Betahistine hydrochloride (Serc) in cerebrovascular disease: a placebo-controlled study

Abstract

A double-blind, placebo-controlled, clinical study was performed to assess the effects of oral betahistine hydrochloride (Serc) on mental impairment and physical disability in patients with established cerebrovascular disease. Fifty-three patients were admitted to the study during 18 months. Forty-five patients completed the study. They received either betahistine 24 mg daily or placebo for eight weeks. Clinical assessments of general functional activity were done and a battery of nine mental function tests was administered pretreatment and at two-weekly intervals during therapy. The results were analysed statistically using distribution-free tests. Significant differences were demonstrated between betahistine and placebo at week 8 of treatment for associate learning, digit retention, general knowledge, orientation, sentence learning and simple arithmetic. These differences were consistently in favour of betahistine at or close to the 5% level of significance. The results of the remaining mental function tests showed no significant differences between betahistine and placebo, but trends were in favour of the former. General functional activity assessments also demonstrated that betahistine-treated patients were significantly better than those on placebo (P less than or equal to 0.05). No untoward side-effects were noted during the study.