中医药防治新型冠状病毒肺炎临床证据质量的提升

The Coronavirus Disease 2019 (COVID-19) is spreading around the world, and there is still no widely recognized effective treatment. The emergence of vaccines brings hope to the global control of the epidemic, but there is still a long way to go. The Chinese government pays much attention to this epidemic, and uses the national strength to mobilize in all aspects to successfully control COVID-19. Its anti-epidemic results have attracted worldwide attention. In China’s anti-epidemic practice, Traditional Chinese Medicine (TCM) has been successfully used to a large extent, and a series of clinical research results have been published. How to form an evidence-based clinical recommendation based on these clinical results and disseminate these results around the world thus to facilitate the control of this pandemic should be further discussed. Among many published clinical research evidence related to COVID-19, the level of evidence is one of the core issues in the COVID-19 management with TCM. The commentary analyzed this challenging problem and put forward a series of corresponding suggestions, hoping to provide a useful reference for clinical research on TCM. The main problems in clinical research of TCM included: (1) Incomplete registration information, especially lack features of TCM; (2) no precise targeted clinical problems, especially what kind of clinical questions will be tested in the trial; (3) no rigorous research design, especially about the randomization, blinding, outcome assessment, etc.; (4) insufficient report about the trial results; (5) no data sharing plan. For emergent, new, and major infectious diseases such as COVID-19, the high-quality research evidence from clinical trials can guide clinical practice through forming high-quality evidence. The high-quality evidence can help the front-line medical staff to make evidence-based decision, which is the cornerstone of improving the clinical treatment effect for such new disease, without previous management experience. Applause should be given to the medical staff due to their efforts in clinical trials under the tremendous clinical work for COVID-19 pandemic. Specific attention should be given to clinical trials with TCM research in COVID-19 with suggestions as follows: (1) Strictly follow international standards to design, register, implement, and report the clinical trials. Pioneers have developed the guidelines in this area, and Chinese scholars also developed the specific recommendations for TCM researches. Previous studies have demonstrated that these guidelines can improve the quality of clinical researches; (2) establish the clinical data sharing mechanisms in China, starting from COVID-19 trials. The mechanism can improve the transparency of the trial, reduce the duplication, and increase the dissemination of the trial results; (3) set up the national unit for the emergent, new, and major infectious diseases thus to coordinate the clinical practice as well as the clinical research for TCM and western medicine. These efforts will facilitate transforming the research and practice results to be recognized high-level evidence thus to improve the clinical efficacy and safety of TCM. The efforts will just affect the evidence quality of COVID-19, but also for the emergent, new, and major infectious diseases in the future.