Comparison of evidence-based research in traditional medicine between China and Japan_West China Medical Journal

Authors：

YUAN Zhongyu ^1,2 , Nakayama Takeo ³ , Mori Rintaro ³ ,  LI Bo ¹

1. Center of Clinical Epidemiology and Evidence Based Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University / Beijing Institute of Traditional Chinese Medicine, Beijing 100010, P. R. China;
2. First School of Clinical Medicine, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
3. Department of Health Informatics, Kyoto University Graduate School of Medicine & School of Public Health, Kyoto 606-8316, Japan;

Corresponding author：

LI Bo, Email: libo@bjzhongyi.com

Keywords：

Traditional Chinese medicine; Japanese Kampo medicine; Evidence-based medicine

DOI：

10.7507/1002-0179.202004019

Video：

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Evidence-based research is the essential method for the modernization of traditional medicine. China and Japan have made great progress in traditional Chinese medicine and Japanese Kampo medicine after years of evidence-based research, but there are also shortcomings. This paper compares the current situation of evidence-based research in traditional medicine from the aspects of the system of clinical evidence production and evaluation, standardization of clinical research report, standardization of traditional medicine in China and Japan, evaluation of the totality of clinical evidence via systematic review, application of clinical evidence via clinical practice guideline and development of research methodology. The purpose of this paper is to seek mutually complementary fields, and to provide enlightenment for future Chinese medicine and Japanese Kampo medicine evidence-based cooperation research.

Citation： YUAN Zhongyu, Nakayama Takeo, Mori Rintaro, LI Bo. Comparison of evidence-based research in traditional medicine between China and Japan. West China Medical Journal, 2021, 36(4): 539-544. doi: 10.7507/1002-0179.202004019 Copy

