Randomized placebo-controlled trial of a selective serotonin reuptake inhibitor in the treatment of nondepressed tinnitus subjects

Objective: To assess the efficacy of a selective serotonin reuptake inhibitor (paroxetine) for relief of tinnitus. Design: One hundred twenty tinnitus sufferers participated in a randomized double-blind placebo-controlled trial. Paroxetine or placebo was increased to a maximally tolerated dose (up to 50 mg/day), and patients were treated for a total of 31 days at the maximal dose. Methods: Patients with chronic tinnitus were recruited from our university-based specialty clinic by referral from otolaryngologists and audiologists in the local community and by advertisement. Patients with psychotic or substance use disorders or suicidal ideation were excluded, as were those using psychoactive medications (this resulted in only I subject with major depression in the study) or any other medications that interact with paroxetine and those with inability to hear at one's tinnitus sensation level. Fifty-eight percent of patients were male, 92% were Caucasian, and the average age was 57. Outcomes Measures: Tinnitus matching, the Tinnitus Handicap Questionnaire, the question: How severe (bothered, aggravating) is your tinnitus? Quality of Well-Being and other psychological questionnaires. Results: Paroxetine was not statistically superior to placebo on the following tinnitus measures (tinnitus matching, 5- or 10-db drop, Tinnitus Handicap Questionnaire, quality of well-being measures, how severe, how bothered, positive change). There was a significant improvement in the single item question, How aggravating is your tinnitus? for those in the paroxetine group compared with the placebo group. Conclusions: These results suggest that the majority of individuals in this study did not benefit from paroxetine in a consistent fashion. Further work remains to be done to determine if subgroups of patients (e.g., those who tolerate higher doses, those who are depressed) may benefit.