NEW YORK (Reuters Health) - For acute otorrhea in children with tympanostomy tubes, antibiotic-glucocorticoid eardrops are not only clinically superior to oral antibiotics and initial observation, they also cost less, according to a study published this week.
Last year in the New England Journal of Medicine, Dr. Thijs van Dongen of the University Medical Center Utrecht in the Netherlands and colleagues reported an open-label trial on the clinical effectiveness of these three treatment strategies in 230 children.
As reported by Reuters Health, 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.
In a study online April 20 in Pediatrics, the researchers report a cost-effectiveness analysis of the treatment strategies, which also favors eardrops.
At two weeks, the total cost in US dollars per patient on average was $42 for antibiotic-glucocorticoid eardrops, $71 for oral antibiotics and $82 for initial observation. At six months, these costs were $368, $421, and $640, respectively, the authors report.
Otorrhea is common in children with tympanostomy tubes; each year, two of every three children develop one or more episodes.
In an email to Reuters Health, Dr. van Dongen noted that the original clinical effectiveness data were "widely covered in the media. At that time, all three treatment strategies were commonly used and with our results we recommended to only use antibiotic-steroid eardrops as the first-line treatment strategy in children with acute tympanostomy-tube otorrhea. In the Netherlands, the guidelines have been adapted based on our results. We hope that through the wide coverage, many physicians now do prescribe eardrops and that clinical practice has already changed."
"With this new publication in Pediatrics, we have an extra argument in favor of starting with ear drops instead of with initial observation, i.e., it is not only clinically superior, it is also has lowest costs," Dr. van Dongen noted.
Dr. Charles Bower, chair of the American Academy of Pediatrics Section on Otolaryngology-Head and Neck Surgery, told Reuters Health there is not a guideline specific to post-tube otorrhea. "The guidelines from AAP deal more with acute otitis media," he noted.
In clinical practice, otolaryngologists "typically have the ability to clean ears, make sure tubes are open, make sure tubes are clean and they are fine, and we would virtually 100% of the time use drops alone," Dr. Bower said. "Pediatricians, if they are very confident from a recent visit that a tube is open and fine, will also frequently use drops alone, which has increased effectiveness as well as some cost savings. If a pediatrician has uncertainty, then we still see a fairly high addition of an oral antibiotic."
The study had no commercial funding and the authors have no relevant disclosures. Microbiological analyses of samples taken as part of the trial were supported by GlaxoSmithKline through the University Medical Center Utrecht.
SOURCE: http://bit.ly/1JqVcZm
Pediatrics 2015.
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