在使用生物标志物驱动的因果调解分析的迷幻随机对照试验中克服盲目的混
1School of Pharmacy, The University of Auckland, Auckland, New Zealand.
Expert review of clinical pharmacology
|November 10, 2023
概括
迷幻疗法对心理健康有希望,但试验结果可能会被期望效应所夸大. 建议使用生物标志物进行因果调解分析,以确认疗效,并在批准前确定明确的治疗途径.
科学领域:
- 精神病学是一个精神病学.
- 临床心理学 临床心理学
- 药理学 药理学是指药理学的学科.
背景情况:
- 迷幻药辅助疗法对心理健康状况越来越感兴趣.
- 最初的随机对照试验 (RCT) 显示出积极的结果.
- 由于参与者和人员的盲目化,预期效应可能会在迷幻RCT中膨胀效应大小.
研究的目的:
- 为RCT引入因果推理概念.
- 建议使用生物标志物的因果调解分析用于迷幻RCT.
- 解决需要建立明确的因果关系途径,以心理治疗的有效性.
主要方法:
- 在RCT中引入因果推断,假设和混因素.
- 用客观测量的生物标志物进行因果调解分析的建议.
- 因果路径的图形说明.
主要成果:
- 预期效应可以在迷幻实验中膨胀效应大小,这是由于失明.
- 因果调解分析可以识别因果途径,即使在脱盲的情况下.
- 基于生物标志物的分析可以增加对心理治疗机制基础的信心.
结论:
- 在明确确定因果途径之前,不应批准迷幻疗法作为获得许可的药物.
- 过早批准的潜在风险包括基于低质量的证据的扩展和随着时间的推移而变化的疗效.
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