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

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.	張曉雨, 陳詩琪, 李承羽, 等. 循證中醫藥學理論研究與應用實踐. 中國循證醫學雜志, 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, 趙晨, 鄭頌華, 等. 中醫藥臨床療效研究報告體系構建過程. 中國循證醫學雜志, 2018, 18(7): 651-653.
12.	吳泰相, 李幼平, 卞兆祥, 等. 中醫藥臨床隨機對照試驗報告規范 (征求意見稿). 中國循證醫學雜志, 2007, 7(8): 601-605.
13.	吳泰相, 李幼平, 卞兆祥, 等. 中醫藥臨床隨機對照試驗報告規范 (征求意見稿). 中國循證醫學雜志, 2007, 7(9): 625-630.
14.	Available at: http://www.consort-statement.org/about-consort/endorsers1.
15.	原源. 《實用中醫內科雜志》2018 作者自檢指南 (論著類論文). 實用中醫內科雜志, 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, 車方遠, 易文慧, 等. 加載口服中成藥對 PCI 術后長期主要不良心腦血管事件影響的 Meta 分析. 中醫雜志, 2018, 59(12): 1024-1030.
28.	成舟, 陳麗芳, 譚登, 等. 中藥熏洗治療跟痛癥的臨床試驗質量評價. 中國中醫骨傷科雜志, 2018, 26(2): 76-80.
29.	鄢丹, 劉娟, 王愛婷, 等. 基于循證醫學證據探討中醫藥優勢病種作用機制的研究思路. 中國中藥雜志, 2018, 43(13): 2633-2638.
30.	于丹丹, 謝雁鳴, 廖星, 等. 《中國中藥雜志》發表隨機對照試驗方法學和報告質量評價研究. 中國中藥雜志, 2018, 43(4): 833-839.
31.	原源, 朱民, 蘇雨, 等. 格式化表達-老中醫經驗類論文撰寫一般要素探討. 中醫藥導報, 2018, 24(13): 130-133.
32.	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, 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. 針刺臨床試驗干預措施報告標準修訂版: CONSORT 聲明的擴展. 中國循證醫學雜志, 2010, 10(10): 1228-1239.
38.	Macpherson H, Altman DG, Hammerschlag R, et al. 針刺臨床試驗干預措施報告標準的修訂: CONSORT 聲明的擴展. 中西醫結合學報, 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, 鄭頌華, 張莉, 等. Consensus-based recommendations for case report in Chinese medicine(CARC). 中國結合醫學雜志 (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.	劉建平, 張玫, 楊閔, 等. 單病例隨機對照試驗設計在中醫藥研究中的應用. 中國中醫藥信息雜志, 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, 溫澤淮. 臨床實踐中推拿手法規范化的思考. 中華中醫藥雜志, 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 聲明: 定義臨床研究方案的標準條目. 中國循證醫學雜志, 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, Maru?ic 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. 張曉雨, 陳詩琪, 李承羽, 等. 循證中醫藥學理論研究與應用實踐. 中國循證醫學雜志, 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, 趙晨, 鄭頌華, 等. 中醫藥臨床療效研究報告體系構建過程. 中國循證醫學雜志, 2018, 18(7): 651-653.
12. 吳泰相, 李幼平, 卞兆祥, 等. 中醫藥臨床隨機對照試驗報告規范 (征求意見稿). 中國循證醫學雜志, 2007, 7(8): 601-605.
13. 吳泰相, 李幼平, 卞兆祥, 等. 中醫藥臨床隨機對照試驗報告規范 (征求意見稿). 中國循證醫學雜志, 2007, 7(9): 625-630.
14. Available at: http://www.consort-statement.org/about-consort/endorsers1.
15. 原源. 《實用中醫內科雜志》2018 作者自檢指南 (論著類論文). 實用中醫內科雜志, 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, 車方遠, 易文慧, 等. 加載口服中成藥對 PCI 術后長期主要不良心腦血管事件影響的 Meta 分析. 中醫雜志, 2018, 59(12): 1024-1030.
28. 成舟, 陳麗芳, 譚登, 等. 中藥熏洗治療跟痛癥的臨床試驗質量評價. 中國中醫骨傷科雜志, 2018, 26(2): 76-80.
29. 鄢丹, 劉娟, 王愛婷, 等. 基于循證醫學證據探討中醫藥優勢病種作用機制的研究思路. 中國中藥雜志, 2018, 43(13): 2633-2638.
30. 于丹丹, 謝雁鳴, 廖星, 等. 《中國中藥雜志》發表隨機對照試驗方法學和報告質量評價研究. 中國中藥雜志, 2018, 43(4): 833-839.
31. 原源, 朱民, 蘇雨, 等. 格式化表達-老中醫經驗類論文撰寫一般要素探討. 中醫藥導報, 2018, 24(13): 130-133.
32. 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, 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. 針刺臨床試驗干預措施報告標準修訂版: CONSORT 聲明的擴展. 中國循證醫學雜志, 2010, 10(10): 1228-1239.
38. Macpherson H, Altman DG, Hammerschlag R, et al. 針刺臨床試驗干預措施報告標準的修訂: CONSORT 聲明的擴展. 中西醫結合學報, 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, 鄭頌華, 張莉, 等. Consensus-based recommendations for case report in Chinese medicine(CARC). 中國結合醫學雜志 (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. 劉建平, 張玫, 楊閔, 等. 單病例隨機對照試驗設計在中醫藥研究中的應用. 中國中醫藥信息雜志, 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, 溫澤淮. 臨床實踐中推拿手法規范化的思考. 中華中醫藥雜志, 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 聲明: 定義臨床研究方案的標準條目. 中國循證醫學雜志, 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, Maru?ic 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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