Methods of developing core traditional Chinese medicine syndromes set_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Ruijin ¹ , SUN Yang ¹ , ZHONG Changming ¹ , LI Min ² , HU Jiayuan ¹ , ZHAO Chen ³ ,  CHEN Jing ⁴ , SHANG Hongcai ¹

1. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, P.R.China;
2. Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, P.R.China;
3. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R.China;
4. Baokang Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, P.R.China;

Corresponding author：

CHEN Jing, Email: cjshcsyc@126.com

Keywords：

Traditional Chinese medicine; Core outcome set; TCM syndrome; Methodology

DOI：

10.7507/1672-2531.202106083

Video：

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Since the concept of core outcome set (COS) was introduced into clinical trials of traditional Chinese medicine (TCM), researchers have paid much more attention to develop COS for specific diseases. Although researchers believe that the characteristics of TCM, such as syndromes, should be considered in the COS of TCM, it was insufficiently addressed. In addition, the naming of TCM syndromes has not been standardized, and the classification and diagnostic criteria for specific diseases have been inconsistent. Thus, it is difficult to include TCM syndromes in the COS. Different diseases may show similar TCM syndromes which makes research difficult. Based on previous studies, this paper provided methods of developing core TCM syndromes set according to the model of combination of disease and syndrome and the model of syndrome dominating disease to provide references for future researches.

Citation： QIU Ruijin, SUN Yang, ZHONG Changming, LI Min, HU Jiayuan, ZHAO Chen, CHEN Jing, SHANG Hongcai. Methods of developing core traditional Chinese medicine syndromes set. Chinese Journal of Evidence-Based Medicine, 2021, 21(11): 1353-1357. doi: 10.7507/1672-2531.202106083 Copy

1.	邱瑞瑾, 李敏, 韩松洁, 等. 《COMET手册》1. 0版解读及其对构建中医临床研究核心指标集的启示. 中国循证医学杂志, 2017, 17(12): 1482-1488.
2.	邢冬梅, 张俊华, 张伯礼. 中医临床研究核心结局指标集形成路径. 中华中医药杂志, 2014, 29(5): 1352-1355.
3.	Zhang L, Zhang J, Chen J, et al. Clinical research of traditional Chinese medicine needs to develop its own system of core outcome sets. Evid Based Complement Alternat Med, 2013, 2013: 202703.
4.	孙亚男, 翁志文, 刘长信, 等. 构建慢性腰背痛中医临床研究核心结局指标集的思考. 中华中医药杂志, 2019, 34(11): 5275-5279.
5.	张冬, 张明妍, 郑文科, 等. 中医药临床试验核心指标集构建及德尔菲法实施规范. 中医杂志, 2017, 58(1): 20-22.
6.	The COMET Initiative. Available at:http://www.comet-initiative.org/.
7.	Qiu R, Li M, Zhang X, et al. Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol. Trials, 2018, 19(1): 541.
8.	Qiu R, Zhong C, Han S, et al. Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol. BMJ Open, 2019, 9(12): e032256.
9.	邱瑞瑾. 中医临床研究核心指标集的方法构建. 北京: 北京中医药大学, 2018.
10.	Qiu R, Zhao C, Liang T, et al. Core outcome set for clinical trials of COVID-19 based on traditional Chinese and Western medicine. Front Pharmacol, 2020, 11: 781.
11.	Li G, Zhou L, Ouyang W, et al. A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey. Trials, 2019, 20(1): 14.
12.	李心怡, 石兆峰, 胡嘉元, 等. 针刺治疗偏头痛核心结局指标集的建立. 世界科学技术-中医药现代化, 2020, 22(1): 7-12.
13.	陈可冀. 病证结合治疗观与临床实践. 中国中西医结合杂志, 2011, 31(8): 1016-1017.
14.	邱瑞瑾, 张晓雨, 商洪才. 证候类中药新药临床疗效评价方法探索. 世界中医药, 2017, 12(6): 1230-1234.
15.	邱瑞瑾, 张晓雨, 李敏, 等. 中医证候命名规范化研究在核心指标集构建中的意义及方法. 中华中医药杂志, 2018, 33(6): 2240-2243.
16.	王永炎, 张启明, 张志斌. 证候要素及其靶位的提取. 山东中医药大学学报, 2006, 30(1): 6-7.
17.	张志斌, 王永炎. 证候名称及分类研究的回顾与假设的提出. 北京中医药大学学报, 2003, 26(2): 1-5.
18.	Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
19.	Fish R, Sanders C, Adams R, et al. A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus. Lancet Gastroenterol Hepatol, 2018, 3(12): 865-873.
20.	Davis K, Gorst SL, Harman N, et al. Choosing important health outcomes for comparative effectiveness research: an updated systematic review and involvement of low and middle income countries. PLoS One, 2018, 13(2): e0190695.

