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在随机对照试验中,将虚假治疗方法伪装成个性化治疗会增加安慰剂效应。

Presenting a sham treatment as personalised increases the placebo effect in a randomised controlled trial.

机构信息

Integrated Program in Neuroscience, McGill University, Montreal, Canada.

Department of Psychology, Harvard University, Cambridge, United States.

出版信息

Elife. 2023 Jul 5;12:e84691. doi: 10.7554/eLife.84691.

DOI:10.7554/eLife.84691
PMID:37405829
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10325710/
Abstract

BACKGROUND

Tailoring interventions to patient subgroups can improve intervention outcomes for various conditions. However, it is unclear how much of this improvement is due to the pharmacological personalisation versus the non-specific effects of the contextual factors involved in the tailoring process, such as the therapeutic interaction. Here, we tested whether presenting a (placebo) analgesia machine as personalised would improve its effectiveness.

METHODS

We recruited 102 adults in two samples (=17, 85) to receive painful heat stimulations on their forearm. During half of the stimulations, a machine purportedly delivered an electric current to reduce their pain. The participants were either told that the machine was personalised to their genetics and physiology, or that it was effective in reducing pain generally.

RESULTS

Participants told that the machine was personalised reported more relief in pain intensity than the control group in both the feasibility study (standardised =-0.50 [-1.08, 0.08]) and the pre-registered double-blind confirmatory study (=-0.20 [-0.36, -0.04]). We found similar effects on pain unpleasantness, and several personality traits moderated the results.

CONCLUSIONS

We present some of the first evidence that framing a sham treatment as personalised increases its effectiveness. Our findings could potentially improve the methodology of precision medicine research and inform practice.

FUNDING

This study was funded by the Social Science and Humanities Research Council (93188) and Genome Québec (95747).

摘要

背景

针对患者亚组进行干预可以改善各种情况下的干预效果。然而,尚不清楚这种改善有多少是由于药理学的个性化,以及与定制过程中涉及的非特异性因素(如治疗相互作用)有关。在这里,我们测试了将(安慰剂)镇痛机器呈现为个性化是否会提高其效果。

方法

我们招募了 102 名成年人,在两个样本中(= 17, 85)接受前臂疼痛热刺激。在一半的刺激中,一台机器据称通过电流来减轻他们的疼痛。参与者被告知该机器是根据他们的遗传和生理特点个性化定制的,或者它通常可以有效减轻疼痛。

结果

与对照组相比,在可行性研究(标准化=-0.50[-1.08,0.08])和预先注册的双盲确认性研究(=-0.20[-0.36,-0.04])中,被告知机器个性化的参与者报告的疼痛强度缓解更多。我们还发现对疼痛不适有类似的影响,并且几个人格特质调节了结果。

结论

我们提出了一些初步证据,表明将虚假治疗方案呈现为个性化可以提高其效果。我们的发现可能会改善精准医学研究的方法学,并为实践提供信息。

资助

这项研究由社会科学和人文研究理事会(93188)和基因组魁北克(95747)资助。

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