OBJECTIVETo explore the therapeutic efficacy of external application of Compound Tripterygium wilfordii (CTW) for treating rheumatoid arthritis (RA) on the basis of treatment by integrative medicine.

METHODSTotally 67 active RA patients of damp-heat stagnation syndrome were randomly assigned to the external application group (35 cases) and the placebo group (32 cases). The reaction standard by American College of Rheumatology and Disease Activity Score (DAS) were taken as the indices for therapeutic assessment. A randomized controlled, single blind clinical trial was performed for 4 weeks, with a 3-month follow-up. The statistical analyses were performed using intention to treat analysis set (ITT).

RESULTSAfter treatment the rate of reaching ACR20 was 34.3% and 12.5% in the external application group and the placebo group respectively. The mean for the average drop of DAS28 ratings was 1.07 in the external application group and 0.40 in the placebo group, showing statistical difference (P < 0.05, P < 0.01). As for the safety, there was no effect on the menstruation in the external application group. Only mild skin allergy occurred in 2 cases of the external application group, but they were alleviated after drug withdrawal.

CONCLUSIONSExternal application of CTW could control the condition of RA and reduce the disease activity of RA. It had better safety.