1. 邱瑞瑾, 李敏, 韩松洁, 等. 《COMET手册》1. 0版解读及其对构建中医临床研究核心指标集的启示. 中国循证医学杂志, 2017, 17(12): 1482-1488.
2. 邢冬梅, 张俊华, 张伯礼. 中医临床研究核心结局指标集形成路径. 中华中医药杂志, 2014, 29(5): 1352-1355.
3. Zhang L, Zhang J, Chen J, et al. Clinical research of traditional Chinese medicine needs to develop its own system of core outcome sets. Evid Based Complement Alternat Med, 2013, 2013: 202703.
4. 孙亚男, 翁志文, 刘长信, 等. 构建慢性腰背痛中医临床研究核心结局指标集的思考. 中华中医药杂志, 2019, 34(11): 5275-5279.
5. 张冬, 张明妍, 郑文科, 等. 中医药临床试验核心指标集构建及德尔菲法实施规范. 中医杂志, 2017, 58(1): 20-22.
6. The COMET Initiative. Available at:http://www.comet-initiative.org/.
7. Qiu R, Li M, Zhang X, et al. Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol. Trials, 2018, 19(1): 541.
8. Qiu R, Zhong C, Han S, et al. Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol. BMJ Open, 2019, 9(12): e032256.
9. 邱瑞瑾. 中医临床研究核心指标集的方法构建. 北京: 北京中医药大学, 2018.
10. Qiu R, Zhao C, Liang T, et al. Core outcome set for clinical trials of COVID-19 based on traditional Chinese and Western medicine. Front Pharmacol, 2020, 11: 781.
11. Li G, Zhou L, Ouyang W, et al. A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey. Trials, 2019, 20(1): 14.
12. 李心怡, 石兆峰, 胡嘉元, 等. 针刺治疗偏头痛核心结局指标集的建立. 世界科学技术-中医药现代化, 2020, 22(1): 7-12.
13. 陈可冀. 病证结合治疗观与临床实践. 中国中西医结合杂志, 2011, 31(8): 1016-1017.
14. 邱瑞瑾, 张晓雨, 商洪才. 证候类中药新药临床疗效评价方法探索. 世界中医药, 2017, 12(6): 1230-1234.
15. 邱瑞瑾, 张晓雨, 李敏, 等. 中医证候命名规范化研究在核心指标集构建中的意义及方法. 中华中医药杂志, 2018, 33(6): 2240-2243.
16. 王永炎, 张启明, 张志斌. 证候要素及其靶位的提取. 山东中医药大学学报, 2006, 30(1): 6-7.
17. 张志斌, 王永炎. 证候名称及分类研究的回顾与假设的提出. 北京中医药大学学报, 2003, 26(2): 1-5.
18. Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
19. Fish R, Sanders C, Adams R, et al. A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus. Lancet Gastroenterol Hepatol, 2018, 3(12): 865-873.
20. Davis K, Gorst SL, Harman N, et al. Choosing important health outcomes for comparative effectiveness research: an updated systematic review and involvement of low and middle income countries. PLoS One, 2018, 13(2): e0190695.

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