Yale University, New Haven, CT, USA.
J Consult Clin Psychol. 2012 Dec;80(6):1108-13. doi: 10.1037/a0030061. Epub 2012 Sep 17.
The longer term efficacy of medication treatments for binge-eating disorder (BED) remains unknown. This study examined the longer term effects of fluoxetine and cognitive behavioral therapy (CBT) either with fluoxetine (CBT + fluoxetine) or with placebo (CBT + placebo) for BED through 12-month follow-up after completing treatments.
81 overweight patients with BED within a randomized double-blind placebo-controlled acute treatment trial allocated to fluoxetine-only, CBT + fluoxetine, and CBT + placebo were assessed before treatment, during treatment, posttreatment, and 6 and 12 months after completing treatments. Outcome variables comprised remission from binge eating (0 binge-eating episodes for 28 days) and continuous measures of binge-eating frequency, eating disorder psychopathology, depression, and weight.
Intent-to-treat remission rates (missing data coded as nonremission) differed significantly across treatments at posttreatment and at 6- and 12-month follow-ups. At 12-month follow-up remission rates were 3.7% for fluoxetine-only, 26.9% for CBT + fluoxetine, and 35.7% for CBT + placebo. Mixed-effects models of all available continuous data (without imputation) at posttreatment and at 6- and 12-month follow-ups (controlling for baseline scores) revealed the treatments differed on all clinical outcome variables, except for weight, across time. CBT + fluoxetine and CBT + placebo did not differ and both were significantly superior to fluoxetine-only on the majority of clinical outcomes.
This represents the first report from any randomized placebo-controlled trial for BED that has reported follow-up data after completing a course of medication-only treatment. CBT + placebo was superior to fluoxetine-only, and adding fluoxetine to CBT did not enhance findings compared to adding placebo to CBT. The findings document the longer term effectiveness of CBT, but not fluoxetine, through 12 months after treatment completion.
暴食障碍(BED)药物治疗的长期疗效尚不清楚。本研究通过完成治疗后 12 个月的随访,检查了氟西汀和认知行为疗法(CBT)单独治疗(CBT+氟西汀)或与安慰剂(CBT+安慰剂)治疗 BED 的长期效果。
在一项随机、双盲、安慰剂对照的急性治疗试验中,81 名超重的 BED 患者被分配到氟西汀单药组、CBT+氟西汀组和 CBT+安慰剂组,在治疗前、治疗期间、治疗后以及完成治疗后 6 个月和 12 个月进行评估。结局变量包括暴食缓解(28 天无暴食发作)和暴食频率、饮食障碍心理病理学、抑郁和体重的连续测量。
意向治疗缓解率(缺失数据编码为未缓解)在治疗后以及 6 个月和 12 个月的随访中,治疗组之间存在显著差异。在 12 个月的随访中,氟西汀单药组的缓解率为 3.7%,CBT+氟西汀组为 26.9%,CBT+安慰剂组为 35.7%。在治疗后和 6 个月和 12 个月的随访中(控制基线分数),对所有可用连续数据(无缺失值)进行混合效应模型分析显示,治疗组在所有临床结局变量上均存在差异,除了体重,随时间变化。CBT+氟西汀组和 CBT+安慰剂组之间没有差异,而且在大多数临床结局上,两者均显著优于氟西汀单药组。
这是第一个来自任何随机安慰剂对照试验的报告,该报告报告了在完成药物治疗课程后进行随访的数据。CBT+安慰剂组优于氟西汀单药组,而在 CBT 中添加氟西汀与添加安慰剂相比,并没有增强发现。这些发现记录了在完成治疗后 12 个月内 CBT 的长期有效性,但氟西汀没有。