• Objective.
—A pilot study to determine if the synthetic prostaglandin E1 misoprostol is effective in treating severe tinnitus, to test the hypothesis that tinnitus production is related to prostaglandin metabolism.
Design.
—Blinded, placebo controlled, hemicrossover.
Setting.
—House Ear Clinic, Los Angeles, Calif.
Patients.
—A volunteer and convenience sample of 24 subjects complaining of severe tinnitus was recruited from mailings, telephone calls, and the clinic population. The patients were not preselected except to be in otherwise good health.
Intervention.
—Subjects were started on a regimen of placebo or 200 µg/d of misoprostol. The dosage was increased every 5 days by 200 µg until a total of 800 µg/d was achieved. After 1 month of drug administration, the placebo group was crossed over to the active drug phase.
Main Outcome Measures.
—Outcome was measured in terms of subjective reports of tinnitus severity, sleep patterns, and ability to concentrate.
Results.
—Eight (33%) of the 24 patients reported improvement during the active drug phase. There were no placebo responders. Responders reported improvement in tinnitus severity, sleep, and concentration.
Conclusions.
—Findings support the contention that prostaglandins may be useful in the treatment of tinnitus. Further studies with larger samples are needed before widespread use of this intervention can be recommended.
(Arch Otolaryngol Head Neck Surg. 1993;119:652-654)
