Misoprostol in the treatment of tinnitus:: A double-blind study

OBJECTIVE: To test the efficacy of misoprostol as a treatment for tinnitus. DESIGN: A prospective, placebo-controlled, double-blind study. SETTING: Baskent University Otolaryngology Clinic. PATIENTS: Forty adult patients who had had tinnitus for a minimum of 6 months and were free of systemic or otolaryngologic disease. Twenty-eight patients were randomly assigned to the experimental group (group I) and 12 to the control group (group II). INTERVENTION: The respective groups received active drug and placebo in increasing doses for 4 months. The effect of medications on tinnitus were evaluated by determining improvement rates in tinnitus loudness and subjective tinnitus scoring. RESULTS: In the experimental group, 18 of 28 patients showed improvement in tinnitus loudness, representing an improvement rate of 64%. The improvement rate based on subjective tinnitus scoring was 36% (10 of 28 patients). In the control group, the improvement rate for tinnitus loudness was 33% (n = 4), and the rate for subjective tinnitus scoring was 17% (n = 2). The difference between improvement rate for tinnitus loudness of the experimental group and control group was found to be statistically significant (P = 0.039), but difference between improvement rate based on subjective tinnitus scoring was insignificant (P = 0.119). When results in the experimental group were analyzed according to etiological factors, the improvement rate was highest in the sudden-onset subgroup (77%). CONCLUSIONS: Misoprostol provided therapeutic relief for some patients with tinnitus we studied, but further investigation of larger groups is needed.