The medical consensus on whether to give antibiotics to young children with ear infections has been swinging from one extreme to the other as conflicting clinical trials have pushed pediatricians first toward widespread use of the drugs, then toward a "watch and wait" approach in which most infections seem to clear up on their own.
Two new trials reported Wednesday in the New England Journal of Medicine are nudging the pendulum back toward treatment of the infections, especially for the youngest children. They show that the use of antibiotics in infants and toddlers under the age of 2 is only modestly effective and reduces the duration of symptoms by only a small amount, but it prevents relapses and progression of the disease.
The trials indicate that treatment helps "when the diagnosis is certain," said Dr. Wilbert Mason, an infectious diseases specialist at Childrens Hospital Los Angeles who was not involved in the study. Though the reduction of symptoms was marginal, he said, treated children "were less likely to have a relapse or to have persistent signs of infection at the end of therapy."
The findings "confirm the current guidelines" for treating children under age 2, said Dr. Al Lieberthal of USC's Keck School of Medicine, who is in charge of the American Academy of Pediatrics committee that prepared the guidelines. They will be revised in light of the new studies, however, to tighten the definition of ear infections, known formally as acute otitis media, he added.
At least a dozen previous clinical trials have studied the use of antibiotics in ear infections, but these have given mixed results because of poor study design and poor diagnosis of the subjects' conditions, according to Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.
"In many cases, [the children] had something that looked like otitis media but really wasn't," he said. The new studies "had really precise criteria to be eligible for enrollment," which makes them "substantial studies."
In one of the studies, Dr. Alejandro Hoberman of the University of Pittsburgh School of Medicine and his colleagues studied 291 children ages 6 to 23 months with stringently defined acute otitis media. Half were given the antibiotic amoxicillin-clavulanate for 10 days and half a placebo.
Eighty percent of the children receiving the antibiotic had a resolution of symptoms by day 7, as did 74% of those who got the placebo. But 67% of those who took the antibiotic had a sustained resolution of symptoms, compared with 53% of those who took the placebo.
In the second study, Dr. Paula A. Tahtinen of Turku University Hospital in Finland and her colleagues studied 319 children ages 6 to 35 months, half of whom were given the antibiotic for seven days and half a placebo.
The Finnish study focused on continuing symptoms of infection, which is known as treatment failure. It found that, at the end of seven days, treatment failure occurred in 18.6% of those who received the antibiotic, compared with 44.9% of those who received the placebo.
That may sound like a big improvement, said Dr. Richard Rosenfeld, chair of otolaryngology at the State University of New York's Downstate Medical Center in Brooklyn, who also helped prepare the AAP's guidelines. "But all it means is that if the eardrum looked nasty, the treatment failed," he said. "Eardrums sometimes take weeks to months to recover. That finding, to me, is a bit of a dubious way to say that everybody needs treatment."
Experts noted, however, that certain children should receive immediate antibiotic treatment regardless of age. That includes those who are under 6 months of age, those who have a draining ear caused by a ruptured eardrum, those with severe symptoms early on, and those with infections in both ears.
But physicians are reluctant to give antibiotics indiscriminately because of the side effects, which may include diarrhea, yeast infections, oral thrush, allergic reactions and resistant bacteria. "You pay a price for a little bit of improvement," Rosenfeld said.