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Randomized Controlled Trial
. 2022 Feb 10:284:114830.
doi: 10.1016/j.jep.2021.114830. Epub 2021 Nov 9.

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  1 , Chunli Liu  1 , Tingping Wang  2 , Jingjing Qi  3 , Xiaoqing Jia  4 , Xiansheng Zeng  5 , Jianling Bai  6 , Wenju Lu  1 , Yu Deng  7 , Bihua Zhong  1 , Wenjun He  1 , Yue Xing  1 , Zhan Lian  2 , Haohao Zhou  3 , Junping Yan  4 , Xuejiao Yang  5 , Hao Yu  6 , Jiawei Zhou  6 , Dansha Zhou  1 , Lixia Qiu  8 , Nanshan Zhong  9 , Jian Wang  10
Affiliations
Randomized Controlled Trial

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 et al. J Ethnopharmacol. .

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.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Image 1
Graphical abstract
Fig. 1
Fig. 1
Study flow chart.
Fig. 2
Fig. 2
Mean changes in 6-min walking distance and Fatigue Assessment Inventory results relative to baseline after three months of treatment in the placebo and BFHX Groups. A. Mean changes from baseline in 6-min walk distance in the BFHX and control groups in the full dataset. B. Mean changes from baseline in 6-min walk distance in the BFHX and control groups in the full dataset in the per-protocol dataset. C. Fatigue Assessment Inventory scores in the BFHX and control groups in the full dataset. D. Fatigue Assessment Inventory scores in the BFHX and control groups in the per-protocol dataset. Data are presented as medians with 95% confidence intervals (95% CI). The last observation carried forward was imputed in the case of death or clinical worsening without a termination visit or measurement at the termination visit. BFHX: Bufei Huoxue.
See this image and copyright information in PMC

References

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