Objective: The relationship between tinnitus and anxiety and depressive disorders has been frequently alluded to, but there are few studies on antidepressants in the treatment of tinnitus, and the efficacy of sertraline on severe refractory tinnitus has not been reported.
Method: Consecutive tinnitus patients (n = 76) considered to be at high risk for severe and disabling tinnitus according to a recently developed screening procedure were randomly assigned to 16 weeks of double-blind treatment with placebo (n = 38) or sertraline (n = 38) at a fixed dose (25 mg/d on the first week and 50 mg/d on the following 15 weeks). Between-group comparisons of Tinnitus Severity Questionnaire scores over 16 weeks were made as the primary outcome measure. Secondary outcomes of tinnitus loudness and tinnitus annoyance were also measured using a visual analogue scale. Severity of depressive and anxiety symptoms was evaluated using the Hamilton rating scales (Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale, interview-based ratings) and the Comprehensive Psychopathological Rating Scale (self-ratings).
Results: The intention-to-treat analysis showed sertraline to be more effective than placebo (P = 0.024) in decreasing reported tinnitus severity according to the Tinnitus Severity Questionnaire at 16 weeks' follow-up. There was also more improvement (P = 0.014) in perceived tinnitus loudness. There were significant correlations between reduction of tinnitus according to the Tinnitus Severity Questionnaire over 16 weeks and improvements in depressive (r = 0.42-0.46) and anxiety symptoms (r = 0.34-0.42). Sertraline was well tolerated after a somewhat high (17%) dropout rate within the first 2 weeks.
Conclusions: Sertraline is more effective than placebo in the treatment of severe refractory tinnitus.