Claudino Angélica M, de Oliveira Irismar R, Appolinario José Carlos, Cordás Táki A, Duchesne Monica, Sichieri Rosely, Bacaltchuk Josué
Department of Psychiatry, Universidade Federal de São Paulo, Brazil.
J Clin Psychiatry. 2007 Sep;68(9):1324-32. doi: 10.4088/jcp.v68n0901.
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.
评估在接受认知行为疗法（CBT）的暴饮暴食症（BED）肥胖患者中，与安慰剂相比，加用托吡酯减轻体重和减少暴饮暴食的疗效及耐受性。
在4个大学中心进行了一项为期21周的双盲、随机、安慰剂对照试验。参与者为73名符合BED（DSM-IV标准）的肥胖（体重指数≥30 kg/m²）门诊患者，不限性别，年龄在18至60岁之间。经过2至5周的导入期后，选定的参与者接受团体CBT（19节课程）以及托吡酯（目标日剂量200 mg）或安慰剂治疗（2003年9月至2005年4月）。主要结局指标为体重变化，次要结局指标为暴饮暴食频率、暴饮暴食缓解情况、暴饮暴食量表（BES）评分以及贝克抑郁量表（BDI）评分。
重复测量随机回归分析显示，在治疗过程中，托吡酯组的体重减轻率更高（p <.001），服用托吡酯的患者实现了临床上显著的体重减轻（-6.8 kg），而服用安慰剂的患者体重减轻了（-0.9 kg）。尽管在治疗期间，两组之间的暴饮暴食频率、BES评分和BDI评分的降低率没有差异，但在试验期间，托吡酯加CBT组中有更多患者（31/37）实现了暴饮暴食缓解，而服用安慰剂的患者为（22/36）（p = 0.03）。两组的完成率没有差异；1名患者（托吡酯组）因不良反应退出。托吡酯组的感觉异常和味觉异常更为常见，而安慰剂组失眠更为常见（p <.05）。
在CBT基础上加用托吡酯可提高其疗效，在短期内增加暴饮暴食缓解率和体重减轻。托吡酯耐受性良好，治疗期间不良事件较少。
ClinicalTrials.gov标识符NCT00307619。
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