A double-blind trial of colchicine in Behcet's syndrome

Objective. Colchicine is a widely used treatment for Behcet's syndrome, eve n though in a previous 6-month controlled study, it was shown to be effecti ve only in controlling erythema nodosum and arthralgias. We reassessed the effect of colchicine in Behcet's syndrome in a study conducted among a larg er group of patients for 2 years. Methods. We randomized 116 patients with Behcet's syndrome (60 male/56 fema le), who had active mucocutaneous disease without eye or major organ involv ement, to receive either placebo or colchicine (1-2 mg/day, adjusted to bod y weight) in a double-blind trial for 2 years. The primary outcome measure was the sustained absence of any lesions during treatment (complete respons e). The secondary outcome measure was the difference in the number of mucoc utaneous lesions or arthritic joints between the active drug and placebo ar ms. Women and men were analyzed separately. Results. Eighty-four patients (72%; 45 male, 39 female) completed the 24-mo nth study. Kaplan-Meier analyses showed significantly more complete respons es in the colchicine treatment group in terms of reduced occurrence of geni tal ulcers (P = 0.004), erythema nodosum (P = 0.004), and arthritis (P = 0. 033) among the women, and reduced occurrence of arthritis (P = 0.012) among the men. The mean numbers of genital ulcers (P = 0.001), erythema nodosum lesions (P = 0.002), and arthritic joints (P = 0.014) among the women were less in the colchicine group, and the mean number of arthritic joints (P = 0.026) among the men was less in the colchicine group. Adverse effects were similar in both groups. Conclusion. Colchicine may be useful for treating some of the manifestation s of Behcet's syndrome, especially among women. This might be a reflection of less severe disease among the women.