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Meta-Analysis
. 2023 Oct 23;10(10):CD015254.
doi: 10.1002/14651858.CD015254.pub2.

Antibiotics for otitis media with effusion (OME) in children

Caroline A Mulvaney  1 , Kevin Galbraith  1 , Katie E Webster  1 , Mridul Rana  2 , Rachel Connolly  3 , Tal Marom  4 , Mat Daniel  5 , Roderick P Venekamp  6 , Anne Gm Schilder  7   8 , Samuel MacKeith  9
Affiliations
Meta-Analysis

Antibiotics for otitis media with effusion (OME) in children

Caroline A Mulvaney et al. Cochrane Database Syst Rev. .

Abstract

Background: Otitis media with effusion (OME) is an accumulation of fluid in the middle ear cavity, common amongst young children. The fluid may cause hearing loss. When persistent, it may lead to developmental delay, social difficulty and poor quality of life. Management of OME includes watchful waiting, autoinflation, medical and surgical treatment. Antibiotics are sometimes used to treat any bacteria present in the effusion, or associated biofilms.

Objectives: To assess the effects (benefits and harms) of oral antibiotics for otitis media with effusion (OME) in children.

Search methods: The Cochrane ENT Information Specialist searched the Cochrane ENT Register, CENTRAL, Ovid MEDLINE, Ovid Embase, Web of Science, ClinicalTrials.gov, ICTRP and additional sources for published and unpublished studies to 20 January 2023.

Selection criteria: We included randomised controlled trials and quasi-randomised trials in children aged 6 months to 12 years with unilateral or bilateral OME. We included studies that compared oral antibiotics with either placebo or no treatment.

Data collection and analysis: We used standard Cochrane methods. Our primary outcomes were determined following a multi-stakeholder prioritisation exercise and were: 1) hearing, 2) otitis media-specific quality of life and 3) anaphylaxis. Secondary outcomes were: 1) persistence of OME, 2) adverse effects, 3) receptive language skills, 4) speech development, 5) cognitive development, 6) psychosocial skills, 7) listening skills, 8) generic health-related quality of life, 9) parental stress, 10) vestibular function and 11) episodes of acute otitis media. We used GRADE to assess the certainty of evidence for each outcome. Although we included all measures of hearing assessment, the proportion of children who returned to normal hearing was our preferred method to assess hearing, due to challenges in interpreting the results of mean hearing thresholds.

Main results: We identified 19 completed studies that met our inclusion criteria (2581 participants). They assessed a variety of oral antibiotics (including penicillins, cephalosporins, macrolides and trimethoprim), with most studies using a 10- to 14-day treatment course. We had some concerns about the risk of bias in all studies included in this review. Here we report our primary outcomes and main secondary outcome, at the longest reported follow-up time. Antibiotics versus placebo We included 11 studies for this comparison, but none reported all of our outcomes of interest and limited meta-analysis was possible. Hearing One study found that more children may return to normal hearing by two months (resolution of the air-bone gap) after receiving antibiotics as compared with placebo, but the evidence is very uncertain (Peto odds ratio (OR) 9.59, 95% confidence interval (CI) 3.51 to 26.18; 20/49 children who received antibiotics returned to normal hearing versus 0/37 who received placebo; 1 study, 86 participants; very low-certainty evidence). Disease-specific quality of life No studies assessed this outcome. Presence/persistence of OME At 6 to 12 months of follow-up, the use of antibiotics compared with placebo may slightly reduce the number of children with persistent OME, but the confidence intervals were wide, and the evidence is very uncertain (risk ratio (RR) 0.89, 95% CI 0.68 to 1.17; 48% versus 54%; number needed to treat (NNT) 17; 2 studies, 324 participants; very low-certainty evidence). Adverse event: anaphylaxis No studies provided specific data on anaphylaxis. Three of the included studies (448 children) did report adverse events in sufficient detail to assume that no anaphylactic reactions occurred, but the evidence is very uncertain (very low-certainty evidence). Antibiotics versus no treatment We included eight studies for this comparison, but very limited meta-analysis was possible. Hearing One study found that the use of antibiotics compared to no treatment may result in little to no difference in final hearing threshold at three months (mean difference (MD) -5.38 dB HL, 95% CI -9.12 to -1.64; 1 study, 73 participants; low-certainty evidence). The only data identified on the return to normal hearing were reported at 10 days of follow-up, which we considered to be too short to accurately reflect the efficacy of antibiotics. Disease-specific quality of life No studies assessed this outcome. Presence/persistence of OME Antibiotics may reduce the proportion of children who have persistent OME at up to three months of follow-up, when compared with no treatment (RR 0.64, 95% CI 0.50 to 0.80; 6 studies, 542 participants; low-certainty evidence). Adverse event: anaphylaxis No studies provided specific data on anaphylaxis. Two of the included studies (180 children) did report adverse events in sufficient detail to assume that no anaphylactic reactions occurred, but the evidence is very uncertain (very low-certainty evidence).

