***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: The efficacy and safety of lisdexamfetamine dimesylate ( LDX ) vs placebo in binge eating disorder ( BED ) was evaluated in two multicenter , double-blind , placebo-controlled trials . Adults ( study 1 , n=383 ; study 2 , n=390 ) meeting DSM-IV-TR BED criteria were r and omized ( 1:1 ) to  placebo  or LDX ( 50 or 70 mg/day ) dose titration ; optimized doses were maintained to the end of double-blind treatment ( week 12/early termination ) . Change from baseline in binge eating days/week at weeks 11−12 ( primary efficacy endpoint ) was assessed with mixed-effects models for repeated measures . Secondary endpoints related to binge eating and medical parameters , safety , and treatment compliance were also assessed . Least squares mean ( 95 % CI ) treatment differences for change from baseline binge eating days/week at weeks 11–12 significantly favored LDX ( study 1 : –1.35 [ –1.70 , –1.01 ] ; study 2 : –1.66 [ –2.04 , –1.28 ] ; both P<0.001 ) . In both studies , treatment-emergent adverse events ( TEAEs ) reported by ⩾10 % of LDX participants were dry mouth , insomnia , and headache . Serious TEAEs occurred in two ( 1.1 % ) placebo participants in each study and in three ( 1.6 % ) and one ( 0.6 % ) LDX participants in study 1 and study 2 , respectively . Across studies , mean increases from baseline at week 12/early termination with LDX for pulse and systolic and diastolic blood pressure ranged from 4.41–6.31 b.p.m . and 0.2–1.45 and 1.06–1.83 mm Hg , respectively . LDX ( 50 and 70 mg/day ) was superior to placebo in decreasing binge eating days/week from baseline and improving binge eating – related key secondary endpoints . Safety results appear consistent with the known safety profile of LDX 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 Lisdexamfetamine dimesylate ( LDX ) demonstrated efficacy in terms of reduced binge eating days per week in adults with binge eating disorder ( BED ) in two r and omized clinical trials ( RCTs ) . Objective The objective of this study was to evaluate the cost effectiveness of LDX versus no pharmacotherapy ( NPT ) in adults with BED from a USA healthcare payer ’s perspective . Study Design and Methods A decision-analytic Markov cohort model was developed using 1-week cycles and a 52-week time horizon . Markov health states were defined based upon the Diagnostic and Statistical Manual of Mental Disorders , 5th Edition criteria of BED . Model parameter estimates were obtained from RCTs , a survey , and literature . The primary outcome was incremental cost-effectiveness ratio ( ICER ) . The analysis assumed a 12-week course of treatment , based upon RCTs ’ treatment duration . One-way deterministic and probabilistic sensitivity analyses were conducted to assess the robustness of the results . Results Patients on LDX therapy gained 0.006 quality -adjusted life years ( QALY ) compared to patients on the NPT arm , while the average total cost was US$ 175 higher for LDX therapy . The estimated ICER  for LDX compared with NPT was US$ 27,618 per QALY , which was shown to be cost effective given a willingness-to-pay threshold of US$ 50,000 . Conclusions Treatment of BED with LDX showed increase in QALYs at an acceptable cost and is considered to be cost effective at the commonly used willingness-to-pay threshold in the USA . Based on the available evidence , the current model focused on short-term benefits only . There is a need to generate additional scientific evidence supporting long-term benefits of LDX therapy for BED OBJECTIVE Establish the Yale-Brown obsessive compulsive scale modified for binge eating ( YBOCS-BE ) as a fit for purpose measure of treatment benefit in clinical trials of binge eating disorder ( BED ) . METHODS YBOCS-BE psychometric properties were evaluated with data from a Phase 2 r and omized controlled trial of lisdexamfetamine dimesylate in 260 adults with BED . Assessment s included : Cohen 's effect size estimates of item-level sensitivity and scale-level external responsiveness ; item-to-total correlations ; Cronbach 's alpha for internal consistency reliability ; Spearman correlations against reference measures for construct validity ; known-groups analyses for discriminating ability ; t tests of within-group differences between baseline and post baseline