Study on the reporting standard system of clinical research of traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

HU Jiayuan ¹ , ZHAO Chen ² , TIAN Ran ² , LI Jiang ³ , CHEN Yaolong ⁴ , ZHANG Xiaoyu ¹ , SUN Yang ¹ , QIU Ruijin ¹ , LI Youping ⁵ , TIAN Guihua ¹ , YANG Kehu ⁴ ,  BIAN Zhaoxiang ² ,  SHANG Hongcai ¹

1. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;
2. School of Chinese Medicine, Hong Kong Baptist University, HongKong, 999077, P.R.China;
3. Program Office for Cancer Screening in Urban China, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, P.R.China;
4. Evidence-Based Medicine Center, Lanzhou University, Lanzhou, 730000, P.R.China;
5. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

BIAN Zhaoxiang, Email: bianzxiang@gmail.com; SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Traditional Chinese medicine; Clinical research; Reporting standard; Randomized controlled trial; Evidence-based medicine

DOI：

10.7507/1672-2531.201807070

Video：

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Abstract Full text Figures/Tables Video References Cited by

Reporting standard system of clinical research of traditional Chinese medicine (TCM) is composed of ten reporting standards in the areas of the design and preparation of TCM clinical researches, researches of different types, randomized controlled trials of various interventions, systematic reviews of the trials and the translation of research evidence, which were developed by different research groups. This article systematically analyzed the current reporting standards of clinical research of TCM. Achievements and problems were found in the review so as to provide insights for the ongoing reporting standards and to assist the construction of the reporting standard system so as to improve the reporting quality of clinical researches of TCM.

Citation： HU Jiayuan, ZHAO Chen, TIAN Ran, LI Jiang, CHEN Yaolong, ZHANG Xiaoyu, SUN Yang, QIU Ruijin, LI Youping, TIAN Guihua, YANG Kehu, BIAN Zhaoxiang, SHANG Hongcai. Study on the reporting standard system of clinical research of traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2018, 18(11): 1151-1157. doi: 10.7507/1672-2531.201807070 Copy

