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. 2023 Dec 13;12(12):CD015255.
doi: 10.1002/14651858.CD015255.pub2.

Topical and oral steroids 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 , Ben Tudor-Green  4 , Tal Marom  5 , Mat Daniel  6 , Roderick P Venekamp  7 , Anne Gm Schilder  8   9 , Samuel MacKeith  10
Affiliations

Topical and oral steroids 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. Although most episodes of OME in children resolve spontaneously within a few months, when persistent it may lead to behavioural problems and a delay in expressive language skills. Management of OME includes watchful waiting, medical, surgical and other treatments, such as autoinflation. Oral or topical steroids are sometimes used to reduce inflammation in the middle ear.

Objectives: To assess the effects (benefits and harms) of topical and oral steroids for OME in children.

Search methods: We searched the Cochrane ENT Register, CENTRAL, Ovid MEDLINE, Ovid Embase, Web of Science, ClinicalTrials.gov, ICTRP and additional sources for published and unpublished studies on 20 January 2023.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 topical or oral steroids with either placebo or watchful waiting (no treatment).

Data collection and analysis: We used standard Cochrane methods. Our primary outcomes, determined by a multi-stakeholder prioritisation exercise, were: 1) hearing, 2) OME-specific quality of life and 3) systemic corticosteroid side effects. Secondary outcomes were: 1) presence/persistence of OME, 2) other adverse effects (including local nasal effects), 3) receptive language skills, 4) speech development, 5) cognitive development, 6) psychosocial outcomes, 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. 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 26 studies in this review (2770 children). Most studies of oral steroids used prednisolone for 7 to 14 days. Studies of topical (nasal) steroids used various preparations (beclomethasone, fluticasone and mometasone) for between two weeks and three months. All studies had at least some concerns regarding risk of bias. Here we report our primary outcomes and main secondary outcome, at the longest reported follow-up. Oral steroids compared to placebo Oral steroids probably result in little or no difference in the proportion of children with normal hearing after 12 months (69.7% of children with steroids, compared to 61.1% of children receiving placebo, risk ratio (RR) 1.14, 95% confidence interval (CI) 0.97 to 1.33; 1 study, 332 participants; moderate-certainty evidence). There is probably little or no difference in OME-related quality of life (mean difference (MD) in OM8-30 score 0.07, 95% CI -0.2 to 0.34; 1 study, 304 participants; moderate-certainty evidence). Oral steroids may reduce the number of children with persistent OME at 6 to 12 months, but the size of the effect was uncertain (absolute risk reduction ranging from 13.3% to 45%, number needed to treat (NNT) of between 3 and 8; low-certainty evidence). The evidence was very uncertain regarding the risk of systemic corticosteroid side effects, and we were unable to conduct any meta-analysis for this outcome. Oral steroids compared to no treatment Oral steroids may result in little or no difference in the persistence of OME after three to nine months (74.5% children receiving steroids versus 73% of those receiving placebo; RR 1.02, 95% CI 0.89 to 1.17; 2 studies, 258 participants; low-certainty evidence). The evidence on adverse effects was very uncertain. We did not identify any evidence on hearing or disease-related quality of life. Topical (intranasal) steroids compared to placebo We did not identify data on the proportion of children who returned to normal hearing. However, the mean change in hearing threshold after two months was -0.3 dB lower (95% CI -6.05 to 5.45; 1 study, 78 participants; very low-certainty evidence). The evidence suggests that nasal steroids make little or no difference to disease-specific quality of life after nine months (OM8-30 score, MD 0.05 higher, 95% CI -0.36 to 0.46; 1 study, 82 participants; low-certainty evidence). The evidence is very uncertain regarding the effect of nasal steroids on persistence of OME at up to one year. Two studies reported this: one showed a potential benefit for nasal steroids, the other showed a benefit with placebo (2 studies, 206 participants). The evidence was also very uncertain regarding the risk of corticosteroid-related side effects, as we were unable to provide a pooled effect estimate. Topical (intranasal) steroids compared to no treatment We did not identify data on the proportion of children who returned to normal hearing. However, the mean difference in final hearing threshold after four weeks was 1.95 dB lower (95% CI -3.85 to -0.05; 1 study, 168 participants; low-certainty evidence). Nasal steroids may reduce the persistence of OME after eight weeks, but the evidence was very uncertain (58.5% of children receiving steroids, compared to 81.3% of children without treatment, RR 0.72, 95% CI 0.57 to 0.91; 2 studies, 134 participants). We did not identify any evidence on disease-related quality of life or adverse effects.

