human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Health risks associated with obesity are well known and compliance with st and ard regimens for weight reduction is frequently unsatisfactory . Fluoxetine is a specific inhibitor of serotonin re-uptake with very minimal affinity for serotonergic or other receptors . It causes a decrement in food intake in animals . Placebo or fluoxetine was given for up to 8 weeks to non-depressed , otherwise healthy , obese patients given minimal dietary advice . Patients given fluoxetine  lost 4.5 + /- 4.0 kg , significantly more than those receiving placebo , 1.4 + /- 0.1 kg . The weight loss was correlated with the degree of obesity in the  fluoxetine-treated patients .  Asthenia was the only event reported significantly more frequently by fluoxetine-treated patients ( 23 percent ) than by those treated with placebo ( 3 percent ) ( P less than 0.01 ) . Fluoxetine appears to be safe and effective in inducing weight loss over periods of up to 8 weeks 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 : Obesity is a very important risk factor for cardiovascular disease , type 2 diabetes mellitus , hypertension , osteoarthritis , fatty liver , metabolic syndrome and respiratory problems . Many weight-reducing drugs can not be used in obese patients because of numerous complications . Fluoxetine , an antidepressant , and metformin , an antidiabetic drug , reduce weight as their side effect , but the potency of each drug is not always enough . Here , we studied the effects of combination therapy of them for weight reduction in obese women . Material s and methods : This study was design ed as an open , prospect i ve , controlled clinical trial . Obese and overweight patients referred to obesity clinics were first put under a diet and behavior therapy education program before being invited to this study . The patients who accepted drug therapy were put in the case group . Those who did not accept drug therapy were put in the control group . Fluoxetine , 20 mg daily , and metformin , 500 mg three times daily , were prescribed to the participants . Weight and body mass index ( BMI ) changes within case and control groups were analyzed by paired t-tests and between groups by t-testing . Side effects were evaluated by interview and question naire . Subjects : Two hundred and three patients were referred to obesity clinics . Of these , 177 were female with 91 being volunteers for this study . Of this 91 , 66 were in the case group and 25 in the control group . Results : In a 6.68-month period , a 7.89 kg decrease in weight ( 9.32 % ) and a 3.43 U decrease in BMI ( 10.14 % ) were observed in participants of the case group that was statistically significant ( P<0.0001 ) . The participants of the control group were followed for a mean period of 8.12 months . In this period , the participants of the control group showed a 0.48 kg decrease in weight ( 0.52 % ) and a 0.11 U decrease in BMI ( 0.42 % ) . This was not significant . No serious side effects of the drugs were observed in the case group . Conclusion : This open-label pilot study of combination therapy of metformin and fluoxetine gave encouraging weight reduction , and these results suggest the need for a r and omized double-blind clinical trial comparing the two components and the combination to placebo PURPOSE We aim ed to assess the impact of spin ( ie , reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results ) on the interpretation of results of abstract s of r and omized controlled trials ( RCTs ) in the field of cancer . METHODS We performed a two-arm , parallel-group RCT . We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion . Two versions of these abstract s were used-the original with spin and a rewritten version without spin . Participants were clinician corresponding authors of articles reporting RCTs , investigators of trials , and review ers of French national grants . The primary outcome was clinicians ' interpretation of the beneficial effect of the experimental treatment ( 0 to 10 scale ) . Participants were blinded to study hypothesis . RESULTS Three hundred clinicians were r and omly assigned using a Web-based system ; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin . For abstract s with spin , the experimental treatment was rated as being more beneficial ( mean difference , 0.71 ; 95 % CI , 0.07 to 1.35 ; P = .030 ) , the trial was rated as being less rigorous ( mean difference , -0.59 ; 95 % CI , -1.13 to 0.05 ; P = .034 ) , and clinicians were more interested in reading the full-text article ( mean difference , 0.77 ; 95 % CI , 0.08 to 1.47 ; P = .029 ) . There was no statistically significant difference in the clinicians ' rating of the importance of the study or the need to run another trial . CONCLUSION Spin in abstract s can have an impact on clinicians ' interpretation of the trial results Humans lose weight when administered fluoxetine , an inhibitor of serotonin reuptake by nerve terminals . To determine whether increased energy expenditure contributes to this weight loss we admitted 20 nondepressed obese women to a metabolic unit where they were r and omly assigned to 3 wk of a 1.76-MJ/d formula diet and either 60 mg fluoxetine/d or a placebo .  