Conclusion: Betahistine at oral doses of 16 mg tid and 24 mg bid provides similar efficacy and tolerability in the treatment of vertigo in patients with Ménière's disease.
Objective: To compare the efficacy and tolerability of betahistine 16 mg tid and 24 mg bid in the treatment of vertigo in patients with Ménière's disease.
Patients and methods: This was a randomized, open-label study of 120 consecutive patients with well-established Ménière's disease treated with betahistine 16 mg tid or 24 mg bid for 24 weeks. Treatment efficacy, assessed by clinical outcome level in terms of severity, frequency and duration of vertigo spells, was evaluated at baseline and at weeks 4, 12 and 24. Between-group comparisons of outcome data (Wilcoxon, Mann-Whitney U test) and adverse events (chi-squared test) were made.
Results: Betahistine 16 mg tid or 24 mg bid showed a significant improvement in clinical outcome level from baseline to week 24 (p < 0.01). There was no significant difference between dosage groups regarding improvement in vertigo at any time point during the study. There was no significant difference between groups in the incidence of adverse events, which was low (maximum: headache, 16 mg tid, 16.7% of patients at week 4; 6.7% at week 24). The number of patients reporting adverse events diminished with time.