Systematic reviewindependent cross-checkabstract only checked★ key study I-ABX-09 in-depth review
Antibiotics for children's ear infections (Cochrane 2023)
Antibiotics for acute otitis media in children.
Overview
Venekamp RP et al.. Cochrane Database Syst Rev 2023 · PMID 37965923 · DOI 10.1002/14651858.CD000219.pub5
Antibiotics helped only a little with pain and caused side effects; serious complications were rare either way.
Does the study support the specific claim? Partly · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Assess antibiotics in AOM.
- How was the study done?
Cochrane review.
- How many people, animals or samples were studied?
13 RCTs.
- What was actually found?
Small benefit, some harm.
- How large was the observed effect?
NNTB 20, NNTH 14.
- What do the results mean in everyday life?
Many ear infections heal alone.
- What are the study's limitations?
High-income only.
- What does it say about Elawady's specific claim?
Supports 'often unnecessary', not 'never'.
- Do the results apply to Germany and Europe?
High.
- What can explicitly not be concluded from this study?
Serious infections.
Scientific in-depth review
1. Full reference
- Authors
- Venekamp RP et al.
- Journal
- Cochrane Database Syst Rev
- Year
- 2023
- Identifier
- PMID 37965923 DOI 10.1002/14651858.CD000219.pub5
- Verification
- verified – PubMed efetch 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Maroeska M Rovers has participated in workshops and educational activities on otitis media organised by GlaxoSmithKline and received a grant from GlaxoSmithKline for a study on the microbiology of otitis media in 2009. Roderick P Venekamp is an Editor for Cochrane Acute Respiratory Infections and Cochrane ENT. Sharon L Sanders declares no conflicts of interests in the current work. Paul P Glasziou is a co‐investigator on a NHMRC‐funded grant Antibiotic Resistance.
2. Research question
Effects of antibiotics for acute otitis media in children
3. Study design and population
- Study design
- Systematic review – Cochrane systematic review of RCTs (GRADE)
- Population
Children with AOM
- Country
High-income countries
- Period
search to Feb 2023
- Sample size
13 placebo trials (3401 children); 6 trials vs expectant observation (1556)
- Inclusion and exclusion criteria
RCTs
4. Methods and endpoints
- Exposure / intervention
Antibiotics
- Comparator
Placebo; expectant observation
- Endpoints
Pain, adverse events, complications
- Statistical methods
Risk ratios, NNTB/NNTH
5. Actual results
- Results
Pain 24 h RR 0.89 (0.78-1.01); 2-3 days RR 0.71 (0.58-0.88), NNTB 20; adverse events RR 1.38 (1.16-1.63), NNTH 14; perforation RR 0.43, NNTB 33; contralateral otitis RR 0.49; severe complications rare and not different.
- Absolute risks
NNTB 20 (pain at 2-3 days); NNTH 14 (adverse events).
- Authors' conclusion
Modest benefits weighed against adverse effects (stated per outcomes in abstract).
6. Strengths
- Cochrane, RCTs, GRADE
7. Weaknesses
- High-income settings only
8. Risk of bias
- Orienting tool
- AMSTAR 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Trials generally low risk of bias.
9. Assessment of the statistical interpretation
10. Relevance to the specific claim
Partly supports C-ABX-12's kernel (many mild infections do not need antibiotics).
11. Independent contrary findings
12. Transferability to Germany and Europe
High.
13. Overall methodological judgement
Shows antibiotics are often not needed for mild AOM - supports stewardship, not abstention in serious infection.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | high |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Low-income settings.