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Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial
P H Kaleida1, M L Casselbrant, H E Rockette
1Otitis Media Research Center, Children's Hospital of Pittsburgh, PA 15213-2583.
Insights
Amoxicillin effectively treats acute otitis media in children, reducing treatment failures and middle-ear effusion duration. Myringotomy is not recommended for routine use in acute otitis media management.
Area of Science:
- Pediatrics
- Infectious Diseases
- Otolaryngology
Background:
- Acute otitis media (AOM) is a common childhood infection.
- Treatment strategies for AOM vary, with ongoing debate regarding antibiotic use and surgical interventions like myringotomy.
Purpose of the Study:
- To evaluate the efficacy of amoxicillin versus placebo for non-severe AOM.
- To compare different treatment regimens, including amoxicillin and myringotomy, for severe AOM in children.
- To assess the long-term impact of treatments on effusion and recurrence rates.
Main Methods:
- Randomized controlled trial involving 536 infants and children with AOM.
- Year-long treatment regimens comparing amoxicillin and placebo for non-severe episodes.
- Comparison of amoxicillin, amoxicillin with myringotomy, and placebo with myringotomy for severe episodes in different age groups.
Main Results:
- Amoxicillin significantly reduced initial treatment failure and middle-ear effusion presence at 2 and 6 weeks for non-severe AOM compared to placebo.
- Children treated with amoxicillin for non-severe AOM experienced less time with effusion over the year.
- Myringotomy alone for severe AOM resulted in higher treatment failure rates than amoxicillin-based treatments.
Conclusions:
- Routine treatment of acute otitis media in children with amoxicillin is recommended.
- Current data do not support the routine use of myringotomy, either alone or as an adjunct, for AOM.
- Amoxicillin demonstrates clear benefits in managing both non-severe and severe episodes of AOM.
Abstract:
A total of 536 infants and children with acute otitis media were randomly assigned to one of six consistent year-long regimens involving the treatment of nonsevere episodes with either amoxicillin or placebo, and severe episodes with either amoxicillin, amoxicillin and myringotomy, or, in children aged 2 years or older, placebo and myringotomy. Nonsevere episodes had more favorable outcomes in subjects assigned to treatment with amoxicillin than with placebo, as measured by the proportions that resulted in initial treatment failure (3.9% vs 7.7%, P = .009) and the proportions in which middle-ear effusion was present at 2 and 6 weeks after onset (46.9% vs 62.5%, P less than .001; and 45.9% vs 51.5%, P = .09, respectively). In subjects whose entry episode was non-severe, those assigned to amoxicillin treatment had less average time with effusion during the succeeding year than those assigned to placebo treatment (36.0% vs 44.4%, P = .004), but recurrence rates of acute otitis media in the two groups were similar. In the 2-year-and-older age group, severe episodes resulted in more initial treatment failures in subjects assigned to receive myringotomy alone than in subjects assigned to receive amoxicillin with, or without, myringotomy (23.5% vs 3.1% vs 4.1%, P = .006). In the study population as a whole, severe episodes in subjects assigned to receive amoxicillin alone, and amoxicillin with myringotomy, had comparable outcomes. It is concluded that children with acute otitis media should routinely be treated with amoxicillin (or an equivalent antimicrobial drug). The data provide no support for the routine use of myringotomy either alone or adjunctively.