Richard Mélina, Bernstein Michael, Gaab Jens, Elger Bernice
Department of Biomedical Engineering, University of Basel, Hegenheimermattweg 167B/C Allschwil, Basel, 4123, Switzerland.
Institute for Biomedical Ethics, University of Basel, Bernoullistrasse 28 - 2nd Floor Basel, Basel, 4056, Switzerland.
Sci Rep. 2025 Apr 10;15(1):12268. doi: 10.1038/s41598-025-96425-5.
Open-label placebos (OLPs), which are transparently administered inert treatments, have gained increasing attention in the research community. They have the potential to harness placebo effects without deceiving the patient. The purpose of this study was to examine and synthesize prior research discussing ethical issues in OLPs. A systematic qualitative literature review was conducted (last search on January 2023) across multiple databases (e.g., MEDLINE, Embase, PsycInfo) using keywords related to OLPs. Publications were screened and assessed for eligibility. Seventeen articles explicitly addressing OLP ethics were included. Data were extracted and thematically analyzed following established qualitative content analysis procedures. 37 distinct ethical issues were identified, grouped into five overarching themes: (1) Sociocultural and Contextual Factors, (2) Implementation and Logistics, (3) Informed Consent, (4) Patient Health Behavior and Dynamics, and (5) Therapeutic Relationship. Frequently mentioned concerns focused on uncertainty of OLP efficacy, the need for further research, and complexities of dose-extending OLPs. The effective integration of OLPs into healthcare necessitates thoughtful consideration and responsible communication. This analysis shows that demonstrating the efficacy of OLPs becomes pivotal for their widespread adoption, underscoring the necessity for additional research to validate their effectiveness. This review was pre-registered on January 26th, 2023, in the Open Science Framework Registry under the identifier: DOI https://doi.org/10.17605/OSF.IO/R6NKG .
开放标签安慰剂(OLPs)是指透明给予的惰性治疗方法,在研究界越来越受到关注。它们有潜力利用安慰剂效应而不欺骗患者。本研究的目的是审查和综合先前讨论开放标签安慰剂伦理问题的研究。我们使用与开放标签安慰剂相关的关键词,在多个数据库(如MEDLINE、Embase、PsycInfo)中进行了系统的定性文献综述(最后一次检索时间为2023年1月)。对出版物进行筛选和资格评估。纳入了17篇明确讨论开放标签安慰剂伦理的文章。按照既定的定性内容分析程序提取数据并进行主题分析。确定了37个不同的伦理问题,分为五个总体主题:(1)社会文化和背景因素,(2)实施和后勤,(3)知情同意,(4)患者健康行为和动态,以及(5)治疗关系。经常提到的担忧集中在开放标签安慰剂疗效的不确定性、进一步研究的必要性以及延长开放标签安慰剂剂量的复杂性。将开放标签安慰剂有效整合到医疗保健中需要深思熟虑和负责任的沟通。该分析表明,证明开放标签安慰剂的疗效对于其广泛应用至关重要,强调了进行更多研究以验证其有效性的必要性。本综述于2023年1月26日在开放科学框架注册中心预注册,标识符为:DOI https://doi.org/10.17605/OSF.IO/R6NKG 。