Effect of a 4-Week Treatment with Cilostazol in Patients with Chronic Tinnitus: A Randomized, Prospective, Placebo-controlled, Double-blind, Pilot Study

Abstract

Objective: The aim of this prospective, double-blind, randomized, placebo-controlled study was to evaluate the efficacy of cilostazol, a selective phosphodiesterase 3 inhibitor, in patients with chronic tinnitus.

Materials and methods: Adult patients of chronic tinnitus lasting more than 3 months were included. Fifty eligible patients were randomly assigned to either cilostazol or control (placebo) group. The study medication of oral 100-mg cilostazol and a matching placebo were used twice a day for 4 weeks. Subjective tinnitus severity was evaluated using the visual analog scale (VAS), tinnitus handicap inventory (THI), and Short-Form 36 health survey (SF-36) at baseline and at 2 and 4 weeks after study initiation. Changes in tinnitus pitch and loudness matching values were also analyzed.

Results: The improvement range in the VAS score was significantly greater in the cilostazol group than in the placebo group after 4 weeks' administration of cilostazol. The SF-36 subscales also showed improvement in quality of life in the physical component summary subscale, the aggregate subscale of the physical category. There were no significant improvements in the cilostazol group compared to the placebo group in the THI subscales and tinnitus characteristics of pitch and loudness matching values. Various degrees of headaches were experienced by 68% of patients in the cilostazol group.

Conclusion: A 4-week administration of oral cilostazol in patients with chronic tinnitus may mitigate the severity of subjective tinnitus.