The Chinese herbal formulation Biminne in management of perennial allergic rhinitis: a randomized, double-blind, placebo-controlled, 12-week clinical trial

Background: Herbal therapies have been widely used in allergic rhinitis (AR), but none have been shown to be effective in controlled scientific clinical trials. Objective: The aim of this study was to test the effects of the Chinese herbal formulation Biminne in patients with moderate to severe perennial AR. Methods: In a randomized, double-blind, placebo-controlled clinical trial, 58 patients were randomized to receive either Biminne capsules (n = 26) or placebo (n = 32) in doses of five capsules twice a day for 12 weeks. Main outcomes were measured by changes in symptom diaries, quality of life scores, patients' evaluations of improvement on visual analog scores, and physicians' overall evaluation. Total serum immunoglobulin E was measured in all patients without knowledge of which group they were in. After 1 year we performed a randomized, double dose-response study in 22 patients who had previously received placebo. Results: The trial outcomes evaluated by four instruments showed a statistically significant improvement in some of the symptoms of AR, whereas others exhibited a positive trend that did not reach statistical significance. Followup 1 year after completion of the trial suggested that benefit of the treatment persisted. A pilot dose-response study showed both half and full strengths were effective. Total serum immunoglobulin E was reduced after the herbal treatment. Conclusions: Our results suggest the Biminne formulation is effective in treatment of perennial AR. Its mode of action is unknown.