Introduction:
The efficacy of amoxicillin combined with clavulanic acid in Acute Otitis Media
(AOM) is not debatable, but studies report a high frequency of gastrointestinal
adverse effects related to this intervention. In this scenario, several studies
about the antibiotic cefprozil report that it has the same efficacy as amoxicillin/clavulanate
for the treatment of AOM with significantly fewer side effects. The aim of our
study was to compare the efficacy and safety of both treatments in AOM. Methodology:
We searched for clinical trials and systematic reviews with or without meta-analyses in the Cochrane Group Register and the MEDLINE database up to November
2013, comparing the two interventions mentioned. Results were expressed as a
rate of treatment failures or favorable response rates (clinical and
microbiological in both cases), and as the rate of adverse events. The analysis
was carried out considering the fixed and random effects models. The
significance level used in the test for heterogeneity was 0.05. Funnel plot was
used to search for publication bias. Results: 7 clinical trials were included
in the analysis and no significant difference was found for both interventions
regarding clinical and bacteriological response (RR = 1.02, 95% CI, 0.97-1.06,
p = 0.780 and RR = 1.02, 95% CI, 0.99-1.07, p = 0.228, respectively).
However, a significant difference was found in the comparison of adverse
effects, showing that amoxicillin/clavulanate has a significantly higher risk
of developing side effects than cefprozil (RR = 0.52, 95% CI, 0.45-0.59, p = 0.000).
Conclusion: Both treatments demonstrated equal clinical and microbiological efficacy.
However, the use of cefprozil is significantly associated with a lower risk of
adverse effects.