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Efficacy and safety of Bufei Huoxue capsules in treating convalescent patients with COVID-19: A multicentre, double-blind, and randomized controlled trial
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  • Yuqin Chen,
  • Chunli Liu,
  • Tingping Wang,
  • Jingjing Qi,
  • Xiaoqing Jia,
  • Xiansheng Zeng,
  • Jianling Bai,
  • Wenju Lu,
  • Bihua Zhong,
  • Wenjun He,
  • Yue Xing,
  • Zhan Lian,
  • Haohao Zhou,
  • Junping Yan,
  • Xuejiao Yang,
  • Hao Yu,
  • Jiawei Zhou,
  • Dansha Zhou,
  • Nan-shan Zhong,
  • Jian Wang
Yuqin Chen
Guangzhou Medical University
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Chunli Liu
The First Affiliated Hospital of Guangzhou Medical University
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Tingping Wang
Wuhan Pulmonary Hospital
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Jingjing Qi
Xiangzhou District People's Hospital
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Xiaoqing Jia
Third Hospital of Baotou City
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Xiansheng Zeng
Xiangyang Central Hospital
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Jianling Bai
Nanjing Medical University
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Wenju Lu
State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
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Bihua Zhong
First Affiliated Hospital of Guangzhou Medical University
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Wenjun He
State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University
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Yue Xing
First Affiliated Hospital of Guangzhou Medical University
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Zhan Lian
Wuhan Pulmonary Hospital
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Haohao Zhou
Xiangzhou District People's Hospital
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Junping Yan
Third Hospital of Baotou City
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Xuejiao Yang
Xiangyang Central Hospital
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Hao Yu
Nanjing Medical University
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Jiawei Zhou
Nanjing Medical University
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Dansha Zhou
First Affiliated Hospital of Guangzhou Medical University
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Nan-shan Zhong
Guangzhou Institute of Respiratory Disease
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Jian Wang
First Affiliated Hospital of Guangzhou Medical University

Corresponding Author:[email protected]

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Abstract

Background and Purpose As of 5 March 2021, coronavirus disease 2019 (COVID-19) has infected more than 116 million people worldwide, with over 91 million convalescent patients. A decrease in function of multiple organs has been reported in recovering patients. In China, traditional Chinese medicine (TCM) is recommended to treat patients in the rehabilitation period; however, its efficacy and safety still need to be confirmed. Experimental Approach We conducted a multicentre, double-blind, randomised controlled trial that recruited patients with COVID-19 during the rehabilitation period. In total, 131 patients were randomly divided into two groups: 66 in the Bufei Huoxue capsules (BFHX)-treated group and 65 in the control group. BFHX was administered orally three times a day (1.4g/dose) for 90 days, and the control group was administered placebo for 90 days. The primary endpoint was to evaluate improvements in fatigue symptoms and exercise tolerance. Key Results After three months of treatment, the six-minute walk distance (6MWD) of the BFHX-treated group was significantly longer than that of the control group, compared to baseline. The Fatigue Assessment Inventory (FAI) was lower in the BFHX-treated group than in the control group. Adverse event rates were higher in the BFHX-treated group, but there was no statistical difference between groups. Conclusions and Implications BFHX may have strong rehabilitative effects on patients recovering from COVID-19 in terms of improvements in physiological activities, such as fatigue symptoms and exercise tolerance. The drug has proven to have favourable safety and effectiveness profiles.