Babies and toddlers with ear infections often benefit from antibiotics, two studies found, backing a decades-old treatment that doctors may forgo because of medical guidelines now facing revision.
The drugs eased symptoms, sped healing and cured infections more than placebos did, in children ages 6 months to 35 months, according to research published today in the New England Journal of Medicine.
Ear infection is the most frequently diagnosed illness in U.S. children and the most common reason kids are given antibiotics, researchers said. Some medical guidelines say doctors may wait to see if an infection clears up on its own, to avoid overuse of antibiotics and prevent drug resistance. The research showed antibiotics may be an important treatment, said Alejandro Hoberman, lead author of one of the studies.
“When children are properly diagnosed and given the right antibiotic, the symptoms get better sooner,” said Hoberman, chief of the Division of General Academic Pediatrics at Children’s Hospital of Pittsburgh, in a telephone interview yesterday. “These two strong studies are the best data we have here to determine the benefits of antimicrobial therapy provided the ear infections are diagnosed properly.”
Hoberman has received honoraria and expense reimbursements from London-based GlaxoSmithKline Plc, whose products include antibiotics. The research he led was supported by a grant from the U.S. National Institute of Allergy and Infectious Diseases, based in Bethesda, Maryland.
Doctors often use an instrument called an otoscope to look in a child’s ear and see how much fluid is in the eardrum, according to the website of the Mayo Clinic in Rochester, Minnesota. The exam can be difficult in an “irritable, squirming infant,” wrote Jerome Klein, a professor of pediatrics at Boston University School of Medicine, in an editorial accompanying the studies in the journal.
The advisory will have tips for doctors to diagnose ear infections, or acute otitis media, correctly and prevent overuse of antibiotics, said Richard Rosenfeld, chairman of otolaryngology at the State University of New York Downstate and Long Island College Hospital in Brooklyn and a member of the guideline panel.
One sign doctors can look for to diagnose an infection is whether the child’s eardrum is bulging, Rosenfeld said in a telephone interview yesterday.
Also, the guidelines will be more specific for which child should get antibiotics. Using 12 previous studies along with the research released today, the guidelines will focus more on symptoms of children who will benefit most from antibiotics, Rosenfeld said. The new guidelines are expected within a year, he said.
Three of four children will have at least one ear infection by the time they turn three years old, according to the U.S. National Institutes of Health, based in Bethesda, Maryland. An ear infection is an inflammation of the middle ear, which occurs when fluid builds up behind the eardrum, the agency said. It is usually caused by bacteria.
In the first study, from researchers at the University of Pittsburgh, 144 children ages 6 months to 23 months were assigned to receive a combination of amoxicillin-clavulanate, also sold as Augmentin by GlaxoSmithKline, for 10 days. An additional 147 were assigned to receive placebo.
Relief of Symptoms
After seven days, 67 percent of the infants who got the antibiotic had a sustained resolution of symptoms -- including fever, lack of appetite and tugging or rubbing their ears -- compared with 53 percent of those who received a placebo. About 16 percent of those on antibiotics and 51 percent of those on placebo still had an ear infection by day 10, said Hoberman, who is also a professor of pediatrics at the University of Pittsburgh School of Medicine.
In the other study, from the University of Turku, in Turku, Finland, 161 children ages 6 months to 35 months were given amoxicillin-clavulanate, and 158 were assigned a placebo for seven days.
The researchers found that 45 percent of children on placebo failed to have their ear infections clear up compared with 19 percent on the antibiotic. Overall, the antibiotics reduced the risk of the ear infection remaining by 62 percent and cut the need for further treatment by 81 percent, the research showed.
More Study Urged
Further studies are needed to determine which children may benefit most from antibiotics, said Aino Ruohola, a pediatrician at the University of Turku, in a telephone interview yesterday.
“Our results can also be interpreted as showing that half the children in the placebo group did not have treatment failure,” the Finnish authors wrote. “These findings suggest that not all patients with acute otitis media need antimicrobial treatment.”
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