Objective: To explore the therapeutic effect and safety of Canshitang combined with colchicine in treatment of the gouty arthritis syndrome of accumulated dampness-heat. Method: A total of 258 patients with gouty arthritis syndrome of accumulated dampness-heat were randomly divided into the traditional Chinese medicine(TCM) group

western medicine group and the integrated Chinese and western medicine group

with 86 cases in each group. The TCM group was treated with Canshitang recipe by oral administration; the colchicine was applied by oral administration in the western medicine group

and Canshitang combined with colchicine was adopted in integrated Chinese and western medicine group

with a course of 14 d in all three groups. The changes in clinical symptoms

serum uric acid (SUA)

erythrocyte sedimentation rate (ESR)

C-reactive protein (CRP) and interleukin-6 (IL-6) levels were observed before and after treatment

and the total effective rate

incidence of adverse reactions and 3-month recurrence rate were compared among these three groups. Result: The 3 cases were removed in TCM group in the treatment; 2 cases were removed in western medicine group

and 5 cases were removed in integrated Chinese and western medicine group. The total effective rate was 93.8% in integrated Chinese and western medicine group

better than 81.9% in TCM group and 83.3% in western medicine group (P<0.05); there was no significant difference between Chinese medicine group and western medicine group. After treatment

the score of the clinical symptoms

UA

ESR

CRP and IL-6 levels in integrated Chinese and western medicine group were better than those in TCM group and the western medicine group (P<0.05)

but there was no significant difference between TCM group and the western medicine group. The incidence of adverse reactions was as follows

TCM group (3.6%) < integrated Chinese and western medicine group (60.5%) < western medicine group (82.1%) (P<0.05); and the recurrence rate was integrated Chinese and western medicine group (7.4%) < TCM group (20.5%) < western medicine group (26.1%) (P<0.05). Conclusion: There was no significant difference in efficacy between Canshitang treatment and colchicine in the treatment of gouty arthritis syndrome of accumulated dampness-heat

but the incidence of adverse reactions and the recurrent rate were lower than those of colchicine. Canshitang combined with colchicine had a synergistic effect for this disease

and the efficacy was superior to that of Canshitang treatment alone or colchicine alone

with lower reverse action incidence and recurrent rate.