RESUMEN
OBJECTIVE: To investigate the effect of combination therapy (fluoxetine + alprazolam) and fluoxetine alone in treatment of tinnitus. MATERIAL AND METHODS: 147 participants with chronic tinnitus were divided into three groups (fluoxetine, fluoxetine+ alprazolam, and placebo). Tinnitus Handicap Inventory (THI), Visual Analogue Scale (VAS), Tinnitus Severity Index (TSI), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) used to assess tinnitus. Effect size according to partial Eta square calculated and level of significance was considered as P < 0.05. RESULTS: Fluoxetine reduced VAS, THI, BDI, and increased BAI. The combination therapy significantly reduced VAS, THI, BAI, and BDI. None of them reduced the TSI. The effect size for BAI and BDI were 0.135 (medium) and 0.075 (small), respectively. There was no significant difference between combination and single-drug therapy. CONCLUSION: Both groups improved THI and VAS. Combination therapy was not significantly different from single-drug treatment. Combination therapy can be considered only according to the psychiatric needs of patients.