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在单相重度抑郁症的短期抗抑郁药物试验中,药物与安慰剂的差异是否比之前认为的要大得多?

Is drug-placebo difference in short-term antidepressant drug trials on unipolar major depression much greater than previously believed?

作者信息

Rihmer Zoltán, Gonda Xénia

机构信息

Department of Clinical and Theoretical Mental Health, Semmelweis University, Faculty of Medicine, Budapest, Hungary.

出版信息

J Affect Disord. 2008 Jun;108(3):195-8. doi: 10.1016/j.jad.2008.01.020. Epub 2008 Feb 15.

DOI:10.1016/j.jad.2008.01.020
PMID:18280581
Abstract

A pooled analysis of randomized placebo-controlled short-term antidepressant trials on unipolar major depression shows that the rate of antidepressant and placebo responders is 50% and 30% respectively. The traditional calculation of antidepressant-placebo difference (50-30=20%) in these drug trials is based on the assumption that all placebo responders should be antidepressant responders, a postulation that has been never investigated and proved. Further studies are needed investigating directly the relationship of placebo response in relation to antidepressant response/nonresponse. If a substantial part of placebo responders were antidepressant nonresponders, the drug-placebo differences in all short-term antidepressant drug trials on unipolar major depression are much more than 20%, and the previously published data on antidepressant-placebo difference should be re-calculated.

摘要

一项对单相重度抑郁症的随机安慰剂对照短期抗抑郁试验的汇总分析表明,抗抑郁药反应者和安慰剂反应者的比例分别为50%和30%。这些药物试验中抗抑郁药与安慰剂差异的传统计算方法(50 - 30 = 20%)是基于这样一种假设,即所有安慰剂反应者都应该是抗抑郁药反应者,而这一假设从未得到研究和证实。需要进一步的研究来直接调查安慰剂反应与抗抑郁药反应/无反应之间的关系。如果很大一部分安慰剂反应者是抗抑郁药无反应者,那么在所有关于单相重度抑郁症的短期抗抑郁药物试验中,药物与安慰剂的差异将远超过20%,并且之前发表的关于抗抑郁药与安慰剂差异的数据应该重新计算。

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Is drug-placebo difference in short-term antidepressant drug trials on unipolar major depression much greater than previously believed?在单相重度抑郁症的短期抗抑郁药物试验中,药物与安慰剂的差异是否比之前认为的要大得多?
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Improving study design for antidepressant effectiveness assessment.改进抗抑郁药疗效评估的研究设计。
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