Tinnitus is the perceived sensation of sound without actual acoustic stimulation. Approximately, 40 million people in the United States experience chronic tinnitus and 10 million of these people consider their tinnitus to be a significant problem. There are many different treatments for tinnitus. However, no one treatment or combinations of treatments have been found to be significantly effective and consequently the FDA has not approved any drugs for tinnitus. Many investigators have noted similarities between tinnitus and chronic naturopathic pain. This has lead to the chronic pain model for tinnitus. Gabapentin is a drug that is widely used for naturopathic pain because it is generally well tolerated, easily triturated, has few drug interactions, and does not require laboratory monitoring. We recently completed an open-label pilot study of gabapentin for troublesome tinnitus. Between November 2001 and April 2002, 19 patients were placed on 900 mg per day of gabapentin. The range of scores on the Tinnitus Handicap Inventory (THI) at baseline was 10 to 94 and the average (+/- 95% CI) score was 44 (32-55). At the end of Week 4, the average (+ 95% CI) score for the 16 (84%) patients who remained in the study was 28 (18-38). The difference in average THl score between Week 0, 2, and 4 was statistically significant (F test =10.31, p=0004). Gabapentin was well tolerated by most patients. The primary specific aim of this study is to evaluate the effect of gabapentin on tinnitus as measured by the change in the THI. The null hypothesis is that gabapentin is no more effective than placebo in the treatment of tinnitus. The alternative hypothesis is that gabapentin is different than placebo in the treatment of tinnitus. There will be four secondary aims of the study. The secondary aims will focus on interesting subgroup responses or interaction between treatment response and important covariates. The results of these secondary aims are likely to generate new and interesting hypotheses. We will employ a double-blind placebo-controlled randomized clinical trial design to assess the efficacy of gabapentin. Adults, between the ages of 18 and 70 with idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsate tinnitus (ICD-9 --388.31) of 6 month's duration or greater and score of 38 or greater on the THI will be eligible. We plan to enroll a total of 160 patients and expect to be able to detect a 30% change in score on the THl Enrollment will begin May 2004 and continue until 160 valuable patients have been enrolled (anticipated end date: January, 2006). The significance of this research is that troublesome tinnitus is a very common health problem and treatment options for these patients are quite limited. The findings from this research could have significant health impact for a large number of Americans.
| Piccirillo, Jay F; Finnell, Joshua; Vlahiotis, Anna et al. (2007) Relief of idiopathic subjective tinnitus: is gabapentin effective? Arch Otolaryngol Head Neck Surg 133:390-7 |
