Systemic Corticosteroids in Pediatric Otitis Media: A Systematic Review and Meta-Analysis

Hayat Alshahrani ,  Areej Alshammari ORCID ,  Shoug Alshammari ORCID ,  Zainab Alshaikh ORCID ,  Lujain Alahamdi ,  Wajan Alqathanin ORCID ,  Wafaa Alnujaimi ,  Fatimah Alfaqih ,  Shahad Bandar ,  Leen Al Malawi ,  Lama Altuwijri ,  Raghida Almuzaini ,  Yazeed A. Alhelali ,  Sahar Alward ,  Kholoud Alshahrani

    Received: 30 September 2025; Revised: 8 December 2025; Accepted: 17 December 2025; Published: 31 December 2025

    Abstract

    Otitis media is a common childhood condition that affects public health because of its frequency, recurrence, and potential long-term consequences. This systematic review and meta-analysis assessed the efficacy and safety of systemic corticosteroids (SCS) in children with acute otitis media and otitis media with an effusion. A comprehensive search of PubMed, Scopus, and Web of Science identified relevant studies published between January 2018 and August 2025. The primary outcomes were effusion resolution, hearing loss, and otitis media recurrence. Secondary outcomes included pain relief, tympanostomy tube placement, speech and language development, quality of life, and adverse events. Four studies, including two Cochrane reviews, one randomized controlled trial, and one meta-analysis, were analyzed. The results showed that SCS provided short-term improvements in effusion clearance and hearing, with risk ratios from 1.08 to 1.20. However, these benefits were temporary, with no significant long-term effects on recurrence rates, persistent effusion, or developmental outcomes. Safety data were limited, with most adverse events being mild and self-resolving. The studies had moderate heterogeneity due to differences in population characteristics, intervention protocols, and outcome definitions. Results suggest that SCS may offer short-term symptom relief in certain cases but cannot be recommended for routine management of pediatric otitis media. Future research should prioritize large-scale multicenter trials with standardized outcomes, extended follow-up periods, and thorough safety assessments to identify the subgroups that might benefit the most from SCS treatment.

