A double-blind placebo-controlled trial of baclofen in the treatment of tinnitus.

OBJECTIVE

To determine the effectiveness of baclofen in ameliorating tinnitus in adult patients.

STUDY DESIGN

Randomized double-blind placebo-controlled trial.

SETTING

California Ear Institute at Stanford, California, a tertiary otology/neurotology referral center.

PATIENTS

Restricted to adults receiving otologic evaluation at the California Ear Institute at Stanford. Some patients had a primary complaint of tinnitus, whereas others with tinnitus were recruited during treatment for another condition. The study population was felt to be representative of the general population with tinnitus.

INTERVENTIONS

Three weeks of baclofen (10 mg orally twice daily for 1 week, 20 mg orally twice daily for the second week, and 30 mg orally twice daily for the third week) or placebo designed to mimic baclofen capsules in route, schedule, appearance, and taste were given to patients.

MAIN OUTCOME MEASURES

Tinnitus handicap inventory, pitch and loudness matching, and maskability of tinnitus.

RESULTS

Subjective and objective evaluation failed to demonstrate any clinical or statistical advantage of baclofen over placebo. Reports of subjective improvement occurred in only 9.7% of the baclofen versus 3.4% of the placebo groups, a nonsignificant difference. Withdrawal from the baclofen arm of the study occurred in 26% due to side effects, which could be attributed to the medication.

CONCLUSIONS

Baclofen is no more effective than placebo in ameliorating tinnitus in adult patients.