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.	国家药监局. 关于印发进一步加强中药科学监管促进中药传承创新发展若干措施的通知. 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, 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.
6.	海帆, 蒋丹, 董愉, 等. 2016-2020年国内5种精神学科期刊临床随机对照试验报告质量的调查. 中国循证医学杂志, 2022, 22(9): 1048-1054.
7.	冯雪, 方赛男, 高雨鑫, 等. 根据CONSORT Harms声明评价雷公藤制剂相关肾毒性RCT的报告质量. 中国中药杂志, 2018, 43(3): 440-445.
8.	Ioannidis J, Evans S, Gøtzsche P, 等. 更好地报告随机试验中的危害声明扩展版. 中国循证医学杂志, 2006, 6(9): 682-688.
9.	卢存存, 乔萌, 王子怡, 等. 康莱特注射液治疗非小细胞肺癌与肝癌论文的关键特征与安全性信息报告: 基于CONSORT-Harms的横断面调查. 中草药, 2023, 54(20): 6791-6797.
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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.	李斌艳, 王丽琼, 段炎珊, 等. 随机试验危害报告指南: Harms 2022声明解读. 中国循证医学杂志, 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.	国家药监局. 关于促进中药传承创新发展的实施意见. 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.	高敬书, 吴效科, 王宇, 等. 中医药临床试验质量控制体系的构建与运行. 中华中医药杂志, 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.	郑蕊, 钟长鸣, 关曼柯, 等. 中药独家品种说明书安全性信息的评价研究. 世界中医药, 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. 核心指标集研究方案的标准报告条目解读及不同核心指标集研究报告指南对中医药领域研究的意义. 中国循证医学杂志, 2019, 19(12): 1492-1497.

1. 国家药监局. 关于印发进一步加强中药科学监管促进中药传承创新发展若干措施的通知. 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, 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.
6. 海帆, 蒋丹, 董愉, 等. 2016-2020年国内5种精神学科期刊临床随机对照试验报告质量的调查. 中国循证医学杂志, 2022, 22(9): 1048-1054.
7. 冯雪, 方赛男, 高雨鑫, 等. 根据CONSORT Harms声明评价雷公藤制剂相关肾毒性RCT的报告质量. 中国中药杂志, 2018, 43(3): 440-445.
8. Ioannidis J, Evans S, Gøtzsche P, 等. 更好地报告随机试验中的危害声明扩展版. 中国循证医学杂志, 2006, 6(9): 682-688.
9. 卢存存, 乔萌, 王子怡, 等. 康莱特注射液治疗非小细胞肺癌与肝癌论文的关键特征与安全性信息报告: 基于CONSORT-Harms的横断面调查. 中草药, 2023, 54(20): 6791-6797.
10. 冯雪. 雷公藤制剂安全性(肾毒性)的循证评价研究. 北京: 北京中医药大学, 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. 李斌艳, 王丽琼, 段炎珊, 等. 随机试验危害报告指南: Harms 2022声明解读. 中国循证医学杂志, 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. 国家药监局. 关于促进中药传承创新发展的实施意见. 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. 高敬书, 吴效科, 王宇, 等. 中医药临床试验质量控制体系的构建与运行. 中华中医药杂志, 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. 郑蕊, 钟长鸣, 关曼柯, 等. 中药独家品种说明书安全性信息的评价研究. 世界中医药, 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. 核心指标集研究方案的标准报告条目解读及不同核心指标集研究报告指南对中医药领域研究的意义. 中国循证医学杂志, 2019, 19(12): 1492-1497.

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