Treatment of Meniere's disease with intratympanic dexamethazone plus high dosage of betahistine

Purpose: The aim of the present study was to assess if the combined therapy of intratympanic dexamethasone (ITD) and high dosage of betahistine (HDBH) is able to provide increased vertigo control compared to ITD alone in patients suffering from definite unilateral Meniere's disease (MD). Materials and methods: Consecutive MD patients were enrolled and randomly divided in two groups, each comprising 33 cases. Group A received a combination of ITD and identical appearing placebo pills while Group B received a combination of ITD and HDBH. ITD protocol consisted of three consecutive daily injections. HDBH comprised 144 mg/day (48 mg tid). The main outcome measures were: 1) vertigo class, pure tone average (PTA), speech discrimination score (SDS) and Functional Level Score (FLS) according to the American Academy of Otolaryngology-Head and Neck Surgery criteria; 2) complete and substantial vertigo control according to the Kaplan-Meier survival method. Results: Sixty two patients completed the 24-month follow-up. A complete vertigo control was achieved in 14 patients (44%) from Group A and in 22 patients (73.3%) from Group B, statistically significant (p = 0.01). Complete vertigo relief is also significant according to the Kaplan-Meier method: p = 0.027, log rank test. Substantial vertigo control was obtained in 21 patients (65.6%) in Group A and 27 patients (90%) in Group B. The difference is statistically significant, p = 0.02. The difference is significant according to the Kaplan-Meier method: p = 0.035, log rank test. No significant differences between hearing levels and tinnitus scores were demonstrated between the groups. Conclusions: Our preliminary results demonstrate that complete and substantial vertigo control is significantly higher in patients treated with a combination of HDBH and ITD. (c) 2016 Elsevier Inc. All rights reserved.