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2.	张晓雨, 陈诗琪, 李承羽, 等. 循证中医药学理论研究与应用实践. 中国循证医学杂志, 2018, 18(1): 86-91.
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5.	Moher D, Jones A, Lepage L, et al. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA, 2001, 285(15): 1992-1995.
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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.	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.
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12.	吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范 (征求意见稿). 中国循证医学杂志, 2007, 7(8): 601-605.
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16.	Cao XJ, Huang X, Liu J, et al. A randomized, double-blind, placebo-controlled trial of Chinese herbal medicine capsules for the treatment of premature ovarian insufficiency. Menopause, 2018, 25(8): 918-926.
17.	Chen S, Xu MB, Zhou XL, et al. Chinese herbal medicine for myasthenia gravis: a systematic review and meta-analysis. Front Pharmacol, 2018, 9: 969.
18.	Kim KI, Jun JH, Baek H, et al. Oral administration of herbal medicines for radiation pneumonitis in lung cancer patients: A systematic review and meta-analysis. PLoS One, 2018, 13(5): e0198015.
19.	Li C, Wang P, Zhang L, et al. Efficacy and safety of Xuebijing injection (a Chinese patent) for sepsis: A meta-analysis of randomized controlled trials. J Ethnopharmacol, 2018, 224: 512-521.
20.	Lin H, Wang X, Du X, et al. Effect of Zhizhu Kuanzhong capsule on functional dyspepsia: Protocol for a systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore), 2018, 97(6): e9731.
21.	Lyu YR, Yang WK, Park SJ, et al. Efficacy and safety of GHX02 in the treatment of acute bronchitis: protocol of a phase II, double-blind, randomised placebo-controlled trial. BMJ Open, 2018, 8(5): e019897.
22.	Myers EF, Parrott JS, Splett P, et al. Using risk of bias domains to identify opportunities for improvement in food- and nutrition-related research: An evaluation of research type and design, year of publication, and source of funding. PLoS One, 2018, 13(7): e0197425.
23.	Tabatabaei-Malazy O, Shadman Z, Ejtahed HS, et al. Quality of reporting of randomized controlled trials of herbal medicines conducted in metabolic disorders in Middle East countries: A systematic review. Complement Ther Med, 2018, 38: 61-66.
24.	Wang F, Tang J, Li P, et al. Chloroquine enhances the radiosensitivity of bladder cancer cells by inhibiting autophagy and activating apoptosis. Cell Physiol Biochem, 2018, 45(1): 54-66.
25.	Zhang HP, Wang L, Wang Z, et al. Chinese herbal medicine formula for acute asthma: A multi-center, randomized, double-blind, proof-of-concept trial. Respir Med, 2018, 140: 42-49.
26.	Zhao XM, Zhang Y, He XH, et al. Chinese herbal medicine Shenzhuo Formula treatment in patients with macroalbuminuria secondary to diabetic kidney disease: study protocol for a randomized controlled trial. Trials, 2018, 19(1): 200.
27.	白洋, 车方远, 易文慧, 等. 加载口服中成药对 PCI 术后长期主要不良心脑血管事件影响的 Meta 分析. 中医杂志, 2018, 59(12): 1024-1030.
28.	成舟, 陈丽芳, 谭登, 等. 中药熏洗治疗跟痛症的临床试验质量评价. 中国中医骨伤科杂志, 2018, 26(2): 76-80.
29.	鄢丹, 刘娟, 王爱婷, 等. 基于循证医学证据探讨中医药优势病种作用机制的研究思路. 中国中药杂志, 2018, 43(13): 2633-2638.
30.	于丹丹, 谢雁鸣, 廖星, 等. 《中国中药杂志》发表随机对照试验方法学和报告质量评价研究. 中国中药杂志, 2018, 43(4): 833-839.
31.	原源, 朱民, 苏雨, 等. 格式化表达-老中医经验类论文撰写一般要素探讨. 中医药导报, 2018, 24(13): 130-133.
32.	张俊华, 李幼平, 张伯礼. 循证中医药学:理论与实践. 中国中药杂志, 2018, 18(1): 1-7.
33.	Wu T, Bian Z, Shang H, et al. Innovation of clinical trials in China: Commentary on the publication of "CONSORT extension for Chinese herbal medicine formulas 2017: Recommendations, explanation, and elaboration". J Evid Based Med, 2017, 10(3): 155-162.
34.	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.
35.	MacPherson H, White A, Cummings M, et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med, 2001, 9(4): 246-249.
36.	Available at: http://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1000261.
37.	Macpherson H, Altman DG, Hammerschlag R, et al. 针刺临床试验干预措施报告标准修订版: CONSORT 声明的扩展. 中国循证医学杂志, 2010, 10(10): 1228-1239.
38.	Macpherson H, Altman DG, Hammerschlag R, et al. 针刺临床试验干预措施报告标准的修订: CONSORT 声明的扩展. 中西医结合学报, 2010, 8(9): 804-818.
39.	Available at: http://kns.cnki.net/kns/brief/default_result.aspx.
40.	Available at: https://embase.com/#advancedSearch/resultspage/history.1/page.1/25.items/orderby.date/source.
41.	付姝菲, 郑颂华, 张莉, 等. Consensus-based recommendations for case report in Chinese medicine(CARC). 中国结合医学杂志 (英文版), 2016, (1): 73-79.
42.	Kim J, Eom YJ, Lee YS, et al. The current status of quality of reporting in acupuncture treatment case reports: an analysis of the core journal in Korea. Evid Based Complement Alternat Med, 2017, 2017: 5810372.
43.	Zhao C, Liu Z, Lin J, et al. Standardizing individualized efficacy evaluation to optimize evidence-using pattern in traditional chinese medicine-preliminarily establishing traditional Chinese medicine evidence-based case reporting system. World J Trad Chin Med, 2016, 2(4): 49-54.
44.	Fu SF, Kun W, Zeng XX, et al. Urgent need to improve the quality of case report in traditional Chinese medicine: assessment on reporting quality of 3417 cases. Chin J Integ Med, 2016, 22(6): 473-480.
45.	Wang Y. Improving general evaluation of clinical consensus statement in chinese medicine by integrating chinese and western medicine and multidisciplinary approaches. J Evid Based Med, 2016, 9(3): 109-111.
46.	Available at: http://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines- under-development-for-systematic-reviews/#65.
47.	刘建平, 张玫, 杨闵, 等. 单病例随机对照试验设计在中医药研究中的应用. 中国中医药信息杂志, 2002, 9(6): 66-68.
48.	Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ, 2015, 350: h1738.
49.	向玉, 温泽淮. 临床实践中推拿手法规范化的思考. 中华中医药杂志, 2018, 33(6): 2455-2458.
50.	Boutron I, Altman DG, Moher D, et al. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med, 2017, 167(1): 40-47.
51.	Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 声明: 定义临床研究方案的标准条目. 中国循证医学杂志, 2013, 13(12): 1501-1507.
52.	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.
53.	Chen Y, Yang K, Marušic A, et al. A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement. Ann Intern Med, 2017, 166(2): 128-132.
54.	Chen Y, Wang C, Shang H, et al. Clinical practice guidelines in China. BMJ, 2018, 360: j5158.
55.	Available at: http://www.who.int/ictrp/trial_reg/en/.

1. Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn’t. BMJ, 1996, 312(7023): 71-72.
2. 张晓雨, 陈诗琪, 李承羽, 等. 循证中医药学理论研究与应用实践. 中国循证医学杂志, 2018, 18(1): 86-91.
3. The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. JAMA, 1994, 272(24): 1926-1931.
4. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276(8): 637-639.
5. Moher D, Jones A, Lepage L, et al. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA, 2001, 285(15): 1992-1995.
6. Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev, 2012, 1: 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. 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.
9. Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration (simplified Chinese version). Ann Intern Med, 2017, 167(2): W21-W34.
10. Linde K, Brinkhaus B. Randomized trials of Chinese herbal medicine: a new extension of the CONSORT statement. Ann Intern Med, 2017, 167(2): 133-134.
11. 田然, 赵晨, 郑颂华, 等. 中医药临床疗效研究报告体系构建过程. 中国循证医学杂志, 2018, 18(7): 651-653.
12. 吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范 (征求意见稿). 中国循证医学杂志, 2007, 7(8): 601-605.
13. 吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范 (征求意见稿). 中国循证医学杂志, 2007, 7(9): 625-630.
14. Available at: http://www.consort-statement.org/about-consort/endorsers1.
15. 原源. 《实用中医内科杂志》2018 作者自检指南 (论著类论文). 实用中医内科杂志, 2018, 32(5): 2.
16. Cao XJ, Huang X, Liu J, et al. A randomized, double-blind, placebo-controlled trial of Chinese herbal medicine capsules for the treatment of premature ovarian insufficiency. Menopause, 2018, 25(8): 918-926.
17. Chen S, Xu MB, Zhou XL, et al. Chinese herbal medicine for myasthenia gravis: a systematic review and meta-analysis. Front Pharmacol, 2018, 9: 969.
18. Kim KI, Jun JH, Baek H, et al. Oral administration of herbal medicines for radiation pneumonitis in lung cancer patients: A systematic review and meta-analysis. PLoS One, 2018, 13(5): e0198015.
19. Li C, Wang P, Zhang L, et al. Efficacy and safety of Xuebijing injection (a Chinese patent) for sepsis: A meta-analysis of randomized controlled trials. J Ethnopharmacol, 2018, 224: 512-521.
20. Lin H, Wang X, Du X, et al. Effect of Zhizhu Kuanzhong capsule on functional dyspepsia: Protocol for a systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore), 2018, 97(6): e9731.
21. Lyu YR, Yang WK, Park SJ, et al. Efficacy and safety of GHX02 in the treatment of acute bronchitis: protocol of a phase II, double-blind, randomised placebo-controlled trial. BMJ Open, 2018, 8(5): e019897.
22. Myers EF, Parrott JS, Splett P, et al. Using risk of bias domains to identify opportunities for improvement in food- and nutrition-related research: An evaluation of research type and design, year of publication, and source of funding. PLoS One, 2018, 13(7): e0197425.
23. Tabatabaei-Malazy O, Shadman Z, Ejtahed HS, et al. Quality of reporting of randomized controlled trials of herbal medicines conducted in metabolic disorders in Middle East countries: A systematic review. Complement Ther Med, 2018, 38: 61-66.
24. Wang F, Tang J, Li P, et al. Chloroquine enhances the radiosensitivity of bladder cancer cells by inhibiting autophagy and activating apoptosis. Cell Physiol Biochem, 2018, 45(1): 54-66.
25. Zhang HP, Wang L, Wang Z, et al. Chinese herbal medicine formula for acute asthma: A multi-center, randomized, double-blind, proof-of-concept trial. Respir Med, 2018, 140: 42-49.
26. Zhao XM, Zhang Y, He XH, et al. Chinese herbal medicine Shenzhuo Formula treatment in patients with macroalbuminuria secondary to diabetic kidney disease: study protocol for a randomized controlled trial. Trials, 2018, 19(1): 200.
