Background: Tinnitus is described as the perception of sound or noise in the absence of real acoustic stimulation. It has been compared with chronic pain, and may be associated with depression or depressive symptoms which can affect quality of life and the ability to work. Antidepressant drugs have been used to treat tinnitus in patients with and without depressive symptoms.
Objectives: To assess the effectiveness of antidepressants in the treatment of tinnitus and to ascertain whether any benefit was due to a direct tinnitus effect or a secondary effect due to treatment of concomitant depressive states.
Search strategy: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) The Cochrane Library Issue 1, 2006); MEDLINE (January 1951 to 2006); EMBASE (1974 to 2006), CINAHL (to 2006), PSYCINFO (to 2006), LILACS (to 2006), and Cambridge Scientific Abstracts. The date of the most recent search was March 2006.
Selection criteria: Randomised controlled clinical studies of antidepressant drugs versus placebo in patients with tinnitus.
Data collection and analysis: The studies retrieved were critically appraised and data extracted independently by two authors. Where necessary study authors were contacted for further information.
Main results: Five trials involving 525 patients were included. Four of these trials looked at the effect of tricyclic antidepressants on tinnitus, investigating 405 patients. One trial investigated the effect of a selective serotonin reuptake inhibitor (SSRI) in a group of 120 patients. No trials involving other antidepressant agents met the inclusion criteria. Only the trial using the SSRI drug met the highest quality standard. None of the other included trials met the highest quality standard, due to use of inadequate outcome measures, large drop out rates or failure to separate the effects on tinnitus from the effects on symptoms of anxiety and depression. All the trials assessing tricyclic antidepressants suggested that there was a slight improvement in tinnitus but these effects may have been attributable to methodological bias. The trial that investigated the SSRI drug found no overall improvement in any of the validated outcome measures that were used in the study although there was possible benefit for a subgroup that received higher doses of the drug. This observation merits further investigation. Reports of side effects including sedation, sexual dysfunction and dry mouth were common.
Authors' conclusions: There is insufficient evidence to say that antidepressant drug therapy improves tinnitus.