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Auris Nasus Larynx. 2004 Sep;31(3):226-32.

Efficacy of misoprostol in the treatment of tinnitus in patients with diabetes and/or hypertension.

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Department of Otolaryngology Head and Neck Surgery, Baş kent University Faculty of Medicine, Ankara, Turkey.



To determine the efficacy of the prostaglandin E1 analogue misoprostol in the treatment of tinnitus in diabetic and/or hypertensive patients.


Double-blind, randomized, placebo-controlled trial.


Tertiary care referral center.


The subjects were 42 patients with hypertension and/or diabetes mellitus who had chronic tinnitus and had experienced tinnitus symptoms for a minimum of 6 months. Twenty-eight patients were randomly assigned to Group I (misoprostol treatment), and 14 patients to the Group II (placebo treatment). Misoprostol therapy was started at 200 microg per day, and was increased 200 microg every 7 days until a dose of 800 microg per day was reached. The same numbers of placebo tablets were given to the control group using the same schedule. Both groups were treated for 1 month. The changes in objective and subjective tinnitus findings from baseline to 1 month were assessed, and the group results were compared. The chi(2)-test, student's t-test and paired-samples t-test were used to analyze the study.


At the completion of treatment, objective assessment showed that tinnitus loudness decreased in 13 (46%) of the 28 patients in the experimental group, whereas this was observed in only two (14%) of the 14 subjects in the placebo group. Subjective tinnitus scoring revealed improvement rates of 29 and 14% for the misoprostol and placebo groups, respectively. When t-test relating to difference between rates were performed, the difference between improvement rate for tinnitus loudness of the experimental group and control group was found to be statistically significant (P = 0.05), but difference between improvement rate based on subjective tinnitus scoring was insignificant (P = 0.22).


Misoprostol is an effective and safe treatment for chronic tinnitus in hypertensive and/or diabetic patients. Our results are encouraging, but further studies of larger series are needed.

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