OBJECTIVE: To evaluate the effectiveness of gabapentin (Neurontin) improve the disease-specific quality of life in patients with moderate tinnitus. STUDY DESIGN: Randomized, double blind, placebo-controlled clinical trial. SETTING: Single-center academic outpatient otolaryngology practice. INTERVENTION: Gabapentin 1800 mg daily versus placebo. MAIN OUTCOME MEASURES: The study design is a randomized, double blind placebo controlled single site trial conducted in an academic medical center. Inclusion criteria included patients between ages 18 and 70 with a complaint of nonpulsatile, subjective tinnitus, bilateral or unilateral, greater than 3 months in duration. The primary outcome measure is the Tinnitus Handicap Inventory; secondary measures include the Profile of Mood States (POMS) rating scale, subjective tinnitus severity. The null hypothesis addressed in this study is that the drug would not result in significant alleviation of the symptom of tinnitus. RESULTS: Seventy-six patients completed the trial; of these 52 received the drug. No significant differences were found between the two groups after 5 weeks of treatment with gabapentin. CONCLUSION: There is insufficient evidence to support the effectiveness of gabapentin in the treatment of tinnitus.
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