Background Recurrent oral ulceration is one of the hallmarks of Behçet’s disease (BD). To date, various clinical manifestations, including aphthous ulcers are treated with limited success. Rebamipide is an anti-ulcer, gastro-protective drug, that increases mucous and stimulates endogenous prostaglandin biosynthesis and has anti-inflammatory actions including inhibition of neutrophilic leukocyte activation.
Objectives To assess the efficacy of rebamipide in the therapy of recurrent oral aphthous ulcers in BD patients.
Methods Fifty four BD patients (50 males; 4 females) of mean age 34.1 years and mean disease duration 6.14 years fulfilling the criteria of the International Study Group for Behçet’s disease were recruited. Exclusion criteria included aphthous ulcers due to other inflammatory conditions. All subjects were from a homogenous ethnic background. Inclusion criteria included presence of oral ulcers within 4 weeks prior to recruitment. Clinical activity was assessed at the time of entry into the study. All 54 patients had recurrent oral aphthous ulcers despite ongoing therapy (colchicine, systemic and/or topical corticosteroids, azathioprine). In this single centre double-blind placebo controlled study, the 54 BD patients were randomized into two groups: 37 were assigned to receive rebamipide 100mg x 3/day and 14 patients received placebo in addition to their standard therapy provided dosages were kept constant throughout the study for 16 weeks. Oral aphthous ulcer count and pain scores were recorded daily by patients and weekly by one of the physicians. Physicians assessed the global improvement in ulcer count and pain using a visual analogue scale (VAS) 0-10. Safety and tolerability were recorded.
Results Improvement in oral ulcer count was found in 4/14 (29%) of the placebo group and in 26/37 (70%) rebamipide group respectively, p=0.006. No new ulcers were recorded in the rebamipide group whereas 29% of the placebo group showed new ulcers. Patient-recorded pain scores decreased significantly in the rebamipide group compared to the placebo group. Physician global assessment of the pain score was statistically different in the intervention group compared to the placebo group, p<0.05.
Conclusions Rebamipide showed improvement in oral aphthae count and pain scores in BD patients compared to placebo. The findings of the present study indicate that rebamipide, a gastro-protective drug, displayed an anti-inflammatory action. Rebamipide may thus be a useful addition in the therapeutic armamentarium of recurrent oral ulcers in BD.
Disclosure of Interest None Declared
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