Objective : to evaluate the effectiveness of betahistine in the treatment of primary tinnitus. Study Design: Clinical, randomized, placebo-controlled, triple-blind trial. Sitting: Betahistine is widely used in the treatment of tinnitus, but there is a lack of scientific evidence to prove its real effectiveness. Methods : Adult patients with primary tinnitus and who were not undergoing treatment for tinnitus in the last six 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: Betahistine Group, whose patients received betahistine 24 mg every 12 hours for 90 days; Control group, whose patients received placebos for 90 days. Parameters evaluated: demographic data, Tinnitus Handicap Inventory (THI), Clinical Global Impression Improvement (CGI-I) and a question of ”Yes” or ”No” to participants about the perception of improvement in symptoms.Results: Recruitment selected 284 participants, of these 62 were randomized between the 2 study groups (betahistine group n-31; Control group n-31); median age (IQ) 54 (48 to 60) years, with a balanced number of men and women. There was no difference in THI outcome after treatment between the study groups (median difference, −2 points; 95% CI, −8 to 6 points); the THI after the intervention was a median (IQ) 4 (-4 to 14) lower points in the betahistine group, and a median (IQ) 2 (-6 to 10) in the placebo group. Conclusion : Betahistine dihydrochloride was ineffective in the treatment of primary tinnitus in adults.