Treatment of Menière's disease with betahistine: an open trial

Introduction: Menière's disease is a frequent inner ear disease which is clinically characterized by recurrent attacks of vertigo, hearing loss, tinnitus, aural fullness and nausea. During the natural course of the disease persistent deficits can develop. Besides spontaneous recovery Menière's disease manifests bilaterally in 15% of patients after 2 years and in 30–60% 10–20 years after disease onset. There is some evidence from previous studies that betahistine, an H1-agonist and H3-antagonist, in a dosage of 16mg three times daily (tid), may be an effective treatment of Menière's disease. However, no state-of-the-art studies have been conducted in this field. According to our experience, many patients profit only from a higher dosage of betahistine, namely 48mg tid. Methods: We, therefore, first performed an open trial, including patients with Menière's disease according to the diagnostic criteria of the American Academy of Ophthalmology and Otolaryngology, Head and Neck Surgery (1995). This trial is currently ongoing. The patients received betahistine in a dosage of 48mg tid. The effects of this therapy regimen on the attacks of vertigo were evaluated after 1, 6 and 12 months. Here we present the results of an interim analysis. Results: So far, 22 patients with Menière's disease have been included. Before inclusion in the study the average number of vertigo attacks was 11.3 attacks per month (standard deviation (SD) 4.24, median 10, minimum 4, maximum 19 attacks per month). So far, 12 patients have been treated with betahistine 48mg tid for 12 months. In these patients the vertigo attacks decreased to an average number of one attack per month (SD 1.35, median 1, minimum 0, maximum 7 attacks per month). The reduction of the frequency of attacks after one month was 57%, after 6 months 78% and after 12 months 93%. Betahistine was in general well tolerated. Only 2 of all patients reported a little nausea. Conclusion: All in all, this interim analysis supports the view that betahistine 48mg tid has a beneficial effect on the course of Menière's disease. These data are the basis for a prospective, randomized, double-blind study comparing placebo with 16mg tid and 48mg tid betahistine.