[A multicenter double blind versus placebos study of trimetazidine in tinnitus. A clinical approach to tinnitus].

This multicenter controlled double-blind study versus placebo was carried out in order to determine in which types of tinnitus trimetazidine dosed at 60 mg/day was likely to be of any therapeutical benefit. This trial was conducted over a period spanning 2 months and involved 13 hospital centers. Enrolled were 315 patients presenting with subjective tinnitus. The analysis bore on 290 patients (136 receiving trimetazidine and 154 receiving placebo). Aside from the epidemiological pertinence of this study, results revealed a significantly higher rate of improvement with trimetazidine, as assessed on the basis of subjective clinical criteria, intensity (p = 0.004), periodicity (p = 0.003), and the extent of discomfort (p less than 0.001), as well as audiometric ones. The evolution of the intensity of tinnitus, as measured either by Fowler's comparative scale method or by masking the sick ear, varied significantly (p = 0.007 and p = 0.026, respectively) depending upon whether patients received trimetazidine or placebo. The type of tinnitus which responded best to trimetazidine was recent-onset tinnitus (less than or equal to 2 years) and ischemic disease related tinnitus.

RCT Entities:   Population Interventions Outcomes