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Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media
Alejandro Hoberman1, Diego Preciado1, Jack L Paradise1
1From the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Insights
Tympanostomy tubes did not significantly reduce acute otitis media episodes in children compared to medical management. This study found similar rates of ear infection recurrence over two years for both treatment approaches.
Area of Science:
- Pediatrics
- Otolaryngology
- Infectious Diseases
Background:
- Recurrent acute otitis media (AOM) in children lacks definitive treatment guidelines.
- Official recommendations vary on the efficacy of tympanostomy tubes versus medical management.
Purpose of the Study:
- To compare the effectiveness of tympanostomy tube placement versus medical management for recurrent AOM in young children.
- To determine the primary outcome of AOM episode rate per child-year over a two-year period.
Main Methods:
- Randomized controlled trial involving children aged 6-35 months with recurrent AOM.
- Comparison between tympanostomy tube insertion and medical management with episodic antimicrobial treatment.
- Primary outcome: mean number of AOM episodes per child-year over 2 years.
Main Results:
- Intention-to-treat analysis showed no significant difference in AOM rates (1.48 vs. 1.56 episodes/child-year).
- Per-protocol analysis also revealed similar rates (1.47 vs. 1.72 episodes/child-year).
- Secondary outcomes showed mixed results, with some favoring tubes (time to first episode) and others favoring medical management (days with otorrhea).
Conclusions:
- Tympanostomy tube placement did not significantly lower the rate of acute otitis media episodes compared to medical management in children aged 6-35 months.
- The findings suggest that medical management is a viable alternative for recurrent AOM in this age group.
Background:
Official recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media.
Methods:
We randomly assigned 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, 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.
Results:
In our 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 (P = 0.66). 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.
Conclusions:
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. (Funded by the National Institute on Deafness and Other Communication Disorders and others; ClinicalTrials.gov number, NCT02567825.).
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