Antibiotic eardrops better for otorrhea than oral therapy: study

By Gene Emery

NEW YORK (Reuters Health) - Antibiotic-glucocorticoid eardrops dramatically reduce the risk of continued otorrhea in children ages 1 to 10 with tympanostomy tubes, according to an open-label study of 230 youngsters.

One week after the end of treatment, only 5% of the 76 children who received the eardrops -- which contained hydrocortisone, bacitracin and colistin -- had otorrhea compared to 44% of the 77 youngsters given an oral amoxicillin-clavulanate suspension.

The rate among the 77 children initially put in an observation group was 55%, which was not significantly different from the cure rate with the oral therapy.

"We were surprised that the difference was this big," chief author Dr. Thijs van Dongen of the University Medical Center Utrecht in the Netherlands told Reuters Health by phone. "Because most earlier studies have been small, there was still some doubt about which treatment was best."

"I do suspect that the results of this study will surprise some portions of the medical community," said Dr. Daniel Choo, director of the division of pediatric otolaryngology at Cincinnati Children's Hospital Medical Center, who was not connected with the research. "There remains a dearth of rigorous, randomized, prospective data to unequivocally validate the practice (of favoring antibiotic drops). That's probably the most valuable aspect of this publication."

Between 26% and 75% of children with tympanostomy tubes develop acute otorrhea, which can cause pain, fever and foul odor as a result of the middle-ear pus draining from the tube. Most previous tests of treatment have been limited, and because the infection can be self-limiting, it has not been clear if the best strategy is watchful waiting.

The new study, released online February 19 in the New England Journal of Medicine, used children whose tympanostomy-tube otorrhea had persisted for as long as seven days. They were treated for seven days.

Dr. Choo told Reuters Health by email that U.S. otolaryngologists currently favor treatment with the drops but emergency physicians and pediatricians are probably far less likely to use them. Dr. van Dongen said guidelines on their use vary from country to country.

"Based on our observations, we would recommend for physicians to change the guidelines to treat these children with eardrops shortly after the onset of symptoms," said Dr. van Dongen.

Five drops were put in each infected ear three times daily. The oral therapy, also given three times a day, was at a daily dose of 30 mg of amoxicillin and 7.5 mg of clavulanate per kilogram of body weight.

When the researchers took a longer-term look, they found that six months after the start of treatment, there had typically been five days of otorrhea in the children who had received the drops versus 13.5 days in the oral antibiotic group (p<0.001). There had been 18 days in the children initially assigned to the observation group (also p<0.001 for comparison with the eardrops group).

During the two-week follow-up period, there were no complications of otitis media; 21% of the children who got eardrops reported some degree of discomfort during administration and gastrointestinal symptoms were reported in 23% of the children getting oral therapy.

The researchers said not only are eardrops the better treatment, the results suggest that "initial observation may not be an adequate management strategy in such children."

The brand of antibiotic eardrop used in the study is generally not available outside of France and the Netherlands. "Although evidence is lacking, we believe that any combination of antibiotic-glucocorticoid eardrops with similar antimicrobial activity, such as ciprofloxacin and dexamethasone, would be likely to have similar results," the researchers said.

Dr. Choo said another advantage to the drops is that they deliver more drug to the site of the infection and reduce the likelihood that antibiotic resistance will develop.

But he said colistin would not be the antibiotic used in the United States because it has been shown to cause hearing loss in animals and has been the focus of lawsuits here. Other drugs may pose a similar risk, he said.

"This is perhaps the main reason why Cortisporin drops were largely abandoned in the U.S. and why Ciprodex is now the most commonly prescribed antibiotic-steroid preparation used in the U.S. for otorrhea," Dr. Choo said.

Dr. van Dongen said chronic otorrhea itself can cause hearing loss, and the new study suggests that guidelines recommending that parents wait a week before contacting a doctor should be revised.

"We would recommend that parents contact the physician when the otorrhea occurs so the children can be quickly treated, can recover more quickly and can also have less recurrences in the following months," he said.

SOURCE: http://bit.ly/1gHZL4I

N Engl J Med 2014

(c) Copyright Thomson Reuters 2014. Click For Restrictions - http://about.reuters.com/fulllegal.asp