Efficacy of sibutramine for the treatment of binge eating disorder: A randomized multicenter placebo-controlled double-blind study
Efficacy of sibutramine for the treatment of binge eating disorder: A randomized multicenter placebo-controlled double-blind study
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DOI：
10.1176/appi.ajp.2007.06121970
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发表时间：
2008-01-01
影响因子：
17.7
通讯作者：
Walsh, B. Timothy
中科院分区：
文献类型：
--
作者：
Wilfley, Denise E.;Crow, Scott J.;Walsh, B. Timothy
目的：初步证据表明，减肥药西布曲明对治疗暴食症有效，对暴食和体重都有影响。这项研究是第一个大规模的，多地点，安慰剂对照试验，以测试西布曲明在暴饮暴食disorder.Method的疗效：参与者（N=304）谁符合DSM-IV标准暴饮暴食disorder. Method的标准被随机分配到24周的双盲西布曲明（15毫克）或安慰剂治疗。结果指标包括暴饮暴食的频率（主要结果）、暴饮暴食日频率、体重指数、体重、总体改善、反应类别、相关饮食病理学和生活质量。连续测量的主要分析是使用方差分析（ANOVA）从基线到终点的变化中的组间差异，末次观察值结转。结果：与接受安慰剂的受试者相比，接受西布曲明的受试者每周狂欢频率显著降低（西布曲明组平均值=2.7 [SD=1.7]，安慰剂组平均值=2.0 [SD=2.3]）;体重减轻（西布曲明组平均值=4.3 kg [SD=4.8]，安慰剂组平均值=0.8 kg [SD=3.5]）;暴饮暴食天数频率降低;体重指数降低;总体改善;反应水平，包括暴饮暴食的戒断百分比（西布曲明组：58.7%;安慰剂组：42.8%）;以及进食病理学（认知抑制、去抑制和饥饿）的减少。生活质量评分的变化不显著。西布曲明与头痛、口干、便秘、失眠和头晕的发病率显著增高相关。结论：这项试验证明了西布曲明在减少暴饮暴食、体重和相关精神病理学方面的疗效。
Objective: Preliminary evidence suggests that the antiobesity agent sibutramine is effective in the treatment of binge eating disorder, impacting both binge eating and weight. This study is the first large-scale, multisite, placebo-controlled trial to test the efficacy of sibutramine in binge eating disorder.Method: Participants (N=304) who met DSM-IV criteria for binge eating disorder were randomly assigned to 24 weeks of double-blind sibutramine (15 mg) or placebo treatment. The outcome measures included the frequency of eating binges (primary outcome), binge day frequency, body mass index, body weight, global improvement, response categories, associated eating pathology, and quality of life. The primary analysis for continuous measures was the difference between groups in the change from baseline to endpoint using analysis of variance (ANOVA) with the last observation carried forward.Results: Compared with subjects receiving placebo, participants who received sibutramine had a significantly greater reduction in weekly binge frequency (sibutramine group mean=2.7 [SD=1.7], placebo group mean=2.0 [SD=2.3]); weight loss (sibutramine group mean=4.3 kg [SD=4.8], placebo group mean=0.8 kg [SD=3.5]); reduction in frequency of binge days; reduction in body mass index; global improvement; level of response, including the percentage of abstinence from binge eating (sibutramine group: 58.7%; placebo group: 42.8%); and reduction in eating pathology (cognitive restraint, disinhibition, and hunger). The change in quality of life scores was not significant. Sibutramine was associated with significantly higher incidence of headache, dry mouth, constipation, insomnia, and dizziness.Conclusions: This trial demonstrated the efficacy of sibutramine in reducing binge eating, weight, and associated psychopathology.