respectively . After 24 months , the caries increment was 3.4 % for GIC sealants and 4.8 % for resin-based sealants ( p>0.05 ) . CONCLUSIONS : The retention of GIC sealants was markedly inferior to the retention of resin-based sealants ; however , GIC when used as a pit and fissure sealant was slightly more effective in preventing occlusal caries ",
"PURPOSE This prospect i ve clinical trial compared the retention rate and caries-preventive efficacy of two types of sealant modalities over a 3-year period . MATERIAL S AND METHODS Using a split-mouth r and omised design , 1280 sealants were r and omly applied on sound permanent second molars of 320 young patients aged between 12 and 16 years . Half of the teeth ( n = 640 ) were sealed with a resin-modified glass ionomer cement ( RMGIC ) ( Vitremer ™ , 3 M ESPE ) and the other half ( n = 640 ) with a conventional light-cure , resin-based fissure sealant ( LCRB ) ( Fluoroshield ® , Dentsply Caulk ) . Teeth were evaluated at baseline , 6- , 12- , 18- , 24- , 30- and 36-month intervals with regard to retention and new caries development . RESULTS On the sealed occlusal surfaces after 3 years , 5.10 % of RMGIC and 91.08 % of LCRB sealants were totally intact and 6.37 % of RMGIC and 7.65 % of LCRB sealants were partially intact . New caries lesions were found in 20.06 % of RMGIC sealed occlusal surfaces , compared to 8.91 % for LCRB sealants . CONCLUSIONS The findings of the present clinical study suggest that RMGIC should be used only as a transitional sealant that can be applied to newly erupting teeth throughout the eruptive process , whereas LCRB sealants are used to successfully prevent occlusal caries lesions once an effective rubber dam can be achieved . It can be concluded that there are differences between the RMGIC and LCRB sealants over a 3-year period in terms of the retention rate and caries-preventive efficacy . RMGIC can serve as a simple and economic sealing solution , however provisional . Due to its poor retention rate , periodic recalls are necessary , even after 6 months , to eventually replace the lost sealant"
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BACKGROUND Panic disorder can be treated with psychotherapy , pharmacotherapy or a combination of both . AIMS To summarise the evidence concerning the short- and long-term benefits and adverse effects of a combination of psychotherapy and antidepressant treatment . METHOD Meta-analyses and meta-regressions were undertaken using data from all relevant r and omised controlled trials identified by a comprehensive literature search . The primary outcome was relative risk ( RR ) of response . RESULTS We identified 23 r and omised comparisons ( 21 trials involving a total of 1709 patients ) . In the acute-phase treatment , the combined therapy was superior to antidepressant pharmacotherapy ( RR=1.24,95 % CI1.02 - 1.52 ) or psychotherapy ( RR=1.16,95 % CI1.03 - 1.30 ) . After termination of the acute-phase treatment , the combined therapy was more effective than pharmacotherapy alone ( RR=1.61,95 % CI1.23 - 2.11 ) and was as effective as psychotherapy ( RR=0.96 , 95 % CI 0.79 - 1.16 ) . CONCLUSIONS Either combined therapy or psychotherapy alone may be chosen as first-line treatment for panic disorder with or without agoraphobia , depending on the patient 's preferences
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"OBJECTIVE To address the lack of a simple and st and ardized instrument to assess overall panic disorder severity , the authors developed a scale for the measurement of panic disorder severity . METHOD Ten independent evaluators used the seven-item Panic Disorder Severity Scale to assess 186 patients with principal DSM-III-R diagnoses of panic disorder ( with no or mild agoraphobia ) who were participating in the Multicenter Collaborative Treatment Study of Panic Disorder . In addition , 89 of these patients were reevaluated with the same scale after short-term treatment . A subset of 24 patients underwent two independent assessment s to establish interrater reliability . Internal consistency , convergent and discriminant validity , and sensitivity to change were also determined . RESULTS The Panic Disorder Severity Scale was associated with excellent interrater reliability , moderate internal consistency , and favorable levels of validity and sensitivity to change . Individual items showed good convergent and discriminant validity . Analysis suggested a two-factor model fit the data best . CONCLUSIONS The Panic Disorder Severity Scale is a simple , efficient way for clinicians to rate severity in patients with established diagnoses of panic disorder . However , further research with more diverse groups of panic disorder patients and with a broader range of convergent and discriminant validity measures is needed",
"The separate and combined effects of clomipramine hydrochlorzide and behaviour therapy on agoraphobic symptoms were investigated in a 28-week placebo-controlled double-blind clinical trial . One hundred and eight women diagnosed as agoraphobic were r and omly assigned to one of four treatment conditions : clomipramine alone , behaviour therapy alone , clomipramine and behaviour therapy or placebo . Sixty women completed the assigned treatment . Clomipramine was prescribed in weekly increments to a maximum of 300 mg per day , with a mean dosage at week 8 of 94.6 mg per day . Behaviour therapy focused on grade d in vivo exposure therapy . Assessment s of patients were performed at six points prior to and during the trial and included st and ardized question naires , daily diaries and a Behavioral Approach Test . Significant main effects for both clomipramine and behaviour therapy on 15 and 12 of the dependent measures respectively were found but no interaction of treatments emerged",
"Thirty-seven severely-disabled agoraphobics were r and omly assigned to ( 1 ) Imipramine-no exposure . ( 2 ) Imipramine + exposure or ( 3 ) Placebo + exposure groups . To provide a more stringent test of the pharmacological effects of imipramine independent of exposure to phobic stimuli , Ss in the Imipramine-no exposure condition received antiexposure instructions during the first 8 weeks of therapy . Assessment s were conducted at 0 , 8 and 26 weeks . At 8 weeks , the group receiving imipramine combined with exposure therapy displayed more improvement than the other two groups , and was the only group to show a reduction in panic attacks . Ss receiving imipramine with antiexposure instructions showed little improvement on phobic indices , no reduction in panic , but significant improvement in anxiety and dysphoric mood . At 26 weeks Ss receiving the combined imipramine + exposure treatment exhibited further improvement result ing in a significant superiority of Imipramine + exposure over Placebo + exposure across a number of different outcome indices . Ss who had received imipramine with antiexposure instructions showed some improvement during the subsequent 18 weeks in which the antiexposure instructions were no longer in effect . However , neither this group nor the Placebo + exposure group showed a reduction in panic attacks . The results of the present trial provide support for the beneficial effects of combining intensive exposure with imipramine , but call into question the thesis that imipramine exerts its effect through a pharmacological blocking of panic attacks . Alternative hypotheses concerning the mode of action of imipramine are presented",
"The issue of panic disorder resistant to treatment ( whether pharmacological or psychological ) has attracted little research attention , despite its clinical frequency and importance . The aim of this study was to compare three treatment modalities , namely exposure alone ( E ) , exposure associated with imipramine ( EI ) and cognitive therapy supplementing exposure ( EC ) , in a sample of 21 patients with DSM‐IV panic disorder and agoraphobia , who failed to respond to a first st and ard course of individual behavioural treatment based on exposure in vivo . Treatments were administered according to a cross‐over , controlled design ( E‐EI‐EC , EI‐EC‐E , EC‐E‐EI ) . Twelve of the 21 patients achieved remission ( panic‐free status ) during the trial . In 8 cases this occurred after exposure alone ( E ) and in two cases each after the other treatments ( EI and EC ) . The results revealed a significant effect of the factor time on a number of variables , and the superiority of exposure alone compared to other treatment modalities with regard to some variables . These findings suggest that long‐term behavioural treatment based on exposure may be necessary in some patients , and may induce clinical remission . However , patients who do not respond to exposure show poor tolerance of and compliance with pharmacological treatment , and are unlikely to achieve remission with imipramine or cognitive therapy , even though this may occur in individual cases",
"Forty-five chronic agoraphobics were r and omly assigned to treatment by placebo or imipramine in doses up to 200 mg/day for 28 weeks . All patients also had systematic self-exposure homework with an instruction manual . In addition , half of each drug group had therapist-aided exposure and half had therapist-aided relaxation , each totalling three hours . Patients in both drug groups improved substantially and maintained their gains for one year of follow-up . Imipramine had no significant therapeutic effect despite satisfactory plasma levels and significant drug side effects . Patients ' low initial Hamilton depression scores might explain the absence of any drug effect . Antidepressants may be ineffective for agoraphobics who have normal mood . Brief therapist-aided exposure improved phobias and panics to a significant but limited extent , and is a useful adjuvant to self-exposure homework , which can be a powerful therapeutic agency by itself",
"BACKGROUND Current recommendations suggest that pharmacotherapy for patients with panic disorder should be continued for at least 1 year [ Am . J. Psychiatry 155 ( 1998 ) 1 ] , despite a paucity of data systematic ally examining outcome for periods greater than 3 - 6 months . It is critically important to obtain more information on the effectiveness of medications over time for patients who initially responded to pharmacotherapy for panic disorder . METHODS Long-term outcome was examined for 78 patients who attained a 2-month period of sustained remission on medication and received maintenance pharmacotherapy for up to 24 months during the Massachusetts General Hospital Longitudinal Study of Panic Disorder , a prospect i ve , naturalistic study . Participants were categorized by their maintenance treatment condition at remission : benzodiazepine alone ( N = 45 , 58 % ) , antidepressant alone ( N = 12 , 16 % ) , and combined treatment with a benzodiazepine and an antidepressant ( N = 21 , 27 % ) . RESULTS Approximately half ( N = 36 , 46 % ) of the patients who had achieved remission relapsed at some time over the 2-year naturalistic study period , despite continued and adequate pharmacotherapy . There was no difference in timing or frequency of relapse by type of maintenance pharmacotherapy . LIMITATIONS Interpretation of the data is limited by the naturalistic nature of the study , and by the relatively low sample size . CONCLUSIONS This data suggests that patients with panic disorder have a high rate of relapse even after acute response to pharmacotherapy , despite continued treatment . In addition , the use of combined pharmacotherapy with antidepressants and benzodiazepines does not appear to provide greater protection from relapse than monotherapy",
"BACKGROUND Both cognitive-behavioral therapy and treatment with selective serotonin reuptake inhibitors ( SSRIs ) have proved to be effective in the treatment of panic disorder . The present study examined the effects of paroxetine added to continued cognitive-behavioral therapy in patients who were unsuccessfully treated with initial cognitive-behavioral therapy alone . METHOD 161 patients with panic disorder with or without agoraphobia ( DSM-IV criteria ) underwent a manual-guided cognitive-behavioral therapy of 15 sessions . Forty-three unsuccessfully treated patients from this group were included in a double-blind , placebo-controlled , next-step treatment study consisting of continued cognitive-behavioral therapy plus adjunctive paroxetine at a dose of 40 mg/day or continued cognitive-behavioral therapy plus placebo . RESULTS Overall , patients in the cognitive-behavioral therapy plus paroxetine condition improved significantly on agoraphobic behavior ( p anxiety discomfort ( p cognitive-behavioral therapy plus placebo condition did not . Effect sizes in the cognitive-behavioral therapy plus paroxetine condition ranged from 1.0 to 1.8 and in the cognitive-behavioral therapy plus placebo condition , from 0.4 to 1.0 . CONCLUSION Patients with panic disorder who are unsuccessfully treated with initial cognitive-behavioral therapy may benefit from the addition of an SSRI as a second treatment modality . The importance of timely evaluation of treatment results is emphasized",
" Eighteen agoraphobic patients with r and omly assigned to 12 week treatment with imipramine ( I ) or imipramine and programmed in-vivo exposure practice ( I+BT ) to investigate the contribution of behavioural instructions to the clinical effects of pharmacotherapy . Significantly greater improvement on phobic measures was found in the I+BT group compared to the I group . Differences were less marked on measures of panic and anxiety . The results suggest that imipramine possesses an antiphobic effect which can be substantially enhanced with programmed practice . Controlled large-scale investigations of the pharmacological and instructional effects of the phamacotherapy of agoraphobia are needed for a definitive evaluation of the specific antiphobic effect of antidepressant drugs",
"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",
" Sixty-two chronically agoraphobic patients completed a controlled study to assess the effects of 1 ) imipramine up to 200 mg/day ( mean = 130 mg/day ) , 2 ) 12 weekly therapist-assisted in vivo exposure sessions ( flooding ) , and 3 ) imipramine plus flooding . The control group received systematic therapeutic instructions for self-directed in vivo exposure ( programmed practice ) . Clinical measures of global severity , phobia , panic , anxiety , depression , and behavioral performance tests were administered before treatment and at Weeks 4 , 8 , and 12 of treatment . Results revealed significant improvement in all groups on all measures over the course of treatment ; almost a third of the control patients showed marked improvement . Imipramine had significant effects on improvement of phobias and markedly increased clinical response rates in patients receiving 150 - 200 mg/day . Less chronicity and severity of condition also predicted better clinical outcome . Flooding had limited effects above and beyond programmed practice , and no imipramine-flooding interactions effects were found",
"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",
"CONTEXT Panic disorder ( PD ) may be treated with drugs , psychosocial intervention , or both , but the relative and combined efficacies have not been evaluated in an unbiased fashion . OBJECTIVE To evaluate whether drug and psychosocial therapies for PD are each more effective than placebo , whether one treatment is more effective than the other , and whether combined therapy is more effective than either therapy alone . DESIGN AND SETTING R and omized , double-blind , placebo-controlled clinical trial conducted in 4 anxiety research clinics from May 1991 to April 1998 . PATIENTS A total of 312 patients with PD were included in the analysis . INTERVENTIONS Patients were r and omly assigned to receive imipramine , up to 300 mg/d , only ( n=83 ) ; cognitive-behavioral therapy ( CBT ) only ( n=77 ) ; placebo only ( n=24 ) ; CBT plus imipramine ( n=65 ) ; or CBT plus placebo ( n=63 ) . Patients were treated weekly for 3 months ( acute phase ) ; responders were then seen monthly for 6 months ( maintenance phase ) and then followed up for 6 months after treatment discontinuation . MAIN OUTCOME MEASURES Treatment response based on the Panic Disorder Severity Scale ( PDSS ) and the Clinical Global Impression Scale ( CGI ) by treatment group . RESULTS Both imipramine and CBT were significantly superior to placebo for the acute treatment phase as assessed by the PDSS ( response rates for the intent-to-treat [ ITT ] analysis , 45.8 % , 48.7 % , and 21.7 % ; P=.05 and P=.03 , respectively ) , but were not significantly different for the CGI ( 48 . 2 % , 53.9 % , and 37.5 % , respectively ) . After 6 months of maintenance , imipramine and CBT were significantly more effective than placebo for both the PDSS ( response rates , 37.8 % , 39.5 % , and 13.0 % , respectively ; P=.02 for both ) and the CGI ( 37.8 % , 42.1 % , and 13.0 % , respectively ) . Among responders , imipramine produced a response of higher quality . The acute response rate for the combined treatment was 60.3 % for the PDSS and 64.1 % for the CGI ; neither was significantly different from the other groups . The 6-month maintenance response rate for combined therapy was 57.1 % for the PDSS ( P=.04 vs CBT alone and P=.03 vs imipramine alone ) and 56.3 % for the CGI ( P=.03 vs imipramine alone ) , but not significantly better than CBT plus placebo in either analysis . Six months after treatment discontinuation , in the ITT analysis CGI response rates were 41.0 % for CBT plus placebo , 31.9 % for CBT alone , 19.7 % for imipramine alone , 13 % for placebo , and 26.3 % for CBT combined with imipramine . CONCLUSIONS Combining imipramine and CBT appeared to confer limited advantage acutely but more substantial advantage by the end of maintenance . Each treatment worked well immediately following treatment and during maintenance ; CBT appeared durable in follow-up . JAMA . 2000;283:2529 -",
"Selective serotonin re-uptake inhibitors ( SSRIs ) and cognitive behavioral therapies ( CBTs ) are both considered as first-line treatments for panic disorder , but the advantages of a combined therapy have yet to be definitively demonstrated . We evaluated in this pilot study the effects of combining SSRIs ( vs. a placebo ) with a very brief form of cognitive-behavioral therapy provided to all participants . Thirty-three subjects with DSM-IV panic disorder , with or without agoraphobia , were r and omized to receive either paroxetine or a placebo with flexible dosing ( 10 - 50 mg/day ) . Medication visits were brief ( 15 min ) , infrequent ( 6 in total ) and non-directive . An expert cognitive-behavior therapist administered one initial 45-min session and one subsequent 30-min session of very brief CBT ( vbCBT ) at weeks 5 and 7 , respectively . Sessions were supplemented with educational and directive reading material s. Patients in both groups ( i.e. vbCBT+paroxetine ; vbCBT+placebo ) improved similarly and substantially on most measures during the 10 weeks of acute treatment . At week 10 , the proportion of panic-free patients was significantly higher in the paroxetine-treated group than in the placebo group ( 80 vs. 25 % ; P<0.007 ) , as was the proportion of subjects who rated themselves as ' very much improved ' at week 10 ( 60 vs. 13 % ; P<0.017 ) . These findings point to the need for additional studies to confirm the effectiveness of very brief forms of CBT , and to document the circumstances in which combined treatment with an SSRI would be warranted",
"BACKGROUND A recent review suggested an association between using unpublished scales in clinical trials and finding significant results . AIMS To determine whether such an association existed in schizophrenia trials . METHOD Three hundred trials were r and omly selected from the Cochrane Schizophrenia Group 's Register . All comparisons between treatment groups and control groups using rating scales were identified . The publication status of each scale was determined and cl aims of a significant treatment effect were recorded . RESULTS Trials were more likely to report that a treatment was superior to control when an unpublished scale was used to make the comparison ( relative risk 1.37 ( 95 % CI 1.12 - 1.68 ) ) . This effect increased when a ' gold-st and ard ' definition of treatment superiority was applied ( RR 1.94 ( 95 % CI 1.35 - 2.79 ) ) . In non-pharmacological trials , one-third of ' gold-st and ard ' cl aims of treatment superiority would not have been made if published scales had been used . CONCLUSIONS Unpublished scales are a source of bias in schizophrenia trials",
"OBJECTIVE The purpose of this comparative outcome study was to investigate whether the effects of exposure in vivo treatment for panic disorder with agoraphobia could be enhanced by adding interventions specifically for panic attacks before the start of exposure treatment . The additional effect of two types of treatment for panic attacks -- pharmacological ( fluvoxamine ) and psychological ( repeated hyperventilation provocations and respiratory training)--was examined . Thus , the combined treatment of panic interventions with exposure in vivo could be compared to exposure in vivo alone . METHOD Ninety-six patients were r and omly assigned to four treatment conditions : double-blind , placebo-controlled fluvoxamine followed by exposure in vivo , psychological panic management followed by exposure , and exposure in vivo alone . Outcome was assessed by self-report measures , a st and ardized multitask behavioral avoidance test , and continuous monitoring of panic attacks . Seventy-six patients completed the study . RESULTS All four treatments were effective and result ed in a significant decrease of agoraphobic avoidance . Moreover , the combination of fluvoxamine and exposure in vivo demonstrated efficacy superior to that of the other treatments and had twice as large an effect size ( difference between pre- and posttreatment scores ) on self-reported agoraphobic avoidance . The other treatments did not differ among each other in effectiveness . CONCLUSIONS Results of the study indicate that the short-term outcome of exposure in vivo treatment can be enhanced by adding fluvoxamine treatment . Psychological panic management combined with exposure was not superior to exposure alone of equal duration",
"BACKGROUND This study compared the efficacy and tolerability of paroxetine with placebo in the treatment of panic disorder . METHOD After three weeks of placebo , patients received 12 weeks of treatment with paroxetine ( 20 , 40 , or 60 mg ) or placebo , and finally two weeks of placebo . Dosages were adjusted according to efficacy and tolerability . St and ardised cognitive therapy was given to all patients . The primary measure of outcome was reduction in the number of panic attacks . RESULTS Analysis of the results showed statistically significant differences in favour of paroxetine between the two treatment groups in two out of the three primary measures of outcome , i.e. 50 % reduction in total number of panic attacks and number of panic attacks reduced to one or zero over the study period . For the third measure of outcome , the mean change in the total number of attacks from baseline , there was a positive trend in favour of paroxetine . The results of the primary measures of outcome were strongly supported by the results of the secondary efficacy measures of outcome . In addition , paroxetine , at all doses , was very well tolerated . CONCLUSION Paroxetine plus cognitive therapy was significantly more effective than placebo plus cognitive therapy in the treatment of panic disorder",
"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",
"BACKGROUND The aim of this study was to analyze the impact of pretreatment characteristics and personality disorders on the onset of response in the treatment of panic disorder . METHODS The data of 73 out- patients with panic disorder who had completed at least 6 weeks of a r and omized trial of 24 weeks of either paroxetine only or paroxetine combined with cognitive group-therapy were analyzed in a Cox proportional hazards model . RESULTS The likelihood of having responded to treatment ( defined by a CGI rating of improvement ) was more than twice as high for patients without a personality disorder or social phobia than for Patients with a personality disorder or social phobia . CONCLUSIONS We suggest that patients with these characteristics do benefit from prolonged treatment , and they may profit from an additional treatment focused on social anxiety"
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OBJECTIVE Carbohydrate staples such as pasta have been implicated in the obesity epidemic . It is unclear whether pasta contributes to weight gain or like other low-glycaemic index ( GI ) foods contributes to weight loss . We synthesis ed the evidence of the effect of pasta on measures of adiposity . DESIGN Systematic review and meta- analysis using the Grading of Recommendations Assessment , Development , and Evaluation ( GRADE ) approach . DATA SOURCES MEDLINE , Embase , CINAHL and the Cochrane Library were search ed through 7 February 2017 . ELIGIBILITY CRITERIA FOR SELECTING STUDIES We included r and omised controlled trials ≥3 weeks assessing the effect of pasta alone or in the context of low-GI dietary patterns on measures of global ( body weight , body mass index ( BMI ) , body fat ) and regional ( waist circumference ( WC ) , waist-to-hip ratio ( WHR ) , sagittal abdominal diameter ( SAD ) ) adiposity in adults . DATA EXTRACTION AND SYNTHESIS Two independent review ers extracted data and assessed risk of bias . Data were pooled using the generic inverse-variance method and expressed as mean differences ( MDs ) with 95 % CIs . Heterogeneity was assessed ( Cochran Q statistic ) and quantified ( I2 statistic ) . GRADE assessed the certainty of the evidence . RESULTS We identified no trial comparisons of the effect of pasta alone and 32 trial comparisons ( n=2448 participants ) of the effect of pasta in the context of low-GI dietary patterns . Pasta in the context of low-GI dietary patterns significantly reduced body weight ( MD=-0.63 kg ; 95 % CI -0.84 to -0.42 kg ) and BMI ( MD=-0.26 kg/m2 ; 95 % CI -0.36 to -0.16 kg/m2 ) compared with higher-GI dietary patterns . There was no effect on other measures of adiposity . The certainty of the evidence was grade d as moderate for body weight , BMI , WHR and SAD and low for WC and body fat . CONCLUSIONS Pasta in the context of low-GI dietary patterns does not adversely affect adiposity and even reduces body weight and BMI compared with higher-GI dietary patterns . Future trials should assess the effect of pasta in the context of other ' healthy ' dietary patterns . TRIAL REGISTRATION NUMBER NCT02961088 ; Results
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"OBJECTIVE To evaluate the effect of the glycemic index ( GI ) on food intake , anthropometric measurements and body composition in subjects with excess body weight . METHODS Crossover study , in which 17 subjects participated in two study sessions ( high GI or low GI ) . Two daily meals were consumed in laboratory for 30 consecutive days in each session . Subjects also consumed under free living conditions 3 daily isocaloric servings of fruits , presenting the same GI as the session in which they were participating . At each 15 days , subjects were su bmi tted to body composition ( lean mass and fatty mass ) and anthropometric indexes ( weight , height , body mass index , waist circumference ( WC ) , hip circumference , hip-waist relation ( WHC ) ) assessment . Habitual food intake was assessed before and at the end of each session . Subjects were instructed to maintain the same level of physical activity during the study . RESULTS There was a significant reduction on WC and WHC after the low GI session . The other parameters did not differ between the treatments applied in this study . CONCLUSION These results suggest that the consumption of low GI foods may favor the prevention and control abdominal obesity and the associated metabolic diseases",
"This study compared satiety after high protein pasta ( 16 g protein , 6 g fiber ) , high fiber pasta ( 11 g protein , 8 g fiber ) or control pasta ( 11 g protein , 6 g fiber ) in a r and omized , placebo-controlled , double-blind crossover trial . Participants were 36 healthy and men and women from the University of Minnesota campus . Fasted men and women ate calorie controlled , but macronutrient different pastas at 12:00 pm along with 500 mL of water . The primary outcome was satiety assessed by Visual Analogue Scales at 0 , 15 , 30 , 45 , 60 , 90 , 120 , and 180 min daily after consuming the pastas . Secondary outcomes were calories consumed at an ad libitum snack at 3:00 pm , calories from food intake , gastrointestinal tolerance , and palatability . No differences were found among the pasta treatments for satiety , snacking , or gastrointestinal tolerance . Men ate significantly more calories for the rest of the ( P = 0.007 ) after the high protein pasta versus the high fiber pasta ( 1701 ± 154 compared with 1083 ± 154 ) with control pasta being intermediate to the other treatments . No significant differences were found for gastrointestinal tolerance , but the palatability ratings showed the high protein pasta was less tasty ( P = 0.03 ) and less pleasant ( P = 0.01 ) than the other 2 pastas . Satisfaction was positively associated with pleasantness and negatively associated with aftertaste . Our results do not support the idea that high protein or high fiber pasta produces a greater satiety response compared to pasta with lower amounts of either nutrient . It is likely that since pasta is already a very satiating food , the subjects were unable to differentiate between the 3 conditions",
"AIMS The aim of this study is to compare the efficacy of low glycaemic index ( GI ) vs. conventional carbohydrate exchange ( CCE ) dietary advice on glycaemic control and metabolic parameters in patients with type 2 diabetes . METHODS A total of 104 patients with type 2 diabetes were r and omly assigned to either a low GI ( GI ) or CCE dietary advice over a 12-week period . The primary end-point was glycaemic control as assessed by glycated haemoglobin A1c ( HbA1c ) , fructosamine level and plasma glucose . The secondary end-points were anthropometric measurements and metabolic parameters that include blood pressure , lipid profile and insulin levels . The oral antidiabetic medications remained unchanged throughout the duration of the study . RESULTS A low-GI diet was associated with significant changes in the fructosamine level ( DeltaGI = -0.20 + /- 0.03 ; DeltaCCE = -0.08 + /- 0.03 mmol/l , p waist circumference ( DeltaGI group = -1.88 + /- 0.30 cm ; DeltaCCE group : -0.36 + /- 0.4 cm , p in fasting glucose ( DeltaGI = -0.03 + /- 0.3 ; DeltaCCE = 0.7 + /- 0.3 mmol/l ; p waist circumference ( DeltaGI = -2.35 + /- 0.47 cm ; DeltaCCE group = -0.66 + /- 0.46 cm ; p changes in postpr and ial glycaemia at time 0 , 60 , 150 and 180 min after consuming the st and ard test meal was lower than with the CCE diet ( p low-GI diet result ed in significant changes of serum fructosamine level , plasma glucose and waist circumference in Asian patients with type 2 diabetes over a 12-week period compared with those following a CCE diet . The effect on HbA1c and other metabolic parameters was not significantly different between the two study groups but the improvement within the GI group was more pronounced and of clinical benefit",
"BACKGROUND The development of obesity has been suggested to involve plasminogen activator inhibitor-1 ( PAI-1 ) and tissue inhibitor of proteinases-1 ( TIMP-1 ) . Plasma PAI-1 is elevated in obesity . A low-glycemic-index ( LGI ) diet may have a beneficial effect on obesity through a decrease in plasma PAI-1 , but whether it affects plasma TIMP-1 in healthy humans has not been studied . OBJECTIVE We investigated whether a 10-wk intake of an LGI or a high-glycemic-index ( HGI ) , high-carbohydrate , low-fat , ad libitum diet is associated with decreases in plasma PAI-1 and TIMP-1 concentrations in overweight women . DESIGN Forty-four overweight women [ body mass index ( BMI ; in kg/m2 ) : 27.5+/-0.23 ] were r and omly assigned to consume an HGI or an LGI diet for 10 wk . A subgroup of 29 women was assigned to participate in an additional 4-h meal test on the last day of the 10-wk intervention . RESULTS PAI-1 activity decreased after 10 wk of the LGI diet and was significantly different between groups . Changes in PAI-1 antigen followed the same trend , but no significant difference was observed between groups . No difference in plasma TIMP-1 concentrations was observed between groups . PAI-1 and TIMP-1 concentrations after the 4-h meal test were not significantly different between groups . CONCLUSION An LGI diet reduces fasting plasma PAI-1 activity and therefore may be useful for diminishing the adverse cardiovascular effects of obesity . This trial was registered at clinical trials.gov as NCT00324090",
