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Rebamipide Recommended For Recurrent Mouth Ulcers
A DGReview of :"Efficacy of Rebamipide as Adjunctive Therapy in the Treatment of Recurrent Oral Aphthous Ulcers in Patients with Behcet's Disease: A Randomised, Double-Blind, Placebo-Controlled Study."
Drugs in R&D
02/13/2003
By David Loshak
Rebamipide, a gastroprotective agent, is recommended as a long-term treatment for recurrent oral aphthous ulcers.
Rebamipide is often used to treat Behcet's disease, an inflammatory disease involving chronic recurrent oral aphthous ulcers (aphthae), uveitis, skin lesions and genital ulcers. But, it might also be useful in preventing and treating frequently recurrent oral aphthous ulcers generally, say investigators in Kawasaki, Japan. The drug improves both aphthae count and pain score, and is also well tolerated and easily administered.
The investigators assessed the efficacy of rebamipide in patients with Behcet's disease whose main symptom was oral aphthosis.
In a multi-centre, double-blind, placebo-controlled study, 35 patients were randomised to receive rebamipide 300 mg. or placebo daily for 12 to 24 weeks. Oral aphthosis must have occurred within the four weeks before enrolment and been visible for at least a week.
Oral aphthae count and pain scores were recorded daily by the patients themselves and totalled monthly.
The rate of change in monthly aphthae count and pain scores in the first three and last three months of treatment were assessed in patients with more severe symptoms.
Of the 17 evaluable patients given rebamipide, 11 (64.7%) showed moderate or marked improvement in aphthae count and pain, compared with five of the 14 evaluable patients (35.7%) given placebo.
From the second to the sixth month of treatment, aphthae count tended to rise. It reached a peak in the fourth month among placebo recipients but fell in those given rebamipide.
Pain score fell by the same extent in both groups for the first three months of treatment. But in months 4 to 6, pain score tended to rise in the placebo group and fall in those given rebamipide.
In patients with high pain scores, both these and aphthae counts fell throughout the six months of rebamipide treatment, but rose over the last three months in the placebo group.
Drugs in R&D 2003;4:1:19-28.
"Efficacy of Rebamipide as Adjunctive Therapy in the Treatment of Recurrent Oral Aphthous Ulcers in Patients with Behcet's Disease: A Randomised, Double-Blind, Placebo-Controlled Study."
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