Objective. Colchicine is a widely used treatment for Behc ¸et's syndrome, even though in a previous 6-month controlled study, it was shown to be effective only in controlling erythema nodosum and arthralgias. We reassessed the effect of colchicine in Behc ¸et's syndrome in a study conducted among a larger group of patients for 2 years.
Methods. We randomized 116 patients with Behc ¸et's syndrome (60 male/56 female), who had active mucocutaneous disease without eye or major organ involvement, to receive either placebo or colchicine (1-2 mg/day, adjusted to body weight) in a double-blind trial for 2 years. The primary outcome measure was the sustained absence of any lesions during treatment (complete response). The secondary outcome measure was the difference in the number of mucocutaneous lesions or arthritic joints between the active drug and placebo arms. Women and men were analyzed separately.
Results. Eighty-four patients (72%; 45 male, 39 female) completed the 24-month study. Kaplan-Meier analyses showed significantly more complete responses in the colchicine treatment group in terms of reduced occurrence of genital 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 manifestations of Behc ¸et's syndrome, especially among women. This might be a reflection of less severe disease among the women. Behc ¸et's syndrome is a systemic vasculitis of unknown etiology that is found in small and large vessels and characterized by variable clinical features. Almost all patients have recurrent oral ulceration, followed in frequency by genital ulcers, a variety of skin lesions, arthritis, panuveitis, thrombophlebitis, gastrointestinal disease, and central nervous system involvement (1).
Colchicine is widely used in Behc ¸et's syndrome. The evidence for its efficacy is based mainly on open studies (2-4). It is claimed that colchicine exerts its beneficial effect through inhibition of leukocyte chemotaxis. However, the evidence for this increase in chemotaxis is, at best, debatable (2-5). We had previously shown that colchicine was effective in Behc ¸et's syndrome only in controlling erythema nodosum and arthralgias. That study, conducted several years ago, was a doubleblind, placebo-controlled, 6-month study conducted among 35 patients (6). In the present study, we assessed the effectiveness of colchicine in a 2-year randomized, double-blind, placebo-controlled study among a larger group of patients of both sexes. The randomization and all analyses were done separately for each sex, because men are known to have distinctly more severe disease compared with women (7,8).
PATIENTS AND METHODS
Patients. The multidisciplinary Behc ¸et's Syndrome Research Center at the Cerrahpas ¸a Medical School, established 25 years ago, has more than 4,000 registered patients and meets weekly. Consecutive patients attending the center were recruited into the study between November 1991 and Decem-