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Antibiotic adverse effects in pediatric acute rhinosinusitis: Systematic review and meta-analysis
Lucas G Axiotakis1, Betsy Szeto1, Joseph N Gonzalez1
1Department of Otolaryngology-Head and Neck Surgery, Columbia University Vagelos College of Physicians and Surgeons, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY, USA.
Insights
Adverse effects from oral antibiotics for pediatric acute bacterial rhinosinusitis (ABRS) are common, including diarrhea and abdominal pain. However, these side effects may not be significantly worse than placebo.
Area of Science:
- Pediatric infectious diseases
- Pharmacovigilance
- Systematic reviews and meta-analyses
Background:
- Pediatric acute bacterial rhinosinusitis (ABRS) treatment commonly involves oral antibiotics.
- Limited data exists on adverse effects (AEs) across different oral antibiotic classes in pediatric ABRS.
- Understanding AEs is crucial for optimizing treatment strategies.
Purpose of the Study:
- To systematically review and meta-analyze the incidence of AEs associated with oral antibiotic use in pediatric ABRS.
- To characterize AE profiles for commonly prescribed antibiotic classes.
- To compare AE incidence between antibiotic treatments and placebo.
Main Methods:
- Systematic literature search of PubMed and Embase (1985-September 2020).
- Inclusion of English-language articles reporting AEs for oral antibiotic therapy in pediatric ABRS (0-18 years).
- Random-effects meta-analysis of prospective studies to estimate AE incidence.
Main Results:
- Eleven studies were included, reporting AEs for amoxicillin/clavulanate, amoxicillin, cephalosporins/carbacephems, and placebo.
- Diarrhea and abdominal pain were common with amoxicillin/clavulanate and amoxicillin.
- Rash incidence was low; overall AE incidence was non-zero for all treatments, including placebo.
- Antibiotic use was associated with a non-significant doubling of AE risk compared to placebo.
- High heterogeneity and risk of bias were noted in most studies.
Conclusions:
- AE reporting in pediatric ABRS literature is limited.
- Adverse effects associated with oral antibiotics in pediatric ABRS are non-negligible.
- The incidence of AEs from oral antibiotics may not significantly exceed placebo in pediatric ABRS.
Background:
Pediatric acute bacterial rhinosinusitis (ABRS) is often treated with oral antibiotics, with limited insight into adverse effects (AEs) across drug classes. In this systematic review and meta-analysis, we characterize AE incidence associated with oral antibiotics in these patients.
Methodology/Principal:
We searched PubMed and Embase for English-language articles published from 1985 to September 2020 reporting AEs of oral antibiotic therapy for ABRS patients aged 0-18 years. Six-hundred and sixty-six articles underwent title and abstract screening, identifying 154 articles for full-length review.
Results:
Eleven articles were included, most of which reported individual and aggregate AE incidences. Amoxicillin/clavulanate, amoxicillin, cephalosporin/carbacephem, and placebo groups were identified. Random-effects meta-analysis of prospective groups identified appreciable incidences of diarrhea and abdominal pain, and low incidence of rash, for amoxicillin-clavulanate and amoxicillin. All antibiotics as well as placebo were associated with non-zero overall AE incidence. Children receiving antibiotics were about twice as likely to incur any AE during treatment in placebo-controlled studies, though this association was not significant. High heterogeneity limited most point estimates, with risk of bias, typically in outcomes measurement, detected in most studies.
Conclusions:
Reporting of AEs associated with oral antibiotic use in pediatric ABRS is limited in current literature. Adverse effects are non-negligible, but may not significantly exceed placebo.
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