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. 2023 Oct 23;10(10):CD015252.
doi: 10.1002/14651858.CD015252.pub2.

Adenoidectomy for otitis media with effusion (OME) in children

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

Adenoidectomy for otitis media with effusion (OME) in children

Samuel MacKeith 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. Adenoidectomy has often been used as a potential treatment for this condition.

Objectives: To assess the benefits and harms of adenoidectomy, either alone or in combination with ventilation tubes (grommets), for OME 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Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials.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: 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 adenoidectomy (alone, or in combination with ventilation tubes) with either no treatment or non-surgical treatment.

Data collection and analysis: We used standard Cochrane methods. Primary outcomes (determined following a multi-stakeholder prioritisation exercise): 1) hearing, 2) otitis media-specific quality of life, 3) haemorrhage.

Secondary outcomes: 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, 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 included 10 studies (1785 children). Many of the studies used concomitant interventions for all participants, including insertion of ventilation tubes or myringotomy. All included studies had at least some concerns regarding the risk of bias. We report results for our main outcome measures at the longest available follow-up. We did not identify any data on disease-specific quality of life for any of the comparisons. Further details of additional outcomes and time points are reported in the review. 1) Adenoidectomy (with or without myringotomy) versus no treatment/watchful waiting (three studies) After 12 months there was little difference in the proportion of children whose hearing had returned to normal, but the evidence was very uncertain (adenoidectomy 68%, no treatment 70%; risk ratio (RR) 0.97, 95% confidence interval (CI) 0.65 to 1.46; number needed to treat to benefit (NNTB) 50; 1 study, 42 participants). There is a risk of haemorrhage from adenoidectomy, but the absolute risk appears small (1/251 receiving adenoidectomy compared to 0/229, Peto odds ratio (OR) 6.77, 95% CI 0.13 to 342.54; 1 study, 480 participants; moderate certainty evidence). The risk of persistent OME may be slightly lower after two years in those receiving adenoidectomy (65% versus 73%), but again the difference was small (RR 0.90, 95% CI 0.81 to 1.00; NNTB 13; 3 studies, 354 participants; very low-certainty evidence). 2) Adenoidectomy (with or without myringotomy) versus non-surgical treatment No studies were identified for this comparison. 3) Adenoidectomy and bilateral ventilation tubes versus bilateral ventilation tubes (four studies) There was a slight increase in the proportion of ears with a return to normal hearing after six to nine months (57% adenoidectomy versus 42% without, RR 1.36, 95% CI 0.98 to 1.89; NNTB 7; 1 study, 127 participants (213 ears); very low-certainty evidence). Adenoidectomy may give an increased risk of haemorrhage, but the absolute risk appears small, and the evidence was uncertain (2/416 with adenoidectomy compared to 0/375 in the control group, Peto OR 6.68, 95% CI 0.42 to 107.18; 2 studies, 791 participants). The risk of persistent OME was similar for both groups (82% adenoidectomy and ventilation tubes compared to 85% ventilation tubes alone, RR 0.96, 95% CI 0.86 to 1.07; very low-certainty evidence). 4) Adenoidectomy and unilateral ventilation tube versus unilateral ventilation tube (two studies) Slightly more children returned to normal hearing after adenoidectomy, but the confidence intervals were wide (57% versus 46%, RR 1.24, 95% CI 0.79 to 1.96; NNTB 9; 1 study, 72 participants; very low-certainty evidence). Fewer children may have persistent OME after 12 months, but again the confidence intervals were wide (27.2% compared to 40.5%, RR 0.67, 95% CI 0.35 to 1.29; NNTB 8; 1 study, 74 participants). We did not identify any data on haemorrhage. 5) Adenoidectomy and ventilation tubes versus no treatment/watchful waiting (two studies) We did not identify data on the proportion of children who returned to normal hearing. However, after two years, the mean difference in hearing threshold for those allocated to adenoidectomy was -3.40 dB (95% CI -5.54 to -1.26; 1 study, 211 participants; very low-certainty evidence). There may be a small reduction in the proportion of children with persistent OME after two years, but the evidence was very uncertain (82% compared to 90%, RR 0.91, 95% CI 0.82 to 1.01; NNTB 13; 1 study, 232 participants). We noted that many children in the watchful waiting group had also received surgery by this time point. 6) Adenoidectomy and ventilation tubes versus non-surgical treatment No studies were identified for this comparison.

