A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus.

Objectives: To evaluate the effectiveness of betahistine in the treatment of primary tinnitus.

Design: To evaluate the effectiveness of betahistine in the treatment of primary tinnitus.

Setting: Universidade estadual Paulista Julio de Mesquita Filho, Botucatu Medical School, São paulo, Brazil.

Participants: Adult patients with primary tinnitus who had not undergone treatment for tinnitus in the last 6 months were included. Patients with profound sensorineural deafness, hearing aid users and patients with metabolic, neurological, psychiatric or decompensated cardiovascular diseases were excluded.

Study Groups: in the betahistine group, patients received betahistine 24 mg every 12 h for 90 days; in the control group, patients received placebo tablets every 12 h for 90 days.

Mean Outcome Measures: Primary outcome measure: Tinnitus Handicap Inventory (THI).

Secondary Outcome Measures: Clinical Global Impression Improvement (CGI-I) and a question of 'Yes' or 'No' to participants about their perception of improvement in symptoms.

Results: Of 284 participants initially identified, 62 were randomised (betahistine group n = 31; control group n = 31). Median age (IQR) 54 (48-60) years, with a balanced number of men and women. There was no difference in THI outcome between the study groups (median difference, -2 points; 95% CI, -8 to 6 points); the THI after the intervention was a median (IQR) 4 (-4 to 14) lower points in the betahistine group, and a median (IQR) 2 (-6 to 10) in the control group. There was no statistical difference in secondary outcome measures. Adverse events were mild and there was no statistical difference between groups.

Conclusions: Betahistine dihydrochloride was ineffective in the treatment of primary tinnitus in adults.