开放式安慰剂后的副作用:一个随机对照试验
Kate Faasse1, Chiara Gasteiger2, Anna Borgmann3
1School of Psychology, University of New South Wales, NSW, Australia.
Journal of psychosomatic research
|January 3, 2025
概括
服用开放式安慰剂,即使参与者知道它是安慰剂,导致更多的报道副作用和负面情绪增加,与没有治疗相比. 这些影响持续了24小时.
科学领域:
- 心理学 心理学 心理学
- 临床试验 临床试验
- 医学伦理 医学伦理
背景情况:
- 这项研究调查了开放标签安慰剂对患者报告结果的影响.
- 该试验在澳大利亚新西兰临床试验注册处预先注册.
研究的目的:
- 为了确定参与者在接受开放标签安慰剂后报告了更多的副作用和情绪下降,与没有接受治疗的对照组相比.
- 检查心理变量对症状报告的影响.
主要方法:
- 随机对照试验比较一个开放标签安慰剂组与一个没有治疗的对照组.
- 主要结局:15分钟和24小时后通过副作用归因量表 (SEAS) 测量报告的副作用.
- 二级结果:负面情绪评估;探索影响症状报告的心理因素.
主要成果:
- 与控制组相比,接受开放式安慰剂的参与者在15分钟和24小时内报告了显著更多的症状.
- 开放标签安慰剂组也报告了在两个时间点显著更大的负面情绪.
- 在症状或情绪方面,没有发现群体和时间之间的显著相互作用. 症状报告与基线焦虑,对药物的感知敏感性或健康担忧没有相关性.
结论:
- 服用开放式安慰剂的行为增加了报告的症状和负面情绪,即使参与者知道他们正在服用安慰剂.
- 这些发现表明,服用治疗的过程,无论其活性成分如何,都可能影响症状感知和情绪.
- 对安慰剂的临床使用和药物的一般处方存在影响,强调了治疗仪式本身的潜在影响.
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