"OBJECTIVE Despite their independent cardiovascular disease ( CVD ) advantages , effects of α-linolenic acid ( ALA ) , monounsaturated fatty acid ( MUFA ) , and low-glycemic-load ( GL ) diets have not been assessed in combination . We therefore determined the combined effect of ALA , MUFA , and low GL on glycemic control and CVD risk factors in type 2 diabetes . RESEARCH DESIGN AND METHODS The study was a parallel design , r and omized trial wherein each 3-month treatment was conducted in a Canadian academic center between March 2011 and September 2012 and involved 141 participants with type 2 diabetes ( HbA1c 6.5%–8.5 % [ 48–69 mmol/mol ] ) treated with oral antihyperglycemic agents . Participants were provided with dietary advice on either a low-GL diet with ALA and MUFA given as a canola oil – enriched bread supplement ( 31 g canola oil per 2,000 kcal ) ( test ) or a whole-grain diet with a whole-wheat bread supplement ( control ) . The primary outcome was HbA1c change . Secondary outcomes included calculated Framingham CVD risk score and reactive hyperemia index ( RHI ) ratio . RESULTS Seventy-nine percent of the test group and 90 % of the control group completed the trial . The test diet reduction in HbA1c units of −0.47 % ( −5.15 mmol/mol ) ( 95 % CI −0.54 % to −0.40 % [ −5.92 to −4.38 mmol/mol ] ) was greater than that for the control diet ( −0.31 % [ −3.44 mmol/mol ] [ 95 % CI −0.38 % to −0.25 % ( −4.17 to −2.71 mmol/mol ) ] , P = 0.002 ) , with the greatest benefit observed in those with higher systolic blood pressure ( SBP ) . Greater reductions were seen in CVD risk score for the test diet , whereas the RHI ratio increased for the control diet . CONCLUSIONS A canola oil – enriched low-GL diet improved glycemic control in type 2 diabetes , particularly in participants with raised SBP , whereas whole grains improved vascular reactivity",
"Objective : To assess whether the addition of viscous fiber at an amount recommended by the US FDA to allow a ‘ low saturated fat , cholesterol , soluble fiber and coronary heart disease ’ , health cl aim label on a food package ( 1.7 g psyllium ) and /or fat ( 30 g sunflower oil and 3 g sodium propionate ) to a pasta meal would affect gastric emptying , postpr and ial glucose , insulin and GLP-1 concentrations . Design : Ten subjects participated in a two-by-two single blind r and omized crossover study . Four meals containing 50 g of available carbohydrate were consumed : pasta with or without psyllium enrichment served with a tomato sauce with ( 520 kcal per meal ) and without ( 240 kcal per meal ) fat . Blood sample s were taken for 240 min following the meal and all subjects consumed a buffet meal at the end of the study . Gastric empting was measured using the paracetamol absorption test . Blood was analysed for glucose , insulin , GLP-1 . Visual analog scales were used to record feelings of hunger , pleasantness and nausea . Results : The psyllium-enriched pasta had no significant effect on gastric emptying or the incremental area under the curve ( IAUC ) for GLP-1 , insulin or glucose compared with the control pasta . The addition of polyunsaturated fat and sodium propionate significantly increased the IAUC for GLP-1 ( P delaying gastric emptying ( P decreasing glucose ( P gastric emptying , postpr and ial GLP-1 , insulin or glucose metabolism . However the addition of 30 g of oil and 3 g of sodium propionate to the pasta did reduce gastric emptying , increase GLP-1 and reduce glucose and insulin concentrations . While this short-term study may have implication s in terms of reducing the risk of diabetes and improving coronary risk factor profiles the long term effects of these nutrients need to be studied . Sponsorship : This study was supported by Kellogg Company",
"BACKGROUND Studies of weight-control diets that are high in protein or low in glycemic index have reached varied conclusions , probably owing to the fact that the studies had insufficient power . METHODS We enrolled overweight adults from eight European countries who had lost at least 8 % of their initial body weight with a 3.3-MJ ( 800-kcal ) low-calorie diet . Participants were r and omly assigned , in a two-by-two factorial design , to one of five ad libitum diets to prevent weight regain over a 26-week period : a low-protein and low-glycemic-index diet , a low-protein and high-glycemic-index diet , a high-protein and low-glycemic-index diet , a high-protein and high-glycemic-index diet , or a control diet . RESULTS A total of 1209 adults were screened ( mean age , 41 years ; body-mass index [ the weight in kilograms divided by the square of the height in meters ] , 34 ) , of whom 938 entered the low-calorie-diet phase of the study . A total of 773 participants who completed that phase were r and omly assigned to one of the five maintenance diets ; 548 completed the intervention ( 71 % ) . Fewer participants in the high-protein and the low-glycemic-index groups than in the low-protein-high-glycemic-index group dropped out of the study ( 26.4 % and 25.6 % , respectively , vs. 37.4 % ; P=0.02 and P=0.01 for the respective comparisons ) . The mean initial weight loss with the low-calorie diet was 11.0 kg . In the analysis of participants who completed the study , only the low-protein-high-glycemic-index diet was associated with subsequent significant weight regain ( 1.67 kg ; 95 % confidence interval [ CI ] , 0.48 to 2.87 ) . In an intention-to-treat analysis , the weight regain was 0.93 kg less ( 95 % CI , 0.31 to 1.55 ) in the groups assigned to a high-protein diet than in those assigned to a low-protein diet ( P=0.003 ) and 0.95 kg less ( 95 % CI , 0.33 to 1.57 ) in the groups assigned to a low-glycemic-index diet than in those assigned to a high-glycemic-index diet ( P=0.003 ) . The analysis involving participants who completed the intervention produced similar results . The groups did not differ significantly with respect to diet-related adverse events . CONCLUSIONS In this large European study , a modest increase in protein content and a modest reduction in the glycemic index led to an improvement in study completion and maintenance of weight loss . ( Funded by the European Commission ; Clinical Trials.gov number , NCT00390637 . )",
"BACKGROUND Dietary guidelines recommend interchanging protein foods ( e.g. , chicken for red meat ) , but they may be exchanged for carbohydrate-rich foods varying in quality [ glycemic load ( GL ) ] . Whether such exchanges occur and how they influence long-term weight gain are not established . OBJECTIVE Our objective was to determine how changes in intake of protein foods , GL , and their interrelationship influence long-term weight gain . DESIGN We investigated the association between 4-y changes in consumption of protein foods , GL , and their interaction with 4-y weight change over a 16- to 24-y follow-up , adjusted for other lifestyle changes ( smoking , physical activity , television watching , sleep duration ) , body mass index , and all dietary factors simultaneously in 3 prospect i ve US cohorts ( Nurses ' Health Study , Nurses ' Health Study II , and Health Professionals Follow-Up Study ) comprising 120,784 men and women free of chronic disease or obesity at baseline . RESULTS Protein foods were not interchanged with each other ( intercorrelations typically long-term weight gain , with positive associations for meats , chicken with skin , and regular cheese ( per increased serving/d , 0.13 - 1.17 kg ; P = 0.02 to P 0.40 for each ) ; and relative weight loss for yogurt , peanut butter , walnuts , other nuts , chicken without skin , low-fat cheese , and seafood ( -0.14 to -0.71 kg ; P = 0.01 to P ) . Increases in GL were independently associated with a 0.42-kg greater weight gain per 50-unit increase ( P weight gain when GL increased , with weight stability when GL did not change , and with weight loss when exchanged for GL ( i.e. , decrease in GL ) . CONCLUSION Protein foods were commonly interchanged with carbohydrate , and changes in protein foods and GL interacted to influence long-term weight gain",
"BACKGROUND The optimal lifestyle intervention that reverses diabetes risk factors is not known . OBJECTIVE We examined the effect of a low-glycemic index ( GI ) diet and exercise intervention on glucose metabolism and insulin secretion in obese , prediabetic individuals . DESIGN Twenty-two participants [ mean ± SEM age : 66 ± 1 y ; body mass index ( in kg/m(2 ) ) : 34.4 ± 0.8 ] underwent a 12-wk exercise-training intervention ( 1 h/d for 5 d/wk at ≈ 85 % of maximum heart rate ) while r and omly assigned to receive either a low-GI diet ( LoGIX ; 40 ± 0.3 units ) or a high-GI diet ( HiGIX ; 80 ± 0.6 units ) . Body composition ( measured by using dual-energy X-ray absorptiometry and computed tomography ) , insulin sensitivity ( measured with a hyperinsulinemic euglycemic clamp with [6,6-(2)H(2)]-glucose ) , and oral glucose-induced insulin and incretin hormone secretion were examined . RESULTS Both groups lost equal amounts of body weight ( -8.8 ± 0.9 % ) and adiposity and showed similar improvements in peripheral tissue ( + 76.2 ± 14.9 % ) and hepatic insulin sensitivity ( + 27.1 ± 7.1 % ) ( all P ) . However , oral glucose-induced insulin secretion was reduced only in the LoGIX group ( 6.59 ± 0.86 nmol in the pre study compared with 4.70 ± 0.67 nmol in the post study , P , changes in insulin secretion were attenuated in the LoGIX group but became significantly elevated in the HiGIX group . CONCLUSIONS Although lifestyle-induced weight loss improves insulin resistance in prediabetic individuals , postpr and ial hyperinsulinemia is reduced only when a low-GI diet is consumed . In contrast , a high-GI diet impairs pancreatic β cell and intestinal K cell function despite significant weight loss . These findings highlight the important role of the gut in mediating the effects of a low-GI diet on type 2 diabetes risk reduction",
"BACKGROUND Despite interest in the glycemic index diets as an approach to weight control , few long-term evaluations are available . OBJECTIVE The objective was to investigate the long-term effect of a low-glycemic-index ( LGI ) diet compared with that of a high-glycemic-index ( HGI ) diet ; all other dietary components were equal . DESIGN After a 6-wk run-in , we r and omly assigned 203 healthy women [ body mass index ( in kg/m2 ) : 23 - 30 ] aged 25 - 45 y to an LGI or an HGI diet with a small energy restriction . The primary outcome measure was weight change at 18 mo . Secondary outcomes included hunger and fasting insulin and lipids . RESULTS Despite requiring a run-in and the use of multiple incentives , only 60 % of the subjects completed the study . The difference in glycemic index between the diets was approximately 35 - 40 units ( 40 compared with 79 ) during all 18 mo of follow-up , and the carbohydrate intake from energy remained at approximately 60 % in both groups . The LGI group had a slightly greater weight loss in the first 2 mo of follow-up ( -0.72 compared with -0.31 kg ) , but after 12 mo of follow-up both groups began to regain weight . After 18 mo , the weight change was not significantly different ( P = 0.93 ) between groups ( LGI : -0.41 kg ; HGI : -0.26 kg ) . A greater reduction was observed in the LGI diet group for triacylglycerol ( difference = -16.4 mg/dL ; P = 0.11 ) and VLDL cholesterol ( difference = -3.7 mg/dL ; P = 0.03 ) . CONCLUSIONS Long-term weight changes were not significantly different between the HGI and LGI diet groups ; therefore , this study does not support a benefit of an LGI diet for weight control . Favorable changes in lipids confirmed previous results",
"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",
"The glycaemic index ( GI ) has been developed in order to classify food according to the postpr and ial glycaemic response . This parameter is of interest , especially for people prone to glucose intolerance ; however , the effects of a low-GI ( LGI ) diet on body weight , carbohydrate and lipid metabolism remain controversial . We studied the effects of either a LGI or high-GI ( HGI ) diet on weight control and cardiovascular risk factors in overweight , non-diabetic subjects . The study was a r and omized 5-week intervention trial . The thirty-eight subjects ( BMI 27.3 ( sem 0.2 ) kg/m2 ) followed an intervention diet in which usual starch was replaced ad libitum with either LGI or HGI starch . Mean body weight decrease was significant in the LGI group ( - 1.1 ( sEM 0.3 ) kg , P = 0.004 ) and was significantly greater than in the HGI group ( - 0.3 ( sEM 0.2 ) kg , P = 0.04 between groups ) . Hunger sensation scales showed a trend towards a decrease in hunger sensation before lunch and dinner in the LGI group when compared with the HGI group ( P = 0.09 ) . No significant increase in insulin sensitivity was noticed . The LGI diet also decreased total cholesterol by 9.6 % ( P LDL-cholesterol by 8.6 % ( P = 0.01 ) and both LDL-:HDL-cholesterol ratio ( 10.1 % , P = 0.003 ) and total : HDL-cholesterol ratio ( 8.5 % , P = 0.001 ) while no significant changes were observed in the HGI group . Lowering the GI of daily meals with simple dietary recommendations results in increased weight loss and improved lipid profile and is relatively easy to implement with few constraints . These potential benefits of consuming a LGI diet can be useful to develop practical dietetic advice",
"Controversy exists about the optimal amount and source of dietary carbohydrate for managing insulin resistance . Therefore , we compared the effects on insulin sensitivity ( SI ) , pancreatic responsivity ( AIRglu ) and glucose disposition index of dietary advice aim ed at reducing the amount or altering the source of dietary carbohydrate in subjects with impaired glucose tolerance ( IGT ) . Subjects were r and omized to high-carbohydrate-high-glycaemic index ( GI ) ( high-GI , n 11 ) , high-carbohydrate-low-GI ( low-GI , n 13 ) , or low-carbohydrate-high-monounsaturated fat ( MUFA , n 11 ) dietary advice , with SI , AIRglu and DI measured using a frequently sample d , intravenous glucose tolerance test before and after 4 months treatment . Carbohydrate and fat intakes and diet GI , respectively , were : high-GI , 53 % , 28 % , 83 ; low-GI , 55 % , 25 % , 76 ; MUFA , 47 % , 35 % , 82 . Weight changes on each diet differed significantly from each other : high-GI , -0.49 ( sem 0.29 ) kg ; low-GI , -0.19 ( sem 0.40 ) kg ; MUFA + 0.27 ( sem 0.45 ) kg . Blood lipids did not change , but glycated haemoglobin increased significantly on MUFA , 0.02 ( sem 0.11 ) % , relative to low-GI , -0.19 ( sem 0.08 ) % , and high-GI , -0.13 ( sem 0.14 ) % . Diastolic blood pressure fell by 8 mmHg on low-GI relative to MUFA ( P=0.038 ) . Although SI and AIRglu did not change significantly , DI , a measure of the ability of beta-cells to overcome insulin resistance by increasing insulin secretion , increased on low-GI by > 50 % ( P=0.02 ) . After adjusting for baseline values , the increase in DI on low-GI , 0.17 ( sem 0.07 ) , was significantly greater than those on MUFA , -0.09 ( sem 0.08 ) and high-GI , -0.03 ( sem 0.02 ) ( P=0.019 ) . Thus , the long-term effects of altering the source of dietary carbohydrate differ from those of altering the amount . High-carbohydrate-low-GI dietary advice improved beta-cell function in subjects with IGT , and may , therefore , be useful in the management of IGT",
"OBJECTIVE To investigate the long-term effects of changes in dietary carbohydrate/fat ratio and simple vs complex carbohydrates . DESIGN R and omized controlled multicentre trial ( CARMEN ) , in which subjects were allocated for 6 months either to a seasonal control group ( no intervention ) or to one of three experimental groups : a control diet group ( dietary intervention typical of the average national intake ) ; a low-fat high simple carbohydrate group ; or a low-fat high complex carbohydrate group . SUBJECTS Three hundred and ninety eight moderately obese adults . MEASUREMENTS The change in body weight was the primary outcome ; changes in body composition and blood lipids were secondary outcomes . RESULTS Body weight loss in the low-fat high simple carbohydrate and low-fat high complex carbohydrate groups was 0.9 kg ( P control diet and seasonal control groups gained weight ( 0.8 and 0.1 kg , NS ) . Fat mass changed by -1.3 kg ( P Changes in blood lipids did not differ significantly between the dietary treatment groups . CONCLUSION Our findings suggest that reduction of fat intake results in a modest but significant reduction in body weight and body fatness . The concomitant increase in either simple or complex carbohydrates did not indicate significant differences in weight change . No adverse effects on blood lipids were observed . These findings underline the importance of this dietary change and its potential impact on the public health implication s of obesity",
"AIM There is insufficient evidence for the efficacy of a low-glycemic index ( GI ) diet in the management of diabetes . The goal of this study was to measure the effect of a low GI versus a st and ard diabetic diet in adults with diabetes type 2 . METHODS This was an open label , r and omized , crossover study . Twenty persons with type 2 diabetes were r and omized to two groups . Each group followed a st and ard diabetic diet or a low glycemic index diet for 3 months . The effectiveness of the two diets was evaluated using a hyperinsulinemic euglycemic clamp with endogenous glucose production measurement , indirect calorimetry and bioimpedance analysis . Outcome measures were body mass , BMI , body fat , glycosylated hemoglobin , fasting glucose , lipid profile , insulin sensitivity and hepatic glucose production . RESULTS Body mass after 3 months following the diabetic diet was 93 kg ( 83 - 104 ) vs. low glycemic index diet 92 kg ( 85 - 104 ) P BMI 31.3 kg/m(2 ) ( 27.5 - 35.9 ) vs. 30.7 kg/m(2 ) ( 27 - 35.3 ) P body fat 28 % ( 25.5 - 43 ) vs. 27 % ( 23 - 43 ) P glycosylated hemoglobin , fasting glucose , lipid profile , insulin sensitivity or hepatic glucose production . CONCLUSIONS The results are comparable with other studies showing a modest effect of a low GI diet in the management of diabetes . We found a modestly greater weight loss , body fat and BMI reduction on the low GI diet",
"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",
"OBJECTIVE To review evidence relating to the consumption of whole grains and healthy body weight ( BW ) . DESIGN Systematic review and analysis of observational studies reporting whole-grain consumption and measures of BW and adiposity , including the effect on macronutrient intakes and lifestyle factors . SETTING Medline and other data bases were search ed for the period 1990 to 2006 to produce a full reference list ; observational studies were retained for further analysis if they included an appropriate control group and reported whole-grain intake and body mass index ( BMI ) or a measure of adiposity . SUBJECTS Fifteen trials were identified which included data from 119 829 male and female subjects aged 13 years and over . RESULTS The combined and weighted mean difference in BMI from 15 studies representing 20 treatment groups ( n = 119 829 ) using a r and om-effects model was 0.630 kg/m2 lower when high versus low whole-grain intake was compared , P adiposity assessed as waist circumference was reduced by 2.7 ( 95 % CI 0.2 , 5.2 ) cm , P = 0.03 ( six data sets , n = 4178 ) or as waist : hip ratio by 0.023 ( 95 % CI 0.016 , 0.030 ) , P increased dietary fibre intake ( 9 g , P total and saturated fat intakes decreased by 11 g and 3.9 g , respectively . CONCLUSION A higher intake of whole grains ( about three servings per day ) was associated with lower BMI and central adiposity . In addition , people who consume more whole grains are likely to have a healthier lifestyle as fewer of them smoke , they exercise more frequently and they tend to have lower fat and higher fibre intakes",
"Background / Objectives : Pasta as a traditional component of Mediterranean diet ( MeD ) in Italy has not been studied in detail in the management of body weight . This study aim ed at evaluating the association of pasta intake with body mass index ( BMI ) and waist-to-hip ratio , in two large epidemiological data sets . Subjects/ Methods : A total of 14 402 participants aged ⩾35 years r and omly recruited from the general population of the Molise region ( Moli-sani cohort ) and 8964 participants aged > 18 years from all over Italy ( Italian Nutrition & HEalth Survey , INHES ) were separately analyzed . The European Prospect i ve Investigation into Cancer and Nutrition (EPIC)-food frequency question naire and one 24-h dietary recall were used for dietary assessment . Weight , height , waist and hip circumference were measured in Moli-sani or self-reported in INHES . Residuals methodology corrected for either total energy intake or body weight was used for the analysis of pasta intake . Results : Higher pasta intake was associated with better adhesion to MeD in both genders ( P for both , pasta-energy residuals were negatively associated with BMI in women but not in men ( β-coef=−0.007 , P=0.003 for women and β-coef=−0.001 , P=0.58 for men ) . When pasta intake-body weight residuals were used , pasta intake was significantly and negatively associated with BMI in crude and multi-adjusted models ( including adhesion to MeD ) in both genders and Moli-sani and INHES studies ( for all β-coef , pasta-body weight residuals were significantly and negatively associated with waist and hip circumference and waist-to-hip ratio ( for all β-coef , pasta consumption was negatively associated with BMI , waist circumference and waist-to-hip ratio and with a lower prevalence of overweight and obesity ",
"BACKGROUND Insulin sensitivity ( Si ) is improved by weight loss and exercise , but the effects of the replacement of saturated fatty acids ( SFAs ) with monounsaturated fatty acids ( MUFAs ) or carbohydrates of high glycemic index ( HGI ) or low glycemic index ( LGI ) are uncertain . OBJECTIVE We conducted a dietary intervention trial to study these effects in participants at risk of developing metabolic syndrome . DESIGN We conducted a 5-center , parallel design , r and omized controlled trial [ RISCK ( Reading , Imperial , Surrey , Cambridge , and Kings ) ] . The primary and secondary outcomes were changes in Si ( measured by using an intravenous glucose tolerance test ) and cardiovascular risk factors . Measurements were made after 4 wk of a high-SFA and HGI ( HS/HGI ) diet and after a 24-wk intervention with HS/HGI ( reference ) , high-MUFA and HGI ( HM/HGI ) , HM and LGI ( HM/LGI ) , low-fat and HGI ( LF/HGI ) , and LF and LGI ( LF/LGI ) diets . RESULTS We analyzed data for 548 of 720 participants who were r and omly assigned to treatment . The median Si was 2.7 × 10(-4 ) mL · μU(-1 ) · min(-1 ) ( interquartile range : 2.0 , 4.2 × 10(-4 ) mL · μU(-1 ) · min(-1 ) ) , and unadjusted mean percentage changes ( 95 % CIs ) after 24 wk treatment ( P = 0.13 ) were as follows : for the HS/HGI group , -4 % ( -12.7 % , 5.3 % ) ; for the HM/HGI group , 2.1 % ( -5.8 % , 10.7 % ) ; for the HM/LGI group , -3.5 % ( -10.6 % , 4.3 % ) ; for the LF/HGI group , -8.6 % ( -15.4 % , -1.1 % ) ; and for the LF/LGI group , 9.9 % ( 2.4 % , 18.0 % ) . Total cholesterol ( TC ) , LDL cholesterol , and apolipoprotein B concentrations decreased with SFA reduction . Decreases in TC and LDL-cholesterol concentrations were greater with LGI . Fat reduction lowered HDL cholesterol and apolipoprotein A1 and B concentrations . CONCLUSIONS This study did not support the hypothesis that isoenergetic replacement of SFAs with MUFAs or carbohydrates has a favorable effect on Si . Lowering GI enhanced reductions in TC and LDL-cholesterol concentrations in subjects , with tentative evidence of improvements in Si in the LF-treatment group . This trial was registered at clinical trials.gov as IS RCT N29111298",
"Objective : To investigate whether a diet with a reduced glycaemic index ( GI ) has effects on appetite , energy intake , body weight and composition in overweight and obese female subjects . Design : R and omized crossover intervention study including two consecutive 12-week periods . Lower or higher GI versions of key carbohydrate-rich foods ( breads , breakfast cereals , rice and pasta/potatoes ) were provided to subjects to be incorporated into habitual diets in ad libitum quantities . Foods intended as equivalents to each other were balanced in macronutrient composition , fibre content and energy density . Subjects : Nineteen overweight and obese women , weight-stable , with moderate hyperinsulinaemia ( age : 34–65 years , body mass index : 25–47 kg m−2 , fasting insulin : 49–156 pmol l−1 ) . Measurements : Dietary intake , body weight and composition after each 12-week intervention . Subjectively rated appetite and short-term ad libitum energy intake at a snack and lunch meal following fixed lower and higher GI test breakfasts ( GI 52 vs 64 ) in a laboratory setting . Results : Free-living diets differed in GI by 8.4 units ( 55.5 vs 63.9 ) , with key foods providing 48 % of carbohydrate intake during both periods . There were no differences in energy intake , body weight or body composition between treatments . On laboratory investigation days , there were no differences in subjective ratings of hunger or fullness , or in energy intake at the snack or lunch meal . Conclusion : This study provides no evidence to support an effect of a reduced GI diet on satiety , energy intake or body weight in overweight/obese women . Cl aims that the GI of the diet per se may have specific effects on body weight may therefore be misleading",
"BACKGROUND AND AIMS Adherence to Mediterranean diet ( MD ) is reportedly declining in the last decades . We aim ed to investigate the adherence to MD over the period 2005 - 2010 and exploring the possible role of the global economic crisis in accounting for the changing in the dietary habits in Italy . METHODS AND RESULTS Cross-sectional analysis in a population -based cohort study which r and omly recruited 21,001 southern Italian citizens enrolled within the Moli-sani study . Food intake was determined by the Italian EPIC food frequency question naire . Adherence to MD was appraised by the Italian Mediterranean Index ( IMI ) . A wealth score was derived to evaluate the economic position and used together with other socioeconomic indicators . Highest prevalence of adherence to MD was observed during the years 2005 - 2006 ( 31.3 % ) while the prevalence dramatically fell down in the years 2007 - 2010 ( 18.3 % ; P elderly , less affluent groups , and among those living in urban areas . Accordingly , we observed that in 2007 - 2010 socioeconomic indicators were strongly associated with higher adherence to MD , whereas no association was detected in the years before the economic crisis began ; both wealth score and education were major determinants of high adherence to MD with 31 % ( 95%CI : 18 - 46 % ) higher adherence to this pattern within the wealthier group compared to the less affluent category . CONCLUSION Adherence to MD has considerably decreased over the last few years . In 2007 - 2010 socioeconomic indicators have become major determinants of adherence to MD , a fact likely linked to the economic downturn",
"BACKGROUND & AIMS Low glycemic index ( GI ) based diets could influence the accompanying physiological adaptations to energy restriction in the treatment of obesity . It was aim ed to investigate the effects of two energy-restricted diets with different food distribution and GI values on weight loss and energy metabolism in the nutritional treatment of obesity . SUBJECTS AND METHODS Participants ( n=32 ; BMI : 32.5+/-4.3 kg/m(2 ) ) were r and omly assigned to follow two energy-restricted diets with higher-GI or lower-GI for 8 weeks . The energy restriction was -30 % in relation to energy expenditure . Anthropometry , energy expenditure and mitochondrial oxidation were assessed at baseline and at the endpoint of the intervention . Body weight was also measured one year after the treatment . The work was approved by the ethical committees of the University of Navarra ( 54/2006 ) . RESULTS Volunteers consuming the lower-GI diet showed a significantly higher weight loss than their counterparts ( -5.3+/-2.6 % vs -7.5+/-2.9 % ; p=0.032 ) , although the decrease in resting energy expenditure ( REE ) was similar between groups ( p=0.783 ) . Mitochondrial oxidation was significantly affected by the type of diet ( p=0.001 ) , being activated after the lower-GI treatment ( p=0.022 ) . Interestingly , one year after the nutritional intervention weight regain was only statistically significant in the higher-GI group ( p=0.033 ) . CONCLUSIONS Lower-GI energy-restricted diets achieved through a specific differential food selection can improve the energy adaptations during obesity treatment , favouring weight loss and probably weight maintenance compared with higher-GI hypocaloric diets",
"BACKGROUND Despite the popularity of low-glycemic index ( GI ) and high-protein diets , to our knowledge no r and omized , controlled trials have systematic ally compared their relative effects on weight loss and cardiovascular risk . METHODS A total of 129 overweight or obese young adults ( body mass index , > or = 25 [ calculated as weight in kilograms divided by the square of height in meters ] ) were assigned to 1 of 4 reduced-fat , high-fiber diets for 12 weeks . Diets 1 and 2 were high carbohydrate ( 55 % of total energy intake ) , with high and low GIs , respectively ; diets 3 and 4 were high protein ( 25 % of total energy intake ) , with high and low GIs , respectively . The glycemic load was highest in diet 1 and lowest in diet 4 . Changes in weight , body composition , and blood chemistry profile were studied . RESULTS While all groups lost a similar mean + /- SE percentage of weight ( diet 1 , -4.2 % + /- 0.6 % ; diet 2 , -5.5 % + /- 0.5 % ; diet 3 , -6.2 % + /- 0.4 % ; and diet 4 , -4.8 % + /- 0.7 % ; P = .09 ) , the proportion of subjects in each group who lost 5 % or more of body weight varied significantly by diet ( diet 1 , 31 % ; diet 2 , 56 % ; diet 3 , 66 % ; and diet 4 , 33 % ; P = .01 ) . Women on diets 2 and 3 lost approximately 80 % more fat mass ( -4.5 + /- 0.5 [ mean + /- SE ] kg and -4.6 + /- 0.5 kg ) than those on diet 1 ( -2.5 + /- 0.5 kg ; P = .007 ) . Mean + /- SE low-density-lipoprotein cholesterol levels declined significantly in the diet 2 group ( -6.6 + /- 3.9 mg/dL [ -0.17 + /- 0.10 mmol/L ] ) but increased in the diet 3 group ( + 10.0 + /- 3.9 mg/dL [ + 0.26 + /- 0.10 mmol/L ] ; P = .02 ) . Goals for energy distribution were not achieved exactly : both carbohydrate groups ate less fat , and the diet 2 group ate more fiber . CONCLUSION Both high-protein and low-GI regimens increase body fat loss , but cardiovascular risk reduction is optimized by a high-carbohydrate , low-GI diet",
"OBJECTIVE The prevalence of obesity has increased dramatically in recent years . However , the role of dietary composition in body weight regulation remains unclear . The purpose of this work was to investigate the acute effects of dietary glycemic index ( GI ) on energy metabolism and voluntary food intake in obese subjects . METHODS Twelve obese teenage boys were evaluated on three separate occasions using a crossover study protocol . During each evaluation , subjects consumed identical test meals at breakfast and lunch that had a low , medium , or high GI . The high- and medium-GI meals were design ed to have similar macronutrient composition , fiber content , and palatability , and all meals for each subject had equal energy content . After breakfast , plasma and serum concentrations of metabolic fuels and hormones were measured . Ad libitum food intake was determined in the 5-hour period after lunch . RESULTS Voluntary energy intake after the high-GI meal ( 5.8 megajoule [ mJ ] ) was 53 % greater than after the medium-GI meal ( 3.8 mJ ) , and 81 % greater than after the low-GI meal ( 3.2 mJ ) . In addition , compared with the low-GI meal , the high-GI meal result ed in higher serum insulin levels , lower plasma glucagon levels , lower postabsorptive plasma glucose and serum fatty acids levels , and elevation in plasma epinephrine . The area under the glycemic response curve for each test meal accounted for 53 % of the variance in food intake within subjects . CONCLUSIONS The rapid absorption of glucose after consumption of high-GI meals induces a sequence of hormonal and metabolic changes that promote excessive food intake in obese subjects . Additional studies are needed to examine the relationship between dietary GI and long-term body weight regulation",
"Objective : Recent epidemiological and prospect i ve trial evidence suggests that consumption of a low glycaemic index ( LGI ) diet will reduce coronary risk . We hypothesise that introduction of an LGI diet will improve the metabolic profile of patients who have undergone coronary artery bypass grafting . Design : We conducted a r and omised parallel group trial comparing a control group ( n=29 , age 61.8±9 y ) , who received currently advocated healthy eating dietary advice only , to an intervention group , who received healthy eating advice emphasising LGI carbohydrates ( n=26 , age 63.6±9.4 y ) over a 12-week period in free-living patients with coronary heart disease . Outcome measures included fasting glucose , insulin , total cholesterol , high-density lipoprotein cholesterol , very low-density lipoprotein cholesterol , low density lipoprotein cholesterol and triglycerides . Results : A significant lower dietary glycaemic index was achieved in the group assigned to an LGI diet compared to the healthy eating control group ( 71±1 vs 81±1 ) ; fibre intake was also higher in the LGI group ( 20±1 vs 15±1 g ) . All biochemical markers of glucose and lipid metabolism measured were similar after 12 weeks of the LGI diet or control diet . Discussion : The LGI group achieved a significant LGI and a higher dietary fibre intake . However , there was no measurable significant effect of either the LGI diet or the health eating diet on lipid levels ; this may have been hidden by concurrent drug therapy",
