Abstract: Objective To observe the clinical effect and safety of traditional Chinese medicine (TCM) treatment in gouty arthritis (GA) based on syndrome differentiation. Methods 81 patients of GA were enrolled from August 2013 to August 2014. They were divided into syndrome differentiation treatment group (27 cases), disease differentiation treatment group (27 cases) and basic treatment group (27 cases). The patients in syndrome differentiation treatment group were given corresponding TCM drug granules prescription by dialectical syndromes classification. The patients in disease differentiation treatment group were given TCM drug granules prescription. The patients in basic treatment group were only given Diclofenac Sodium sustained-release tablets in acute phase, and Benzbromarone tablets in chronic phase. After 12 weeks treatments, all the patients received the measurements of serum uric acid (SUA), serum creatinine (SCr), blood urea nitrogen (BUN), triacylglycerol (TG), cholesterol (TC).The clinical efficacy, recurrence rate and adverse reactions were recorded and analyzed. Results Syndrome differentiation treatment group achieved higher clinical efficacy than basic treatment group and disease differentiation treatment group (P<0.05). Moreover, syndrome differentiation treatment were superior to disease differentiation treatment in improving of recurrence rate (P<0.05). There were no obvious adverse reactions occurred. There were no clinical significant changes in blood, urine routine analysis, and electrocardiogram examination before and 3 months after the treatments. Conclusion The treatment of TCM in patients with GA based on syndrome differentiation showed definite therapeutic effects.