Allergic rhinitis is the type I hypersensitivity reaction of nasal mucosa to environmental
allergen. It is characterized by one or more symptoms including sneezing, itching ,
rhinorrhea and nasal congestion. The prevalence of allergic rhinitis in Taiwan is
approximately 20%-30% and increases annually. However, symptom relapse still bothered the
majority of patients though there were certain advances in western medicine. In addition,
side effects of western medicine, such as lethargy, mouth dryness after taking anti-histamine
and immunosuppression after using steroid are also concerned by patient.
Traditional Chinese medicine has been used widely in Taiwan for several disease, especially
allergic diseases, such as allergic rhinitis. Among all Chinese herbal products, qi-tonifying
regimen play a central role for allergic diseases control. Bu-zhong-yi-qi-tang (BZYQT), one
of the famous qi-tonifying herbal products, has been proved to have immuno-modulation effect
in previous studies. However, proof of clinical investigation of therapeutic efficacy and
cellular level response are still lacking.
In this study, a double-blinded, randomized, placebo control design is applied and total 120
intermittent allergic rhinitis patients will be enrolled in our study. All subjects will be
divided into BZYQT and placebo control groups, each group will have 60 subjects. Subjects of
BZYQT group will receive capsule of BZYQT, 3gm tid, 9gm a day, while control group will
receive similar placebo capsule with same scheme. Total 2 month treatment course will be
done. Clinical evaluation, including symptom severity, quality of life and chronic fatigue
degree will be done once per month and one month after completed treatment. Additionally,
various parameters for immunologic response will be checked before and after the treatment,
including the total IgE amount, the ratio of CD4/CD8 of T lymphocytes, the profile of
cytokine such as IL-4,IL-5,IL-8,IL-10,IL-13, IFN-γ as well as PGE2, LTC4, sICAM-1 , the mRNA
expression of COX2 and neutrophil phagocytosis. Dendritic cell function, presumably the most
important immune-response inducer, will also be checked through test for IL-10 and IL-12.
Results will be analyzed statistically including gender analysis. We hope that therapeutic
efficacy and possible cellular mechanism of immune-modulation will be elucidated after
completing this clinical trial.
