OBJECTIVE: The aim of the study was to evaluate effects of middle ear pressure changes on the electrocochleographic responses in patients with well-defined Menière's disease. STUDY DESIGN AND INTERVENTIONS: The investigation was conducted as a placebo-controlled, randomized clinical study. Electrocochleographic measurements were performed before and after the insertion of a transtympanic ventilation tube and immediately after the exposure to active or placebo treatment. SETTING: The study was carried out in one secondary referral center and one tertiary referral center on an ambulatory basis. PATIENTS: Thirty-nine patients with well-defined Menière's disease were included in the study. MAIN OUTCOME MEASURES: The summating potential/action potential ratio of the electrocochleographic response complex was chosen as the main variable for statistical evaluation of results. Other parameters of the recordings such as responses to low-frequency burst stimulation also were evaluated. Subjective symptoms (e.g., vertigo, tinnitus, and aural pressure) were assessed before and after insertion of the ventilation tube and before and after exposure to treatment. RESULTS: A statistical difference was shown in the electrocochleographic response in the active group before and after exposure to middle ear pressure changes. In the placebo group, no change was found. Changes in electrocochleographic parameters in the active group indicated an improvement in inner ear electrophysiology. No significant changes were found in subjective symptoms in the active or the placebo group. Evaluation before and after insertion of the ventilation tube showed no significant improvement in any variable. CONCLUSIONS: This is the first study in which electrophysiologic parameters were evaluated in a placebo-controlled clinical trial of overpressure treatment in Menière's disease. The results show that electrophysiologic parameters can be improved by the application of positive pressure pulses of low amplitude in the middle ear.
RCT Entities:
OBJECTIVE: The aim of the study was to evaluate effects of middle ear pressure changes on the electrocochleographic responses in patients with well-defined Menière's disease. STUDY DESIGN AND INTERVENTIONS: The investigation was conducted as a placebo-controlled, randomized clinical study. Electrocochleographic measurements were performed before and after the insertion of a transtympanic ventilation tube and immediately after the exposure to active or placebo treatment. SETTING: The study was carried out in one secondary referral center and one tertiary referral center on an ambulatory basis. PATIENTS: Thirty-nine patients with well-defined Menière's disease were included in the study. MAIN OUTCOME MEASURES: The summating potential/action potential ratio of the electrocochleographic response complex was chosen as the main variable for statistical evaluation of results. Other parameters of the recordings such as responses to low-frequency burst stimulation also were evaluated. Subjective symptoms (e.g., vertigo, tinnitus, and aural pressure) were assessed before and after insertion of the ventilation tube and before and after exposure to treatment. RESULTS: A statistical difference was shown in the electrocochleographic response in the active group before and after exposure to middle ear pressure changes. In the placebo group, no change was found. Changes in electrocochleographic parameters in the active group indicated an improvement in inner ear electrophysiology. No significant changes were found in subjective symptoms in the active or the placebo group. Evaluation before and after insertion of the ventilation tube showed no significant improvement in any variable. CONCLUSIONS: This is the first study in which electrophysiologic parameters were evaluated in a placebo-controlled clinical trial of overpressure treatment in Menière's disease. The results show that electrophysiologic parameters can be improved by the application of positive pressure pulses of low amplitude in the middle ear.