Grilo Carlos M, White Marney A, Masheb Robin M, Gueorguieva Ralitza
Department of Psychiatry, Yale University School of Medicine.
Department of Biostatistics, Yale University School of Public Health.
J Consult Clin Psychol. 2015 Apr;83(2):387-94. doi: 10.1037/a0038635. Epub 2015 Jan 26.
We examined rapid response among obese patients with binge-eating disorder (BED) in a randomized clinical trial testing antiobesity medication and self-help cognitive-behavioral therapy (shCBT), alone and in combination, in primary-care settings.
One hundred four obese patients with BED were randomly assigned to 1 of 4 treatments: sibutramine, placebo, shCBT + sibutramine, or shCBT + placebo. Treatments were delivered by generalist primary-care physicians and the medications were given double-blind. Independent assessments were performed by trained and monitored doctoral research clinicians monthly throughout treatment, posttreatment (4 months), and at 6- and 12-month follow-ups (i.e., 16 months after randomization). Rapid response, defined as ≥65% reduction in binge eating by the fourth treatment week, was used to predict outcomes.
Rapid response characterized 47% of patients, was unrelated to demographic and baseline clinical characteristics, and was significantly associated, prospectively, with remission from binge eating at posttreatment (51% vs. 9% for nonrapid responders), 6-month (53% vs. 23.6%), and 12-month (46.9% vs. 23.6%) follow-ups. Mixed-effects model analyses revealed that rapid response was significantly associated with greater decreases in binge-eating or eating-disorder psychopathology, depression, and percent weight loss.
Our findings, based on a diverse obese patient group receiving medication and shCBT for BED in primary-care settings, indicate that patients who have a rapid response achieve good clinical outcomes through 12-month follow-ups after ending treatment. Rapid response represents a strong prognostic indicator of clinically meaningful outcomes, even in low-intensity medication and self-help interventions. Rapid response has important clinical implications for stepped-care treatment models for BED.
clinicaltrials.gov: NCT00537810 (PsycINFO Database Record
在一项随机临床试验中,我们对初级保健机构中接受抗肥胖药物和自助认知行为疗法(shCBT)单独及联合治疗的暴饮暴食症(BED)肥胖患者的快速反应进行了研究。
104名患有BED的肥胖患者被随机分配到4种治疗方法中的一种:西布曲明、安慰剂、shCBT + 西布曲明或shCBT + 安慰剂。治疗由普通初级保健医生提供,药物采用双盲给药。在整个治疗过程、治疗后(4个月)以及6个月和12个月随访(即随机分组后16个月)期间,由经过培训和监督的博士研究生临床医生每月进行独立评估。快速反应定义为在治疗第四周暴饮暴食减少≥65%,用于预测治疗结果。
47%的患者具有快速反应,这与人口统计学和基线临床特征无关,并且前瞻性地与治疗后(快速反应者为51%,非快速反应者为9%)、6个月(53%对23.6%)和12个月(46.9%对23.6%)随访时暴饮暴食的缓解显著相关。混合效应模型分析显示,快速反应与暴饮暴食或饮食失调精神病理学、抑郁以及体重减轻百分比的更大降幅显著相关。
我们的研究结果基于在初级保健机构中接受药物和shCBT治疗BED的多样化肥胖患者群体,表明快速反应的患者在治疗结束后的12个月随访中取得了良好的临床结果。快速反应代表了具有临床意义结果的强有力预后指标,即使在低强度药物和自助干预中也是如此。快速反应对BED的阶梯式护理治疗模式具有重要的临床意义。
clinicaltrials.gov:NCT00537810(PsycINFO数据库记录)