Betahistine in Ménière's disease

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Abstract
The effects of betahistine hydrochloride (Serc) on the clinical features of Meniere''s disease were assessed in 2 double-blind, placebo-controlled, cross-over, clinical studies. The diagnosis was based on a peripheral, fluctuating, recruiting, cochlear (sensorineural) deafness in 1 or both ears, tinnitus (usually of low tone) and paroxysmal attacks of rotational vertigo. Appropriate auditory and vestibular analyses confirmed the diagnosis. Patients (24) were admitted to the studies after careful screening over 2.5 yr. Patients (22) completed the studies, 10 of whom received betahistine and placebo for 8 wk each; the remaining 12 were given betahistine and placebo for 12 wk each. The dose of betahistine was the same (16 mg. t.i.d. [3 times a day]) 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 favor of betahistine but these did not attain statistical significance. Objective measurements of deafness (mean dB loss), however, showed a highly significant improvement in favor of betahistine when compared with placebo (P < 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.

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