Oral vs Intratympanic Corticosteroid Therapy for Idiopathic Sudden Sensorineural Hearing Loss A Randomized Trial

Department of Otology and Laryngology, Harvard Medical School, Massachusetts Eye and Ear Infirmary, 243 Charles St, Boston, MA 02114, USA.
JAMA The Journal of the American Medical Association (Impact Factor: 30.39). 05/2011; 305(20):2071-9. DOI: 10.1001/jama.2011.679
Source: PubMed

ABSTRACT 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.
To compare the effectiveness of oral vs intratympanic steroid to treat sudden sensorineural hearing loss.
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.
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.
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.
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.
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. Identifier: NCT00097448.

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Available from: William H Slattery, Aug 21, 2015
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    • "The effect of topical corticosteroid administration is not inferior to systemic corticosteroid administration [7]. Hence, systemic corticosteroids should be replaced with topical treatment when treating SSHL in patients with relative contraindications to corticosteroids [1] [2] [7]. Incidental adrenal masses must be included among the contraindications for corticosteroid administration. "
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    ABSTRACT: A 63-year-old man, who was diagnosed with sudden sensorineural hearing loss (SSHL), showed severe hypertension 10 hours after prednisolone administration. Subsequently, the patient suddenly died due to pulmonary edema. The autopsy indicated a pheochromocytoma in the right adrenal gland, and the cause of death was determined to be a pheochromocytoma crisis induced by systemic administration of prednisolone. Pheochromocytoma crisis is a life-threatening condition and can result from the use of corticosteroids. Physicians should consider the risk of a pheochromocytoma crisis due to systemic corticosteroids in the treatment of patients with sudden sensorineural hearing loss.
    02/2013; 2013:734131. DOI:10.1155/2013/734131
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    • "In adults, steroids, systemic and more recently intratympanic, are the only interventions that have shown any reproducible efficacy, although there is disagreement regarding the degree of effectiveness [2] [3] [4]. The lack of standardization of approaches to the diagnosis and management of SSNHL leaves children without treatment during a critical window where steroids could potentially be effective. "
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    ABSTRACT: OBJECTIVE: Sudden sensorineural hearing loss (SSNHL) is an underappreciated issue in pediatric patient care. The goal of this study was to identify children who met the criteria for SSNHL and examine the etiologies, useful diagnostic studies, and treatment outcomes for these patients. METHODS: A retrospective medical records review was performed in patients meeting the criteria for SSNHL seen at a tertiary care pediatric hospital from 2007 to 2012. Information collected included age, gender, audiometric evaluations, onset and duration of hearing loss, additional symptoms, diagnostic studies and response to any medical management. The Institutional Review Board approved this project. RESULTS: 12/20 patients were male. Mean age was 11.41 years (3 months-24 years). Hearing loss was bilateral in 9/20 patients. Degree of hearing loss ranged from mild to profound across frequencies. Probable etiologies were viral of unknown type (n=12), late presentation of congenital CMV (n=1), noise-related (n=1), non organic (n=1), enlarged vestibular aqueduct (EVA) (n=1), one with both acute Epstein-Barr virus (EBV) and significant ototoxic exposure (n=1), one had significant ototoxic exposure and an inflammatory cerebrovascular incident (n=1), and unknown (n=2). Diagnostic studies included temporal bone computed tomography (CT) (n=15) and/or magnetic resonance imaging (MRI) (n=15), Lyme titers (n=9), streptococcal throat culture (n=1) and EBV (n=1) and mumps titers (n=1). Positive diagnostic studies included 1 MRI consistent with congenital CMV, and one CT that showed an EVA. 15/20 patients received systemic steroids, 3 received antivirals, and 4 got antibiotics. Response to steroids varied from complete resolution of SSNHL to worsening. Symptoms reported, in addition to the hearing loss included tinnitus (n=9), vertigo (n=9), sensation of a blocked ear (n=6), and otalgia (n=4). CONCLUSIONS: The incidence of SSNHL in pediatric patients is unknown. Etiologies of SSNHL include viral, EVA, ototoxicity, noise, and non-organic. Most studies were non-diagnostic although 2/22 CT/MRI provided an etiology. Identification of other causes required careful history review. The incidence of SSNHL in the pediatric population needs to be studied, and the timing, dosage, route and efficacy of steroids further evaluated.
    International journal of pediatric otorhinolaryngology 01/2013; 77(4). DOI:10.1016/j.ijporl.2013.01.004 · 1.32 Impact Factor
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    • "(e) A super database needs to be established to collect data from multiple centers. This could fall under the auspices of CHARGE (Witsell et al., 2011) or built on the larger studies already designed and analyzed (Rauch et al., 2011). Online entering of data from participating clinics without patient identifiers could easily be done with a small investment, possibly funded by the National Institute on Deafness and Other Communication Disorders. "
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    ABSTRACT: This review addresses the current status of steroid therapies for hearing and vestibular disorders and how certain misconceptions may be undermining the efficacy in restoring normal ear function, both experimentally and clinically. Specific misconceptions addressed are that steroid therapy is not effective, steroid-responsive hearing loss proves an underlying inflammatory problem in the ear, and steroids only have application to the hearing disorders listed below. Glucocorticoid therapy for hearing and balance disorders has been employed for over 60 years. It is recommended in cases of sudden hearing loss, Meniére's disease, immune-mediated hearing loss, and any vestibular dysfunction suspected of having an inflammatory etiology. The predominant steroids employed today are dexamethasone, prednisone, prednisolone, and methylprednisolone. Despite years of use, little is known of the steroid responsive mechanisms in the ear that are influenced by glucocorticoid therapy. Furthermore, meta-analyses and clinical study reviews occasionally question whether steroids offer any benefit at all. Foremost in the minds of clinicians is the immune suppression and anti-inflammatory functions of steroids because of their efficacy for autoimmune hearing loss. However, glucocorticoids have a strong binding affinity for the mineralocorticoid (aldosterone) and glucocorticoid receptors, both of which are prominent in the ear. Because the auditory and vestibular end organs require tightly regulated endolymph and perilymph fluids, this ion homeostasis role of the mineralocorticoid receptor cannot be overlooked in both normal and pathologic functions of the ear. The function of the glucocorticoid receptor is to provide anti-inflammatory and antiapoptotic signals by mediating survival factors. Anat Rec, 2012. © 2012 Wiley Periodicals, Inc.
    The Anatomical Record Advances in Integrative Anatomy and Evolutionary Biology 11/2012; 295(11):1928-43. DOI:10.1002/ar.22576 · 1.53 Impact Factor
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