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

Original publication

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
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualityhigh
Risk of biaslow
Precision of resultshigh
Directnessdirect
Reproducibilityreplicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

Low-income settings.

15. Linked fact checks