Fixed Combination of Cinnarizine and Dimenhydrinate Versus Betahistine Dimesylate
in the Treatment of Ménière's Disease: A Randomized, Double-Blind,
Parallel Group Clinical Study
Miroslav Novotny and Rom Kostica
Ear, Nose, and Throat Department, Masaryk University of Brno, Czech Republic
Abstract:
In a randomized, double-blind clinical study, we evaluated the efficacy and tolerability
of the fixed combination of cinnarizine, 20 mg, and dimenhydrinate, 40 mg (Arlevert
[ARL]) in comparison to betahistine dimesylate (12 mg) in 82 patients suffering
from Ménière's disease for at least 3 months and showing the characteristic triad
of symptoms (paroxysmal vertigo attacks, cochlear hearing loss, and tinnitus).
The treatment (one tablet three times daily) extended to 12 weeks, with control
visits at 1, 3, 6, and 12 weeks after drug intake. The study demonstrated for
both the fixed-combination ARL and for betahistine a highly efficient reduction
of vertigo symptoms in the course of the 12 weeks of treatment; however, no statistically
significant difference between the two treatment groups could be established.
Similar results were found for tinnitus (approximately 60% reduction) and for
the associated vegetative symptoms (almost complete disappearance). Vestibulospinal
reactions, recorded by means of craniocorpography, also improved distinctly, with
a statistically significant superiority of ARL versus betahistine (p < .042) for
the parameter of lateral sway (Unterberger's test). The caloric tests (electronystagmography)
showed only minor changes for both treatment groups in the course of the study.
A statistically significant improvement of hearing function of the affected ear
(p = .042) was found for the combination preparation after 12 weeks of treatment.
The tolerability was judged by the vast majority of patients (97.5%) in both groups
to be very good. Only one patient (betahistine group) reported a nonserious adverse
event, and two betahistine patients did not complete the study. In conclusion,
the combination preparation proved to be a highly efficient and safe treatment
option for Ménière's disease and may be used both in the management of acute episodes
and in long-term treatment. Efficacy and safety were found to be similar to the
widely used standard therapy with betahistine.
Key Words:
betahistine; cinnarizine and dimenhydrinate; Ménière's disease; vertigo