Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: Randomized placebo-controlled clinical trial of self-help and medication
Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: Randomized placebo-controlled clinical trial of self-help and medication
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DOI：
10.1016/j.brat.2014.04.002
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发表时间：
2014-07-01
影响因子：
4.1
通讯作者：
Garcia, Rina
中科院分区：
文献类型：
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作者：
Grilo, Carlos M.;Masheb, Robin M.;Garcia, Rina
目的是确定专科治疗中心对暴食症 (BED) 已证实有效的治疗是否可以在初级保健机构中有效地向种族/民族不同的肥胖 BED 患者提供。这项研究比较了自助认知行为疗法 (shCBT) 和抗肥胖药物（西布曲明）单独和联合使用的有效性，这只是第二项针对 BED 药物的安慰剂对照试验，用于评估治疗停止后的长期效果。 104 名患有 BED 的肥胖患者（73% 为女性，55% 非白人）被随机分配接受四种 16 周治疗（平衡 2×2 因子设计）之一：西布曲明 (N = 26)、安慰剂 (N = 27)、shCBT + 西布曲明 (N = 26) 或 shCBT + 安慰剂 (N = 25)。药物以双盲方式施用。在整个治疗期间、治疗后以及 6 个月和 12 个月的随访（随机化后 16 个月）时每月进行一次独立评估。混合模型分析显示，时间和药物随时间的相互作用对体重减轻百分比有显着的影响，西布曲明而非安慰剂与随时间的显着变化相关。在治疗第三个月和治疗后，西布曲明和安慰剂之间的体重减轻百分比存在显着差异。治疗后停药后，西布曲明组的体重重新增加，并且在 6 个月和 12 个月的随访中，四种治疗方法的体重减轻百分比不再有差异。对于暴食，混合模型显示了显着的时间和 shCBT 逐时间交互作用：shCBT 在 6 个月的随访中暴食频率显着降低，但治疗在任何其他时间点都没有显着差异。人口因素并不能显着预测或调节临床结果。我们的研究结果表明，相对于安慰剂，纯自助 CBT 和西布曲明在治疗初级保健中的种族/民族多样化肥胖患者的 BED 方面并未显示出长期有效性。总体而言，这些治疗方法在暴饮暴食和相关结果方面差异不大。与安慰剂相比，西布曲明与显着更大的急性体重减轻有关，并且在停药后观察到的体重恢复表明需要继续使用抗肥胖药物来维持体重减轻。人口因素并不能预测/调节这个不同患者群体的临床结果。 (C) 2014 Elsevier Ltd. 保留所有权利。
The objective was to determine whether treatments with demonstrated efficacy for binge eating disorder (BED) in specialist treatment centers can be delivered effectively in primary care settings to racially/ethnically diverse obese patients with BED. This study compared the effectiveness of self-help cognitive-behavioral therapy (shCBT) and an anti-obesity medication (sibutramine), alone and in combination, and it is only the second placebo-controlled trial of any medication for BED to evaluate longer-term effects after treatment discontinuation. 104 obese patients with BED (73% female, 55% non-white) were randomly assigned to one of four 16-week treatments (balanced 2-by-2 factorial design): sibutramine (N = 26), placebo (N = 27), shCBT + sibutramine (N = 26), or shCBT + placebo (N = 25). Medications were administered in double-blind fashion. Independent assessments were performed monthly throughout treatment, post-treatment, and at 6- and 12-month follow-ups (16 months after randomization). Mixed-models analyses revealed significant time and medication-by-time interaction effects for percent weight loss, with sibutramine but not placebo associated with significant change over time. Percent weight loss differed significantly between sibutramine and placebo by the third month of treatment and at post-treatment. After the medication was discontinued at post-treatment, weight re-gain occurred in sibutramine groups and percent weight loss no longer differed among the four treatments at 6- and 12-month follow-ups. For binge-eating, mixed-models revealed significant time and shCBT-by-time interaction effects: shCBT had significantly lower binge-eating frequency at 6-month follow-up but the treatments did not differ significantly at any other time point. Demographic factors did not significantly predict or moderate clinical outcomes. Our findings suggest that pure self-help CBT and sibutramine did not show long-term effectiveness relative to placebo for treating BED in racially/ethnically diverse obese patients in primary care. Overall, the treatments differed little with respect to binge-eating and associated outcomes. Sibutramine was associated with significantly greater acute weight loss than placebo and the observed weight-regain following discontinuation of medication suggests that anti-obesity medications need to be continued for weight loss maintenance. Demographic factors did not predict/moderate clinical outcomes in this diverse patient group. (C) 2014 Elsevier Ltd. All rights reserved.