Phase 2 study examining magnesium-dependent tinnitus.

BACKGROUND Recent studies in noise-induced and idiopathic sensorineural hearing loss have suggested that magnesium supplementation may lessen both hearing loss and the severity of tinnitus in patients. Further epidemiological evidence indicates that all age groups of Americans fall short of the recommended daily allowance for magnesium by 100 mg daily. PURPOSE The purpose of this study was to examine any potential benefit in lessening the severity of tinnitus in patients taking supplemental magnesium. RESEARCH DESIGN The study was a single-arm, open-label, before-and-after study of oral magnesium (532 mg per day) in 26 patients for 3 months. Tinnitus severity was evaluated and recorded daily by the patient using the Tinnitus Distress Rating (TDR) scale of 0 (no tinnitus) to 10 (worst possible tinnitus). The Tinnitus Handicap Inventory (THI) was administered before and at the end of the study, and scores were converted to the grades of the 5-item Tinnitus Severity Scale (TSS). The purpose of this phase 2 study was to investigate whether the treatment was effective at all, and, as such, a placebo control was not performed. All data were collected at Mayo Clinic in Scottsdale, Arizona, between March 6 and December 10, 2008. STUDY SAMPLE Patients with moderate to very severe tinnitus (TDR score of 3 through 8). INTERVENTION Daily magnesium supplementation, 532 mg; patient completion of the THI; and daily self-report of TDR. DATA COLLECTION AND ANALYSIS The main outcome measures were mean TDR scale scores and THI scores as converted to TSS grades. The primary analysis was done on the basis of intention to treat. RESULTS Twenty-six patients were enrolled; 19 completed the study. The extent of handicap, as measured by THI/TSS, for subjects with slight or greater impairment was significantly decreased (P=.03). Patients who ranked slight or greater on the THI/TSS before intervention showed a significant decrease in the severity of their tinnitus at post-testing (P=.008). CONCLUSION The results suggest that magnesium may have a beneficial effect on perception of tinnitus-related handicap when scored with the THI.