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一剂疑虑:关于安慰剂监管的定性研究

A dose of doubt: a qualitative study on placebo regulations.

作者信息

Richard Mélina, Ganz Manuela, Elger Bernice S, Gaab Jens

机构信息

Institute for Biomedical Ethics, University of Basel, Basel, Switzerland.

Department of Biomedical Engineering, University of Basel, Basel, Switzerland.

出版信息

Front Med (Lausanne). 2025 Jun 16;12:1574022. doi: 10.3389/fmed.2025.1574022. eCollection 2025.

DOI:10.3389/fmed.2025.1574022
PMID:40589967
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12206773/
Abstract

INTRODUCTION

Placebo use is common in primary care, yet ethical and legal concerns persist, and few qualitative studies have explored physicians' views on placebo regulation.

METHODS

We conducted semi-structured interviews with 10 primary care physicians from 2 German-speaking Swiss cantons to explore their definitions of placebos, usage in clinical practice, knowledge of existing regulations, and attitudes toward potential regulatory frameworks. Participants were recruited from a publicly available physician registry, yielding a 4.9% response rate.

RESULTS

Participants consistently reported using at least impure placebos in their practice, while references to the use of pure placebos were relatively uncommon. A distinction between pure and impure placebos emerged, with the latter generally viewed as more ethically acceptable. Risk-benefit evaluation was emphasized as the primary justification for placebo use. Most participants had not actively sought legal information, and knowledge about current regulations varied considerably. While clear support for specific regulation was rare, most participants did not perceive it as necessary, often citing distrust in regulatory systems or concerns that formal rules could restrict therapeutic flexibility. Expert bodies such as the Swiss Medical Association were mentioned as potential sources of guidance.

DISCUSSION

The findings highlight a practice-oriented, risk-benefit-driven approach to placebo use, shaped by skepticism toward regulation and limited legal awareness. Despite frequent use, physicians operate in a legally ambiguous space and express limited demand for regulatory clarity, suggesting a need for targeted professional discourse rather than strict formal regulation.

摘要

引言

安慰剂在初级医疗中使用普遍,但伦理和法律方面的担忧依然存在,而且很少有定性研究探讨医生对安慰剂监管的看法。

方法

我们对来自瑞士两个讲德语州的10名初级医疗医生进行了半结构化访谈,以探究他们对安慰剂的定义、在临床实践中的使用情况、对现有法规的了解以及对潜在监管框架的态度。参与者从一个公开的医生登记册中招募,回复率为4.9%。

结果

参与者一致表示在其临床实践中至少使用过不纯的安慰剂,而提及使用纯安慰剂的情况相对较少。出现了纯安慰剂和不纯安慰剂的区分,后者通常被认为在伦理上更可接受。强调风险效益评估是使用安慰剂的主要理由。大多数参与者没有积极寻求法律信息,对现行法规的了解差异很大。虽然很少有人明确支持具体的监管,但大多数参与者认为没有必要,他们经常提到对监管系统的不信任或担心正式规则会限制治疗的灵活性。瑞士医学协会等专家机构被提及为潜在的指导来源。

讨论

研究结果凸显了一种以实践为导向、由风险效益驱动的安慰剂使用方法,这种方法受到对监管的怀疑态度和有限的法律意识的影响。尽管安慰剂使用频繁,但医生们处于法律模糊的空间,对监管明确性的需求有限,这表明需要进行有针对性的专业讨论,而不是严格的正式监管。

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