Objective: To determine the clinical response to intratympanic administration of gentamicin in patients with Ménière's disease and to ascertain whether the pure-tone average, caloric test, or disease duration might predict clinical control.
Design: Prospective study. Patients were followed for at least 2 years after the first injection (mean follow up time, 39 mo), and a Kaplan-Meier analysis was used to determine the survival curve that best explains the response to treatment.
Setting: Tertiary center, University hospital.
Patients: Individuals diagnosed with unilateral Ménière's disease that did not respond to previous medical treatment and who had not previously undergone surgery. Of the initial 83 patients recruited, 9 were lost during the follow-up, and thus, 74 subjects were included in the study.
Intervention: In the consultant's surgery, a myringotomy was performed with topic administration of phenol before the intratympanic administration of 2 to 3 ml of gentamicin (26.7 mg/ml). Further injections were administered if vertigo was not controlled and recurred.
Main outcome measures: Absence of vertigo and the need for subsequent injections as measured in using a Kaplan-Meier time-to-event process. To test predictive variables, the log-rank test was used.
Results: Complete control of vertigo was obtained with a single injection of gentamicin in 53% of the patients. Subsequent injections offered a 50% chance of obtaining complete control. Better results were obtained in patients in whom disease duration was less than 3 years.
Conclusion: On-demand administration of intratympanic gentamicin provides an alternative treatment for medically refractory Ménière's disease. Moreover, the Kaplan-Meier analysis was useful to analyze recurrent manifestations, such as vertigo attacks in Ménière's disease.
© 2011, Otology & Neurotology, Inc.