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Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study

PURPOSE: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an essential occurrence in COPD management and is the leading cause of morbidity and mortality. Chinese herbal medicine is widely used in the treatment of AECOPD, but high quality randomized controlled trials are limite...

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Autores principales: Li, Jiansheng, Zhang, Hailong, Ruan, Huanrong, Si, Yimei, Sun, Zikai, Liu, Hong, Feng, Jihong, Wang, Yanqing, Li, Lihua, Bai, Li, Sun, Hui
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670171/
https://www.ncbi.nlm.nih.gov/pubmed/33209019
http://dx.doi.org/10.2147/COPD.S276082
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author Li, Jiansheng
Zhang, Hailong
Ruan, Huanrong
Si, Yimei
Sun, Zikai
Liu, Hong
Feng, Jihong
Wang, Yanqing
Li, Lihua
Bai, Li
Sun, Hui
author_facet Li, Jiansheng
Zhang, Hailong
Ruan, Huanrong
Si, Yimei
Sun, Zikai
Liu, Hong
Feng, Jihong
Wang, Yanqing
Li, Lihua
Bai, Li
Sun, Hui
author_sort Li, Jiansheng
collection PubMed
description PURPOSE: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an essential occurrence in COPD management and is the leading cause of morbidity and mortality. Chinese herbal medicine is widely used in the treatment of AECOPD, but high quality randomized controlled trials are limited. This study aimed to evaluate the efficacy and safety of Chinese herbal medicine as adjuvant therapy for patients with AECOPD. METHODS: This was a randomized, double-blind, placebo-controlled study of 378 participants from eight centers in China. Participants were randomly assigned to receive 10 g of Chinese herbal medicine (according to the type of Traditional Chinese medicine syndrome: Sanhanhuayin, Qingrehuatan, or Zaoshihuatan granules) or placebo, two times per day, for 14 days, in addition to conventional medicine. Participants were followed up for 84 days after the treatment. The primary end point was the COPD assessment test (CAT) score. Secondary end points included the Modified British Medical Research Council (mMRC) questionnaire and the COPD patient-reported outcome scale (COPD-PRO). We also assessed treatment failure and treatment success rate, length of hospitalization, number of patients with acute exacerbations, number of patients readmitted due to AECOPD, and number of deaths and intubation. RESULTS: The between-group difference in the change from baseline for CAT on day 14 (end of treatment) was −2.11 (95% confidence interval [CI], −3.198 to −1.050; P<0.001), exceeding the minimal clinically important difference. The mMRC and COPD-PRO scores were lower in the intervention group compared to the control group (between-group difference in the change from baseline, −0.28; 95% CI, −0.48 to −0.08; P=0.007 and −2.51; 95% CI, −4.087 to −0.929; P=0.002, respectively) on day 14. The intervention group had a significantly shorter duration of hospital stay than the control group (mean difference, −1.21days; 95% CI, −2.041 to −0.419; P=0.003), significantly lower of number of exacerbations (risk ratio [RR], 0.60; 95% CI, 0.409 to 0.892; P=0.010), and significantly lower number of readmissions due to AECOPD (RR, 0.41; 95% CI, 0.193 to 0.865; P=0.015). Significant differences in the number of treatment failures or successes, deaths, and intubation were not observed. The difference in safety variables and adverse events between the two groups was not observed. CONCLUSION: Chinese herbal medicine appears to be safe and beneficial for AECOPD and can be considered a complementary treatment for patients with AECOPD.
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spelling pubmed-76701712020-11-17 Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study Li, Jiansheng Zhang, Hailong Ruan, Huanrong Si, Yimei Sun, Zikai Liu, Hong Feng, Jihong Wang, Yanqing Li, Lihua Bai, Li Sun, Hui Int J Chron Obstruct Pulmon Dis Clinical Trial Report PURPOSE: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an essential occurrence in COPD management and is the leading cause of morbidity and mortality. Chinese herbal medicine is widely used in the treatment of AECOPD, but high quality randomized controlled trials are limited. This study aimed to evaluate the efficacy and safety of Chinese herbal medicine as adjuvant therapy for patients with AECOPD. METHODS: This was a randomized, double-blind, placebo-controlled study of 378 participants from eight centers in China. Participants were randomly assigned to receive 10 g of Chinese herbal medicine (according to the type of Traditional Chinese medicine syndrome: Sanhanhuayin, Qingrehuatan, or Zaoshihuatan granules) or placebo, two times per day, for 14 days, in addition to conventional medicine. Participants were followed up for 84 days after the treatment. The primary end point was the COPD assessment test (CAT) score. Secondary end points included the Modified British Medical Research Council (mMRC) questionnaire and the COPD patient-reported outcome scale (COPD-PRO). We also assessed treatment failure and treatment success rate, length of hospitalization, number of patients with acute exacerbations, number of patients readmitted due to AECOPD, and number of deaths and intubation. RESULTS: The between-group difference in the change from baseline for CAT on day 14 (end of treatment) was −2.11 (95% confidence interval [CI], −3.198 to −1.050; P<0.001), exceeding the minimal clinically important difference. The mMRC and COPD-PRO scores were lower in the intervention group compared to the control group (between-group difference in the change from baseline, −0.28; 95% CI, −0.48 to −0.08; P=0.007 and −2.51; 95% CI, −4.087 to −0.929; P=0.002, respectively) on day 14. The intervention group had a significantly shorter duration of hospital stay than the control group (mean difference, −1.21days; 95% CI, −2.041 to −0.419; P=0.003), significantly lower of number of exacerbations (risk ratio [RR], 0.60; 95% CI, 0.409 to 0.892; P=0.010), and significantly lower number of readmissions due to AECOPD (RR, 0.41; 95% CI, 0.193 to 0.865; P=0.015). Significant differences in the number of treatment failures or successes, deaths, and intubation were not observed. The difference in safety variables and adverse events between the two groups was not observed. CONCLUSION: Chinese herbal medicine appears to be safe and beneficial for AECOPD and can be considered a complementary treatment for patients with AECOPD. Dove 2020-11-12 /pmc/articles/PMC7670171/ /pubmed/33209019 http://dx.doi.org/10.2147/COPD.S276082 Text en © 2020 Li et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Clinical Trial Report
Li, Jiansheng
Zhang, Hailong
Ruan, Huanrong
Si, Yimei
Sun, Zikai
Liu, Hong
Feng, Jihong
Wang, Yanqing
Li, Lihua
Bai, Li
Sun, Hui
Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study
title Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study
title_full Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study
title_fullStr Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study
title_full_unstemmed Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study
title_short Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study
title_sort effects of chinese herbal medicine on acute exacerbations of copd: a randomized, placebo-controlled study
topic Clinical Trial Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670171/
https://www.ncbi.nlm.nih.gov/pubmed/33209019
http://dx.doi.org/10.2147/COPD.S276082
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