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TMR Integrative Medicine  2018, Vol. 2 Issue (3): 133-139     DOI: 10.12032/TMRIM201802030
Review     
Necessities and feasibilities of the establishment of traditional Chinese medicine clinical research protocol database
Si Jin-Hua1, Li Nan2, Du Liang3, Cheng Yao-Long4,5,6, Shang Hong-Cai7,*()
1Tianjin University of Traditional Chinese Medicine, Tianjin, China
2Medical Identification Center,Jiangsu Medical Association, Nanjing, China
3Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China
4Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China
5Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou, China
6Chinese GRADE Center, Lanzhou University, Lanzhou, China
7Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
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Highlights:

This research collected TCM clinical research protocols which were published in international journals and established Traditional Chinese Medicine Clinical Protocol Database (TCMCPD), in order to promote the localization of high quality researches and improve the ability of TCM clinical research in China. Further describes the necessities and feasibilities of building Traditional Chinese Medicine Clinical Protocol Database (TCMCPD) and puts forward some basic technological ideas, so as to provide a theoretical foundation for building the database.

Abstract

With the internationalization and modernization of traditional Chinese medicine (TCM), TCM clinical research has accumulated a lot of research information resources. However, these information resources are often scattered in various retrieval systems, which brings some difficulties to the reference and use of this information. Therefore, we collected TCM clinical research protocols which were published in international journals and established Traditional Chinese Medicine Clinical Research Protocol Database (TCMCRPD), in order to promote the localization of high-quality researches and improve the ability of TCM clinical research in China. After analyzing the major existing problems of TCM clinical research protocols, this essay describes the necessities and feasibilities of building Traditional Chinese Medicine Clinical Research Protocol Database (TCMCRPD) and puts forward some basic technological ideas, so as to provide a theoretical foundation for building the database.



Key wordsTraditional Chinese Medicine      Clinical research      Protocol database      Necessity      Feasibility     
Published: 14 September 2018
Corresponding Authors: Shang Hong-Cai     E-mail: shanghongcai@foxmail.com
Cite this article:

Si Jin-Hua, Li Nan, Du Liang, Cheng Yao-Long, Shang Hong-Cai. Necessities and feasibilities of the establishment of traditional Chinese medicine clinical research protocol database. TMR Integrative Medicine, 2018, 2 (3): 133-139.  

URL:

https://www.tmrjournals.com/im/EN/10.12032/TMRIM201802030     OR     https://www.tmrjournals.com/im/EN/Y2018/V2/I3/133

Figure 1 The temporal distribution of the literatures about clinical research of TCM in PubMed
Figure 2 The Technology Roadmap to Establish TCMCPD
1.   Mao B, Wang G, Fan T.The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China. Clin Ther 2007, 29: 1456-1467.
doi: 10.1016/j.clinthera.2007.07.023
2.   Min Jie, Mao B, Liu A.Quality assessment of randomized controlled trials related to traditional Chinese medicine published in the Chinese journal of evidence-based medicine. Chin J Evid-based Med 2010, 10: 362-366.
3.   Tian JH,Huang ZH, Ge L, et al. Evaluation of quality of randomized controlled trials research papers among Chinese abstracts for the breast. Chin J General Practice 2016, 14: 1182-1185.
4.   Lao LX.Acupuncture clinical studies and evidence-based medicine-an update. Acupunc ture Res 2008, 33: 53-61.
pmid: 18386647
5.   Liu JP, Kjaergard LL, Gluud C.Misuse of randomization: a review of Chinese randomized trials of herbal medicines for chronic hepatitis B. Am J Chin Med 2002, 30: 173-176.
doi: 10.1142/S0192415X0200017X
6.   Li T.Some problems on clinical trails evaluation of herbs medicine for insomnia. Chin J Pharmacol Ther 2006, 4: 375-378.
7.   Wu CS, Chen JX, Hu LS.Duble percent method, the new method to determine the weight coefficient in building diagnostic criteria in TCM with delpi method. Chin J Basic Med in Tradit Chin Med 2006, 12: 254-255.
8.   Zhang Fan, Liu GH,Zhang Z.Thinking about indicators of TCM clinical evaluation. Chin Tradit Med 2013, 31: 1285-1287.
9.   Han M, Yang GY, Wang YY.Chinese medicine clinical trial protocol design and report specifications. CJITWM 2014, 34: 907-910.
pmid: 25223170
10.   Tetzlaff JM, Moher D, Chan AW.Developing a guideline for clinical trial protocol Content: Delphi consensus survey. Trials 2013, 13: 176.
doi: 10.1186/1745-6215-13-176 pmid: 23006145
11.   Li S.Discussion on the characteristics of TCM syndromes from the concepts of dimensions and ranks: approaches to the standardization of TCM syndromes. J Beijing Univer TCM 2003, 26: 1-4.
12.   Liu JP.Methodological quality assessment of clinical trials in traditional Chinese medicine: the principles of evidence-based medicine. J Chin Integrative Med 2006, 4: 1-6.
doi: 10.3736/jcim
13.   Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med 2010, 7: e1000217.
doi: 10.1371/journal.pmed.1000217 pmid: 2821895
14.   Liu XM, LI YP, WU TX, et al. A survey of the status of funding of registered Chinese clinical trials. Chin J Evid-based Med 2008, 8: 305-311.
15   Current Controlled Trials.News [EB/OL]. [2013-03-04].
16   Australian New Zealand Clinical Trials Registry. What is the ANZCTR [EB/OL]? Teff see 2015, 1: 11-15.
17.   International committee of medical journal editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication (2010-04).
18.   Hui L, Liu JP.Quality and validity of randomized controlled trials in China from the perspective of systematic reviews. J Chin Integr Med 2011, 9: 697-701.
doi: 10.3736/jcim
19.   Liu ZS, Yan SY, Wu JN, et al. Acupuncture for chronic severe functional constipation a randomized, controlled trial. Ann Intern Med 2016, 13: 13.
doi: 10.7326/M15-3118 pmid: 27618593
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