Double-blind, randomized, placebo-controlled trial of topiramate plus cognitive-behavior therapy in binge-eating disorder.
ABSTRACT To evaluate the efficacy and tolerability of adjunctive topiramate compared to placebo in reducing weight and binge eating in obese patients with binge-eating disorder (BED) receiving cognitive-behavior therapy (CBT).
A double-blind, randomized, placebo-controlled trial of 21 weeks' duration was conducted at 4 university centers. Participants were 73 obese (body mass index >or= 30 kg/m(2)) outpatients with BED (DSM-IV criteria), both genders, and aged from 18 to 60 years. After a 2- to 5-week run-in period, selected participants were treated with group CBT (19 sessions) and topiramate (target daily dose, 200 mg) or placebo (September 2003-April 2005). The main outcome measure was weight change, and secondary outcome measures were binge frequencies, binge remission, Binge Eating Scale (BES) scores, and Beck Depression Inventory (BDI) scores.
Repeated-measures random regression analysis revealed a greater rate of weight reduction associated with topiramate over the course of treatment (p < .001), with patients taking topiramate attaining a clinically significant weight loss (-6.8 kg) compared to patients taking placebo (-0.9 kg). Although rates of reduction of binge frequencies, BES scores, and BDI scores did not differ between groups during treatment, a greater number of patients of the topiramate plus CBT group (31/37) attained binge remission compared to patients taking placebo (22/36) during the trial (p = .03). No difference between groups was found in completion rates; 1 patient (topiramate group) withdrew for adverse effect. Paresthesia and taste perversion were more frequent with topiramate, and insomnia was more frequent with placebo (p < .05).
Topiramate added to CBT improved the efficacy of the later, increasing binge remission and weight loss in the short run. Topiramate was well tolerated, as shown by few adverse events during treatment.
ClinicalTrials.gov identifier NCT00307619.
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ABSTRACT: Objective The objective was to determine whether treatments with demonstrated efficacy for binge eating disorder (BED) in specialist treatment centers can be delivered effectively in primary care settings to racially/ethnically diverse obese patients with BED. This study compared the effectiveness of self-help cognitive-behavioral therapy (shCBT) and an anti-obesity medication (sibutramine), alone and in combination, and it is only the second placebo-controlled trial of any medication for BED to evaluate longer-term effects after treatment discontinuation. Method 104 obese patients with BED (73% female, 55% non-white) were randomly assigned to one of four 16-week treatments (balanced 2-by-2 factorial design): sibutramine (N=26), placebo (N=27), shCBT+sibutramine (N=26), or shCBT+placebo (N=25). Medications were administered in double-blind fashion. Independent assessments were performed monthly throughout treatment, post-treatment, and at 6- and 12-month follow-ups (16 months after randomization). Results Mixed-models analyses revealed significant time and medication-by-time interaction effects for percent weight loss, with sibutramine but not placebo associated with significant change over time. Percent weight loss differed significantly between sibutramine and placebo by the third month of treatment and at post-treatment. After the medication was discontinued at post-treatment, weight re-gain occurred in sibutramine groups and percent weight loss no longer differed among the four treatments at 6- and 12-month follow-ups. For binge-eating, mixed-models revealed significant time and shCBT-by-time interaction effects: shCBT had significantly lower binge-eating frequency at 6-month follow-up but the treatments did not differ significantly at any other time point. Demographic factors did not significantly predict or moderate clinical outcomes. Discussion Our findings suggest that pure self-help CBT and sibutramine did not show long-term effectiveness relative to placebo for treating BED in racially/ethnically diverse obese patients in primary care. Overall, the treatments differed little with respect to binge-eating and associated outcomes. Sibutramine was associated with significantly greater acute weight loss than placebo and the observed weight-regain following discontinuation of medication suggests that anti-obesity medications need to be continued for weight loss maintenance. Demographic factors did not predict/moderate clinical outcomes in this diverse patient group.Behaviour Research and Therapy 07/2014; · 3.85 Impact Factor
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ABSTRACT: Background Drug treatments used in substance use disorders are not effective in all patients. Objective To assess the effectiveness of topiramate use in the treatment of substance use disorders. Information sources Medline database from January 1966 to December 2013, Cochrane database and clinicaltrials.gov. Selection of studies We used keywords topiramate, addiction, substance abuse, alcohol, tobacco, nicotine, cocaine, methamphetamine, opiate, heroin, benzodiazepine, cannabis, bulimia nervosa, binge eating disorder, gambling. All clinical trials were included. Animal trials, laboratory tests, reviews, answers to writers, case-reports, case series and publications unrelated to the topic were excluded. Twenty-eight articles investigating the efficacy of topiramate in substance use were included. Results In alcohol-related disorder, several trials and a meta-analysis showed a reduction of days of consumption. In a single-center trial on tobacco-related disorder, topiramate was not found effective in reducing the carbon monoxide expired. In cocaine-related disorder, one single-center trial showed a reduction of days of consumption and two single-center trials have found a trend in favour of topiramate. In alcohol and cocaine co-dependency, a single-center trial found a trend in favour of topiramate. In methamphetamine-related disorder, a multicenter trial found a trend in favour of topiramate. In bulimia nervosa, two single-center trials showed a reduction in binge eating and compensatory behaviours. In binge eating disorder, several trials showed a reduction of binge eating and weight. In gambling, one single-center trial did not show any significant results. There were no randomized controlled trials found in opioid-related disorder, benzodiazepines-related disorder, and cannabis-related disorder. Limitations Definition of abstinence and methods to assess the efficacy of topiramate differed between trials. The methodological quality of included trials was variable, especially with no double-blind procedure in eight trials. Conclusion Topiramate showed interest mainly in alcoholism, binge eating disorder and bulimia nervosa. No definitive conclusions can be reached for other substance use disorders such as nicotine dependence, cocaine dependence, amphetamine dependence or cannabis dependence and for gambling.La Presse Médicale 09/2014; · 1.17 Impact Factor
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ABSTRACT: Binge eating disorder (BED) has limited therapeutic options. Repetitive transcranial magnetic stimulation (rTMS) is a modulation technique of cortical excitability that has shown good results in treating certain psychiatric disorders by correcting dysfunctional cortical regions. We hypothesize that rTMS could be an alternative therapy for BED through potential modulation action on frontostriatal abnormalities and dopaminergic pathways noted by neuroimaging. We report the case of a young woman presenting refractory BED and comorbid depression treated with 20 sessions of rTMS for 30 minutes over the left dorsolateral prefrontal cortex at 10 Hz for about a month (2400 stimuli per day). She answered two self-report questionnaires, the Binge Eating Scale (BES) and the Beck Depression Inventory (BDI). Before rTMS treatment, the BES score was 38, and the BDI score was 42. Three days after rTMS treatment, the BES score was 27 and the BDI score was 27, and the patient referred to no binge eating episodes for that week. Therefore, rTMS could offer a new option of treatment for BED and comorbid depression.CNS & neurological disorders drug targets 05/2014; 13. · 3.57 Impact Factor