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首页> 外文期刊>The journal of clinical psychiatry >Correlation between different levels of placebo response rate and clinical trial outcome in major depressive disorder: A meta-analysis
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Correlation between different levels of placebo response rate and clinical trial outcome in major depressive disorder: A meta-analysis

机译：重大抑郁症患者不同水平的安慰剂缓解率与临床试验结果之间的相关性：一项荟萃分析

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Objective:lo investigate the relationship between specific levels of placebo response rates and the drug response rate and the relative risk of response to drug versus placebo in clinical trials of antidepressant monotherapy and adjunctive polypharmacy for MDD. Data Sources: MEDLINE/PubMed databases were searched for studies published in the English language between January 1980 and March 2011 by using the search terms depression, placebo, augmentation, adjunct, adjunctive, and each of the antidepressant agents identified.The search was supplemented by manual bibliographic review and examination of relevant review articles. Study Selection: The analysis included randomized, double-blind, placebo-controlled trials of antidepressants used as monotherapy for MDD, 4 weeks or longer, and of augmentation/combination treatments for antidepressant partial respondersonresponders with MDD, 1 week or longer. 169 antidepressant monotherapy studies and 35 adjunctive polypharmacy studies were found eligible for inclusion in our analysis. Data Extraction: Data extracted included number of patients enrolled, patient characteristics, drug dosages and scheme (fixed vs flexible dosing), duration of the trial, and response rates. Results: In antidepressant monotherapy studies, a higher placebo response rate correlated with a lower risk ratio of responding to antidepressant versus placebo (P<.001) and correlated with higher antidepressant response rates (P<.001); the number needed to treat (NNT) for response was approximately 4,6, and 9 in trials with placebo response rates <30%, ≥30% and <40%, and ≥40%, respectively. In adjunctive trials, a higher placebo response rate correlated with a lower risk ratio of responding to the adjunctive drug versus placebo (P<.001) and correlated with a trend toward statistical significance with higher response rates to the adjunctive drug (P= .050); the NNT was approximately 6,7,11, and 17 in trials with placebo response rates < 20%, ≥ 20% and < 30%, ≥ 30% and <40%, and ≥40%, respectively. Conclusions:These results suggest that the relative efficacy of the active drug compared to placebo in clinical trials for MDD is highly heterogeneous across studies with different placebo response rates, with a worse performance in showing a superiority of the drug versus placebo for studies with placebo response rates ≥ 30% and ≥40%, respectively, for monotherapy and adjunctive trials. It is important to maintain placebo response rates below this critical threshold, since this is one of the most challenging obstacles for new treatment development in MDD.
机译：目的：研究抗抑郁药单一疗法和辅助性多药治疗MDD的临床试验中安慰剂应答率的特定水平与药物应答率之间的关系以及对药物与安慰剂的相对应答风险。数据来源：检索MEDLINE / PubMed数据库以查找1980年1月至2011年3月之间以英语发布的研究，这些研究使用了抑郁，安慰剂，增强，辅助，辅助和每种已确定的抗抑郁药进行检索，并辅以以下内容：手工书目审查和有关审查文章的审查。研究选择：该分析包括4周或更长时间的抗抑郁药作为MDD单一疗法的随机，双盲，安慰剂对照试验，以及1周或更长时间的针对MDD的抗抑郁局部缓解/无应答的增强/联合治疗。发现有169项抗抑郁药物单药研究和35项辅助多药研究符合我们的分析要求。数据提取：提取的数据包括入组患者的人数，患者特征，药物剂量和方案（固定剂量与灵活剂量），试验持续时间和缓解率。结果：在抗抑郁药单一疗法研究中，较高的安慰剂反应率与较低的抗抑郁药风险比（P <.001）和较高的抗抑郁药反应率（P <.001）相关;在安慰剂缓解率分别小于30％，≥30％和<40％和≥40％的试验中，需要治疗（NNT）的人数分别约为4,6和9。在辅助试验中，较高的安慰剂反应率与对辅助药物相对于安慰剂的较低风险比相关（P <.001），并且与具有统计学意义的趋势相关，对辅助药物的响应率较高（P = .050） ）;在安慰剂缓解率分别为<20％，≥20％和<30％，≥30％和<40％和≥40％的试验中，NNT分别约为6,7,11和17。结论：这些结果表明，在具有不同安慰剂反应率的研究中，MDD临床试验中活性药物与安慰剂的相对疗效高度异质，在安慰剂反应研究中显示出的药物优于安慰剂的性能较差单药治疗和辅助试验的发生率分别≥30％和≥40％。保持安慰剂缓解率低于此临界阈值很重要，因为这是MDD中新疗法开发的最具挑战性的障碍之一。

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