在临床试验中尽量减少安慰剂反应
Christina Emborg1, Simple Futarmal Kothari1, Nanna Brix Finnerup2
1Department of Psychology and Behavioural Sciences, School of Business and Social Sciences, Aarhus University, Aarhus, Denmark.
Handbook of clinical neurology
|October 29, 2025
概括
对神经疾病的临床试验面临挑战,因为安慰剂反应很高. 尽量减少安慰剂效应可能不会提高药物的疗效,这表明需要通过纳入患者感知来完善试验方法.
科学领域:
- 神经学 神经学
- 临床试验设计 临床试验设计
- 心理药理学 心理药理学
背景情况:
- 许多针对神经系统疾病的临床试验都未能证明活性疗法优于安慰剂.
- 增加安慰剂反应率是导致这些试验失败的潜在因素,影响新疗法开发.
- 当前的研究经常假设将安慰剂反应最小化对改善药物与安慰剂比率有益.
研究的目的:
- 在临床试验中探索基于文献的策略,以尽量减少安慰剂反应.
- 评估支持最小化安慰剂效应的证据.
- 讨论是否降低安慰剂反应可以提高药物的疗效和试验成功.
主要方法:
- 在临床试验中,对建议的方法进行文献综述,以尽量减少安慰剂反应.
- 评估支持这些方法的证据.
- 关于降低安慰剂反应和提高药物反应之间的关系的讨论.
- 关于完善随机对照试验 (RCT) 方法的建议.
主要成果:
- 本章回顾了在临床试验中尽量减少安慰剂反应的各种建议.
- 支持这些最小化策略的证据得到了批判性评估.
- 假设减少安慰剂反应一定会改善药物反应和试验结果的假设受到质疑.
结论:
- 减少安慰剂反应可能不会本质上提高药物的疗效或保证成功的临床试验.
- 建议通过结合患者的感知,情绪和期望来完善随机对照试验 (RCT) 方法.
- 这种方法可以为神经病治疗带来更生态有效的结果,无论是药理还是非药理.
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