1.	Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on. Lancet, 2017, 390(10092): 415-423.
2.	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, 43(1): 1-7.
3.	李幼平, 刘鸣. 循证医学与中医药现代化. 中国中医药信息杂志, 1999: 14-16, 32.
4.	刘保延. 中医临床疗效评价研究的现状与展望. 中国科学基金, 2010, 24(5): 268-274.
5.	国家中医药管理局国家中医临床研究基地办公室. 我国16个重点病种的国家中医临床研究基地论文统计表(2008年—2013年). 世界科学技术-中医药现代化, 2013(5): 1161-1261.
6.	郭新峰, 赖世隆. 日本汉方医学领域循证医学研究现状及其启示. 中国循证医学杂志, 2010, 10(5): 625-628.
7.	Task Force for Evidence Reports, Committee for Evidence-based Medicine, The Japan Society for Oriental Medicine. Evidence reports of Kampo treatment (EKAT) appendix 2015. (2017-03-31)[2020-11-08]. http://www.jsom.or.jp/medical/ebm/pdf/EKATE_Appendix_2015.pdf.
8.	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.
9.	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.
10.	Fu SF, Cheng CW, Zhang L, et al. Consensus-based recommendations for case report in Chinese medicine (CARC). Chin J Integr Med, 2016, 22(1): 73-79.
11.	Li J, Hu JY, Zhai JB, et al. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM): recommendations, explanation and elaboration. Complement Ther Med, 2019, 46: 180-188.
12.	张霄潇, 孙磊, 冯雪, 等. 中医药标准化体系建设现状、问题与对策探讨. 中国中药杂志, 2019, 44(21): 4745-4750.
13.	World Health Organization. Groups that were involved in ICD-11 revision process. (2018-06-18)[2020-11-08]. https://www.who.int/classifications/icd/revision/en/.
14.	赵佩婕. 日本中医药标准化发展研究//国家标准化管理委员会. 市场践行标准化—第十一届中国标准化论坛论文集. 北京: 中国标准化协会, 2014: 7.
15.	Motoo Y, Hakamatsuka T, Kawahara N, et al. Standards of reporting kampo products (STORK) in research articles. J Integr Med, 2017, 15(3): 182-185.
16.	王家莹, 王俊峰, 承诗琪, 等. 中医药系统评价/meta分析19年发展及现状分析. 中医杂志, 2017, 58(11): 919-925, 前插1.
17.	He J, Du L, Liu G, et al. Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews. Trials, 2011, 12: 122.
18.	赵国桢, 冯硕, 张霄潇, 等. 中医药临床实践指南: 现状和思考. 中国循证医学杂志, 2018, 18(12): 1386-1390.
19.	刘建平. 传统医学证据体的构成及证据分级的建议. 中国中西医结合杂志, 2007, 27(12): 1061-1065.
20.	刘为民, 刘保延, 何丽云, 等. 引入GRADE体系制定中医药国际标准的思考与实践探析. 亚太传统医药, 2011, 7(1): 1-5.
21.	李慧, 陈耀龙, 谢秀丽, 等. 中医(中西医结合)临床实践指南制修订方法—证据质量分级. 中华中医药杂志, 2016, 31(7): 2652-2656.
22.	Hansson SO. Why and for what are clinical trials the gold standard?. Scand J Public Health, 2014, 42(13 Suppl): 41-48.
23.	陈可冀, 钱振淮, 张问渠, 等. 精制冠心片对冠心病心绞痛双盲望法治疗112例疗效分析. 医学研究通讯, 1982(11): 24-25.
24.	Liu Z, Yan S, Wu J, et al. Acupuncture for chronic severe functional constipation: a randomized trial. Ann Intern Med, 2016, 165(11): 761-769.
25.	Liu Z, Liu Y, Xu H, et al. Effect of electroacupuncture on urinary leakage among women with stress urinary incontinence: a randomized clinical trial. JAMA, 2017, 317(24): 2493-2501.
26.	Wu XK, Stener-Victorin E, Kuang HY, et al. Effect of acupuncture and clomiphene in chinese women with polycystic ovary syndrome: a randomized clinical trial. JAMA, 2017, 317(24): 2502-2514.
27.	常静, 李廷谦, 万美华, 等. 中国4种中医药大学学报随机对照临床试验文献的质量评价. 中国循证医学杂志, 2006, 6(3): 171-178.
28.	张明妍, 杨丰文, 李越, 等. 《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究. 中国循证医学杂志, 2017, 17(3): 357-363.
29.	Harasawa S, Miyoshi A, Miwa T. Multicenter clinical trial of Rikkunshito on dysmotility-like dyspepsia using double blind between groups comparison analysis. Igaku no Ayumi, 1998, 187(3): 207-229.
30.	Sasaki D, Uehara S, Hiwata N. Clinical efficacy of Keishikashakuyakuto on irritable bowel syndrome. Rinshou to Kenkyu, 1998, 75: 1136-1152.
31.	Kumada S, Kumada H, Yoshiba M. Double blind placebo controlled trial of shakuyakukanzouto on muscle spasms. Rinshou Iyaku, 1999, 15(3): 499-523.
32.	Kawakita K, Shichidou T, Inoue E, et al. Do Japanese style acupuncture and moxibustion reduce symptoms of the common cold?. Evid Based Complement Alternat Med, 2008, 5(4): 481-489.
33.	Guyatt G. N of 1 randomized trials: a commentary. J Clin Epidemiol, 2016, 76: 4-5.
34.	Jackson A, MacPherson H, Hahn S. Acupuncture for tinnitus: a series of six n=1 controlled trials. Complement Ther Med, 2006, 14(1): 39-46.
35.	何俏, 时景璞. 临床真实世界研究中的实验性研究设计. 中华流行病学杂志, 2018, 39(4): 519-523.
36.	孙梦华, 章轶立, 谢雁鸣, 等. 真实世界中使用脉血康胶囊的老年人群特征及用药分析. 世界中医药, 2020, 15(20): 3088-3093.
37.	张宏伟, 谢雁鸣, 高阳, 等. 真实世界中丹参川芎嗪注射液临床病症特点及联合用药特征研究. 中华中医药学刊. (2020-10-20)[2020-11-08]. http://kns.cnki.net/kcms/detail/21.1546.R.20201020.0916.026.html.
38.	田峰, 谢雁鸣. 真实世界研究: 中医干预措施效果评价的新理念. 中西医结合学报, 2010, 8(4): 301-306.

1. Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on. Lancet, 2017, 390(10092): 415-423.
2. 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, 43(1): 1-7.
3. 李幼平, 刘鸣. 循证医学与中医药现代化. 中国中医药信息杂志, 1999: 14-16, 32.
4. 刘保延. 中医临床疗效评价研究的现状与展望. 中国科学基金, 2010, 24(5): 268-274.
5. 国家中医药管理局国家中医临床研究基地办公室. 我国16个重点病种的国家中医临床研究基地论文统计表(2008年—2013年). 世界科学技术-中医药现代化, 2013(5): 1161-1261.
6. 郭新峰, 赖世隆. 日本汉方医学领域循证医学研究现状及其启示. 中国循证医学杂志, 2010, 10(5): 625-628.
7. Task Force for Evidence Reports, Committee for Evidence-based Medicine, The Japan Society for Oriental Medicine. Evidence reports of Kampo treatment (EKAT) appendix 2015. (2017-03-31)[2020-11-08]. http://www.jsom.or.jp/medical/ebm/pdf/EKATE_Appendix_2015.pdf.
8. 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.
9. 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.
10. Fu SF, Cheng CW, Zhang L, et al. Consensus-based recommendations for case report in Chinese medicine (CARC). Chin J Integr Med, 2016, 22(1): 73-79.
11. Li J, Hu JY, Zhai JB, et al. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM): recommendations, explanation and elaboration. Complement Ther Med, 2019, 46: 180-188.
12. 张霄潇, 孙磊, 冯雪, 等. 中医药标准化体系建设现状、问题与对策探讨. 中国中药杂志, 2019, 44(21): 4745-4750.
13. World Health Organization. Groups that were involved in ICD-11 revision process. (2018-06-18)[2020-11-08]. https://www.who.int/classifications/icd/revision/en/.
14. 赵佩婕. 日本中医药标准化发展研究//国家标准化管理委员会. 市场践行标准化—第十一届中国标准化论坛论文集. 北京: 中国标准化协会, 2014: 7.
15. Motoo Y, Hakamatsuka T, Kawahara N, et al. Standards of reporting kampo products (STORK) in research articles. J Integr Med, 2017, 15(3): 182-185.
16. 王家莹, 王俊峰, 承诗琪, 等. 中医药系统评价/meta分析19年发展及现状分析. 中医杂志, 2017, 58(11): 919-925, 前插1.
17. He J, Du L, Liu G, et al. Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews. Trials, 2011, 12: 122.
18. 赵国桢, 冯硕, 张霄潇, 等. 中医药临床实践指南: 现状和思考. 中国循证医学杂志, 2018, 18(12): 1386-1390.
19. 刘建平. 传统医学证据体的构成及证据分级的建议. 中国中西医结合杂志, 2007, 27(12): 1061-1065.
20. 刘为民, 刘保延, 何丽云, 等. 引入GRADE体系制定中医药国际标准的思考与实践探析. 亚太传统医药, 2011, 7(1): 1-5.
21. 李慧, 陈耀龙, 谢秀丽, 等. 中医(中西医结合)临床实践指南制修订方法—证据质量分级. 中华中医药杂志, 2016, 31(7): 2652-2656.
22. Hansson SO. Why and for what are clinical trials the gold standard?. Scand J Public Health, 2014, 42(13 Suppl): 41-48.
23. 陈可冀, 钱振淮, 张问渠, 等. 精制冠心片对冠心病心绞痛双盲望法治疗112例疗效分析. 医学研究通讯, 1982(11): 24-25.
24. Liu Z, Yan S, Wu J, et al. Acupuncture for chronic severe functional constipation: a randomized trial. Ann Intern Med, 2016, 165(11): 761-769.
25. Liu Z, Liu Y, Xu H, et al. Effect of electroacupuncture on urinary leakage among women with stress urinary incontinence: a randomized clinical trial. JAMA, 2017, 317(24): 2493-2501.
26. Wu XK, Stener-Victorin E, Kuang HY, et al. Effect of acupuncture and clomiphene in chinese women with polycystic ovary syndrome: a randomized clinical trial. JAMA, 2017, 317(24): 2502-2514.
27. 常静, 李廷谦, 万美华, 等. 中国4种中医药大学学报随机对照临床试验文献的质量评价. 中国循证医学杂志, 2006, 6(3): 171-178.
28. 张明妍, 杨丰文, 李越, 等. 《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究. 中国循证医学杂志, 2017, 17(3): 357-363.
29. Harasawa S, Miyoshi A, Miwa T. Multicenter clinical trial of Rikkunshito on dysmotility-like dyspepsia using double blind between groups comparison analysis. Igaku no Ayumi, 1998, 187(3): 207-229.
30. Sasaki D, Uehara S, Hiwata N. Clinical efficacy of Keishikashakuyakuto on irritable bowel syndrome. Rinshou to Kenkyu, 1998, 75: 1136-1152.
31. Kumada S, Kumada H, Yoshiba M. Double blind placebo controlled trial of shakuyakukanzouto on muscle spasms. Rinshou Iyaku, 1999, 15(3): 499-523.
32. Kawakita K, Shichidou T, Inoue E, et al. Do Japanese style acupuncture and moxibustion reduce symptoms of the common cold?. Evid Based Complement Alternat Med, 2008, 5(4): 481-489.
33. Guyatt G. N of 1 randomized trials: a commentary. J Clin Epidemiol, 2016, 76: 4-5.
34. Jackson A, MacPherson H, Hahn S. Acupuncture for tinnitus: a series of six n=1 controlled trials. Complement Ther Med, 2006, 14(1): 39-46.
35. 何俏, 时景璞. 临床真实世界研究中的实验性研究设计. 中华流行病学杂志, 2018, 39(4): 519-523.
36. 孙梦华, 章轶立, 谢雁鸣, 等. 真实世界中使用脉血康胶囊的老年人群特征及用药分析. 世界中医药, 2020, 15(20): 3088-3093.
37. 张宏伟, 谢雁鸣, 高阳, 等. 真实世界中丹参川芎嗪注射液临床病症特点及联合用药特征研究. 中华中医药学刊. (2020-10-20)[2020-11-08]. http://kns.cnki.net/kcms/detail/21.1546.R.20201020.0916.026.html.
38. 田峰, 谢雁鸣. 真实世界研究: 中医干预措施效果评价的新理念. 中西医结合学报, 2010, 8(4): 301-306.

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Comparison of evidence-based research in traditional medicine between China and Japan

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