Intratympanic Dexamethasone Injections as a Treatment for Severe, Disabling Tinnitus

OBJECTIVE: To test the effectiveness of intratympanic dexamethasone injections as a treatment for severe disabling cochlear tinnitus. DESIGN: Randomized, prospective, single-blind study. SETTING: Academic tertiary referral hospital. PATIENTS: Thirty-six patients with severe disabling tinnitus predominantly of cochlear origin were randomly assigned to receive intratympanic injections of a dexamethasone solution or isotonic sodium chloride (saline) solution. INTERVENTIONS: Under topical anesthesia and after randomization, 36 patients received 0.5-mL intratympanic injections once per week for 4 weeks of either a 4-mg/mL dexamethasone solution or saline solution. Five patients were excluded from analysis because they did not complete the treatment or did not return for follow-up. MAIN OUTCOME MEASURE: Improvement of tinnitus measured with a visual analog scale. RESULTS: The 2 groups were similar in age, sex, tinnitus laterality, measurement of tinnitus intensity on the visual analog scale, and main otologic diagnosis. We considered a 2-point improvement on the visual analog scale to be significant. Twenty-nine percent of the ears in the saline group and 33% of the ears in the dexamethasone group showed significant improvement immediately after completion of treatment. These measurements were not significantly different from each other. Follow-up varied from 13 to 31 months, and the patients with improved tinnitus returned to the initial measurements over time. CONCLUSIONS: There was no advantage in intratympanic injections of dexamethasone over saline solution in the treatment of severe, disabling tinnitus. Both solutions produced a placebolike improvement.