Quality evaluation of randomized controlled trials of Chinese medicine formulated granules based on CONSORT-CHM formulas_Chinese Journal of Evidence-Based Medicine

Authors：

MA Huilin ¹ , HE Zhenfan ¹ , ZHANG Shen ² , SHAN Zejun ² , YE Zhiyu ² , LIANG Haojia ² , SHUAI Yuxing ¹ , XU Qian ¹ ,  CHEN Lixia ¹ , CHEN Xinlin ¹

1. School of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou 510405, P. R. China;
2. Guangzhou University of Chinese Medicine, Guangzhou 510405, P. R. China;

Corresponding author：

CHEN Lixia, Email: chenxlsums@126.com

Keywords：

Chinese medicine formula granules; Methodological study; Quality evaluation; Randomized controlled trial

DOI：

10.7507/1672-2531.202406013

Video：

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Objective To evaluate the quality of randomized controlled trials (RCTs) of Chinese medicine (TCM) formulated granules published in core journals in China. Methods Computerized searches were conducted in CNKI, VIP, WanFang Data and CBM databases. The publicly published RCTs of TCM formulated granules were collected, with sources from Peking University Core, CSSCI and EI. The following information was extracted: including title, the first author, the journals name, type of disease, year of publication, and source of drug. The included studies were evaluated using the CONSORT extension for CHM formulas (CONSORT-CHM formulas 2017), which included 25 items from title, abstract and keywords, introduction, research methods, steps, results, discussion, and other information. Results A total of 125 papers were included, which mainly included digestive system diseases (n=25), respiratory system diseases (n=17), and circulatory system diseases (n=17). The results showed that the overall reporting quality of RCTs of TCM formulated granules was poor. After the publication of the CONSORT-CHM formulas 2017, the reporting quality of RCTs of TCM formulated granules had no significant changes, while some items were still reported with poor quality. For example, 42.2% of RCTs did not adequately report how to generate allocation sequence, 93.3% of RCTs did not adequately report allocation concealment, and 62.2% of RCTs did not adequately report how to solve the missing data. Conclusion The quality of RCTs reports on TCM formula granules published in Chinese journals still needs to be improved. It is recommended that researchers, journals and reviewers attach importance to the application of CONSORT-CHM formula throughout the whole process of paper writing. In the future, more scientific and detailed requirements should be put forward for trial design and reporting standards in line with the characteristics of clinical trials of TCM formula granules.

Citation： MA Huilin, HE Zhenfan, ZHANG Shen, SHAN Zejun, YE Zhiyu, LIANG Haojia, SHUAI Yuxing, XU Qian, CHEN Lixia, CHEN Xinlin. Quality evaluation of randomized controlled trials of Chinese medicine formulated granules based on CONSORT-CHM formulas. Chinese Journal of Evidence-Based Medicine, 2025, 25(3): 334-338. doi: 10.7507/1672-2531.202406013 Copy

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2.	路露, 施钧瀚, 侯富国, 等. 中药配方颗粒: 历史、现状及“后试点时代”的发展展望. 中国中药杂志, 2022, 47(8): 2008-2014.
3.	《国家及各地区国民经济和社会发展第十四个五年规划和2035年远景目标纲要》. 中国信息界, 2022, (5): 110.
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8.	杨鹤年, 张津铖, 吴宿慧, 等. 中药配方颗粒制备工艺、质量评价、与传统汤剂一致性的研究现状分析. 中国实验方剂学杂志, 2023, 29(8): 266-274.
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14.	潘岳松, 金奥铭, 王梦星. 临床研究样本量的估计方法和常见错误. 中国卒中杂志, 2022, 17(1): 31-35.
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22.	Ioannidis JPA, Evans SJW, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med, 2004, 141(10): 781-788.
23.	吴蕾, 许银姬, 陈远彬, 等. 风寒方治疗感染后咳嗽85例多中心双盲随机对照临床研究. 中医杂志, 2013, 54(22): 1917-1921.
24.	杨克新, 高春雨, 朱立国, 等. 中医综合保守疗法治疗退行性腰椎滑脱症61例临床观察. 中医杂志, 2013, 54(8): 677-680.
25.	强晓钰, 马毓聪, 陈哲, 等. 中药改善新型冠状病毒感染恢复期患者临床症状的系统评价. 中国循证医学杂志, 2023, 23(6): 647-653.
26.	黄庆花, 肖静, 孙艳梅, 等. 中药复方安慰剂的制作方法及质量评价. 中医杂志, 2015, 56(15): 1294-1297.
27.	龙德怀, 刘建平, 刘红旭. T1级中医药科技期刊2018年发表的随机对照试验质量评价. 中医杂志, 2021, 62(11): 956-960.
28.	韩梅, 夏芸, 李雪梅, 等. 中药配方颗粒临床研究现状、疗效与安全性的概况性评价—以华润三九配方颗粒为例. 中医杂志, 2021, 62(10): 861-867.
29.	吴成凤, 廖嘉宝, 李丹, 等. 中药配方颗粒临床安全性集中监测评价. 中国中药杂志, 2023, 48(15): 4231-4236.

