OBJECTIVE: To investigate the benefits of intratympanic administration of dexamethasone in the treatment of unilateral Meniere's disease, with particular attention to the symptoms of hearing loss and tinnitus. STUDY DESIGN: A prospective, randomized, double-blind, crossover study comparing improvements in hearing loss, tinnitus, aural fullness, and caloric vestibular response secondary to intratympanic dexamethasone and sodium hyaluronate injection versus placebo consisting of saline and sodium hyaluronate. SETTING: A private otology/neurotology practice. PATIENTS: Twenty patients diagnosed with either definite or probable Meniere's disease as defined by the American Academy of Otolaryngology Head and Neck Surgery Committee on Hearing and Equilibrium. All patients were < or =21 years old and were not receiving any other form of treatment for their Meniere's disease. Each patient's primary symptoms of concern were hearing loss, aural fullness, and roaring tinnitus. INTERVENTIONS: Three consecutive daily administrations of intratympanic dexamethasone or placebo to the involved ear. MAIN OUTCOME MEASURES: Changes in audiometric pure-tone averages, speech reception thresholds, caloric vestibular responses, scores on the tinnitus handicap inventories, questionnaires, and telephone interview responses. RESULTS: No significant changes were observed in any measured parameter. Patients were unable to consistently identify which medication was dexamethasone and which was placebo. CONCLUSIONS: Intratympanic administration of dexamethasone in a group of patients with unilateral Meniere's disease (Shea's stage IV) showed no benefit over placebo for the treatment of hearing loss and tinnitus.
RCT Entities:
OBJECTIVE: To investigate the benefits of intratympanic administration of dexamethasone in the treatment of unilateral Meniere's disease, with particular attention to the symptoms of hearing loss and tinnitus. STUDY DESIGN: A prospective, randomized, double-blind, crossover study comparing improvements in hearing loss, tinnitus, aural fullness, and caloric vestibular response secondary to intratympanic dexamethasone and sodium hyaluronate injection versus placebo consisting of saline and sodium hyaluronate. SETTING: A private otology/neurotology practice. PATIENTS: Twenty patients diagnosed with either definite or probable Meniere's disease as defined by the American Academy of Otolaryngology Head and Neck Surgery Committee on Hearing and Equilibrium. All patients were < or =21 years old and were not receiving any other form of treatment for their Meniere's disease. Each patient's primary symptoms of concern were hearing loss, aural fullness, and roaring tinnitus. INTERVENTIONS: Three consecutive daily administrations of intratympanic dexamethasone or placebo to the involved ear. MAIN OUTCOME MEASURES: Changes in audiometric pure-tone averages, speech reception thresholds, caloric vestibular responses, scores on the tinnitus handicap inventories, questionnaires, and telephone interview responses. RESULTS: No significant changes were observed in any measured parameter. Patients were unable to consistently identify which medication was dexamethasone and which was placebo. CONCLUSIONS: Intratympanic administration of dexamethasone in a group of patients with unilateral Meniere's disease (Shea's stage IV) showed no benefit over placebo for the treatment of hearing loss and tinnitus.
Authors: C Martín González; F M González; A Trinidad; A Ibáñez; M Pinilla; A Martínez Ruiz-Coello; A Rodríguez Valiente; C López-Cortijo Journal: Eur Arch Otorhinolaryngol Date: 2010-05-08 Impact factor: 2.503
Authors: Andrew A McCall; Erin E Leary Swan; Jeffrey T Borenstein; William F Sewell; Sharon G Kujawa; Michael J McKenna Journal: Ear Hear Date: 2010-04 Impact factor: 3.570