RESUMO
OBJECTIVE: To evaluate the clinical efficacy and safety of Rebixiao (RBX) Chinese herbal tablets (CHT) and Chinese formula granules (CFG) in the treatment of acute gout arthritis (AGA). METHODS: This randomized, multicenter, double-blind, controlled trial included 165 AGA patients with the damp-heat symptom pattern who were randomly divided into an RBX CHT group and an RBX CFG group and treated for 7 d at three centers. The total effective rates of the joint symptom score, Traditional Chinese Medicine (TCM) symptoms score, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were used to evaluate the clinical efficacy. Safety assessments were also performed. RESULTS: Of the 165 enrolled patients, 147 completed the clinical observation. There was no difference in baseline between the two groups. The total effective rates of the joint symptom score were 94.36% and 97.36%, and the total effective rates of the TCM symptoms score were 95.77% and 97.36% in the CFG group and CHT group, respectively. No statistical difference was found between the two groups (P > 0.05). Additionally, ESR and CRP were similar in both groups (P > 0.05). Furthermore, treatment efficacy regarding TCM and joint symptoms, the ESR, and CRP were consistent within each center and among the different centers (P > 0.05). In addition, the incidence of adverse events was 4.22% and 2.63% in the CFG group and CHT group, respectively, and no difference was observed between the two groups (P > 0.05). CONCLUSION: RBX CFG and CHT have significant and similar efficacy in the treatment of AGA, and CFG did not increase adverse side effects.