Treatment of Binge Eating in Obese Patients in Primary Care

描述（由申请人提供）：暴饮暴食是一种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。认知行为疗法（CBT）和某些药物在专门研究诊所的几项对照研究中被发现对治疗暴饮暴食有效。这种治疗是否可以有效地管理在非专业的初级保健设置是未知的。研究表明，肥胖者反复暴饮暴食与高医疗保健利用率有关，但很少接受有效的治疗。本研究的目的是检查这种有效的治疗方法，如果适当调整，可以有效地管理在初级保健环境。该研究将测试两种治疗方法的有效性：使用纯自助方法（CBTsh）的CBT和西布曲明（抗肥胖药物）也被发现对减少暴饮暴食有效。150名反复暴饮暴食的肥胖患者（没有不适当的体重控制行为）将由非专科临床医生在初级保健机构进行治疗。参与者将被随机分配到四种治疗之一（平衡2 × 2析因设计），持续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。将以双盲方式给予药物，最大限度地减少临床管理。因此，治疗在临床时间上是紧密匹配的，以控制部分注意力，更重要的是，以反映其在忙碌的初级保健环境中的潜在用途的临床现实。将在活性治疗结束时（4个月）和治疗结束后6个月和12个月（随机化后10个月和16个月）由独立评价者评价整个治疗过程中的变化，并进行主要结局评估。综合评估将评估暴饮暴食和肥胖及其相关结果（饮食失调的特征，心理功能，生物学变量），并将允许探索结果的介导者和调节者。这项研究，只有第二个对照试验的CBT和药物单独和结合暴食的肥胖患者，将提供重要信息的实用性，具体的治疗方法，供非专家在初级保健设置。本研究将提供有关这些治疗在治疗完成后一年内的持久性或维持性的必要信息。

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.