Grant Jon E, Chamberlain Samuel R, Redden Sarah A, Odlaug Brian L, van Ameringen Michael, Dougherty Darin D, Keuthen Nancy J, Kim Suck W
aDepartment of Psychiatry and Behavioral Neuroscience, Pritzker School of Medicine, University of Chicago, Chicago, Illinois bDepartment of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts cDepartment of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA dSchool of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen eH. Lundbeck A/S, Copenhagen fDepartment of Psychiatry, University of Cambridge gCambridge and Peterborough NHS Foundation Trust, Cambridge, UK hDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.
Int Clin Psychopharmacol. 2017 Nov;32(6):350-355. doi: 10.1097/YIC.0000000000000185.
Trichotillomania is a functionally impairing, often overlooked disorder with no Food and Drug Administration-approved medications indicated for its treatment. The ability of clinical trials to detect the beneficial effects of pharmacologic treatment in trichotillomania has been hampered by the high placebo response rate. Very little is known about baseline demographic and clinical characteristics that may be predictive of placebo response in such patients. Overall, 104 participants assigned to placebo were pooled from five double-blind trials conducted at three sites in the USA and Canada. Participants were classified as placebo responders or nonresponders on the basis of a cutoff of a 35% reduction in symptom severity on the Massachusetts General Hospital Hair Pulling Scale. Baseline group differences were characterized using t-tests and equivalent nonparametric tests as appropriate. Thirty-one percent of individuals assigned to placebo treatment showed a significant clinical response to placebo. Placebo responders (n=32) and nonresponders (n=72) did not differ significantly on any demographic or clinical variable. Predictors of placebo response for trichotillomania remain elusive and do not appear to be similar to those reported for other mental health disorders.
拔毛癖是一种功能受损且常被忽视的疾病,目前尚无美国食品药品监督管理局批准用于治疗该病的药物。临床试验检测药物治疗拔毛癖疗效的能力受到高安慰剂反应率的阻碍。对于可能预测此类患者安慰剂反应的基线人口统计学和临床特征,人们了解甚少。总体而言,104名分配到安慰剂组的参与者来自在美国和加拿大三个地点进行的五项双盲试验。根据麻省总医院拔毛量表症状严重程度降低35%的临界值,将参与者分为安慰剂反应者或无反应者。基线组间差异采用t检验和适当的等效非参数检验进行描述。分配到安慰剂治疗组的个体中有31%对安慰剂表现出显著的临床反应。安慰剂反应者(n = 32)和无反应者(n = 72)在任何人口统计学或临床变量上均无显著差异。拔毛癖安慰剂反应的预测因素仍然难以捉摸,似乎与其他精神健康障碍报告的因素不同。