Resting energy expenditure of the control subjects fell below normal after 5.6 + /- 0.6 d of energy restriction , whereas that of the fluoxetine-treated subjects increased by 4.4 + /- 1.8 % ( P < 0.005 ) within 3 d of commencing treatment . This increased resting energy expenditure then reversed and fell below normal after 9.8 + /- 0.9 d of energy restriction . Basal body temperature of the control subjects decreased insignificantly during the period of energy restriction , but that of the fluoxetine-treated subjects increased by 0.28 + /- 0.10 degrees C ( P < 0.05 ) within 3 d of commencing diet and drug treatment . Urinary norepinephrine excretion and the serum triiodothyronine concentration decreased equally in both groups . Despite identical energy intakes and equal nitrogen balance , the fluoxetine-treated subjects lost weight faster than the control subjects during the final week of energy restriction ( P < 0.05 ) . We propose that serotonin reuptake inhibition increases energy expenditure by increasing basal body temperature Forty-five obese subjects with a mean weight of 102.9 kg and a body mass index ( in kg/m2 ) of 37.6 were r and omly assigned to a fluoxetine-diet group ( n = 23 ) or a placebo-diet group ( n = 22 ) for 52 wk . At week 29 , 14 subjects on fluoxetine who completed the study attained their maximum weight loss of 12.4 kg , an amount significantly greater than the maximum weight loss of 4.5 kg for the 16 on placebo who completed the study . The fluoxetine group 's significantly greater mean weight loss continued through week 45 . However , those on fluoxetine  regained a mean of 4.2 kg from their lowest weight ( P less than 0.001 ) whereas the placebo group did not . By the end of the study , each group weighed significantly less than they did at baseline ( fluoxetine : -8.2 kg ; placebo : -4.5 kg ; P less than 0.05 ) although the difference between groups was no longer significant ( P greater than 0.05 ) . Several factors were considered as possible causes for the regain with fluoxetine OBJECTIVE The study aims to provide information about variance components of psychosocial outcomes : within and between-participant variance , within-participant correlation and for cluster r and omised trials , the intra-cluster correlation ( ICC ) and , also , to demonstrate how estimates of these variance components and ICCs can be used to design r and omised trials and cluster r and omised trials . METHOD Data from 15 longitudinal multi-centre psycho-oncology studies were analysed , and variance components including ICCs were estimated . Studies with psychosocial outcomes that had at least one measurement post-baseline including individual r and omised controlled trials , cluster r and omised trials and observational studies were included . RESULTS Variance components and ICCs from 87 outcome measures were estimated . The unadjusted , single timepoint ( first post-baseline ) ICCs ranged from 0 to 0.16 , with a median value of 0.022 and inter-quartile range 0 to 0.0605 . The longitudinal ICCs ranged from 0 to 0.09 with a median value of 0.0007 and inter-quartile range 0 to 0.018 . CONCLUSIONS Although the magnitude of variance components and ICCs used for sample -size calculation can not be known in advance of the study , published estimates can help reduce the uncertainty in sample -size calculations . Psycho-oncology research ers should be conservative in their sample -size calculations and use approaches that improve efficiency in their design and analysis 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 AIMS Nicotine replacement therapy ( NRT ) is an established aid in stopping smoking , while the role of antidepressants remains uncertain . Antidepressants added to NRT might improve abstinence rates . Our aim was to determine the efficacy of nicotine inhaler and fluoxetine vs. nicotine inhaler and placebo in attempts to quit smoking . DESIGN A r and omized , double-blind , placebo-controlled trial . SETTING A smoker 's cessation clinic . PARTICIPANTS One hundred volunteers smoking 10 cigarettes/day or more . INTERVENTIONS Subjects were instructed to start taking a daily dose of 10 mg of fluoxetine or placebo 16 days before stopping smoking , then 20 mg 10 days before quitting , continuing for up to at least 3 months . Subjects were instructed to use 6 - 12 units per day of nicotine inhalers after stopping smoking for up to 6 months . MEASUREMENTS Continuous abstinence rates recorded at various time points up to 12 months from the quit date . FINDINGS The sustained abstinence rate for the inhaler-fluoxetine group was 54 % , 40 % , 29 % and 21 % after 1.5 , 3 , 6 and 12 months , respectively , compared to 48 % , 40 % , 32 % and 23 % for the inhaler-placebo group . The differences were not significant at any time point . Abstinence up to 3 months was more likely in older smokers , those with a lower Beck Depression Inventory Score ( BDI ) , lower Fagerström Test of Nicotine Dependence ( FTND ) score and no history of alcoholism . Fluoxetine appeared to increase abstinence rates among high BDI smokers compared to high BDI smokers assigned placebo .  Serum levels of nicotine during treatment in 
    Output:
    
agent
Low-certainty evidence suggests that off-label fluoxetine may decrease weight compared with placebo .
