Impact of Acamprosate on Chronic Tinnitus: A Randomized-Controlled Trial.

OBJECTIVES

Tinnitus is a common and distressing otologic symptom, with various probable pathophysiologic mechanisms, such as an imbalance between excitatory and inhibitory mechanisms. Acamprosate, generally used to treat alcoholism, is a glutaminergic antagonist and GABA agonist suggested for treating tinnitus. Thus, we aimed to evaluate the efficacy and safety of acamprosate in the treatment of tinnitus.

METHODS

The current randomized-controlled trial study included 20 subjects with chronic tinnitus. After performing psycho-acoustic, psychometric and electrophysiological evaluations, all studied tinnitus subjects were randomly divided into two groups of acamprosate and placebo. The first group received oral acamprosate (two tablets of 333 mg/d, three times a day), whereas the second group was given placebo treatment (two tablets, three times a day). After the first 30 days, all evaluations were repeated for the studied groups just in the same manner before the study. Subsequently, the final results of each evaluation were compared together with the baseline values.

RESULTS

Nine studied subjects randomly received acamprosate, whereas eleven others received a placebo. There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus (P = .039). For those subjects who were receiving acamprosate, a significant reduction was observed in tinnitus handicap inventory (P = .006), tinnitus questionnaire scores (P = .007), and the visual analog scores (P = .007) compared to the placebo group. There was a significant reduction in Action Potential latency (P = .048) as well as an increase in the amplitude of distortion product otoacoustic emissions at 4 kHz (P = .048).

CONCLUSIONS

The study results indicated a subjective relief of tinnitus as well as some degree of the electrophysiological improvement at the level of the cochlear and the distal portion of the auditory nerve among the subjects who received the acamprosate.

CLINICAL TRIAL REGISTRATION CODE: IRCT2013121115751N1.