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Acta Otorrinolaringológica Española Efficacy and safety of the cinnarizine/dimenhydrinate combination versus betahis...
Journal Information
Vol. 76. Issue 6.
(November - December 2025)
Vol. 76. Issue 6.
(November - December 2025)
Review article
Efficacy and safety of the cinnarizine/dimenhydrinate combination versus betahistine in the treatment of vertigo: A systematic literature review
Eficacia y seguridad de la combinación cinarizina/dimenhidrinato frente a betahistina en el tratamiento del vértigo: revisión sistemática de la literatura
David Martín-Enguixa,b,
Corresponding author
davidm123m45@hotmail.com

Corresponding author.
, Niceto Gómez Gabaldónc, Francisco J. Amaro-Gaheteb,d,e
a Centro de Salud Fortuny (Velutti), Distrito Sanitario Granada Metropolitano, Granada, Spain
b Instituto de Investigación Biosanitaria (ibs. Granada), Granada, Spain
c Servicio de Otorrinolaringología. Complejo Hospitalario Universitario de Albacete, Albacete, Spain
d Department of Physiology, Faculty of Medicine, University of Granada, Granada, Spain
e CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Granada, Spain
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Table 1. Main characteristics of the studies included in the systematic review.
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Abstract

Vertigo is a frequent reason for medical consultation and may result from a wide range of aetiologies. Betahistine and the fixed low-dose combination of cinnarizine 20 mg and dimenhydrinate 40 mg are commonly used therapeutic options, each with distinct antivertigo profiles. This systematic review, conducted in accordance with the PRISMA guidelines, aims to compare the efficacy and safety of these two treatments in patients with vertigo of various origins. A comprehensive search was conducted in PubMed, Cochrane Library, Google Scholar, and ClinicalTrials.gov, with no restrictions on language or publication date. Eligible studies included clinical trials and meta-analyses comparing the fixed low-dose combination (20 mg/40 mg) versus betahistine (12 or 16 mg), assessing efficacy through the Mean Vertigo Score (MVS) and safety based on the incidence of adverse events (AEs). The RoB 2 and ROBIS tools were used to evaluate the risk of bias. A total of nine studies were identified (six clinical trials and three meta-analyses). In five of the six clinical trials, the fixed low-dose combination significantly reduced MVS compared with betahistine at weeks 1 and/or 4 (p < .05); these findings were corroborated by the three meta-analyses. Regarding safety, both treatments were well tolerated, with no serious AEs reported and a generally lower incidence observed in the fixed low-dose combination group. Overall, the fixed low-dose combination demonstrated superior clinical efficacy from the first week of treatment, along with a more favourable tolerability and safety profile. These results support its preferential use in the management of acute vestibular syndrome.

Keywords:
Vertigo
Betahistine
Cinnarizine
Dimenhydrinate
Anti-vertiginous agents
Systematic review
Resumen

El vértigo es un motivo frecuente de consulta médica que puede deberse a múltiples etiologías. La betahistina y la combinación fija a dosis bajas de cinarizina 20 mg y dimenhidrinato 40 mg se emplean habitualmente como tratamiento, con perfiles antivertiginosos diferenciados. Esta revisión sistemática, realizada conforme a la declaración PRISMA, tiene como objetivo comparar la eficacia y seguridad de ambos fármacos en pacientes con vértigo de origen diverso. Se consultaron las bases de datos PubMed, Cochrane Library, Google Scholar y ClinicalTrials.gov sin restricciones de idioma ni fecha. Se incluyeron ensayos clínicos y metaanálisis que compararan la combinación fija a dosis bajas 20 mg/40 mg vs. betahistina 12 o 16 mg, evaluando eficacia mediante el Mean Vertigo Score (MVS) y seguridad por incidencia de eventos adversos (EA). Se aplicaron las herramientas RoB 2 y ROBIS para evaluar el riesgo de sesgo. Se identificaron 9 estudios (6 ensayos clínicos y 3 metaanálisis). En 5 de los 6 ensayos clínicos, la combinación fija a dosis bajas redujo significativamente el MVS frente a betahistina en las semanas 1 y/o 4 (p < 0,05), resultados también confirmados por los 3 metaanálisis. En términos de seguridad, ambos tratamientos fueron bien tolerados, sin EA graves y generalmente con menor incidencia en el grupo de la combinación fija a dosis bajas. En conjunto, la combinación fija a dosis bajas mostró mayor eficacia clínica desde la primera semana de tratamiento, así como una mejor tolerancia y perfil de seguridad. Estos resultados respaldan su uso preferente en el tratamiento del síndrome vestibular agudo.

Palabras clave:
Vértigo
Betahistina
Cinarizina
Dimenhidrinato
Agentes antivertiginosos
Revisión sistemática

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