Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA.
Behav Res Ther. 2013 Mar;51(3):167-75. doi: 10.1016/j.brat.2013.01.002. Epub 2013 Jan 18.
This study was a randomized placebo-controlled trial testing the addition of orlistat to behavioral weight loss for obesity in Spanish-speaking-only Latino/as with versus without binge eating disorder (BED) performed at a community mental health center serving educationally- and economically-disadvantaged patients. Latino/as have high rates of obesity but are under-represented in obesity treatment studies and despite comparable-to-or-higher rates of BED than Whites, Latino/as are under-represented in BED treatment studies. BED is associated with obesity but whether it predicts/moderates treatment outcomes remains uncertain. Thus, this study also tested whether BED prospectively predicts/moderates outcomes.
Seventy-nine obese Spanish-speaking-only Latino/as with BED (N=40) versus without BED (N=39) at a community mental health center were randomly assigned to four-months of orlistat-plus-BWL or placebo-plus-BWL. BWL was culturally-enhanced modification of Diabetes-Prevention-Program delivered in weekly sessions in Spanish. Orlistat (120 mg tid) and matching-placebo delivered with standard clinical-management. Participants were assessed independently throughout treatment, post-treatment, and six-month follow-up.
78% completed treatments; completion rates did not differ significantly by medication or BED. Intent-to-treat mixed-models analyses revealed significant improvements in binge eating, eating-psychopathology, and depression, and significant--albeit modest--weight-loss. Overall, the addition of orlistat to BWL was not associated with greater improvements; however, BED moderated weight-loss: orlistat-plus-BWL produced significantly greater weight-loss in non-BED group but not in BED. Improvements were maintained through 6-month follow-up; BED significantly predicted/moderated increases in eating concerns and depression following treatment. Within BED-group, binge-eating remission rates were 65% (post-treatment) and 50% (follow-up).
In this controlled trial performed at community mental health center serving educationally- and economically-disadvantaged Spanish-speaking-only Latino/as with co-morbid psychiatric needs, we observed outcomes for the BWL plus orlistat/placebo medication that approximate or are slightly dampened relative to the literature for efficacy trials with much more restrictive obese and BED samples. In this complex patient group, adding orlistat to BWL produced greater weight-loss than adding placebo among obese patients without BED but not among those with BED. Although 50% of BED patients maintained abstinence from binge-eating following these specific obesity treatments (BWL plus orlistat/placebo), BED was a negative prognostic indicator for some outcome variables.
clinicaltrials.gov Identifier: NCT00516919.
本研究是一项随机安慰剂对照试验，旨在检验奥利司他对西班牙语裔肥胖患者（伴有或不伴有暴食障碍）的行为减肥的附加作用，该研究在一家社区心理健康中心进行，服务对象为教育和经济劣势患者。拉丁裔人群肥胖率较高，但在肥胖治疗研究中代表性不足，尽管与白人相比，拉丁裔人群的暴食障碍患病率或更高，但在暴食障碍治疗研究中代表性不足。暴食障碍与肥胖有关，但它是否预测/调节治疗结果尚不确定。因此，本研究还测试了暴食障碍是否能前瞻性地预测/调节结果。
在一家社区心理健康中心，共有 79 名西班牙语裔肥胖患者（伴有暴食障碍的患者 N=40，不伴有暴食障碍的患者 N=39）参与了本研究，他们被随机分配接受为期四个月的奥利司他+行为减肥或安慰剂+行为减肥治疗。行为减肥是在西班牙语每周一次的会议中进行的糖尿病预防计划的文化增强型修改版。奥利司他（120mg tid）和匹配的安慰剂与标准临床管理一起使用。参与者在整个治疗期间、治疗后和六个月随访期间进行独立评估。
78%的参与者完成了治疗；药物治疗和暴食障碍对完成率没有显著影响。意向治疗混合模型分析显示，暴食行为、进食心理病理和抑郁症状均有显著改善，体重也有适度减轻。总体而言，奥利司他对行为减肥的附加作用并不显著；然而，暴食障碍调节了体重减轻：奥利司他+行为减肥在非暴食障碍组中产生了显著的体重减轻，但在暴食障碍组中没有。改善结果在六个月随访中得到维持；暴食障碍显著预测/调节了治疗后进食担忧和抑郁的增加。在暴食障碍组中，暴食缓解率为 65%（治疗后）和 50%（随访）。
在这项在社区心理健康中心进行的、针对有共病精神需求的教育和经济劣势的西班牙语裔肥胖患者的对照试验中，我们观察到了行为减肥加奥利司他/安慰剂药物治疗的结果，与更严格的肥胖和暴食障碍样本的疗效试验文献相比，这些结果接近或略有降低。在这个复杂的患者群体中，与添加安慰剂相比，奥利司他在没有暴食障碍的肥胖患者中添加到行为减肥中可以产生更大的体重减轻，但在有暴食障碍的患者中则不然。尽管在这些特定的肥胖治疗（行为减肥加奥利司他/安慰剂）后，50%的暴食障碍患者保持了对暴食的戒除，但暴食障碍对某些结果变量是一个负面的预后指标。
clinicaltrials.gov 标识符：NCT00516919。