Authors' conclusions: The evidence for the use of antibiotics for OME is of low to very low certainty. Although the use of antibiotics compared to no treatment may have a slight beneficial effect on the resolution of OME at up to three months, the overall impact on hearing is very uncertain. The long-term effects of antibiotics are unclear and few of the studies included in this review reported on potential harms. These important endpoints should be considered when weighing up the potential short- and long-term benefits and harms of antibiotic treatment in a condition with a high spontaneous resolution rate.

Trial registration: ClinicalTrials.gov NCT00539149.

PubMed Disclaimer

Conflict of interest statement

Caroline A Mulvaney: none known.

Kevin Galbraith: none known.

Katie Webster: none known.

Mridul Rana: no relevant interests; core surgical trainee, Oxford University Hospitals.

Rachel Connolly: National Institute for Health and Care Excellence (employment: systematic reviewer on the upcoming NICE guideline on otitis media with effusion in under 12s).

Tal Marom: no relevant interests; attending otolaryngologist.

Mat Daniel: Aventa Med (stock; consultant); Nottingham University Hospitals NHS Trust (employment: ENT consultant); has published research papers relevant to the interventions in the work; co‐author of the TARGET trial.

Roderick P Venekamp: no relevant interests; works as a GP; editorial board member of Cochrane ARI and Cochrane ENT, but had no role in the editorial process for this review.

Anne GM Schilder: Joint Co‐ordinating Editor of Cochrane ENT until April 2020, but had no role in the editorial process for this review; treats patients with OME in her NHS practice; her evidENT team at the UCL Ear Institute is supported by the National Institute of Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC), with research projects being supported by the NIHR, Wellcome Trust, RNiD, ENT UK and industry; National Specialty Lead for the NIHR Clinical Research Network ENT and Surgical Specialty Lead for ENT for the Royal College of Surgeons of England's Clinical Research Initiative; in her role as Director of the NIHR UCLH BRC Deafness and Hearing Problems Theme, she advises CRO, biotech and pharma companies in the hearing field on clinical trial design and delivery.

Samuel MacKeith: ENT private practice (employment); sees patients with general ENT problems in NHS and private practice; Assistant Co‐ordinating Editor of Cochrane ENT 2020 to 2023, but had no role in the editorial process for this review.

