Efficacy and safety of Tuomin Zhiti decoction on patients with seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the clinical efficacy and safety of Tuomin Zhiti decoction (, TZD) in the short-term treatment of seasonal allergic rhinitis (SAR). METHODS: This study is a randomized, double-blind placebo-controlled, and single-center clinical trial. In April 2021, during the spring pollen season in Beijing, 94 SAR patients aged 19-60 years were randomized (1:1 ratio) to receive two weeks of TZD or placebo. The primary outcomes were the change of Total Nasal Symptom Score (TNSS) and Total Ocular Symptom Score (TOSS) from baseline to the end of treatment. Secondary outcomes were the changed score of the mini Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Rescue Medication Score (RMS), and Patient Global Impression of Change (PGIC). All adverse events were recorded and evaluated by two senior physicians. RESULTS: TZD significantly reduced both the total nasal symptom scores and total ocular symptom scores compared to scores at baseline, while the placebo group showed an increasing trajectory in both symptom scores. Compared to the placebo group, the TZD group also showed a greater improvement in the quality of life, scores of RMS, nasal and eye symptoms scores after TZD treatment (P < 0.001). Most notably, at the end of treatment, the proportion of remission measured by PGIC was significantly higher in the TZD group (82.97%) compared with the placebo group (47.72%, P < 0.001). CONCLUSION: This study suggested that two weeks of TZD is an effective and safe treatment for SAR patients and spring pollen allergy, TZD could significantly improve the nasal and eye symptoms and improve the quality of life of patients.