Authors' conclusions: Overall, oral steroids may have little effect in the treatment of OME, with little improvement in the number of children with normal hearing and no effect on quality of life. There may be a reduction in the proportion of children with persistent disease after 12 months. However, this benefit may be small and must be weighed against the potential for adverse effects associated with oral steroid use. The evidence for nasal steroids was all low- or very low-certainty. It is therefore less clear if nasal steroids have any impact on hearing, quality of life or persistence of OME. Evidence on adverse effects was very limited. OME is likely to resolve spontaneously for most children. The potential benefit of treatment may therefore be small and should be balanced with the risk of adverse effects. Future studies should aim to determine which children are most likely to benefit from treatment, rather than offering interventions to all children.

Trial registration: ClinicalTrials.gov NCT03590912 NCT02541760 NCT00279916.

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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).

Ben Tudor‐Green: none known.

Tal Marom: no relevant interests; attending otolaryngologist.

Mat Daniel: Aventamed (stock; consultant); has published research papers relevant to the interventions in the work; ENT consultant; 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; sees patients with general ENT problems in NHS and private practice; Assistant Co‐ordinating Editor of Cochrane ENT (now closed), but was not involved in the editorial process for this review.

Figures

1
1
The Cochrane Pregnancy and Childbirth Trustworthiness Screening Tool
2
2
PRISMA flow diagram
3
3
4
4
1.1
1.1. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 1: Normal hearing (very short‐term ‐ up to 6 weeks)
1.2
1.2. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 2: Normal hearing (very short‐term ‐ up to 6 weeks, adjusted OR)
1.3
1.3. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 3: Normal hearing defined as complete improvement in air‐bone gap (short‐term ‐ up to 3 months)
1.4
1.4. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 4: Normal hearing (medium‐term ‐ up to 1 year)
1.5
1.5. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 5: Hearing threshold (very short‐term ‐ up to 6 weeks)
1.6
1.6. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 6: Hearing threshold (difference in adjusted mean, very short‐term ‐ up to 6 weeks)
1.7
1.7. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 7: Disease‐specific quality of life (very short‐term ‐ up to 6 weeks)
1.8
1.8. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 8: Disease‐specific quality of life (medium‐term ‐ up to 1 year)
1.9
1.9. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 9: Persistence of OME (very short‐term ‐ up to 6 weeks)
1.10
1.10. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 10: Sensitivity analysis: persistence of OME (very short‐term); persistence in all affected ears (Berman 1990)
1.11
1.11. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 11: Sensitivity analysis: persistence of OME (very short‐term); effusion in both ears (Niederman 1984)
1.12
1.12. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 12: Persistence of OME (short‐term ‐ up to 3 months); ICC = 0.5
1.13
1.13. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 13: Sensitivity analysis: persistence of OME (short‐term); ICC = 1.0
1.14
1.14. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 14: Sensitivity analysis: persistence of OME (short‐term); ICC = zero
1.15
1.15. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 15: Sensitivity analysis: persistence of OME (short‐term); persistence in all affected ears (Macknin 1985)
1.16
1.16. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 16: Persistence of OME (medium‐term ‐ up to 1 year)
1.17
1.17. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 17: Acute otitis media (very short‐term ‐ up to 6 weeks)
1.18
1.18. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 18: Generic health‐related quality of life (PedsQL, very short‐term ‐ up to 6 weeks)
1.19
1.19. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 19: Generic health‐related quality of life (PedsQL, medium‐term ‐ up to 1 year)
1.20
1.20. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 20: Generic health‐related quality of life (HU13, very short‐term ‐ up to 6 weeks)
1.21
1.21. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 21: Generic health‐related quality of life (HU13, medium‐term ‐ up to 1 year)
1.22
1.22. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 22: Subgroup analysis: normal hearing: allergy versus none (very short‐term ‐ up to 6 weeks)
