How do they add up? The interaction between the placebo and treatment effect: A systematic review.
How do they add up? The interaction between the placebo and treatment effect: A systematic review.
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DOI：
10.1111/bcp.15345
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发表时间：
2022-08
影响因子：
3.4
通讯作者：
中科院分区：
文献类型：
--
作者：
安慰剂效应和特定效应通常被认为是相加的(加法模型)。可加性是否成立会极大地影响试验的外部有效性。Kleijnen等人在1994年对这一可加性假设进行了检验，但此后产生的数据尚未被合成。在这篇综述中，我们的目的是系统地回顾文献以确定可加性是否成立。我们搜索了截至2019年1月10日的Medline和mental Info。包括使用平衡安慰剂设计(BPD)的研究，测试安慰剂的两种不同强度。通过用方差或协方差分析比较BPD中的每一组来评估交互作用的存在。纳入了30项研究，总体偏倚风险很高：4项研究发现了可加性证据，16项研究发现了交互作用的证据(7项研究发现了正可加性证据)。在纳入的研究中，安慰剂和治疗的特定特征之间相加的证据很少。我们建议，对安慰剂敏感型疾病的干预措施应该在试验中进行测试，一旦探索性随机对照试验以足够的内部有效性证明了它们的有效性，就应该认真对待相互作用。
The placebo effect and the specific effect are often thought to add up (additive model). Whether additivity holds can dramatically influence the external validity of a trial. This assumption of additivity was tested by Kleijnen et al in 1994 but the data produced since then have not been synthetized. In this review, we aimed to systematically review the literature to determine whether additivity held. We searched Medline and PsychInfo up to 10 January 2019. Studies using the balanced placebo design (BPD), testing two different strengths of placebos, were included. The presence of interaction was evaluated by comparing each group in the BPD with analysis of variance or covariance. Thirty studies were included and the overall risk of bias was high: four found evidence of additivity and 16 studies found evidence of interaction (seven had evidence of positive additivity). Evidence of additivity between placebo and specific features of treatments was rare in included studies. We suggest interventions for placebo‐sensitive ailments should be tested in trials designed to take interactions seriously once an exploratory RCTs has proven their efficacy with sufficient internal validity.
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影响因子：
--
作者：
Boehm, Katja;Berger, Bettina;Heusser, Peter
通讯作者：
Heusser, Peter
影响因子：
4.2
作者：
Faasse, Kate;Martin, Leslie R.;Petrie, Keith J.
通讯作者：
Petrie, Keith J.
影响因子：
2.7
作者：
Colagiuri, Ben
通讯作者：
Colagiuri, Ben
影响因子：
2.6
作者：
Boussageon, Remy;Gueyffier, Francois;Felden-Dominiak, Geraldine
通讯作者：
Felden-Dominiak, Geraldine
影响因子：
4.7
作者：
de Craen, AJM;Lampe-Schoenmaeckers, AJEM;Kleijnen, J
通讯作者：
Kleijnen, J