Objective: Evaluate melatonin as a treatment for subjective tinnitus.
Study design: Randomized, prospective, double-blind, placebo-controlled crossover trial. Patients were given 3.0 mg melatonin, which was taken nightly for 30 days followed or preceded by a placebo nightly for 30 days, with a 7-day washout period between medications.
Setting: Outpatient, private, neurotology practice.
Patients: Thirty patients with subjective tinnitus.
Main outcome measures: Tinnitus matching, Tinnitus Handicap Inventory (THI), patient questionnaire and interview.
Results: The average pretreatment THI score was 33.91 as compared with 26.43 after the placebo and 26.09 after melatonin. The difference in the THI scores between melatonin and placebo treatment were not statistically significant. The average pretreatment THI score for patients who reported overall improvement with melatonin was statistically higher (P = 0.02) than the average pretreatment THI score for patients who reported no improvement with melatonin. Among subjects reporting difficulty sleeping attributable to their tinnitus, 46.7% reported an overall improvement after melatonin compared with 20.0% for placebo (P = 0.04). There was also a statistically significant difference in improvement with melatonin for those patients with bilateral tinnitus compared with those with unilateral tinnitus (P = 0.02).
Conclusion: Melatonin has been shown to be useful in the treatment of subjective tinnitus. Patients with high THI scores and/or difficulty sleeping are most likely to benefit from treatment with melatonin. In light of its minimal side effects, melatonin should be a part of the physician's armamentarium in the treatment of tinnitus.