Betahistine 8mg/5ml oral solution

Abstract Objective: To evaluate the efficacy and safety of betahistine in adults with definite Menière’s disease (Hydropic Ear Disease) based on double-blind, placebo-controlled randomised trials. Data Sources: MEDLINE (PubMed), Embase, and the Cochrane Central Register of Controlled Trials were searched without language or date restrictions. Study Selection: Randomised, double-blind, placebo-controlled trials investigating betahistine in definite Menière’s disease were eligible. For cross-over trials, only first-period data were analysed to preserve parallel-group comparability. Data Extraction: Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Certainty of evidence was evaluated using GRADE with prespecified clinically important thresholds. Results: Two trials met inclusion criteria, resulting in a population of 261 patients. In the BEMED trial, rate ratios for vertigo attack frequency were 1.036 (95% CI 0.942–1.140) for low dose and 1.012 (95% CI 0.919–1.114) for high dose versus placebo, excluding a ≥20% relative reduction. Even a ≥10% reduction was excluded. Dizziness Handicap Inventory and VDADL outcomes likewise excluded clinically important differences (high certainty). For the composite vertigo score in the Schmidt 1992 trial, clinically important effects could not be excluded due to imprecision (moderate certainty). Safety outcomes showed no clear signal of harm, but clinically important differences could not be excluded (moderate certainty). Conclusions: High certainty evidence indicates that betahistine does not achieve a clinically meaningful reduction in vertigo attack frequency or improve dizziness-related quality of life in adults with definite Ménière’s disease.

Abstract licence: CC BY 4.0