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Promising drug proves ineffective as treatment for hearing loss

tudies where Methotrexate was used to treat AIED, the initial results appeared positive. The current study was designed to determine in a controlled, double-blind fashion if Methotrexate could maintain the hearing improvement achieved initially with Prednisone," Harris says.

The study enrolled 116 patients with AIED, treating each of them with one month of high dose Prednisone. At the end of the first phase, 67 who showed significant hearing improvement were randomized to receive either Methotrexate or placebo. Prednisone was slowly tapered in both groups over a 3-month period while the Methotrexate and placebo doses were increased.

The results showed that Methotrexate was no more effective than the placebo in maintaining the hearing gain achieved with Prednisone. Of the 67 patients who went on to receive Methotrexate or placebo, 61 were disqualified from continuing the study due to further hearing losses.

Of the 116 patients who received the initial high dose steroids, 63% responded to Prednisone in one ear while 37% responded in both ears, and the researchers observed that long-term Prednisone was well tolerated under the close management of the treating physicians involved in this study.

Harris says the results underscore the importance of well-controlled studies to test the efficacy of drugs in the treatment of AIED, adding it also demonstrates the urgent need to discover more effective and lasting treatments for this condition that usually leads to acute deafness.


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Contact: Jeffree Itrich
jitrich@ucsd.edu
619-543-6163
University of California - San Diego
7-Oct-2003


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