Authors' conclusions: When assessed with the GRADE approach, the evidence for adenoidectomy in children with OME is very uncertain. Adenoidectomy may reduce the persistence of OME, although evidence about the effect of this on hearing is unclear. For patients and carers, a return to normal hearing is likely to be important, but few studies measured this outcome. We did not identify any evidence on disease-specific quality of life. There were few data on adverse effects, in particular postoperative bleeding. The risk of haemorrhage appears to be small, but should be considered when choosing a treatment strategy for children with OME. Future studies should aim to determine which children are most likely to benefit from treatment, rather than offering interventions to all children.

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Conflict of interest statement

Samuel MacKeith: treats patients with OME in his NHS and private practice and was Assistant Co‐ordinating Editor of Cochrane ENT (2020 to 2023), but was not involved in the editorial process for this review.

Caroline A Mulvaney: none known.

Kevin Galbraith: none known.

Katie Webster: none known.

Aye Paing: none known.

Rachel Connolly: none known.

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

Mat Daniel: 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
4
4
1.1
1.1. Analysis
Comparison 1: Adenoidectomy (with or without myringotomy) versus no treatment/watchful waiting, Outcome 1: Proportion of children whose hearing has returned to normal
1.2
1.2. Analysis
Comparison 1: Adenoidectomy (with or without myringotomy) versus no treatment/watchful waiting, Outcome 2: Serious adverse event: haemorrhage
1.3
1.3. Analysis
Comparison 1: Adenoidectomy (with or without myringotomy) versus no treatment/watchful waiting, Outcome 3: Presence or persistence of OME
1.4
1.4. Analysis
Comparison 1: Adenoidectomy (with or without myringotomy) versus no treatment/watchful waiting, Outcome 4: Sensitivity analysis: presence or persistence of OME (complete correlation between ears)
1.5
1.5. Analysis
Comparison 1: Adenoidectomy (with or without myringotomy) versus no treatment/watchful waiting, Outcome 5: Sensitivity analysis: presence or persistence of OME (no correlation between ears)
1.6
1.6. Analysis
Comparison 1: Adenoidectomy (with or without myringotomy) versus no treatment/watchful waiting, Outcome 6: Time with effusion
1.7
1.7. Analysis
Comparison 1: Adenoidectomy (with or without myringotomy) versus no treatment/watchful waiting, Outcome 7: Number of doctor‐diagnosed acute otitis media episodes
2.1
2.1. Analysis
Comparison 2: Adenoidectomy and bilateral ventilation tubes versus bilateral ventilation tubes only, Outcome 1: Return to normal hearing
2.2
2.2. Analysis
Comparison 2: Adenoidectomy and bilateral ventilation tubes versus bilateral ventilation tubes only, Outcome 2: Final hearing threshold
2.3
2.3. Analysis
Comparison 2: Adenoidectomy and bilateral ventilation tubes versus bilateral ventilation tubes only, Outcome 3: Serious adverse event: haemorrhage
2.4
2.4. Analysis
Comparison 2: Adenoidectomy and bilateral ventilation tubes versus bilateral ventilation tubes only, Outcome 4: Presence/persistence of OME
2.5
2.5. Analysis
Comparison 2: Adenoidectomy and bilateral ventilation tubes versus bilateral ventilation tubes only, Outcome 5: Time with effusion
2.6
2.6. Analysis
Comparison 2: Adenoidectomy and bilateral ventilation tubes versus bilateral ventilation tubes only, Outcome 6: Sensitivity analysis: return to normal hearing ICC 0
2.7
2.7. Analysis
Comparison 2: Adenoidectomy and bilateral ventilation tubes versus bilateral ventilation tubes only, Outcome 7: Sensitivity analysis: return to normal hearing ICC 1
2.8
2.8. Analysis
Comparison 2: Adenoidectomy and bilateral ventilation tubes versus bilateral ventilation tubes only, Outcome 8: Sensitivity analysis: presence/persistence of OME ICC 0
2.9
2.9. Analysis
Comparison 2: Adenoidectomy and bilateral ventilation tubes versus bilateral ventilation tubes only, Outcome 9: Sensitivity analysis: presence/persistence of OME ICC 1
3.1
3.1. Analysis
Comparison 3: Adenoidectomy and unilateral ventilation tube versus unilateral ventilation tube only, Outcome 1: Return to normal hearing (medium‐term)
3.2
3.2. Analysis
Comparison 3: Adenoidectomy and unilateral ventilation tube versus unilateral ventilation tube only, Outcome 2: Hearing threshold
3.3
3.3. Analysis
Comparison 3: Adenoidectomy and unilateral ventilation tube versus unilateral ventilation tube only, Outcome 3: Presence or persistence of OME
3.4
3.4. Analysis
Comparison 3: Adenoidectomy and unilateral ventilation tube versus unilateral ventilation tube only, Outcome 4: Adverse events: tympanosclerosis
3.5
3.5. Analysis
Comparison 3: Adenoidectomy and unilateral ventilation tube versus unilateral ventilation tube only, Outcome 5: Adverse events: perforation/retraction
4.1
4.1. Analysis
Comparison 4: Adenoidectomy and ventilation tubes versus no treatment/watchful waiting, Outcome 1: Hearing threshold
4.2
4.2. Analysis
Comparison 4: Adenoidectomy and ventilation tubes versus no treatment/watchful waiting, Outcome 2: Presence/persistence of OME
4.3
4.3. Analysis
Comparison 4: Adenoidectomy and ventilation tubes versus no treatment/watchful waiting, Outcome 3: Time with effusion
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD015252

