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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

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Abstract

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.

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Acknowledgements

The conduct, statistical analysis and publication of this study were financially supported by Hennig Arzneimittel, Floersheim am Main, Germany. The authors thank Dr Andreas Iwanowitsch for the statistical analysis.

Mario Schwarz and Wolfgang Baumann are employees of Hennig Arzneimittel. The other authors have no potential conflicts of interest that are directly relevant to the contents of this manuscript.

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Authors and Affiliations

  1. ENT Clinic Pilsen of Charles University, Prague, Czech Republic

    Zdenek Cirek

  2. Department of Clinical Research, Hennig Arzneimittel, Liebigstrasse 1-2, D-65439, Floersheim am Main, Germany

    Mario Schwarz & Wolfgang Baumann

  3. ENT Clinic Sv. Anna Hospital, Masaryk University, Brno, Czech Republic

    Miroslav Novotny

Authors
  1. Zdenek Cirek
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  2. Mario Schwarz
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  3. Wolfgang Baumann
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  4. Miroslav Novotny
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Correspondence to Mario Schwarz.

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Cirek, Z., Schwarz, M., Baumann, W. et al. Efficacy and Tolerability of a Fixed Combination of Cinnarizine and Dimenhydrinate versus Betahistine in the Treatment of Otogenic Vertigo. Clin. Drug Investig. 25, 377–389 (2005). https://doi.org/10.2165/00044011-200525060-00003

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  • DOI: https://doi.org/10.2165/00044011-200525060-00003

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