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.	張俊華, 李幼平, 張伯禮. 循證中醫藥學: 理論與實踐. 中國中藥雜志, 2018, 43(1): 1-7.
3.	李幼平, 劉鳴. 循證醫學與中醫藥現代化. 中國中醫藥信息雜志, 1999: 14-16, 32.
4.	劉保延. 中醫臨床療效評價研究的現狀與展望. 中國科學基金, 2010, 24(5): 268-274.
5.	國家中醫藥管理局國家中醫臨床研究基地辦公室. 我國16個重點病種的國家中醫臨床研究基地論文統計表(2008年—2013年). 世界科學技術-中醫藥現代化, 2013(5): 1161-1261.
6.	郭新峰, 賴世隆. 日本漢方醫學領域循證醫學研究現狀及其啟示. 中國循證醫學雜志, 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.	張霄瀟, 孫磊, 馮雪, 等. 中醫藥標準化體系建設現狀、問題與對策探討. 中國中藥雜志, 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.	趙佩婕. 日本中醫藥標準化發展研究//國家標準化管理委員會. 市場踐行標準化—第十一屆中國標準化論壇論文集. 北京: 中國標準化協會, 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.	王家瑩, 王俊峰, 承詩琪, 等. 中醫藥系統評價/meta分析19年發展及現狀分析. 中醫雜志, 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.	趙國楨, 馮碩, 張霄瀟, 等. 中醫藥臨床實踐指南: 現狀和思考. 中國循證醫學雜志, 2018, 18(12): 1386-1390.
19.	劉建平. 傳統醫學證據體的構成及證據分級的建議. 中國中西醫結合雜志, 2007, 27(12): 1061-1065.
20.	劉為民, 劉保延, 何麗云, 等. 引入GRADE體系制定中醫藥國際標準的思考與實踐探析. 亞太傳統醫藥, 2011, 7(1): 1-5.
21.	李慧, 陳耀龍, 謝秀麗, 等. 中醫(中西醫結合)臨床實踐指南制修訂方法—證據質量分級. 中華中醫藥雜志, 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.	陳可冀, 錢振淮, 張問渠, 等. 精制冠心片對冠心病心絞痛雙盲望法治療112例療效分析. 醫學研究通訊, 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.	常靜, 李廷謙, 萬美華, 等. 中國4種中醫藥大學學報隨機對照臨床試驗文獻的質量評價. 中國循證醫學雜志, 2006, 6(3): 171-178.
28.	張明妍, 楊豐文, 李越, 等. 《中國中西醫結合雜志》刊載中醫藥隨機對照試驗報告質量的研究. 中國循證醫學雜志, 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, 時景璞. 臨床真實世界研究中的實驗性研究設計. 中華流行病學雜志, 2018, 39(4): 519-523.
36.	孫夢華, 章軼立, 謝雁鳴, 等. 真實世界中使用脈血康膠囊的老年人群特征及用藥分析. 世界中醫藥, 2020, 15(20): 3088-3093.
37.	張宏偉, 謝雁鳴, 高陽, 等. 真實世界中丹參川芎嗪注射液臨床病癥特點及聯合用藥特征研究. 中華中醫藥學刊. (2020-10-20)[2020-11-08]. http://kns.cnki.net/kcms/detail/21.1546.R.20201020.0916.026.html.
38.	田峰, 謝雁鳴. 真實世界研究: 中醫干預措施效果評價的新理念. 中西醫結合學報, 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. 張俊華, 李幼平, 張伯禮. 循證中醫藥學: 理論與實踐. 中國中藥雜志, 2018, 43(1): 1-7.
3. 李幼平, 劉鳴. 循證醫學與中醫藥現代化. 中國中醫藥信息雜志, 1999: 14-16, 32.
4. 劉保延. 中醫臨床療效評價研究的現狀與展望. 中國科學基金, 2010, 24(5): 268-274.
5. 國家中醫藥管理局國家中醫臨床研究基地辦公室. 我國16個重點病種的國家中醫臨床研究基地論文統計表(2008年—2013年). 世界科學技術-中醫藥現代化, 2013(5): 1161-1261.
6. 郭新峰, 賴世隆. 日本漢方醫學領域循證醫學研究現狀及其啟示. 中國循證醫學雜志, 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. 張霄瀟, 孫磊, 馮雪, 等. 中醫藥標準化體系建設現狀、問題與對策探討. 中國中藥雜志, 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. 趙佩婕. 日本中醫藥標準化發展研究//國家標準化管理委員會. 市場踐行標準化—第十一屆中國標準化論壇論文集. 北京: 中國標準化協會, 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. 王家瑩, 王俊峰, 承詩琪, 等. 中醫藥系統評價/meta分析19年發展及現狀分析. 中醫雜志, 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. 趙國楨, 馮碩, 張霄瀟, 等. 中醫藥臨床實踐指南: 現狀和思考. 中國循證醫學雜志, 2018, 18(12): 1386-1390.
19. 劉建平. 傳統醫學證據體的構成及證據分級的建議. 中國中西醫結合雜志, 2007, 27(12): 1061-1065.
20. 劉為民, 劉保延, 何麗云, 等. 引入GRADE體系制定中醫藥國際標準的思考與實踐探析. 亞太傳統醫藥, 2011, 7(1): 1-5.
21. 李慧, 陳耀龍, 謝秀麗, 等. 中醫(中西醫結合)臨床實踐指南制修訂方法—證據質量分級. 中華中醫藥雜志, 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. 陳可冀, 錢振淮, 張問渠, 等. 精制冠心片對冠心病心絞痛雙盲望法治療112例療效分析. 醫學研究通訊, 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. 常靜, 李廷謙, 萬美華, 等. 中國4種中醫藥大學學報隨機對照臨床試驗文獻的質量評價. 中國循證醫學雜志, 2006, 6(3): 171-178.
28. 張明妍, 楊豐文, 李越, 等. 《中國中西醫結合雜志》刊載中醫藥隨機對照試驗報告質量的研究. 中國循證醫學雜志, 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, 時景璞. 臨床真實世界研究中的實驗性研究設計. 中華流行病學雜志, 2018, 39(4): 519-523.
36. 孫夢華, 章軼立, 謝雁鳴, 等. 真實世界中使用脈血康膠囊的老年人群特征及用藥分析. 世界中醫藥, 2020, 15(20): 3088-3093.
37. 張宏偉, 謝雁鳴, 高陽, 等. 真實世界中丹參川芎嗪注射液臨床病癥特點及聯合用藥特征研究. 中華中醫藥學刊. (2020-10-20)[2020-11-08]. http://kns.cnki.net/kcms/detail/21.1546.R.20201020.0916.026.html.
38. 田峰, 謝雁鳴. 真實世界研究: 中醫干預措施效果評價的新理念. 中西醫結合學報, 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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