Clinical Study On YiQiWenYang Formula In The Treatment Of Allergic Rhinitis

Allergic rhinitis is also known as hypersensitive rhinitis. Chinese herbal medication used for allergic rhinitis has good therapeutic effects, which can generally be interpreted in two aspects:first, choose effective antiallergic herbal medicine; second, regulate yin and yang of blood and viscera in the body, by which it can improve the body inner environment to reduce its sensitivity to external differences .For comparison, the first one has the advantage of fast effectiveness, while the latter one has long-lasting therapeutic effects with fewer side effects and reflects the characteristics of traditional Chinese medication.Allergic rhinitis belongs to the category of "biqiu" in Chinese medication, where rhinitis is often seen on people with syndrome of deficient-cold of spleen-lung, most likely over 80% In this study, by selecting the most common clinical syndromes with a prospective, multicenter and blind-controlled clinical research method,-we obtained scientific evidence of clinical efficacy. By applying industry objective indicators, we also evaluated the clinic effect of Yiqiwenyang formula for treating allergic rhinitis with syndrome of deficient-cold of spleen-lung, and expected to establish a standard herbal therapy for diagnosis and treatment of allergic rhinitis.Objective:By comparison with placebo and Cetirizine, to evaluate the clinical efficacy of Yiqiwenyang formula to allergic rhinitis with syndrome of deficient-cold of spleen-lung. By measuring the IL-4, IFN-y, IL-5 and IL-10 levels from supernatants of PBMC culture before and after the treatment from healthy and diseased people, to reflect the Thl/Th2 balance, and further evaluate the clinic efficacy of Yiqiwenyang formula for allergic rhinitis with syndrome of deficient-cold of spleen-lung by using objective indicators and explore the correlations between Yiqiwenyang formula and immune regulation in allergic rhinitis with syndrome of deficient-cold of spleen-lung.Methodology:1. Study of the clinic effect on Yiqiwenyang formula for treating allergic rhinitis with spleen-lung deficient-cold syndrome, subdivided into two studies:①StudyⅠ:Stratified randomized, double-blind, placebo-controlled study, sample size 100 (1:1).②StudyⅡ:Differential Treatment of herbal medicine and Cetirizine, total sample size 231.2. Study of the influence of Yiqiwenyang formula on IL-4, IFN-γand other cytokines from supernatants of patient's PBMC culture.40 patients who meet the criteria and 5 healthy people are selected for comparison. The 40 patients were divided into two groups,20 each, giving yiqiwenyang method and Cetirizine respectively. After 4 weeks, we use the before and after comparison and inter-group comparison to observe the changes of major and side symptoms by accumulated points. We also take blood samples of 2ml each person before and after the treatment. After separating mononuclear cells (PBMC) and stimulating T-cell in vitro, the IL-4, IFN-y, IL-5and IL-10 levels are measured in PBMC culture supernatant, and compared between herbal medicine group, modern medicine group and control group for before and after treatment.Results:1.Study I:After the treatment in the herbal medicine group, there are 37 cases excellent,9 cases effective and 4 no effective. The total effective rate is 92% and excellent effective rate is 74%. General syndromes of fear of cold and loose stool are greatly improved. In control group:there are 13 cases excellent,14 cases effective and 23 no effective. The total effective rate is 54% and excellent effective rate is 26%. There also has pronounced difference on the accumulated points of symptoms and signs between herbal treatment group and control group. In control group, the general syndromes of fear of cold and loose stool remain unchanged.Study 2:After the treatment in herbal medicine group, there are 78 cases excellent,53 cases effective and 8 no effective. The total effective rate is 94.2%and excellent effective rate is 56.1%. General syndromes of fear of cold and loose stool are greatly improved. In modern medicine group: there are 60 cases excellent,28 cases effective and 4 no effective. The total effective rate is 95.65% and excellent effective rate is 65.22% and almost no general symptom is improved. The comparison shows that both groups present the therapeutic result and high effective rate, but the improvement of general symptoms are obviously higher in the herbal medicine group.2. After the treatment, the concentrations of IL-4 and IFN-y are greatly lowered in the treatment groups (p<0.01), which indicates both yiqiwenyang formula and Cetirizine are effective in decreasing IL-4 and IFN-y in the supernatants of PBMC culture and improving patients'immune system. But the comparison between the groups shows no big difference in decreasing IL-4 and IFN-y in the supernatants of PBMC culture (p>0.05), which proved that the Yiqiwenyang formula has the same therapeutic effects as Cetirizine in treating allergic rhinitis, improving the imbalance between Thl and Th2, which serves as the immunological basis for occurrence of allergic rhinitis.Conclusion:Yiqiwenyang formula is a sort of effective Chinese herbs to treatment allergic rhinitis allergic rhinitis with syndrome of deficient-cold of spleen-lung, so it is worth to clinical application widely.