1. Tympanostomy tubes were not shown to be superior to medical management for recurrent acute otitis media.
2. There was no substantial difference for elevated antimicrobial resistance in medical management compared to tympanostomy tube treatment.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Acute otitis media is the second most commonly diagnosed childhood illness in the United States. Recurrent otitis media is defined as either three or more otitis media episodes within six months or at least four episodes within a 12-month span with at least one of the episodes in the past six months. This study compared the use of tympanostomy tubes to medical management of antimicrobial treatment for recurrent otitis media. The study determined tympanostomy tubes were not superior to medical management as the difference between episodes of otitis media in both groups was not significant after two years of follow-up. However, the tympanostomy tubes did show a longer median time to the first occurrence after placement compared to the medical management. Furthermore, the study did not find an increase in antimicrobial resistance in the medical management group even with greater antimicrobial use. A limitation of the study occurred when some children in the medical management group received a tympanostomy tube due to failure of treatment or at the parent’s request. Nonetheless, the study’s findings are significant as they showed tympanostomy tubes were not superior to medical management for recurrent acute otitis media.
In-Depth [randomized controlled trial]: This randomized-controlled trial enrolled 250 children at the 3 sites in the United States. Patients between 6 to 35 months of age and confirmed recurrent otitis media diagnosis were included in the study. Patients with congenital anomalies that increase the risk of otitis media, chronic illnesses, previous adenoidectomy or tonsillectomy, or previous tympanostomy tube placement were excluded from the study. Children were stratified by age (6-11 months, 12-23 months, and 24-35 months) and by exposure or non-exposure prior to randomization. Within each age stratum, blocks of four children were randomized to receive either a tympanostomy tube or medical management. The medical management involved oral amoxicillin-clavulanate dosed by weight for 10 days or ceftriaxone intramuscularly dosed by weight as the second line if the amoxicillin-clavulanate failed. In the tympanostomy tube group, acute infection was treated with five drops of ofloxacin, twice daily, for 10 days or amoxicillin-clavulanate similar to the medical management group if symptoms persisted after seven days. The primary endpoint was the mean number of episodes of acute otitis media during the two-year follow-up period. The tympanostomy group had a mean rate±standard deviation of occurrence of 1.48±0.08, while the medical management group had a mean rate±standard deviation of 1.56±0.08 (risk ratio, 0.97; 95% confidence interval [CI], 0.84 to 1.12; P=0.66). In the secondary outcomes, the tympanostomy group had a median time to first recurrence after placement of 4.34 months compared to 2.33 months in the medical management group (hazard ratio, 0.68; 95% CI, 0.52 to 0.90). No significant difference was found in antimicrobial resistance despite the increased use of antimicrobial treatment in the medical management group. Overall, the study determined tympanostomy tubes were not shown to be superior to medical management for recurrent acute otitis media treatment with no significant difference in antimicrobial resistance between the two treatments.
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