Figures

1
1
The Cochrane Pregnancy and Childbirth Trustworthiness Screening Tool
2
2
A flow chart of study retrieval and selection.
3
3
Risk of bias graph (our judgements about each risk of bias item presented as percentages across all included studies).
4
4
Risk of bias summary (our judgements about each risk of bias item for each included study).
1.1
1.1. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 1: Normal hearing (as complete improvement in air‐bone gap in worst ear): short‐term
1.2
1.2. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 2: Hearing threshold: speech reception threshold (short‐term). Correction of variance assuming correlation coefficient of 0.5
1.3
1.3. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 3: Sensitivity analysis: speech reception threshold: assuming correlation coefficient of 0.3
1.4
1.4. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 4: Sensitivity analysis: speech reception threshold: assuming correlation coefficient of 0.7
1.5
1.5. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 5: Hearing threshold: speech awareness threshold (short‐term)
1.6
1.6. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 6: Persistence of OME (short‐term)
1.7
1.7. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 7: Sensitivity analysis: persistence (short‐term) including cases of acute otitis (Mandel 1987)
1.8
1.8. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 8: Sensitivity analysis: persistence (short‐term) assuming ICC of 1.0 (complete correlation between ears) (Puhakka 1985)
1.9
1.9. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 9: Sensitivity analysis: persistence (short‐term) assuming ICC of zero (no correlation between ears) (Puhakka 1985)
1.10
1.10. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 10: Persistence of OME (medium‐term)
1.11
1.11. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 11: Sensitivity analysis: persistence of OME (medium‐term); defined as 'OME' or 'AOM without perforation' (Leach 2008)
1.12
1.12. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 12: Adverse event: eardrum perforation
1.13
1.13. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 13: Adverse event: 'gastrointestinal'
1.14
1.14. Analysis
Comparison 1: Antibiotic versus placebo, Outcome 14: Episodes of acute otitis media
2.1
2.1. Analysis
Comparison 2: Antibiotic versus no treatment, Outcome 1: Hearing returned to normal (very short‐term)
2.2
2.2. Analysis
Comparison 2: Antibiotic versus no treatment, Outcome 2: Final hearing threshold (short‐term)
2.3
2.3. Analysis
Comparison 2: Antibiotic versus no treatment, Outcome 3: Persistence of OME (short‐term)
2.4
2.4. Analysis
Comparison 2: Antibiotic versus no treatment, Outcome 4: Sensitivity analysis 1: persistence of OME (short‐term). ICC = zero
2.5
2.5. Analysis
Comparison 2: Antibiotic versus no treatment, Outcome 5: Sensitivity analysis 2: persistence of OME (short‐term). ICC = 1.0
2.6
2.6. Analysis
Comparison 2: Antibiotic versus no treatment, Outcome 6: Episodes of acute otitis media (short‐term)
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD015254

References

References to studies included in this review

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de Castro 1982 {published data only}
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Kobayashi 2001 {published data only}
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Leonetti 1988 {published data only}
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Marks 1981 {published data only}
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Paradise 1997 {published data only}
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Parlea 2012 {published data only}
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Perrin 1974 {published data only}
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Persico 1978 {published data only}
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Principi 1989 {published data only}
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Roark 1997 {published data only}
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Rohail 2006 {published data only}
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Schloss 1988 {published data only}
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Schwartz 1982 {published data only}
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Schwartz 1982a {published data only}
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Shubich 1996 {published data only}
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Smales 1992 {published data only}
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Stenstrom 2005 {published data only}
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Tracy 1995 {published data only}
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van Balen 1997 {published data only}
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Varsano 1985 {published data only}
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Velepic 2011 {published data only}
    1. Velepic M, Starcevic R, Bonifacic M, Ticac R, Kujundzic M, Udovic DS, et al. The clinical status of the eardrum: an inclusion criterion for the treatment of chronic secretory otitis media in children. International Journal of Pediatric Otorhinolaryngology 2011;75(5):686-90. [CENTRAL: CN-00784332] [EMBASE: 51315541] [PMID: ] - PubMed
Yeldandi 2001 {published data only}
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Yin 2002 {published data only}
    1. Yin TF, Tang QL, Xie DH, Lu YD. Efficacy of cefaclor in treating children with secretory otitis media. Shanghai Medicine 2002;23(2):65-6. [CENTRAL: CN-00416980]
Zocconi 1994 {published data only}
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References to studies awaiting assessment

Koay 1998 {published data only}
    1. Koay B, Commins DJ, Bates S, Mitchell B, Moore A, Bates G, et al. In search of a medical treatment for otitis media with effusion (OME): a randomised double-blind controlled trial (RCT). In: 7th International Congress of Pediatric Otorhinolaryngology. Helsinki, Finland, 7-10 June, 1998. 1998:64. [ABSTRACT NUMBER: 289] [CENTRAL: CN-00292550]
Tawfik 2002 {published data only}
    1. Tawfik S, Belal A, Sorour W. A comparative study of the different treatment modalities of otitis media with effusion in children. In: 8th International Congress of Paediatric Otorhinolaryngology (ESPO). Oxford, UK, 11-14 September, 2002. 2002:151, Abstract No. P2.26. [CENTRAL: CN-00508402]

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References to other published versions of this review

Mulvaney 2022b
    1. Mulvaney CA, Galbraith K, MacKeith S, Marom T, Daniel M, Venekamp RP, et al. Antibiotics for otitis media with effusion (OME) in children. Cochrane Database of Systematic Reviews 2022, Issue 4. Art. No: CD015254. [DOI: 10.1002/14651858.CD015254] - DOI - PMC - PubMed
Venekamp 2016
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