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. 2023 Sep 26;9(9):CD015253.
doi: 10.1002/14651858.CD015253.pub2.

Autoinflation for otitis media with effusion (OME) in children

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

Autoinflation for otitis media with effusion (OME) in children

Katie E Webster 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 behavioural problems and a delay in expressive language skills. Management of OME includes watchful waiting, medical, surgical and mechanical treatment. Autoinflation is a self-administered technique, which aims to ventilate the middle ear and encourage middle ear fluid clearance by providing a positive pressure of air in the nose and nasopharynx (using a nasal balloon or other handheld device). This positive pressure (sometimes combined with simultaneous swallow) encourages opening of the Eustachian tube and may help ventilate the middle ear.

Objectives: To assess the efficacy (benefits and harms) of autoinflation for the treatment of otitis media with effusion in children.

Search methods: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 20 January 2023.

Selection criteria: We included randomised controlled trials (RCTs) and quasi-randomised trials in children aged 6 months to 12 years with unilateral or bilateral OME. We included studies that compared autoinflation with either watchful waiting (no treatment), non-surgical treatment or ventilation tubes.

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) OME-specific quality of life and 3) pain and distress. Secondary outcomes were: 1) persistence of OME, 2) other adverse effects (including eardrum perforation), 3) compliance or adherence to treatment, 4) receptive language skills, 5) speech development, 6) cognitive development, 7) psychosocial skills, 8) listening skills, 9) generic health-related quality of life, 10) parental stress, 11) vestibular function and 12) 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 11 completed studies that met our inclusion criteria (1036 participants). The majority of studies included children aged between 3 and 11 years. Most were carried out in Europe or North America, and they were conducted in both hospital and community settings. All compared autoinflation (using a variety of different methods and devices) to no treatment. Most studies required children to carry out autoinflation two to three times per day, for between 2 and 12 weeks. The outcomes were predominantly assessed just after the treatment phase had been completed. Here we report the effects at the longest follow-up for our main outcome measures. Return to normal hearing The evidence was very uncertain regarding the effect of autoinflation on the return to normal hearing. The longest duration of follow-up was 11 weeks. At this time point, the risk ratio was 2.67 in favour of autoinflation (95% confidence interval (CI) 1.73 to 4.12; 85% versus 32%; number needed to treat to benefit (NNTB) 2; 1 study, 94 participants), but the certainty of the evidence was very low. Disease-specific quality of life Autoinflation may result in a moderate improvement in quality of life (related to otitis media) after short-term follow-up. One study assessed quality of life using the Otitis Media Questionnaire-14 (OMQ-14) at three months of follow-up. Results were reported as the number of standard deviations above or below zero difference, with a range from -3 (better) to +3 (worse). The mean difference was -0.42 lower (better) for those who received autoinflation (95% CI -0.62 to -0.22; 1 study, 247 participants; low-certainty evidence; the authors report a change of 0.3 as clinically meaningful). Pain and distress caused by the procedure Autoinflation may result in an increased risk of ear pain, but the evidence was very uncertain. One study assessed this outcome, and identified a risk ratio of 3.50 for otalgia in those who received autoinflation, although the overall occurrence of pain was low (95% CI 0.74 to 16.59; 4.4% versus 1.3%; number needed to treat to harm (NNTH) 32; 1 study, 320 participants; very low-certainty evidence). Persistence of OME The evidence suggests that autoinflation may slightly reduce the persistence of OME at three months. Four studies were included, and the risk ratio for persistence of OME was 0.88 for those receiving autoinflation (95% CI 0.80 to 0.97; 4 studies, 483 participants; absolute reduction of 89 people per 1000 with persistent OME; NNTB 12; low-certainty evidence).

Authors' conclusions: All the evidence we identified was of low or very low certainty, meaning that we have little confidence in the estimated effects. However, the data suggest that autoinflation may have a beneficial effect on OME-specific quality of life and persistence of OME in the short term, but the effect is uncertain for return to normal hearing and adverse effects. The potential benefits should be weighed against the inconvenience of regularly carrying out autoinflation, and the possible risk of ear pain.

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Conflict of interest statement

Katie Webster: none known.

Caroline A Mulvaney: none known.

Kevin Galbraith: none known.

Mridul Rana: none known.

Samuel MacKeith: treats patients with OME in his NHS and private practice and is Assistant Co‐ordinating Editor of Cochrane ENT but has not been involved in the editorial process for this review.

