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Betahistin für die Menière‐Krankheit oder das Pseudo‐Menière‐Syndrom

Abstract

Background

This is an update of a Cochrane Review first published in The Cochrane Library in Issue 1, 2001 and previously updated in 2008.

Ménière's disease is characterised by attacks of hearing loss, tinnitus and disabling vertigo. Betahistine (Serc®, Betaserc®) is used by many people to reduce the frequency and severity of these attacks but there is conflicting evidence relating to its effects.

Objectives

The objective of this review was to assess the effects of betahistine in people with Ménière's disease.

Search methods

We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP; and additional sources for published and unpublished trials. The date of the most recent search was 25 November 2010, following a previous update search in June 2007.

Selection criteria

Randomised controlled studies of betahistine versus placebo in Ménière's disease.

Data collection and analysis

Two authors independently assessed trial quality and extracted data. Study authors were contacted for further information.

Main results

Seven trials involving 243 patients were included. No trial met the highest quality standard set by the review because of inadequate diagnostic criteria or methods, and none assessed the effect of betahistine on vertigo adequately. Most trials suggested a reduction of vertigo with betahistine and some suggested a reduction in tinnitus but all these effects may have been caused by bias in the methods. One trial with good methods showed no effect of betahistine on tinnitus compared with placebo in 35 patients. None of the trials showed any effect of betahistine on hearing loss. No serious adverse effects were found with betahistine.

Authors' conclusions

There is insufficient evidence to say whether betahistine has any effect on Ménière's disease.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Plain language summary

Betahistin für die Menière‐Krankheit oder das Pseudo‐Menière‐Syndrom

Die Menière‐Krankheit ist eine unter Umständen sehr behindernde Erkrankung des Innenohres, welche mit Drehschwindel (Vertigo), Hörverlust und Ohrensausen (Tinnitus) einhergeht. Die Ursache ist unbekannt. Treten die Beschwerden als Folge einer bekannten Innenohrerkrankung auf, werden sie als Pseudo‐Menière‐Syndrom bezeichnet. Die Diagnosestellung bei beiden Erkrankungen kann sehr schwierig sein. Das Medikament Betahistin‐Hydrochlorid (Serc®, Betaserc®) wird benutzt, um die Häufigkeit und Schwere der Anfälle zu verringern. Während das Medikament für die Patienten gut verträglich ist, konnten für diese Übersicht nicht genügend Evidenz gefunden werden, um die Wirksamkeit zu beurteilen. Mehr Forschung auf diesem Gebiet ist notwendig.