The study is designed so that 250 patients, 125 in each study arm, will allow the investigators to make statistically significant analyses, Dr. Rauch said. The study is being conducted at eight centers that are listed on the Web site hosted by the NIH (see below). The investigators will follow the patients for six months, with assessments after one week of treatment, at the end of the two-week treatment period, and at two months and six months after enrollment into the study. Some of the parameters of the trial include the time course of the recovery, the stability of the recovery, and adverse events.
Explore This IssueApril 2006
Experts Weigh In
Two experts not involved in the study discussed its importance and their hopes that it will provide some clarity to treatment for SSNHL. We don’t know what causes SSNHL and this has hampered our ability to develop effective treatments, said Stephen Cass, MD, Associate Professor of Otolaryngology at the University of Colorado School of Medicine in Denver.
Steroids have stood the test of time, but some people don’t tolerate steroids very well, he added. Therefore, we’ve seen more interest in targeting the ear more directly by placing medications into the ear. This approach has advantages, because we can get a high dose of steroids right to the ear with minimal side effects. Often oral medications don’t get to the ear very well, and the injection is relatively easy to do. The problem is, does the injection help the patient?
Dr. Cass agreed with Dr. Rauch that intratympanic injections have become something that is frequently performed without a lot of evidence to substantiate it. He said, We’ve had a lot of studies with no control group and no blinding. Results are difficult to interpret without those controls. That’s why it’s so important to do this kind of study. Studies like this reduce the guesswork and make us better doctors.
The only way of knowing with reasonable certainty is a large-scale study such as the one sponsored by the NIH, said Steven W. Cheung, MD, Associate Professor of Otolaryngology at the University of California-San Francisco. I’m really excited that the trial has gone forward. We face this difficult problem all the time. In some patients, particularly those with osteoporosis and diabetes, oral corticosteroids can cause complications, and an alternative would be very attractive, provided it would confer similar benefits to the oral route.
There have been anecdotal reports that the intratympanic method has been successful in restoring some level of hearing in patients who have not responded to oral steroids, he said. What is confusing is that some patients will recover hearing some time beyond the oral steroid dose. We don’t really know whether some of the patients treated with intratympanic steroids would have gotten better. This study is designed to that question, because there is a direct comparison between the two treatment modalities.