Clinical Study of Isosorbide on Meniere's Disease

Inter-group Comparative Study with Betahistine Mesylate by Multi-centered Double-blind Trial

Abstract

Clinical effect of Isosorbide (ISO) was studied in patients with Meniere's disease from their subjective symptoms and objective findings by multi-centered double-blind trial with Betahistine Mesylate (BM) as a reference drug. 1) Global improvement rating: ISO-treated group was more superior than BM-treated group in 2 weeks and 4 weeks after administration with a statistically significant difference (P<0.05) in Wilcoxon test when statistical analysis was made based on the judgement by investigators, however, there was no statistically significant difference between both groups when analyzed based on the judgement by the Committee. 2) Utility rate: Upon the judgement by investigators, ISO-treated group was more superior than BM-treated group in 2 weeks and 4 weeks after administration with a tendency of statistical difference in Wilcoxon test, however, there was no statistically significant difference between both groups upon the judgement by the Committee. 3) Side effect, clinical laboratory test and safety rate: There was no particular difference between both groups. From the above results, it was concluded that ISO was an effective and useful drug for Meniere's disease.