Is betahistine effective for improving symptoms of primary tinnitus?
Betahistine, an antihistamine used in many countries but no longer approved for use in the United States, was ineffective at maximum dose to decrease patients’ self-reported symptoms of nonpulsatile tinnitus. This small study’s results support those of a Cochrane Systematic Review from 2018, which also failed to find evidence of benefit. 1b-
Randomized controlled trial (double-blinded)
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.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine