The findings come from two clinical trials, one in the U.S. and one in Finland. For young children with middle ear infections — otitis media — both studies found immediate antibiotic treatment far superior to watchful waiting.
Current treatment recommendations in the U.S., Canada, and Europe allow for a watch-and-wait approach to suspected middle ear infections in young children. Change is coming, predicts study leader Alejandro Hoberman, MD, of Children’s Hospital of Pittsburgh.
“The real issue for children with acute otitis media is that the circumstances for when to give antibiotic treatment are unclear,” Hoberman tells WebMD. “I truly believe, based on our results, that once they are diagnosed properly, more young children will recover more quickly when treated with antibiotics.”
Infectious disease expert Jerome Klein, MD, of Boston University School of Medicine, notes that U.S. pediatricians wait and watch only when the diagnosis of otitis media is uncertain. In Canada and many European nations, doctors are more likely to wait.
“What these studies do is refute the European experience, and support the opinion of most U.S. doctors and parents that otitis media is a treatable disease,” Klein tells WebMD. Klein was not involved in either study; his editorial accompanies their publication in the Jan. 13 issue of the New England Journal of Medicine.
Previous studies of the treatment of middle ear infections have come under fire for failing to ensure that all participants actually had ear infections and not just fluid in the ear. Both of the new studies avoid this problem by including only children with strictly diagnosed otitis media according to stringent criteria — particularly a bulging eardrum as seen with an otoscope.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci, MD, says the new studies show that when doctors diagnose otitis media using strict criteria, antibiotic treatment is best.
“It was very clear that the duration of symptoms were clearly better in the kids who took antibiotics,” Fauci tells WebMD. Fauci was not involved in either study.
In the Finnish study, Paula A. Tahtinen, MD, and colleagues at Turku University studied 319 children aged 6 to 35 months with acute otitis media. Half were treated with a seven-day course of Augmentin, a powerful antibiotic. The other half were given inactive placebos.
Only 18.6% of the children treated with antibiotics got worse or failed to improve, compared with 44.9% of the children in the placebo group. However, nearly half the children treated with antibiotics had diarrhea, compared to only about a quarter of the kids in the placebo group.
Hoberman’s University of Pittsburgh team studied 291 children aged 6 to 23 months with acute otitis media. Again, half were treated with Augmentin for seven days, while half received a placebo.
Four or five days after Augmentin treatment, only 4% of kids got worse or failed to improve — nearly six times better than the 23% of kids who got worse or no better on placebo.
So will doctors start using antibiotics willy-nilly? No, Hoberman and Klein suggest.
“Our study underscores the need to treat only kids who meet stringent criteria for a diagnosis of otitis media,” Hoberman says. “lf that is the case, we won’t have to treat half the kids now getting antibiotics for uncertain ear infection. The idea is to stick with the ones that have strictly defined otitis media.”
And that shouldn’t be too hard, Klein says. Although he notes that it’s hard to look into the ear of a screaming, squirming infant, it’s nothing a pediatrician doesn’t do every day.
“Let’s say a pediatrician sees just 10 ill children a day: That’s 20 ears a day or about 5,000 ears a year. So most pediatricians are very good at otoscopic diagnosis,” Klein says.