Objective: Evaluate melatonin as a treatment for subjective tinnitus.
Study Design: Randomized, prospective, double-blind, placebo-controlle
d crossover trial. Patients were given 3.0 mg melatonin, which was tak
en nightly for 30 days followed or preceded by a placebo nightly for 3
0 days, with a 7-day washout period between medications. Setting: Outp
atient, private, neurotology practice. Patients: Thirty patients with
subjective tinnitus. Main Outcome Measures: Tinnitus matching, Tinnitu
s Handicap Inventory (THI), patient questionnaire and interview. Resul
ts: The average pretreatment THI score was 33.91 as compared with 26.4
3 after the placebo and 26.09 after melatonin. The difference in the T
HI scores between melatonin and placebo treatment were not statistical
ly significant. The average pretreatment THI score for patients who re
ported overall improvement with melatonin was statistically higher (P
= 0.02) than the average pretreatment THI score for patients who repor
ted no improvement with melatonin. Among subjects reporting difficulty
sleeping attributable to their tinnitus, 46.7% reported an overall im
provement after melatonin compared with 20.0% for placebo (P = 0.04).
There was also a statistically significant difference in improvement w
ith 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. Patie
nts with high THI scores and/or difficulty sleeping are most likely to
benefit from treatment with melatonin. In light of its minimal side e
ffects, melatonin should be a part of the physician's armamentarium in
the treatment of tinnitus.