Increased clinical failures when treating acute otitis media with macrolides: a meta-analysis

Area of Science:

• Pediatric Infectious Diseases
• Pharmacology
• Evidence-Based Medicine

Background:

• Macrolide antibiotics are frequently prescribed for acute otitis media (AOM) in children.
• Current guidelines suggest avoiding macrolides in favor of penicillin-based treatments unless a penicillin allergy exists.

Purpose of the Study:

• To conduct a meta-analysis comparing the efficacy of amoxicillin or amoxicillin/clavulanate against macrolide antibiotics for treating pediatric AOM.
• To evaluate clinical failure rates and safety profiles of these antibiotic classes.

Main Methods:

• Systematic literature search of major databases (MEDLINE, EMBASE, International Pharmaceutical Abstracts) through September 2008.
• Inclusion of randomized, blinded, controlled trials comparing guideline-recommended antibiotics with macrolides in pediatric AOM.
• Primary outcome: clinical failure assessed 10-16 days post-therapy; secondary outcome: adverse reactions and diarrhea.

Main Results:

• Meta-analysis of 10 trials (N=2766) revealed a significantly increased risk of clinical failure with macrolide use (RR 1.31; p=0.008).
• Macrolide group showed significantly lower rates of adverse reactions (RR 0.74; p=0.003) and diarrhea (RR 0.41; p<0.0001).

Conclusions:

• Macrolide antibiotics are associated with a higher likelihood of clinical failure in pediatric AOM treatment.
• Findings support existing recommendations to reserve macrolides for children unable to take amoxicillin or amoxicillin/clavulanate.