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.