Summary: | 碩士 === 長庚大學 === 傳統中國醫學研究所 === 97 === In order to evaluate the therapeutic effect of herbal formula AR-1 on allergic rhinitis, we conducted a randomized double-blind, placebo -controlled clinical trial in allergic rhinitis patients from 18-45 years old in the clinic of Traditional Chinese Medicine at Chang Gung Memorial Hospital, Taoyuan Branch. Following the confirmed diagnosis by otorhinolaryngologists, the trial participants were randomized to take either AR-1(formula of Long Dan Xie Gan Tang and Zhi Bai Di Huang Wan) or placebo for 4 weeks. Before and after every visit, the Rhinoconjunctivitis Quality of Life Questionnaires(RQLQ) were filled by the participants, and the cold and heat syndrome differentiation, as well as the incidence of the craniofacial symptoms were evaluated and recorded by traditional Chinese medical doctors. Laboratory tests including total IgE and eosinophil cationic protein (ECP) were also evaluated.
There were totally 47 participants at an average age of 31 years old completed the treatment without adverse effects in two years. In the present study, the overall RQLQ score positively correlated with the incidence of the heat syndrome, i.e., redness of the tongue, dizziness, headache, dry nose with burning pain, yellowish nasal mucus, ear itches, earache, and halitosis (p<0.05). After treatment, both the experimental group and the control group showed significant improvements in the seven domains and overall RQLQ scores ( p< 0.05), but no statistical difference between these two groups; neither the levels of total IgE and ECP nor the scores of syndrome differentiation for cold and heat symptoms revealed statistical difference. For the relief of the dry nose with burning pain and the running nose after the treatment, the experimental group had a statistically significant lower score compared to the control group (p<0.05). In addition, for the relief of the overall cold and heat syndrome differentiation score and nasal congestion after the treatment, the patients with heat pattern had a statistically significant lower score compared to the patients with cold-heat complex pattern in the experimental group (p<0.05). AR-1 is effective to improve the craniofacial symptoms in allergic rhinitis, and the heat pattern patients showed a superior improvement with a remission of the systemic heat symptoms.
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