Misoprostol in the Treatment of Tinnitus: A Double‐Blind Study

Abstract

OBJECTIVE To test the efficacy of misoprostol as a treatment for tinnitus. DESIGN A prospective, placebo‐controlled, double‐blind study. SETTING Başkent 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. (Otolaryngol Head Neck Surg 2004;130:604‐10.)