"Evidence suggests that a low-glycemic index ( LGI ) diet has a satiating effect and thus may enhance weight maintenance following weight loss . This study was conducted at Hammersmith Hospital , London , UK , and assessed the effect of altering diet GI on weight-loss maintenance . It consisted of a weight-loss phase and a 4-month r and omized weight maintenance phase . Subjects were seen monthly to assess dietary compliance and anthropometrics . Appetite was assessed bimonthly by visual analogue scales while meal challenge postpr and ial insulin and glucose concentrations were assessed before and after the intervention . Following a median weight loss of 6.1 ( interquartile range : 5.2 - 7.1 ) % body weight , subjects were r and omized to a high-glycemic index ( HGI ) ( n = 19 ) or LGI ( n = 23 ) diet . Dietary composition differed only in GI ( HGI group : 63.7 + /- 9.4 ; LGI group : 49.7 + /- 5.7 , P body weight ( weight change over 4 months , HGI group : 0.3 + /- 1.9 kg ; LGI group : -0.7 + /- 2.9 kg , P = 0.3 ) or other anthropometric measurements . This pilot study suggests that in the setting of healthy eating , changing the diet GI does not appear to significantly affect weight maintenance",
"BACKGROUND & AIMS The role of glycemic index of the diet in glucose control and cardiovascular prevention is still not clear . The aim of this study was to determine the effects of hypocaloric diets with different glycemic indexes and glycemic loads on endothelial function and glycemic variability in nondiabetic participants at increased cardiovascular risk . METHODS Forty nondiabetic obese participants were r and omly assigned to a three-month treatment with either a low glycemic index ( LGI ; n=19 ) or high glycemic index ( HGI ; n=21 ) hypocaloric diet with similar macronutrient and fiber content . Endothelial function was measured as flow-mediated dilatation ( FMD ) of the brachial artery before and after dieting . In addition , 48-h continuous subcutaneous glucose monitoring was done before and after dieting in a subgroup of 24 participants . RESULTS The amount of weight loss after dieting was similar in both groups . The glycemic index of the diet significantly influenced the FMD ( P change of FMD was 2.3±2.6 % following the LGI diet , and -0.9±3.6 % after the HGI diet ( P The mean 48-h glycemia decreased significantly after dietary treatment ( P 48-h glycemic variability measured as coefficient of variability ( CV% ; P The CV% decreased after the LGI diet ( from 23.5 to 20.0 % ) and increased after the HGI diet ( from 23.6 to 26.6 % ) . The change in percentage of FMD was inversely correlated with the change in the 48-h glycemic CV% ( r=-0.45 ; P Endothelial function and glycemic variability ameliorate in association with the adherence to an LGI hypocaloric diet in nondiabetic obese persons . CLINICAL TRIAL REGISTRATION NUMBER IS RCT N56834511",
"OBJECTIVE Evaluate the effect of glycemic index ( GI ) on biochemical parameters , food intake , energy metabolism , anthropometric measures and body composition in overweight subjects . MATERIAL S AND METHODS Simple blind study , in which nineteen subjects were r and omly assigned to consume in the laboratory two daily low GI ( n = 10 ) or high GI ( n = 9 ) meals , for forty-five consecutive days . Habitual food intake was assessed at baseline . Food intake , anthropometric measures and body composition were assessed at each 15 days . Energy metabolism and biochemical parameters were evaluated at baseline and the end of the study . RESULTS Low GI meals increased fat oxidation , and reduced waist circumference and HOMA-IR , while high GI meals increased daily dietary fiber and energy intake compared to baseline . There was a higher reduction on waist circumference and body fat , and a higher increase on postpr and ial fat oxidation in response to the LGI meals than after high GI meals . High GI meals increased fasting respiratory coefficient compared to baseline and low GI meals . CONCLUSION The results of the present study showed that the consumption of two daily low GI meals for forty-five consecutive days has a positive effect on obesity control , whereas , the consumption of high GI meals result has the opposite effect",
"We aim ed to determine whether altering dietary glycemic index ( GI ) in addition to healthy eating and weight loss advice affects arterial compliance and 24-hour blood pressure ( BP ) , both coronary heart disease ( CHD ) risk factors . Middle-aged men with at least 1 CHD risk were r and omized to a 6-month low-GI ( LGI ) or high-GI ( HGI ) diet . All were advised on healthy eating and weight loss . They were seen monthly to assess dietary compliance and anthropometrics . Carotid-femoral pulse wave velocity ( PWV ) , fasting blood lipid profile , and glucose and insulin concentrations were measured at baseline and at months 3 and 6 . Six-hour postpr and ial glucose and insulin responses and 24-hour ambulatory BP were also assessed at baseline and month 6 . Thirty-eight subjects ( HGI group , n = 16 ; LGI group , n = 22 ) completed the study . At month 6 , groups differed in dietary GI , glycemic load , and carbohydrate intake ( P Fasting insulin concentration and insulin resistance ( calculated by homeostatic model assessment ) were lower in the LGI than the HGI group ( P total cholesterol and 24-hour BP was bigger in the LGI than the HGI group ( P PWV , low-density lipoprotein cholesterol , and triacylglycerol concentration . There were no differences in postpr and ial glucose or insulin responses between the groups . The results suggest that an LGI diet may be more beneficial in reducing CHD risk , including PWV and 24-hour BP , even in the setting of healthy eating and weight loss ; and thus , further study is warranted",
"Objective : To determine whether glycemic index ( GI ) differentially affects improved glucose and lipid profiles observed during weight loss in overweight subjects previously diagnosed with type 2 diabetes with variable glucose tolerance . Methods : Twenty-three female and twenty-two male overweight subjects participated in 12 weeks of energy restriction ( average BMI 33.2 kg/m2 , age 56.7 years , glycated hemoglobin ( GHb ) 6.7 % ) . After a four-week run-in on a high saturated fat ( SFA ) diet ( 1540 kcal/day , 17 % SFA ) , the free-living subjects were r and omly assigned to either a high- ( 75 GI units ) or low- ( 43 GI units ) GI diet ( 1440 kcal/day , 60 % carbohydrate , 5 % SFA ) for eight weeks . Weight , serum lipids , plasma glucose and glycated hemoglobin were measured every four weeks . An oral glucose tolerance test ( OGTT ) was also performed at baseline , weeks 4 and 12 . From the baseline OGTT results subjects were divided into three groups of low , median and high glucose tolerance . Results : At baseline , BMI , age and glycated hemoglobin concentrations were not different between subjects allocated to the high- or low-GI diets . After four weeks , weight loss was 3.6 ± 0.3 kg . Fasting glucose ( −5.6 % ) , glycated hemoglobin ( −2.8 % ) , area under the glucose curve ( −13.0 % ) and triglyceride ( −13.8 % ) concentrations were reduced ( p reductions were observed in weight ( −4.9 % ) , fasting glucose ( −4.6 % ) , area under glucose curve ( −10.1 % ) , glycated hemoglobin ( −7.2 % ) , triglyceride ( −7.5 % ) and LDL-C ( −13.2 % ) concentrations . Weight loss was not different between low and high-GI diets . However , glycated hemoglobin was reduced twofold more in subjects consuming a low-GI diet as compared to subjects consuming a high-GI diet , but this was not statistically significant . LDL concentrations were also reduced more in subjects with low glucose tolerance on the low-GI diet ( p = 0.02 ) . Conclusion : Weight loss produces substantial improvements in glycemic control and lipoprotein metabolism . Lowering the glycemic index of high carbohydrate , low fat diets increases the fall in LDL cholesterol in subjects with type 2 diabetes with low glucose tolerance , but has little effect on glycemic control",
"Low glycaemic index ( GI ) diets may facilitate weight loss via behavioural and /or endocrine mechanisms . This study investigated whether the outcomes of the Weight Watchers POINTS Weight-Loss System could be improved by encouraging dieters to select low GI , high-carbohydrate foods . Ninety-six women ( age 20 - 72 years ; BMI 25 - 40 kg/m2 ) were recruited as they started the Weight Watchers POINTS programme for 12 weeks . Weekly classes were r and omized so that seven ( forty-five women ) followed the regular programme while seven others ( fifty-one women ) followed a revised programme encouraging the selection of low GI foods . Anthropometric and biochemical parameters were measured before and after the 12-week diets . Participants rated hunger and desire to eat using visual analogue scales on 1 d per week , several times per d. Attrition was the same in both groups ( 32 v. 30 % ) , as well as many benefits ( 5 % weight loss , decreases in insulinaemia and blood lipids , waist and hip circumferences , blood pressure ) . Hunger and desire to eat were rated consistently lower in the low GI group over the 12-week diet . Group differences in subjective sensations were especially large in the afternoon . The 12-week weight management yielded many significant anthropometric and biochemical benefits that were not improved by encouraging dieters to select low GI foods . The subjective benefits ( lower hunger and desire to eat ) of the low GI diet may be a worthwhile contribution to the motivation of dieters that might affect adherence to the diet over the long term",
"The published literature contains numerous reports of clinical studies . A problem in their interpretation is that studies in which the observed efficacy of the treatment is high are much more likely to be reported than those in which the observed efficacy is average or poor . This phenomenon has had the consequence of generally discrediting the reliability of the literature , especially that of non-r and omized studies . In this paper a model is developed which permits estimation of the potential magnitude by which the reported efficacy of a treatment might be inflated . This quantity is termed the publication bias . The magnitude of the bias depends on the sample size of the study and the number of similar studies conducted concurrently . Tabulated values of the bias are presented , permitting easy computation . The new measure may have potential use for physicians in clinical decision making in that it characterizes the reliability of results from a specific published study , especially when there are no definitive r and omized studies . However , correction of publication bias in this manner is not a substitute for a well controlled or a r and omized study . The technique merely assists in the interpretation of available evidence from the literature . Moreover , it must be used with due caution in recognition of the assumptions and approximations involved in the calculation",
"OBJECTIVE The current paper aims to present the main results of the Italian National Food Consumption Survey INRAN-SCAI 2005 - 06 . DESIGN A cross-sectional study was performed . Households were r and omly selected after geographical stratification of the national territory . Food consumption was assessed on three consecutive days through individual estimated dietary records . SETTING Italy . SUBJECTS The final study sample comprised 3323 subjects ( 1501 males and 1822 females ) aged 0.1 to 97.7 years belonging to 1329 households : fifty-two infants ( 0 - 2.9 years ) , 193 children ( 3 - 9.9 years ) , 247 teenagers ( 10 - 17.9 years ) , 2313 adults ( 18 - 64.9 years ) and 518 elderly ( 65 years and above ) . RESULTS Participation rate was 33 % . The mean ratio of estimated energy intake to estimated BMR was 1.41 in adults . Indicators of mean and high individual consumption are presented for fifteen large categories and fifty-one subcategories of foods and beverages , in the total population and in consumers , by age and sex categories . The overall consumption of fruit and vegetables was 418 g/d . The consumption of red meat was approximately 700 g/week , expressed as raw weight . Some specific aspects of the Italian food consumption pattern were confirmed : a large contribution from bread , pasta and pizza to cereals , from olive oil to fats and from wine to alcoholic beverages . CONCLUSIONS The data base obtained from the survey will be the key reference for Italian food consumption during the coming years and will be utilized for a variety of purpose s including the assessment of nutrient intakes and risk analysis"
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The objective of this study was to systematic ally review studies describing the association between vasomotor symptoms and metabolic syndrome , type 2 diabetes and insulin resistance in peri- and postmenopausal women . A systematic search of studies was performed in EMBASE , MEDLINE , Web-of-science , Scopus , PubMed publisher , Cochrane Library , Google scholar . To identify studies eligible for inclusion , the following criteria were defined : r and omised trials , cohort , case-control , and cross-sectional studies investigating the association between vasomotor symptoms and metabolic syndrome , type 2 diabetes and insulin resistance in peri- and postmenopausal women with natural menopause . Method ological quality was assessed using a modified NewCastle Ottawa Assessment Scale . After screening 2660 titles and abstract s , four studies , of which two cohort studies met the criteria of high method ological quality , were included in the review . Because of the heterogeneity and the limited number of studies , there is no sufficient evidence on the potential role of vasomotor symptoms in metabolic health . However , both high- quality cohort studies , with large study population s and adjustment for multiple confounding variables showed positive associations between vasomotor symptoms and insulin resistance and type 2 diabetes mellitus . These findings suggest that there is an association between vasomotor symptoms and metabolic health outcomes . To confirm this and to strengthen the evidence , more high quality longitudinal research on this topic is needed
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"Aims /hypothesis Prospect i ve data directly investigating the role of endogenous sex hormones in diabetes risk have been scant , particularly in women . We aim ed to examine comprehensively plasma sex hormones in connection with risk of developing type 2 diabetes in postmenopausal women . Methods We conducted a prospect i ve , nested case – control study of plasma oestradiol , testosterone and dehydroepi and rosterone sulfate and risk of type 2 diabetes in a cohort of women health professionals with a mean age of 60.3 and 12.2 years since menopause . Among women not using hormone therapy and free of baseline cardiovascular disease , cancer and diabetes , 359 incident cases of type 2 diabetes were matched with 359 controls during an average follow-up of 10 years . Results Oestradiol and testosterone were each strongly and positively associated with risk of type 2 diabetes . After adjustment for BMI , family history , lifestyle and reproductive variables , the multivariable relative risks ( 95 % CI ) comparing the highest vs lowest quintile were 12.6 ( 2.83–56.3 ) for total oestradiol ( p = 0.002 for trend ) , 13.1 ( 4.18–40.8 ) for free oestradiol ( p total testosterone ( p = 0.019 for trend ) and 14.8 ( 4.44–49.2 ) for free testosterone ( p postmenopausal women , higher plasma levels of oestradiol and testosterone were strongly and prospect ively related to increased risk of developing type 2 diabetes . These prospect i ve data indicate that endogenous levels of sex hormones may play important roles in the pathogenesis of type 2 diabetes . Clinical Trials.gov ID no. : NCT00000479",
"Objective Recent data have indicated that menopausal hot flashes may be a determinant for cardiovascular health . Therefore , we studied the impact of hot flashes on insulin resistance , one of the most powerful markers of cardiovascular health , in recently postmenopausal women . Methods We studied 143 recently postmenopausal ( amenorrhea 6 - 36 mo ) healthy and normal-weight women without previous hormone therapy use . The women prospect ively recorded the number and severity of hot flashes for 2 weeks , and a vali date d total symptom score , the hot flash weekly weighted score , was calculated for each woman . Insulin resistance was assessed from fasting blood levels of glucose and insulin with the homeostasis model assessment . Results In 12 women , the assessment of insulin ( n = 11 ) or glucose ( n = 1 ) failed , and they were excluded from further analysis . Thus , hot flashes were absent in 19 , mild in 32 , moderate in 27 , and severe in 53 women . The levels of glucose or insulin , or HOMA showed no differences between these groups , nor was insulin resistance related to the number or severity of hot flashes or to the levels of C-reactive protein or sex hormone – binding globulin . Overall , insulin resistance showed a positive association with body mass index ( mean difference , 0.058 ; 95 % CI , 0.015 - 0.102 ; P = 0.009 ) and a negative association with level of estradiol ( mean difference , −0.002 ; 95 % CI , −0.003 to −0.001 ; P = 0.009 ) . Conclusions Insulin resistance may not be involved in hot flash – related changes in cardiovascular health . However , because of the small sample size , these findings need to be interpreted with caution",
"Objective : The aim of this study was to examine changes in health-related quality of life ( HRQL ) during the menopausal transition , controlling for chronological aging , symptoms , and other covariates . Methods : This was a prospect i ve , longitudinal study of women aged 42 to 52 years at baseline recruited at seven US sites ( N = 3,302 ) in the multiethnic Study of Women 's Health Across the Nation . Women eligible for the cohort had an intact uterus , had at least one ovary , were not currently using exogenous hormones , were either premenopausal or early perimenopausal , and were self-identified as one of the study 's design ated racial/ethnic groups . Data from the baseline interview and six annual follow-up visits are reported . HRQL was assessed with five subscales from the Medical Outcomes Study Short-Form Health Survey , with reduced functioning defined as being in the lowest 25 % on a subscale . Covariates included symptoms , medical conditions , sociodemographics variables , physical activity , and psychological factors . Results : With adjustment for baseline age , chronological aging , and relevant covariates , the odds of reduced role-physical functioning were significantly greater at late perimenopause ( odds ratio , 1.46 ; 95 % CI , 1.08 - 1.99 ) and postmenopause ( odds ratio , 1.49 ; 95 % CI , 1.09 - 2.04 ) compared with premenopause . Menopause status was unrelated to bodily pain , vitality , role-emotional , or social functioning . Hormone therapy users were more likely to report reduced functioning . Other variables significantly related to HRQL across all domains included vasomotor symptoms , urine leakage , poor sleep , arthritis , depressed mood , perceived stress , and stressful life events . Conclusions : The menopausal transition showed little impact on HRQL when adjusted for symptoms , medical conditions , and stress",
"OBJECTIVE : To compare 2 subjective and 1 objective method for assessing hot flush frequency : prospect i ve paper hot flush diaries , prospect i ve electronic event markers , and the Biolog ambulatory sternal skin conductance monitor . METHODS : Fifty-five breast cancer survivors provided two 24-hour periods of data , 1 week apart , at baseline before being r and omized for an intervention study . Women completed a prospect i ve paper hot flush diary and pressed an event marker to subjectively record each hot flush they experienced while wearing a sternal skin conductance monitor . RESULTS : Sensitivity was uniformly low ( hot flush subjectively by diary or event marker was between 36 % and 50 % of the time if she was awake and between 22 % and 42 % of the time if she was asleep . Underreporting of diary hot flushes consequently result ed in more than 50 % missing severity and bother ratings . Specificity was high ( 96–98 % ) for both the diary and event marker , for both weeks , and for both waking and sleeping times . The positive predictive value was low ( 34–52 % ) , and negative predictive value was high ( 94–97 % ) . This indicates that , rather than overreporting hot flushes when they did not exist , women tended to underreport hot flushes when they did exist . CONCLUSION : Use of prospect i ve paper hot flush diaries and electronic event markers may seriously underestimate hot flush frequency and result in missed intensity and bother ratings . LEVEL OF EVIDENCE :"
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BACKGROUND Atrial fibrillation ( AF ) is a common arrhythmia that can promote or worsen heart failure ( HF ) . Our purpose was to compare the effects of rate and rhythm control in patients with atrial fibrillation and heart failure . METHODS We developed a systematic search in August 2010 through CENTRAL and MEDLINE data bases to identify r and omised controlled trials ( RCTs ) comparing rate control with rhythm control in patients with both AF and HF . We analysed mortality , hospitalisations , stroke/thromboembolic events , quality of life , and drugs adverse events . Relative risks ( RR ) and 95 % confidence intervals ( 95 % CI ) were calculated for mortality and hospitalisations . The remaining outcomes were analysed qualitatively . RESULTS Four RCTs with a total of 2486 patients with atrial fibrillation and heart failure were identified . Mortality and stroke/thromboembolic events were not significantly different in rate and rhythm control arms [ RR 1.03 ; 95 % CI : 0.90 - 1.17 ] and [ RR 1.09 ; 95 % CI : 0.61 - 1.96 ] , respectively . Hospitalisations were less frequent with rate control than with rhythm control [ RR 0.92 ; 95 % CI : 0.86 - 0.98 ; p=0.008 ] , in 3 studies involving 2425 patients . Number needed to treat to prevent one hospitalisation was 19 patients . CONCLUSIONS In patients with AF and HF , rate control compared with rhythm control showed inferior risk of hospitalisation
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"BACKGROUND Several studies have indicated that treatment with angiotensin converting enzyme ( ACE ) inhibitors and angiotensin II type 1 receptor blockers ( ARBs ) may reduce the incidence of atrial fibrillation ( AF ) in hypertensive patients and patients with left ventricular dysfunction . However , there is limited data on the effect of ACE-inhibitors and ARBs in patients undergoing electrical cardioversion for persistent AF . We hypothesized that treatment with the ARB c and esartan , without adjunct antiarrhythmic therapy , would reduce the recurrence rate of AF after successful cardioversion . METHODS In a double blind , placebo-controlled study , 171 patients with persistent AF were r and omized to receive c and esartan 8 mg once daily ( n=86 ) or placebo ( n=85 ) for 3 - 6 weeks before and c and esartan 16 mg once daily or placebo for 6 months after electrical cardioversion . Primary endpoint was recurrence of AF . RESULTS A total of 68 patients in the c and esartan group and 69 patients in the placebo group were successfully cardioverted . Forty-eight patients ( 71 % ) in the c and esartan group and 45 ( 65 % ) in the placebo group had a recurrence of AF during 6 months follow-up . Median time to recurrence was 8 and 9 days in the c and esartan and placebo groups , respectively . The differences between the groups were not statistically significant . CONCLUSION Treatment with the ARB c and esartan for 3 - 6 weeks before and 6 months after electrical cardioversion had no effect on the recurrence rate of AF",
"Background Although previous clinical trials demonstrated the non-inferiority of a rate control to rhythm control strategy for management of atrial fibrillation ( AF ) , the optimal treatment strategy for paroxysmal AF ( PAF ) remains unclear . Methods and Results A r and omized , multicenter comparison of rate control vs rhythm control in Japanese patients with PAF ( the Japanese Rhythm Management Trial for Atrial Fibrillation ( J-RHYTHM ) study ) was conducted . The primary endpoint was a composite of total mortality , symptomatic cerebral infa rct ion , systemic embolism , major bleeding , hospitalization for heart failure , or physical/psychological disability requiring alteration of treatment strategy . In the study , 823 patients with PAF were followed for a mean period of 578 days . The primary endpoint occurred in 64 patients ( 15.3 % ) assigned to rhythm control and in 89 patients ( 22.0 % ) to rate control ( P=0.0128 ) . No significant differences between the treatment strategies were observed in the incidences of death , stroke , bleeding and heart failure . Meanwhile , significantly fewer patients requested changes of assigned treatment strategy in the rhythm control vs the rate control group , which was accompanied by improvement in AF-specific quality of life scores . Conclusion The J-RHYTHM study showed that rhythm control was associated with fewer primary endpoints than rate control . However , mortality and cardiovascular morbidity were not affected by the treatment strategy ( umin-CTR No. C000000106 )",
"The aim of this study was to compare the effect of valsartan/amlodipine and atenolol/amlodipine combination in preventing the recurrence of atrial fibrillation ( AF ) in hypertensive diabetic patients with a history of recent paroxysmal atrial fibrillation . Two hundred ninty-six hypertensive patients with well-controlled type 2 diabetes in sinus rhythm but with at least 2 ECG-documented episodes of AF in the previous 6 months were r and omized to 160 mg of valsartan plus amlodipine ( titrated from 2.5 to 10 mg ) or to 100 mg of atenolol plus amlodipine ( 2.5 to 10 mg ) in addition to their previous antiarrhythmic treatment ( if any ) and were followed up for 1 year . Blood pressure ( BP ) and a 24-hour ECG were evaluated monthly . The patients were asked to report any episode of symptomatic AF and to perform an ECG as early as possible . SBP/DBP values were significantly reduced after 12 months with valsartan/amlodipine ( from 150.4/93.5 to 126.37/7.4 mm Hg , P atenolol/amlodipine ( from 151.1/94.2 to 127.1/77.9 mm Hg , P ECG-documented episode of AF was reported in 20.3 % of the patients treated with valsartan/amlodipine and in 34.1 % of those treated with atenolol/amlodipine , with a significant difference between treatments ( P valsartan/amlodipine combination on AF recurrence was more evident in patients treated with amiodarone or propafenone than in patients treated with other antiarrhythmic drugs or without antiarrhythmic treatment . Despite similar BP reduction , valsartan/amlodipine combination was more effective in patients treated with amiodarone or propafenone than atenolol/amlodipine in preventing new episodes of AF in hypertensive diabetic patients",
"BACKGROUND Amiodarone is effective in maintaining sinus rhythm in atrial fibrillation but is associated with potentially serious toxic effects . Dronedarone is a new antiarrhythmic agent pharmacologically related to amiodarone but developed to reduce the risk of side effects . METHODS In two identical multicenter , double-blind , r and omized trials , one conducted in Europe ( Clinical Trials.gov number , NCT00259428 [ Clinical Trials.gov ] ) and one conducted in the United States , Canada , Australia , South Africa , and Argentina ( termed the non-European trial , NCT00259376 [ Clinical Trials.gov ] ) , we evaluated the efficacy of dronedarone , with 828 patients receiving 400 mg of the drug twice daily and 409 patients receiving placebo . Rhythm was monitored transtelephonically on days 2 , 3 , and 5 ; at 3 , 5 , 7 , and 10 months ; during recurrence of arrhythmia ; and at nine scheduled visits during a 12-month period . The primary end point was the time to the first recurrence of atrial fibrillation or flutter . RESULTS In the European trial , the median times to the recurrence of arrhythmia were 41 days in the placebo group and 96 days in the dronedarone group ( P=0.01 ) . The corresponding duration s in the non-European trial were 59 and 158 days ( P=0.002 ) . At the recurrence of arrhythmia in the European trial , the mean ( + /-SD ) ventricular rate was 117.5+/-29.1 beats per minute in the placebo group and 102.3+/-24.7 beats per minute in the dronedarone group ( P Rates of pulmonary toxic effects and of thyroid and liver dysfunction were not significantly increased in the dronedarone group . CONCLUSIONS Dronedarone was significantly more effective than placebo in maintaining sinus rhythm and in reducing the ventricular rate during recurrence of arrhythmia",
"BACKGROUND Dronedarone is a new antiarrhythmic drug that is being developed for the treatment of patients with atrial fibrillation . METHODS We conducted a multicenter trial to evaluate the use of dronedarone in 4628 patients with atrial fibrillation who had additional risk factors for death . Patients were r and omly assigned to receive dronedarone , 400 mg twice a day , or placebo . The primary outcome was the first hospitalization due to cardiovascular events or death . Secondary outcomes were death from any cause , death from cardiovascular causes , and hospitalization due to cardiovascular events . RESULTS The mean follow-up period was 21+/-5 months , with the study drug discontinued prematurely in 696 of the 2301 patients ( 30.2 % ) receiving dronedarone and in 716 of the 2327 patients ( 30.8 % ) receiving placebo , mostly because of adverse events . The primary outcome occurred in 734 patients ( 31.9 % ) in the dronedarone group and in 917 patients ( 39.4 % ) in the placebo group , with a hazard ratio for dronedarone of 0.76 ( 95 % confidence interval [ CI ] , 0.69 to 0.84 ; P deaths ( 5.0 % ) in the dronedarone group and 139 ( 6.0 % ) in the placebo group ( hazard ratio , 0.84 ; 95 % CI , 0.66 to 1.08 ; P=0.18 ) . There were 63 deaths from cardiovascular causes ( 2.7 % ) in the dronedarone group and 90 ( 3.9 % ) in the placebo group ( hazard ratio , 0.71 ; 95 % CI , 0.51 to 0.98 ; P=0.03 ) , largely due to a reduction in the rate of death from arrhythmia with dronedarone . The dronedarone group had higher rates of bradycardia , QT-interval prolongation , nausea , diarrhea , rash , and an increased serum creatinine level than the placebo group . Rates of thyroid- and pulmonary-related adverse events were not significantly different between the two groups . CONCLUSIONS Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation . ( Clinical Trials.gov number , NCT00174785 .",
"Background —In patients with left ventricular dysfunction , atrial fibrillation and flutter ( AF and AFl , respectively ) are common arrhythmias associated with increased morbidity and mortality . The present study investigated the potential of dofetilide in AF-AFl patients with left ventricular dysfunction to restore and maintain sinus rhythm , which might reduce mortality and hospitalizations . Methods and Results —In the Danish Investigations of Arrhythmia and Mortality ON Dofetilide ( DIAMOND ) studies , 506 patients were in AF-AFl at baseline . Over the course of study , cardioversion occurred in 148 ( 59 % ) dofetilide- and 86 ( 34 % ) placebo-treated patients . In these patients , the probability of maintaining sinus rhythm for 1 year was 79 % with dofetilide versus 42 % with placebo ( P Dofetilide had no effect on all-cause mortality , but restoration and maintenance of sinus rhythm was associated with significant reduction in mortality ( risk ratio [ RR ] , 0.44 ; 95 % CI , 0.30 to 0.64;P dofetilide therapy was associated with a significantly lower risk ratio versus placebo for either all-cause ( RR , 0.70 ; 95 % CI , 0.56 to 0.89;P ≤0.005 ) or congestive heart failure ( RR , 0.69 ; 95 % CI , 0.51 to 0.93;P ≤0.02 ) rehospitalization . Conclusions —Dofetilide is safe and increases the probability of obtaining and maintaining sinus rhythm in patients with structural heart disease . The present study suggests that restoration of sinus rhythm is associated with improved survival",
"BACKGROUND Dronedarone is a novel antiarrhythmic drug with electrophysiological properties that are similar to those of amiodarone , but it does not contain iodine and thus does not cause iodine-related adverse reactions . Therefore , it may be of value in the treatment of patients with heart failure . METHODS In a multicenter study with a double-blind design , we planned to r and omly assign 1000 patients who were hospitalized with symptomatic heart failure and severe left ventricular systolic dysfunction to receive 400 mg of dronedarone twice a day or placebo . The primary end point was the composite of death from any cause or hospitalization for heart failure . RESULTS After inclusion of 627 patients ( 310 in the dronedarone group and 317 in the placebo group ) , the trial was prematurely terminated for safety reasons , at the recommendation of the data and safety monitoring board , in accordance with the board 's predefined rules for termination of the study . During a median follow-up of 2 months , 25 patients in the dronedarone group ( 8.1 % ) and 12 patients in the placebo group ( 3.8 % ) died ( hazard ratio in the dronedarone group , 2.13 ; 95 % confidence interval [ CI ] , 1.07 to 4.25 ; P=0.03 ) . The excess mortality was predominantly related to worsening of heart failure--10 deaths in the dronedarone group and 2 in the placebo group . The primary end point did not differ significantly between the two groups ; there were 53 events in the dronedarone group ( 17.1 % ) and 40 events in the placebo group ( 12.6 % ) ( hazard ratio , 1.38 ; 95 % CI , 0.92 to 2.09 ; P=0.12 ) . More increases in the creatinine concentration were reported as serious adverse events in the dronedarone group than in the placebo group . CONCLUSIONS In patients with severe heart failure and left ventricular systolic dysfunction , treatment with dronedarone was associated with increased early mortality related to the worsening of heart failure . ( Clinical Trials.gov number , NCT00543699 .",
