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, 施鈞瀚, 侯富國, 等. 中藥配方顆粒: 歷史、現狀及“后試點時代”的發展展望. 中國中藥雜志, 2022, 47(8): 2008-2014.
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8.	楊鶴年, 張津鋮, 吳宿慧, 等. 中藥配方顆粒制備工藝、質量評價、與傳統湯劑一致性的研究現狀分析. 中國實驗方劑學雜志, 2023, 29(8): 266-274.
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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, 黃瓦炎, 梁奕榮, 等. 精制顆粒與傳統飲片治療痹病的臨床觀察. 新中醫, 2001, 33(3): 27-28.
12.	《中國的中醫藥》白皮書(全文). 中國中醫藥報, 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, 金奧銘, 王夢星. 臨床研究樣本量的估計方法和常見錯誤. 中國卒中雜志, 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.
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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, G?tzsche 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, G?tzsche 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.	吳蕾, 許銀姬, 陳遠彬, 等. 風寒方治療感染后咳嗽85例多中心雙盲隨機對照臨床研究. 中醫雜志, 2013, 54(22): 1917-1921.
24.	楊克新, 高春雨, 朱立國, 等. 中醫綜合保守療法治療退行性腰椎滑脫癥61例臨床觀察. 中醫雜志, 2013, 54(8): 677-680.
25.	強曉鈺, 馬毓聰, 陳哲, 等. 中藥改善新型冠狀病毒感染恢復期患者臨床癥狀的系統評價. 中國循證醫學雜志, 2023, 23(6): 647-653.
26.	黃慶花, 肖靜, 孫艷梅, 等. 中藥復方安慰劑的制作方法及質量評價. 中醫雜志, 2015, 56(15): 1294-1297.
27.	龍德懷, 劉建平, 劉紅旭. T1級中醫藥科技期刊2018年發表的隨機對照試驗質量評價. 中醫雜志, 2021, 62(11): 956-960.
28.	韓梅, 夏蕓, 李雪梅, 等. 中藥配方顆粒臨床研究現狀、療效與安全性的概況性評價—以華潤三九配方顆粒為例. 中醫雜志, 2021, 62(10): 861-867.
29.	吳成鳳, 廖嘉寶, 李丹, 等. 中藥配方顆粒臨床安全性集中監測評價. 中國中藥雜志, 2023, 48(15): 4231-4236.

1. 何軍, 朱旭江, 楊平榮, 等. 中藥配方顆粒的現狀與發展新思路. 中草藥, 2018, 49(20): 4717-4725.
2. 路露, 施鈞瀚, 侯富國, 等. 中藥配方顆粒: 歷史、現狀及“后試點時代”的發展展望. 中國中藥雜志, 2022, 47(8): 2008-2014.
3. 《國家及各地區國民經濟和社會發展第十四個五年規劃和2035年遠景目標綱要》. 中國信息界, 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. 如何做一個好的系統綜述和Meta分析. 北京大學學報(醫學版), 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. 楊鶴年, 張津鋮, 吳宿慧, 等. 中藥配方顆粒制備工藝、質量評價、與傳統湯劑一致性的研究現狀分析. 中國實驗方劑學雜志, 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, 黃瓦炎, 梁奕榮, 等. 精制顆粒與傳統飲片治療痹病的臨床觀察. 新中醫, 2001, 33(3): 27-28.
12. 《中國的中醫藥》白皮書(全文). 中國中醫藥報, 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, 金奧銘, 王夢星. 臨床研究樣本量的估計方法和常見錯誤. 中國卒中雜志, 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, G?tzsche 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, G?tzsche 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. 吳蕾, 許銀姬, 陳遠彬, 等. 風寒方治療感染后咳嗽85例多中心雙盲隨機對照臨床研究. 中醫雜志, 2013, 54(22): 1917-1921.
24. 楊克新, 高春雨, 朱立國, 等. 中醫綜合保守療法治療退行性腰椎滑脫癥61例臨床觀察. 中醫雜志, 2013, 54(8): 677-680.
25. 強曉鈺, 馬毓聰, 陳哲, 等. 中藥改善新型冠狀病毒感染恢復期患者臨床癥狀的系統評價. 中國循證醫學雜志, 2023, 23(6): 647-653.
26. 黃慶花, 肖靜, 孫艷梅, 等. 中藥復方安慰劑的制作方法及質量評價. 中醫雜志, 2015, 56(15): 1294-1297.
27. 龍德懷, 劉建平, 劉紅旭. T1級中醫藥科技期刊2018年發表的隨機對照試驗質量評價. 中醫雜志, 2021, 62(11): 956-960.
28. 韓梅, 夏蕓, 李雪梅, 等. 中藥配方顆粒臨床研究現狀、療效與安全性的概況性評價—以華潤三九配方顆粒為例. 中醫雜志, 2021, 62(10): 861-867.
29. 吳成鳳, 廖嘉寶, 李丹, 等. 中藥配方顆粒臨床安全性集中監測評價. 中國中藥雜志, 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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