插入假针的具体效果及其对随机对照试验中针治疗效果估计的影响: 一项系统调查
Xiao-Chao Luo1, Jia-Li Liu1, Ming-Hong Yao1
1Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, Cochrane China Center and MAGIC China Center, West China Hospital, Sichuan University, Chengdu 610041 Sichuan Province, China; NMPA Key Laboratory for Real-world Data Research and Evaluation in Hainan, Chengdu 610041 Sichuan Province, China; Sichuan Center of Technology Innovation for Real-world Data, Chengdu 610041 Sichuan Province, China.
Journal of integrative medicine
|August 12, 2025
概括
插入假针具有特定的效果 (PIES),影响随机对照试验 (RCT) 中针治疗的评估. 控制PIES变化研究结果的控制,建议在使用插入假作为安慰剂时谨慎使用.
科学领域:
- 综合医学是一个整体的医学.
- 临床研究方法论 临床研究方法论
- 针研究 针研究
背景情况:
- 在随机对照试验 (RCT) 中使用插入假针作为安慰剂是有争议的,因为潜在的特定效应.
- 这些影响可能会导致低估真正的针治疗疗效.
研究的目的:
- 调查假针 (PIES) 的插入特异效应的大小.
- 确定PIES是否影响RCT中针治疗效果的估计.
主要方法:
- 对将针与假针和没有治疗进行比较的RCT的系统调查 (PubMed,Embase,Cochrane).
- 分析量化自然历史 (PNE) 和情境效应 (PCE).
- 假针 (PIES) 的插入特异效应的计算及其对结果解释的影响.
主要成果:
- 假针 (PIES) 的插入特异效应占针总效应的18.90%.
- 排除PIES在45.45%的纳入RCT和40.91%的外部验证RCT中改变了治疗效应的统计学意义.
结论:
- 在RCT中,PIES对治疗效果的评估产生了重大影响.
- 超过40%使用插入假针的RCT可能会得出不同的结论,如果PIES受到控制.
- 在RCT中使用插入假针作为安慰剂时建议谨慎使用.
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