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Increased clinical failures when treating acute otitis media with macrolides: a meta-analysis
Joshua D Courter1, William L Baker, Katherine S Nowak
1Connecticut Children's Medical Center, Hartford, CT 06106, USA.
Background:
Macrolide antibiotics are often used to treat children with acute otitis media (AOM); however, the 2004 American Academy of Pediatrics (AAP) and American Academy of Family Physicians guidelines recommend against their use in patients without history of a type I allergic reaction to penicillins.
Objective:
To evaluate via meta-analysis the comparative efficacy of amoxicillin or amoxicillin/clavulanate to that of macrolide antibiotics in the treatment of children with AOM.
Methods:
A systematic literature search of MEDLINE, EMBASE, and International Pharmaceutical Abstracts was conducted from the earliest available date through September 2008. We used the following MeSH and key words: amoxicillin, amoxicillin/clavulanate, Augmentin, azithromycin, ceftriaxone, clarithromycin, macrolides, AND media, otitis media, and effusion. Included studies were randomized, blinded, and controlled trials evaluating guideline-recommended antibiotics (amoxicillin or amoxicillin/clavulanate) compared to macrolide antibiotics (azithromycin or clarithromycin) in AOM in children. The primary outcome assessed was clinical failure measured between days 10 and 16 after starting antibiotic therapy. Results are reported as relative risks (RRs) with 95% confidence intervals and were calculated using a random-effects model.
Results:
A total of 10 trials (N = 2766) evaluating children 6 months-15 years old were included in the meta-analysis. Upon meta-analysis, the use of macrolide antibiotics was associated with an increased risk of clinical failure (RR 1.31 [95% CI 1.07 to 1.60]; p = 0.008) corresponding to a number needed to harm of 32. Upon safety analysis, rates of any adverse reaction (RR 0.74 [95% CI 0.60 to 0.90]; p = 0.003) and diarrhea (RR 0.41 [95% CI 0.32 to 0.52]; p < 0.0001) were significantly lower in the macrolide group.
Conclusions:
The meta-analysis suggests that patients treated with macrolides for AOM may be more likely to have clinical failures. As such, it supports the current AAP AOM recommendation that macrolides be reserved for patients who can not receive amoxicillin or amoxicillin/clavulanate.
Insights
Macrolide antibiotics show increased clinical failure rates for acute otitis media (AOM) in children compared to amoxicillin. Current guidelines recommending amoxicillin or amoxicillin/clavulanate for AOM are supported by this evidence.
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.
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