Colchicine versus placebo in Behçet’s disease: randomized, double-blind, controlled crossover trial

Abstract

The effect of colchicine was evaluated in a large cohort of Behçet's disease (BD) patients and compared to placebo. In a randomized, double-blind, controlled crossover trial, 169 patients without major organ involvement were selected consecutively. They fulfilled the International Criteria for Behçet's Disease. Patients were randomly assigned to colchicine or placebo. At 4 months, they were swapped over (colchicine to placebo, placebo to colchicine) for another 4 months. The primary outcome was the overall disease activity index, the IBDDAM. The secondary outcome was the responses of the individual symptoms. A Student's paired t test was used to evaluate results within each group, and an ANOVA to check for differences between colchicine and placebo. Analysis was performed using the "intention to treat" method. For placebo, IBDDAM worsened from 3.17 to 3.63 (t = 1.750, P = 0.08). For colchicine, IBDDAM improved from 3.35 to 2.75 (t = 4.143, P < 0.0001). Oral aphthosis, genital aphthosis, pseudofolliculitis, and erythema nodosum improved significantly with colchicine but not with placebo. According to the ANOVA, the difference in IBDDAM between colchicine and placebo was highly significant (F = 14.674, P = 0.00016). The difference between the results for males and females was not significant (F = 0.181, P = 0.67). In conclusion, colchicine, but not placebo, significantly improved the overall disease activity index. The difference between the results for colchicine and placebo was also statistically significant.

Guidelines for the treatment of skin and mucosal lesions in Behçet's disease: A secondary publication

“…In the study by Davatchi et al . (CQ10), the overall disease activity index decreased significantly with colchicine, as did erythema nodosum, although that was not an isolated effect. In the other study noted above (CQ10), erythema nodosum and arthralgia were both significantly improved by colchicine .…”

“…In a cross‐over study in 169 patients with Behçet's disease with no lesions in major organs, Davatchi et al . found that oral ulcers improved significantly more with colchicine than with placebo . In contrast, in a controlled study in 84 patients randomized to colchicine (1–2 mg/day) and placebo groups, Yurdakul et al .…”

“…found a significant decrease in the incidence of genital ulcers in women ( P = 0.04) and the number of ulcers ( P = 0.001). In the study by Davatchi et al . of 169 patients without organ involvement described above (CQ3), genital ulcers significantly improved with colchicine compared with placebo.…”

“…Explanation : As with other Behçet's disease manifestations (CQ3), colchicine in 169 patients led to significant improvement in acneiform eruptions after 4 months of oral treatment . Based on this outcome, oral colchicine is recommended.…”

Behcet′s disease in India: A dermatological perspective

“…In a randomized, double blind, crossover trial comprising of 169 BD patients without major organ involvement, Davatchi et al, reported significant improvement with colchicine in the overall disease activity, oral and genital ulcers, papulopustular lesions, and erythema nodosum. [37] Dapsone was used in our patients as an alternative to colchicine with good clinical response but relapse was seen in 2 out of 7 patients. Sharquie et al, [38] in their double-blind, crossover study of 20 patients, reported significant reductions in the number, duration, and frequency of oral ulcers and number of genital ulcers with dapsone.…”