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Abstract

Evaluation of the Real-World Effectiveness of Traditional Chinese Medicine in Treating Coronavirus Disease-2019

Author(s): Yajie Liu, Rumei Xiang, Jinliang Yang, Jiaheng Shi, Yaoyue Hu, Lianguo Ruan, Tao Bai, Jiaqi Chai, Xinghua Xiang, Mimi Xiao, Jingyu Zhang, Wei Xu, Hui Zhao, Jie Liu, Yang Yang and Qiuling Shi*
Department of Traditional Chinese Medicine, Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, 1China Center for Evidence-Based Traditional Chinese Medicine, 2Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, 3Chongqing Medical University, Chongqing 400016, 4Wuhan Jinyintan Hospital, Wuhan 430023, 5China Academy of Chinese Medical Sciences, Beijing 100700, China

Correspondence Address:
Qiuling Shi, Chongqing Medical University, Chongqing 400016, China, E-mail: qshi@cqmu.edu.cn


Coronavirus disease 2019, caused by severe acute respiratory syndrome coronavirus 2, has become a major public health event. In China, traditional Chinese medicine has played a crucial role in controlling epidemics. However, there is limited real-world evidence regarding the use of traditional Chinese medicine in routine clinical practice. The aim of this study is to analyze multi-center clinical record data during the epidemic; provide an in-depth description of traditional Chinese medicine application in coronavirus disease-2019 patients; and evaluate the effectiveness and economy of traditional Chinese medicine. This is a multicenter retrospective cohort study. Adult patients infected with severe acute respiratory syndrome coronavirus 2 will be included. We will use the observational medical outcomes partnership common data model to extract patient data from each hospital’s electronic medical record and convert the data contained in different observational databases into a common structured format with a common representation (terminology, vocabulary, and coding scheme) that can be directly imported into common statistical software such as Statistical Analysis Systems, R and others. The outcomes of treatment regimens (traditional Chinese medicine under the national protocols vs. without traditional Chinese medicine under the national protocols) in the two groups will be compared, including clinical efficacy, public health impact and other exploratory indicators. Statistical analysis included propensity score matching, meta-analysis and sensitivity analysis. In the face of coronavirus disease-2019, the national diagnosis and treatment protocol for patients provides differential traditional Chinese medicine treatment for different types of syndromes. Randomized controlled trials or retrospective studies of a single drug or formulation cannot fully reflect the efficacy and therapeutic advantages of traditional Chinese medicine in the real world. This study can evaluate the effectiveness and economy of traditional Chinese medicine treatment under the application scenario of national diagnosis and treatment protocols, fill the gap of real-world evidence on traditional Chinese medicine treatment of coronavirus disease-2019, and inspire the application of traditional Chinese medicine in the prevention and treatment of infectious diseases in the future.

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