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: 35.29). 05/2011; 305(20):2071-9. DOI: 10.1001/jama.2011.679
Source: PubMed


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.
clinicaltrials.gov Identifier: NCT00097448.

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    • "Intratympanic glucocorticoids are effective in the treatment of sudden sensorineural hearing loss (SSNHL) (1, 2, 3), in the stabilization of Ménière's disease (MD) (4), and in autoimmune ear disorders (5). By the intratympanic route of administration, the varied systemic side effects of oral or intravenous glucocorticoids should be minimized, in particular the suppression of the hypothalamic–pituitary–adrenal (HPA) axis or the inhibition of osteoblast function. "
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    ABSTRACT: Objective: The study aims to assess the possible systemic effects of intratympanic dexamethasone on the hypothalamic-pituitary-adrenal axis, inflammation and bone metabolism. Design: Prospective cohort study including 30 adult patients of a tertiary referral ENT clinic treated with 9.6 mg intratympanic dexamethasone over a period of 10 days. Methods: Effects on plasma and salivary cortisol concentrations [basal and after low-dose (1µg) ACTH stimulation], peripheral white blood cell count and biomarkers for bone turnover were measured before (day 0) and after intratympanic dexamethasone (day 16). Additional measurements for bone turnover were performed 5 months after therapy. Clinical information and medication with possible dexamethasone interaction was recorded. Results: Intratympanic dexamethasone was well tolerated, and no effect was detected on the hypothalamic-hypopituitary-adrenal axis (stimulated plasma and salivary cortisol concentration on day 0: 758 +/- 184 nmol/l, and 44.5 +/- 22.0 nmol/l, and on day 16: 718 +/- 154 nmol/l, and 39.8 +/- 12.4 nmol/l, p=0.58, and p=0.24, respectively). Concentrations of osteocalcin and bone specific alcaline phosphatase did not differ after dexamethasone (osteocalcin 24.1 +/- 10.5 µg/l and 23.6 +/- 8.8 µg/l on day 0 and 16 resp., and bone specific alcaline phosphatase on day 0, 16 and after 5 months, resp.: 11.5 +/- 4.2 µg/l, 10.3 +/- 3.4 µg/l and 12.6 +/- 5.06 µg/l); similarly there was no difference in the peripheral white blood cell count (5.7 x 1012/l and 6.1 x 1012/l on day 0 and 16, resp.). Conclusions: Intratympanic dexamethasone therapy did not interfere with the endogenous cortisol secretion and the bone metabolism.
    Endocrine Connections 07/2014; 3(3). DOI:10.1530/EC-14-0076
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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(3):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 · 1.19 Impact Factor
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