DOI
10.1016/j.phymed.2022.154057
Treatment with JianPiYiFei II granules for patients with moderate to very severe chronic obstructive pulmonary disease: A 52-week randomised, double-blinded, placebo-controlled, multicentre trial
作者地址
Department of Pulmonary and Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China
摘要
Background: Complementary and alternative therapy is widely used to treat chronic obstructive pulmonary disease (COPD). A Chinese herbal medicine, JianPiYiFei (JPYF) II granules, have been shown to improve COPD patients' quality of life, however long-term effectiveness has not been examined.
Purpose: To investigate whether long-term treatment with JPYF II granules is effective and safe for patients with stable, moderate to very severe COPD.
Study design and methods: A multicentre, randomised, double-blinded, placebo-controlled trial was conducted. Eligible participants from six hospitals were randomly assigned 1:1 to receive either JPYF II granules or placebo for 52 weeks. The primary outcome was the change in St. George's Respiratory Questionnaire (SGRQ) score during treatment. Secondary outcomes included the frequency of acute exacerbations during treatment, COPD Assessment Test (CAT), 6-minute walking test (6MWT), lung function, body mass index, airflow obstruction, dyspnoea, exercise capacity (BODE) index, and peripheral capillary oxygen saturation (SpO2) at the end of treatment.
Results: A total of 276 patients (138 in each group) were included in the analysis. JPYF II granules led to a significantly greater reduction in SGRQ score (-7.33 points, 95% CI -10.59 to -4.07; p < 0.0001) which reflects improved quality of life. JPYF II granules improved CAT (-3.49 points, 95% CI -5.12 to -1.86; p < 0.0001) and 6MWT (45.61 metres, 95% CI 20.26 to 70.95; p = 0.0005), compared with placebo. Acute exacerbations were less frequent with JPYF II granules than with placebo (0.87 vs. 1.34 events per patient; p = 0.0043). There were no significant differences between the groups in lung function, BODE index and SpO2. JPYF II granules were well tolerated and no significant adverse effects were noted.
Conclusions: Long-term treatment with JPYF II granules is effective in moderate to very severe COPD, improving quality of life and exercise capacity, decreasing the risk of acute exacerbation, and relieving symptoms.
资助信息
National Natural Science Foundation of China (82074370, 82074343); State Key Laboratory of Dampness Syndrome of Chinese Medicine (SZ2021ZZ42); The 2020 Guangdong Provincial Science and Technology Innovation Strategy Special Fund (Guangdong-Hong Kong-Macau Joint Lab, 2020B1212030006), Technology Planning Project of Guangzhou (202002020042); double first-class and high-level university discipline collaborative innovation team project of Guangzhou University of Chinese Medicine (2021XK27)
资助机构
国家自然科学基金委员会
;
广州中医药大学
;
广东省科学技术厅
WOS学科分类
Plant Sciences
;
Chemistry
;
Medicinal
;
Integrative & Complementary Medicine
;
Pharmacology & Pharmacy
WOS关键词
CHINESE HERBAL MEDICINE
;
COPD
;
EXACERBATIONS
附件
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456 Treatment with JianPiYiFei II granules for patients with moderate to very severe chronic obstructive pulmonary disease A 52-week randomised, double-blinded, placebo-controlled, multicentre trial.pdf
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