Comparative Evaluation of Melatonin as an Alternative Therapy in Tinnitus: A Double-Blind, Placebo-Controlled Randomized Trial

Tinnitus is an auditory perception that is described as a perception of noise without any external acoustic stimulant. Tinnitus causes many problems including sleep disturbances and difficulty in concentrating for patients.

In this trial, we evaluated melatonin as an alternative therapy in tinnitus.

In this clinical trial, tinnitus patients (n = 90) were randomly assigned to 12 weeks of double-blind treatment with melatonin (n = 30) at a fixed-dose (3 mg once daily), sertraline (n = 30) at a fixed dose (50 mg once daily) and placebo (n = 30) once daily. The treatment outcomes were measured using THI (Tinnitus Handicap Inventory), tinnitus loudness score, and tinnitus awareness score after 3 months.

The baseline assessment with THI (Tinnitus Handicap Inventory) showed no significant difference in THI score between groups before treatment (p-value = 0.38). The mean THI score shows a significant decrease in both melatonin and sertraline groups (p-value < 0.03). Overall, a mean of 20% decrease in tinnitus loudness score and a 2-fold decrease in tinnitus awareness score was seen in the melatonin group. In contrast, a mean of 2% decrease in tinnitus loudness score and 25% decrease in tinnitus awareness score was seen in the sertraline group.

Both melatonin and sertraline reduce tinnitus loudness score and tinnitus awareness score within 12 weeks in primary care, but melatonin showed a more significant outcome. Our findings support the prescription of melatonin in tinnitus management.