Chinese herbal medicine formula for acute asthma: A multi-center, randomized, double-blind, proof-of-concept trial

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/).

Keywords: Acute asthma; Chinese herbal medicine formula; Inflammatory cytokines; Proof-of-concept; Randomized controlled trial.