Chinese herbal medicine formula for acute asthma: A multi-center, randomized, double-blind, proof-of-concept trial
| Autor: | Wang Zhen, Hong Ping Zhang, Xian Rong Xu, Xian Mei Zhou, Gang Wang, Alan Hsu, Jun Wang, Lv Yuan He, Gang Liu, Wei Min Li, Lei Wang |
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| Rok vydání: | 2017 |
| Předmět: |
Pulmonary and Respiratory Medicine
Adult Male medicine.medical_specialty Evening Adolescent Peak Expiratory Flow Rate Placebo Asthma management Proof of Concept Study Severity of Illness Index Drug Administration Schedule law.invention Double blind 03 medical and health sciences Young Adult 0302 clinical medicine Randomized controlled trial Double-Blind Method law Internal medicine medicine Humans Albuterol Anti-Asthmatic Agents Lung function Morning Asthma Aged business.industry Middle Aged medicine.disease Bronchodilator Agents 030220 oncology & carcinogenesis Acute Disease Cytokines Drug Therapy Combination Female business 030217 neurology & neurosurgery Biomarkers Drugs Chinese Herbal |
| Zdroj: | Respiratory medicine. 140 |
| ISSN: | 1532-3064 |
| Popis: | Background Despite advances in asthma management, exacerbations constitute a significant health economic burden. Objective To observe the efficacy and safety of Chinese herbal medicine formula entitled PingchuanYiqi (PCYQ) granule, on acute asthma and to explore its possible mechanism. Materials and methods This proof-of-concept study consisted of a randomized, double-blind, placebo-controlled trial in patients with acute asthma (n = 300). Participants with acute mild-to-moderate asthma recruited from seven centers in China were randomly assigned to receive PCYQ or placebo. The primary outcomes were PEF (L/min) and total asthma symptom scores. Furthermore, a panel of cytokines including serum IL-4, IL-5, IL-6, IL-8, IL-1β, IL-17A, IFN-α, IFN-β, IFN-γ, CRP, CCL-5, IP-10, and PGD2 levels was detected using ELISA. Results The PCYQ (n = 139) significantly improved the morning PEF on day 4 (349.73 ± 93.92 vs. 313.56 ± 92.91 L/min, P = 0.004) and day 7 (360.42 ± 94.39 vs. 329.52 ± 95.97 L/min, P = 0.023), and the evening PEF on day 4 (352.65 ± 95.47 vs. 320.58 ± 95.30 L/min, P = 0.012) and day 7 (360.42 ± 94.39 vs. 336.86 ± 95.59 L/min, P = 0.029) in comparison with the placebo (n = 143). The PCYQ also improved the clinical symptoms scores and reduced the puffs of short-acting β2-agonist (all P Conclusion The PCYQ as the Chinese herbal medicine formula significantly improves lung function and symptoms of acute asthma, and reduces SABA dosage possibly via decrease of inflammatory biomarkers such as IL-5, IL-8, IL-1β and PGD2. Trial registration ISRCTN61674768 ( http://www.isrctn.com/ ). |
| Databáze: | OpenAIRE |
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