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Direct injection of steroids into the middle ear for the treatment of sudden deafness was shown to be no more or less effective than oral steroids in restoring hearing levels in a large comparison study of patients.
Steven D. Rauch, M.D., a professor of otology at the Massachusetts Eye and Ear Infirmary at Harvard Medical School in Boston, led the study team of clinical investigators in 16 medical centers across the United States. The study results appear in the May 25, 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. It is the largest treatment trial ever conducted to study the outcomes, over time, of patients with this condition.
“During the past 15 years, there has been an increase in the use of injected steroids as a treatment for sudden deafness, but there were no comparative studies to support the practice,” said James F. Battey, Jr., M.D., Ph.D., director of the NIDCD. “This is the first large, randomized clinical trial to compare the two treatments. Its findings—that both are equally effective—will offer more options for doctors so that they can select the treatment that best fits their patients’ needs.”
There is a large difference in the costs of the two treatments. The cost of a prescription for oral steroids is less than $10, as compared to more than $800 (an average of $200 per injection, according to the Centers for Medicare and Medicaid Services physician fee schedules) for IT treatment.
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. Experts estimate that it strikes 1 person in 5,000 per year, typically in adults between the ages of 43 and 53. The number of new cases each year could be much higher, however, since sudden deafness often goes undiagnosed because many people recover quickly and never seek medical help or they think their hearing loss is due to congestion or earwax blockage.
Since the early 1980s, doctors have prescribed a tapering course of oral corticosteroids (prednisone or methylprednisolone) over a two-week period as the standard of care for sudden deafness. Recently, intratympanic (IT) corticosteroid treatment by direct injection into the middle ear has gained popularity among otolaryngologists (ear, nose, and throat doctors). IT treatment is thought to offer the advantages of a higher concentration of steroids at the target site and a lower risk for the side effects that accompany systemic steroid use, such as changes in appetite, sleep, or mood; elevation of blood pressure and blood sugar; and stomach irritation. However, IT treatment requires repeated visits to the doctor, and a half-hour rest period after each injection, over a two-week period.
The clinical trial followed more than 250 patients with sudden deafness for six months. The oral treatment group received 60 milligrams of oral prednisone per day for 14 days, followed by a tapering-off period of an additional five days. The IT group received 40 milligrams of methylprednisolone injected through the eardrum, or tympanic membrane, into the middle ear four times over the course of two weeks. Hearing was tested after one and two weeks of treatment, and again at two and six months during follow-up.
Study results showed that IT treatment and oral treatment were equally effective in restoring hearing to study participants. The side effects in the oral treatment group were as expected and manageable. The side effects in the IT group were local—pain at the injection site, a short period of dizziness after the injection, and some instances of perforated eardrum and middle ear infection (otitis media).
“The comfort, cost, and convenience of oral steroid treatment are preferable to IT treatment,” says Dr. Rauch, “but injected steroids are an equally effective alternative for people who, for medical reasons, can’t take the oral steroids. People with sudden deafness should discuss the risks and benefits of both treatments with their doctor.”
About Mass. Eye and Ear: Founded in 1824, Massachusetts Eye and Ear Infirmary is an independent specialty hospital providing patient care for disorders of the eye, ear, nose, throat, head and neck. Mass. Eye and Ear is an international leader in Ophthalmology and Otolaryngology research and a teaching partner of Harvard Medical School. For more information, call 617-523-7900 or visit http://www.masseyeandear.org/.
NIDCD supports and conducts research and research training on the normal and disordered processes of hearing, balance, smell, taste, voice, speech and language and provides health information, based upon scientific discovery, to the public. For more information about NIDCD programs, see the Web site at www.nidcd.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.