Critical of the additive model of the randomized controlled trial
Critical of the additive model of the randomized controlled trial
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DOI：
10.2515/therapie:2008015
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发表时间：
2008-01-01
期刊：
影响因子：
2.6
通讯作者：
Felden-Dominiak, Geraldine
中科院分区：
文献类型：
--
作者：
Boussageon, Remy;Gueyffier, Francois;Felden-Dominiak, Geraldine
随机、双盲、安慰剂对照临床试验是目前证明药物临床有效性的最佳方式。其方法依赖于差异法（John Stuart Mill），通过该方法观察到的两组（药物与安慰剂）之间的差异可以归因于所测试药物的药理作用。然而，如果药理效应和安慰剂效应之间存在统计相互作用，这种加性模型可能会受到质疑。不同领域的证据表明，安慰剂效应可以影响有效成分的效果。本文评估了这种现象的方法论、临床和认识论后果。处理的主题包括推断结果、解释异质性结果、证明安慰剂效应中多个因素的存在、针对给定症状或病理考虑这些因素的必要性，以及“特定”效应的问题。
Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.