草药试验中的方法挑战:基于证据的实践的障碍
Yixuan Li1, Ziwen Xu1, Peipei Du1
1Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Journal of clinical epidemiology
|March 13, 2025
概括
草药 (HM) 试点试验往往缺乏方法严格性和清晰的报告,阻碍了它们指导更大规模研究的能力. 需要改进标准,以基于证据的整合HM在医疗保健.
科学领域:
- 综合医学是一个整体的医学.
- 临床试验方法论 临床试验方法论
- 药理学 药理学是指药理学的学科.
背景情况:
- 草药 (HM) 的使用在全球范围内不断增加,需要强大的临床试验以实现基于证据的整合.
- 在大规模研究之前,试点试验对于完善方法和评估可行性至关重要.
- 现有的HM试点试验在设计质量,可行性评估和报告方面面临挑战.
研究的目的:
- 评估草药试验的设计质量,可行性和报告.
- 评估HM试点试验能够为未来的全面研究提供信息的能力.
- 确定影响HM试验报告完整性和进展的因素.
主要方法:
- 通过PubMed,科学网络和Embase识别的123个HM试点试验的系统审查.
- 提取关于试验特征,报告质量和进展到全面研究的数据.
- 评估遵守综合报告试验标准 (CONSORT) 的指导方针,并对进展数据进行作者跟进.
主要成果:
- 在可行性评估 (13.1%),样本大小推理 (47.2%) 和随机化 (35.8%) 中发现了重大报告缺口.
- 不一致地报告有关HM的具体细节,如成分加工,质量控制和安全.
- 只有3.3%的试验取得了全面研究的进展;试验注册和议定书发布与报告的完整性有积极的相关性.
结论:
- 由于方法上的局限,目前的HM试点试验不足以可靠地指导全面研究.
- 加强报告标准,包括HM特定的检查清单,对于提高严格性至关重要.
- 加强试验试验方法是基于证据的草药整合的关键.
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