Abstract
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.
Highlights
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
Hedrick et al [16] divide the results of clinical response into two age groups: 6 months - 2 years old and 2 - 7 years old, while Aronovitz et al, Gehanno et al and Stutman et al divided the results according to the frequency of adverse effects in a group younger than 3 years and a group older than 3 years [12] [13] [20]
Analysis of the data showed that cefprozil has a lower risk of adverse effects compared with amoxicillin/clavulanate
Summary
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. 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). AOM is diagnosed by a physical examination in patients when there is a presence of middle ear effusion with sudden onset of inflammation and symptoms such as pain, irritability or fever [8]
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