Quality assessment of randomized controlled trials on "pattern dominating disease" using the CONSORT extension for Chinese herbal medicine formulas_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Lu ¹ , WANG Jiajia ^1,2 , ZHANG Yingying ² , LUO Xufei ³ ,  LI Jiansheng ^1,2 ,  CHEN Yaolong ^4,5,6,7

1. Lung Disease Diagnosis and Treatment Center, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450003, P. R. China;
2. Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province & Education Ministry of P. R. China/Henan Key Laboratory of Chinese Medicine for Respiratory Diseases, Henan University of Chinese Medicine, Zhengzhou 450046, P. R. China;
3. Vincent V.C. Woo Chinese Medicine Clinical Research Institute, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong 999077, P. R. China;
4. Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
5. Key Laboratory of Evidence-Based Medicine of Gansu Province, Lanzhou 730000, P. R. China;
6. Institute of Health Data Science, Lanzhou University, Lanzhou 730000, P. R. China;
7. WHO Collaborating Centre for Guideline Implementation and Knowledge Translation, Lanzhou University, Lanzhou 730000, P. R. China;

Corresponding?author：

LI Jiansheng, Email: li_js8@163.com; CHEN Yaolong, Email: chevidence@lzu.edu.cn

Keywords：

Pattern dominating disease; Randomized controlled trial; Quality assessment

DOI：

10.7507/1672-2531.202606087

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective To evaluate the quality of randomized controlled trials (RCTs) on traditional Chinese medicine (TCM) compound formulations conducted under the "Pattern Dominating Disease" model. Methods RCTs on "Syndrome Dominating Disease" published in the CBM, CNKI, WanFang Data, VIP, PubMed, Cochrane Library, Embase, and Web of Science databases were collected from inception to November 1, 2025. Two researchers independently screened the literature, extracted data, and assessed the quality of the included studies using the CONSORT extension for TCM formulas checklist and the Cochrane Collaboration's Risk of Bias tool. Results A total of 14 RCTs were included, primarily involving three types: basic syndrome patterns, common syndrome patterns, and compound syndrome patterns. Among the 25 items of the CONSORT extension for TCM formulas checklist, the reporting compliance rates for items 6b, 13a, and 16 were 100% across all studies. Items 3b, 10, 12b, 18, 23, and 24 were not reported in any study. The reporting compliance for the remaining items varied. The risk of bias assessment indicated that all studies were judged to have an "unclear risk" concerning blinding of outcome assessors, selective reporting bias, and other biases. Conclusion RCTs investigating the "Pattern Dominating Disease" model show notable deficiencies in both reporting quality and methodological quality. It is recommended that, based on existing tools, dedicated evaluation and reporting instruments be developed to enhance the quality of such RCTs.

Citation： WANG Lu, WANG Jiajia, ZHANG Yingying, LUO Xufei, LI Jiansheng, CHEN Yaolong. Quality assessment of randomized controlled trials on "pattern dominating disease" using the CONSORT extension for Chinese herbal medicine formulas. Chinese Journal of Evidence-Based Medicine, 2026, 26(9): 1046-1052. doi: 10.7507/1672-2531.202606087 Copy