"BACKGROUND Electrical isolation of the pulmonary veins by catheter ablation is an emerging treatment modality for the treatment of atrial fibrillation ( AF ) and is increasingly used in patients with heart failure . METHODS The catheter ablation versus st and ard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation trial ( CASTLE-AF ) is a r and omized evaluation of ablative treatment of atrial fibrillation in patients with left ventricular dysfunction . The primary endpoint is the composite of all-cause mortality or worsening of heart failure requiring unplanned hospitalization using a time to first event analysis . Secondary endpoints are all-cause mortality , cardiovascular mortality , cerebrovascular accidents , worsening of heart failure requiring unplanned hospitalization , unplanned hospitalization due to cardiovascular reason , all-cause hospitalization , quality of life , number of therapies ( shock and antitachycardia pacing ) delivered by the implantable cardioverter-defibrillator ( ICD ) , time to first ICD therapy , number of device-detected ventricular tachycardia and ventricular fibrillation episodes , AF burden , AF free interval , left ventricular function , exercise tolerance , and percentage of right ventricular pacing . CASTLE-AF will r and omize 420 patients for a minimum of 3 years at 48 sites in the United States , Europe , Australia , and South America",
"BACKGROUND Sudden death from cardiac causes remains a leading cause of death among patients with congestive heart failure ( CHF ) . Treatment with amiodarone or an implantable cardioverter-defibrillator ( ICD ) has been proposed to improve the prognosis in such patients . METHODS We r and omly assigned 2521 patients with New York Heart Association ( NYHA ) class II or III CHF and a left ventricular ejection fraction ( LVEF ) of 35 percent or less to conventional therapy for CHF plus placebo ( 847 patients ) , conventional therapy plus amiodarone ( 845 patients ) , or conventional therapy plus a conservatively programmed , shock-only , single-lead ICD ( 829 patients ) . Placebo and amiodarone were administered in a double-blind fashion . The primary end point was death from any cause . RESULTS The median LVEF in patients was 25 percent ; 70 percent were in NYHA class II , and 30 percent were in class III CHF . The cause of CHF was ischemic in 52 percent and nonischemic in 48 percent . The median follow-up was 45.5 months . There were 244 deaths ( 29 percent ) in the placebo group , 240 ( 28 percent ) in the amiodarone group , and 182 ( 22 percent ) in the ICD group . As compared with placebo , amiodarone was associated with a similar risk of death ( hazard ratio , 1.06 ; 97.5 percent confidence interval , 0.86 to 1.30 ; P=0.53 ) and ICD therapy was associated with a decreased risk of death of 23 percent ( 0.77 ; 97.5 percent confidence interval , 0.62 to 0.96 ; P=0.007 ) and an absolute decrease in mortality of 7.2 percentage points after five years in the overall population . Results did not vary according to either ischemic or nonischemic causes of CHF , but they did vary according to the NYHA class . CONCLUSIONS In patients with NYHA class II or III CHF and LVEF of 35 percent or less , amiodarone has no favorable effect on survival , whereas single-lead , shock-only ICD therapy reduces overall mortality by 23 percent",
"Background The incidence of thromboembolism and the benefit of anticoagulation in congestive heart failure are controversial . Methods and Results The data base provided by the Veterans Affairs Vasodilator-Heart Failure Trials ( V-HeFT I and II ) was examined retrospectively to address these issues . In V-HeFT I , 642 men with heart failure were followed an average of 2.28 years , providing 1,464 patient-years of follow-up . In V-HeFT II , 804 men were followed an average of 2.56 years , with 2,061 patient-years of follow-up . Mean left ventricular ejection fraction was 30%o in V-HeFT I and 29 % in V-HeFT II . Functional capacity was at the interface of classes II and III with a peak exercise oxygen consumption of 14.7 mL. kg -1 . min-1 in V-HeFT I and 13.7 mL- kg-1 min-1 in V-HeFT II . Warfarin and antiplatelet agents were administered at the discretion of individual investigators . The incidence of all thromboembolic events during 1,068 patient-years without warfarin in V-HeFIT I was 2.7/100 patient-years and during 1,188 patient-years in V-HeFT II was 2.1/100 patient-years and was not reduced in patients treated with warfarin . Patients experiencing events had a lower peak exercise oxygen consumption ( P mean ejection fraction ( P=0.10 in V-HeFT I and P=0.07 in V-HeFT II ) . Atrial fibrillation was not associated with an increased risk of thromboembolic events . Conclusions The incidence of thromboembolism and stroke in class II or III congestive heart failure is not high and may not be significantly reduced with warfarin treatment . Routine use of anticoagulants in patients with heart failure may not be justified",
"Abstract Background : R and omized control trials and observational studies show high- quality warfarin therapy leads to safe and effective stroke prophylaxis . In usual community practice , patient , physician and health care system factors are barriers to optimal anticoagulation . We examined the predictive relationship between inpatient and outpatient INR values in chronic non-valvular atrial fibrillation ( AF ) patients hospitalized for ischemic stroke ( S ) , bleed ( B ) and control events ( C ) in usual community practice . Methods : This nested case-control analysis identified AF patients hospitalized for S , B and C using medical and pharmacy cl aims spanning 4.5 years ( ‘ 98–‘03 ) and validating diagnosis with chart abstract ion . AF was defined as 2 medical cl aims for AF ≥ 42 days apart with a related prescription cl aim for warfarin . INRs from both outpatient and inpatient setting s were used to yield a continuous history of coagulation status . Time-in-therapeutic-range ( TTR ) was calculated by Rosendaal ’s linear interpolation method . Correlation of inpatient and prognostic utility of last outpatient INRs was tested with S or B hospitalizations using univariate and multivariate logistic regression . Results : Overall , 614 hospitalizations ( means : age 73.9 , CHADS2 = 3.24 ; 52 % male ) included S ( n = 98 ) , B ( n = 101 ) and C ( n = 415 ) events . Average TTR was 28.6 % ( 49.4 % at INR 3.0 ) . First INR on admission ( INR 3.0 ) was associated with S and B hospitalizations ( OR-adjusted [ 95%CI ] , 1.68 [ 1.04–2.73 ] and 1.72 [ 1.02–2.90 ] ) , respectively . Last outpatient INR 3.0 was not associated with B ( OR-adjusted [ 95%CI ] , 1.25 [ 0.67–2.32 ] ) . Last outpatient INR measurement occurred at 28 , 22 and 24 days ( median ; S , B & C , respectively ) before hospitalization . Conclusion : Patients were observed within therapeutic range less than 30 % of their time on warfarin . While inpatient INRs were clearly associated with both ischemic stroke and bleed events , last outpatient INR before event was not predictive",
"BACKGROUND Pulmonary-vein isolation is increasingly being used to treat atrial fibrillation in patients with heart failure . METHODS In this prospect i ve , multicenter clinical trial , we r and omly assigned patients with symptomatic , drug-resistant atrial fibrillation , an ejection fraction of 40 % or less , and New York Heart Association class II or III heart failure to undergo either pulmonary-vein isolation or atrioventricular-node ablation with biventricular pacing . All patients completed the Minnesota Living with Heart Failure question naire ( scores range from 0 to 105 , with a higher score indicating a worse quality of life ) and underwent echocardiography and a 6-minute walk test ( the composite primary end point ) . Over a 6-month period , patients were monitored for both symptomatic and asymptomatic episodes of atrial fibrillation . RESULTS In all , 41 patients underwent pulmonary-vein isolation , and 40 underwent atrioventricular-node ablation with biventricular pacing ; none were lost to follow-up at 6 months . The composite primary end point favored the group that underwent pulmonary-vein isolation , with an improved question naire score at 6 months ( 60 , vs. 82 in the group that underwent atrioventricular-node ablation with biventricular pacing ; P 6-minute-walk distance ( 340 m vs. 297 m , P ejection fraction ( 35 % vs. 28 % , P underwent pulmonary-vein isolation , 88 % of patients receiving antiarrhythmic drugs and 71 % of those not receiving such drugs were free of atrial fibrillation at 6 months . In the group that underwent pulmonary-vein isolation , pulmonary-vein stenosis developed in two patients , pericardial effusion in one , and pulmonary edema in another ; in the group that underwent atrioventricular-node ablation with biventricular pacing , lead dislodgment was found in one patient and pneumothorax in another . CONCLUSIONS Pulmonary-vein isolation was superior to atrioventricular-node ablation with biventricular pacing in patients with heart failure who had drug-refractory atrial fibrillation . ( Clinical Trials.gov number , NCT00599976 .",
"INTRODUCTION We compared the efficacy and safety of amiodarone and dronedarone in patients with persistent atrial fibrillation ( AF ) . METHODS Five hundred and four amiodarone-naïve patients were r and omized to receive dronedarone 400 mg bid ( n = 249 ) or amiodarone 600 mg qd for 28 days then 200 mg qd ( n = 255 ) for at least 6 months . Primary composite endpoint was recurrence of AF ( including unsuccessful electrical cardioversion , no spontaneous conversion and no electrical cardioversion ) or premature study discontinuation . Main safety endpoint ( MSE ) was occurrence of thyroid- , hepatic- , pulmonary- , neurologic- , skin- , eye- , or gastrointestinal-specific events , or premature study drug discontinuation following an adverse event . RESULTS Median treatment duration was 7 months . The primary composite endpoint was 75.1 and 58.8 % with dronedarone and amiodarone , respectively , at 12 months ( hazard ratio [ HR ] 1.59 ; 95 % confidence interval [ CI ] 1.28 - 1.98 ; P AF recurrence with dronedarone compared with amiodarone ( 63.5 vs 42.0 % ) . AF recurrence after successful cardioversion was 36.5 and 24.3 % with dronedarone and amiodarone , respectively . Premature drug discontinuation tended to be less frequent with dronedarone ( 10.4 vs 13.3 % ) . MSE was 39.3 and 44.5 % with dronedarone and amiodarone , respectively , at 12 months ( HR = 0.80 ; 95 % CI 0.60 - 1.07 ; P = 0.129 ) , and mainly driven by fewer thyroid , neurologic , skin , and ocular events in the dronedarone group . CONCLUSION In this short-term study , dronedarone was less effective than amiodarone in decreasing AF recurrence , but had a better safety profile , specifically with regard to thyroid and neurologic events and a lack of interaction with oral anticoagulants",
"Background : Atrial fibrillation ( AF ) and heart failure ( HF ) often coexist . The aim was to investigate whether restoring sinus rhythm ( SR ) could improve cardiac function , symptoms , exercise capacity and quality of life ( QoL ) in patients with chronic heart failure . Methods : Patients with HF and persistent AF receiving guideline -recommended treatments , including anticoagulants , were eligible for the study . Patients were r and omised to either rhythm ( treated with amiodarone for at least 3 months prior to attempting biphasic external cardioversion and continued amiodarone long-term if SR was restored ) or rate control . Anticoagulants were continued throughout the study regardless of rhythm , unless contraindications developed . Both groups were treated with beta blockers and /or digoxin to reduce the heart rate to 80 bpm at rest and walking . Symptoms , walk distance ( 6-minute corridor walk test , 6MWT ) , QoL and cardiac function were assessed at baseline and 1 year . Results : 61 patients with HF and persistent AF ( median duration 14 months ( IQR 5 to 32 ) ) were r and omly assigned to a rate or rhythm control strategy . Of patients assigned to rhythm control ( n = 30 ) , 66 % were in SR at 1 year , and 90 % of those assigned to rate control ( n = 31 ) achieved the heart rate target . At 1 year , NYHA class ( p = 0.424 ) and 6MWT distance ( p = 0.342 ) were similar between groups but patients assigned to rhythm control had improved LV function ( p = 0.014 ) , NT-proBNP concentration ( p = 0.046 ) and QoL ( p = 0.019 ) compared with those assigned to rate control . Greatest improvement was seen in patients in whom SR was maintained . Conclusion : Restoring SR in patients with AF and heart failure may improve QoL and LV function when compared with a strategy of rate control",
"1 . Rapid ventricular rate ( VR ) and rhythm irregularity during atrial fibrillation ( AF ) impair cardiac performance . Although digoxin has been widely used in patients with AF , its efficacy for the control of VR and rhythm irregularity is unsatisfactory . Whether low‐dose amiodarone is more effective remains unclear",
"The safety and efficacy of diltiazem were compared with digoxin maintenance therapy for control of ventricular response in 19 patients with chronic atrial fibrillation . The relationship between drug plasma levels and cardiovascular effects was also investigated . After 7 days of combined therapy with diltiazem ( 60 mg three times a day in 10 patients and four times a day in nine patients ) and digoxin ( 0.125 mg/day in two patients and 0.250 mg/day in 17 patients ) , the 24-hour mean heart rate derived from ambulatory ECG recording was reduced by 16.3 % in comparison with digoxin therapy alone ; the serum digoxin level was not significantly changed ( 1.06 + /- 0.43 vs 1.05 + /- 0.61 ng/ml ) . After a st and ardized bicycle exercise test ( 50 watts for 3 minutes ) , maximal heart rate was reduced by 19.9 % , diastolic blood pressure was decreased by 8.9 % , and systolic pressure-rate product was decreased by 12.5 % . Diltiazem plasma levels ( mean 120.9 + /- 63.3 ng/ml ) were linearly correlated with percentage variations in maximal heart rate , diastolic blood pressure , systolic blood pressure , and pressure-rate product during exercise . Eighteen patients in succession discontinued digoxin therapy ; after 14 days of diltiazem alone , the 24-hour mean heart rate returned to control values of digoxin therapy , whereas maximal heart rate and pressure-rate product during exercise were significantly reduced ( -17.2 % and -14.1 % , respectively ) , with no changes in blood pressure . Diltiazem plasma levels ( 135.0 + /- 83.2 ng/ml ) showed a linear correlation with the percentage of reduction in maximal heart rate . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVES The purpose of this study was to determine quality of life ( QOL ) and exercise performance ( EP ) in patients with persistent atrial fibrillation ( AF ) converted to sinus rhythm ( SR ) compared with those remaining in or reverting to AF . BACKGROUND Restoration of SR in patients with AF improving QOL and EP remains controversial . METHODS Patients with persistent AF were r and omized double-blind to amiodarone , sotalol , or placebo . Those not achieving SR at day 28 were cardioverted and classified into SR or AF groups at 8 weeks ( n = 624 ) and 1 year ( n = 556 ) . The QOL ( SF-36 ) , symptom checklist ( SCL ) , specific activity scale ( SAS ) , AF severity scale ( AFSS ) , and EP were assessed . RESULTS Favorable changes were seen in SR patients at 8 weeks in physical functioning ( p physical role limitations ( p = 0.03 ) , general health ( p = 0.002 ) , and vitality ( p general health ( p = 0.007 ) and social functioning ( p = 0.02 ) . Changes in the scores for SCL severity ( p = 0.01 ) , functional capacity ( p = 0.003 ) , and AFSS symptom burden ( p SCL severity ( p AF symptom burden ( p EP in SR versus AF was greater from baseline to 8 weeks ( p = 0.01 ) and to 1 year ( p = 0.02 ) . The EP correlated with physical functioning and functional capacity except in the AF group at 1 year . CONCLUSIONS In patients with persistent AF , restoration and maintenance of SR was associated with improvements in QOL measures and EP . There was a strong correlation between QOL measures and EP",
"BACKGROUND The present study aim ed to determine whether quality of life ( QOL ) in permanent atrial fibrillation ( AF ) patients would be improved by monotherapy with beta-blocker ( BB ) or calcium antagonist ( CAA ) as compared with digitalis . METHODS AND RESULTS Twenty-nine patients with permanent AF under digitalis were r and omized into BB ( bisoprolol , atenolol or metoprolol ) or CAA ( verapamil ) monotherapy treatment group . Twenty-five were men and the mean age was 67+/-8 years . After the assigned monotherapy , 12 patients received the other monotherapy in a cross-over fashion . Under each treatment , efficacy of rate control was determined by Holter electrocardiogram ( ECG ) , treadmill testing and QOL question naire ( Short Form-36 ( SF-36 ) and Quality of Life of Atrial Fibrillation ( AFQLQ ) ) , and compared with the baseline digitalis treatment . CAA significantly increased mean and minimum heart rate ( HR ) in Holter ECG as compared with digitalis , whereas BB increased only minimum HR . Exercise duration in treadmill testing was significantly prolonged by CAA treatment , although it only tended to be prolonged by BB treatment . CAA but not BB improved role function-physical score of SF-36 , and frequency and severity of symptoms of AFQLQ . CONCLUSION These results indicate that CAA is preferable to digitalis when monotherapy is selected for short-term improvement of QOL and exercise tolerance in patients with permanent AF",
"In severe heart failure many deaths are sudden and are presumed to be due to ventricular arrhythmias . The GESICA trial evaluated the effect of low-dose amiodarone on two-year mortality in patients with severe heart failure . Our prospect i ve multicentre trial included 516 patients on optimal st and ard treatment for heart failure . Patients were r and omised to 300 mg/day amiodarone ( 260 ) or to st and ard treatment ( 256 ) . Intention-to-treat analysis showed 87 deaths in the amiodarone group ( 33.5 % ) compared with 106 in the control group ( 41.4 % ) ( risk reduction 28 % ; 95 % CI 4%-45 % ; log rank test p = 0.024 ) . There were reductions in both sudden death ( risk reduction 27 % ; p = 0.16 ) and death due to progressive heart failure ( risk reduction 23 % ; p = 0.16 ) . Fewer patients in the amiodarone group died or were admitted to hospital due to worsening heart failure ( 119 versus 149 in the control group ; risk reduction 31 % ; 95 % CI 13 - 46 % ; p = 0.0024 ) . The decrease in mortality and hospital admission was present in all subgroups examined and independent of the presence of non-sustained ventricular tachycardia . Side-effects were reported in 17 patients ( 6.1 % ) ; amiodarone was withdrawn in 12 . Low-dose amiodarone proved to be an effective and reliable treatment , reducing mortality and hospital admission in patients with severe heart failure independently of the presence of complex ventricular arrhythmias",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"STUDY OBJECTIVES The relative risks and benefits of strategies of rate control vs rhythm control in patients with atrial fibrillation ( AF ) remain to be fully explored . DESIGN The How to Treat Chronic Atrial Fibrillation ( HOT CAFE ) Polish trial was design ed to evaluate in a r and omized , multicenter , and prospect i ve manner the feasibility and long-term outcomes of rate control vs rhythm control strategies in patients with persistent AF . PATIENTS Our study population comprised 205 patients ( 134 men and 71 women ; mean [ + /- SD ] age , 60.8 + /- 11.2 years ) with a mean AF duration of 273.7 + /- 112.4 days . The mean observation period was 1.7 + /- 0.4 years . One hundred one patients were r and omly assigned to the rate control group and received rate-slowing therapy guided by repeated 24-h Holter monitoring . Direct current cardioversion and atrioventricular junctional ablation with pacemaker placement were alternative nonpharmacologic strategies for patients with tachycardia that was resistant to medical therapy . One hundred four patients were r and omized to sinus rhythm restoration and maintenance using serial cardioversion supported by a predefined stepwise antiarrhythmic drug regimen ( ie , disopyramide , propafenone , sotalol , and amiodarone ) . In both groups , thromboembolic prophylaxis followed current guidelines . MEASUREMENTS AND RESULTS At the end of follow-up , 63.5 % of patients in the rhythm control arm remained in sinus rhythm . No significant differences in the composite end point ( ie , all-cause mortality , number of thromboembolic events , or major bleeding ) were found between the rate control group and the rhythm control group ( odds ratio , 1.98 ; 95 % confidence interval , 0.28 to 22.3 ; p > 0.71 ) . The incidence of hospital admissions was much lower in the rate control arm ( 12 % vs 74 % , respectively ; p New York Heart Association functional class improved in both study groups , while mean exercise tolerance , as measured by the maximal treadmill workload , improved only in the rhythm control group ( 5.2 + /- 5.1 vs 7.6 + /- 3.3 metabolic equivalents , respectively ; p mean left ventricular fractional shortening ( 29 + /- 7 % vs 31 + /- 7 % , respectively ; p pulmonary embolism occurred in the rate control group despite oral anticoagulation therapy , while three patients in the rhythm control arm of the study experienced ischemic strokes ( not significant ) . CONCLUSIONS The Polish HOT CAFE study revealed no significant differences in major end points between the rate control group and the rhythm control group",
"OBJECTIVES This study was design ed to compare two treatment strategies in patients with atrial fibrillation(AF ) : rhythm-control ( restoration and maintenance of sinus rhythm ) and rate-control ( pharmacologic or invasive rate-control and anticoagulation ) . BACKGROUND Atrial fibrillation is the most common arrhythmia . It is unclear whether a strategy of rhythm- or rate-control is better in terms of mortality , morbidity , and quality of life . METHODS The Strategies of Treatment of Atrial Fibrillation ( STAF ) multicenter pilot trial r and omized 200 patients ( 100 per group ) with persistent AF to rhythm- or rate-control . The combined primary end point was a combination of death , cardiopulmonary resuscitation , cerebrovascular event , and systemic embolism . RESULTS After 19.6 + /- 8.9 months ( range 0 to 36 months ) there was no difference in the primary end point between rhythm-control ( 9/100 ; 5.54%/year ) and rate-control ( 10/100 ; 6.09%/year ; p = 0.99 ) . The percentage of patients in sinus rhythm in the rhythm-control group after up to four cardioversions during the follow-up period ( rate-control group ) was 23 % ( 0 % ) at 36 months . Eighteen primary end points occurred in atrial fibrillation ; only one occurred in sinus rhythm ( p = 0.049 ) . CONCLUSIONS The STAF pilot study showed no differences between the two treatment strategies in all end points except hospitalizations . These data suggest that there was no benefit in attempting rhythm-control in these patients with a high risk of arrhythmia recurrence . It remains unclear whether the results in the rhythm-control group would have been better if sinus rhythm had been maintained in a higher proportion of patients , as all but one end point occurred during AF",
"BACKGROUND The impact of atrial fibrillation ( AF ) and its treatment on health-related quality of life ( QOL ) is not well understood . We assessed QOL in patients with symptomatic AF participating in the Canadian Trial of Atrial Fibrillation . METHODS Self-report QOL question naires including the Short-Form-36 ( SF-36 ) , symptom checklist ( SCL ) and AF Severity Scale ( AFSS ) were completed at baseline and 3 , and 12 months after r and omization . RESULTS The study group was aged 65 + /- 10 years and 59 % were male . By design , 50 % of patients were r and omized to amiodarone ( n = 132 ) , 25 % to sotalol ( n = 66 ) , and 25 % to propafenone ( n = 66 ) . Most patients had normal left ventricular function ( 89 % ) . Physical ( 41.9 + /- 9.3 to 43.7 + /- 9.2 , P = .001 ) and mental health ( 47.5 + /- 10.5 to 49.0 + /- 9.8 , P = .023 ) summary measures from the SF-36 improved significantly from baseline to 3 months . Arrhythmia symptom frequency and severity ( SCL ) also improved markedly from baseline to 3 months ( symptom frequency 20.4 + /- 9.4 to 16.2 + /- 9.5 and symptom severity 16.7 + /- 8.2 to 12.9 + /- 7.4 , both P QOL improvements were not significantly different among the groups r and omized to amiodarone , sotalol , or propafenone . However , patients with no symptomatic recurrences of AF had higher scores at 3 months on measures of global well-being than those with recurrences in the first 3 months ( 7.4 + /- 1.8 vs 6.9 + /- 1.8 , P QOL changes from the 3 to 12 month assessment . CONCLUSION In patients with symptomatic AF , QOL improves after treatment , independent of the specific drug used for treatment . This is especially true for patients in whom treatment prevents AF recurrence",
"BACKGROUND Maintenance of sinus rhythm is the main therapeutic goal in patients with atrial fibrillation . However , recurrences of atrial fibrillation and side effects of antiarrhythmic drugs offset the benefits of sinus rhythm . We hypothesized that ventricular rate control is not inferior to the maintenance of sinus rhythm for the treatment of atrial fibrillation . METHODS We r and omly assigned 522 patients who had persistent atrial fibrillation after a previous electrical cardioversion to receive treatment aim ed at rate control or rhythm control . Patients in the rate-control group received oral anticoagulant drugs and rate-slowing medication . Patients in the rhythm-control group underwent serial cardioversions and received antiarrhythmic drugs and oral anticoagulant drugs . The end point was a composite of death from cardiovascular causes , heart failure , thromboembolic complications , bleeding , implantation of a pacemaker , and severe adverse effects of drugs . RESULTS After a mean ( + /-SD ) of 2.3+/-0.6 years , 39 percent of the 266 patients in the rhythm-control group had sinus rhythm , as compared with 10 percent of the 256 patients in the rate-control group . The primary end point occurred in 44 patients ( 17.2 percent ) in the rate-control group and in 60 ( 22.6 percent ) in the rhythm-control group . The 90 percent ( two-sided ) upper boundary of the absolute difference in the primary end point was 0.4 percent ( the prespecified criterion for noninferiority was 10 percent or less ) . The distribution of the various components of the primary end point was similar in the rate-control and rhythm-control groups . CONCLUSIONS Rate control is not inferior to rhythm control for the prevention of death and morbidity from cardiovascular causes and may be appropriate therapy in patients with a recurrence of persistent atrial fibrillation after electrical cardioversion",
"BACKGROUND Uncertainty persists about the safety and efficacy of amiodarone for the management of heart failure . METHODS AND RESULTS We r and omized 3029 patients with chronic heart failure to receive carvedilol or metoprolol and followed patients for a median of 58 months . One hundred fifty-five of 1466 patients in New York Heart Association ( NYHA ) Class II and 209 of 1563 in Class III or IV received amiodarone at baseline . Persistence with amiodarone treatment was high and 66 % received amiodarone after 4 years . During follow-up , 38.7 % and 58.9 % of patients receiving amiodarone in NYHA Classes II and III + IV died versus 26.2 % and 43.3 % not receiving amiodarone ( P increased risk of death due to circulatory failure ( HR 2.4 , CI 1.9 - 3.1 , P amiodarone . Sudden death was not different ( HR 1.07 , CI 0.8 - 1.4 , P = .7 ) . The increased risk was similar across NYHA classes with HR of 1.60 ( CI 1.2 - 2.1 , P amiodarone was associated with an increased risk of death from circulatory failure independent of functional class",
"This study examined the independent relation of health-related quality of life ( HRQL ) to mortality and congestive heart failure (CHF)-related hospitalizations in patients with an ejection fraction of A brief HRQL question naire was administered at baseline to patients r and omized to placebo or enalapril in the Studies of Left Ventricular Dysfunction ( SOLVD ) trial . Participants had an ejection fraction of Baseline assessment of HRQL predicted mortality and CHF-related hospitalizations in symptomatic and asymptomatic patients r and omized to enalapril and placebo treatment . Domains that were the stronger univariate predictors of mortality and CHF-related hospitalizations were activities of daily living ( relative risk [ RR ] for mortality : 1.163 , p general health ( RR for mortality : 1.205 , p social functioning ( RR for mortality 1.098 , p activities of daily living ( RR for mortality 1.41 , p general health ( RR for mortality 1.21 , p heart failure symptoms ( RR for mortality 1.02 , p mortality and CHF-related hospitalizations after adjustment for ejection fraction , age , treatment , and New York Heart Association classification in patients with an ejection fraction of , r and omized to enalapril and placebo treatment . HRQL provides additional clinical information regarding disease course and outcome that is not captured by traditional indexes of clinical status",
"OBJECTIVE The objective of this prespecified sub study of the AFFIRM study , in which no differences in survival or event rates were found in patients with atrial fibrillation ( AF ) r and omized to either rate control or rhythm control , was to test the None hypothesis that quality of life ( QoL ) is equal with rate- versus rhythm-control treatment strategies in AF . METHODS Fifty-six ( 25 % ) of AFFIRM sites were r and omly selected to recruit AFFIRM patients for the QoL sub study . Instruments used in the QoL assessment were ( 1 ) Perceived Health ; ( 2 ) the Cantril Ladder of Life ; ( 3 ) the Short Form 36 survey ; ( 4 ) the QoL Index ; and ( 5 ) the Symptom Checklist : Frequency and Severity . Data were collected at baseline , 2 months , 12 months , and annually ; data are reported through 4 years of follow-up . RESULTS Baseline characteristics of the AFFIRM QoL patients ( n = 716 ) were generally similar to those of the rest of AFFIRM patients . Quality -of-life scores were similar in rate- and rhythm-control assignment groups at all time points . Quality -of-life scores were similar whether the actual rhythm was sinus or AF . Scores increased from baseline to subsequent time points similarly for both groups ; these improvements were not additive over time . CONCLUSIONS Quality of life was comparable between rate- and rhythm-control treatment strategies . In addition , QoL was similar with sinus rhythm versus AF . Attempts to improve QoL by restoring sinus rhythm will usually be unsuccessful",
"OBJECTIVE Characterization of current morbidity and mortality among heart failure ( HF ) out patients in Galicia ( N.W. Spain ) , together with their main determinants . DESIGN Prospect i ve multicentre study involving 149 primary care physicians . SETTING Primary care physicians selected r and omly from among all ( 1959 ) primary care physicians in Galicia . PATIENTS Clinical and epidemiological information for 1195 out patients with HF were collected in 2006 , with a mean follow-up of 6.5+/-1.5 months . MAIN OUTCOME MEASURES Survival rates were calculated by Cox 's proportional hazard model . RESULTS Mean patient age was 76 years , 48 % were male , 82 % had a history of arterial hypertension , and 32 % ischaemic cardiopathy . Echocardiography had been performed in 67 % , showing preserved systolic function in 61 % . Ninety-two ( 8 % ) died during follow-up [ 74 ( 80 % ) of them from cardiac causes ] , and 313 ( 29 % ) were re-admitted to hospital [ 230 ( 73 % ) of them for cardiac reasons ] . Multivariate analysis identified the following independent predictors of cardiovascular death and /or readmission : ischaemic cardiopathy [ hazard ratio ( HR ) 1.76 , 95 % confidence interval ( CI ) 1.29 - 4.40 ] , stroke ( HR 1.79 , CI 1.18 - 2.73 ) , oedema ( HR 1.49 , CI 1.10 - 2.03 ) , anaemia ( HR 1.66 , CI 1.21 - 2.27 ) , deteriorated systolic function ( HR 1.62 , CI 1.19 - 2.20 ) , and previous cardiovascular admissions ( HR 2.33 , CI 1.67 - 3.24 ) . Residence in the Barbanza district was identified as an independent predictor of survival free from cardiovascular admission ( HR 0.56 , CI 0.37 - 0.86 ) . CONCLUSION Morbidity and mortality are currently high among Galician HF patients , and their best single predictor is previous hospitalization for cardiovascular reasons",
