Evaluation of botox in treatment of tinnitus

Abstract

Objectives: The purpose of this study was to evaluate the potential benefit of BOTOX® in treatment of tinnitus using a prospective, double-blinded study design. Methods: Thirty patients with tinnitus present for ≥2 months were randomly assigned to 1 of 2 treatment arms. Patients either recieved BOTOX® (20–50units) or saline injection at the first treatment, and the opposite solution 4 months later. Patients and investigator reviewing data were blinded to the treatment. Prospective data including tinnitus matching test, tinnitus handicap inventory (THI), tinnitus rating scale and patient questionnaires were obtained over a 4-month period following each injection. Results: Twenty-eight patients completed both injections and were included in data analysis. Following BOTOX® treatment, subjective tinnitus changes included 6 patients improved, 4 worsened, and 18 unchanged. Following placebo treatment, 2 patients were improved, 7 worsened, and 19 unchanged. Comparison of the treatment and placebo groups was statistically significant ( P < 0.005) when including better, worse, and same effects. Results were not statistically significant evaluating the better versus worse and unchanged effects combined. A significant decrease in THI scores between pretreatment and 4 months post-BOTOX injection ( P = 0.0021) was recorded. None of the other comparisons of pretreatment - 1 month or pretreatment - 4 months were significantly different. Conclusions: This small study found a statistically significant difference in THI scores and patient subjective results following BOTOX® injection, compared to placebo, suggesting a possible benefit of BOTOX® in tinnitus management. Larger studies need to be completed to further evaluate potential benefits of BOTOX® in treatment of this difficult problem.