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Source: Del Mar C, et al. Are antibiotics indicated as initial treatment for children with acute otitis media? A meta-analysis. BMJ 1997;314:1526-1529.
Del mar and colleagues searched the literature looking for research studies of satisfactory quality that were randomized, controlled trials of antimicrobial drugs vs. placebo in the management of acute otitis media. Only six studies met criteria to allow analysis of outcome. Sixty percent of placebo-treated children in these studies were pain-free within 24 hours of presentation, and this was not significantly different in the antibiotic treatment groups. After 2-7 days, only 14% of the children in the placebo groups still had pain. However, in the 2-14-day period, those who were given antibiotics at the outset had a 41% less chance of having pain. There was no difference between the two groups in the rate of subsequent attacks of acute otitis media or deafness at one month. Antibiotics were associated with a near doubling of the risk of side effects including rashes, diarrhea, and vomiting. Del Mar et al conclude that the use of antibiotics provides only a modest benefit in acute otitis media and that to prevent one child from experiencing pain at 2-7 days after presentation, 17 children must be treated with antibiotics early.
This study analyzes treatment for otitis media, one of the most common disorders of children. It has been shown that in primary care pediatric practice, one-third of visits are related to otitis media. Nevertheless, there is no agreement as to which children require treatment with antibiotics, nor has any antibiotic been shown to be superior to other antibiotics with respect to outcome. Antibiotics are generally advertised to be superior on the basis of convenience, taste, or cost. Our American approach to treatment of children with acute otitis media varies considerably from other Western countries. Our European counterparts are considerably more selective than American physicians and are "shocked" by the amount of antibiotic treatment we use. Del Mar et al quote data that Australian and U.S. physicians use antibiotics to treat acute otitis media in 98% of cases while in the Netherlands it is only 31%. This is not surprising. A study from the Netherlands showed no difference in outcome whether acute otitis media was treated with antibiotics, myringotomy, antibiotics plus myringotomy, or placebo.1 Lest anyone think the study by Del Mar et al is a fluke, an even more extensive meta-analysis performed by U.S. researchers was published in 1994 and had similar results.2 They looked specifically at absence of symptoms at 7-14 days after presentation. They found a spontaneous resolution rate of 81%, which was improved by 14% in those who received antibiotics. Thus, seven children had to be treated for one to benefit.
We need to look carefully at these studies and othersespecially at the European experience. The U.S. literature contains many studies with end points such as microbiologic improvement (sterile middle ear exudate) and antibiotic levels in blood and middle ear exudate. Are these really practice-relevant end points? Many experts feel they are, but the clinical end points looked at in the Del Mar et al article also merit attention. We are in an era where there are rising rates of antibiotic resistance in community-acquired infections. Treatment of otitis and minor respiratory infections in children with antibiotics may play a major role in the development of resistance. The degree to which we restrain ourselves in the use of antibiotics will relate to how seriously we look at data such as those presented in this article and how seriously we are concerned by the problems of antibiotic resistance in community-acquired infections.
1. van Buchem FL, et al. Therapy of acute otitis media: Myringotomy, antibiotics, or neither? A double blind study in children. Lancet 1981;ii:883-887.
2. Rosenfeld RM, et al. Clinical efficacy of antimicrobial drugs for acute otitis media: Meta analysis of 5400 children from thirty-three randomized trials. J Pediatr 1994;124:355-367.