"BACKGROUND Atrial fibrillation occurs frequently in patients with congestive heart failure and commonly results in clinical deterioration and hospitalization . Sinus rhythm may be maintained with antiarrhythmic drugs , but some of these drugs increase the risk of death . METHODS We studied 1518 patients with symptomatic congestive heart failure and severe left ventricular dysfunction at 34 Danish hospitals . We r and omly assigned 762 patients to receive dofetilide , a novel class III antiarrhythmic agent , and 756 to receive placebo in a double-blind study . Treatment was initiated in the hospital and included three days of cardiac monitoring and dose adjustment . The primary end point was death from any cause . RESULTS During a median follow-up of 18 months , 311 patients in the dofetilide group ( 41 percent ) and 317 patients in the placebo group ( 42 percent ) died ( hazard ratio , 0.95 ; 95 percent confidence interval , 0.81 to 1.11 ) . Treatment with dofetilide significantly reduced the risk of hospitalization for worsening congestive heart failure ( risk ratio , 0.75 ; 95 percent confidence interval , 0.63 to 0.89 ) . Dofetilide was effective in converting atrial fibrillation to sinus rhythm . After one month , 22 of 190 patients with atrial fibrillation at base line ( 12 percent ) had sinus rhythm restored with dofetilide , as compared with only 3 of 201 patients ( 1 percent ) given placebo . Once sinus rhythm was restored , dofetilide was significantly more effective than placebo in maintaining sinus rhythm ( hazard ratio for the recurrence of atrial fibrillation , 0.35 ; 95 percent confidence interval , 0.22 to 0.57 ; P torsade de pointes in the dofetilide group ( 3.3 percent ) as compared with none in the placebo group . CONCLUSIONS In patients with congestive heart failure and reduced left ventricular function , dofetilide was effective in converting atrial fibrillation , preventing its recurrence , and reducing the risk of hospitalization for worsening heart failure . Dofetilide had no effect on mortality",
"BACKGROUND Atrial fibrillation is the most common cardiac arrhythmia , and no current therapy is ideal for control of this condition . Experimental studies suggest that angiotensin II-receptor blockers ( ARBs ) can influence atrial remodeling , and some clinical studies suggest that they may prevent atrial fibrillation . METHODS We conducted a large , r and omized , prospect i ve , placebo-controlled , multicenter trial to test whether the ARB valsartan could reduce the recurrence of atrial fibrillation . We enrolled patients who were in sinus rhythm but had had either two or more documented episodes of atrial fibrillation in the previous 6 months or successful cardioversion for atrial fibrillation in the previous 2 weeks . To be eligible , patients also had to have underlying cardiovascular disease , diabetes , or left atrial enlargement . Patients were r and omly assigned to receive valsartan or placebo . The two primary end points were the time to a first recurrence of atrial fibrillation and the proportion of patients who had more than one recurrence of atrial fibrillation over the course of 1 year . RESULTS A total of 1442 patients were enrolled in the study . Atrial fibrillation recurred in 371 of the 722 patients ( 51.4 % ) in the valsartan group , as compared with 375 of 720 ( 52.1 % ) in the placebo group ( adjusted hazard ratio , 0.97 ; 96 % confidence interval [ CI ] , 0.83 to 1.14 ; P=0.73 ) . More than one episode of atrial fibrillation occurred in 194 of 722 patients ( 26.9 % ) in the valsartan group and in 201 of 720 ( 27.9 % ) in the placebo group ( adjusted odds ratio , 0.89 ; 99 % CI , 0.64 to 1.23 ; P=0.34 ) . The results were similar in all predefined subgroups of patients , including those who were not receiving angiotensin-converting-enzyme inhibitors . CONCLUSIONS Treatment with valsartan was not associated with a reduction in the incidence of recurrent atrial fibrillation . ( Clinical Trials.gov number , NCT00376272 .",
"Post hoc analyses of the Digitalis Investigation Group ( DIG ) trial indicate that digoxin at low ( 0.5 to 0.9 ng/ml ) serum digoxin concentration ( SDC ) reduces mortality , which is eliminated at higher ( > or=1 ng/ml ) SDC , and that low-dose digoxin ( patients with ambulatory chronic systolic and diastolic heart failure ( HF ) ( n = 7,788 ) in normal sinus rhythm receiving angiotensin-converting enzyme inhibitors and diuretics were r and omized to receive placebo ( n = 3,899 ) or digoxin ( n = 3,889 ) . The median dose of digoxin ( 0.25 mg/day ) and the target SDC ( 0.8 to 2.5 ng/ml ) were higher than what are currently recommended , which in part may explain the lack of long-term mortality benefit of digoxin in the DIG trial . To test this hypothesis , we examined the effect of digoxin on short-term outcomes ; 1-year all-cause mortality occurred in 392 and 448 patients respectively in the digoxin and placebo groups ( hazard ratio for digoxin 0.87 , 95 % confidence interval [ CI ] 0.76 to 0.995 , p = 0.043 ) . Respective hazard ratios for cardiovascular and HF deaths were 0.87 ( 95 % CI 0.76 to 1.01 , p = 0.072 ) and 0.66 ( 95 % CI 0.52 to 0.85 , p = 0.001 ) . All-cause hospitalization occurred in 1,411 and 1,529 patients receiving digoxin and placebo respectively ( hazard ratio 0.89 , 95 % CI 0.83 to 0.96 , p = 0.002 ) . Respective hazard ratios for cardiovascular and HF hospitalizations were 0.82 ( 95 % CI 0.75 to 0.89 , p digoxin reduced 1-year mortality and hospitalization in patients with chronic HF receiving angiotensin-converting enzyme inhibitors and diuretics . R and omized clinical trials are needed to determine the effect of low-dose digoxin in contemporary patients with chronic HF"
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Background Both the US FDA and the European Medicines Agency ( EMA ) have approved aripiprazole for use in adolescents for specific indications . Given the assumed favorable side-effect profile of aripiprazole , its use in children and adolescents has increased for both official and off-label indications ( anxiety disorders , eating disorders , personality disorders ) . However , several cases of children and adolescents with new-onset extrapyramidal symptoms ( EPS ) after commencing treatment with aripiprazole have been reported , and a more systematic appraisal of this possible risk is lacking . Objective We conducted a systematic review and a meta- analysis to assess the evidence for acute EPS ( acute dystonia , akathisia , Parkinsonism ) associated with the use of aripiprazole in children and adolescents . Method We search ed the MEDLINE and Embase data bases ( 2003–10 April 2016 ) for clinical trials in pediatric patients ( aged 0–18 years ) using the keywords ‘ aripiprazole ’ ( regardless of the formulation ) and ‘ extrapyramidal symptoms ’ . We evaluated the abstract s of papers using the following exclusion criteria : ( 1 ) study design : case report , letter to the editor , editorial , or poster presentation data ; ( 2 ) unrelated PICOS ( population , intervention , comparators , outcomes , study ) structure . We performed a meta- analysis , in which we used effect sizes with 95 % confidence intervals ( CIs ) . To examine the homogeneity of the effect size distribution , we used a Q-statistic . When we observed heterogeneity in effect sizes , we assessed the possible influence of moderator variables ( age and sex , mean dose , study duration , and method of measuring EPS incidence ) and evaluated the suitability of either a fixed or a r and om model . Finally , we assessed the incidence of EPS in children and adolescents treated with aripiprazole compared with placebo . Results An initial search via PubMed and Embase yielded 328 hits . A manual search of the reference lists of review papers revealed seven additional relevant articles . We included 41 studies , with 2114 pediatric patients , in the meta- analysis . For the analysis of the mean incidence of EPS , data were provided by 24 studies , with a total of 1446 pediatric patients . Meta- analysis revealed a mean EPS incidence of 17.1 % ( 95 % CI 0.128–0.223 ) . In terms of the incidence of various extrapyramidal side effects , overall , no significant effects of age , sex , mean dose , study duration , or measuring method could be demonstrated . The side effects ‘ EPS ’ , ‘ parkinsonism ’ , and ‘ tremor ’ were significantly more common in children and adolescents treated with aripiprazole than in those treated with placebo . Conclusion Our meta- analysis provides evidence for a non-negligible incidence of acute EPS in children and adolescents treated with aripiprazole . Although the study has several limitations and further investigation is needed , these findings may help clinicians make more balanced treatment choices and more closely monitor the use of this drug in youth
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"In this paper , we review and discuss ten common method ological mistakes found in retrospective chart review s. The retrospective chart review is a widely applicable research methodology that can be used by healthcare disciplines as a means to direct subsequent prospect i ve investigations . In many cases in this review , we have also provided suggestions or accessible re sources that research ers can apply as a “ best practice s ” guide when planning , conducting , or review ing this investigative method",
"Rationale Fragile X syndrome ( FXS ) is the most common inherited form of developmental disability and most common single gene cause of autism . Persons with FXS frequently exhibit irritable behavior marked by aggression , self-injury , and severe tantrums . Despite frequent clinical use of atypical antipsychotic drugs to target this behavioral cluster , no systematic trials to date have assessed the efficacy and safety of these drugs in persons with FXS . Methods We conducted a prospect i ve open-label 12-week trial of aripiprazole in 12 persons aged 6–25 years ( mean age , 14.3 years ) with FXS who were free of concomitant psychoactive drugs . Results Aripiprazole use ( mean dose , 9.8 mg/day ) was associated with treatment response ( defined by a Clinical Global Impressions-Improvement scale score of much improved or very much improved and a ≥25 % improvement on the Aberrant Behavior Checklist-Irritability subscale ) in 10 of 12 ( 87 % ) persons . Two individuals ( 13 % ) discontinued aripiprazole prior to study completion due to adverse events . One discontinuation was due to akathisia , mild drooling , and mild tiredness and the other due to moderate tiredness and moderate drooling . No significant changes in vital signs including weight or laboratory measures occurred during treatment with aripiprazole . Conclusions Aripiprazole was generally safe and well tolerated and was associated with significant improvement in irritable behavior . Given these findings , a double-blind , placebo-controlled study of aripiprazole in FXS is warranted",
"INTRODUCTION Retrospective research has become largely undervalued and underutilized in child and adolescent psychiatry with the increasing singular focus on r and omized control trials , despite the wealth of clinical ly relevant data available in historical medical records . In this paper a systematic and scientific approach to chart review research methodology for psychiatry is described . METHOD Informed by available literature , a method ological stepwise approach for retrospective chart review was developed . RESULTS A nine step method aim ed at maximizing benefits and minimizing limitations is discussed . CONCLUSIONS Retrospective chart review is an important methodology with distinct advantages and has the potential to provide psychiatry with valuable research opportunities . This method of study should not be lost in the field of psychiatry",
"OBJECTIVE The aim of this study was to conduct a prospect i ve safety and tolerability study of aripiprazole for the treatment of tics in children and adolescents with Tourette 's disorder ( TD ) . METHOD Eleven subjects ( 10 males ) with TD ( age 9 - 19 years , mean 13.36 , st and ard deviation [ SD ] 3.33 ) who did not respond or were unable to tolerate previous tic medication were treated with aripiprazole in an open-label , flexible-dosing study over 10 weeks . Tic severity was rated using the Yale Global Tic Severity Scale ( YGTSS ) and the Clinical Global Impressions Scale for tics ( CGI-Tics ) at baseline and at follow-up . RESULTS The mean ( + /-SD ) daily dose for aripiprazole was 4.5 + /- 3.0 mg . Mean ( + /-SD ) YGTSS Global Severity scores reduced from 61.82 + /- 13.49 at baseline to 33.73 + /- 15.18 at end point ; mean YGTSS total tic scores reduced from 28.18 + /- 7.74 at baseline to 16.73 + /- 7.54 at end point . Mean ( + /-SD ) CGI-Tic severity scores reduced from 4.45 + /- 0.52 ( moderate-marked ) at baseline to 3.18 + /- 0.60 ( mild ) at end point . On the CGI-Tic improvement scale , 10 ( 91 % ) subjects achieved 1 ( \" very much improved \" ) or 2 ( \" much improved \" ) at end point . Most common adverse effects included appetite increase and weight gain in 5 subjects , mild extrapyramidal effects in 7 subjects , and headaches and tiredness/fatigue in 7 subjects ; 1 subject experienced akathisia and muscle cramps . CONCLUSION Aripiprazole appears to be a safe and tolerable treatment in children and adolescents with TD that appears to reduce tics ; it should be further investigated as a treatment option in controlled trials",
"OBJECTIVE : The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums , aggression , self-injurious behavior , or a combination of these . METHODS : This 8-week , double-blind , r and omized , placebo-controlled , parallel-group study was conducted of children and adolescents ( aged 6–17 years ) with autistic disorder . Patients were r and omly assigned ( 1:1 ) to flexibly dosed aripiprazole ( target dosage : 5 , 10 , or 15 mg/day ) or placebo . Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression – Improvement score ( CGI-I ) . Safety and tolerability were also assessed . RESULTS : Ninety-eight patients were r and omly assigned to receive placebo ( n = 51 ) or aripiprazole ( n = 47 ) . Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8 . Aripiprazole demonstrated significantly greater global improvements than placebo , as assessed by the mean CGI-I score from week 1 through week 8 ; however , clinical ly significant residual symptoms may still persist for some patients . Discontinuation rates as a result of adverse events ( AEs ) were 10.6 % for aripiprazole and 5.9 % for placebo . Extrapyramidal symptom-related AE rates were 14.9 % for aripiprazole and 8.0 % for placebo . No serious AEs were reported . Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8 . CONCLUSIONS : Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated",
" Forty-six patients ( 36 male , mean age 11.9 ± 2.6 ) with a variety of diagnoses and with significant aggressive behavior were treated in an open , non-r and omized fashion with Aripiprazole or Ziprasidone . Patients were diagnosed with the Mini International Neuropsychiatric Interview and the Child/Adolescent Symptom Inventory . The primary outcome measure was the Overt Aggression Scale ( OAS ) . After 2 months , 34 patients were still in treatment . The average improvement of the OAS in these 34 patients was 63 % . Clinical Global Impression-Improvement Scale was 2.1 ± 1.2 . Neither at baseline , nor at 2 months , were there any statistically significant differences between the Aripiprazole and Ziprasidone groups . Sedation was the most common side effect",
"OBJECTIVES This study aim ed to investigate the efficacy and tolerability of aripiprazole , an atypical antipsychotic with dual agonist and antagonist actions toward dopaminergic imbalance and partial serotonin-2A receptor antagonism , for treating children and adolescents with tic disorders . METHOD Twenty-four out patients aged 7 to 18 years with DSM-IV-diagnosed tic disorders were treated with aripiprazole using an open-label , flexible dosing schedule for 8 weeks from January 2005 to August 2006 . The Korean versions of the Yale Global Tic Severity Scale ( YGTSS ) , the Clinical Global Impressions-Improvement scale ( CGI-I ) , and the CGI-Severity of Illness scale ( CGI-S ) scores were used to measure the drug efficacy . Side effects were assessed using an adverse effect checklist , the Extrapyramidal Symptom Rating Scale , height and weight measurements , laboratory tests , and electrocardiograms . RESULTS Aripiprazole was prematurely discontinued in 6 ( 25 % ) of the 24 subjects due to intolerable adverse effects . After a mean of 9.8 + /- 4.8 mg/day of aripiprazole for 8 weeks , there was a 52.8 % reduction in the mean YGTSS Total Tic scores ( from 26.7 + /- 5.5 to 12.6 + /- 7.6 , p CGI-S score was also reduced ( from 5.5 + /- 0.5 to 3.0 + /- 1.4 , p aripiprazole for 2 weeks was also found to reduce tic symptoms significantly ( Total Tic scores decreased from 26.7 + /- 5.5 to 17.9 + /- 8.7 , p unwanted side effects , the most common being hypersomnia ( 37.5 % ) , nausea ( 20.8 % ) , and headache ( 16.6 % ) . CONCLUSION This open-label study suggests that aripiprazole is an efficacious and safe treatment for children and adolescents with tic disorders ",
"OBJECTIVE To examine the short-term efficacy and tolerability of aripiprazole for children and adolescents with Tourette 's disorder . METHOD This 10-week multicenter , double-blind , r and omized , placebo-controlled trial was conducted from August 2008 to April 2010 . Children and adolescents ( aged 6 - 18 years ) with a DSM-IV diagnosis of Tourette 's disorder and a Yale Global Tic Severity Scale total tic score of 22 or more were r and omly assigned ( 1:1 ratio ) to placebo or aripiprazole . The primary outcome measure was mean change from baseline in the total tic score on the Yale Global Tic Severity Scale ( last observation carried forward ) . Assessment s of safety and tolerability included spontaneously reported adverse events , extrapyramidal symptoms , serum prolactin level , metabolic variables , and other laboratory evaluations . RESULTS Of 61 subjects , 89 % completed the study . Patients who received aripiprazole demonstrated a significant reduction from baseline to end of study on the mean ( SD ) total tic score of the Yale Global Tic Severity Scale compared to those who received placebo ( -15.0 [ 8.4 ] and -9.6 [ 8.8 ] , respectively , P=.0196 ) . Response rate on the Tourette 's Syndrome Clinical Global Impression-Improvement was 66 % and 45 % in the aripiprazole and placebo groups , respectively . Mean decrease in the Tourette 's Syndrome Clinical Global Impression-Severity of Illness score was significantly different between the groups ( P=.0321 ) . In general , aripiprazole was well tolerated and there were no early discontinuations due to adverse events . The incidence of treatment-emergent adverse events between the groups was not significantly different ( P=.7550 ) . While aripiprazole decreased serum prolactin concentration ( P mean body weight , body mass index , and waist circumference significantly ( P=.0055 , P=.0142 , and P=.0270 , respectively ) . CONCLUSIONS In comparison with placebo , aripiprazole was efficacious , generally tolerated and safe in the short-term treatment of children and adolescents with Tourette 's disorder . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00706589",
"OBJECTIVE Evaluate the long-term safety and tolerability of aripiprazole in the treatment of irritability in pediatric subjects ( 6 - 17 years ) with autistic disorder . METHOD A 52-week , open-label , flexibly dosed ( 2 - 15 mg/d ) study of the safety and tolerability of aripiprazole in out patients with a DSM-IV-TR diagnosis of autistic disorder who either had completed 1 of 2 antecedent , 8-week r and omized trials or were enrolled de novo ( ie , not treated in the r and omized trials ) . Safety and tolerability measures included incidences of adverse events , extrapyramidal symptoms , weight , metabolic measures , vital signs , and other clinical assessment s. RESULTS Subjects were enrolled between September 2006 and June 2009 . Three hundred thirty subjects entered the treatment phase : 86 de novo , 174 prior aripiprazole , and 70 prior placebo . A total of 199 ( 60.3 % ) subjects completed 52 weeks of treatment . Adverse events were experienced by 286/330 subjects ( 86.7 % ) . Common adverse events included weight increase , vomiting , nasopharyngitis , increased appetite , pyrexia , upper respiratory tract infection , and insomnia . Discontinuations due to adverse events occurred in 35/330 r and omized subjects (10.6%)-most commonly aggression and weight increase . One patient discontinued from the study due to a laboratory-related adverse event ( moderately increased alanine transaminase and aspartate transaminase ) . Nine subjects experienced serious adverse events-most frequently aggression . Extrapyramidal symptoms-related adverse events occurred in 48/330 subjects (14.5%)-most commonly tremor ( 3.0 % ) , psychomotor hyperactivity ( 2.7 % ) , akathisia ( 2.4 % ) , and dyskinesia ( not tardive , 2.4 % ) . At > 9 months ' aripiprazole exposure ( n = 220 ) , mean change in body weight z score was 0.33 and body mass index z score was 0.31 . The percentages of subjects with clinical ly significant fasting metabolic abnormalities at > 9 months were 2 % for glucose , 5 % for total cholesterol , 7 % for low-density lipoprotein cholesterol , 30 % for high-density lipoprotein cholesterol , and 5 % for triglycerides . CONCLUSIONS Aripiprazole was generally safe and well tolerated in the long-term treatment of irritability associated with autistic disorder in pediatric subjects . Weight should be proactively monitored during long-term treatment . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00365859",
"Tourette 's disorder ( TD ) in children and adolescents is frequently co-morbid with attention-deficit/hyperactivity disorder ( ADHD ) . Dopamine-blockers are the first line treatment for TD , whereas dopamine-agonists , such as stimulants , are the gold-st and ard in the treatment of ADHD . These contrasting effects supported concerns about the risk that stimulants for treating ADHD may trigger or worsen co-morbid tics . Aripiprazole , a partial dopamine agonist , acts as an antagonist at dopamine D2 receptors in hyperdopaminergic conditions and displays agonist properties under hypodopaminergic conditions . The present study describes the use of aripiprazole ( 10.0 ± 4.8 mg/day ) in a consecutive group of 28 patients with a primary diagnosis of TD and co-morbid ADHD , combined subtype . The Yale Global Tic Severity Scale ( YGTSS ) and the ADHD-Rating Scale ( ADHD-RS-IV ) were used as primary outcome measures and both significantly improved ( p treatment . Global measures of severity ( Clinical Global Impressions-Severity ) and of functional impairment ( Children 's Global Assessment Scale ) also significantly improved during the treatment ( p At the YGTSS there was a reduction of 42.5 % , in motor tics , of 47.9 % in phonic tics ( 44.7 % for the combined scores ) , and of 32.3 % in tic impairment . Nineteen patients ( 67.9 % ) had a reduction of at least 50 % of the YGTSS score ( motor+phonic tics ) . The improvement at the ADHD-RS-IV score was 22.5 % , 12 patients ( 42.8 % ) presented an improvement of 30 % , but only 2 ( 7.1 % ) an improvement greater than 50 % . Using a logistic regression model , a reduction of at least 30 % in ADHD-RS-IV score was more likely to occur in the obsessive-compulsive disorder co-morbid group . Aripiprazole was well tolerated and none of the patients discontinued medication because of side effects . In summary , aripiprazole result ed in an effective treatment for TD , but it was only moderately effective on co-occurring ADHD symptomatology . Our preliminary data suggest that aripiprazole may represent a possible therapeutic option , among other possible monotherapies addressing both tics and ADHD",
"BACKGROUND The adverse effect profiles of typical and atypical antipsychotics are problematic because of their extrapyramidal and endocrine adverse effects , respectively . METHODS Ten adolescent male patients diagnosed with conduct disorder received aripiprazole in doses of ≤20 mg/d in an open-label , intent-to-treat design to establish and characterize the efficacy of the drug in reducing aggressive behavior . RESULTS Based on clinician and parent observations , aripiprazole was effective in reducing aggressive behavior in adolescent boys . The change in clinician-observed aggression ratings appears to have been driven by a decrease in physical aggression , whereas the change in parent-observed aggression ratings appears to have been driven by a decrease in verbal aggression and aggression against objects and animals . CONCLUSIONS Aripiprazole was an effective and relatively well-tolerated treatment for overall aggression in adolescent males with conduct disorder , in the view of both clinicians and parents . Depending on the observer , aripiprazole improved aggression categorized as physical aggression , verbal aggression , and aggression against objects and animals",
"INTRODUCTION Juvenile bipolar disorder ( JBD ) is a highly impairing chronic mental health condition that affects children and adolescents ' overall functioning . Comorbidity with attention-deficit/hyperactivity disorder ( ADHD ) is extremely prevalent and may determine worse response to treatment . Few investigations have addressed the use of recent atypical antipsychotics in JBD , although several guidelines suggest their use . METHODS We conducted a 6-week open trial with aripiprazole in 10 children and adolescents with JBD comorbid with ADHD to assess impact on mania and ADHD symptoms , respectively , by means of the Young Mania Rating Scale and the Swanson , Nolan and Pelham Scale , as well as on global functioning ( Clinical Global Impressions-Severity ) , and adverse events . RESULTS Significant improvement in global functioning scores ( F=3.17 , P=.01 , effect size=0.55 ) , manic symptoms ( F=5.63 , P ADHD symptoms ( t=3.42 , P positive tolerability was reported , significant weight gain ( F=3.07 , P=.05 ) was observed . CONCLUSION Aripiprazole was effective in improving mania and ADHD symptoms , but neither JBD nor ADHD symptom remission was observed in most of the cases . R and omized placebo-controlled trials for JBD and ADHD are needed",
"OBJECTIVE The aim of this study was to determine the effectiveness and tolerability of aripiprazole for irritability in pervasive developmental disorder not otherwise specified ( PDD-NOS ) and Asperger 's disorder . METHOD This is a 14-week , prospect i ve , open-label investigation of aripiprazole in 25 children and adolescents diagnosed with PDD-NOS or Asperger 's disorder . Primary outcome measures included the Clinical Global Impressions-Improvement ( CGI-I ) scale and the Irritability subscale of the Aberrant Behavior Checklist ( ABC-I ) . RESULTS Twenty-five subjects , ages 5 - 17 years ( mean 8.6 years ) received a mean final aripiprazole dosage of 7.8 mg/day ( range 2.5 - 15 mg/day ) . Full-scale intelligence quotient ( IQ ) scores ranged from 48 to 122 ( mean 84 ) . Twenty-two ( 88 % ) of 25 subjects were responders in regard to interfering symptoms of irritability , including aggression , self-injury , and tantrums , with a final CGI-I of 1 or 2 ( very much or much improved ) and a 25 % or greater improvement on the ABC-I. The final mean CGI-I was 1.6 ( p ABC-I scores ranged from 18 to 43 ( mean 29 ) at baseline , whereas scores at week 14 ranged from 0 to 27 ( mean 8.1 ) ( p Aripiprazole was well tolerated . Mild extrapyramidal symptoms ( EPS ) were reported in 9 subjects . Age- and sex-normed body mass index ( BMI ) increased from a mean value of 20.3 at baseline to 21.1 at end point ( p Prolactin significantly decreased from a mean value of 9.3 at baseline to 2.9 at end point ( p drug-related adverse event . CONCLUSIONS These preliminary data suggest that aripiprazole may be effective and well tolerated for severe irritability in pediatric patients with PDD-NOS or Asperger 's disorder . Larger-scale placebo-controlled studies are needed to eluci date the efficacy and tolerability of aripiprazole in this understudied population",
"OBJECTIVE To review published literature regarding aripiprazole in child and adolescent psychiatry . METHOD A literature review was conducted using the medline search term : ' aripiprazole ' with limits : Human trials , English language , All Child ( aged 0 - 18 years ) . Additional articles were identified from reference information and poster presentation data . RESULTS Aripiprazole is an atypical antipsychotic which was recently approved for use in Canada , but has been available for several years in the United States . Pharmacologically , aripiprazole is a partial agonist at D(2 ) and 5-HT(1A ) receptors and an antagonist at 5-HT(2A ) receptors . R and omized controlled trial data is available showing efficacy for aripiprazole in the treatment of children and adolescents with schizophrenia , bipolar disorder and behavioural problems associated with autism . Open-label evidence is also available for use of aripiprazole in other disorders such as tic disorders , aggression and disruptive behavior disorders . Unlike some other available atypical antipsychotics , there does not appear to be any effect on QTc interval on the electrocardiogram . Adverse effects including extrapyramidal symptoms ( EPS ) , akathisia , sedation , headache , nausea were significant in clinical trials in children and adolescents . The possibility of aripiprazole causing tardive dyskinesia can not be excluded . In this population , aripiprazole appears to have minimal impact on the metabolic profile compared to most other atypical antipsychotics , with minimal changes in weight or body mass index , no significant changes in glucose or lipid metabolism , and a decrease in serum prolactin . CONCLUSION Aripiprazole may represent an important alternative for some children and adolescents who have experienced poor efficacy or significant metabolic adverse effects with their current antipsychotic treatment regimen",
"OBJECTIVE The purpose of this open-label study was to describe the effectiveness of aripiprazole ( APZ ) in the treatment of children with bipolar disorders suffering from manic symptomatology . METHOD Symptomatic out patients ( Young Mania Rating Scale [ YMRS ] score ≥15 ) meeting strict , unmodified , Diagnostic and Statistical Manual of Mental Disorders , 4th edition , diagnostic symptom criteria for a bipolar disorder , ages 4 - 9 years , were eligible . Subjects were treated prospect ively with flexible doses of APZ ( maximum daily dose of 15 mg/day ) , for up to 16 weeks or until a priori response criteria were met . Outcome measures included the YMRS , Clinical Global Impressions Scale-Severity , Children 's Global Assessment Scale ( CGAS ) , and the Children 's Depression Rating Scale-Revised ( CDRS-R ) . A priori response criteria consisted of 3 of 4 consecutive weeks with ( 1 ) CDRS-R 50 . RESULTS Ninety-six children ( 62 males ; mean age of 6.9 ( SD = 1.7 ) , received APZ for an average length of treatment of 12.5 ( SD = 3.9 ) weeks . Significant improvements in YMRS , CDRS-R , CGAS , and Clinical Global Impressions Scale-Severity scores ( p were stomachache , increased appetite , and headache . Two subjects were removed from the study due to side effects [ epistaxis ( n = 1 ) ; akathisia ( n = 1 ) ] . Subjects experienced an average weight gain of 2.4 ( SD = 1.9 ) kg . CONCLUSION APZ may be effective in the acute treatment of symptoms of children with bipolar illnesses",
"Abstract Background : In the UK , treatment with antipsychotic medications for children is usually initiated by specialists in secondary care . Recent studies have shown an increase in the prescribing of atypical antipsychotics in children . The severity of possible adverse effects to antipsychotics in adults has lead to awareness of the importance of investigating the potential adverse effects of these agents in children . Additionally , there have been many reports proposing that the newer atypical antipsychotics are associated with many of the same adverse effects seen with the older generation drugs in children . The aim of the Paediatric Atypical Antipsychotic Monitoring Safety ( PAMS ) study was to determine the feasibility of conducting a prospect i ve targeted pharmacovigilance study to monitor adverse drug reactions ( ADRs ) associated with atypical antipsychotic therapy in children seen in secondary - and tertiary-care setting s. Methods : Participants were identified from the clinical members of the UK Paediatric Psychopharmacology Groups in London and the West Midl and s. Participating clinicians reported the number of patients ( aged ≤18 years ) taking atypical antipsychotic treatment who were under their care and any reportable ADRs experienced by these patients during the period September 2006–September 2007 . Participants contributed data via password protected online data collection forms . Results : A total of 35 clinicians consented to participate in the study . However , data from 22 of the participating clinicians were excluded because of incomplete reporting . Data from the remaining 13 ( 37 % ) clinicians were eligible for the final analysis . There were 281 patients who received atypical antipsychotic treatment under the care of the 13 participating clinicians . From these 281 patients , 40 ADR reports ( 0.14 ADR reports per patient ; 95 % CI 0.10 , 0.19 ) from 37 patients were entered into the data base . Of the 37 patients , 13 experienced more than one ADR , bringing the total number of ADRs to 56 ( 0.20 ADR per patient ; 95 % CI 0.15 , 0.25 ) . The most commonly reported ADRs were weight gain , extrapyramidal symptoms and hyperprolactinaemia . Rare ADRs , including neuroleptic malignant syndrome , were also reported . The duration s of atypical antipsychotic drug exposure were recorded for 54 of the 56 ADRs reported . The median duration of exposure was 42 days ( interquartile range 23.25–90 days ) . Conclusions : Our study demonstrates that a clinician-based targeted pharmacovigilance study on atypical antipsychotics in children provides useful qualitative data . However , this pilot study raised many method ological issues , which should be addressed for the study to be extended nationally . Specifically , significant funding is needed to improve the reporting rate and the overall data obtained . Furthermore , the study yielded a very high incidence of serious ADRs , thus supporting the need for a larger and improved pharmacovigilance study to evaluate the safety of atypical antipsychotics in children",
