Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, UK.
Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
J Psychopharmacol. 2023 Sep;37(9):866-875. doi: 10.1177/02698811231182602. Epub 2023 Jun 30.
The randomized controlled trial (RCT) research design assumes that a drug's "specific" effect can be isolated, added, and subtracted from the "nonspecific" effect of context and person. While RCTs are helpful in assessing the added benefit of a novel drug, they tend to obscure the curative potential of extra-pharmacological variables, known as "the placebo effect." Ample empirical evidence suggests that person/context-dependent physical, social, and cultural variables not only add to, but also shape drug effects, making them worth harnessing for patient benefits. Nevertheless, utilizing placebo effects in medicine is challenging due to conceptual and normative obstacles. In this article, we propose a new framework inspired by the field of psychedelic science and its employment of the "set and setting" concept. This framework acknowledges that drug and nondrug factors have an interactive and synergistic relationship. From it, we suggest ways to reintegrate nondrug variables into the biomedical toolbox, to ethically harness the placebo effect for improved clinical care.
随机对照试验（RCT）研究设计假设药物的“特定”作用可以从背景和个体的“非特定”作用中分离、添加和减去。虽然 RCT 在评估新药的附加益处方面很有帮助，但它们往往掩盖了非药物治疗变量的治疗潜力，这些变量被称为“安慰剂效应”。大量经验证据表明，与人/环境相关的生理、社会和文化变量不仅增加了药物的作用，而且还塑造了药物的作用，使其值得为患者的利益而利用。然而，由于概念和规范上的障碍，在医学中利用安慰剂效应具有挑战性。在本文中，我们提出了一个新的框架，该框架受到迷幻科学领域及其对“设定和环境”概念的应用的启发。该框架承认药物和非药物因素具有相互作用和协同关系。从中，我们提出了将非药物变量重新整合到生物医学工具包中的方法，以伦理地利用安慰剂效应来改善临床护理。
