For decades there has been debate over whether or not antibiotics really help in a child with acute otitis media. This is an area where there has been genuine uncertainty, especially since it’s hard to know when the cause of this distressing and painful condition is viral or bacterial. Two new studies ask the question- Do infants and young children with acute otitis media benefit from amoxicillin– clavulanate therapy initiated at the time of diagnosis? – and provide evidence that they do.
The first study comes from Hoberman et al. at the University of Pittsburgh, where 291 children with carefully diagnosed acute otitis media were randomized to receive treatment with amoxicillin–clavulanate or placebo for 10 days. Among the children who received amoxicillin–clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7. Amoxicillin-clavulanate had a modest but measurable benefit with respect to the time to resolution of symptoms but was associated with an increased frequency of diarrhea and diaper-area dermatitis.
In a study by Tähtinen et al. from Turku, Finland, once diagnosed with stringently-defined acute otitis media, 161 children received amoxicillin-clavulanate and 158 received placebo for 7 days. By day 3, 13.7% of the children who received amoxicillin–clavulanate, as compared with 25.3% of those who received placebo, had treatment failure. Overall, amoxicillin–clavulanate reduced the progression to treatment failure by 62% and the need for rescue treatment by 81%. Amoxicillin–clavulanate was shown to significantly reduce the rate of treatment failure and the need for rescue treatment but was associated with more diarrhea and rash.
In an accompanying editorial, Dr. Jerome Klein from Boston University Medical Center concludes, “The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly when they are treated with an appropriate antimicrobial agent.”
Will these results influence your treatment of acute otitis media in patients? Current guidelines recommend initial observation. Should guidelines change?