潜在的安慰剂偏差在当前的妄预防试验: 86个随机对照试验的网络元分析随机对照试验
Bing-Yan Zeng1,2, Chih-Sung Liang3,4, Chih-Wei Hsu5
1Institute of Biomedical Sciences, National Sun Yat-sen University, Kaohsiung, Taiwan.
Psychiatry and clinical neurosciences
|June 18, 2025
概括
在高风险患者中,标准护理加安慰剂显著降低了妄发病率,相比单独使用标准护理. 这突显了在妄预防试验中的安慰剂效应.
科学领域:
- 老年医学 老年医学
- 临床药理学 临床药理学
- 证据综合 证据综合
背景情况:
- 网络元分析 (NMAs) 显示,妄预防药物治疗的结果不一致.
- 研究设计的差异,特别是安慰剂与标准护理 (SoC) 对照的差异,可能解释了不一致性.
研究的目的:
- 在随机对照试验 (RCT) 中,重新检查 SoC 加安慰剂和 SoC 单独之间的事件妄想率.
- 调查研究设计对妄预防有效性的影响.
主要方法:
- 在2023年11月之前,系统地在文献中搜索关于预防狂妄症的药物疗法的RCT.
- 使用风险比率 (RR) 和95%信心区间 (CI) 的频率网络元分析 (NMA).
- 主要结局:妄想发病率;次要结局:所有原因的死亡率.
主要成果:
- 对86个RCT (19,889名参与者) 的分析显示,SoC加安慰剂降低了妄想风险,而仅仅是SoC (RR,0.60 [95%CI,0.41-0.88]).
- 两组对照组之间没有观察到任何原因死亡率的显著差异.
结论:
- 安慰剂效应显著影响高风险患者的RCT中的妄想发病率.
- 未来的RCT应该使用三臂设计 (SoC +安慰剂,单独SoC) 来区分安慰剂效应.
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