Efficacy and Safety of Yiqi Tongqiao Pill for Allergic Rhinitis With Lung-Spleen Qi Deficiency: A Multicenter Randomized Double-Blind Phase III Trial.

OBJECTIVE: To evaluate the clinical efficacy and safety of Yiqi Tongqiao Pill (YQTP) in treating allergic rhinitis (AR) with a Traditional Chinese Medicine (TCM) pattern of Lung-Spleen Qi Deficiency. METHODS: A multicenter, randomized, double-blind, parallel-controlled, phase III clinical trial was conducted. A total of 480 patients with allergic rhinitis were randomly assigned in a 3:1 ratio to a treatment group (oral YQTP, n=360) and a control group (oral low-dose mimic agent, n=119) for a 2-week course. The primary efficacy endpoint was the change from baseline in the Total Nasal Symptom Score (TNSS) after 2 weeks of treatment. RESULTS: The Full Analysis Set (FAS) included 479 patients. After 2 weeks of treatment, the reduction in TNSS score in the treatment group (5.79±2.23) was significantly greater than that in the control group (0.84±1.82) (P<0.0001). The treatment group also demonstrated significant superiority over the control group in terms of overall response rate (92.78% vs 10.92%), improvement in TCM syndrome score, quality of life, and speed of symptom relief (all P<0.0001). There was no statistically significant difference in the incidence of adverse events between the two groups, indicating a good safety profile. CONCLUSION: YQTP significantly improved nasal symptoms and quality of life over 2 weeks in patients with SAR with the TCM pattern of lung-spleen qi deficiency, with a safety profile comparable to the mimic control. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR-TRC-13003137); http://www.chictr.org.cn.