1.23
1.23. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 23: Subgroup analysis: persistence of OME: allergy versus none (very short‐term ‐ up to 6 weeks)
1.24
1.24. Analysis
Comparison 1: Oral steroid versus placebo, Outcome 24: Subgroup analysis: persistence of OME: age < 4 versus ≥ 4 (very short‐term ‐ up to 6 weeks)
2.1
2.1. Analysis
Comparison 2: Oral steroid versus no treatment, Outcome 1: Persistence of OME (very short‐term ‐ up to 6 weeks)
2.2
2.2. Analysis
Comparison 2: Oral steroid versus no treatment, Outcome 2: Persistence of OME (short‐term ‐ up to 3 months)
2.3
2.3. Analysis
Comparison 2: Oral steroid versus no treatment, Outcome 3: Persistence of OME (medium‐term ‐ up to 1 year)
3.1
3.1. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 1: Change in hearing threshold (short‐term ‐ up to 3 months); ICC = 0.5
3.2
3.2. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 2: Sensitivity analysis: change in hearing threshold (short‐term); ICC = 1.0
3.3
3.3. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 3: Sensitivity analysis: change in hearing threshold (short‐term); ICC = zero
3.4
3.4. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 4: Final hearing threshold (short‐term ‐ up to 3 months)
3.5
3.5. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 5: Disease‐specific quality of life (short‐term ‐ up to 3 months)
3.6
3.6. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 6: Disease‐specific quality of life (medium‐term ‐ up to 1 year)
3.7
3.7. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 7: Persistence of OME (very short‐term ‐ up to 6 weeks); ICC = 0.5
3.8
3.8. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 8: Sensitivity analysis: persistence of OME (very short‐term); ICC = 1.0
3.9
3.9. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 9: Sensitivity analysis: persistence of OME (very short‐term); ICC = zero
3.10
3.10. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 10: Persistence of OME (short‐term ‐ up to 3 months)
3.11
3.11. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 11: Sensitivity analysis: persistence of OME (short‐term); ICC = 1.0
3.12
3.12. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 12: Sensitivity analysis: persistence of OME (short‐term); ICC = zero
3.13
3.13. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 13: Persistence of OME (medium‐term ‐ up to 1 year)
3.14
3.14. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 14: Adverse event: nasal bleeding (medium‐term ‐ up to 1 year)
3.15
3.15. Analysis
Comparison 3: Nasal steroid versus placebo, Outcome 15: Generic health‐related quality of life (medium‐term ‐ up to 1 year)
4.1
4.1. Analysis
Comparison 4: Nasal steroid versus no treatment, Outcome 1: Final hearing threshold (very short‐term ‐ up to 6 weeks)
4.2
4.2. Analysis
Comparison 4: Nasal steroid versus no treatment, Outcome 2: Persistence of OME (very short‐term ‐ up to 6 weeks); ICC = 0.5
4.3
4.3. Analysis
Comparison 4: Nasal steroid versus no treatment, Outcome 3: Sensitivity analysis: persistence of OME (very short‐term); ICC = 1.0
4.4
4.4. Analysis
Comparison 4: Nasal steroid versus no treatment, Outcome 4: Sensitivity analysis: persistence of OME (very short‐term); ICC = zero
4.5
4.5. Analysis
Comparison 4: Nasal steroid versus no treatment, Outcome 5: Persistence of OME (short‐term ‐ up to 3 months); ICC = 0.5
4.6
4.6. Analysis
Comparison 4: Nasal steroid versus no treatment, Outcome 6: Sensitivity analysis: persistence of OME (short‐term); ICC = 1.0
4.7
4.7. Analysis
Comparison 4: Nasal steroid versus no treatment, Outcome 7: Sensitivity analysis: persistence of OME (short‐term); ICC = zero
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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    1. ISRCTN38988331. A double-blind randomised placebo-controlled trial of topical nasal steroids in 4-11 year old children with persistent bilateral Otitis Media with Effusion (OME) in primary care. https://www.isrctn.com/ISRCTN38988331 (first received 9 October 2003). [CENTRAL: CN-01013264]
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    1. Williamson I, Benge S, Barton S, Petrou S, Letley L, Fasey N, et al. A double-blind randomised placebo-controlled trial of topical intranasal corticosteroids in 4- to 11-year-old children with persistent bilateral otitis media with effusion in primary care. Health Technology Assessment (Winchester, England) 2009;13(37):1-144. [CENTRAL: CN-01705886] [EMBASE: 2009594755] [PMID: ] - PubMed
    1. Williamson I, Benge S, Barton S, Petrou S, Letley L, Fasey N, et al. Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial. BMJ (Clinical Research Ed.) 2009 Dec 16;339(7737):b4984. [CENTRAL: CN-00732682] [EMBASE: 358169071] [PMID: ] - PMC - PubMed