"Despite few supportive data , aripiprazole was being administered to children and adolescents for management of mood instability , aggression , and psychosis . Using a retrospective review ( n = 11 ) and prospect i ve recruitment ( n = 6 ) , 17 children and adolescents received aripiprazole 5 to 20 mg/day . Only 4 of 16 bipolar and autistic subjects ( 25 % ) demonstrated reduced aggression without adverse events , and the symptoms of 2 of 4 psychotic subjects improved . Coadministration of sedative medications ( particularly guanfacine or clonidine ) and weight risk of adverse events , such as increased lability and aggression . All three children old , all four children developed adverse events prior to clinical efficacy . Age > 11 years , weight > 58 kg , and absence of sedative medications were associated with a 56 % ( five of nine ) success rate . Until larger , prospect i ve studies are completed , caution is advised when considering aripiprazole for smaller children and children receiving sedative medications . ( J Child Neurol 2005;20:603—610 )",
"OBJECTIVE To assess response to treatment with aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder ( ADHD ) . METHOD Children and adolescents were extensively assessed according to DSM-IV criteria for bipolar disorder comorbid with ADHD ( n = 710 ) . Those with this comorbidity who were acutely manic or in mixed states were r and omly assigned in a 6-week double-blind , placebo-controlled trial to aripiprazole ( n = 18 ) or placebo ( n = 25 ) . Primary outcome measures were assessed weekly and included the Young Mania Rating Scale ; the Swanson , Nolan , and Pelham Scale-Version IV ; and weight . Secondary outcome measures were the Clinical Global Impressions-Severity of Illness scale , the Child Mania Rating Scale-Parental Version ( CMRS-P ) , the Children 's Depression Rating Scale-Revised , the Kutcher Adolescent Depression Scale , and adverse events . The trial was conducted at the Hospital de Clínicas de Porto Alegre , Rio Gr and e do Sul , Brazil , from January 2005 to November 2007 . RESULTS The group receiving aripiprazole showed a significantly greater reduction in YMRS scores ( P = .02 , effect size [ ES ] = 0.80 ) , CMRS-P scores ( P = .02 ; ES = 0.54 ) , and CGI-S scores ( P = .04 ; ES = 0.28 ) from baseline to endpoint than the placebo group . In addition , higher rates of response ( P = .02 ) and remission ( P = .01 ) were found for the aripiprazole group . No significant between-group differences were found in weight , ADHD symptoms , and depressive symptoms . Adverse events significantly more frequent in the aripiprazole group were somnolence and sialorrhea . CONCLUSION Aripiprazole was effective in reducing manic symptoms and improving global functioning without promoting severe adverse events or weight gain . No significant treatment effect in ADHD symptoms was observed . Studies are needed to assess psychopharmacologic interventions for improving ADHD symptoms in juvenile bipolar disorder comorbid with ADHD . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00116259",
"OBJECTIVE Second-generation antipsychotic ( SGA ) effects in youth were monitored to quantify extrapyramidal side effects ( EPS ) and to identify risk profiles for treatment-emergent EPS . METHOD Data were analyzed for the nonr and omized , prospect i ve Second-generation Antipsychotic Treatment Indications , Effectiveness and Tolerability in Youth ( SATIETY ) inception cohort study . EPS were assessed at baseline and 4 , 8 , and 12 weeks after naturalistic SGA initiation for schizophrenia , mood , disruptive behavior , and autism spectrum disorders using the Simpson-Angus Scale ( SAS ) , Barnes Akathisia Scale , Abnormal Involuntary Movement Scale ( AIMS ) , and Treatment Emergent Side Effect Scale . Drug-induced parkinsonism was defined by incident mean SAS score > 0.33 , anticholinergic initiation , or increasing total SAS score ≥2 in patients with baseline EPS . RESULTS In 342 youth aged 13.6 ± 3.5 years ( male = 58.2 % , antipsychotic-naive = 65.8 % ) , 15.2 % developed drug-induced parkinsonism . Raw SGA-grouped drug-induced parkinsonism rates were as follows : quetiapine = 1.5 % , olanzapine = 13.8 % , risperidone = 16.1 % , ziprasidone = 20.0 % , and aripiprazole = 27.3 % . SGA type , dose , higher age , and lower baseline functioning were jointly associated with drug-induced parkinsonism ( R(2 ) = 0.18 ; p factors , drug-induced parkinsonism rates were significantly lower only for quetiapine and olanzapine . Subjectively reported EPS ( 5 % ) , EPS-related treatment discontinuation ( 3.3 % ) , and anticholinergic initiation ( 3 % ) were infrequent . Anticholinergic initiation was most frequent with risperidone ( 10.2 % ; p = .0004 ) . Treatment-emergent dyskinesia ranged from 4.5 % ( aripiprazole ) to 15.5 % ( olanzapine ) . SGA type , younger age , white race/ethnicity , and baseline AIMS were jointly associated with treatment-emergent dyskinesia ( R(2 ) = 0.31 ; p , treatment-emergent dyskinesia rates differed among SGA subgroups , with higher rates with olanzapine and ziprasidone . At baseline , psychostimulant use was associated with dyskinesia , and number of psychotropic comedications was associated with subjective EPS . CONCLUSION In youth , SGA-related EPS rates did not generally exceed those reported in adults , with particularly low rates with quetiapine and olanzapine",
"OBJECTIVES To determine the efficacy and safety of aripiprazole for the treatment of pediatric bipolar I disorder , manic or mixed episode , with or without psychotic features . METHOD Subjects were enrolled between March 2005 and February 2007 in a r and omized , multicenter , double-blind 4-week study of aripiprazole 10 mg/d , aripiprazole 30 mg/d , and placebo . Subjects ( n = 296 ) were 10 to 17 years old with a DSM-IV diagnosis of bipolar I disorder with current manic or mixed episodes , with or without psychotic features , and a Young Mania Rating Scale ( YMRS ) score > or = 20 . The primary efficacy variable was change from baseline in the YMRS total score . RESULTS Both doses of aripiprazole were superior to placebo on the YMRS total score beginning at week 1 and continuing through week 4 . Aripiprazole 10 mg and 30 mg were more effective than placebo on global improvement , mania , and overall bipolar illness outcome measures . Response ( > or = 50 % reduction in YMRS total score ) at week 4 was achieved by 44.8 % , 63.6 % , and 26.1 % of subjects in the aripiprazole 10 mg , aripiprazole 30 mg , and placebo groups , respectively ( P tolerated . The most common adverse events were extrapyramidal disorder and somnolence ; rates were higher for aripiprazole 30 mg compared with aripiprazole 10 mg . Average weight gain was not significantly different between the aripiprazole 10 mg ( + 0.82 kg ) or 30 mg ( + 1.08 kg ) groups compared with the placebo group ( + 0.56 kg ) ( P = .35 and P = .13 , respectively ) . CONCLUSIONS Aripiprazole in daily doses of 10 mg or 30 mg is an effective and generally well-tolerated acute treatment for pediatric subjects with bipolar I mania or mixed episodes . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00110461",
"INTRODUCTION Aripiprazole is a novel second-generation antipsychotic approved for the treatment of bipolar disorder in adults but there is no systematic data available in pediatric bipolar disorder . METHODS This was an 8-week , open-label , prospect i ve study of aripiprazole 9.4+/-4.2 mg/day monotherapy to assess the efficacy and tolerability of this compound in treating pediatric bipolar disorder . Assessment s included the Young Mania Rating Scale , Clinical Global Impressions-Improvement scale , and Brief Psychiatric Rating Scale . Adverse events were assessed through spontaneous self-reports , vital signs weight monitoring , and laboratory analysis . RESULTS Fifteen of the 19 bipolar youth ( 79 % ) completed the study . Aripiprazole treatment was associated with clinical ly and statistically significant improvement in mean Young Mania Rating Scale scores ( -18.0+/-6.9 , P body weight ( 1.8+/-1.7 kg , P=.2 ) . CONCLUSION Open-label aripiprazole treatment was beneficial in the treatment of mania in youth with bipolar disorder . Future placebo-controlled , double-blind studies are warranted",
"BACKGROUND Primarily safe and efficacious treatments for chronic tic disorders are needed . Also needed are such treatments that target co-morbid conditions . Aripiprazole , a dopaminergic/serotonergic agent with partial agonist properties at the D2 dopamine receptor and 5-hydrdoxytryptamine 1A ( 5-HT(1A ) ) receptor and antagonist properties at the 5-HT(2A ) receptor , holds promise in both regards . OBJECTIVE This was an open-label , flexible-dose study to evaluate the safety of aripiprazole in children and adolescents with a primary diagnosis of a chronic tic disorder with/without co-morbid disorder(s ) . METHOD Sixteen children ( 15 males ) aged 8 - 17 years participated in the 6-week trial . Ratings for tic , obsessive compulsive disorder ( OCD ) , attention-deficit/hyperactivity disorder ( ADHD ) , and side effects were administered weekly . Baseline and exit laboratory measures , electrocardiograms ( ECGs ) , weight , and height were obtained . RESULTS The average daily aripiprazole dose was 3.3 mg ( range 1.25 - 7.5 mg ) . Significant pre- and posttreatment differences were ascertained for the Yale Global Tic Severity Scale motor ( p phonic ( p total tic ( p OCD , ADHD , and depressive disorders . Although aripiprazole was well tolerated , increases in weight were found . CONCLUSION In this preliminary open-label trial , aripiprazole was a well-tolerated treatment for tics and co-morbid OCD and ADHD symptoms . Improvements in co-morbid conditions may be secondary to tic reduction or to specific to aripiprazole therapy ; however , further study is warranted",
"A modification of an earlier rating scale for extrapyramidal system disturbance is described , and evidence for the validity and reliability of the scale is presented . The usefulness of the scale in studies of neuroleptic drugs is discussed . By its application it is possible to quantify extrapyramidal side effects and to separate them into four principal factors",
"OBJECTIVE To evaluate the efficacy and safety of aripiprazole versus placebo in preventing relapse of irritability symptoms associated with autistic disorder in pediatric patients . METHOD This multicenter , double-blind , r and omized , placebo-controlled , relapse-prevention trial enrolled patients ( 6 - 17 years ) who met the current Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision ( DMS-IV-TR ) criteria for autistic disorder and who also had serious behavioral problems ( ie , tantrums , aggression , self-injurious behavior , or a combination of these behavioral problems ) between March 2011 and June 2012 . In phase 1 , single-blind aripiprazole was flexibly dosed ( 2 - 15 mg/d ) for 13 - 26 weeks . Patients with a stable response ( ≥ 25 % decrease in Aberrant Behavior Checklist-irritability subscale score and a rating of \" much improved \" or \" very much improved \" on the Clinical Global Impressions-Improvement scale ) for 12 consecutive weeks were r and omized into phase 2 to continue aripiprazole or switch to placebo . Treatment was continued until relapse or up to 16 weeks . The primary end point was time from r and omization to relapse . RESULTS Eighty-five patients were r and omized in phase 2 . The difference in time to relapse between aripiprazole and placebo was not statistically significant ( P = .097 ) . Kaplan-Meier relapse rates at week 16 were 35 % for aripiprazole and 52 % for placebo ( hazard ratio [ HR ] = 0.57 ; number needed to treat [ NNT ] = 6 ) . The most common adverse events during phase 1 were weight increase ( 25.2 % ) , somnolence ( 14.8 % ) , and vomiting ( 14.2 % ) ; and , during phase 2 ( aripiprazole vs placebo ) , they were upper respiratory tract infection ( 10.3 % vs 2.3 % ) , constipation ( 5.1 % vs 0 % ) , and movement disorder ( 5.1 % vs 0 % ) . CONCLUSIONS In this study , there was no statistically significant difference between aripiprazole and placebo in time to relapse during maintenance therapy . However , the HR and NNT suggest some patients will benefit from maintenance treatment . Patients receiving aripiprazole should be periodically reassessed to determine the continued need for treatment . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01227668",
"OBJECTIVE To evaluate the short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder . METHOD Two hundred eighteen children and adolescents ( aged 6 - 17 years ) with a diagnosis of autistic disorder , and with behaviors such as tantrums , aggression , self-injurious behavior , or a combination of these symptoms , were r and omized 1:1:1:1 to aripiprazole ( 5 , 10 , or 15 mg/day ) or placebo in this 8-week double-blind , r and omized , placebo-controlled , parallel-group study . Efficacy was evaluated using the caregiver-rated Aberrant Behavior Checklist Irritability subscale ( primary efficacy measure ) and the clinician-rated Clinical Global Impressions-Improvement score . Safety and tolerability were also assessed . RESULTS At week 8 , all aripiprazole doses produced significantly greater improvement than placebo in mean Aberrant Behavior Checklist Irritability subscale scores ( 5 mg/day , -12.4 ; 10 mg/day , -13.2 ; 15 mg/day , -14.4 ; versus placebo , -8.4 ; all p aripiprazole doses demonstrated significantly greater improvements in mean Clinical Global Impressions-Improvement score than placebo at week 8 . Discontinuation rates due to adverse events were as follows : placebo 7.7 % , aripiprazole 5 mg/day 9.4 % , 10 mg/day 13.6 % , and 15 mg/day 7.4 % . The most common adverse event leading to discontinuation was sedation . There were two serious adverse events : presyncope ( 5 mg/day ) and aggression ( 10 mg/day ) . At week 8 , mean weight change ( last observation carried forward ) was as follows : placebo + 0.3 kg , aripiprazole 5 mg/day + 1.3 kg , 10 mg/day + 1.3 kg , and 15 mg/day + 1.5 kg ; all p Aripiprazole was efficacious and generally safe and well tolerated in the treatment of children and adolescents with irritability associated with autistic disorder",
"The objective of this study was to evaluate the effectiveness and tolerability of aripiprazole use in child and adolescent psychiatric in patients . This was a naturalistic , retrospective evaluation of the discharged patients treated with aripiprazole on the child and adolescent unit at the Austin State Hospital . To be included , patients had to be aripiprazole for at least two consecutive weeks during their hospital stay . We used a chart extracted Clinical Global Impression of Improvement , and a chart extracted Clinical Global Impression of Severity of Illness score to determine their effectiveness . Adverse events and side effects recorded in the physician or nursing notes were collected to establish tolerability . Forty-five patients met the criteria and were included in this analysis . Average clinical global impression of severity of illness scores at baseline and endpoint were 5.04±0.91 and 3.33±1.24 respectively . This difference was statistically significant ( Wilcoxon 's signed-rank test : Z=−5.179 , P a clinical global impression of severity of illness score that was much improved or very much improved ( clinical global impression of improvement score of 1 or 2 ) . Significant reduction in clinical global impression of severity of illness scores suggests a decline in the symptom severity for patients treated with aripiprazole . On the basis of the reported adverse events and side effects , aripiprazole was generally well tolerated . R and omized controlled trials of aripiprazole in childhood mental disorders are warranted",
"OBJECTIVE Aripiprazole is a dopamine partial agonist approved for use in adults for short- and long-term treatment of schizophrenia and bipolar disorder . This study was design ed to examine the acute efficacy , safety , and tolerability of aripiprazole for adolescents with schizophrenia . METHOD This was a 6-week multicenter , double-blind , r and omized , placebo-controlled trial . Subjects 13 to 17 years old with a DSM-IV diagnosis of schizophrenia and a Positive and Negative Syndrome Scale ( PANSS ) total score of 70 or more were r and omly assigned ( 1:1:1 ratio ) to placebo or 10 or 30 mg/day of aripiprazole . The primary endpoint was mean change from baseline to endpoint ( last observation carried forward ) in PANSS total score . Assessment s of safety and tolerability included spontaneously reported adverse events , extrapyramidal symptom scores , serum prolactin concentration , body weight , and metabolic measures . RESULTS Of 302 patients , 85 % completed the 6-week study . The mean baseline PANSS score was 94.1 . At the end of the study , both aripiprazole doses showed statistically significant differences from placebo in reduction in PANSS total score . Adverse events occurring in more than 5 % of either aripiprazole group and with a combined incidence at least twice the rate for placebo were extrapyramidal disorder , somnolence , and tremor . Mean changes in prolactin were -8.45 , -11.93 , and -15.14 ng/ml for placebo and 10 mg and 30 mg of aripirazole , respectively . Mean body weight changes were -0.8 , 0.0 , and 0.2 kg for placebo and 10 mg and 30 mg of aripiprazole , respectively . CONCLUSION Both 10- and 30-mg/day doses of aripiprazole were superior to placebo in the acute treatment of adolescents with schizophrenia . Aripiprazole was generally well tolerated",
"BACKGROUND Research studies for the treatment of the putative prodromal phase of psychotic disorders have begun to appear . AIMS To obtain preliminary evidence of the short-term efficacy and safety of aripiprazole treatment in people with the psychosis prodrome . METHOD Fifteen participants meeting prodrome criteria ( mean age 17.1 years , s.d.=5.5 ) enrolled in an open-label , single-site trial with fixed-flexible dosing of aripiprazole ( 5 - 30 mg/day ) for 8 weeks . RESULTS In the mixed-effects repeated- measures analysis , improvement from baseline on the Scale of Prodromal Symptoms total score was statistically significant by the first week . No participant converted to psychosis and 13 completed treatment . Neuropsychological measures showed no consistent improvement ; mean weight gain was 1.2 kg . Akathisia emerged in 8 participants , but the mean Barnes Akathisia Scale score fell to baseline levels by the final visit . Adverse events were otherwise minimal . CONCLUSIONS Aripiprazole shows a promising efficacy and safety profile for the psychosis prodrome . Placebo-controlled studies are indicated"
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OBJECTIVE Surgical complications may affect patients psychologically due to challenges such as prolonged recovery or long-lasting disability . Psychological distress could further delay patients ' recovery as stress delays wound healing and compromises immunity . This review investigates whether surgical complications adversely affect patients ' postoperative well-being and the duration of this impact . METHODS The primary data sources were ' PsychINFO ' , ' EMBASE ' and ' MEDLINE ' through OvidSP ( year 2000 to May 2012 ) . The reference lists of eligible articles were also review ed . Studies were eligible if they measured the association of complications after major surgery from 4 surgical specialties ( ie , cardiac , thoracic , gastrointestinal and vascular ) with adult patients ' postoperative psychosocial outcomes using vali date d tools or psychological assessment . 13,605 articles were identified . 2 research ers independently extracted information from the included articles on study aims , participants ' characteristics , study design , surgical procedures , surgical complications , psychosocial outcomes and findings . The studies were synthesis ed narratively ( ie , using text ) . Supplementary meta-analyses of the impact of surgical complications on psychosocial outcomes were also conducted . RESULTS 50 studies were included in the narrative synthesis . Two-thirds of the studies found that patients who suffered surgical complications had significantly worse postoperative psychosocial outcomes even after controlling for preoperative psychosocial outcomes , clinical and demographic factors . Half of the studies with significant findings reported significant adverse effects of complications on patient psychosocial outcomes at 12 months ( or more ) postsurgery . 3 supplementary meta-analyses were completed , 1 on anxiety ( including 2 studies ) and 2 on physical and mental quality of life ( including 3 studies ) . The latter indicated statistically significantly lower physical and mental quality of life ( p patients who suffered surgical complications . CONCLUSIONS Surgical complications appear to be a significant and often long-term predictor of patient postoperative psychosocial outcomes . The results highlight the importance of attending to patients ' psychological needs in the aftermath of surgical complications
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"Introduction The aim of this prospect i ve study was to analyze the impact of different surgical techniques on patients undergoing intestinal surgery for Crohn ’s disease ( CD ) in terms of recovery , quality of life , and direct and indirect costs . Patients and methods Forty-seven consecutive patients admitted for intestinal surgery for CD were enrolled in this prospect i ve study . Surgical procedures were evaluated as possible predictors of outcome in terms of disability status ( Barthel ’s Index ) , quality of life ( Clevel and Global Quality of Life score ) , body image , disease activity ( Harvey – Bradshaw Activity Index ) , and costs ( calculated in 2008 Euros ) . Univariate and multivariate analyses were performed . Results Significant predictors of a long postoperative hospital stay were the creation of a stoma , postoperative complications , disability status on the third post-operative day , and surgical access ( R2 = 0.59 , p Barthel ’s index at discharge was independently predicted by laparoscopic-assisted approach , ileal CD , and colonic CD ( R2 = 0.53 , p disability status at admission showed to be an independent predictor of quality of life score at follow-up . The overall cost for intestinal surgery for CD was 12,037 ( 10,117–15,795 ) euro per patient and stoma creation revealed to be its only predictor ( p = 0.006 ) . Conclusions Laparoscopy was associated with a shorter postoperative length of stay ; stoma creation was associated with a long and expensive postoperative hospital stay , and stricturoplasty was associated with a slower recovery of bowel function",
"BACKGROUND Despite more than three decades of research on iatrogenesis , surgical adverse events have not been subjected to detailed study to identify their characteristics . This information could be invaluable , however , for guiding quality assurance and research efforts aim ed at reducing the occurrence of surgical adverse events . Thus we conducted a retrospective chart review of 15,000 r and omly selected admissions to Colorado and Utah hospitals during 1992 to identify and analyze these events . METHODS We selected a representative sample of hospitals from Utah and Colorado and then r and omly sample d 15,000 nonpsychiatric discharges from 1992 . With use of a 2-stage record- review process modeled on previous adverse event studies , we estimated the incidence , morbidity , and preventability of surgical adverse events that caused death , disability at the time of discharge , or prolonged hospital stay . We characterized their distribution by type of injury and by physician specialty and determined incidence rates by procedure . RESULTS Adverse events were no more likely in surgical care than in nonsurgical care . Nonetheless , 66 % of all adverse events were surgical , and the annual incidence among hospitalized patients who underwent an operation or child delivery was 3.0 % ( confidence interval 2.7 % to 3.4 % ) . Among surgical adverse events 54 % ( confidence interval 48.9 % to 58.9 % ) were preventable . We identified 12 common operations with significantly elevated adverse event incidence rates that ranged from 4.4 % for hysterectomy ( confidence interval 2.9 % to 6.8 % ) to 18.9 % for abdominal aortic aneurysm repair ( confidence interval 8.3 % to 37.5 % ) . Eight operations also carried a significantly higher risk of a preventable adverse event : lower extremity bypass graft ( 11.0 % ) , abdominal aortic aneurysm repair ( 8.1 % ) , colon resection ( 5.9 % ) , coronary artery bypass graft/cardiac valve surgery ( 4.7 % ) , transurethral resection of the prostate or of a bladder tumor ( 3.9 % ) , cholecystectomy ( 3.0 % ) , hysterectomy ( 2.8 % ) , and appendectomy ( 1.5 % ) . Among all surgical adverse events , 5.6 % ( confidence interval 3.7 % to 8.3 % ) result ed in death , accounting for 12.2 % ( confidence interval 6.9 % to 21.4 % ) of all hospital deaths in Utah and Colorado . Technique-related complications , wound infections , and postoperative bleeding produced nearly half of all surgical adverse events . CONCLUSION These findings provide direction for research to identify the causes of surgical adverse events and for targeted quality improvement efforts",
"The main purpose of the present study was to investigate the association between perceived stress and impaired cutaneous wound healing in humans using a novel wound assessment technique , and taking into account putative mediating factors such as cortisol levels , health behaviours , and personality factors . The study made use of a prospect i ve , within-subjects design in which 24 male non-smokers participated . Every subject received a st and ard 4mm-punch biopsy , and the healing progress was monitored via high-resolution ultrasound scanning . Participants completed question naires on perceived stress , health behaviours , and personality factors , and sample d saliva for cortisol assessment after awakening at 2 weeks prior , directly after , and 2 weeks after the biopsy . The overall results showed a significant negative correlation between speed of wound healing , and both Perceived Stress scale ( PSS ) scores ( r=-.59 ; p General Health Question naire ( GHQ ) scores ( r=-.59 ; p morning cortisol response curve was negatively correlated with speed of wound healing ( r=-.55 ; p stress levels ( PSS t=3.93 , p GHQ t=2.50 , p lower trait optimism ( t=3.25 , p higher cortisol levels to awakening ( F=5.60 , p alcohol consumption , exercise , healthy eating , and sleep ) were correlated with healing speed at any time point . Our data hint at a considerable influence of stress on wound healing , and suggests that elevated cortisol levels , rather than altered health behaviours , play a role in this effect",
"Background The project aim ed at testing the feasibility of a quality improvement system based on patient-reported outcomes in short-stay surgery for cholecystectomy . Methods In two centers for short-stay surgery , patients referred for laparoscopic cholecystectomy were surveyed between Aug 1999 and Jan 2002 . Patients reported on health-related quality of life ( SF-36 ) , symptoms ( gallstone symptom checklist , GSCL ) and other indicators preoperatively ( T0 ) , 14 days ( T1 ) and 6 months postoperatively ( T2 ) . The SF-36 subscales physical functioning , bodily pain , and role physical as well as the GSCL and treatment satisfaction at T2 were considered as main outcomes . The main outcomes were analyzed by generalized linear models with regard to predictors . Results At T0 a total of 205 patients were included . The response rate at T2 was 63.4 % ( 74.6 % females , 53.6 years of age ) . The GSCL score at T0 ( 29.4 % preoperatively ) fell slightly to 27.9 % at T1 and decreased to 14.8 % at T2 ( T0–T2 : p SF-36 subscales showed a different course over time ( decrease of health-related quality of life at T1 and large increase at T2 ) . The level of satisfaction with the outcome of cholecystectomy was 82.3 % . The patient-reported outcomes were mainly influenced by the preoperative level , age and self-reported postoperative complaints . Conclusion The low response rate was mainly due to nondelivery of question naires at T1 during the regular postoperative visit by the operating physician . Though nonresponse occurs under conditions of routine care , meaningful information was gained , which should be used for quality improvement activities . Because the preoperative level is a major determinant of the postoperative health outcomes , the prospect i ve pre – post measurement should be preferred if institutional comparisons are intended",
"We investigated the impact of perioperative complications on patients ' health-related quality of life ( HRQL ) and intermediate-term survival after cardiac surgery . Improved results for cardiac surgery are well demonstrated in low rates of operative mortality and morbidity . However , the association between perioperative morbid events , HRQL at 1 year , and survival is unclear . We performed a prospect i ve study among 836 elective cardiac surgery patients to assess the impact of perioperative outcomes on survival and HRQL at 1 year . Health-related quality of life was generated using the 20-item short-form question naire . Kaplan-Meier and life-table estimates were used to examine the relationship of HRQL at 1-year and intermediate-term survival . All HRQL domains were statistically improved at 1 year , with the highest gains in general health perception ( + 19.4 % ) and the least gains in social ( + 5.1 % ) and mental ( + 5.1 % ) domains . Patients experiencing 1 or more perioperative complication or increased length of stay reported similar HRQL scores as patients with no complications . Patients with negative changes in social ( 94.5 % vs 99.2 % , P general health perception ( 99.4 % vs 95.5 % , P reduced survival compared with patients with positive HRQL gains at 2 to 5 years after surgery . Perioperative complications had minimal or no effect on HRQL at 1 year after cardiac surgery",
"Aim To evaluate the effects of Lichtenstein tension-free inguinal hernioplasty on sexual function and generic quality of life , testicular volume , and perfusion . Patients and methods In a prospect i ve study , testicular volume , testicular perfusion , sexual function , generic quality of life , chronic inguinal pain , and groin sepsis were investigated before and 3 and 9 months after surgical hernia repair . Results Forty male patients completed this study . No differences in testicular volume or in peak systolic velocity were observed between the hernia and healthy sides of the body ( P > 0.05 ) . Preoperatively , there was a significantly higher end diastolic velocity ( P resistive index ( P sexual function domains , except orgasm domain , and total sexual score presented significant improvement ( Ps mean total sexual score and the number of patients with enhanced total score had showed further clinical progress . The total generic quality -of-life score , general health perception and physical function , vitality , and social domains were statistically recovered at 3 months postoperative ( P superficial groin sepsis , and seven ( 17.5 % ) experienced chronic inguinal pain . Conclusion Inguinal hernia impaired testicular perfusion that improved postoperatively . Lichtenstein tension-free hernioplasty improved sexual function and generic quality of life without adverse mesh effects on testicular volume or perfusion",
"Few prospect i ve longitudinal studies have used a vali date d quality of life ( QOL ) instrument in patients undergoing liver resection for hepatobiliary malignancy",
