Efficacy of Rebixiao Chinese herbal tablets and Chinese formula granules in acute gout arthritis patients:a randomized,multicenter,double-blind,controlled trial

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.