For children with ear tubes, topical antibiotic drops treat the leaky discharge caused by an ear infection much more effectively than oral antibiotics or observation, according to a study published in The New England Journal of Medicine on Wednesday.
Each year, roughly 670,000 children in the United States have tiny plastic tubes placed in the eardrum in one of the most common surgeries of childhood. If the ear gets infected afterward, clear or bloody discharge can drip out, and a foul smell may be noticeable. This condition of drippy ears, which may or may not be painful, is known as tympanostomy tube otorrhea. In a 2013 study, 67 percent of children who had ear tubes put in experienced one or more episodes of otorrhea in the year after the procedure.
Smaller trials with different designs have found that ear drops are more effective than systemic antibiotics for this common problem. But the new study is the first to include a no-treatment, wait-and-see group, and provides the best evidence to date for the superiority of ear drops for children with tubes.
“This is a big study, very high quality and very rigorous. It’s more of a definitive study,” said Dr. Richard M. Rosenfeld, chairman of otolaryngology at SUNY Downstate Medical Center in Brooklyn, who was not involved in the research. Putting drops into the ear canal, he said, is akin to “dropping a Scud missile on the bacteria.”
There are two benefits, he said. “It resolves the otorrhea more effectively and faster than oral medicine,” he said. “More importantly, you avoid the problem of resistant germs, which is a major, major problem.”
In the new study, 230 children ages 1 to 10 with acute tube discharge were randomly assigned to three groups: some got ear drops, some got oral antibiotics, and some were simply observed.
At two weeks, 5 percent of the children treated with drops still had discharge from an infection, compared with 44 percent of those treated with oral antibiotics and 55 percent of those who were only observed.
The study suggests that drippy ears in children with tubes might take two weeks or longer to resolve without treatment — a long time if the child has trouble sleeping or cannot participate in activities.
“No previous study assessed the actual need to treat these children,” said Dr. Thijs M.A. van Dongen, the lead author of the study and an epidemiologist at University Medical Center Utrecht in the Netherlands.
In a six-month follow-up, the study found that children who were not treated for the first two weeks had a median total of 18 days of discharge, compared with five days for those who got ear drops, and 13.5 days for those given oral antibiotics.
“It’s better to start treatment quickly after onset of symptoms,” Dr. van Dongen said. “They improve more quickly, and they have less recurrence in following months.”
But Dr. Rosenfeld said it was not clear that all children with tube otorrhea should promptly start ear drops. Watching and waiting is an option, he said, if the drainage is not profuse and causes no discomfort, and the child still sleeps and acts normally. Drops can be expensive, and if used excessively they can cause hard-to-treat yeast overgrowth.
Last July, practice guidelines issued by the American Academy of Otolaryngology-Head and Neck Surgery strongly recommended that clinicians prescribe only topical antibiotic ear drops for children with uncomplicated cases of tube discharge.
But some pediatricians and family physicians still routinely prescribe systemic antibiotics for these cases. Among otolaryngologists, the new guidelines are “fairly well accepted,” said Dr. Joseph E. Kerschner, a professor of otolaryngology and the dean of the medical school at Medical College of Wisconsin in Milwaukee. “Still, there’s evidence that not all physicians have gotten the message.”
A 2013 survey found that 54 percent of emergency-medicine physicians used oral antibiotics to treat an ear infection in a child with ear tubes, compared with just 9 percent of ear, nose and throat doctors, almost all of whom used topical antibiotics.
Most children do not see ear, nose and throat specialists first, said Dr. Seth R. Schwartz, an otolaryngologist and the director of the Listen for Life Center at Virginia Mason Medical Center in Seattle, so “it’s important that all physicians who treat children with this condition are aware.”
The bottom line is that “oral antibiotics don’t work well” in these cases, he said, and they may cause stomach upset or diarrhea.
In an uncomplicated case of tube discharge, Dr. Kerschner advised parents to say to pediatricians, “’Hey, my kid has a draining ear, how about using topical antibiotics instead of oral antibiotics?’ The child will get better faster and more reliably.”
In children without ear tubes who get an ear infection, drops are not effective as they cannot get behind the ear drum. For those children, oral antibiotics are a common treatment. Lately, Dr. Schwartz said, “there’s a higher recognition that you can treat with observation initially with close follow-up.”
Source: New York Times