A large clinical trial over six years shows the more expensive injected steroids no better or worse as a treatment for sudden deafness than oral steroids. The findings appear in the 25 May 2011 issue of the Journal of the American Medical Association.
The multicenter clinical trial was funded by the National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health. The trial followed more than 250 patients with sudden deafness for six months between 2004 and 2009.
Sudden sensorineural hearing loss, commonly known as sudden deafness, occurs as an unexplained, rapid loss of hearing — usually in one ear — either at once or over several days, typically in adults between the ages of 43 and 53. NIDCD recommends that the condition be considered a medical emergency that requires immediate attention.
In the trial, the oral treatment group (121 patients) received 60 milligrams of oral prednisone per day for 14 days, followed by a tapering-off period of an additional five days. The intratympanic therapy (IT, 129 patients) received 40 milligrams of methylprednisolone injected through the eardrum, or tympanic membrane, into the middle ear four times over the course of two weeks.
Study results showed that IT treatment and oral treatment were equally effective in restoring hearing to study participants. Audiologists, blinded to the treatments, tested the patients’ hearing by air- and bone-conducted pure tone audiometry and speech audiometry at screening, after 1 and 2 weeks of treatment, and at 2 and 6 months of follow-up.
NIDCD notes large differences in the costs of the two treatments. A prescription for oral steroids costs less than $10, while IT treatments costs more than $800. The IT costs are calculated as four injections at an average of $200 each, according to the Centers for Medicare and Medicaid Services physician fee schedules.
The oral treatment group experienced side effects typical of systemic steroid use, including mood, sleep, or appetite changes, increased thirst or dry mouth, elevated blood glucose levels, and abnormal complete blood count. The side effects in the IT group were considered typical of local injections: pain at the injection site, a short period of dizziness after the injection, and some instances of perforated eardrum and middle ear infection.
Read more: Field Test of New Clinical Trial Method Underway
Photo: Hey Paul/Flickr
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