References

References to studies included in this review

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Ardehali 2008 {published data only}
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Mattila 2003 {published data only}
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Maw 1993 {published data only}
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Maw 1999 {published data only}
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MRC Multicentre Otitis Media Study 2004 {published data only}
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NCT00629694 {published data only}
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NCT04302337 {published data only}
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NCT04584073 {published data only}
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Paradise 1980 {published data only}
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Paradise 1997 {published data only}
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Parker 1989 {published data only}
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Shishegar 2007 {published data only}
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Shubich 1996 {published data only}
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Stenstrom 2005 {published data only}
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Tao 2020 {published data only}
    1. Tao J, Luo R, Chen Y, Hou C, Qin H. Myringotomy or tympanostomy tube insertion, comparison of surgical treatment of adenoid hypertrophy and otitis media with effusion in children. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke za Zhi [Journal of Clinical Otorhinolaryngology, Head, and Neck Surgery] 2020;34(3):207-10. [CENTRAL: CN-02183648] [EMBASE: 632817486] [PMID: ] - PMC - PubMed
Velepic 2011 {published data only}
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Worley 2007 {published data only}
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References to studies awaiting assessment

Diacova 2016 {published data only}
    1. Diacova S, McDonald TJ, Ababii I. Clinical, functional, and surgical findings in chronic bilateral otitis media with effusion in childhood. Ear, Nose, & Throat Journal 2016;95(8):E31-7. [CENTRAL: CN-01339417] [EMBASE: 614412861] [PMID: ] - PubMed
Marshak 1980 {published data only}
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Maw 1986 {published data only}
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Tawfik 2002 {published data only}
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References to ongoing studies

ACTRN12611000380998 {published data only}
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NCT05545345 {published data only}
    1. NCT05545345. Adjuvant adenoidectomy for the treatment of chronic OME in children [Adjuvant adenoidectomy plus tympanostomy tube placement for the treatment of chronic OME in children]. https://clinicaltrials.gov/show/NCT05545345 (first received 2022). [CENTRAL: CN-02462316]

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References to other published versions of this review

MacKeith 2022b
    1. MacKeith S, Mulvaney CA, Galbraith K, Marom T, Daniel M, Venekamp RP, et al. Adenoidectomy for otitis media with effusion (OME) in children. Cochrane Database of Systematic Reviews 2022, Issue 4. Art. No: CD015252. [DOI: 10.1002/14651858.CD015252] - DOI - PMC - PubMed

Publication types