Efficacy and safety of Bufei Huoxue capsules in treating convalescent
patients with COVID-19: A multicentre, double-blind, and randomized
controlled trial
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.