Article

Double-blind, randomized, placebo-controlled trial of topiramate plus cognitive-behavior therapy in binge-eating disorder

Department of Psychiatry, Universidade Federal de São Paulo, Brazil.
The Journal of Clinical Psychiatry (Impact Factor: 5.14). 09/2007; 68(9):1324-32. DOI: 10.4088/JCP.v68n0901
Source: PubMed

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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    • "h in the obesity field ( Wadden et al . , 2005 ) . Our finding that sibutramine enhanced shCBT weight loss outcomes is consistent with two previous studies reporting sig - nificant " additive " effects by combining certain specific medica - tions with weight - loss effects ( e . g . , orlistat , topiramate ) and " guided " CBT treatments for BED ( Claudino et al . , 2007 ; Grilo , Masheb , & Salant , 2005 ) . Comparisons with the existing treatment literature , as offered descriptively for context above , can only be made cautiously given potentially important differences between generalist and specialist treatment settings and providers . For example , we note striking differences in findings from two "
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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.
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    • "Interestingly, research has found that combining treatments, for example combining pharmacotherapy, has generally not enhanced outcomes (Reas & Grilo, 2008). Possible notable exceptions have included findings from controlled trials suggesting that adding orlistat (Grilo, Masheb, & Salant, 2005) or topiramate (Claudino et al., 2007) may enhance weight losses achieved with CBT for BED. It has been suggested that greater attention to non-normative eating behaviors and patterns (Masheb & Grilo, 2006) in addition to the CBT focus on normalization of eating meals and reducing binge eating may facilitate greater weight loss. "
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    • "The main measures for efficacy were changes in the number of binge episodes per week, days with binge episodes per week and weight. 3. Results We found five randomized clinical trials on the use of topiramate in eating disorders associated with obesity; three trials had been performed on BED [13] [19] [20], and the remaining two had been performed on BN [10] [21]. All five trials were placebo controlled. "
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    ABSTRACT: The objective of this review was to establish the efficacy of topiramate as treatment for eating disorders associated with obesity. We reviewed all five published controlled clinical trials that tested the efficacy of topiramate in treating bulimia nervosa (BN) or binge-eating disorder (BED). Two trials involving 128 patients studied topiramate efficacy in BN, and three trials (528 patients) studied patients with BED. Data on the number of participants, weeks of follow-up, dropouts, binge frequency and weight were extracted. Short-term treatment with topiramate is more effective than treatment with placebo in decreasing binge episodes per week (overall result: topiramate group: -5.0+/-0.6; placebo group: -3.3+/-1.2), binge days per week (topiramate group: -3.5+/-0.6; placebo group: -2.3+/-0.7) and corporal weight (topiramate group: -4.6+/-2.3; placebo group: -0.5+/-0.6) in both BN and BED. The high number of withdrawals and the small sample sizes in four of the five controlled clinical trials limit the generalizability of this result. Topiramate is effective in the short-term treatment of eating disorders associated with obesity. Additional studies are needed to prove its efficacy in the long term and to determine the optimal effective dose.
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