Tympanostomy tubes don't offer long lasting benefit over antibiotics for ear infections in children: Study
USA: Tympanostomy-tube placement compared to medical management did not significantly lower the rate of acute otitis media during a 2-year period in children with recurrent acute otitis media, finds a recent study in NEJM.
The trial results are among the first since the addition of pneumococcal vaccine to pediatric vaccination schedules, providing updated evidence that may help in forming pediatric guidelines on treating recurrent ear functions. In addition, the trial found no evidence of increased bacterial resistance among children in the medical-management group despite greater use of antibiotics.
"Subjecting a young child to the risks of anesthesia and surgery, the possible development of structural changes of the tympanic membrane, blockage of the tube or persistent drainage through the tube for recurrent ear infections, which ordinarily occur less frequently as the child ages, is not something I would recommend in most instances," said lead author Alejandro Hoberman, director of the Division of General Academic Pediatrics at UPMC Children's Hospital and the Jack L. Paradise Endowed Professor of Pediatric Research at Pitt's School of Medicine.
"We used to often recommend tubes to reduce the rate of ear infections, but in our study, episodic antibiotic treatment worked just as well for most children," he said. "Another theoretical reason to resort to tubes is to use topical ear drops rather than systemic oral antibiotics in subsequent infections in the hope of preventing the development of bacterial resistance, but in this trial, we did not find increased resistance with oral antibiotic use. So, for most children with recurrent ear infections, why undergo the risks, cost and nuisance of surgery?"
Prior to this study, the researchers say that there is a variation in official recommendations regarding the placement of tympanostomy-tube in children with recurrent acute otitis media. To fill this knowledge gap, Alejandro Hoberman and colleagues included children 6 to 35 months of age who had had at least three episodes of acute otitis media within 6 months, or at least four episodes within 12 months with at least one episode within the preceding 6 months.
They were randomly assigned to either undergo tympanostomy-tube placement or receive medical management involving episodic antimicrobial treatment. The primary outcome was the mean number of episodes of acute otitis media per child-year (rate) during a 2-year period.
Key findings of the study include:
- In main, intention-to-treat analysis, the rate (±SE) of episodes of acute otitis media per child-year during a 2-year period was 1.48±0.08 in the tympanostomy-tube group and 1.56±0.08 in the medical-management group.
- Because 10% of the children in the tympanostomy-tube group did not undergo tympanostomy-tube placement and 16% of the children in the medical-management group underwent tympanostomy-tube placement at parental request, we conducted a per-protocol analysis, which gave corresponding episode rates of 1.47±0.08 and 1.72±0.11, respectively.
- Among secondary outcomes in the main analysis, results were mixed.
- Favoring tympanostomy-tube placement were the time to a first episode of acute otitis media, various episode-related clinical findings, and the percentage of children meeting specified criteria for treatment failure.
- Favoring medical management was children's cumulative number of days with otorrhea.
- Outcomes that did not show substantial differences included the frequency distribution of episodes of acute otitis media, the percentage of episodes considered to be severe, and antimicrobial resistance among respiratory isolates.
- Trial-related adverse events were limited to those included among the secondary outcomes of the trial.
"Most children outgrow ear infections as the Eustachian tube, which connects the middle-ear with the back of the throat, works better," Hoberman said. "Previous studies of tubes were conducted before children were universally immunized with pneumococcal conjugate vaccine, which also has reduced the likelihood of recurrent ear infections. It's important to recognize that most children outgrow ear infections as they grow older. However, we must appreciate that for the relatively few children who continue to meet criteria for recurrent ear infections--three in six months or four in one year--after having met those criteria initially, placement of tympanostomy tubes may well be beneficial."
"Among children 6 to 35 months of age with recurrent acute otitis media, the rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management," wrote the authors.
The study titled, "Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media," is published in the New England Journal of Medicine.