27. 白洋, 车方远, 易文慧, 等. 加载口服中成药对 PCI 术后长期主要不良心脑血管事件影响的 Meta 分析. 中医杂志, 2018, 59(12): 1024-1030.
28. 成舟, 陈丽芳, 谭登, 等. 中药熏洗治疗跟痛症的临床试验质量评价. 中国中医骨伤科杂志, 2018, 26(2): 76-80.
29. 鄢丹, 刘娟, 王爱婷, 等. 基于循证医学证据探讨中医药优势病种作用机制的研究思路. 中国中药杂志, 2018, 43(13): 2633-2638.
30. 于丹丹, 谢雁鸣, 廖星, 等. 《中国中药杂志》发表随机对照试验方法学和报告质量评价研究. 中国中药杂志, 2018, 43(4): 833-839.
31. 原源, 朱民, 苏雨, 等. 格式化表达-老中医经验类论文撰写一般要素探讨. 中医药导报, 2018, 24(13): 130-133.
32. 张俊华, 李幼平, 张伯礼. 循证中医药学:理论与实践. 中国中药杂志, 2018, 18(1): 1-7.
33. Wu T, Bian Z, Shang H, et al. Innovation of clinical trials in China: Commentary on the publication of "CONSORT extension for Chinese herbal medicine formulas 2017: Recommendations, explanation, and elaboration". J Evid Based Med, 2017, 10(3): 155-162.
34. 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.
35. MacPherson H, White A, Cummings M, et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med, 2001, 9(4): 246-249.
36. Available at: http://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1000261.
37. Macpherson H, Altman DG, Hammerschlag R, et al. 针刺临床试验干预措施报告标准修订版: CONSORT 声明的扩展. 中国循证医学杂志, 2010, 10(10): 1228-1239.
38. Macpherson H, Altman DG, Hammerschlag R, et al. 针刺临床试验干预措施报告标准的修订: CONSORT 声明的扩展. 中西医结合学报, 2010, 8(9): 804-818.
39. Available at: http://kns.cnki.net/kns/brief/default_result.aspx.
40. Available at: https://embase.com/#advancedSearch/resultspage/history.1/page.1/25.items/orderby.date/source.
41. 付姝菲, 郑颂华, 张莉, 等. Consensus-based recommendations for case report in Chinese medicine(CARC). 中国结合医学杂志 (英文版), 2016, (1): 73-79.
42. Kim J, Eom YJ, Lee YS, et al. The current status of quality of reporting in acupuncture treatment case reports: an analysis of the core journal in Korea. Evid Based Complement Alternat Med, 2017, 2017: 5810372.
43. Zhao C, Liu Z, Lin J, et al. Standardizing individualized efficacy evaluation to optimize evidence-using pattern in traditional chinese medicine-preliminarily establishing traditional Chinese medicine evidence-based case reporting system. World J Trad Chin Med, 2016, 2(4): 49-54.
44. Fu SF, Kun W, Zeng XX, et al. Urgent need to improve the quality of case report in traditional Chinese medicine: assessment on reporting quality of 3417 cases. Chin J Integ Med, 2016, 22(6): 473-480.
45. Wang Y. Improving general evaluation of clinical consensus statement in chinese medicine by integrating chinese and western medicine and multidisciplinary approaches. J Evid Based Med, 2016, 9(3): 109-111.
46. Available at: http://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines- under-development-for-systematic-reviews/#65.
47. 刘建平, 张玫, 杨闵, 等. 单病例随机对照试验设计在中医药研究中的应用. 中国中医药信息杂志, 2002, 9(6): 66-68.
48. Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ, 2015, 350: h1738.
49. 向玉, 温泽淮. 临床实践中推拿手法规范化的思考. 中华中医药杂志, 2018, 33(6): 2455-2458.
50. Boutron I, Altman DG, Moher D, et al. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med, 2017, 167(1): 40-47.
51. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 声明: 定义临床研究方案的标准条目. 中国循证医学杂志, 2013, 13(12): 1501-1507.
52. 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.
53. Chen Y, Yang K, Marušic A, et al. A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement. Ann Intern Med, 2017, 166(2): 128-132.
54. Chen Y, Wang C, Shang H, et al. Clinical practice guidelines in China. BMJ, 2018, 360: j5158.
55. Available at: http://www.who.int/ictrp/trial_reg/en/.

Chinese Journal of Evidence-Based Medicine

Study on the reporting standard system of clinical research of traditional Chinese medicine

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