"OBJECTIVE Perioperative myocardial infa rct ion ( PMI ) is a well-described complication of coronary artery bypass grafting ( CABG ) . Data on its effect on patients ' subsequent health-related quality of life ( QOL ) and on other related consequences is deficient . The aim here was to evaluate in a prospect i ve follow-up design the risk factors for and consequences of PMI and especially its possible impact on health-related QOL . METHODS Comprehensive data , including preoperative risk profile , perioperative variables and postoperative morbidity up to discharge were collected of 501 CABG patients in the Heart Center of Tampere University Hospital and in all eighteen postoperative care hospitals . Eighty patients ( 16 % ) fulfilled ECG or cardiac enzyme criteria for PMI and they were compared to patients with no PMI . The R AND -36 Health Survey ( R AND -36 ) was used as an indicator of QOL . The primary outcomes were change in physical component summary ( PCS ) , mental component summary ( MCS ) and the eight dimensions of health-related QOL from the R AND -36 . Symptomatic status was estimated according to New York Heart Association ( NYHA ) class . Assessment s were made preoperatively and repeated 12 months later . RESULTS Multivariate logistic regression analysis identified long cardiopulmonary bypass time ( P=0.006 ) and high age ( P=0.049 ) as independent predictors for PMI . Thirty-day mortality was adversely affected by PMI ( 6.3 vs 1.0 % , P=0.001 ) . In discharged patients , the occurrence of PMI did not affect 1-year survival adversely ( 98.7 vs 98.6 % ) . The PMI patients showed significant ( P six of the eight dimensions of R AND -36 , but they presented with a negative change in their ' general health ' scores at the follow-up . All QOL scores improved significantly ( P R AND -36 PCS and MCS scores in both groups although PMI patients showed significantly ( P=0.002 ) smaller change in their PCS scores . Both groups showed similar freedom from anginal symptoms at 1 year ( 89.6 vs 90.1 % ) but in the PMI group later readmissions due to cardiac-related causes were more common ( 23 vs 10 % , P=0.002 ) . CONCLUSIONS PMI increases 30-day mortality and affects also adversely on later health-related QOL following CABG",
"Purpose The recovery benefits of laparoscopy are traditionally believed to minimize the initial negative impact of surgery on early postoperative quality of life ( QOL ) . We evaluate whether laparoscopic colectomy leads to recovery of QOL early after surgery and evaluate factors associated with the change in QOL . Methods Preoperative and early postoperative QOL data ( SF-36 ) were prospect ively accrued for patients undergoing laparoscopic colorectal resection ( LCR ) ( 2002–2009 ) . Changes in postoperative QOL from preoperative values and effects of patient , disease , operation and postoperative outcomes on these changes were evaluated . Results One hundred and sixty-six patients ( female = 86 ) underwent LCR for cancer ( n = 79 ) , Crohn ’s disease ( n = 24 ) , diverticulitis ( n = 38 ) , and ulcerative colitis ( n = 25 ) with complete SF-36 scores . Median age was 56.9 ( range : 15–91 ) years , mean body mass index 27.4 ± 6.2 kg/m2 with American Society of Anesthesiologists ( ASA ) class being II in 94 patients . Median operative time was 152.5 ( range : 50–358 ) min ; mean length of stay ( LOS ) 4.5 ± 3.3 days . At 4 weeks , the postoperative SF-36 physical component scale ( PCS ) continued to be lower than the preoperative PCS ( 41.8 ± 8.8 vs. 47.1 ± 9.4 , P postoperative SF-36 mental component scale ( MCS ) was similar to the preoperative MCS ( 45.6 ± 10.2 vs. 46.1 ± 11.9 , P = 0.17 ) . Gender , age , operation , LOS , surgeon , ASA , BMI , complications , and readmission were not associated with a change in QOL from preoperative values . Cancer as an indication for surgery was associated with less improvement of MCS and PCS ( P = 0.024 and 0.004 , respectively ) . Conclusions Although patients who undergo LCR may have clinical evidence of healing at 4 weeks after surgery , QOL does not return to the preoperative level . This finding may help develop evidence -based recommendations pertaining to timing of return to full activity",
"Introduction : The aim was to analyze the association between selected patient variables and health-related quality of life 6 months after surgery for lung cancer . Methods : In a prospect i ve population -based cohort study , Short Form 36 ( SF-36 ) was used to assess quality of life before and 6 months after surgery for lung cancer . The change in SF-36 summary and subscale scores were used to categorize quality of life in two groups ( worse or stable/improved ) at 6 months compared with baseline . Logistic regression models adjusting for potential confounding factors were used to analyze the association between patient variables and quality of life 6 months after surgery . Results : A baseline SF-36 question naire was completed by 249 patients . Nonresponders at 6 months ( n = 36 ) were excluded , and 14 patients who died before 6 months follow-up remained in the study , leaving 213 patients available for analysis . Gender , comorbidity , occurrence of postoperative complications , and tumor stage were not associated with the physical aspect of quality of life 6 months after surgery . The extent of resection , age , and adjuvant therapy was significantly associated with a clinical ly relevant decline in the SF-36 physical component summary score 6 months postoperatively . No patient variables were predictive of a decline in the mental component summary score . Conclusions : The extent of resection , age , and adjuvant therapy was associated with a clinical ly relevant decline in the physical aspect of health-related quality of life 6 months after surgery . Further studies are needed to explore possible mechanisms",
"To evaluate influence of laparoscopic gastric b and ing ( LGB ) on quality of life ( QOL ) in patients with morbid obesity . Laparoscopic adjustable gastric b and ing is a popular bariatric operation in Europe . The objectives of surgical therapy in patients with morbid obesity are reduction of body weight , and a positive influence on the obesity-related comorbidity as well the concomitant psychologic and social restrictions of these patients . In a prospect i ve clinical trial , development of the individual patient QOL was analyzed , after LGB in patients with morbid obesity . From October 1999 to January 2001 , 152 patients [ 119 women , 33 men , mean age 38.4 y ( range 24 to 62 ) , mean body mass index 44.3 ( range 38 to 63 ) ] underwent evaluation for LGB according the following protocol : history of obesity ; concise counseling of patients and relative on nonsurgical treatment alternatives , risk of surgery , psychologic testing , question naire for eating habits , necessity of lifestyle change after surgery ; medical evaluation including endocrinologic and nutritionist work-up , upper GI endoscopy , evaluation of QOL using the Gastro Intestinal Quality of Life Index ( GIQLI ) . Decision for surgery was a multidisciplinay consensus . This group was follow-up at least 2 years , focusing on weight loss and QOL . Mean operative time was 82 minutes ; mean hospital stay was 2.3 days and the mean follow-up period was 34 months . The BMI dropped from 44.3 to 29.6 kg/m2 and all comorbid conditions improved markedly : diabetes melitus resolved in 71 % of the patients , hypertension in 33 % , and sleep apnea in 90 % . However , 26 patients ( 17 % ) had late complications requiring reoperation . Preoperative global GIQLI score was 95 ( range 56 to 140 ) , significant different of the healthy volonteers score ( 120 ) ( 70 to 140 ) P weight loss ( percentage loss of overweight and BMI ) , the global score of the group increased to 100 at 3 months , 104 at 6 , 111 at 1 year to reach 119 at 2 years which is no significant different of healthy patients . Analyzing the subscale , physical condition , emotional status , and social integration increased significantly ( P global Giqli score is not modified . Patients who have required successfull revisional surgery for late complications ( 6.5 % ) have an excellent QOL outcome that are not different from the whole group . Together with a satisfactory reduction of the excess overweight , laparoscopic gastric b and ing may lead in a carefully selected population of patients with morbid obesity to a significant improvment of patient QOL , in at least 2 years follow-up",
"Background Initial experience with the laparoscopic repair of paraesophageal and type III mixed hiatal hernias showed that it is safe and feasible , with excellent immediate and short-term results . However , after a longer follow-up , a recurrence rate of ≤40 % has been demonstrated . Data related to the outcome of paraesophageal hernia repair and the recurrence rate are still lacking . Quality -of-life scores may offer a better means of assessing the impact of surgical treatment on the overall health status of patients . Therefore , we performed prospect i ve evaluation of anatomic and /or symptomatic recurrences after paraesophageal or large hiatal hernia repair . In addition , we investigated the correlation between recurrence and the patient ’s quality of life . Methods All patients after who had undergone repair of paraesophageal of mixed hiatal hernia were identified prospect ively from a data base consisting of all patients who had had laparoscopic operations for gastroesophageal pathology at our hospital between February 1998 and December 2002 . The preoperative symptoms were taken from patients ’ clinical files . In March 2003 , all patients with ≥6 months of follow-up had a barium swallow and were examined for radiological and clinical signs of recurrence . Thereafter , the patients ’ quality of life after surgery was evaluated using three st and ard question naires ( Short Form 36 [ SF-36 ] , Glasgow Dyspepsia Severity Score [ GDSS ] , and Gastrointestinal Quality of Life Index [ GIQLI ] . Result During the study period , 46 patients had been operated on . The mean age was 63 years ( range , 28–93 ) . Thirty seven of them had a follow-up of ≥6 months . Eight patients ( 21 % ) had postoperative gastrointestinal symptoms . Barium swallow was performed in 30 patients ( 81 % ) and showed a recurrence in six of them ( 20 % ) . According to SF-36 and GDSS , the patients ’ postoperative quality of life reached normal values and did not differ significantly from the st and ard values for the Spanish population of similar age and with similar comorbidities . Successfully operated patients reached a GIQLI value comparable to the st and ard population . However , symptomatic patients had significantly lower GIQLI scores than the asymptomatic or the Rx-recurrent group . Conclusion The laparoscopic treatment of large paraesophageal and mixed hiatal hernias is not only feasible and safe but also offers a good quality of life on a midterm basis . However , the anatomic and functional recurrence rate is high . The next step is to identify the subset of patients who are at risk of failure and to establish technical alternatives that would ensure the durability of the repair",
"BACKGROUND Patients with critical limb ischemia ( CLI ) have multiple comorbidities and limited life spans . The ability of infrainguinal vein bypass to improve quality of life ( QoL ) in patients with CLI has therefore been question ed . Prospect i ve preoperative and postoperative QoL data for patients undergoing lower extremity vein bypass for CLI are presented . METHODS A vali date d , disease-specific QoL question naire ( VascuQoL ) with activity , symptom , pain , emotional , and social domains and responses scored 1 ( lowest QoL ) to 7 ( best QoL ) was administered before surgery and at 3 and 12 months after lower extremity vein bypass for CLI . Changes in QoL at 3 and 12 months after lower extremity vein bypass and multiple predetermined variables potentially influencing QoL after lower extremity vein bypass were analyzed to determine the effect of lower extremity vein bypass on QoL in CLI patients . RESULTS A total of 1404 patients had lower extremity vein bypass for CLI at 83 centers in the United States and Canada as part of the PREVENT III clinical trial . Surveys were completed in 1296 patients at baseline , 862 patients at 3 months , and 732 patients at 12 months . The global QoL score ( mean + /- SD ) was 2.8 + /- 1.1 at baseline and was 4.7 + /- 1.4 and 5.1 + /- 1.4 at 3 and 12 months , respectively . Mean changes from baseline at 3 and 12 months were statistically significant ( P QoL scores extended across all domains . Diabetes and the development of graft-related events were associated with decreased improvement in QoL scores , though the mean relative change from baseline remained positive . CONCLUSIONS Patients with CLI have a low QoL at baseline that is improved at 3 and 12 months after lower extremity vein bypass . QoL improvements are lower in diabetic patients and those who develop graft-related events . Successful revascularization can be expected to improve QoL in patients with CLI , with benefits that are sustained to at least 1 year",
"BACKGROUND The effect of surgery on quality of life ( QOL ) in the early postoperative period is important in Crohn 's disease because of the multiple surgical procedures that patients undergo and the acute QOL benefits that might occur as a result of modifications of medical treatment . Earlier studies of the effect of surgery on QOL have been retrospective and assessed changes 3 to 24 months after surgery . This study prospect ively assesses the effect of surgery on QOL in the early postoperative period . STUDY DESIGN Patients requiring surgical management of sequelae of Crohn 's disease were obtained from a prospect ively entered data base including data on QOL . Preoperative and 30-day postoperative QOL were determined in 82 patients using Clevel and Global Quality of Life ( CGQL ) scores ( range from 0 [ worst ] to 10 [ best possible ] QOL ) . Preoperative and postoperative scores were compared using a paired t-test to determine the significance of any change in QOL after surgery . The effect of other variables on change in QOL after surgery was assessed using the t-test or analysis of variance . Multifactor analysis of variance was used to assess the effect of several independent variables . RESULTS Eighty-two patients ( 41 women ) of 142 patients who had had surgery ( 58 % ) had complete preoperative and 30-day postoperative scores . The incidence of complications was 23 % ( 11 % were major ) . There was a significant improvement in QOL 30 days after surgery as measured by CGQL ( 0.6 + /- 0.2 preoperative to 0.7 + /- 0.2 postoperative ; mean + /- SD ; p preoperative CGQL was 0.56 + /- 0.24 and the mean improvement was 0.11 + /- 0.20 toward a better QOL . Female patients ( p complications within 30 days of surgery ( p CGQL after surgery than other groups . No other factor was predictive of improved outcomes . CONCLUSIONS QOL as measured by CGQL improves early after surgery ( 30 days postoperatively ) . Improvement in CGQL is greater in female patients and patients who do not develop complications in the postoperative period . It is not affected by other patient characteristics , nature of disease , indication , or procedure performed . Most patients who undergo surgery for Crohn 's disease feel that surgery has helped them and would undergo surgery again",
"Background and objective : Acute renal failure is a serious complication of cardiac surgery . We studied the long‐term survival and quality of life of patients requiring renal replacement therapy after cardiac surgery , since they represent a heavy burden on hospital re sources and their outcome has never been adequately evaluated . Methods : Out of 7846 consecutive cardiac surgical patients , 126 ( 1.6 % ) required postoperative renal replacement therapy : their preoperative status and hospital course was compared with patients who had no need of postoperative renal replacement therapy . A multivariate analysis identified predictors of renal replacement therapy . Long‐term survival and quality of life was collected in patients who had renal replacement therapy and in case‐matched controls . Results : Hospital mortality in the study group was 84/126 ( 66.7 % ) vs. 118/7720 ( 1.5 % ) in the control population ( P underwent renal replacement therapy and were discharged from the hospital ( 42 patients ) had a reasonable long‐term outcome : at 42 ± 23 months , 30 out of 42 patients were alive , with only 3 patients complaining of limitations in daily activities . Predictors of in‐hospital renal replacement therapy were : emergency surgery , preoperative renal impairment , intra‐aortic balloon pumping , reoperation for bleeding , previous cardiac surgery , female gender , low ejection fraction , bleeding > 1000 mL , chronic obstructive pulmonary disease and age . Conclusions : This study confirms that the in‐hospital mortality of patients requiring renal replacement therapy is high and shows a low long‐term mortality with reasonable quality of life in patients discharged from hospital alive",
"Background Improved quality of life ( QoL ) is a desirable outcome of cardiac surgery . The aim of the current study was to measure the association between quality of recovery 3 days after surgery and QoL measured 3 months later . Methods After obtaining ethics committee approval and consent , 120 adult cardiac surgical patients were studied . A 40-item quality of recovery score ( QoR-40 ) was used to measure postoperative health status on days 1–3 and 1 month after surgery . QoL was measured using the short-form health survey ( SF-36 ) at 1 and 3 months after surgery . The effect size ( & Dgr;mean/SD ) was used to define responsiveness , a clinical ly important difference in health . Associations were measured using correlation and reliability coefficients . Results There was a significant change in the mean QoR-40 for up to 1 month after surgery ( P QoL was improved at 3 months ( P SF-36 ( r = 0.39;P recovery in hospital predicted a poor QoL at 3 months ( adjusted odds ratio , 4.20 ; 95 % confidence interval , 1.41–12.5;P = 0.01 ) . Conclusions The QoR-40 is a valid measure of quality of recovery after surgery and anesthesia . When compared with the SF-36 , it is a better measure of early postoperative recovery . A poor- quality recovery on the days after surgery can predict a poor QoL at 3 months after surgery . This may allow earlier and more effective support strategies while patients are still in the hospital ( counseling , home assistance , local doctor notification , cardiac rehabilitation )",
"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",
"BACKGROUND Pain after thoracotomy is common . The objective of this study was to assess whether pain 3 months postthoracotomy negatively impacts quality of life . METHODS One hundred ten patients were prospect ively assessed using the Medical Outcomes Study 36-Item Short Form Health Survey before and 3 months after elective thoracotomy . Pain and medication use were evaluated by question naire . Patients experiencing pain at 3 months were compared with patients who did not have postthoracotomy pain . RESULTS Seventy-five patients ( 68 % ) had pain 3 months postthoracotomy ; 12 patients ( 11 % ) rated their average pain greater than 3 ( out of 10 ) . Eighteen ( 16 % ) patients required opioid analgesics . The pain group reported lower SF-36 scores in physical functioning ( p = 0.049 ) , bodily pain ( p = 0.0002 ) , and vitality ( p = 0.044 ) . There were no other significant differences in any SF-36 scale between the pain and non-pain groups . CONCLUSIONS Pain is commonly reported at 3 months after elective thoracotomy but is generally mild , shows improvement with time , and does not usually require opioid analgesics . Patients who experience postthoracotomy pain at 3 months are at risk for significantly decreased physical functioning and vitality , but are not at risk for significantly decreased social , emotional , or mental health functioning compared with patients who do not experience postthoracotomy pain at 3 months",
"Aim The aim of the study was to analyse the incidence of benign colorectal anastomotic stenoses in consecutive patients operated on in a single institution and to assess risk factors for their development . Their impact on quality of life was also evaluated",
"A prospect i ve investigation is described which sought to test the role of illness cognitions in determining patient responses to a surgical intervention for osteoarthritis . Illness cognitions were assessed amongst a consecutive sample of patients with osteoarthritis of the knee or hip prior to undergoing joint replacement surgery . Functional activity and depression were assessed pre-operatively , and at 3 and 9 months post surgery . At pre-operative assessment , functional activity and depression were univariately associated with the perceived consequences of osteoarthritis . Path analyses using longitudinal data demonstrated that illness cognitions had predictive value in explaining outcomes . Depression at 3 months was associated with higher pre-operative perceived control beliefs suggesting that patients who have high control pre-operatively may be at risk for temporary depressed mood in the immediate aftermath of surgery . This effect was not maintained at 9 months . Depression at 9 months was lower amongst patients who were more active at 3 months , who did not attribute their condition to wear and tear and who had higher expectations of surgery . Functional activity at 9 months was higher amongst those who did not attribute their condition to growing older and who perceived more control over symptoms . Socio-demographic variables were not associated with change in functional activity or depression over the course of surgery . The results provide support for an illness cognition approach in explaining functional activity and depression outcomes following surgery"
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4117f014-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES The effects of statins on insulin sensitivity , metabolic homeostasis and adipokines in humans are controversial . Several studies have investigated the impact of statin therapy on plasma leptin concentrations but the results have been inconsistent . The aim of the present study was to conduct a systematic review and meta- analysis of available evidence to calculate the effect size of statin therapy in changing serum leptin concentrations . METHODS A systematic search in PubMed - Medline , SCOPUS , Web of Science and Google Scholar data bases was performed to identify r and omized placebo-controlled trials investigating the effect of statins on plasma leptin concentrations . A r and om-effects model and generic inverse variance method were used for meta- analysis . Sensitivity analysis , risk-of-bias evaluation and publication bias assessment were carried out using st and ard methods . R and om-effects meta-regression was used to evaluate the impact of treatment duration on the estimated effect size . RESULTS Six trials , with a total of 425 subjects , met the eligibility criteria . Overall , statin therapy had no significant effect on leptin levels ( weighted mean difference -0.32 ng ml-1 , 95 % confidence nterval : -2.94 , 2.30 , P = 0.813 ) . This effect was robust in the sensitivity analysis and in subgroup analyses of trials with the duration of statin therapy and changes in plasma leptin levels . Furthermore , there was no differential effect of hydrophilic and lipophilic statins on plasma leptin concentrations . CONCLUSION Unless more consistent evidence becomes available in the future , the hypothesis of a relationship between statin use and serum leptin concentrations seem to be unfounded
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[
"INTRODUCTION Diabetic Nephropathy ( DN ) is one of the main complications of diabetes mellitus , mostly ending to end-stage renal disease . Leptin and C-reactive protein ( CRP ) , as inflammatory markers implicated in the progression of DN , increase in diabetes mellitus , while transferrin and albumin , as members of anti-oxidant defense mechanism , are found to decline . MATERIAL S AND METHODS In a controlled clinical trial , 65 patients with type 2 DN were assigned to receive lovastatin or placebo , for 3 months , to assess statins ' impact on serum levels of leptin , CRP , transferrin , albumin , and lipid profile . RESULTS Serum levels of CRP ( 3.52 + /- 4.16 mg/dL to 2.84 + /- 3.06 mg/dL , P = .02 ) , leptin ( 10.78 + /- 8.30 mg/dL to 7.80 + /- 5.41 mg/dL , P = .006 ) , low-density lipoprotein cholesterol ( 116.16 + /- 46.54 mg/dL to 85.46 + /- 29.22 mg/dL , P = .001 ) , and total cholesterol ( 199.00 + /- 43.33 mg/dL to 164.67 + /- 35.19 mg/dL , P = .001 ) were lowered after lovastatin therapy . Mean serum level of high-density lipoprotein cholesterol increased ( 40.00 mg/dL to 42.80 mg/dL , P = .005 ) after the treatment . Lovastatin had no significant effect on albumin and transferrin . Placebo did not change any of the parameters after 3 months . CONCLUSIONS The effect of statins on the inflammatory markers involved in the development of DN is a new approach to evidence supporting the pleiotropic effect of this drug group",
"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 The effect of statins on insulin resistance is controversial and poorly studied in nondiabetic subjects . In addition , the effect of statins on leptin and adiponectin has never been studied . METHODS Forty healthy nondiabetic volunteers ( 22 men and 18 women ) aged 28 to 72 were r and omized either to placebo or pravastatin 40 mg daily for a 12-week period . Insulin resistance , assessed using the Quantitative Insulin Sensitivity Check Index ( QUICKI ) , as well as serum leptin and adiponectin levels , was measured at baseline and at the end of therapy . RESULTS Pravastatin treatment decreased total cholesterol , low-density lipoprotein cholesterol , and triglycerides levels by 24 % , 32 % , and 14 % , respectively ( P glucose and insulin levels , the ( QUICKI ) index , and adiponectin and leptin levels . When stratification was performed according to QUICKI index or sex , no significant differences were observed in the prevalues and postvalues of leptin , adiponectin , or QUICKI index in the pravastatin group . Adiponectin , leptin , and QUICKI index were statistically higher in women than in men ( P Adiponectin was negatively correlated with body mass index ( BMI ; r = -0.39 , P QUICKI index ( r = 0.54 , P high-density lipoprotein cholesterol ( r = 0.50 , P adiponectin and QUICKI index remained significant after adjustment for sex and BMI ( P = .005 and P = .007 , respectively ) . Leptin was only related to BMI ( r = 0.57 , P leptin ( P pravastatin 40 mg/d does not change the QUICKI index and leptin and adiponectin levels in healthy volunteers . In addition , our results emphasize the importance of sex and BMI in the determination of both adiponectin and leptin . Adiponectin was also related to QUICKI index , whereas this relation was not found with leptin"
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4117f082-06ff-11f0-808a-c43d1ab1c353
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Background : People living with overweight and obesity often experience weight-based stigmatization . Investigations of the prevalence and correlates of weight bias and evaluation of weight bias reduction interventions depend upon psychometrically-sound measurement . Our paper is the first to comprehensively evaluate the psychometric properties , use of people-first language within items , and suitability for use with various population s of available self-report measures of weight bias . Methods : We search ed five electronic data bases to identify English- language self-report question naires of weight bias . We rated each question naire 's psychometric properties based on initial validation reports and subsequent use , and examined item language . Results : Our systematic review identified 40 original self-report question naires . Most question naires were brief , demonstrated adequate internal consistency , and tapped key cognitive and affective dimensions of weight bias such as stereotypes and blaming . Current psychometric evidence is incomplete for many question naires , particularly with regard to the properties of test-retest reliability , sensitivity to change as well as discriminant and structural validity . Most question naires were developed prior to debate surrounding terminology preferences , and do not employ people-first language in the items administered to participants . Conclusions : We provide information and recommendations for clinicians and research ers in selecting psychometrically sound measures of weight bias for various purpose s and population s , and discuss future directions to improve measurement of this construct
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[
"OBJECTIVES The authors used nationwide survey data to characterize current public conceptions related to recognition of mental illness and perceived causes , dangerousness , and desired social distance . METHODS Data were derived from a vignette experiment included in the 1996 General Social Survey . Respondents ( n = 1444 ) were r and omly assigned to 1 of 5 vignette conditions . Four vignettes described psychiatric disorders meeting diagnostic criteria , and the fifth depicted a \" troubled person \" with sub clinical problems and worries . RESULTS Results indicate that the majority of the public identifies schizophrenia ( 88 % ) and major depression ( 69 % ) as mental illnesses and that most report multicausal explanations combining stressful circumstances with biologic and genetic factors . Results also show , however , that smaller proportions associate alcohol ( 49 % ) or drug ( 44 % ) abuse with mental illness and that symptoms of mental illness remain strongly connected with public fears about potential violence and with a desire for limited social interaction . CONCLUSIONS While there is reason for optimism in the public 's recognition of mental illness and causal attributions , a strong stereotype of dangerousness and desire for social distance persist . These latter conceptions are likely to negatively affect people with mental illness",
"Objective : The objective of this research was to compare the effects of different causal attributions for overweight and obesity , among individuals with overweight and obesity , on weight-related beliefs , stigmatising attitudes and policy support . Design : In Study 1 , an online sample of 95 US adults rated the extent to which they believed various factors caused their own weight status . In Study 2 , 125 US adults read one of three r and omly assigned online passages attributing obesity to personal responsibility , biology , or the ‘ food environment . ’ All participants in both studies were overweight or obese . Main outcome measures : All participants reported beliefs about weight loss , weight-stigmatising attitudes , and support for obesity-related policies . Results : In Study 1 , biological attributions were associated with low weight-malleability beliefs and blame , high policy support , but high internalised weight bias . ‘ Food environment ’ attributions were not associated with any outcomes , while ‘ personal responsibility ’ attributions were associated with high prejudice and blame . In Study 2 , participants who received information about the food environment reported greater support for food-related policies and greater self-efficacy to lose weight . Conclusion : Emphasising the role of the food environment in causing obesity may promote food policy support and health behaviours without imposing the negative consequences associated with other attributions",
"The purpose of the present study was to investigate whether changing children 's beliefs about the controllability of obesity would reduce their negative attitudes toward fat people . The participants were 74 children from Grade s 4 - 6 , 42 in the experimental group and 32 in the control group . The experimental group were presented with a brief intervention which focussed on the uncontrollability of weight . The study found that the intervention was successful in reducing the amount of controllability that children assigned to obesity , but was not successful in reducing negative stereotyping of the obese among the experimental group compared to the control group . These results indicate that while children 's beliefs about the controllability of obesity can be changed , reducing their negative stereotyping is more difficult",
"This study was design ed to develop and test an instrument to measure nurses ' attitudes towards obesity and obese adult patients . Items were based on an earlier version of the instrument , obesity discrimination research , and clinical experience . After content validation of items , the instrument was sent to 1,400 r and omly selected Registered Nurses . Factor analysis yielded a 5-factor solution , with 36 items reaching loadings of .4 or greater . Cronbach 's alpha was .81 for the reduced scale , with a range of .45 to .79 on the five factors . Construct validity was supported by significant differences between contrast groups on three factors and consistency with underlying theory . Overall the instrument demonstrated acceptable psychometric properties and could be used in future research"
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4117f0f0-06ff-11f0-808a-c43d1ab1c353
