ZHI Yingjie, XIE Yanming. Discussion on the Main Points of the Report on Clinical Trial of Chinese Medicine for Coronavirus Disease 2019[J]. Journal of Traditional Chinese Medicine2020, 61(20): 1756-1761.
ZHI Yingjie, XIE Yanming. Discussion on the Main Points of the Report on Clinical Trial of Chinese Medicine for Coronavirus Disease 2019[J]. Journal of Traditional Chinese Medicine2020, 61(20): 1756-1761.DOI: 10.13288/j.11-2166/r.2020.20.002.
Discussion on the Main Points of the Report on Clinical Trial of Chinese Medicine for Coronavirus Disease 2019
Rigorous clinical trial design is a necessary condition for standardized reporting
and standardized reporting is the ultimate manifestation of rigorous trial design. On the premise of referring to the CONSORT and STROBE statements
combined with the guidelines for clinical research methods of traditional Chinese medicine(TCM) and integrated traditional Chinese and western medicine
and based on the registered clinical research of coronavirus disease 2019(COVID-19)
the relevant clinical research report specifications are discussed. The main points of the randomized controlled clinical trial report were summarized from the aspects of randomization
subject inclusion and exclusion criteria
intervention measures
blinding implementation and placebo preparation
outcome indicators
etc. Meanwhile
according to different types of observational research such as case series studies
case-control studies
cohort studies and case report
the main point of the reports were discussed. Researchers follow the law of diagnosis and treatment of TCM while standardize the expression of clinical research results
which will be more conducive to the accumulation of diagnosis and treatment experience and the promotion and reference of research evidence in response to sudden and emerging infectious diseases in TCM.