References to studies excluded from this review

Al‐Zaidi 2023 {published data only}
    1. Al-Zaidi HMH. Is mometasone effective in treating otitis media with effusion? Journal of Medical and Health Studies 2023;4(1):47-55.
Ardehali 2008 {published data only}
    1. Ardehali MM, Seraj JM, Asiabar MK, Adibi H. The possible role of gastroesophageal reflux disease in children suffering from chronic otitis media with effusion. Acta Medica Iranica 2008;46(1):33-7. [CENTRAL: CN-00708224] [EMBASE: 351792703]
Crawford‐Faucher 2010 {published data only}
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Daly 1991 {published data only}
    1. Daly K, Giebink GS, Batalden PB, Anderson RS, Le CT, Lindgren B, et al. Resolution of otitis media with effusion with the use of a stepped treatment regimen of trimethoprim-sulfamethoxazole and prednisone. Pediatric Infectious Disease Journal 1991;10(7):500-6. [CENTRAL: CN-00077629] [PMID: ] - PubMed
    1. Daly K, Giebink GS, Lindgren B, Anderson RS. Controlled clinical trial for prevention of chronic otitis media with effusion. In: Proceedings of the 4th International Symposium on Recent Advances in Otitis Media; 1987 Jun 1-4; Toronto (ON). 1987:247-50. [CENTRAL: CN-00452502]
Damoiseaux 2010 {published data only}
    1. Damoiseaux RA, Rovers MM. Topical intranasal corticosteroids for otitis media with effusion in primary care. BMJ (Clinical Research Ed.) 2010;340(7737):b5380. [EMBASE: 358169045] [PMID: ] - PubMed
El‐Anwar 2015 {published data only}
    1. El-Anwar MW, Nofal AA, Khazbak AO, Sayed AE, Hassan MR. The efficacy of nasal steroids in treatment of otitis media with effusion: a comparative study. International Archives of Otorhinolaryngology 2015;19(4):298-301. [CENTRAL: CN-01332850] [EMBASE: 614397848] [PMID: ] - PMC - PubMed
Endo 1997 {published data only}
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Ferrara 2005 {published data only}
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Gibson 1996 {published data only}
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Giebink 1990 {published data only}
    1. Giebink GC, Batalden PB, Le CT, Russ JN, Knox JK, Anderson RS, et al. Randomized controlled trial comparing trimethoprim-sulfamethoxazole, prednisone, ibuprofen, and no treatment in chronic otitis media with effusion. Recent Advances Otitis Media: Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media; 1988 Jun 1-4; Toronto (Canada) 1988:240-4. [CENTRAL: CN-00452593]
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Gluth 2011 {published data only}
    1. Gluth MB, McDonald DR, Weaver AL, Bauch CD, Beatty CW, Orvidas LJ. Management of eustachian tube dysfunction with nasal steroid spray: a prospective, randomized, placebo-controlled trial. Archives of Otolaryngology--Head & Neck Surgery 2011;137(5):449-55. [CENTRAL: CN-00788460] [PMID: ] - PubMed
    1. NCT00279916. Short term relief of Eustachian tube dysfunction and serous otitis media using intranasal steroid sprays [Short term relief of Eustachian tube dysfunction and serous otitis media using intranasal steroid sprays: a randomized placebo-controlled study]. https://clinicaltrials.gov/show/NCT00279916 (first received 18 January 2006). [CENTRAL: CN-02035934]
Han 2009 {published data only}
    1. Han Z, Zhibin C, Dengyuan W, Xia X, Xiaonian Z, Guangqian X. The therapeutic effects of oral administration and intratympanic injection of glucocorticoid in the treatment of otitis media with effusion. Journal of Audiology and Speech Pathology 2009;6:019. [CENTRAL: CN-00858712]
Hughes 2019 {published data only}
    1. Hughes A, Khong T. Do oral steroids improve hearing outcomes in children with otitis media with effusion? Drug and Therapeutics Bulletin 2019;57(11):166-7. [CENTRAL: CN-02081693] [EMBASE: 629508876] [PMID: ] - PubMed
Iino 1989 {published data only}
    1. Iino Y, Ishitoya J, Ikeda M, Ito Y, Usami M, Kawashiro N, et al. Factors on delayed recovery of otitis media with effusion in children--clinical and bacteriological study. Nihon Jibiinkoka Gakkai Kaiho 1989;92(8):1183-91. [CENTRAL: CN-00063873] [PMID: ] - PubMed
Isaacs 2018 {published data only}
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Marchisio 1998 {published data only}
    1. Marchisio P, Principi N, Passali D, Salpietro DC, Boschi G, Chetri G, et al. Epidemiology and treatment of otitis media with effusion in children in the first year of primary school. Acta Oto-laryngologica 1998;118(4):557-62. [CENTRAL: CN-00154484] [EMBASE: 1998254893] [PMID: ] - PubMed
Mayor 2018 {published data only}