visits for internal responsiveness ; and multiple anchor-based approaches to estimate minimum clinical ly important change ( MCIC ) . RESULTS No significant distribution anomalies were seen . Items appear sensitive to treatment group differences . Item-to-total correlations were positive . Internal consistency is 0.81 . Large correlations ( > 0.50 ) were seen between YBOCS-BE score change and the Clinical Global Impression-Improvement ( CGI-I ; 0.58 ) and score changes for the following ; number of binge days ( 0.38 ) , Clinical Global Impression-Severity ( CGI-S ; 0.57 ) , the disinhibition ( 0.57 ) and hunger ( 0.52 ) subscales of the Three-Factor Eating Question naire ( TFEQ ) , and the Barratt Impulsiveness Scale ( BIS-11 ; 0.58 ) . MCIC estimates range from -4 to -17 . DISCUSSION The YBOCS-BE was found to be a reliable and valid measure of an important and unique concept in BED-related clinical studies . Study limitations include using protocol -defined BED severity level and the exclusion of psychiatric comorbidities IMPORTANCE  Binge-eating disorder ( BED ) , a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome , lacks approved pharmacotherapies . OBJECTIVE To examine the efficacy and safety of lisdexamfetamine dimesylate , a dextroamphetamine prodrug , to treat moderate to severe BED . DESIGN , SETTING , AND PARTICIPANTS We performed a r and omized , double-blind , parallel-group , forced dose titration , placebo-controlled clinical trial at 30 sites from May 10 , 2011 , through January 30 , 2012 . Safety and intention-to-treat analyses included 259 and 255 adults with BED , respectively . INTERVENTIONS Lisdexamfetamine dimesylate at dosages of 30 , 50 , or 70 mg/d or placebo were provided to study participants ( 1:1:1:1 ) . Dosages were titrated across 3 weeks and maintained for 8 weeks . We followed up participants for a mean ( SD ) of 7 ( 2 ) days after the last dose . MAIN OUTCOMES AND MEASURES We assessed the change in binge-eating ( BE ) behaviors measured as days per week ( baseline to week 11 ) with a mixed-effects model using transformed log ( BE days per week ) + 1 . Secondary measures included BE cessation for 4 weeks . Safety assessment s included treatment-emergent adverse events , vital signs , and change in weight . RESULTS At week 11 , log-transformed BE days per week decreased with the 50-mg/d ( least squares [ LS ] mean [ SE ] change , -1.49 [ 0.066 ] ; P = .008 ) and 70-mg/d ( LS mean [ SE ] change , -1.57 [ 0.067 ] ; P < .001 ) treatment groups but not the 30-mg/d treatment group ( LS mean [ SE ] change , -1.24 [ 0.067 ] ; P = .88 ) compared with the placebo group . Nontransformed mean ( SD ) days per week decreased for placebo and the 30- , 50- , and 70-mg/d treatment groups by -3.3 ( 2.04 ) , -3.5 ( 1.95 ) , -4.1 ( 1.52 ) , and -4.1 ( 1.57 ) , respectively . The percentage of participants achieving 4-week BE cessation was lower with the placebo group ( 21.3 % ) compared with the 50-mg/d ( 42.2 % [ P = .01 ] ) and 70-mg/d ( 50.0 % [ P < .001 ] ) treatment groups . The incidence of any treatment-emergent adverse events was 58.7 % for the placebo group and 84.7 % for the combined treatment group . In the treatment groups , 1.5 % of participants had serious treatment-emergent adverse effects . Events with a frequency of at least 5 % and changes in heart rate were generally consistent with the known safety profile . The mean ( SD ) change in body weight was -0.1 ( 3.09 ) , -3.1 ( 3.64 ) , -4.9 ( 4.43 ) , -4.9 ( 3.93 ) , and -4.3 ( 4.09 ) kg for the placebo group , the 30- , 50- , and 70-mg/d treatment groups , and the combined treatment groups , respectively ( P < .001 for each dose vs placebo group comparison in post hoc analysis ) . CONCLUSIONS AND RELEVANCE The 50- and 70-mg/d treatment groups demonstrated efficacy compared with the placebo group in decreased BE days , BE cessation , and global improvement . The safety profile was generally consistent with previous findings in adults with attention-deficit/hyperactivity disorder . Further investigation of lisdexamfetamine in BED is ongoing . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01291173 
    Output:
    
Across the included acute phase RCTs , lisdexamfetamine ( at 30 , 50 , or 70 mg/day ) led to significant reduction in a number of clinical ly relevant outcomes compared to placebo .