Treatment of Binge Eating in Obese Patients in Primary Care

描述(由申请人提供)：暴饮暴食是与肥胖相关的常见问题，并增加了精神和医学发病率的风险，被认为是一个重大的健康问题。在专门研究诊所的几项对照研究中，认知行为疗法(CBT)和某些药物被发现对治疗暴饮暴食有效。目前尚不清楚此类治疗能否在非专科初级保健环境中有效实施。研究证明，肥胖者反复暴饮暴食与医疗保健利用率高有关，但很少与接受证明有效的治疗有关。这项研究的目的是检查这种有效的治疗方法，如果适当调整，是否可以在初级保健环境中有效地实施。这项研究将测试两种治疗方法的有效性：使用纯自助方法进行CBT(CBTsh)和西布曲明(抗肥胖药物)也被发现对减少暴饮暴食有效。150名经常暴饮暴食(没有不适当的体重控制行为)的肥胖患者将在初级保健环境中接受非专科临床医生的治疗。参与者将随机接受四种治疗方法之一(平衡2×2因子设计)，为期16周：(1)西布曲明(15 mg/d)(2)安慰剂；(3)CBTsh和西布曲明(15 mg/d)安慰剂；或(4)CBTsh和安慰剂。药物将以双盲方式给予，临床管理最少。因此，治疗在临床时间上是紧密匹配的，部分是为了控制注意力，更重要的是反映它们在繁忙的初级保健环境中潜在使用的临床现实。将对整个治疗过程中的变化进行评估，并由独立评估员在积极治疗结束时(4个月)以及治疗结束后6个月和12个月(随机化后10个月和16个月)进行主要结果评估。综合评估将评估暴饮暴食和肥胖及其相关结果(进食障碍的特征、心理功能、生物变量)，并将允许探索结果的中介和调节因素。这项研究只是CBT和一种药物单独或联合治疗肥胖症患者暴饮暴食的第二次对照试验，将提供关于非专科医生在初级保健环境中使用的特定治疗的效用的重要信息。这项研究将提供有关这些治疗在治疗完成后一年的耐久性或维护性的必要信息。

DESCRIPTION (provided by applicant): Binge eating is a common problem associated with obesity and with increased risk for psychiatric and medical morbidity and is recognized as a significant health problem. Cognitive behavioral therapy (CBT) and certain medications have been found to be effective for treating binge eating in several controlled studies at specialized research clinics. Whether such treatments can be effectively administered in non-specialist primary care settings is unknown. Research has documented that recurrent binge eating in obese persons is associated with high healthcare utilization but infrequently with receipt of treatments with demonstrated efficacy. This study aims to examine whether such efficacious treatments, if suitably adapted, can be effectively administered in primary care settings. The study will test the effectiveness of two treatments: CBT using a pure-self help approach (CBTsh) and sibutramine (anti-obesity medication) also found to be effective for reducing binge eating. 150 obese patients with recurrent binge eating (without inappropriate weight control behaviors) will be treated by non-specialist clinicians in primary care settings. Participants will be randomized to one of four treatments (balanced 2-by-2 factorial design) for 16 weeks: (1) sibutramine (15 mg/d) (2) placebo; (3) CBTsh and sibutramine (15 mg/d) placebo; or (4) CBTsh and placebo. Medication will be given in double-blind fashion with minimal clinical management. Thus, treatments are closely matched in clinical time to control partly for attention and, more importantly, to reflect the clinical reality of their potential use in busy primary care settings. Changes throughout the course of treatments will be evaluated and major outcome assessments will be performed by independent evaluators at the end of active treatment (4 months) and at 6- and 12-months after ending treatments (10 and 16 months after randomization). Comprehensive evaluations will assess both binge eating and obesity and their associated outcomes (features of eating disorders, psychological functioning, biological variables) and will allow for exploration of mediators and moderators of outcomes. This study, only the second controlled trial of CBT and a medication alone and in combination for binge eating in obese patients, will provide important information about the utility of specific treatments for use by non-specialists in primary care settings. This study will provide needed information about the durability or maintenance of these treatments for the year following treatment completion.