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Paradise 1997 {published data only}
    1. Paradise J, Campbell T, Dollaghan C, Feldman H, Bernard B, Colborn K, et al. Receptive vocabulary, cognition, and parent-rated behavior at age 3 years in relation to otitis media in the first 3 years of life. In: Abstract Book of the Association of Health Service Research. Vol. 14. 1997:350-1. [CENTRAL: CN-00452820]
Parlea 2012 {published data only}
    1. Parlea E, Georgescu M, Calarasu R. Tympanometry as a predictor factor in the evolution of otitis media with effusion. Journal of Medicine and Life 2012;5(4):452-4. [CENTRAL: CN-00850240] [EMBASE: 369159817] [PMID: ] - PMC - PubMed
Persico 1978 {published data only}
    1. Persico M, Podoshin L, Fradis M, Fradis M. Otitis media with effusion: a steroid and antibiotic therapeutic trial before surgery. Annals of Otology, Rhinology, and Laryngology 1978;87:191-5. - PubMed
Rohail 2006 {published data only}
    1. Rohail A, Gill ZI, Butt MR. A comparison of medical treatment versus surgical treatment for the management of otitis media with effusion. Annals of King Edward Medical College 2006;12(1):64-7. [CENTRAL: CN-00597368]
Salmen 2021 {published data only}
    1. Salmen MM, Saleh EM, Abd EMM. The efficacy of nasal steroids in treatment of otitis media with effusion: a comparative study. Egyptian Journal of Neck Surgery and Otorhinolaryngology 2021;7(1):20-7.
Schwartz 1980a {published data only}
    1. Schwartz RH, Schwartz DM, Grundfast KM. Intranasal beclomethasone in the treatment of middle ear effusion: a pilot study. Annals of Allergy 1980;45(5):284-7. [PMID: ] - PubMed
Shapiro 1982 {published data only}
    1. Shapiro GG, Bierman CW, Furukawa CT, Pierson WE, Berman R, Donaldson J, et al. Treatment of persistent Eustachian tube dysfunction in children with aerosolized nasal dexamethasone phosphate versus placebo. Annals of Allergy 1982;49(2):81-5. [CENTRAL: CN-00028488] [EMBASE: 1982193995] [PMID: ] - PubMed
Shubich 1996 {published data only}
    1. Shubich I. Otitis media with effusion and allergy control in children: a prospective study. In: Sixth International Symposium on Otitis Media; 1996; Fort Lauderdale (FL). 1996:173-4. [CENTRAL: CN-00452904]
Stenstrom 2005 {published data only}
    1. Stenstrom R, Pless IB, Bernard P. Hearing thresholds and tympanic membrane sequelae in children managed medically or surgically for otitis media with effusion. Archives of Pediatrics & Adolescent Medicine 2005;159(12):1151-6. [CENTRAL: CN-00532329] [PMID: ] - PubMed
Tracy 1995 {published data only}
    1. Tracy JM, Demain JG, Hoffman K, Goetz DW. Intranasal beclomethasone as an adjunct to treatment of chronic middle ear effusion. Annals of Allergy, Asthma & Immunology 1995;74:59. [CENTRAL: CN-00285148] - PubMed
    1. Tracy JM, Demain JG, Hoffman KM, Goetz DW. Intranasal beclomethasone as an adjunct to treatment of chronic middle ear effusion. Annals of Allergy, Asthma & Immunology 1998;80(2):198-206. [CENTRAL: CN-00148310] [PMID: ] - PubMed
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}
    1. Yeldandi V, MacLeod C, Mulvaney AM. Open-label, randomised, comparative study of usual care with or without clarithromycin suspension in serous otitis media with inflammation. In: 22nd International Congress of Chemotherapy; 2001 Jun 30-Jul 3; Amsterdam (the Netherlands). 2001. [ABSTRACT NO.: P10.009] [CENTRAL: CN-00453008]
Zocconi 1994 {published data only}
    1. Zocconi E. Antibiotics and oral steroids in the treatment of otitis media with effusion. Pediatria Medica e Chirurgica 1994;16(3):273-5. - PubMed

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]

References to ongoing studies

NCT03491098 {published data only}
    1. NCT03491098. The efficacy of nasal steroids in treatment of otitis media with effusion: a comparative study. https://clinicaltrials.gov/show/nct03491098 (first received 24 March 2018). [CENTRAL: CN-01586095]

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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. Topical and oral steroids for otitis media with effusion (OME) in children. Cochrane Database of Systematic Reviews 2022, Issue 4. Art. No: CD015255. [DOI: 10.1002/14651858.CD015255] - DOI - PMC - PubMed
Simpson 2011
    1. Simpson SA, Lewis R, Voort J, Butler CC. Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. Cochrane Database of Systematic Reviews 2011, Issue 5. Art. No: CD001935. [DOI: 10.1002/14651858.CD001935.pub3] - DOI - PMC - PubMed

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