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
Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:284 |
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| Enthalten in: |
Journal of ethnopharmacology - 284(2022) vom: 10. Feb., Seite 114830 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Chen, Yuqin [VerfasserIn] |
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| Links: |
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| Themen: |
Antiviral Agents |
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| Anmerkungen: |
Date Completed 13.12.2021 Date Revised 21.12.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jep.2021.114830 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM333009460 |
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| 245 | 1 | 0 | |a Efficacy and safety of Bufei Huoxue capsules in the management of convalescent patients with COVID-19 infection |b A multicentre, double-blind, and randomised controlled trial |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 13.12.2021 | ||
| 500 | |a Date Revised 21.12.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Bufei Huoxue capsules | |
| 650 | 4 | |a COVID-19 convalescence | |
| 650 | 4 | |a Chinese Materia Medica | |
| 650 | 4 | |a Randomised controlled trial | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 650 | 7 | |a Drugs, Chinese Herbal |2 NLM | |
| 700 | 1 | |a Liu, Chunli |e verfasserin |4 aut | |
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| 700 | 1 | |a Zhou, Haohao |e verfasserin |4 aut | |
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| 700 | 1 | |a Yang, Xuejiao |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Hao |e verfasserin |4 aut | |
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| 700 | 1 | |a Zhong, Nanshan |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jian |e verfasserin |4 aut | |
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