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Betahistine hydrochloride (Serc) in cerebrovascular disease: a placebo-controlled study
Insights
Betahistine hydrochloride (Serc) improved cognitive function and physical disability in patients with cerebrovascular disease. This clinical study found significant benefits in learning, memory, and orientation, with no adverse effects.
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Cerebrovascular disease often leads to cognitive impairment and physical disability.
- Effective treatments for these deficits remain a critical area of research.
Purpose of the Study:
- To evaluate the efficacy of oral betahistine hydrochloride (Serc) in mitigating mental impairment and physical disability.
- To assess the impact of betahistine on cognitive functions in patients with established cerebrovascular disease.
Main Methods:
- A double-blind, placebo-controlled clinical study involving 45 patients who completed the trial.
- Patients received either 24 mg of betahistine daily or a placebo for eight weeks.
- Cognitive function was assessed using nine mental tests, alongside general functional activity evaluations.
Main Results:
- Betahistine significantly improved associate learning, digit retention, general knowledge, orientation, sentence learning, and simple arithmetic at week 8.
- Trends favored betahistine in other cognitive tests not reaching statistical significance.
- Patients treated with betahistine showed significantly better general functional activity compared to the placebo group (P ≤ 0.05).
Conclusions:
- Oral betahistine hydrochloride demonstrates significant efficacy in improving cognitive deficits associated with cerebrovascular disease.
- Betahistine treatment also led to notable improvements in physical functional activity.
- The study found no significant adverse side-effects, suggesting a favorable safety profile for betahistine in this patient population.
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.