Guerdjikova Anna I, McElroy Susan L, Welge Jeffrey A, Nelson Erik, Keck Paul E, Hudson James I
Department of Psychiatry, University of Cincinnati College of Medicine, Lindner Center of HOPE, Mason, Ohio 45040, USA.
Int Clin Psychopharmacol. 2009 May;24(3):150-8. doi: 10.1097/YIC.0b013e328329c7b5.
This study evaluated the efficacy and safety of lamotrigine in binge-eating disorder (BED) associated with obesity. Fifty-one outpatients with BED by Diagnostic and Statistical Manual of Mental Disorders, fourth edition criteria, and obesity were randomized to receive either lamotrigine (N=26) or placebo (N=25) in a 16-week, double-blind, flexible-dose study. Lamotrigine (236+/-150 mg/day) and placebo had similar rates of reduction of weekly frequency of binge-eating episodes and binge days, weight and BMI, measures of eating pathology, obsessive-compulsive symptoms, impulsivity, and global severity of illness. However, lamotrigine was associated with a numerically greater amount of weight loss (1.17 vs. 0.15 kg) and significant reductions in fasting levels of glucose, insulin, and triglycerides. It was also well tolerated and associated with no serious adverse events. As a result of an exceptionally high placebo response, it is likely that for efficacy measures except for body weight and metabolic indices, the study was incapable of detecting potentially clinically important drug-placebo difference.
本研究评估了拉莫三嗪治疗与肥胖相关的暴饮暴食症（BED）的疗效和安全性。按照《精神疾病诊断与统计手册》第四版标准确诊为BED且伴有肥胖的51名门诊患者，在一项为期16周的双盲、灵活剂量研究中被随机分为两组，分别接受拉莫三嗪治疗（N = 26）或安慰剂治疗（N = 25）。拉莫三嗪（236±150毫克/天）与安慰剂在每周暴饮暴食发作频率、暴饮暴食天数、体重和体重指数、饮食病理学指标、强迫症状、冲动性以及疾病整体严重程度的降低率方面相似。然而，拉莫三嗪在数值上与更大程度的体重减轻相关（1.17千克 vs. 0.15千克），并且空腹血糖、胰岛素和甘油三酯水平显著降低。它的耐受性也良好，且未出现严重不良事件。由于安慰剂反应异常高，除体重和代谢指标外，该研究可能无法检测到潜在的具有临床重要意义的药物与安慰剂差异。
