Article

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

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.
clinicaltrials.gov Identifier: NCT00097448.

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    • "Since agents are not diluted by the serum that occurs in systemic administration, a high concentration gradient of agents from the middle ear to the perilymph contributes to enrichment of agents in the inner ear transportated across the round and oval windows. Intratympanic corticosteroids injections are reportedly beneficial in treating idiopathic sudden sensorineural hearing loss, Meniere's disease and noise-induced hearing loss (Filipo et al., 2013;Garduno-Anaya et al., 2005;Hong et al., 2009;Lavigne et al., 2015;Rauch et al., 2011;Zhou et al., 2013). In order to further reduce accumulation of agents in unwanted areas in individuals, we reported a targeted tympanic medial wall delivery method (Zou et al., 2011). "
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    ABSTRACT: Postaurical injection of therapeutics was recently applied in clinical practice to treat inner ear diseases based on supposed existence of a direct channel from the postaurical area to the inner ear. Doubting on the associated reports and aiming to provide evidence on the inner ear uptake mechanism, the present study tracked the dynamic distribution of gadolinium-tetra-azacyclo-dodecane-tetra-acetic acid (Gd-DOTA) in rat inner ears after postaurical injection using MRI. A targeted tympanic medial wall delivery was utilized as control. The results showed that, at the early time points after postaurical injection, Gd-DOTA distributed mainly in tissues surrounding the bulla, temporal bone and skull and neck space. In the inner ear, there was gradual uptake of Gd-DOTA on both the ipsilateral and contralateral sides with equal signal intensities. There was no sign of direct channel carrying the agent from the postaurical area to the inner ear. Targeted tympanic medial wall delivery induced significantly greater uptake of Gd-DOTA in the inner ear than did postaurical injection. At 30 min post-administration, targeted tympanic medial wall delivery yielded 4.6-folds higher signal intensity than did postaurical injection. The total dose of Gd-DOTA delivered by the targeted tympanic medial wall approach was only 0.1% of that delivered by postaurical injection. In conclusion, postaurical injection is a systemic administration, which is similar to hypodermic injection, rather than a focal delivery method. By contraries, targeted tympanic medial wall delivery induces fast and abundant uptake of Gd-DOTA in the ipsilateral inner ear without significant distribution in unwanted areas.
    Full-text · Article · Jan 2016
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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.
    Full-text · Article · Jul 2014 · Endocrine Connections
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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.
    Full-text · Article · Feb 2013
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