1. 何军, 朱旭江, 杨平荣, 等. 中药配方颗粒的现状与发展新思路. 中草药, 2018, 49(20): 4717-4725.
2. 路露, 施钧瀚, 侯富国, 等. 中药配方颗粒: 历史、现状及“后试点时代”的发展展望. 中国中药杂志, 2022, 47(8): 2008-2014.
3. 《国家及各地区国民经济和社会发展第十四个五年规划和2035年远景目标纲要》. 中国信息界, 2022, (5): 110.
4. Moher D, Altman DG, Schulz KF, et al. Opportunities and challenges for improving the quality of reporting clinical research: CONSORT and beyond. CMAJ, 2004, 171(4): 349-350.
5. 詹思延. 如何做一个好的系统综述和Meta分析. 北京大学学报(医学版), 2010, 42(6): 644-647.
6. Muka T, Glisic M, Milic J, et al. A 24-step guide on how to design, conduct, and successfully publish a systematic review and meta-analysis in medical research. Eur J Epidemiol, 2020, 35(1): 49-60.
7. Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration (traditional Chinese version). Ann Intern Med, 2017, 167(2): W7-W20.
8. 杨鹤年, 张津铖, 吴宿慧, 等. 中药配方颗粒制备工艺、质量评价、与传统汤剂一致性的研究现状分析. 中国实验方剂学杂志, 2023, 29(8): 266-274.
9. Rezende M, Martins ACR, da Silva JA, et al. Compliance of randomized controlled trials in posterior restorations with the CONSORT statement: a systematic review of methodology. Clin Oral Invest, 2022, 26(1): 41-64.
10. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary. Control Clin Trials, 1996, 17(1): 1-12.
11. 戚操其, 黄瓦炎, 梁奕荣, 等. 精制颗粒与传统饮片治疗痹病的临床观察. 新中医, 2001, 33(3): 27-28.
12. 《中国的中医药》白皮书(全文). 中国中医药报, 2016.
13. Korevaar DA, Cohen JF, Hooft L, et al. Literature survey of high-impact journals revealed reporting weaknesses in abstracts of diagnostic accuracy studies. J Clin Epidemiol, 2015, 68(6): 708-715.
14. 潘岳松, 金奥铭, 王梦星. 临床研究样本量的估计方法和常见错误. 中国卒中杂志, 2022, 17(1): 31-35.
15. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c332.
16. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c869.
17. Boutron I, Moher D, Altman DG, et al. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med, 2008, 148(4): 295-309.
18. Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet, 2002, 359(9306): 614-618.
19. Altman DG, Schulz KF. Statistics notes: concealing treatment allocation in randomised trials. BMJ, 2001, 323(7310): 446-447.
20. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med, 2013, 158(3): 200-207.
21. Higgins JPT, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ, 2011, 343: d5928.
22. Ioannidis JPA, Evans SJW, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med, 2004, 141(10): 781-788.
23. 吴蕾, 许银姬, 陈远彬, 等. 风寒方治疗感染后咳嗽85例多中心双盲随机对照临床研究. 中医杂志, 2013, 54(22): 1917-1921.
24. 杨克新, 高春雨, 朱立国, 等. 中医综合保守疗法治疗退行性腰椎滑脱症61例临床观察. 中医杂志, 2013, 54(8): 677-680.
25. 强晓钰, 马毓聪, 陈哲, 等. 中药改善新型冠状病毒感染恢复期患者临床症状的系统评价. 中国循证医学杂志, 2023, 23(6): 647-653.
26. 黄庆花, 肖静, 孙艳梅, 等. 中药复方安慰剂的制作方法及质量评价. 中医杂志, 2015, 56(15): 1294-1297.
27. 龙德怀, 刘建平, 刘红旭. T1级中医药科技期刊2018年发表的随机对照试验质量评价. 中医杂志, 2021, 62(11): 956-960.
28. 韩梅, 夏芸, 李雪梅, 等. 中药配方颗粒临床研究现状、疗效与安全性的概况性评价—以华润三九配方颗粒为例. 中医杂志, 2021, 62(10): 861-867.
29. 吴成凤, 廖嘉宝, 李丹, 等. 中药配方颗粒临床安全性集中监测评价. 中国中药杂志, 2023, 48(15): 4231-4236.

Chinese Journal of Evidence-Based Medicine

Quality evaluation of randomized controlled trials of Chinese medicine formulated granules based on CONSORT-CHM formulas

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