Hong Ping Zhang1, Lei Wang1, Zhen Wang2, Xian Rong Xu3, Xian Mei Zhou4, Gang Liu5, Lv Yuan He6, Jun Wang7, Alan Hsu8, Wei Min Li9, Gang Wang10. 1. Pneumology Group, Department of Integrated Traditional Chinese and Western Medicine, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Collaborative Innovation Centre for Biotherapy, Chengdu 610041, China. 2. Department of Respiratory Medicine, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou 310006, China. 3. Department of Respiratory Medicine, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China. 4. Department of Respiratory Medicine, Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing 210029, China. 5. Department of Respiratory Medicine, Wenzhou Hospital of Traditional Chinese Medicine, Wenzhou 325000, China. 6. Department of Respiratory Medicine, Jinhua Hospital of Traditional Chinese Medicine, Jinhua 321001, China. 7. Department of Respiratory Medicine, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250001, China. 8. Priority Research Centre for Healthy Lungs, Hunter Medical Research Institute, University of Newcastle, New Lambton Heights, 2305 NSW, Australia. 9. Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu 610041, China. 10. Pneumology Group, Department of Integrated Traditional Chinese and Western Medicine, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Collaborative Innovation Centre for Biotherapy, Chengdu 610041, China; Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu 610041, China. Electronic address: wcums-respiration@hotmail.com.
Abstract
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 < 0.05). Furthermore, the PCYQ statistically reduced IL-5, IL-8, IL-1β and PGD2 in serum. 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/).
RCT Entities:
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 < 0.05). Furthermore, the PCYQ statistically reduced IL-5, IL-8, IL-1β and PGD2 in serum. 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/).