Cermolacce M, Belzeaux R, Adida M, Micoulaud Franchi J-A, Fakra E, Azorin J-M
SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
Encephale. 2016 Dec;42(6S):S18-S25. doi: 10.1016/S0013-7006(17)30049-0.
Placebo effect remains a crucial issue in current clinical trials. Most clinical trials rely on the hypothesis of equivalent placebo response rates in both placebo and specific drug arms ("additive model"). But contrary to this dominant and rarely questioned hypothesis, several aspects may influence placebo response. A few recent meta-analyses and reviews have shown evidence for several clinical and methodological factors, which are able to modulate placebo response. In psychiatry research, placebo response has been mainly explored through antidepressant trials. In early clinical trials, drug-placebo differences were initially significant and robust. However, more recent clinical trials have not yielded similar results, and rather show narrowed antidepressant-placebo differences. Several factors may be involved in this absence of comparability: intrinsic properties of new antidepressants, changes in clinical criteria and classifications, symptomatic remission rather than global remission criteria, industrial and institutional constraints. Moreover, results from antidepressant trials (laboratory conditions) remain hardly fully transposable to clinical routine (ecological conditions).
安慰剂效应仍是当前临床试验中的一个关键问题。大多数临床试验依赖于安慰剂组和特定药物组中安慰剂反应率相当的假设（“相加模型”）。但与这一占主导地位且很少受到质疑的假设相反，有几个方面可能会影响安慰剂反应。最近的一些荟萃分析和综述已经证明了一些临床和方法学因素的存在，这些因素能够调节安慰剂反应。在精神病学研究中，安慰剂反应主要是通过抗抑郁试验来探索的。在早期临床试验中，药物与安慰剂的差异最初是显著且稳定的。然而，最近的临床试验并未得出类似结果，反而显示出抗抑郁药与安慰剂之间的差异缩小了。这种缺乏可比性可能涉及几个因素：新型抗抑郁药的内在特性、临床标准和分类的变化、症状缓解而非整体缓解标准、行业和机构限制。此外，抗抑郁试验（实验室条件）的结果很难完全转化为临床常规（实际环境）。
