No More Watchful Waiting with Ear Infections

Amid the ongoing controversy over routine antibiotic use for children with acute ear infections, two new studies published in the New England Journal of Medicine support the practice when stringent diagnostic criteria are met.

Researchers from Children's Hospital of Pittsburgh and the University of Turku in Finland found antibiotics more effective than a placebo in reducing ear infection severity and duration in toddlers. In both studies, the rate of clinical failure—defined as persistent signs of acute infection—was dramatically lower days later among those prescribed amoxicillin-clavulanate (Augmentin) than in children left untreated.

Acute ear infection, known medically as otitis media, is the most frequent bacterial illness diagnosed during early childhood and the most common reason antibiotics are prescribed for children in the United States, according to prior research.

"The study underscores the need to restrict antibiotic treatment to those with certain infection," said Alejandro Hoberman, MD, a pediatrician at Children’s Hospital of Pittsburgh and lead author of one of the studies, in a statement. "I would say the really important point to understand is that the key to optimal management of acute otitis media is an accurate diagnosis. I do hope our findings… will settle the topic."

Hoberman and Jerome Klein, MD, a professor of pediatrics at Boston University School of Medicine, said a rash of research in recent decades from Western Europe triggered debate over the necessity of antibiotics by suggesting they initially be withheld from children with ear infections as part of a watchful waiting strategy.

That approach, along with widespread fear over the increasing emergence of antibiotic-resistant bacteria, has fueled the treatment controversy, they said. However, the European studies typically didn't enforce strict criteria for diagnosing ear infections, whose symptoms can resemble upper respiratory illnesses.

"What it boils down to is that a lot of uncertainty in prior investigations was because the diagnosis was not always as secure as these two papers, where they've really been very careful," said Klein, who wrote an editorial supporting the results of both studies that appeared in the Jan. 13 issue of the NEJM.

"A more casual approach to treatment muddied the waters" over antibiotic use in prior studies, Klein added, noting that he didn't expect the debate to die despite the latest findings.

In the Pittsburgh study, 291 children between the ages of 6 months and 23 months old with certain ear infections—as defined by the presence of a bulging eardrum and parental observations, among other symptoms—were split into groups receiving antibiotics or placebos for 10 days.

Among those who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day two; 61% by day four; and 80% by day seven. In contrast, of those on placebo, 28% had initial resolution of symptoms by day two, 54% by day four and 74% by day seven.

But the rate of clinical failure for those on antibiotics after day four or five was only 4%, vs. 23% for those on placebo, the study found.

The Finnish research looked at 319 children between the ages of 6 months and 35 months for seven days, finding that treatment failure occurred by the end of the study period in 18.6% of children who received amoxicillin, compared to 44.9% of those on placebo.

More research is needed to help doctors identify the children who will benefit most from treatment, the authors said. Such studies could reduce unnecessary use of antibiotics and the potential for antibiotic resistance, they said.

For more:

• Treatment of Acute Otitis Media in Children under 2 Years of Age (NEJM)
• A Placebo-Controlled Trial of Antimicrobial Treatment for Acute Otitis Media (NEJM)
• Studies Show that for Kids' Ear Infections, Antibiotics Work Better than Waiting (Washington Post)