Enlightenment of CONSORT harms 2022 on the harm reporting of Chinese herbal medicine formulas_Chinese Journal of Evidence-Based Medicine

Authors：

ZHENG Rui ^1,2 , WANG Shuangqiu ¹ , CHEN Zhuo ¹ , WAN Siqi ³ , QIU Ruijin ^1,4 ,  SHANG Hongcai ¹

1. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine, Beijing 100029, P. R. China;
2. Faculty of Health Sciences, McMaster University, Hamilton L8N 1Y3, Canada;
3. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
4. University of Liverpool, Liverpool L693GL, UK;

Corresponding?author：

SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Randomized controlled trials; CONSORT Harms; Safety; Traditional Chinese medicine; Methodology

DOI：

10.7507/1672-2531.202312023

Video：

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Abstract Full text Figures/Tables Video References Cited by

High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms. The CONSORT (consolidated standards of reporting trials) working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials. Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs. The harms of traditional Chinese medicine formulas need to be reported in a standard. This study suggests that researchers should pay attention to enhancing the professional competence of research teams, developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials, and incorporating relevant guidelines into journal publication requirements. These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.

Citation： ZHENG Rui, WANG Shuangqiu, CHEN Zhuo, WAN Siqi, QIU Ruijin, SHANG Hongcai. Enlightenment of CONSORT harms 2022 on the harm reporting of Chinese herbal medicine formulas. Chinese Journal of Evidence-Based Medicine, 2024, 24(5): 617-620. doi: 10.7507/1672-2531.202312023 Copy

1.	國家藥監局. 關于印發進一步加強中藥科學監管促進中藥傳承創新發展若干措施的通知. 2023.
2.	Phillips R, Hazell L, Sauzet O, et al. Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ Open, 2019, 9(2): e024537.
3.	Junqueira DR, Phillips R, Zorzela L, et al. Time to improve the reporting of harms in randomized controlled trials. J Clin Epidemiol, 2021, 136: 216-220.
4.	Zorzela L, Golder S, Liu Y, et al. Quality of reporting in systematic reviews of adverse events: systematic review. BMJ, 2014, 348: f7668.
5.	Ioannidis JP, Evans SJ, 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.
6.	海帆, 蔣丹, 董愉, 等. 2016-2020年國內5種精神學科期刊臨床隨機對照試驗報告質量的調查. 中國循證醫學雜志, 2022, 22(9): 1048-1054.
7.	馮雪, 方賽男, 高雨鑫, 等. 根據CONSORT Harms聲明評價雷公藤制劑相關腎毒性RCT的報告質量. 中國中藥雜志, 2018, 43(3): 440-445.
8.	Ioannidis J, Evans S, G?tzsche P, 等. 更好地報告隨機試驗中的危害聲明擴展版. 中國循證醫學雜志, 2006, 6(9): 682-688.
9.	盧存存, 喬萌, 王子怡, 等. 康萊特注射液治療非小細胞肺癌與肝癌論文的關鍵特征與安全性信息報告: 基于CONSORT-Harms的橫斷面調查. 中草藥, 2023, 54(20): 6791-6797.
10.	馮雪. 雷公藤制劑安全性(腎毒性)的循證評價研究. 北京: 北京中醫藥大學, 2017.
11.	Junqueira DR, Zorzela L, Golder S, et al. CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials. BMJ, 2023, 381: e073725.
12.	Ferrante M, Panaccione R, Baert F, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet, 2022, 399(10340): 2031-2046.
13.	李斌艷, 王麗瓊, 段炎珊, 等. 隨機試驗危害報告指南: Harms 2022聲明解讀. 中國循證醫學雜志, 2024, 24(3): 339-347.
14.	Alomar MJ. Factors affecting the development of adverse drug reactions (review article). Saudi Pharm J, 2014, 22(2): 83-94.
15.	Péron J, Maillet D, Gan HK, et al. Adherence to CONSORT adverse event reporting guidelines in randomized clinical trials evaluating systemic cancer therapy: a systematic review. J Clin Oncol, 2013, 31(31): 3957-3963.
16.	國家藥監局. 關于促進中藥傳承創新發展的實施意見. 2020.
17.	Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet, 2001, 357(9263): 1191-1194.
18.	高敬書, 吳效科, 王宇, 等. 中醫藥臨床試驗質量控制體系的構建與運行. 中華中醫藥雜志, 2020, 35(12): 6177-6181.
19.	Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother, 2010, 1(2): 100-107.
20.	Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg, 2010, 8(5): 336-341.
21.	Zorzela L, Loke YK, Ioannidis JP, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ, 2016, 352: i157.
22.	鄭蕊, 鐘長鳴, 關曼柯, 等. 中藥獨家品種說明書安全性信息的評價研究. 世界中醫藥, 2019, 14(10): 2578-2581.
23.	Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med, 2017, 167(2): 112-121.
24.	Gagnier JJ, Boon H, Rochon P, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med, 2006, 144(5): 364-367.
25.	MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med, 2010, 7(6): e1000261.
26.	邱瑞瑾, 胡嘉元, 李敏, 等. 核心指標集研究方案的標準報告條目解讀及不同核心指標集研究報告指南對中醫藥領域研究的意義. 中國循證醫學雜志, 2019, 19(12): 1492-1497.