However , low-certainty evidence suggests an increase in the risk for dizziness , drowsiness , fatigue , insomnia and nausea following fluoxetine treatment
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Health risks associated with obesity are well known and compliance with st and ard regimens for weight reduction is frequently unsatisfactory . Fluoxetine is a specific inhibitor of serotonin re-uptake with very minimal affinity for serotonergic or other receptors . It causes a decrement in food intake in animals . Placebo or fluoxetine was given for up to 8 weeks to non-depressed , otherwise healthy , obese patients given minimal dietary advice . Patients given fluoxetine  lost 4.5 + /- 4.0 kg , significantly more than those receiving placebo , 1.4 + /- 0.1 kg . The weight loss was correlated with the degree of obesity in the  fluoxetine-treated patients .  Asthenia was the only event reported significantly more frequently by fluoxetine-treated patients ( 23 percent ) than by those treated with placebo ( 3 percent ) ( P less than 0.01 ) . Fluoxetine appears to be safe and effective in inducing weight loss over periods of up to 8 weeks 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 : Obesity is a very important risk factor for cardiovascular disease , type 2 diabetes mellitus , hypertension , osteoarthritis , fatty liver , metabolic syndrome and respiratory problems . Many weight-reducing drugs can not be used in obese patients because of numerous complications . Fluoxetine , an antidepressant , and metformin , an antidiabetic drug , reduce weight as their side effect , but the potency of each drug is not always enough . Here , we studied the effects of combination therapy of them for weight reduction in obese women . Material s and methods : This study was design ed as an open , prospect i ve , controlled clinical trial . Obese and overweight patients referred to obesity clinics were first put under a diet and behavior therapy education program before being invited to this study . The patients who accepted drug therapy were put in the case group . Those who did not accept drug therapy were put in the control group . Fluoxetine , 20 mg daily , and metformin , 500 mg three times daily , were prescribed to the participants . Weight and body mass index ( BMI ) changes within case and control groups were analyzed by paired t-tests and between groups by t-testing . Side effects were evaluated by interview and question naire . Subjects : Two hundred and three patients were referred to obesity clinics . Of these , 177 were female with 91 being volunteers for this study . Of this 91 , 66 were in the case group and 25 in the control group . Results : In a 6.68-month period , a 7.89 kg decrease in weight ( 9.32 % ) and a 3.43 U decrease in BMI ( 10.14 % ) were observed in participants of the case group that was statistically significant ( P<0.0001 ) . The participants of the control group were followed for a mean period of 8.12 months . In this period , the participants of the control group showed a 0.48 kg decrease in weight ( 0.52 % ) and a 0.11 U decrease in BMI ( 0.42 % ) . This was not significant . No serious side effects of the drugs were observed in the case group . Conclusion : This open-label pilot study of combination therapy of metformin and fluoxetine gave encouraging weight reduction , and these results suggest the need for a r and omized double-blind clinical trial comparing the two components and the combination to placebo PURPOSE We aim ed to assess the impact of spin ( ie , reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results ) on the interpretation of results of abstract s of r and omized controlled trials ( RCTs ) in the field of cancer . METHODS We performed a two-arm , parallel-group RCT . We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion . Two versions of these abstract s were used-the original with spin and a rewritten version without spin . Participants were clinician corresponding authors of articles reporting RCTs , investigators of trials , and review ers of French national grants . The primary outcome was clinicians ' interpretation of the beneficial effect of the experimental treatment ( 0 to 10 scale ) . Participants were blinded to study hypothesis . RESULTS Three hundred clinicians were r and omly assigned using a Web-based system ; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin . For abstract s with spin , the experimental treatment was rated as being more beneficial ( mean difference , 0.71 ; 95 % CI , 0.07 to 1.35 ; P = .030 ) , the trial was rated as being less rigorous ( mean difference , -0.59 ; 95 % CI , -1.13 to 0.05 ; P = .034 ) , and clinicians were more interested in reading the full-text article ( mean difference , 0.77 ; 95 % CI , 0.08 to 1.47 ; P = .029 ) . There was no statistically significant difference in the clinicians ' rating of the importance of the study or the need to run another trial . CONCLUSION Spin in abstract s can have an impact on clinicians ' interpretation of the trial results Humans lose weight when administered fluoxetine , an inhibitor of serotonin reuptake by nerve terminals . To determine whether increased energy expenditure contributes to this weight loss we admitted 20 nondepressed obese women to a metabolic unit where they were r and omly assigned to 3 wk of a 1.76-MJ/d formula diet and either 60 mg fluoxetine/d or a placebo .  