McElroy Susan L, Hudson James I, Capece Julie A, Beyers Karen, Fisher Alan C, Rosenthal Norman R
Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267-0559, USA.
Biol Psychiatry. 2007 May 1;61(9):1039-48. doi: 10.1016/j.biopsych.2006.08.008. Epub 2007 Jan 29.
In a single-center, placebo-controlled study, topiramate reduced binge eating and weight in patients with binge eating disorder (BED) and obesity. The current investigation evaluated the safety and efficacy of topiramate in a multicenter, placebo-controlled trial.
Eligible patients between 18 and 65 years with >or= 3 binge eating days/week and a body mass index (BMI) between 30 and 50 kg/m2 were randomized.
A total of 407 patients enrolled; 13 failed to meet inclusion criteria, resulting in 195 topiramate and 199 placebo patients. Topiramate reduced binge eating days/week (-3.5 +/- 1.9 vs. -2.5 +/- 2.1), binge episodes/week (-5.0 +/- 4.3 vs. -3.4 +/- 3.8), weight (-4.5 +/- 5.1 kg vs. .2 +/- 3.2 kg), and BMI (-1.6 +/- 1.8 kg/m2 vs. .1 +/- 1.2 kg/m2) compared with placebo (p < .001). Topiramate induced binge eating remission in 58% of patients (placebo, 29%; p < .001). Discontinuation rates were 30% in each group; adverse events (AEs) were the most common reason for topiramate discontinuation (16%; placebo, 8%). Paresthesia, upper respiratory tract infection, somnolence, and nausea were the most common AEs with topiramate.
This multicenter study in patients with BED associated with obesity demonstrated that topiramate was well tolerated and efficacious in improving the features of BED and in reducing obesity.
在一项单中心、安慰剂对照研究中，托吡酯可减少暴食症（BED）和肥胖患者的暴饮暴食及体重。本研究在一项多中心、安慰剂对照试验中评估了托吡酯的安全性和有效性。
将年龄在18至65岁之间、每周暴饮暴食天数≥3天且体重指数（BMI）在30至50kg/m²之间的符合条件的患者随机分组。
共有407名患者入组；13名未达到纳入标准，最终有195名服用托吡酯的患者和199名服用安慰剂的患者。与安慰剂相比，托吡酯可减少每周暴饮暴食天数（-3.5±1.9天对-2.5±2.1天）、每周暴饮暴食发作次数（-5.0±4.3次对-3.4±3.8次）、体重（-4.5±5.1kg对0.2±3.2kg）和BMI（-1.6±1.8kg/m²对0.1±1.2kg/m²）（p<0.001）。托吡酯使58%的患者暴饮暴食症状缓解（安慰剂组为29%；p<0.001）。两组的停药率均为30%；不良事件（AE）是托吡酯停药的最常见原因（16%；安慰剂组为8%）。感觉异常、上呼吸道感染、嗜睡和恶心是托吡酯最常见的不良事件。
这项针对伴有肥胖的BED患者的多中心研究表明，托吡酯耐受性良好，在改善BED症状和减轻肥胖方面有效。