Tal Marom: treats patients with OME in his public sector and private practice.

Mat Daniel: treats patients with OME in his NHS practice. He has a financial interest in Aventamed, a company that produces a ventilation tube insertion device.

Roderick P Venekamp: is an Editor for Cochrane Acute Respiratory Infections and Cochrane ENT, but had no role in the editorial process for this review.

Anne GM Schilder: Professor Anne Schilder was joint Co‐ordinating Editor of Cochrane ENT until April 2020, but had no role in the editorial process for this review. She 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. She is the 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.

Figures

1
1
The Cochrane Pregnancy and Childbirth Trustworthiness Screening Tool
2
2
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: Autoinflation versus watchful waiting/no treatment, Outcome 1: Proportion of children whose hearing is normal (very short‐term, < 6 weeks)
1.2
1.2. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 2: Proportion of children whose hearing is normal (short‐term, > 6 weeks to ≤ 3 months)
1.3
1.3. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 3: Hearing threshold (very short‐term, < 6 weeks)
1.4
1.4. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 4: Hearing threshold (short‐term, > 6 weeks to ≤ 3 months)
1.5
1.5. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 5: Disease‐specific quality of life (short‐term, > 6 weeks to ≤ 3 months)
1.6
1.6. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 6: Adverse events ‐ pain and distress caused by the procedure (otalgia)
1.7
1.7. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 7: Persistence of OME (very short‐term, < 6 weeks)
1.8
1.8. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 8: Persistence of OME (short‐term, > 6 weeks to ≤ 3 months)
1.9
1.9. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 9: Episodes of acute otitis media (short‐term, > 6 weeks to ≤ 3 months)
1.10
1.10. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 10: Sensitivity analysis: Proportion of children whose hearing is normal (very short‐term, < 6 weeks). Per ear data (ICC of 1, complete correlation between ears)
1.11
1.11. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 11: Sensitivity analysis: Proportion of children whose hearing is normal (very short‐term, < 6 weeks). Per ear data (ICC of 0, no correlation between ears)
1.12
1.12. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 12: Sensitivity analysis: Hearing threshold (short‐term, > 6 weeks to ≤ 3 months). Right ear data
1.13
1.13. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 13: Sensitivity analysis: Hearing threshold (short‐term, > 6 weeks to ≤ 3 months). Left ear data
1.14
1.14. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 14: Sensitivity analysis: Persistence of OME (very short‐term, < 6 weeks). Per ear data (ICC of 0)
1.15
1.15. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 15: Sensitivity analysis: Persistence of OME (very short‐term, < 6 weeks). Per ear data (ICC of 1)
1.16
1.16. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 16: Sensitivity analysis: Persistence of OME (very short‐term, < 6 weeks). Per child data, where available
1.17
1.17. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 17: Sensitivity analysis: Persistence of OME (short‐term, > 6 weeks to ≤ 3 months). Per ear data (ICC of 0)
1.18
1.18. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 18: Sensitivity analysis: Persistence of OME (short‐term, > 6 weeks to ≤ 3 months). Per ear data (ICC of 1)
1.19
1.19. Analysis
Comparison 1: Autoinflation versus watchful waiting/no treatment, Outcome 19: Sensitivity analysis: Persistence of OME (short‐term, > 6 weeks to ≤ 3 months). Per child data, where available
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD015253

References

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References to ongoing studies

INFLATE (ACTRN12617001652369) {published data only}
    1. ACTRN12617001652369. Autoinflation for Aboriginal and Torres Strait Islander children with bilateral OME (middle ear infection) [A multi-centre randomised controlled trial to compare the efficacy of nasal balloon autoinflation versus no nasal balloon autoinflation for bilateral otitis media with effusion in Aboriginal and Torres Strait Islander children]. http://www.who.int/trialsearch/Trial2.aspx?TrialID=ACTRN12617001652369 (first received 2017). [CENTRAL: CN-01896354]
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NCT00393159 {published data only}
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NCT02038400 {published data only}
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NCT05324696 {published data only}
    1. NCT05324696. Autoinflation: alternative in the treatment of otitis media with effusion (OME). https://clinicaltrials.gov/show/NCT05324696 (first received 12 April 2022). Accessed 15/01/2023.

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References to other published versions of this review

Galbraith 2022
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