对安慰剂无反应者:对其随时间的不可靠性进行实验性调查
Fabrizio Benedetti1, Wilma Thoen2, Aziz Shaibani3
1University of Turin Medical School, Neuroscience Department, Turin 10125, Italy; Innovative Clinical Training, Trials & Healthcare Initiative, Zermatt CH-3920, Switzerland.
The journal of pain
|January 13, 2025
概括
临床试验中安慰剂不响应者在时间上不一致. 这项研究质疑选择这些人的可靠性,建议重新考虑研究中安慰剂运行方案.
科学领域:
- 临床研究方法论 临床研究方法论
- 疼痛感知和安慰剂效应的影响
背景情况:
- 临床试验经常使用安慰剂运行阶段来识别未响应者以进行随后的随机化.
- 对安慰剂无反应者是那些对安慰剂治疗没有显著反应的人.
- 调查安慰剂无反应的稳定性对于完善临床试验设计至关重要.
研究的目的:
- 为了研究通过经典的安慰剂运行和不匹配条件范式识别的安慰剂无响应者的日复一日变化.
- 评估选择安慰剂无响应者在临床研究环境中随机选择的可靠性.
主要方法:
- 在实验室环境中模拟了一项临床试验.
- 使用两个不同的方法确定了安慰剂无反应者:安慰剂运行 (组RUN) 和不匹配条件 (组MIS).
- 随机识别的无反应者继续接受安慰剂或局部0.5%利多卡因,测量疼痛值.
主要成果:
- 在第一天发现的安慰剂无反应者在第二天在RUN和MIS组中表现出不同的反应.
- 在两个组中,在安慰剂和利多卡因治疗之间没有观察到疼痛值的显著差异.
- 无论使用何种识别方法,安慰剂无响应者状态的变化是明显的.
结论:
- 对安慰剂无反应者在时间上并不稳定,即使在受控的实验室模拟中也是如此.
- 这些发现挑战了选择安慰剂无反应者的有效性和实用性,作为临床研究中的方法方法.
- 建议重新考虑安慰剂运行方案,因为已识别的非响应者的潜在不可靠性.
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