The impact of sertraline on health-related quality of life in severe refractory tinnitus: A double-blind, randomized, placebo-controlled study

Abstract Objective: Little is known about the influence of antidepressants on tinnitus patients’ health-related quality of life (HR-QoL). We have addressed this question by investigating the efficacy of sertraline on severe refractory tinnitus. Study design: Seventy-five consecutive patients without socially disabling hearing loss, who fulfilled risk criteria for developing severe refractory tinnitus based on a screening procedure with established validity, were randomly assigned to 16 weeks of placebo (n = 38) or sertraline (n = 37) at a fixed dose (50 mg/day) in a double-blind treatment trial. After completion of the placebo-controlled trial, all patients were offered to continue with sertraline and to participate in another follow-up after 12 weeks. The remaining sertraline group at 16 weeks was studied for a total of 28 weeks treatment. Psychological General Well-Being (PGWB) index served as an indicator of HR-QoL and was administered at baseline before treatment and at 16 and 28 weeks follow-up. Results: The intention-to-treat analysis showed sertraline to be more effective than placebo (p < 0.001) in improving HR-QoL after 16 weeks treatment. The improvement after 16 weeks was maintained at 28 weeks. Conclusion: We conclude that sertraline improves the HR-QoL in severe refractory tinnitus compared to placebo and that improvements in HR-QoL are maintained over time.