Quality evaluation of clinical trial literatures on the COVID-19 treatment with traditional Chinese medicine (TCM)
10.12206/j.issn.1006-0111.202012012
- VernacularTitle:中药治疗新型冠状病毒肺炎临床研究文献的质量评价
- Author:
Jiangwei JIN
1
,
2
;
Jianrong SHI
3
;
Jian CAI
4
;
Guihua LI
5
;
Saihua LU
5
;
Feng XU
5
Author Information
1. Sixth People’s Hospital South Campus Affiliated to Shanghai University of Medicine & Health Sciences, Shanghai 201400, China
2. School of Pharmacy, Shanghai University of Medicine & Health Sciences, Shanghai 201318, China.
3. Chongming Baozhen Community Health Center, Shanghai 202159, China.
4. Fengxian Mental Health Center, Shanghai 201499, China.
5. Sixth People’s Hospital South Campus Affiliated to Shanghai University of Medicine & Health Sciences, Shanghai 201400, China.
- Keywords:
traditional Chinese medicine;
COVID-19;
clinical trials;
literature quality evaluation
- From:
Journal of Pharmaceutical Practice
2021;39(3):206-210
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the quality of the clinical trial literatures published on the treatment of COVID-19 with TCM, find out the shortcomings and put forward corresponding suggestions, in order to promote TCM against COVID-19. Methods "COVID-19", "New Coronavirus Pneumonia", "TCM", "Chinese Medicine", "Clinical Trial", "Lianhua Qingwen", "Huoxiang Zhengqi", "Jinhua Qinggan", and other keywords were used to search relevant literatures in CNKI and PubMed database. Among the all the screened relevant literatures on the treatment of COVID-19 with TCM, the literature quality was assessed according to evaluation criteria of clinical trial literatures. Results A total of 463 papers related to the treatment of COVID-19 with TCM were obtained. 440 papers on theoretical research on the network pharmacology mechanism of Chinese medicine treatment of COVID-19 were excluded. Among the 23 articles included in the quality analysis, there are 3 randomized controlled studies, 1 multi-center prospective randomized controlled trial, 2 disease case report trials, and 5 uncontrolled single arm studies, 5 controlled trials and 7 retrospective studies. In the period of more than half a year, although many clinical trial documents of TCM for the treatment of COVID-19 have been published, the clinical trial design reflected in most TCM clinical trials were not standardized. There are problems in "randomness and rationality", such as no control group, no randomization design, only case studies, no blinding method in controlling bias, and insufficient objectivity in the evaluation criteria of efficacy. All of these need to be improved. Conclusion The treatment of new coronavirus pneumonia with TCM still requires more and standardized clinical trial verifications and publications to generate strong evidence-based results, such as adding control groups, increasing sample size, and using blinding methods to increase the credibility of clinical trials.
