ntly negative. Children who received decongestants alone or in combination with antihistamines were no more likely to be cured within one month than children who received a placebo. The same results were seen when children were evaluated at one to three months or after more than three months.
Likewise, for each of the other major outcomes the reviewers examined — hearing loss, risk of recurrent OME, development of acute otitis media and the need for surgery to drain fluid from the middle ear — the drugs performed no better than placebo. In fact, for hearing loss, there was a trend toward worse outcomes among the children who received medication.
In parallel with the consistent lack of benefit, the reviewers also found a significant risk of harm. In the six studies that evaluated side effects, 17 percent of children who received medication suffered side effects, compared with 6 percent of children who received a placebo.
The 11 percent difference in side effects means that for every nine children treated with these drugs, one would be harmed while none would benefit.
The results of this review came as no surprise to Richard Rosenfeld, M.D., director of pediatric otolaryngology at Long Island College Hospital in Brooklyn, N.Y. The real surprise, he said, is that physicians continue to prescribe these medications for a condition that in the vast majority of cases resolves on its own.
The 2004 American Academy of Pediatrics guideline for OME, for which Rosenfeld was co-chairman, recommended against the use of antihistamines and decongestants for OME based on the preponderance of harm over benefit. A 1994 guideline also found no data supporting the use of these drugs.
"There is absolutely no question that these products don’t work," said Rosenfeld. "We have a very old, very consistent body of knowledge, all of which says the same thing, and yet these products are still commonly used by practicing cliPage: 1 2 3 Related medicine news :1
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