Abstract
The purpose of this study was to evaluate the efficacy and safety of Uyghur medical formula Loki zupa in patients with chronic asthma. Adult patients with chronic asthma randomly received placebo or Loki zupa as add-on to inhaled corticosteroids (ICS) maintenance treatment. Loki zupa or mimics was administered orally 10 ml per time, three times a day for 8 weeks. The primary endpoints were asthma control test (ACT) score and peak expiratory flow (PEF). The secondary endpoints were acute exacerbation rate, lung function, night waking days, and symptom-free days in the near 2 weeks, Asthma Quality of Life Questionnaire (AQLQ) score and some inflammatory cytokines in peripheral blood. A total of 240 adult patients with chronic asthma were enrolled, and 218 patients were randomized to placebo (n = 109) or Loki zupa (n = 109) in addition to ICS for 8 weeks. Treatment with Loki zupa resulted in significant improvement in ACT score compared to the placebo group (p = 0.002). Furthermore, oral taken of Loki zupa increased the PEF obviously (p = 0.026). Loki zupa treatment did not improve the forced expiratory volume in 1 s (FEV1, p = 0.131) and FEV1/FVC compared to the placebo treatment (p = 0.805). The placebo group had higher rates of acute exacerbations than the Loki zupa group (6.3% vs. 0, p = 0.027). Subjects randomized to Loki zupa had increased daytime symptom-free days within 2 weeks than placebo (p = 0.016). However, Loki zupa had no effect on night waking days in the near 2 weeks (p = 0.369) and AQLQ score (p = 0.113). No significant effect was found on inflammatory cytokines (IL-2, IL-4, IL-5, IL-10, IL-13, IL-17, IL-33, IFN-γ, and TGF-β) between the two groups (p > 0.05). No adverse events and severe asthma exacerbations were recorded in the two groups (p > 0.05). Loki zupa add-on to standard ICS produced clinically significant improvements in ACT score, PEF, daytime symptom-free days and acute exacerbation in patients with chronic asthma.Clinical trial: This study is registered at http://www.chictr.org.cn/ with identifier number ChiCTR-IPR-16008106.
Highlights
Asthma is a common, chronic respiratory disease affecting 1–18% of the population in different countries
The results showed that subjects with chronic asthma randomized to Loki zupa treatment group had significant improvement in asthma control test (ACT) score than the placebo group after 8 weeks treatment (p = 0.002, Figure 3)
Our results showed that patients randomized to Loki zupa for 8 weeks had significant improvement in ACT score than Loki zupa mimics, indicating that Loki zupa is effective in improving the symptoms of asthma and is beneficial to control asthma
Summary
Chronic respiratory disease affecting 1–18% of the population in different countries. Asthma is characterized by variable symptoms of wheeze, shortness of breath, chest tightness and/or cough, and by variable expiratory airflow limitation (Global Strategy for Asthma Management and Prevention, 2016). Inhaled corticosteroids (ICS) and β2-adrenoceptor agonists treatments are significantly effective in relieving asthma (Nagai, 2012; Holgate, 2013). Current asthma therapy could not completely control the asthma symptoms and future risks, and there was still a proportion of people could not be well treated with current drugs (Partridge et al, 2011). There is still a number of people using asthma medications having side effects, such as oral thrush and dysphonia, and long-term and/or high-dose ICS may induce systemic side effects including easy bruising, an increase beyond the usual age-related risk of osteoporosis, cataracts and glaucoma, and adrenal suppression (Global Strategy for Asthma Management and Prevention, 2016)
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