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Rauch SD, Halpin CF, Antonelli PJ, et al. Oral vs Intratympanic Corticosteroid Therapy for Idiopathic Sudden Sensorineural Hearing Loss: A Randomized Trial. JAMA. 2011;305(20):2071–2079. doi:10.1001/jama.2011.679
Author Affiliations: Department of Otology and Laryngology (Drs Rauch, Halprin, and Lee), Harvard Medical School, and Department of Audiology (Dr Halprin), Massachusetts Eye and Ear Infirmary (Drs Rauch and Lee), Boston; Department of Otolaryngology, University of Florida, Gainesville (Dr Antonelli); Michigan Ear Institute, Farmington Hills (Dr Babu); Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins University, Baltimore, Maryland (Dr Carey); Department of Otolaryngology–Head and Neck Surgery, University of Iowa, Iowa City (Dr Gantz); Department of Otolaryngology–Head and Neck Surgery, Washington University, St Louis, Missouri (Dr Goebel); Department of Otolaryngology, New York University, New York (Dr Hammerschlag); Department of Otolaryngology–Head and Neck Surgery, University of California-San Diego (Dr Harris); Department of Otolaryngology–Head and Neck Surgery, University of Texas Southwestern, Dallas (Dr Isaacson); Department of Otolaryngology, New York Eye and Ear Infirmary, New York (Dr Linstrom); Department of Otolaryngology–Head and Neck Surgery, University of West Ontario, London, Canada (Dr Parnes); Cooperative Studies Program Coordinating Center, Hines VA Hospital, Hines, Illinois (Ms Shi and Dr Reda); House Ear Institute, Los Angeles, California (Dr Slattery); Department of Otolaryngology–Head and Neck Surgery, University of Michigan, Ann Arbor (Dr Telian); and Department of Otolaryngology–Head and Neck Surgery, Baylor College of Medicine, Houston, Texas (Dr Vrabec).
Context Idiopathic sudden sensorineural hearing loss has been treated with oral corticosteroids for more than 30 years. Recently, many patients' symptoms have been managed with intratympanic steroid therapy. No satisfactory comparative effectiveness study to support this practice exists.
Objective To compare the effectiveness of oral vs intratympanic steroid to treat sudden sensorineural hearing loss.
Design, Setting, and Patients Prospective, randomized, noninferiority trial involving 250 patients with unilateral sensorineural hearing loss presenting within 14 days of onset of 50 dB or higher of pure tone average (PTA) hearing threshold. The study was conducted from December 2004 through October 2009 at 16 academic community-based otology practices. Participants were followed up for 6 months.
Intervention One hundred twenty-one patients received either 60 mg/d of oral prednisone for 14 days with a 5-day taper and 129 patients received 4 doses over 14 days of 40 mg/mL of methylprednisolone injected into the middle ear.
Main Outcome Measures Primary end point was change in hearing at 2 months after treatment. Noninferiority was defined as less than a 10-dB difference in hearing outcome between treatments.
Results In the oral prednisone group, PTA improved by 30.7 dB compared with a 28.7-dB improvement in the intratympanic treatment group. Mean pure tone average at 2 months was 56.0 for the oral steroid treatment group and 57.6 dB for the intratympanic treatment group. Recovery of hearing on oral treatment at 2 months by intention-to-treat analysis was 2.0 dB greater than intratympanic treatment (95.21% upper confidence interval, 6.6 dB). Per-protocol analysis confirmed the intention-to-treat result. Thus, the hypothesis of inferiority of intratympanic methylprednisolone to oral prednisone for primary treatment of sudden sensorineural hearing loss was rejected.
Conclusion Among patients with idiopathic sudden sensorineural hearing loss, hearing level 2 months after treatment showed that intratympanic treatment was not inferior to oral prednisone treatment.
Trial Registration clinicaltrials.gov Identifier: NCT00097448
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