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A Randomized, Placebo-Controlled, Double-blind Study

Erkan Alpsoy, MD; Hanife Er, MD; Cicek Durusoy, MD; Ertan Yilmaz, MD

Arch Dermatol. 1999;135:529-532.

Objective  To determine the efficacy of topically applied sucralfate suspension in the treatment of oral and genital ulceration of Behçet disease.

Design and Setting  A randomized, placebo-controlled, double-blind study at a university referral center.

Patients  Forty patients with Behçet disease were included in the study.

Intervention  Patients were given topical sucralfate or placebo 4 times a day for 3 months and examined clinically at biweekly intervals.

Main Outcomes Measures  For each lesion, the mean frequency, healing time, and pain were evaluated during the pretreatment, treatment, and follow-up periods. No patients were given any concurrent disease-specific or immunosuppressive topical and systemic drugs during the 9-month study period.

Results  Of the 40 patients included in the study, the results in 30 patients (16 patients treated with sucralfate and 14 patients treated with placebo, ranging in age from 16 to 52 years [mean±SD age, 34.3±8.1 years]) were evaluable for efficacy. Treatment with sucralfate decreased significantly the mean frequency, healing time, and pain of oral ulceration and healing time and pain of genital ulceration compared with the pretreatment period. The effectiveness of sucralfate on the frequency and healing time of oral ulceration continued during the posttreatment period. In the placebo group, no significant difference was found in measured parameters of oral and genital ulceration except the pain of the oral ulceration between the pretreatment and treatment periods.

Conclusion  Our results showed that topical sucralfate suspension is an easy, safe, inexpensive, and effective treatment for oral and genital ulceration in patients with Behçet disease.

From the Department of Dermatology, Akdeniz University School of Medicine, Antalya, Turkey.

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