Construction and evaluation of the evidence chain for the efficacy of traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

 ZHANG Junhua ^1,2,3 , PANG Wentai ^1,2,3 , YANG Fengwen ^1,2,3 , CAO Lujia ^1,2,3 , JI Zhaochen ^1,2,3 ,  ZHANG Boli ^1,2,3

1. Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P. R. China;
2. Key Laboratory of Evidence-Based Evaluation of Traditional Chinese Medicine, National Medical Products Administration, Tianjin 301617, P. R. China;
3. National Key Laboratory of Chinese Medicine Modernization, Tianjin 301617, P. R. China;

Corresponding author：

ZHANG Junhua, Email: zjhtcm@foxmail.com; ZHANG Boli, Email: zhangbolipr@163.com

Keywords：

Traditional Chinese medicine; Efficacy evaluation; Clinical value; Evidence-based medicine; Evidence chain

DOI：

10.7507/1672-2531.202412121

Video：

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With the advancement of modern research in traditional Chinese medicine (TCM), evidence regarding the clinical efficacy and mechanisms of action of TCM has rapidly accumulated. However, due to a lack of methodological safeguards, the disconnection between clinical and basic research in TCM has become increasingly prominent, making it difficult to form an evidence chain that supports the scientific value of TCM in a manner that is "clear and understandable". Therefore, it is necessary to develop methods for the translation and integration of clinical and basic research evidence oriented towards clinical value, to form a reliable evidence chain that can further discover patterns, confirm efficacy, and highlight advantages. This article discusses the construction and evaluation methods of the evidence chain for the efficacy of TCM, aiming to provide theoretical and methodological references for related work.

Citation： ZHANG Junhua, PANG Wentai, YANG Fengwen, CAO Lujia, JI Zhaochen, ZHANG Boli. Construction and evaluation of the evidence chain for the efficacy of traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2025, 25(4): 479-484. doi: 10.7507/1672-2531.202412121 Copy

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13.	高阳, 王桂倩, 谢雁鸣, 等. 基于中医“异病同治”的桂枝茯苓胶囊临床整合证据链的研究. 中国中药杂志, 2020, 45(10): 2304-2309.
14.	文建庭, 刘健. 构建从脾治痹多元融合的证据链. 风湿病与关节炎, 2021, 10(10): 39-43.
15.	李国祥, 李敬华, 于琦, 等. 脾胃病中成药循证证据链系统的构建与应用研究. 中国数字医学, 2023, 18(10): 92-97.
16.	Minozzi S, Cinquini M, Gianola S, et al. The revised Cochrane risk of bias tool for randomized trials (RoB 2) showed low interrater reliability and challenges in its application. J Clin Epidemiol, 2020, 126: 37-44.
17.	Slim K, Nini E, Forestier D, et al. Methodological index for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg, 2003, 73(9): 712-716.
18.	Stang A. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur J Epidemiol, 2010, 25(9): 603-605.
19.	Hooijmans CR, Rovers MM, de Vries RB, et al. SYRCLE's risk of bias tool for animal studies. BMC Med Res Methodol, 2014, 14: 43.
20.	赵霏, 赵晋, 郭忠, 等. 细胞实验系统评价制作流程的构建. 中国循证心血管医学杂志, 2019, 11(6): 658-663, 669.

1. 中华人民共和国中央人民政府. 习近平对中医药工作作出重要指示. 2019.
2. 中华人民共和国中央人民政府. 习近平: 进一步发展中医药. 2021.
3. 张俊华, 孙鑫, 李幼平, 等. 循证中医药学的现在和未来. 中国循证医学杂志, 2019, 19(5): 515-520.
4. 本刊讯. 第一届循证中医药学国际论坛在天津召开. 中医杂志, 2016, 57(13): 1165.
5. 张俊华. 循证中医药研究的几个关键问题. 天津中医药, 2024, (1): 1-5.
6. Sandercock P, Roberts I. Systematic reviews of animal experiments. Lancet, 2002, 360(9333): 586.
7. 赵冰, 胡凯燕, 曾宪涛, 等. 中医药动物实验系统评价的报告指南. 中国循证医学杂志, 2022, 22(5): 508-516.
8. 张俊华, 张伯礼. 大数据时代的中医药循证评价研究. 首届两岸四地中医药循证高峰论坛, 2015.
9. 张俊华, 孙鑫. 循证中医药学. 上海: 上海科学技术出版社, 2018.
10. 张俊华, 李幼平, 张伯礼, 等. 循证中医药研究: 北京宣言. 中国循证医学杂志, 2020, 20(8): 869-870.
11. 肖小河, 罗烨, 赵旭, 等. 中药有效性评价新策略、新方法: 整合证据链法. 中国中药杂志, 2024, 49(19): 5113-5124.
12. 陆丽明, 唐纯志, 许能贵. 针灸临床研究整合证据链的构建. 中国针灸, 2019, 39(12): 1340-1342.
13. 高阳, 王桂倩, 谢雁鸣, 等. 基于中医“异病同治”的桂枝茯苓胶囊临床整合证据链的研究. 中国中药杂志, 2020, 45(10): 2304-2309.
14. 文建庭, 刘健. 构建从脾治痹多元融合的证据链. 风湿病与关节炎, 2021, 10(10): 39-43.
15. 李国祥, 李敬华, 于琦, 等. 脾胃病中成药循证证据链系统的构建与应用研究. 中国数字医学, 2023, 18(10): 92-97.
16. Minozzi S, Cinquini M, Gianola S, et al. The revised Cochrane risk of bias tool for randomized trials (RoB 2) showed low interrater reliability and challenges in its application. J Clin Epidemiol, 2020, 126: 37-44.
17. Slim K, Nini E, Forestier D, et al. Methodological index for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg, 2003, 73(9): 712-716.
18. Stang A. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur J Epidemiol, 2010, 25(9): 603-605.
19. Hooijmans CR, Rovers MM, de Vries RB, et al. SYRCLE's risk of bias tool for animal studies. BMC Med Res Methodol, 2014, 14: 43.
20. 赵霏, 赵晋, 郭忠, 等. 细胞实验系统评价制作流程的构建. 中国循证心血管医学杂志, 2019, 11(6): 658-663, 669.

Chinese Journal of Evidence-Based Medicine

Construction and evaluation of the evidence chain for the efficacy of traditional Chinese medicine

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