Objective: To determine whether Betahistine mesilate is effective in treating tinnitus.
Methods: Randomized, prospective, double-blind, controlled trial was used in our study. The study group consisted of 60 adult patients who consulted our outpatient clinic complaining of subjective tinnitus, excluded objective tinnitus and the patients who had tinnitus caused by obvious diseases, such as outer and middle ear diseases. Thirty patients were given Betahistine mesilate and Flunarizine Hydrochloride as an experimental group, 30 patients were given Vitamin B6 and Flunarizine Hydrochloride as a control group. After a week of treatment the efficacy of the medicines in two groups was observed. Tinnitus questionnaire was performed before the treatment, and pure tone audiogram, tinnitus pitch and loudness matching were performed both in the beginning and at the end of the treatment.
Results: Completion of treatment, tinnitus loudness matching assessment showed that the efficacy of the Betahistine mesilate group was better then the control group. The efficacy of treatment was respectively 65.5% by per protocol (PP) and 63.3% by intend to treat (ITT) in the Betahistine mesilate group and 39.3% by PP and 36.7% by ITT in the control group. The difference of tinnitus loudness improvement rate between the experimental group and control group was statistically significant. But the subjective tinnitus improvement rate showed no difference between two groups. There were not serious side effects in the two groups.
Conclusions: Betahistine mesilate can be a choice for tinnitus treatment clinically. Further studies of larger series and placebo-controlled trial are needed.