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Predictors of placebo response in bipolar depression

机译：双相抑郁症中安慰剂反应的预测因子

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The aim of this work is to investigate placebo response rates in placebo-controlled randomized clinical trials (RCTs) of pharmacological therapy in bipolar depression (BPD) and to identify predictors of placebo response and clinical trial outcome in BPD. Medline/PubMed publication databases were searched for RCTs of oral drugs used as monotherapy for the treatment of BPD, published between January 1980 and September 2013. Data extracted from 12 manuscripts and one poster, representing a total of 17 clinical trials, were pooled. Pooled response rates for drug and placebo were 55.1 and 39.2%, corresponding to a risk ratio for responding to active treatment versus placebo of 1.29 (P<0.001). The probability of receiving placebo and trial duration correlated with the response rate to placebo. A meta-regression showed that trial duration and baseline severity correlated with the risk ratio of responding to drug versus placebo. There was a trend toward statistical significance for a greater probability of receiving placebo to predict greater drug-placebo 'separation'. In conclusion, several modifiable factors, specifically the probability of receiving placebo, baseline illness severity, and trial duration, correlate with placebo response rates and/or clinical trial outcome in RCTs of pharmacotherapy for BPD, and should be taken into account when designing studies for BPD. Copyright (C) 2015 Wolters Kluwer Health, Inc. All rights reserved.
机译：这项工作的目的是调查安慰剂对照双相抑郁症（BPD）药物治疗的随机临床试验（RCT）中的应答率，并确定安慰剂应答和BPD中临床试验结果的预测因子。检索Medline / PubMed出版物数据库中1980年1月至2013年9月之间发布的用于治疗BPD的单一疗法的口服药物的RCT。汇总了从12篇手稿和一张海报中提取的数据，代表了总共17项临床试验。药物和安慰剂的总缓解率分别为55.1和39.2％，对应于积极治疗对安慰剂的风险比为1.29（P <0.001）。接受安慰剂的概率和试验持续时间与对安慰剂的反应率相关。荟萃回归显示，试验持续时间和基线严重程度与药物对安慰剂反应的风险比相关。有统计学意义的趋势是接受安慰剂的可能性更大，以预测更大的药物-安慰剂“分离”。总之，在BPD药物治疗的RCT中，有几个可修改的因素，特别是接受安慰剂的可能性，基线疾病的严重程度和试验持续时间，与安慰剂反应率和/或临床试验结果相关，应予以考虑。 BPD。版权所有（C）2015 Wolters Kluwer Health，Inc.保留所有权利。

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