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Trans-Tympanic Drug Delivery for the Treatment of Ototoxicity
Published on: March 16, 2018
Antibiotic treatment to prevent pediatric acute otitis media infectious complications: A meta-analysis
Nicole E Smolinski1,2, Emma J Djabali3, Julie Al-Bahou1,4
1Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States of America.
Background:
Most US children with acute otitis media [AOM] receive prompt antibiotic treatment, though guidelines encourage watchful waiting. Previous systematic reviews of antibiotics versus watchful waiting have focused on symptom resolution and RCTs, limiting the assessment of serious, rare complications. We sought to evaluate these complications by including observational studies.
Methods:
RCTs and observational studies that compared antibiotics to placebo or watchful waiting for pediatric clinician diagnosed AOM were identified [PubMed/MEDLINE, Embase, Cochrane Database of Systematic Reviews, Central Register of Controlled Trials, and Web of Science] and reviewed for meta-analysis. Two reviewers independently extracted study characteristics, patient characteristics, and outcomes. We assessed publication bias, study bias with ROBINS-1 and RoB-2 and used random-effects models to assess treatment effects.
Results:
24 studies were included. Antibiotics decreased the risk of acute mastoiditis [incidence 0.02%, RR 0.48, 95% CI 0.40-0.59; NNT 5,368]. This protective effect may be underestimated because of misclassification of non-suppurative conditions as AOM. Intracranial complications remained too rare to assess. Antibiotics markedly increased the risk of adverse effects [incidence 10.5%, RR 1.49, 1.27-1.73; NNH 23]. Studies used non-specific criteria for acute mastoiditis, potentially underestimating treatment effects.
Conclusions:
Prompt antibiotic therapy reduces the risk for some AOM complications. The NNT to prevent serious, rare complications is high, while the NNH is relatively low. Large-scale population-based observational studies using real-world datasets with validated measures of severe complications are needed to improve understanding of risk factors for serious AOM complications, facilitate more selective antibiotic therapy, and optimize individual outcomes and public health.
Insights
Prompt antibiotics for acute otitis media (AOM) reduce mastoiditis risk but increase adverse effects. The number needed to treat for rare complications is high, while the number needed to harm is low, suggesting careful consideration of antibiotic use in children.
Area of Science:
- Pediatric infectious diseases
- Evidence-based medicine
- Pharmacovigilance
Background:
- US children with acute otitis media (AOM) often receive prompt antibiotics, contrary to guidelines favoring watchful waiting.
- Previous reviews focused on symptom resolution and RCTs, neglecting rare complications.
- This study incorporates observational data to assess serious AOM complications.
Purpose of the Study:
- To evaluate serious complications of acute otitis media (AOM) by comparing antibiotic treatment versus watchful waiting.
- To include observational studies alongside RCTs for a comprehensive risk-benefit analysis.
- To inform clinical practice and public health regarding antibiotic use in pediatric AOM.
Main Methods:
- Systematic review and meta-analysis of RCTs and observational studies comparing antibiotics to placebo or watchful waiting for pediatric AOM.
- Independent extraction of study and patient characteristics, and outcomes by two reviewers.
- Assessment of publication bias and study bias (ROBINS-1, RoB-2), using random-effects models for treatment effect estimation.
Main Results:
- Twenty-four studies were included in the meta-analysis.
- Antibiotics reduced the risk of acute mastoiditis (NNT 5,368), though this effect may be overestimated due to misclassification.
- Antibiotics significantly increased the risk of adverse effects (NNH 23), with an incidence of 10.5%.
Conclusions:
- Prompt antibiotic therapy for AOM offers a protective effect against certain complications like acute mastoiditis.
- The number needed to treat (NNT) for serious complications is high, while the number needed to harm (NNH) for adverse effects is low.
- Further large-scale, population-based observational studies with validated measures are crucial for refining antibiotic strategies and optimizing patient outcomes.
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