Ménière's disease is a disorder of the inner ear which results in a spinning form of dizziness (vertigo), hearing loss and ringing in the ear (tinnitus), and can be disabling. It has no known cause. When it is secondary to a known inner ear disorder, it is called Ménière's syndrome. Both can be difficult to diagnose. The drug betahistine hydrochloride (Serc®, Betaserc®) has been used to reduce the frequency and severity of the attacks. While the drug is very acceptable to those who use it, the review of trials did not find enough evidence to show whether it is helpful. Further research is needed.
There is insufficient evidence to say whether betahistine has any effect on Ménière's disease.
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.
The objective of this review was to assess the effects of betahistine in people with Ménière's disease.
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Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP; and additional sources for published and unpublished trials.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.
Randomised controlled studies of betahistine versus placebo in Ménière's disease.
Two authors independently assessed trial quality and extracted data. Study authors were contacted for further information.
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.