盐酸苯丁胺-托吡酯缓释剂与安慰剂治疗暴饮暴食症和神经性贪食症的随机双盲交叉试验的研究方案及基本原理。
Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa.
作者信息
Dalai Shebani Sethi, Adler Sarah, Najarian Thomas, Safer Debra Lynn
机构信息
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford 94305, CA, USA.
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford 94305, CA, USA.
出版信息
Contemp Clin Trials. 2018 Jan;64:173-178. doi: 10.1016/j.cct.2017.10.007. Epub 2017 Oct 14.
INTRODUCTION
Bulimia nervosa (BN) and binge eating disorder (BED) are associated with severe psychological and medical consequences. Current therapies are limited, leaving up to 50% of patients symptomatic despite treatment, underscoring the need for additional treatment options. Qsymia, an FDA-approved medication for obesity, combines phentermine and topiramate ER. Topiramate has demonstrated efficacy for both BED and BN, but limited tolerability. Phentermine is FDA-approved for weight loss. A rationale for combined phentermine/topiramate for BED and BN is improved tolerability and efficacy. While a prior case series exploring Qsymia for BED showed promise, randomized studies are needed to evaluate Qsymia's safety and efficacy when re-purposed in eating disorders. We present a study protocol for a Phase I/IIa single-center, prospective, double-blinded, randomized, crossover trial examining safety and preliminary efficacy of Qsymia for BED and BN.
METHODS
Adults with BED (n=15) or BN (n=15) are randomized 1:1 to receive 12weeks Qsymia (phentermine/topiramate ER, 3.75mg/23mg-15mg/92mg) or placebo, followed by 2-weeks washout and 12-weeks crossover, where those on Qsymia receive placebo and vice versa. Subsequently participants receive 8weeks follow-up off study medications. The primary outcome is the number of binge days/week measured by EDE. Secondary outcomes include average number of binge episodes, percentage abstinence from binge eating, and changes in weight/vitals, eating psychopathology, and mood.
DISCUSSION
To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of phentermine/topiramate in BED and BN. We highlight the background and rationale for this study, including the advantages of a crossover design.
TRIAL REGISTRATION
Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824.
引言
神经性贪食症（BN）和暴饮暴食症（BED）会导致严重的心理和医学后果。目前的治疗方法有限，尽管进行了治疗，仍有高达50%的患者有症状，这突出表明需要更多的治疗选择。Qsymia是一种经美国食品药品监督管理局（FDA）批准用于治疗肥胖症的药物，它将苯丁胺和缓释托吡酯结合在一起。托吡酯已被证明对BED和BN均有效，但耐受性有限。苯丁胺经FDA批准用于减肥。将苯丁胺/托吡酯联合用于治疗BED和BN的理论依据是提高耐受性和疗效。虽然之前一项探索Qsymia治疗BED的病例系列研究显示出了前景，但需要进行随机研究来评估Qsymia在用于饮食失调时的安全性和疗效。我们展示了一项针对BED和BN的I/IIa期单中心、前瞻性、双盲、随机、交叉试验的研究方案，该试验旨在研究Qsymia的安全性和初步疗效。
方法
患有BED（n = 15）或BN（n = 15）的成年人按1:1随机分组，接受为期12周的Qsymia（苯丁胺/缓释托吡酯，3.75毫克/23毫克 - 15毫克/92毫克）或安慰剂治疗，随后进行2周的洗脱期，然后进行12周的交叉治疗，在此期间接受Qsymia治疗的患者改为接受安慰剂治疗，反之亦然。随后，参与者在不服用研究药物的情况下接受8周的随访。主要结局指标是通过饮食失调检查问卷（EDE）测量的每周暴饮暴食天数。次要结局指标包括暴饮暴食发作的平均次数、停止暴饮暴食的百分比，以及体重/生命体征、饮食心理病理学和情绪的变化。
讨论
据我们所知，这是第一项研究苯丁胺/托吡酯在BED和BN中的安全性和疗效的随机、双盲方案。我们强调了这项研究的背景和理论依据，包括交叉设计的优势。
试验注册
Clinicaltrials.gov标识符NCT02553824，于2015年9月17日注册。https://clinicaltrials.gov/ct2/show/NCT02553824 。
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