Efficacy and safety of Jiawei Simiaoyongan granules in the treatment of non-infectious anterior uveitis: a randomized open-label trial

OBJECTIVE: To observe the clinical efficacy and safety of Chinese herbal medicine Jiawei Simiao Yongan granules (加 味 四 妙 勇 安 颗 粒, JWSMYAG) in the treatment of non‐infectious anterior uveitis (NIAU). METHODS: We conducted a single‐center, randomized, open‐labeled clinical trial in adults with NIAU. Patients received standard treatment or a combination of JWSMYAG (twice daily) for three months, with a 3‐month withdrawal period for observation. The primary endpoint was the recurrence rate within six months. RESULTS: A total of 98 patients were included in the intention‐to‐treat analysis, including 49 patients in the Traditional Chinese Medicine (TCM) group and 49 patients in the control group. Compared with the control group, the number of relapses was significantly lower in the TCM group [24.5% vs 6.1%, P = 0.0224; Hazard Ratio = 0.208, 95% Confidence Interval (0.059, 0.737)]; in addition, patients in the TCM group had lower symptom scores of eye pain, insomnia, and bitter taste within two weeks (all P < 0.05). There was no significant difference between the two groups in terms of the difference in best corrected visual acuity change over six months, the number of intraocular pressure elevations > 10 mm Hg, the scoring of anterior chamber cells, the number of patients with keratic precipitates (+) after 1/2 weeks of treatment, and the scores of conjunctival hyperemia, headache, photophobia, and lacrimation. The difference in the number of adverse events between the two groups over six months was not statistically significant. CONCLUSION: JWSMYAG can reduce the recurrence rate of NIAU, alleviate ocular pain, insomnia, and bitter taste symptoms in patients with NIAU, and have a favorable safety profile.