Behçet's disease is a multisystem inflammatory condition, probably of autoimmune origin, that is triggered by infectious antigens or other antigens in genetically predisposed persons. Recurrent, painful ulcerations of the oral and genital mucosa are the most common symptoms. Therapeutic agents, such as topical or intralesional corticosteroids, generally are used only for palliative therapy. Sucralfate, which is commonly used in the treatment of peptic ulcers, can also heal ulcers of the gastrointestinal tract. However, its effectiveness in healing oral and genital ulcerations is unknown. Alpsoy and associates evaluated the efficacy of topical sucralfate suspension in the treatment of the mucocutaneous lesions associated with Behçet's disease.
Forty patients with Behçet's disease were randomized to receive either sucralfate or a placebo four times a day for three months. Sucralfate and the placebo were identical in appearance. All patients were instructed to use 5 mL of sucralfate or placebo as an oral rinse for one to two minutes after routine mouth care and before sleep. Patients with genital ulcerations were also given sucralfate or placebo, to be applied as topical therapy or a vaginal douche. Patients were examined every two weeks during the study period and again three months after the treatment ended. The mean frequency, healing time and pain of ulcerations were evaluated before treatment and compared with responses after treatment.
Data were evaluated for 30 of the 40 patients eligible for the study. Disease parameters at baseline were similar between groups. Patients in the treatment group had significantly decreased mean frequency, healing time and pain associated with oral ulcerations, and decreased healing time and pain associated with genital ulcerations compared with the pretreatment period. Patients in the placebo group showed no significant differences between the pretreatment and treatment periods, except for decreased pain of oral ulcerations. Only mean frequency and healing time of oral ulcerations were significantly different in patients in the treatment group at the follow-up visit.
The authors conclude that topical sucralfate suspension is effective and inexpensive in treating the oral and genital ulcerations characteristic of Behçet's disease and offers an option to palliative therapy. The differences in improvement ratings for oral ulcerations between groups were significant. Despite the fact that the healing time and pain associated with genital ulcerations decreased clinically, this difference did not achieve statistical significance. A striking finding was the marked decrease in pain scores in both groups. Although the percentage of decrease was higher in the treatment group, the results indicate that coating agents are helpful in the palliation of pain.