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.

Key words::

• clinical trial
• sertraline
• tinnitus
• quality of life

Acknowledgements

The study was approved by the ethics committee at Sahlgrenska University Hospital and by the Swedish Medical Products Agency and was initiated by the investigators and independent of Pfizer Ltd., as well as other commercial parties. We are grateful to The Göteborg Medical Society, the Regional Health Authority in West Sweden, Sahlgrenska Academy and Sahlgrenska University Hospital for financial support. We also wish to thank Margareta Magnusson, Anette Eliasson and Inger Pringle for clinical assistance and express our gratitude to statistician Gunnar Ekeroth and Jonny Lindqvist for helpful statistical analyses. We are also grateful to Jonas Wenge at Pfizer AB, Sweden, for supplying us with active substance and placebo for this investigation.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.