Efficacy and safety of Sanfeng Tongqiao Diwan in patients with allergic rhinitis: a single-arm clinical trial in China

Background: Traditional Chinese medicine (TCM) has a long history and its own characteristics in the treatment of allergic rhinitis. In this study, the efficacy and safety of patients with allergic rhinitis treated with Sanfeng Tongqiao Diwan were observed to support the clinical medication of patients with allergic rhinitis. Methods: A total of 61 patients with allergic rhinitis aged 12-70 years from the First Affiliated Hospital of Guangzhou Medical University were included in this study. All the patients were treated with Sanfeng Tongqiao Diwan for a period of 7 days. Return visits were carried out 24 hours after the first medication, the 4th day of medication, and the 7th day of medication, during which the efficacy and safety were assessed. Results: The effective rates of Sanfeng Tongqiao Diwan at 24 hours, 4 days, and 7 days were 49.2%, 60.7%, and 65.6%, respectively. Comparing the severity of various symptoms after treatment to baseline, significant differences were found in nasal secretion (2.95 +/- 0.67 vs. 2.26 +/- 1.30, P<0.001), stuffy nose (5.66 +/- 2.95 vs. 3.34 +/- 2.57, P<0.001), mucosa congestion (7.08 +/- 1.82 vs. 4.23 +/- 2.28, P<0.001), running nose (5.21 +/- 1.81 vs. 2.90 +/- 1.89, P<0.001), and sneezing (3.00 +/- 0 vs. 1.92 +/- 1.45, P<0.001). The full symptom scores showed progressive decline during treatment, measuring 20.21 +/- 5.13 at baseline and 12.02 +/- 6.47 at 7 days (P<0.001). Compared to the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score of 64.61 +/- 30.27 at baseline, statistical significance (P<0.001) was found at 24 hours, 4 days, and 7 days, measuring 43.11 +/- 28.01, 40.74 +/- 28.6, and 39.97 +/- 40.48, respectively. The incidence rate of adverse events (AEs) was 3.3% (2/61), with no serious AEs. Conclusions: In this study, the use of Sanfeng Tongqiao Diwan is effective in the treatment of allergic rhinitis patients, especially in patients with severe symptoms. Although the treatment system of TCM, is different from that of Western medicine, the application of TCM will provide a new direction for the treatment of chronic diseases. Follow-up studies with an increased sample size are required for verification.