1.	Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement[J]. JAMA, 1996, 276(8): 637-639.
2.	Moher D, Schulz KF, Altman D, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials[J]. JAMA, 2001, 285(15): 1987-1991.
3.	Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials[J]. BMJ, 2010, 340: c332.
4.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials[J]. BMJ, 2025, 389: e081123.
5.	Dimairo M, Pallmann P, Wason J, et al. The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design[J]. BMJ, 2020, 369: m115.
6.	Kahan BC, Hall SS, Beller EM, et al. Reporting of factorial randomized trials: extension of the CONSORT 2010 statement[J]. JAMA, 2023, 330(21): 2106-2114.
7.	Liu X, Cruz Rivera S, Moher D, et al. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension[J]. Lancet Digit Health, 2020, 2(10): e537-e548.
8.	Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration[J]. Ann Intern Med, 2017, 167(2): 112-121.
9.	鄭頌華, 吳泰相, 商洪才, 等. 中藥復方臨床隨機對照試驗報告規范2017-CONSORT聲明的擴展、說明與詳述[J]. 中西醫結合心腦血管病雜志, 2019, 17(1): 1-14.
10.	李建生. 基于病證結合模式重視以證統病的診療形式[J]. 中醫雜志, 2011, 52(7): 558-561.
11.	王露, 王佳佳, 李建生. 以肺氣虛證為例的中醫臨床療效評價若干問題思考[J]. 中華中醫藥雜志, 2024, 39(12): 6427-6431.
12.	國家中醫藥管理局, 國家藥監局. 關于發布證候類中藥新藥臨床研究技術指導原則的通告(2018年第109號)[Z]. 2018.
13.	朱文鋒. 證素辨證學[M]. 北京: 人民衛生出版社, 2008.
14.	李建生, 余學慶, 王至婉. 病證結合模式下證候診斷標準建立的關鍵環節[J]. 中醫雜志, 2013, 54(15): 1261-1264.
15.	國家技術監督局. 中醫臨床診療術語?證候部分[S]. 北京: 中國標準出版社, 1997.
16.	Higgins JPT, Thomas J, Chandler J, et al. Cochrane handbook for systematic reviews of interventions[Z]. 2022.
17.	徐丹, 過偉峰, 趙洋, 等. 加味柴胡加龍骨牡蠣湯治療情志病熱郁少陽證的臨床療效[J]. 實用心腦肺血管病雜志, 2024, 32(12): 98-103.
18.	陸源鴻. 參芪扶正注射液治療老年疾病氣虛證的隨機雙盲對照試驗[D]. 廣州: 廣州中醫藥大學, 2022.
19.	黃海彬. 參芪扶正注射液治療老年疾病氣虛證的臨床療效觀察[D]. 廣州: 廣州中醫藥大學, 2021.
20.	季小鈺. 強志組方對抽動障礙患兒反復呼吸道感染的影響[D]. 濟南: 山東中醫藥大學, 2021.
21.	鄧鈺杰, 施秀娟, 吳美海, 等. “異病同治”理論指導下川芎、三七、天麻研粉沖服治療瘀血頭痛60例[J]. 飲食保健, 2020, 7(6): 35-36.
22.	劉麗莎. 丹紅化瘀口服液干預氣滯血瘀證的多中心隨機對照客觀化評價研究[D]. 成都: 成都中醫藥大學, 2019.
23.	韓芳, 范吉平, 郭盛楠, 等. 針對肝郁化熱證的證候類中藥新藥臨床評價研究[J]. 世界中醫藥, 2018, 13(7): 1633-1636,1640.
24.	丁正香, 朱沛, 尹天雷, 等. 裸花紫珠片治療熱(瘀)毒證的證病結合臨床研究[J]. 世界中醫藥, 2017, 12(12): 3128-3132, 3137.
25.	張振賢, 董書桂, 黃瑤, 等. 溫振運氣方異病同治三類情志障礙患者療效觀察[J]. 遼寧中醫雜志, 2015, 42(12): 2346-2349.
26.	王曉鳴, 陳健, 馬效東, 等. 參芪健兒顆粒防治體弱兒的臨床研究[J]. 浙江中醫雜志, 2011, 46(12): 876-877.
27.	尹天雷, 喬鐵, 劉天舒, 等. 熱炎寧顆粒治療風熱證148例臨床觀察及中醫“以證統病”的臨床科研思路探討[J]. 中國醫藥導報, 2009, 6(11): 20-22.
28.	肖建橋. 加味三妙湯治療下肢皮膚血管病82例[J]. 中國中醫藥信息雜志, 2002, (5): 63.
29.	吳勝斌, 曹振東, 戚清權, 等. 通心絡膠囊治療慢性腎功能不全40例[J]. 上海中醫藥雜志, 2002, (2): 17-19.
30.	李家邦, 陳澤奇, 張翔, 等. 清肝利濕湯治療肝膽濕熱證的臨床研究[J]. 湖南中醫學院學報, 1996, (2): 26-28.
31.	曹乾安, 付勇, 董志威, 等. 艾灸隨機對照試驗與系統評價質量評價發展的回顧性分析[J]. 遼寧中醫雜志, 2022, 49(9): 217-220.
32.	王瑞平. 隨機對照臨床試驗設計中的樣本量估算方法[J]. 上海醫藥, 2023, 44(1): 48-52.
33.	劉玉秀. 臨床試驗隨機化要領[J]. 醫學研究生學報, 2015, 28(2): 113-117.
34.	沈文娟, 吳效科, 王桂媛, 等. 中醫臨床試驗研究方案設計常見問題及解決策略[J]. 中醫藥學報, 2015, 43(4): 1-4.
35.	張鈺菁, 張雪飛, 晏利姣, 等. 傳統醫學臨床試驗注冊現狀及特征分析[J]. 中國循證醫學雜志, 2025, 25(2): 162-168.
36.	陳君超, 何迎春, 陳歡, 等. 隨機化方法與技術在當前臨床試驗中的應用[J]. 中國新藥雜志, 2019, 28(13): 1582-1586.
37.	劉津池, 劉暢, 華成舸. 隨機對照試驗偏倚風險評價工具RoB2(2019修訂版)解讀[J]. 中國循證醫學雜志, 2021, 21(6): 737-744.
38.	Wang Y, Keitz S, Briel M, et al. Development of ROBUST-RCT: risk of bias instrument for use in systematic reviews-for randomised controlled trials[J]. BMJ, 2025, 388: e081199.

1. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement[J]. JAMA, 1996, 276(8): 637-639.
2. Moher D, Schulz KF, Altman D, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials[J]. JAMA, 2001, 285(15): 1987-1991.
3. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials[J]. BMJ, 2010, 340: c332.
4. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials[J]. BMJ, 2025, 389: e081123.
5. Dimairo M, Pallmann P, Wason J, et al. The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design[J]. BMJ, 2020, 369: m115.
6. Kahan BC, Hall SS, Beller EM, et al. Reporting of factorial randomized trials: extension of the CONSORT 2010 statement[J]. JAMA, 2023, 330(21): 2106-2114.
7. Liu X, Cruz Rivera S, Moher D, et al. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension[J]. Lancet Digit Health, 2020, 2(10): e537-e548.
8. Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration[J]. Ann Intern Med, 2017, 167(2): 112-121.
9. 鄭頌華, 吳泰相, 商洪才, 等. 中藥復方臨床隨機對照試驗報告規范2017-CONSORT聲明的擴展、說明與詳述[J]. 中西醫結合心腦血管病雜志, 2019, 17(1): 1-14.
10. 李建生. 基于病證結合模式重視以證統病的診療形式[J]. 中醫雜志, 2011, 52(7): 558-561.
11. 王露, 王佳佳, 李建生. 以肺氣虛證為例的中醫臨床療效評價若干問題思考[J]. 中華中醫藥雜志, 2024, 39(12): 6427-6431.
12. 國家中醫藥管理局, 國家藥監局. 關于發布證候類中藥新藥臨床研究技術指導原則的通告(2018年第109號)[Z]. 2018.
13. 朱文鋒. 證素辨證學[M]. 北京: 人民衛生出版社, 2008.
14. 李建生, 余學慶, 王至婉. 病證結合模式下證候診斷標準建立的關鍵環節[J]. 中醫雜志, 2013, 54(15): 1261-1264.
15. 國家技術監督局. 中醫臨床診療術語?證候部分[S]. 北京: 中國標準出版社, 1997.
16. Higgins JPT, Thomas J, Chandler J, et al. Cochrane handbook for systematic reviews of interventions[Z]. 2022.
17. 徐丹, 過偉峰, 趙洋, 等. 加味柴胡加龍骨牡蠣湯治療情志病熱郁少陽證的臨床療效[J]. 實用心腦肺血管病雜志, 2024, 32(12): 98-103.
18. 陸源鴻. 參芪扶正注射液治療老年疾病氣虛證的隨機雙盲對照試驗[D]. 廣州: 廣州中醫藥大學, 2022.
19. 黃海彬. 參芪扶正注射液治療老年疾病氣虛證的臨床療效觀察[D]. 廣州: 廣州中醫藥大學, 2021.
