在传统中医药中随机对照试验协议的报告特征和质量:一个横截面研究
Frontiers in pharmacology
|June 24, 2024
概括
传统中医 (TCM) 随机对照试验 (RCT) 协议的报告质量仍然很低,SPIRIT-TCM 2018年扩展指南的平均合规率为35.4%. 需要采取协调一致的努力,以提高对这些基本报告标准的遵守.
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
- 基于证据的医学基于证据的医学.
背景情况:
- 标准协议项目:传统中国医学的干预试验建议 (SPIRIT-TCM) 2018年扩展提供了报告TCM临床试验协议的指导方针.
- 这一指南对TCM随机对照试验 (RCT) 协议报告质量的影响尚不清楚.
研究的目的:
- 评估过去三年出版的TCM RCT协议的报告特征和质量.
- 评估是否遵守SPIRIT-TCM扩展2018年报告准则的情况.
主要方法:
- 从2020年1月到2023年8月,针对英语出版物的多个数据库进行了广泛的文献搜索.
- 两个独立审查员评估了协议的资格,提取了数据,并使用SPIRIT-TCM扩展2018检查清单评估了报告质量.
- 该审查包括中国草药配方 (CHMF),针和的协议.
主要成果:
- 总共分析了420个符合条件的方案,包括163个关于CHMF,239个关于针和18个关于moxibustion.
- 平均报告合规率低至35.4%,大约一半的项目报告不足 (合规率<65%).
- 与CHMF协议相比,针和催化剂协议显示了更高的报告合规性.
结论:
- 在应用和推广SPIRIT-TCM扩展2018年报告准则方面需要显著改进.
- 期刊,编辑,审稿人和调查人员的协调努力对于提高TCM RCT协议报告的质量至关重要.
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