Sunday, January 16, 2011

The antibiotic pendulum for treatment of Acute Otitis Media swings back

In the antibiotic era, the complications of acute bacterial otitis media (AOM) largely disappeared. One of the complications,mastoiditis, became a rare entity.Antibiotic treatment for AOM was standard treatment but in recent years the practice became challenged.

Several clinical research papers concluded that a number of children recovered from AOM without antibiotic treatment and seemingly without sequelae. Those findings were amplified by a couple of meta-analyses which derived the number needed to treat with antibiotic (NNT) and claimed that at least 7 children need to be treated (NNT) to shorten the illness of one child.

Perhaps encouraged by policies regarding antibiotic treatment in Europe and the growing concern about bacterial resistance caused by widespread and at times imprudent antibiotic use, several medical professional bodies issued guidelines that said antibiotics need not always be given to a child with AOM.

Now, two articles in the January 13, 2011 issue of NEJM present evidence from which one may reasonably conclude that antibiotic treatment is a good thing after all.An accompanying editorial supports a pull back from the current guidelines. The editorialist and authors of at least one of the two NEJM articles point out serious flaws in the clinical trials which lead to the current guidelines including ; imprecise criteria for the diagnosis of AOM,inclusion of children with minimal disease,ambiguous endpoints,small sample size and improper choice and dosing of the antibiotics used.

If the trials were as poorly done as implied about you have to wonder how repacking them in the fancy wrapping of meta-analyses strengthened the argument that lead several medical organizations to recommend a watchful waiting approach to AOM.A meta-analysis is only as good as the underlying studies that are included in the data set. I have repeatedly argued that meta-analysis should not rest at or near the top of the hierarchical structure of doctrinaire Evidence Based Medicine.

The specter of antibiotic resistance or rather the concern over the resistance may have played a role there. It is interesting that in regard to the treatment of AOM, it seems that resistance has not actually become a major factor.Apparently there has been a unexplained shift in the bacteria that cause AOM.Previously beta-hemolytic streptococcus was the major player and now the less invasive Hemophilus influenza ( H.Flu) and Moraxella catarrhalis are more common.

Although dissenting views were offered in 2003 by Dr. E.R. Wald ( one of the authors of one of the two NEJM articles) from the pediatrics department at the University of Pittsburgh in 2003, both the AAP and the AAFP issued guidelines in 2004 recommending initial observation in some cases ( described as nonsevere) rather than immediate treatment with antibiotics.Other groups joined the parade as well.

It will be interesting to see if these two publications lead to changes in recommendations and if so how much of a lag time there will be.

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