Betahistine is ineffective for the treatment of primary tinnitus

Reference

Castilho GL, Dias NH, Martins RHG. A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus. Clin Otolaryngol 2023;48(1):50-57.

Synopsis

These authors recruited 62 patients, via social media and clinician referrals, who had mild to severe nonpulsatile tinnitus (median Tinnitus Handicap Inventory [THI] score = 44 for a median 5 years). The THI asks respondents for the functional, emotional, and catastrophic effects of tinnitus, and is scored from 0 (no effect) to 100 (catastrophic impact). The participants were randomized, using concealed allocation, to receive placebo or betahistine (Serc) 24 mg every 12 hours for 3 months. The investigators used intention-to-treat analysis. After 3 months of treatment, THI scores dropped minimally in both groups and were not statistically different, an average 2 points with placebo and 4 points with betahistine. The investigators considered a 10-point difference to represent the minimum clinically important difference. Most patients (90%) did not consider their tinnitus to be improved with either treatment. The study had 80% power to find a minimally clinically important difference.