针临床试验中的失明状态和特征:系统性审查和元分析
Tinglan Liu1, Lijiao Jiang2, Shuangjing Li1
1School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
Systematic reviews
|December 6, 2024
概括
这次元分析发现,虽然大多数针试验正确地使参与者对真针失明,但一些假针控制可能会受到损害. 人口和针技术等因素可能会影响盲目的成功.
科学领域:
- 整合和补充医学是整合和补充医学.
- 临床试验方法论 临床试验方法论
- 基于证据的医疗保健
背景情况:
- 虚假针是针试验中常见的对照,但其盲目的有效性往往不清楚.
- 在模拟控制针试验中评估失明状态和失明评估的特征对于方法严格至关重要.
- 这项研究解决了在针研究中对盲目的综合评估的需要.
研究的目的:
- 评估虚假控制针临床试验中的整体失明状态.
- 探索在这些试验中使用的盲目评估的特点.
- 为了确定影响虚假针盲目的效果的因素.
主要方法:
- 一个对英语随机对照试验 (RCT) 的元分析,其中包括盲目的评估.
- 搜索了PubMed,Embase和Web of Science数据库,从创立到2024年4月.
- 使用贝叶斯的层次模型,按照PRISMA指南,将Bang's Blinding Index (Bang's BI) 进行了聚合.
主要成果:
- 包括1999年至2024年间发表的64项符合条件的研究.
- 平均Bang的BI为假针的 -0.24和真针的0.41.
- 亚组分析表明,试验区域,研究中心数量,治疗次数,针点数量和评估时间点影响了盲目的结果.
结论:
- 虽然许多试验成功地实现了对真针的失明,但一些假针控制可能会受到损害.
- 诸如人口 (例如,亚洲人),透假针和参与者查询等因素可能会增加解盲风险.
- 研究人员必须仔细考虑假针控制设计,监测失明状态,并透明地报告评估细节.
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