Betahistine in Ménière's disease.

The effects of betahistine hydrochloride (Serc) on the clinical features of Ménière's disease were assessed in two double-blind, placebo-controlled, cross-over clinical studies. The diagnosis was based on a peripheral, fluctuating, recruiting, cochlear (sensorineural) deafness in one or both ears, tinnitus (usually of low tone) and paroxysmal attacks of rotational vertigo. Appropriate auditory and vestibular analyses confirmed the diagnosis. Twenty-four patients were admitted to the studies after careful screening over two-and-a-half years. Twenty-two patients completed the studies, ten of whom received betahistine and placebo for eight weeks each whereas the remaining twelve were given betahistine and placebo for twelve weeks each. the dose of betahistine was the same (16 mg. t.i.d.) in both studies. Daily symptom score cards kept by all patients throughout the studies showed a statistically significant preference for betahistine over placebo with regard to vertigo (p = 0-025), tinnitus (p = 0-010) and fullness of the ear (p = 0-036). Symptom scores of deafness and vomiting indicated trends in favour of betahistine but these did not attain statistical significance. Objective measurements of deafness (mean db. loss), however, showed a highly significant improvement in favour of betahistine, when compared with placebo (p less than 0-001). Vestibular testing revealed no important difference between betahistine and placebo. No unwanted effects or adverse reactions attributable to betahistine were observed during the studies.

RCT Entities:   Population Interventions Outcomes