ETHNOPHARMACOLOGICAL RELEVANCE: Biyuan Tongqiao granules (BYTQ granules) is a commonly used traditional Chinese medicine for the treatment of allergic rhinitis (AR), made from 14 herbal ingredients. Studies have shown that this medicine can increase the permeability of nasal capillaries, inhibit inflammatory mediators, and help alleviate the symptoms of rhinitis, proving its effectiveness in treating AR. AIM OF THE STUDY: This study aimed to assess the effectiveness and safety of BYTQ granules as an adjunctive treatment for AR. MATERIALS AND METHODS: Seven databases were searched to identify eligible randomized controlled trials (RCTs) involving the BYTQ granules therapy for AR until October 1, 2024. The primary outcome included the clinical efficacy, and the secondary outcomes were symptom scores and inflammatory cytokines. We assessed the risk of bias utilizing the Cochrane ROB2, performed the analysis using RevMan 5.3 software and assessed the quality of evidence through the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. RESULTS: The systematic review and meta-analysis comprised 38 RCTs with a total of 4228 participants. BYTQ granules paired with Western Medicine (WM) were superior to WM alone in individuals with AR, as showed by higher clinical efficacy (RR = 1.17, 95%CI: 1.14-1.20, P <
0.00002), more pronounced reductions in nasal symptom scores and greater decreases in inflammatory cytokines, including IL-4 (SMD = -1.30, 95%CI: -1.62 ∼ -0.98, P <
0.00002) and TNF-α levels. Moreover, the TSA analysis reinforced these findings by demonstrating a lower incidence of adverse reactions. CONCLUSION: BYTQ granules with WM demonstrated superior efficacy in treating AR, including a lower recurrence rate based on the available results. Nonetheless, further RCTs are required to validate these results more conclusively.