1. 國家藥監局. 關于印發進一步加強中藥科學監管促進中藥傳承創新發展若干措施的通知. 2023.
2. Phillips R, Hazell L, Sauzet O, et al. Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ Open, 2019, 9(2): e024537.
3. Junqueira DR, Phillips R, Zorzela L, et al. Time to improve the reporting of harms in randomized controlled trials. J Clin Epidemiol, 2021, 136: 216-220.
4. Zorzela L, Golder S, Liu Y, et al. Quality of reporting in systematic reviews of adverse events: systematic review. BMJ, 2014, 348: f7668.
5. Ioannidis JP, Evans SJ, 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.
6. 海帆, 蔣丹, 董愉, 等. 2016-2020年國內5種精神學科期刊臨床隨機對照試驗報告質量的調查. 中國循證醫學雜志, 2022, 22(9): 1048-1054.
7. 馮雪, 方賽男, 高雨鑫, 等. 根據CONSORT Harms聲明評價雷公藤制劑相關腎毒性RCT的報告質量. 中國中藥雜志, 2018, 43(3): 440-445.
8. Ioannidis J, Evans S, G?tzsche P, 等. 更好地報告隨機試驗中的危害聲明擴展版. 中國循證醫學雜志, 2006, 6(9): 682-688.
9. 盧存存, 喬萌, 王子怡, 等. 康萊特注射液治療非小細胞肺癌與肝癌論文的關鍵特征與安全性信息報告: 基于CONSORT-Harms的橫斷面調查. 中草藥, 2023, 54(20): 6791-6797.
10. 馮雪. 雷公藤制劑安全性(腎毒性)的循證評價研究. 北京: 北京中醫藥大學, 2017.
11. Junqueira DR, Zorzela L, Golder S, et al. CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials. BMJ, 2023, 381: e073725.
12. Ferrante M, Panaccione R, Baert F, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet, 2022, 399(10340): 2031-2046.
13. 李斌艷, 王麗瓊, 段炎珊, 等. 隨機試驗危害報告指南: Harms 2022聲明解讀. 中國循證醫學雜志, 2024, 24(3): 339-347.
14. Alomar MJ. Factors affecting the development of adverse drug reactions (review article). Saudi Pharm J, 2014, 22(2): 83-94.
15. Péron J, Maillet D, Gan HK, et al. Adherence to CONSORT adverse event reporting guidelines in randomized clinical trials evaluating systemic cancer therapy: a systematic review. J Clin Oncol, 2013, 31(31): 3957-3963.
16. 國家藥監局. 關于促進中藥傳承創新發展的實施意見. 2020.
17. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet, 2001, 357(9263): 1191-1194.
18. 高敬書, 吳效科, 王宇, 等. 中醫藥臨床試驗質量控制體系的構建與運行. 中華中醫藥雜志, 2020, 35(12): 6177-6181.
19. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother, 2010, 1(2): 100-107.
20. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg, 2010, 8(5): 336-341.
21. Zorzela L, Loke YK, Ioannidis JP, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ, 2016, 352: i157.
22. 鄭蕊, 鐘長鳴, 關曼柯, 等. 中藥獨家品種說明書安全性信息的評價研究. 世界中醫藥, 2019, 14(10): 2578-2581.
23. Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med, 2017, 167(2): 112-121.
24. Gagnier JJ, Boon H, Rochon P, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med, 2006, 144(5): 364-367.
25. MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med, 2010, 7(6): e1000261.
26. 邱瑞瑾, 胡嘉元, 李敏, 等. 核心指標集研究方案的標準報告條目解讀及不同核心指標集研究報告指南對中醫藥領域研究的意義. 中國循證醫學雜志, 2019, 19(12): 1492-1497.

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