This was the first study to examine intratympanic steroids as the primary treatment for idiopathic sudden deafness, although there had been prior reports in the literature using intratympanic steroids as salvage treatment when oral steroids didn’t work. The key here, he said, was that data showed a statistically significant difference in overall hearing after treatment and improved treatment in patients treated after 10 days.
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December 2006We admit this was a small study with a limited sample size of 26 patients, and admit there was a lack of a control arm, but we were able to make this direct compairision in patients treated within 10 days and those treated after 10 days, Dr. Parnes said.We need more data and a bigger study. But it shows that within 10 days this is a safe and possibly effective treatment for SSHL and a multicenter study is needed to define and outline the role of this treatment.
Using Evidence-Based Medicine
Harvard’s Steven D. Rauch, MD, continued from there, talking about his National Institute on Deafness and Other Communication Disorders (NIDCD)-sponsored trial and the importance of relying on science instead of faith.
The era of evidence-based medicine is hurtling toward us and in most other specialties it is already there and we are behind the curve in that regard, he said. Faithbased medicine isn’t going to cut it, and just because you believe something is the right treatment just isn’t enough. We’re in a special window of time right now where there is a great billing code for intratympanic drug injection, but not a lot of evidence of its efficacy exists and that window is going to close unless there really is evidence that it’s a good treatment.
Dr. Rauch, whose own study won’t be complete until 2009, preached caution where thereapies are concerned.
None of us are satisfied with the efficacy of oral steroids for hearing loss, he said. That is why intratympanic therapy is here. It uses the ‘If some is good, more is better’ philosophy. But that is really simple thinking and it may not be the correct thinking.
Dr. Rauch said his current study is comparing the efficacy of intratympanic injections and oral administration head-to-head.
This is a noninferiority study,he said. If one drug [oral steroids] is accepted, you can compare the other [intratympanic] and say that it is at least as good. Can we say that intratympanic therapy is at least as good as oral? I’ll tell you in 2009.
Developments in Drug Therapy
Commander Ben J. Balough, MD, Chief of Otolaryngology at the Naval Medical Center, San Diego, and Michael Seidman, MD, of the Henry Ford Health System in Detroit, ended the session talking about the newest, cutting-edge drugs.