Efficacy and Tolerability of a Fixed Combination of Cinnarizine and Dimenhydrinate versus Betahistine in the Treatment of Otogenic Vertigo : A Double-Blind, Randomised Clinical Study.

INTRODUCTION: Peripheral vestibular disorders frequently lead to the manifestation of symptoms of vertigo. The objective of this study was to compare the efficacy and tolerability of a fixed combination of cinnarizine 20mg and dimenhydrinate 40mg per tablet with betahistine (betahistine dimesylate) 12mg per tablet in the treatment of patients with otogenic vertigo.

PATIENTS AND METHODS: Sixty-one patients with vertigo due to peripheral vestibular disorders (otogenic vertigo) participated in this prospective, double-blind, comparative, single-centre study. Patients were randomly allocated to treatment with betahistine 12mg or the fixed combination of cinnarizine 20mg and dimenhydrinate 40mg, both treatments given three times daily for 4 weeks. Efficacy was determined by patients' assessments of vertigo symptoms after 1 and 4 weeks of treatment using a visual analogue scale to determine a 'mean vertigo score'.

RESULTS: Treatment with the fixed combination led to significantly greater improvements in mean vertigo scores compared with the reference therapy betahistine. This was evident as early as 1 week after the onset of treatment (p = 0.002). Over 4 weeks of therapy, the fixed combination decreased the intensity of vertigo symptoms about 2-fold compared with betahistine (p = 0.001). Furthermore, reductions in symptoms typically associated with vertigo were more pronounced (p = 0.009) in the fixed-combination group compared with the betahistine group after 4 weeks of treatment. No serious adverse events were reported in either treatment group. Tolerability of the fixed combination was judged as 'very good' by 97% (betahistine 90%) and as 'good' by 3% (betahistine 10%) of patients.

CONCLUSION: The fixed combination of cinnarizine and dimenhydrinate was shown to be an effective and very well tolerated treatment option for patients with otogenic vertigo. It proved to be statistically more efficient in reducing vertigo than the widely used betahistine. Therefore, the fixed combination of cinnarizine and dimenhydrinate may be considered a first-line treatment option for the treatment of otogenic vertigo.