病药理试验中的安慰剂和安慰剂反应:一个元分析
Simeng Wang1, Zhiyi Xiong2, Yuehua Cui1
1Department of Pediatrics, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
概括
对于动障碍 (TD) 的临床试验显示了显著的安慰剂和无效果效应. 了解这些反应对于改善未来的试验设计和TD患者护理至关重要.
科学领域:
- 神经学 神经学
- 临床药理学 临床药理学
- 精神病学是一个精神病学.
背景情况:
- 提克障碍 (TD) 的临床试验经常报告负面结果.
- 安慰剂和安慰剂反应显著影响随机对照试验 (RCT) 的解释,但在TD中仍未得到充分研究.
研究的目的:
- 在药理干预RCT中量化安慰剂和nocebo反应,用于TD.
- 识别可能影响这些反应的因素.
主要方法:
- 在主要数据库 (Embase,Medline,Cochrane,PsycINFO) 进行系统的文献搜索.
- 包括RCT比较活性药物与TD的安慰剂.
- 定义的安慰剂反应作为安慰剂组的症状变化;安慰剂组的不良事件作为nocebo反应.
- 利用子组分析和元回归来探索影响因素.
主要成果:
- 分析了24项试验,共有2222名参与者.
- 在TD症状严重程度方面确定了实质性的安慰剂反应 (综合效应大小-0.79).
- 观察到显著的nocebo反应,其中44%的安慰剂组患者经历了不良事件.
- 发现了样本大小,研究设计和随机化比率与安慰剂/安慰剂反应大小之间的相关性.
结论:
- 滴疾病临床试验显示了相当大的安慰剂和无效疗法反应.
- 这些发现对于优化未来的TD试验设计和为临床实践提供信息非常重要.
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