Department of Psychiatry, Yale University School of Medicine, 301 Cedar St, PO Box 208098, New Haven, CT 06520, USA.
J Clin Psychiatry. 2013 Apr;74(4):400-6. doi: 10.4088/JCP.12m08071.
Binge-eating disorder (BED) is defined by recurrent binge eating (eating unusually large quantities of food during which a subjective loss of control is experienced), marked distress about the binge eating, and the absence of inappropriate weight compensatory behaviors. BED is strongly associated with excess weight, and many available psychological and pharmacologic approaches fail to produce much weight loss. The objective of this study was to perform a randomized placebo-controlled trial to evaluate the short-term efficacy of bupropion for the treatment of BED in overweight and obese women.
Sixty-one overweight and obese (mean body mass index [BMI] = 35.8) women who met DSM-IV-TR research criteria for BED were randomly assigned to receive bupropion (300 mg/d) or placebo for 8 weeks. Participants were enrolled from November 2006 to December 2010. No dietary or lifestyle intervention was given. Primary outcome measures were binge-eating frequency and percent BMI loss. Secondary outcome measures were dimensional measures of eating disorder psychopathology, food craving, and depression levels.
Eighty-nine percent (n = 54) of randomized participants completed the trial, without differential dropout between the bupropion and placebo groups. Mixed-effects analyses revealed significant time effects for all outcomes but no significant differences between bupropion and placebo on any outcome measure except for weight loss. Participants taking bupropion lost significantly more weight (1.8% vs 0.6% BMI loss; F = 10.57, P = .002).
Bupropion was well tolerated and produced significantly greater-albeit quite modest-short-term weight loss in overweight and obese women with BED. Bupropion did not improve binge eating, food craving, or associated eating disorder features or depression relative to placebo. Our findings do not support bupropion as a stand-alone treatment for BED. The preliminary findings regarding short-term weight losses suggest the need for larger and longer-term trials to evaluate the potential utility of bupropion for enhancing outcomes of psychological interventions that have demonstrated effectiveness for BED but fail to produce weight loss.
ClinicalTrials.gov identifier: NCT00414167
暴食症(BED)的定义是反复发作的暴食行为(在暴食期间经历主观失控感)、对暴食行为的明显困扰,以及不存在不适当的体重补偿行为。BED 与超重密切相关,许多现有的心理和药物治疗方法都未能产生明显的体重减轻。本研究的目的是进行一项随机安慰剂对照试验,以评估安非他酮治疗超重和肥胖女性暴食症的短期疗效。
61 名符合 DSM-IV-TR 研究标准的超重和肥胖(平均体重指数 [BMI] = 35.8)女性被随机分配接受安非他酮(300mg/d)或安慰剂治疗 8 周。参与者于 2006 年 11 月至 2010 年 12 月招募。没有给予饮食或生活方式干预。主要结局指标是暴食发作频率和 BMI 减轻百分比。次要结局指标是饮食障碍心理病理学、食物渴望和抑郁水平的多维测量。
89%(n=54)的随机参与者完成了试验,安非他酮组和安慰剂组的脱落率没有差异。混合效应分析显示所有结局均有显著的时间效应,但除体重减轻外,安非他酮和安慰剂在任何结局测量上均无显著差异。服用安非他酮的参与者体重减轻显著更多(1.8% vs 0.6% BMI 减轻;F = 10.57,P =.002)。
安非他酮耐受性良好,在患有暴食症的超重和肥胖女性中产生了显著但相当适度的短期体重减轻。与安慰剂相比,安非他酮并未改善暴食、食物渴望或相关的饮食障碍特征或抑郁。我们的研究结果不支持安非他酮作为暴食症的独立治疗方法。关于短期体重减轻的初步发现表明,需要更大规模和更长时间的试验来评估安非他酮在增强对暴食症有效的心理干预措施的疗效方面的潜在效用,但这些措施未能产生体重减轻。
ClinicalTrials.gov 标识符:NCT00414167