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Background : Cholesteryl ester transfer protein ( CETP ) inhibitors increase serum high-density lipoprotein cholesterol ( HDL-c ) concentration ; however , their impact on cardiovascular outcomes is not clear . This systematic review examines the effect of CETP inhibitors on serum lipid profiles , cardiovascular events , and all-cause mortality . Methods : We search ed MEDLINE , Embase , and the Cochrane Library of Clinical Trials for placebo-controlled r and omized controlled trials ( RCTs ) that examined the effect of a CETP inhibitor ( dalcetrapib , anacetrapib , evacetrapib , or TA-8995 ) on all-cause mortality , major adverse cardiovascular events ( MACE ) , or the components of MACE at ≥6 months . Data were pooled using r and om-effects models . Results : A total of 11 RCTs ( n = 62,431 ) were included in our systematic review ; 4 examined dalcetrapib ( n = 16,612 ) , 6 anacetrapib ( n = 33,682 ) , and 1 evacetrapib ( n = 12,092 ) . Compared to dalcetrapib , anacetrapib and evacetrapib were more efficacious at raising HDL-c levels ( ∼100–130 vs. ∼30 % ) . Anacetrapib and evacetrapib also decreased low-density lipoprotein cholesterol ( LDL-c ) by approximately 30 % while dalcetrapib did not affect the LDL-c level . Overall , CETP inhibitors were not associated with the incidence of MACE ( pooled relative risk [ RR ] : 0.97 ; 95 % confidence interval [ CI ] : 0.91–1.04 ) . CETP inhibitors may decrease the risks of nonfatal myocardial infa rct ion ( MI ) ( RR : 0.93 ; 95 % CI : 0.87–1.00 ) and cardiovascular death ( RR : 0.92 ; 95 % CI : 0.83–1.01 ) , though these trends did not reach statistical significance . Conclusions : CETP inhibitors are not associated with an increased risk of MACE or all-cause mortality . There is a trend towards small reductions in nonfatal MI and cardiovascular death , though the clinical importance of such reductions is likely modest
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[
"The British Regional Heart Study ( BRHS ) reported in 1986 that much of the inverse relation of high-density lipoprotein cholesterol ( HDLC ) and incidence of coronary heart disease was eliminated by covariance adjustment . Using the proportional hazards model and adjusting for age , blood pressure , smoking , body mass index , and low-density lipoprotein cholesterol , we analyzed this relation separately in the Framingham Heart Study ( FHS ) , Lipid Research Clinics Prevalence Mortality Follow-up Study ( LRCF ) and Coronary Primary Prevention Trial ( CPPT ) , and Multiple Risk Factor Intervention Trial ( MRFIT ) . In CPPT and MRFIT ( both r and omized trials in middle-age high-risk men ) , only the control groups were analyzed . A 1-mg/dl ( 0.026 mM ) increment in HDLC was associated with a significant coronary heart disease risk decrement of 2 % in men ( FHS , CPPT , and MRFIT ) and 3 % in women ( FHS ) . In LRCF , where only fatal outcomes were documented , a 1-mg/dl increment in HDLC was associated with significant 3.7 % ( men ) and 4.7 % ( women ) decrements in cardiovascular disease mortality rates . The 95 % confidence intervals for these decrements in coronary heart and cardiovascular disease risk in the four studies overlapped considerably , and all contained the range 1.9 - 2.9 % . HDLC levels were essentially unrelated to non-cardiovascular disease mortality . When differences in analytic methodology were eliminated , a consistent inverse relation of HDLC levels and coronary heart disease event rates was apparent in BRHS as well as in the four American studies",
"BACKGROUND In observational analyses , higher levels of high-density lipoprotein ( HDL ) cholesterol have been associated with a lower risk of coronary heart disease events . However , whether raising HDL cholesterol levels therapeutically reduces cardiovascular risk remains uncertain . Inhibition of cholesteryl ester transfer protein ( CETP ) raises HDL cholesterol levels and might therefore improve cardiovascular outcomes . METHODS We r and omly assigned 15,871 patients who had had a recent acute coronary syndrome to receive the CETP inhibitor dalcetrapib , at a dose of 600 mg daily , or placebo , in addition to the best available evidence -based care . The primary efficacy end point was a composite of death from coronary heart disease , nonfatal myocardial infa rct ion , ischemic stroke , unstable angina , or cardiac arrest with resuscitation . RESULTS At the time of r and omization , the mean HDL cholesterol level was 42 mg per deciliter ( 1.1 mmol per liter ) , and the mean low-density lipoprotein ( LDL ) cholesterol level was 76 mg per deciliter ( 2.0 mmol per liter ) . Over the course of the trial , HDL cholesterol levels increased from baseline by 4 to 11 % in the placebo group and by 31 to 40 % in the dalcetrapib group . Dalcetrapib had a minimal effect on LDL cholesterol levels . Patients were followed for a median of 31 months . At a prespecified interim analysis that included 1135 primary end-point events ( 71 % of the projected total number ) , the independent data and safety monitoring board recommended termination of the trial for futility . As compared with placebo , dalcetrapib did not alter the risk of the primary end point ( cumulative event rate , 8.0 % and 8.3 % , respectively ; hazard ratio with dalcetrapib , 1.04 ; 95 % confidence interval , 0.93 to 1.16 ; P=0.52 ) and did not have a significant effect on any component of the primary end point or total mortality . The median C-reactive protein level was 0.2 mg per liter higher and the mean systolic blood pressure was 0.6 mm Hg higher with dalcetrapib as compared with placebo ( P In patients who had had a recent acute coronary syndrome , dalcetrapib increased HDL cholesterol levels but did not reduce the risk of recurrent cardiovascular events . ( Funded by F. Hoffmann-La Roche ; dal- OUTCOMES Clinical Trials.gov number , NCT00658515 . )",
"This phase 3 , multiregional , r and omized , double-blind , placebo-controlled study assessed the efficacy/safety profile of anacetrapib added to ongoing therapy with statin ± other lipid-modifying therapies in patients with hypercholesterolemia who were not at their low-density lipoprotein ( LDL-C ) goal ( as per the National Cholesterol Education Program Adult Treatment Panel III guidelines ) and in those with low high-density lipoprotein cholesterol ( HDL-C ) . Patients on a stable dose of statin ± other lipid-modifying therapies and with LDL-C ≥70 to a ratio of 1:1 to anacetrapib 100 mg ( n = 290 ) or placebo ( n = 293 ) for 24 weeks , followed by a 12-week off-drug phase . The co- primary end points were % change from baseline in LDL-C and HDL-C and the safety profile of anacetrapib . Treatment with anacetrapib reduced LDL-C ( BQ ) by 37 % ( 95 % confidence interval -42.5 , -31.0 ) and increased HDL-C by 118 % ( 95 % confidence interval 110.6 , 125.7 ) relative to placebo ( p Anacetrapib also reduced non-HDL-C , apolipoprotein B , and lipoprotein a and increased apolipoprotein AI versus placebo ( p the anacetrapib and placebo groups in the % patients who discontinued drug due to an adverse event or in abnormalities in liver enzymes , creatine kinase , blood pressure , electrolytes , or adjudicated cardiovascular events . Treatment with anacetrapib substantially reduced LDL-C and also increased HDL-C and was well tolerated over 24 weeks in statin-treated patients with hypercholesterolemia or low",
"BACKGROUND AND AIMS We aim ed to assess the effects of cholesteryl ester transfer protein inhibitor anacetrapib added to statin ± other lipid-modifying therapies ( LMT ) in Japanese patients with dyslipidemia who were not at their LDL-C goal . METHODS Patients on a stable dose of statin ± other LMT with LDL-C ≥100 mg/dL to anacetrapib 100 mg ( n = 204 ) or placebo ( n = 103 ) for 24 weeks , followed by a 28-week open-label extension phase ( anacetrapib 100 mg ) and a 12-week off-drug safety follow-up phase . The primary endpoint was percent change from baseline in LDL-C ( beta-quantification method ) , as well as the safety profile of anacetrapib at Week 24 ; HDL-C was a key secondary endpoint . RESULTS Anacetrapib 100 mg further reduced LDL-C ( 38.0 % ) , non-HDL-C ( 35.1 % ) , ApoB ( 28.7 % ) , and Lp(a ) ( 48.3 % ) and increased HDL-C ( 148.9 % ) and ApoAI ( 50.7 % ) versus placebo ( p the proportion of patients with liver enzymes elevations ( 2.0 % vs. 0 % ) , creatine kinase elevations overall ( 0.5 % vs. 0 % ) or with muscle symptoms ( 0.5 % vs. 0 % ) , blood pressure , electrolytes or adjudicated cardiovascular events ( 0.5 % vs. 0 % ) . In the open-label period , sustained effects on lipid parameters were observed with anacetrapib and the treatment was generally well tolerated . CONCLUSIONS Long-term treatment with anacetrapib 100 mg substantially reduced LDL-C , increased HDL-C and was well tolerated in Japanese patients with dyslipidemia ( Clinical Trials.gov number NCT01760460 )",
"Importance Some cholesteryl ester transfer protein ( CETP ) inhibitors lower low-density lipoprotein cholesterol ( LDL-C ) levels without reducing cardiovascular events , suggesting that the clinical benefit of lowering LDL-C may depend on how LDL-C is lowered . Objective To estimate the association between changes in levels of LDL-C ( and other lipoproteins ) and the risk of cardiovascular events related to variants in the CETP gene , both alone and in combination with variants in the 3-hydroxy-3-methylglutaryl-CoA reductase ( HMGCR ) gene . Design , Setting , and Participants Mendelian r and omization analyses evaluating the association between CETP and HMGCR scores , changes in lipid and lipoprotein levels , and the risk of cardiovascular events involving 102 837 participants from 14 cohort or case-control studies conducted in North America or the United Kingdom between 1948 and 2012 . The associations with cardiovascular events were externally vali date d in 189 539 participants from 48 studies conducted between 2011 and 2015 . Exposures Differences in mean high-density lipoprotein cholesterol ( HDL-C ) , LDL-C , and apolipoprotein B ( apoB ) levels in participants with CETP scores at or above vs below the median . Main Outcomes and Measures Odds ratio ( OR ) for major cardiovascular events . Results The primary analysis included 102 837 participants ( mean age , 59.9 years ; 58 % women ) who experienced 13 821 major cardiovascular events . The validation analyses included 189 539 participants ( mean age , 58.5 years ; 39 % women ) with 62 240 cases of coronary heart disease ( CHD ) . Considered alone , the CETP score was associated with higher levels of HDL-C , lower LDL-C , concordantly lower apoB , and a corresponding lower risk of major vascular events ( OR , 0.946 [ 95 % CI , 0.921 - 0.972 ] ) that was similar in magnitude to the association between the HMGCR score and risk of major cardiovascular events per unit change in levels of LDL-C ( and apoB ) . When combined with the HMGCR score , the CETP score was associated with the same reduction in LDL-C levels but an attenuated reduction in apoB levels and a corresponding attenuated nonsignificant risk of major cardiovascular events ( OR , 0.985 [ 95 % CI , 0.955 - 1.015 ] ) . In external validation analyses , a genetic score consisting of variants with naturally occurring discordance between levels of LDL-C and apoB was associated with a similar risk of CHD per unit change in apoB level ( OR , 0.782 [ 95 % CI , 0.720 - 0.845 ] vs 0.793 [ 95 % CI , 0.774 - 0.812 ] ; P = .79 for difference ) , but a significantly attenuated risk of CHD per unit change in LDL-C level ( OR , 0.916 [ 95 % CI , 0.890 - 0.943 ] vs 0.831 [ 95 % CI , 0.816 - 0.847 ] ; P LDL-C and apoB levels and a corresponding risk of cardiovascular events that was proportional to the attenuated reduction in apoB but significantly less than expected per unit change in LDL-C. The clinical benefit of lowering LDL-C levels may therefore depend on the corresponding reduction in apoB-containing lipoprotein particles",
"BACKGROUND Present guidelines emphasise the importance of low concentrations of LDL cholesterol ( LDL-C ) in patients with familial hypercholesterolaemia . In most patients with the disease , however , these concentrations are not achieved with present treatments , so additional treatment is therefore warranted . Inhibition of cholesteryl ester transfer protein has been shown to reduce LDL-C concentrations in addition to regular statin treatment in patients with hypercholesterolaemia or at high risk of cardiovascular disease . We aim ed to investigate the safety and efficacy of anacetrapib , a cholesteryl ester transfer protein inhibitor , in patients with heterozygous familial hypercholesterolaemia . METHODS In this multicentre , r and omised , double-blind , placebo-controlled , phase 3 study , patients aged 18 - 80 years with a genotype-confirmed or clinical diagnosis of heterozygous familial hypercholesterolaemia , on optimum lipid-lowering treatment for at least 6 weeks , and with an LDL-C concentration of 2·59 mmol/L or higher without cardiovascular disease or 1·81 mmol/L or higher with cardiovascular disease from 26 lipid clinics across nine countries were eligible . We r and omly allocated participants with a computer-generated allocation schedule ( 2:1 ; block size of six ; no stratification ) to oral anacetrapib 100 mg or placebo for 52 weeks , with a 12 week post-treatment follow-up afterwards . We masked patients , care providers , and those assessing outcomes to treatment groups throughout the study . The primary outcome was percentage change from baseline in LDL-C concentration . We did analysis using a constrained longitudinal repeated measures model . This trial is registered with Clinical Trials.gov , number NCT01524289 . FINDINGS Between Feb 10 , 2012 , and Feb 12 , 2014 , we r and omly allocated 204 patients to anacetrapib and 102 to placebo . One patient in the anacetrapib group did not receive the drug . At week 52 , anacetrapib reduced mean LDL-C concentration from 3·3 mmol/L ( SD 0·8 ) to 2·1 mmol/L ( 0·8 ; percentage change 36·0 % [ 95 % CI -39·5 to -32·5 ] compared with an increase with placebo from 3·4 mmol/L ( 1·2 ) to 3·5 mmol/L ( 1·6 ; percentage change 3·7 % [ -1·2 to 8·6 ] , with a difference in percentage change between anacetrapib and placebo of -39·7 % ( 95 % CI -45·7 to -33·7 ; p events was increased in patients given anacetrapib compared with those given placebo ( 4 [ 2 % ] of 203 vs none [ 0 % ] of 102 ; p=0·1544 ) , but the proportion with adverse events leading to discontinuation was similar ( 12 [ 6 % ] of 203 vs five [ 5 % ] of 102 ) . INTERPRETATION In patients with heterozygous familial hypercholesterolaemia , treatment with anacetrapib for 1 year was well tolerated and result ed in substantial reductions in LDL-C concentration . Whether this change leads to a reduction of cardiovascular events will be answered in an outcome study . FUNDING Merck & Co ,",
"BACKGROUND Dyslipidaemia remains a significant risk factor for cardiovascular disease and additional lipid-modifying treatments are warranted to further decrease the cardiovascular disease burden . We assessed the safety , tolerability and efficacy of a novel cholesterol esterase transfer protein ( CETP ) inhibitor TA-8995 in patients with mild dyslipidaemia . METHODS In this r and omised , double-blind , placebo-controlled , parallel-group phase 2 trial , we recruited patients ( aged 18 - 75 years ) from 17 sites ( hospitals and independent clinical research organisations ) in the Netherl and s and Denmark with fasting LDL cholesterol levels between 2·5 mmol/L and 4·5 mmol/L , HDL cholesterol levels between 0·8 and 1·8 mmol/L and triglyceride levels below 4·5 mmol/L after washout of lipid-lowering treatments . Patients were r and omly allocated ( 1:1 ) by a computer-generated r and omisation schedule to receive one of the following nine treatments : a once a day dose of 1 mg , 2·5 mg , 5 mg , or 10 mg TA-8995 or matching placebo ; 10 mg TA-8995 plus 20 mg atorvastatin ; 10 mg TA-8995 plus 10 mg rosuvastatin or 20 mg atorvastatin or 10 mg rosuvastatin alone . We overencapsulated statins to achieve masking . The primary outcome was percentage change in LDL cholesterol and HDL cholesterol from baseline at week 12 , analysed by intention to treat . This study is registered with Clinical Trials.gov , number NCT01970215 . FINDINGS Between Aug 15 , 2013 , and Jan 10 , 2014 , 364 patients were enrolled . At week 12 , LDL cholesterol levels were reduced by 27·4 % in patients assigned to the 1 mg dose , 32·7 % in patients given the 2·5 mg dose , 45·3 % in those given the 5 mg dose , and 45·3 % in those given the 10 mg dose ( p cholesterol levels were reduced by 68·2 % in patients given 10 mg TA-8995 plus atorvastatin , and by 63·3 % in patients given rosuvastatin plus 10 mg TA-8995 ( p mg TA-8995 increased HDL cholesterol levels by 75·8 % , 2·5 mg by 124·3 % , 5 mg by 157·1 % , and 10 mg dose by 179·0 % ( p mg TA-8995 and 20 mg atorvastatin HDL cholesterol levels increased by 152·1 % and in patients receiving 10 mg TA-8995 and 10 mg rosuvastatin by 157·5 % . We recorded no serious adverse events or signs of liver or muscle toxic effects . INTERPRETATION TA-8995 , a novel CETP inhibitor , is well tolerated and has beneficial effects on lipids and apolipoproteins in patients with mild dyslipidaemia . A cardiovascular disease outcome trial is needed to translate these effects into a reduction of cardiovascular disease events . FUNDING Dezima",
"AIMS High-density lipoprotein cholesterol ( HDL-C ) is inversely associated with cardiovascular ( CV ) events and thus an attractive therapeutic target . However , in spite of marked elevations in HDL-C , the first cholesterol transport protein ( CETP ) inhibitor torcetrapib raised blood pressure ( BP ) , impaired endothelial function , and increased CV mortality and morbidity . Dalcetrapib is a novel molecule acting on CETP with a different chemical structure to torcetrapib . As HDL stimulates nitric oxide ( NO ) , suppresses inflammation , and exerts protective CV effects , we investigated the effects of dalcetrapib on endothelial function , blood pressure , inflammatory markers , and lipids in patients with , or at risk of , coronary heart disease ( CHD ) in a double-blind r and omized placebo-controlled trial ( clinical trials.gov number NCT00655538 ) . METHODS AND RESULTS Patients with target low-density lipoprotein cholesterol ( LDL-C ) levels received dalcetrapib 600 mg/day or placebo for 36 weeks on top of st and ard therapy ( including statins ) . The primary outcome measures were the change from baseline of flow-mediated dilatation ( % FMD ) of the right brachial artery after 5 min of cuff occlusion at 12 weeks and the 24 h ambulatory blood pressure monitoring ( ABPM ) at week 4 . Secondary outcomes included change from baseline in FMD after 36 weeks and the change in ABPM at 12 and 36 weeks , changes in HDL-C , LDL-C , triglycerides , CETP activity , as well as st and ard safety parameters . Four hundred seventy-six patients were r and omized . Baseline FMD was 4.1 ± 2.2 and 4.0 ± 2.4 % with placebo or dalcetrapib , respectively and did not change significantly from placebo after 12 and 36 weeks ( P = 0.1764 and 0.9515 , respectively ) . After 4 , 24 , and 36 weeks of treatment with dalcetrapib , CETP activity decreased by 51 , 53 , and 56 % ( placebo corrected , all P 12 , and 36 HDL-C increased by 25 , 27 , and 31 % ( placebo corrected , all P did not change . At baseline , ABPM was 125 ± 12/74 ± 8mmHg in the placebo and 128 ± 11/75 ± 7mmHg in the dalcetrapib group ( P = 0.3372 and 0.1248 , respectively , placebo-corrected change from baseline ) and did not change for up to 36 weeks . Biomarkers of inflammation , oxidative stress , and coagulation did not change during follow-up except for Lp-PLA(2 ) mass levels which increased by 17 % ( placebo corrected ) . Overall 7 patients given dalcetrapib and 8 patients given placebo experienced at least one pre-specified adjudicated event ( 11 events with dalcetrapib and 12 events with placebo ) . CONCLUSION The dal-VESSEL trial has established the tolerability and safety of CETP-inhibition with dalcetrapib in patients with or at risk of CHD . Dalcetrapib reduced CETP activity and increased HDL-C levels without affecting NO-dependent endothelial function , blood pressure , or markers of inflammation and oxidative stress . The dal- OUTCOMES trial ( NCT00658515 ) will show whether dalcetrapib improves outcomes in spite of a lack of effect on endothelial function ",
"BACKGROUND Anacetrapib is a cholesteryl ester transfer protein inhibitor that raises high-density lipoprotein ( HDL ) cholesterol and reduces low-density lipoprotein ( LDL ) cholesterol . METHODS We conducted a r and omized , double-blind , placebo-controlled trial to assess the efficacy and safety profile of anacetrapib in patients with coronary heart disease or at high risk for coronary heart disease . Eligible patients who were taking a statin and who had an LDL cholesterol level that was consistent with that recommended in guidelines were assigned to receive 100 mg of anacetrapib or placebo daily for 18 months . The primary end points were the percent change from baseline in LDL cholesterol at 24 weeks ( HDL cholesterol level was a secondary end point ) and the safety and side-effect profile of anacetrapib through 76 weeks . Cardiovascular events and deaths were prospect ively adjudicated . RESULTS A total of 1623 patients underwent r and omization . By 24 weeks , the LDL cholesterol level had been reduced from 81 mg per deciliter ( 2.1 mmol per liter ) to 45 mg per deciliter ( 1.2 mmol per liter ) in the anacetrapib group , as compared with a reduction from 82 mg per deciliter ( 2.1 mmol per liter ) to 77 mg per deciliter ( 2.0 mmol per liter ) in the placebo group (P anacetrapib beyond that seen with placebo . In addition , the HDL cholesterol level increased from 41 mg per deciliter ( 1.0 mmol per liter ) to 101 mg per deciliter ( 2.6 mmol per liter ) in the anacetrapib group , as compared with an increase from 40 mg per deciliter ( 1.0 mmol per liter ) to 46 mg per deciliter ( 1.2 mmol per liter ) in the placebo group (P anacetrapib beyond that seen with placebo . Through 76 weeks , no changes were noted in blood pressure or electrolyte or aldosterone levels with anacetrapib as compared with placebo . Prespecified adjudicated cardiovascular events occurred in 16 patients treated with anacetrapib ( 2.0 % ) and 21 patients receiving placebo ( 2.6 % ) ( P = 0.40 ) . The prespecified Bayesian analysis indicated that this event distribution provided a predictive probability ( confidence ) of 94 % that anacetrapib would not be associated with a 25 % increase in cardiovascular events , as seen with torcetrapib . CONCLUSIONS Treatment with anacetrapib had robust effects on LDL and HDL cholesterol , had an acceptable side-effect profile , and , within the limits of the power of this study , did not result in the adverse cardiovascular effects observed with torcetrapib . ( Funded by Merck Research Laboratories ; Clinical Trials.gov number , NCT00685776 . )",
"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 Dalcetrapib modulates cholesteryl ester transfer protein ( CETP ) activity to raise high-density lipoprotein cholesterol ( HDL-C ) . After the failure of torcetrapib it was unknown if HDL produced by interaction with CETP had pro-atherogenic or pro-inflammatory properties . dal-PLAQUE is the first multicentre study using novel non-invasive multimodality imaging to assess structural and inflammatory indices of atherosclerosis as primary endpoints . METHODS In this phase 2b , double-blind , multicentre trial , patients ( aged 18 - 75 years ) with , or with high risk of , coronary heart disease were r and omly assigned ( 1:1 ) to dalcetrapib 600 mg/day or placebo for 24 months . R and omisation was done with a computer-generated r and omisation code and was stratified by centre . Patients and investigators were masked to treatment . Co primary endpoints were MRI-assessed indices ( total vessel area , wall area , wall thickness , and normalised wall index [ average carotid ] ) after 24 months and (18)F-fluorodeoxyglucose ( (18)F-FDG ) PET/CT assessment of arterial inflammation within an index vessel ( right carotid , left carotid , or ascending thoracic aorta ) after 6 months , with no-harm boundaries established before unblinding of the trial . Analysis was by intention to treat . This trial is registered at Clinical Trials.gov , NCT00655473 . FINDINGS 189 patients were screened and 130 r and omly assigned to placebo ( 66 patients ) or dalcetrapib ( 64 patients ) . For the co primary MRI and PET/CT endpoints , CIs were below the no-harm boundary or the adverse change was numerically lower in the dalcetrapib group than in the placebo group . MRI-derived change in total vessel area was reduced in patients given dalcetrapib compared with those given placebo after 24 months ; absolute change from baseline relative to placebo was -4·01 mm(2 ) ( 90 % CI -7·23 to -0·80 ; nominal p=0·04 ) . The PET/CT measure of index vessel most-diseased-segment target-to- background ratio ( TBR ) was not different between groups , but carotid artery analysis showed a 7 % reduction in most-diseased-segment TBR in the dalcetrapib group compared with the placebo group ( -7·3 [ 90 % CI -13·5 to -0·8 ] ; nominal p=0·07 ) . Dalcetrapib did not increase office blood pressure and the frequency of adverse events was similar between groups . INTERPRETATION Dalcetrapib showed no evidence of a pathological effect related to the arterial wall over 24 months . Moreover , this trial suggests possible beneficial vascular effects of dalcetrapib , including the reduction in total vessel enlargement over 24 months , but long-term safety and clinical outcomes efficacy of dalcetrapib need to be analysed . FUNDING F Hoffmann-La Roche",
"Aims Co- primary objectives were to evaluate dalcetrapib ( JTT-705/RO4607381 ) , which targets cholesteryl ester transfer protein ( CETP ) , effects on high-density lipoprotein cholesterol ( HDL-C ) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenteric lymph nodes . Methods and results Double-blind trial with participants r and omized ( 2:1 ) to dalcetrapib 900 mg/day ( higher than 600 mg phase III dose ) or placebo , both with atorvastatin , for 24 weeks ( n = 135 ; one without post-baseline efficacy data was excluded from intent-to-treat population ) ; a subset continued for 24-week extension ( n = 77 ) . Lipid changes and safety parameters were assessed . Mesenteric lymph nodes were evaluated by magnetic resonance imaging . Dalcetrapib increased HDL-C ( 33.4 % , Week 24 ; 33.8 % , Week 48 ) , decreased CETP activity ( –53.5 % , Week 24 ; –56.5 % , Week 48 ) , and increased apolipoprotein A-I ( 11.4 % , Week 24 ; 16.4 % , Week 48 ) . Dalcetrapib showed no clinical ly relevant differences vs. placebo in adverse events , laboratory parameters including aldosterone , electrocardiograms , and vital signs including blood pressure ( BP ) . Dalcetrapib had no measurable , clinical ly relevant effect on lymph node size . Conclusion Dalcetrapib 900 mg administered for up to 48 weeks showed no clinical ly relevant changes in lymph nodes , BP , or other safety parameters . Dalcetrapib effectively increased HDL-C over 48 weeks of treatment",
"To assess the effects of anacetrapib added to statin ± other lipid-modifying therapies in patients with hypercholesterolemia and not at their low-density lipoprotein cholesterol ( LDL-C ) goal ( as per National Cholesterol Education Program Adult Treatment Panel III [ NCEP ATP III ] guidelines ) and in those with low high-density lipoprotein cholesterol ( HDL-C ) . Patients on a stable dose of moderate/high-intensity statin ± other lipid-modifying therapies with LDL-C ≥70 , ≥100 , ≥130 , or ≥160 mg/dl for very high , high , moderate , and low coronary heart disease risk , respectively , or at LDL-C goal with HDL-C ≤40 mg/dl , were r and omized 1:1:1 , stratified by background therapy use , to anacetrapib 100 mg ( n = 153 ) , anacetrapib 25 mg ( n = 152 ) , or placebo ( n = 154 ) for 24 weeks , followed by a 12-week off-drug reversal phase . The primary end points were percent change from baseline in LDL-C ( beta-quantification method ) and HDL-C , as well as the safety profile of anacetrapib . Both doses of anacetrapib reduced LDL-C , non-HDL-C , apolipoprotein ( Apo ) B , and lipoprotein a and increased HDL-C and Apo AI versus placebo ( p the anacetrapib 25 mg , 100 mg , and placebo groups in the proportions of discontinuations due to drug-related adverse events ( 0.7 % , 1.3 % vs 1.3 % ) or in abnormalities in liver enzymes ( 0 % , 0 % vs 0.7 % ) , creatine kinase elevations overall ( 0 % , 0.7 % vs 0 % ) or with muscle symptoms ( none seen ) , blood pressure , electrolytes , or adjudicated cardiovascular events ( 0.7 % , 0.7 % vs 1.3 % ) . In conclusion , treatment with anacetrapib result ed in substantial reductions in LDL-C and increases in HDL-C and was generally well tolerated ",
"BACKGROUND The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high‐density lipoprotein ( HDL ) cholesterol level , reduces the low‐density lipoprotein ( LDL ) cholesterol level , and enhances cellular cholesterol efflux capacity . We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high‐risk vascular disease . METHODS In a multicenter , r and omized , double‐blind , placebo‐controlled phase 3 trial , we enrolled 12,092 patients who had at least one of the following conditions : an acute coronary syndrome within the previous 30 to 365 days , cerebrovascular atherosclerotic disease , peripheral vascular arterial disease , or diabetes mellitus with coronary artery disease . Patients were r and omly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo , administered daily , in addition to st and ard medical therapy . The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes , myocardial infa rct ion , stroke , coronary revascularization , or hospitalization for unstable angina . RESULTS At 3 months , a 31.1 % decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0 % increase with placebo , and a 133.2 % increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6 % increase with placebo . After 1363 of the planned 1670 primary end‐point events had occurred , the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy . After a median of 26 months of evacetrapib or placebo , a primary end‐point event occurred in 12.9 % of the patients in the evacetrapib group and in 12.8 % of those in the placebo group ( hazard ratio , 1.01 ; 95 % confidence interval , 0.91 to 1.11 ; P=0.91 ) . CONCLUSIONS Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers , treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high‐risk vascular disease . ( Funded by Eli Lilly ; ACCELERATE Clinical Trials.gov number , NCT01687998 .",
"BACKGROUND Inhibition of cholesteryl ester transfer protein ( CETP ) has been shown to have a substantial effect on plasma lipoprotein levels . We investigated whether torcetrapib , a potent CETP inhibitor , might reduce major cardiovascular events . The trial was terminated prematurely because of an increased risk of death and cardiac events in patients receiving torcetrapib . METHODS We conducted a r and omized , double-blind study involving 15,067 patients at high cardiovascular risk . The patients received either torcetrapib plus atorvastatin or atorvastatin alone . The primary outcome was the time to the first major cardiovascular event , which was defined as death from coronary heart disease , nonfatal myocardial infa rct ion , stroke , or hospitalization for unstable angina . RESULTS At 12 months in patients who received torcetrapib , there was an increase of 72.1 % in high-density lipoprotein cholesterol and a decrease of 24.9 % in low-density lipoprotein cholesterol , as compared with baseline ( P systolic blood pressure , a decrease in serum potassium , and increases in serum sodium , bicarbonate , and aldosterone ( P risk of cardiovascular events ( hazard ratio , 1.25 ; 95 % confidence interval [ CI ] , 1.09 to 1.44 ; P=0.001 ) and death from any cause ( hazard ratio , 1.58 ; 95 % CI , 1.14 to 2.19 ; P=0.006 ) . Post hoc analyses showed an increased risk of death in patients treated with torcetrapib whose reduction in potassium or increase in bicarbonate was greater than the median change . CONCLUSIONS Torcetrapib therapy result ed in an increased risk of mortality and morbidity of unknown mechanism . Although there was evidence of an off-target effect of torcetrapib , we can not rule out adverse effects related to CETP inhibition . ( Clinical Trials.gov number , NCT00134264 [ Clinical Trials.gov ] . )",
"The cholesteryl ester transfer protein ( CETP ) inhibitor evacetrapib has been previously shown to increase high-density lipoprotein cholesterol ( HDL-C ) and decrease low-density lipoprotein cholesterol ( LDL-C ) levels , as monotherapy or in combination with statins . In this study , 165 Japanese patients with elevated LDL-C or low HDL-C levels were r and omly assigned to receive placebo , evacetrapib monotherapy 30 mg , 100 mg , or 500 mg , atorvastatin 10 mg , or evacetrapib 100 mg in combination with atorvastatin 10 mg . After 12 weeks , evacetrapib monotherapy increased HDL-C levels by 74 % , 115 % , and 136 % and decreased LDL-C levels by 15 % , 23 % , and 22 % and CETP activity by 50 % , 83 % , and 95 % ( for the 30-mg , 100-mg , and 500-mg dose groups , respectively ) versus placebo . In combination with atorvastatin 10 mg , evacetrapib 100 mg increased HDL-C levels by 103 % and decreased LDL-C levels by 15 % and CETP activity by 68 % versus atorvastatin alone . After a 4- to 6-week washout , HDL-C , LDL-C , and CETP mass and activity returned to baseline levels in the evacetrapib-treated groups , and most patients had evacetrapib concentrations below the quantitation limit . Evacetrapib monotherapy or in combination with atorvastatin was not likely to be associated with any significant change in blood pressure and did not have any adverse effects on mineralocorticoid or glucocorticoid measures . Notably , plasma evacetrapib concentrations were mostly undetectable , and all pharmacodynamic biomarkers ( HDL-C and LDL-C levels and CETP mass and activity ) returned to baseline after a 4- to 6-week washout . In conclusion , evacetrapib as monotherapy or in combination with atorvastatin effectively decreased CETP activity and LDL-C levels and increased HDL-C levels after 12 weeks in Japanese patients with dyslipidemia"
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