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疼痛性糖尿病神经病变中的安慰剂和安慰剂反应:系统性审查和元分析
Elisa Frisaldi1, Jan Vollert2,3,4,5, Husam Al Sultani6
1Rita Levi Montalcini Department of Neuroscience, University of Turin Medical School, Turin, Italy.
Pain
|August 2, 2023
概括
这一系统性审查证实了在疼痛性糖尿病神经病变 (PDN) 试验中显著的安慰剂和安慰剂效应. 研究开始的年份适度了安慰剂反应,强调需要考虑患者的背景.
科学领域:
- 神经科学是一个神经科学.
- 临床药理学 临床药理学
- 基于证据的医学基于证据的医学.
背景情况:
- 疼痛性糖尿病神经病变 (PDN) 是糖尿病的一个常见并发症.
- 假药和nocebo反应显著影响临床试验结果.
- 关于PDN试验中这些反应的先前文献需要更新.
研究的目的:
- 系统地审查和元分析安慰剂和nocebo响应在安慰剂控制的随机临床试验 (RCTs) 的PDN.
- 更新过去二十年关于这些反应的现有文献.
主要方法:
- 关于口服药物的PDN测试的RCT的系统审查和元分析.
- 在四个数据库中搜索了过去20年发表的试验.
- 对安慰剂/安慰剂反应的评估大小,偏差风险,异质性和调节者.
主要成果:
- 分析了21项涉及2425名安慰剂治疗患者的研究.
- 聚合的安慰剂反应:-1.54疼痛强度的变化 (中等效果大小).
- 聚合安慰剂50%的应答率:25%;53.3%在安慰剂手臂中经历了不良事件.
结论:
- 在PDN试验中,安慰剂和nocebo反应是相当大的.
- 研究开始的年份是安慰剂反应的唯一显著调节者.
- 环境因素,如患者的信心和先前的经验影响了结果.
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