Efficacy and safety of Bufei Huoxue capsules in the management of convalescent patients with COVID-19 infection: A multicentre, double-blind, and randomised controlled trial

Yuqin Chen; Chunli Liu; Tingping Wang; Jingjing Qi; Xiaoqing Jia; Xiansheng Zeng; Jianling Bai; Wenju Lu; Yu Deng; Bihua Zhong; Wenjun He; Yue Xing; Zhan Lian; Haohao Zhou; Junping Yan; Xuejiao Yang; Hao Yu; Jiawei Zhou; Dansha Zhou; Lixia Qiu; Nanshan Zhong; Jian Wang

doi:10.1016/j.jep.2021.114830

Efficacy and safety of Bufei Huoxue capsules in the management of convalescent patients with COVID-19 infection: A multicentre, double-blind, and randomised controlled trial

J Ethnopharmacol. 2022 Feb 10:284:114830. doi: 10.1016/j.jep.2021.114830. Epub 2021 Nov 9.

Authors

Yuqin Chen¹, Chunli Liu¹, Tingping Wang², Jingjing Qi³, Xiaoqing Jia⁴, Xiansheng Zeng⁵, Jianling Bai⁶, Wenju Lu¹, Yu Deng⁷, Bihua Zhong¹, Wenjun He¹, Yue Xing¹, Zhan Lian², Haohao Zhou³, Junping Yan⁴, Xuejiao Yang⁵, Hao Yu⁶, Jiawei Zhou⁶, Dansha Zhou¹, Lixia Qiu⁸, Nanshan Zhong⁹, Jian Wang¹⁰

Affiliations

¹ State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangdong-Hong Kong-Macao Joint Laboratory for respiratory infectious disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
² Department of Out-patient and Emergency, Wuhan Institute for Tuberculosis Control, Wuhan Pulmonary Hospital, Wuhan, Hubei, China.
³ Department of Respiratory and Critical Care Medicine, Xiangzhou District People's Hospital, Xiangyang, Hubei, China.
⁴ Department of Respiratory, Third Hospital of Baotou City, Baotou, Inner Mongolia, China.
⁵ Department of Respiratory and Critical Care Medicine, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, Hubei, China.
⁶ Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.
⁷ Department of Radiology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
⁸ Hangzhou YITU Healthcare Technology Co., Ltd., Hangzhou, Zhejiang, China.
⁹ State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangdong-Hong Kong-Macao Joint Laboratory for respiratory infectious disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China. Electronic address: nanshan@vip.163.com.
¹⁰ State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangdong Key Laboratory of Vascular Disease, Guangdong-Hong Kong-Macao Joint Laboratory for respiratory infectious disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China. Electronic address: jianwang1986@yahoo.com.

Abstract

Background: As of September 17, 2021, coronavirus disease 2019 (COVID-19) has infected more than 226 million people in a worldwide pandemic, with conservative estimates suggesting that there are more than 204 million convalescent patients with COVID-19. Previous studies have indicated that patients in the recovery phase exhibit decreased function of multiple organs. In China, traditional Chinese medicine (TCM) treatment is recommended in the rehabilitation period of COVID-19; however, the safety and efficacy of such treatment remain to be confirmed.

Aim of study: The present study aimed to evaluate the efficacy and safety of Bufei Huoxue (BFHX) in restoring the functional status and exercise tolerance of patients recovering from COVID-19.

Methods: A total of 131 patients in the rehabilitation period of COVID-19 infection were randomly divided into a Bufei Huoxue (BFHX) group (n = 66) and a placebo group (n = 65). BFHX or placebo was given orally three times a day (1.4 g/dose) for 90 days. The primary outcomes was to evaluate improvements in exercise tolerance and imaging manifestations on chest computed tomography (CT).

Results: After the exclusion of two patients who withdrew prior to receiving any medications, 129 patients were recruited, including 64 patients in the BFHX group and 65 patients in the placebo group. After 3 months of treatment, the BFHX group exhibited greater attenuation of pneumonia lesions on chest CT than the placebo group (P<0.05). Improvements in 6-min walk distance (6MWD) relative to baseline were also significantly better in the BFHX group than in the placebo group (P<0.01). Scores on the Fatigue Assessment Inventory (FAI) were lower in the BFHX group than in the placebo group (P<0.05). Although the rate of adverse events was higher in the BFHX group than in the placebo group (9.38% vs. 4.62%), the difference was not significant (P=0.3241).

Conclusions: BFHX may exert strong rehabilitative effects on physiological activity in patients recovering from COVID-19, which may in turn attenuate symptoms of fatigue and improve exercise tolerance.

Keywords: Bufei Huoxue capsules; COVID-19 convalescence; Chinese Materia Medica; Randomised controlled trial.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Adolescent
Adult
Aged
Antiviral Agents / therapeutic use*
COVID-19 Drug Treatment*
Convalescence
Double-Blind Method
Drugs, Chinese Herbal / therapeutic use*
Female
Humans
Male
Middle Aged
SARS-CoV-2*
Young Adult

Substances

Antiviral Agents
Drugs, Chinese Herbal