Resting energy expenditure of the control subjects fell below normal after 5.6 + /- 0.6 d of energy restriction , whereas that of the fluoxetine-treated subjects increased by 4.4 + /- 1.8 % ( P < 0.005 ) within 3 d of commencing treatment . This increased resting energy expenditure then reversed and fell below normal after 9.8 + /- 0.9 d of energy restriction . Basal body temperature of the control subjects decreased insignificantly during the period of energy restriction , but that of the fluoxetine-treated subjects increased by 0.28 + /- 0.10 degrees C ( P < 0.05 ) within 3 d of commencing diet and drug treatment . Urinary norepinephrine excretion and the serum triiodothyronine concentration decreased equally in both groups . Despite identical energy intakes and equal nitrogen balance , the fluoxetine-treated subjects lost weight faster than the control subjects during the final week of energy restriction ( P < 0.05 ) . We propose that serotonin reuptake inhibition increases energy expenditure by increasing basal body temperature Forty-five obese subjects with a mean weight of 102.9 kg and a body mass index ( in kg/m2 ) of 37.6 were r and omly assigned to a fluoxetine-diet group ( n = 23 ) or a placebo-diet group ( n = 22 ) for 52 wk . At week 29 , 14 subjects on fluoxetine who completed the study attained their maximum weight loss of 12.4 kg , an amount significantly greater than the maximum weight loss of 4.5 kg for the 16 on placebo who completed the study . The fluoxetine group 's significantly greater mean weight loss continued through week 45 . However , those on fluoxetine  regained a mean of 4.2 kg from their lowest weight ( P less than 0.001 ) whereas the placebo group did not . By the end of the study , each group weighed significantly less than they did at baseline ( fluoxetine : -8.2 kg ; placebo : -4.5 kg ; P less than 0.05 ) although the difference between groups was no longer significant ( P greater than 0.05 ) . Several factors were considered as possible causes for the regain with fluoxetine OBJECTIVE The study aims to provide information about variance components of psychosocial outcomes : within and between-participant variance , within-participant correlation and for cluster r and omised trials , the intra-cluster correlation ( ICC ) and , also , to demonstrate how estimates of these variance components and ICCs can be used to design r and omised trials and cluster r and omised trials . METHOD Data from 15 longitudinal multi-centre psycho-oncology studies were analysed , and variance components including ICCs were estimated . Studies with psychosocial outcomes that had at least one measurement post-baseline including individual r and omised controlled trials , cluster r and omised trials and observational studies were included . RESULTS Variance components and ICCs from 87 outcome measures were estimated . The unadjusted , single timepoint ( first post-baseline ) ICCs ranged from 0 to 0.16 , with a median value of 0.022 and inter-quartile range 0 to 0.0605 . The longitudinal ICCs ranged from 0 to 0.09 with a median value of 0.0007 and inter-quartile range 0 to 0.018 . CONCLUSIONS Although the magnitude of variance components and ICCs used for sample -size calculation can not be known in advance of the study , published estimates can help reduce the uncertainty in sample -size calculations . Psycho-oncology research ers should be conservative in their sample -size calculations and use approaches that improve efficiency in their design and analysis 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 AIMS Nicotine replacement therapy ( NRT ) is an established aid in stopping smoking , while the role of antidepressants remains uncertain . Antidepressants added to NRT might improve abstinence rates . Our aim was to determine the efficacy of nicotine inhaler and fluoxetine vs. nicotine inhaler and placebo in attempts to quit smoking . DESIGN A r and omized , double-blind , placebo-controlled trial . SETTING A smoker 's cessation clinic . PARTICIPANTS One hundred volunteers smoking 10 cigarettes/day or more . INTERVENTIONS Subjects were instructed to start taking a daily dose of 10 mg of fluoxetine or placebo 16 days before stopping smoking , then 20 mg 10 days before quitting , continuing for up to at least 3 months . Subjects were instructed to use 6 - 12 units per day of nicotine inhalers after stopping smoking for up to 6 months . MEASUREMENTS Continuous abstinence rates recorded at various time points up to 12 months from the quit date . FINDINGS The sustained abstinence rate for the inhaler-fluoxetine group was 54 % , 40 % , 29 % and 21 % after 1.5 , 3 , 6 and 12 months , respectively , compared to 48 % , 40 % , 32 % and 23 % for the inhaler-placebo group . The differences were not significant at any time point . Abstinence up to 3 months was more likely in older smokers , those with a lower Beck Depression Inventory Score ( BDI ) , lower Fagerström Test of Nicotine Dependence ( FTND ) score and no history of alcoholism . Fluoxetine appeared to increase abstinence rates among high BDI smokers compared to high BDI smokers assigned placebo .  Serum levels of nicotine during treatment in 
    Output:
    