20. 季小鈺. 強志組方對抽動障礙患兒反復呼吸道感染的影響[D]. 濟南: 山東中醫藥大學, 2021.
21. 鄧鈺杰, 施秀娟, 吳美海, 等. “異病同治”理論指導下川芎、三七、天麻研粉沖服治療瘀血頭痛60例[J]. 飲食保健, 2020, 7(6): 35-36.
22. 劉麗莎. 丹紅化瘀口服液干預氣滯血瘀證的多中心隨機對照客觀化評價研究[D]. 成都: 成都中醫藥大學, 2019.
23. 韓芳, 范吉平, 郭盛楠, 等. 針對肝郁化熱證的證候類中藥新藥臨床評價研究[J]. 世界中醫藥, 2018, 13(7): 1633-1636,1640.
24. 丁正香, 朱沛, 尹天雷, 等. 裸花紫珠片治療熱(瘀)毒證的證病結合臨床研究[J]. 世界中醫藥, 2017, 12(12): 3128-3132, 3137.
25. 張振賢, 董書桂, 黃瑤, 等. 溫振運氣方異病同治三類情志障礙患者療效觀察[J]. 遼寧中醫雜志, 2015, 42(12): 2346-2349.
26. 王曉鳴, 陳健, 馬效東, 等. 參芪健兒顆粒防治體弱兒的臨床研究[J]. 浙江中醫雜志, 2011, 46(12): 876-877.
27. 尹天雷, 喬鐵, 劉天舒, 等. 熱炎寧顆粒治療風熱證148例臨床觀察及中醫“以證統病”的臨床科研思路探討[J]. 中國醫藥導報, 2009, 6(11): 20-22.
28. 肖建橋. 加味三妙湯治療下肢皮膚血管病82例[J]. 中國中醫藥信息雜志, 2002, (5): 63.
29. 吳勝斌, 曹振東, 戚清權, 等. 通心絡膠囊治療慢性腎功能不全40例[J]. 上海中醫藥雜志, 2002, (2): 17-19.
30. 李家邦, 陳澤奇, 張翔, 等. 清肝利濕湯治療肝膽濕熱證的臨床研究[J]. 湖南中醫學院學報, 1996, (2): 26-28.
31. 曹乾安, 付勇, 董志威, 等. 艾灸隨機對照試驗與系統評價質量評價發展的回顧性分析[J]. 遼寧中醫雜志, 2022, 49(9): 217-220.
32. 王瑞平. 隨機對照臨床試驗設計中的樣本量估算方法[J]. 上海醫藥, 2023, 44(1): 48-52.
33. 劉玉秀. 臨床試驗隨機化要領[J]. 醫學研究生學報, 2015, 28(2): 113-117.
34. 沈文娟, 吳效科, 王桂媛, 等. 中醫臨床試驗研究方案設計常見問題及解決策略[J]. 中醫藥學報, 2015, 43(4): 1-4.
35. 張鈺菁, 張雪飛, 晏利姣, 等. 傳統醫學臨床試驗注冊現狀及特征分析[J]. 中國循證醫學雜志, 2025, 25(2): 162-168.
36. 陳君超, 何迎春, 陳歡, 等. 隨機化方法與技術在當前臨床試驗中的應用[J]. 中國新藥雜志, 2019, 28(13): 1582-1586.
37. 劉津池, 劉暢, 華成舸. 隨機對照試驗偏倚風險評價工具RoB2(2019修訂版)解讀[J]. 中國循證醫學雜志, 2021, 21(6): 737-744.
38. Wang Y, Keitz S, Briel M, et al. Development of ROBUST-RCT: risk of bias instrument for use in systematic reviews-for randomised controlled trials[J]. BMJ, 2025, 388: e081199.

Chinese Journal of Evidence-Based Medicine

Quality assessment of randomized controlled trials on "pattern dominating disease" using the CONSORT extension for Chinese herbal medicine formulas

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content