    Keywords

    References

    1. 1. Kenna, M.A. Acute Otitis Media—The Long and the Short of It. N. Engl. J. Med. 2016, 375, 2492–2493. DOI: https://doi.org/10.1056/NEJMe1614712
    2. 2. Lieberthal, A.S.; Carroll, A.E.; Chonmaitree, T.; et al. The Diagnosis and Management of Acute Otitis Media. Pediatrics 2013, 131, e964–e999. DOI: https://doi.org/10.1542/peds.2012-3488
    3. 3. Kaur, R.; Morris, M.; Pichichero, M.E. Epidemiology of Acute Otitis Media in the Postpneumococcal Conjugate Vaccine Era. Pediatrics 2017, 140, e20170181. DOI: https://doi.org/10.1542/peds.2017-0181
    4. 4. Steele, D.W.; Adam, G.P.; Di, M.; et al. Effectiveness of Tympanostomy Tubes for Otitis Media: A Meta-analysis. Pediatrics 2017, 139, e20170125. DOI: https://doi.org/10.1542/peds.2017-0125
    5. 5. Rosenfeld, R.M.; Tunkel, D.E.; Schwartz, S.R.; et al. Clinical Practice Guideline: Tympanostomy Tubes in Children (Update). Otolaryngol. Head. Neck. Surg. 2022, 166, S1–S55. DOI: https://doi.org/10.1177/01945998211065662
    6. 6. Hoberman, A.; Paradise, J.L.; Rockette, H.E.; et al. Treatment of Acute Otitis Media in Children under 2 Years of Age. N. Engl. J. Med. 2011, 364, 105–115. DOI: https://doi.org/10.1056/NEJMoa0912254
    7. 7. Hoberman, A.; Paradise, J.L.; Rockette, H.E.; et al. Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children. N. Engl. J. Med. 2016, 375, 2446–2456. DOI: https://doi.org/10.1056/NEJMoa1606043
    8. 8. Hoberman, A.; Preciado, D.; Paradise, J.L.; et al. Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media. N. Engl. J. Med. 2021, 384, 1789–1799. DOI: https://doi.org/10.1056/NEJMoa2027278
    9. 9. Wald, E.R. Management of Recurrent Acute Otitis Media. N. Engl. J. Med. 2021, 384, 1859–1860. DOI: https://doi.org/10.1056/NEJMe2104952
    10. 10. Pichichero, M.E. Helping Children with Hearing Loss from Otitis Media with Effusion. Lancet 2018, 392, 533–534. DOI: https://doi.org/10.1016/S0140-6736(18)31862-2
    11. 11. Coker, T.R.; Chan, L.S.; Newberry, S.J.; et al. Diagnosis, Microbial Epidemiology, and Antibiotic Treatment of Acute Otitis Media in Children: A Systematic Review. JAMA 2010, 304, 2161–2169. DOI: https://doi.org/10.1001/jama.2010.1651
    12. 12. Jamal, A.; Alsabea, A.; Tarakmeh, M.; et al. Etiology, Diagnosis, Complications, and Management of Acute Otitis Media in Children. Cureus 2022, 14, e28019. DOI: https://doi.org/10.7759/cureus.28019
    13. 13. Barzilay, J.R.; Jackson, M.A.; Tunkel, D. Watchful Waiting versus Antibiotics for Acute Otitis Media in Pediatric Patients. N. Engl. J. Med. 2024, 391, 1648–1650. DOI: https://doi.org/10.1056/NEJMclde2404416
    14. 14. Spiro, D.M.; Tay, K.Y.; Arnold, D.H.; et al. Wait-and-See Prescription for the Treatment of Acute Otitis Media: A Randomized Controlled Trial. JAMA 2006, 296, 1235–1241. DOI: https://doi.org/10.1001/jama.296.10.1235
    15. 15. McKinsey, J.; Lee, B.R.; Wyly, D.; et al. Increasing Safety Net Antibiotic Prescriptions for Acute Otitis Media in Urgent Care Clinics. J. Pediatr. Clin. Pract. 2024, 14, 200122. DOI: https://doi.org/10.1016/j.jpedcp.2024.200122
    16. 16. Shafik, A.G.; Hassabalah, M.S.; Maarouf, A.M.; et al. Effect of Local versus Systemic Steroids in Treatment of Children with Otitis Media with Effusion. QJM 2020, 113, hcaa047.007. DOI: https://doi.org/10.1093/qjmed/hcaa047.007
    17. 17. Rasheed, A.M. Is Topical Nasal Steroid Useful for Treatment of Otitis Media with Effusion in Children? Int. Tinnitus. J. 2023, 27, 62–67. DOI: https://doi.org/10.5935/0946-5448.20230011
    18. 18. American Academy of Family Physicians; American Academy of Otolaryngology–Head and Neck Surgery; American Academy of Pediatrics Subcommittee on Otitis Media With Effusion. Otitis Media with Effusion. Pediatrics 2004, 113, 1412–1429. DOI: https://doi.org/10.1542/peds.113.5.1412
    19. 19. Roberts, J.E.; Rosenfeld, R.M.; Zeisel, S.A. Otitis Media and Speech and Language: A Meta-analysis of Prospective Studies. Pediatrics 2004, 113, e238–e248. DOI: https://doi.org/10.1542/peds.113.3.e238
    20. 20. Page, M.J.; McKenzie, J.E.; Bossuyt, P.M.; et al. The PRISMA 2020 Statement: An Updated Guideline for Reporting Systematic Reviews. BMJ 2021, 372, n71. DOI: https://doi.org/10.1136/bmj.n71
    21. 21. Ranakusuma, R.W.; Pitoyo, Y.; Safitri, E.D.; et al. Systemic Corticosteroids for Acute Otitis Media in Children. Cochrane Database Syst. Rev. 2018, 3, CD012289. DOI: https://doi.org/10.1002/14651858.CD012289.pub2
    22. 22. Mulvaney, C.A.; Galbraith, K.; Webster, K.E.; et al. Topical and Oral Steroids for Otitis Media with Effusion (OME) in Children. Cochrane Database Syst. Rev. 2023, 12, CD015255. DOI: https://doi.org/10.1002/14651858.CD015255.pub2
    23. 23. Francis, N.A.; Cannings-John, R.; Waldron, C.A.; et al. Oral Steroids for Resolution of Otitis Media with Effusion in Children (OSTRICH): A Double-Blinded, Placebo-Controlled Randomised Trial. Lancet 2018, 392, 557–568. DOI: https://doi.org/10.1016/S0140-6736(18)31490-9
    24. 24. Ikeda, R.; Hidaka, H.; Ito, M.; et al. Pharmacotherapy Focusing on the Management of Otitis Media with Effusion in Children: Systematic Review and Meta-analysis. Auris Nasus Larynx 2022, 49, 748–754. DOI: https://doi.org/10.1016/j.anl.2022.03.017
    25. 25. Anwar, M.; Abdel-Aziz, M.; Nassar, A.; et al. A Comparative Study of the Efficacy of Topical Nasal Steroids versus Systemic Steroids in the Treatment of Otitis Media with Effusion in Children. Egypt. J. Otolaryngol. 2015, 31, 208–212. DOI: https://doi.org/10.4103/1012-5574.168210
    26. 26. Berman, S. Otitis Media in Children. N. Engl. J. Med. 1995, 332, 1560–1565. DOI: https://doi.org/10.1056/NEJM199506083322307
    27. 27. Ghaffar, A.; Feldman, W.; Dolovich, J. Otitis Media in Children. Can. Fam. Physician 1981, 27, 1399–1402.
    28. 28. Ranakusuma, R.W.; McCullough, A.R.; Safitri, E.D.; et al. Oral Prednisolone for Acute Otitis Media in Children: A Pilot, Pragmatic, Randomised, Open-Label, Controlled Study (OPAL Study). Pilot Feasibility Stud. 2020, 6, 121. DOI: https://doi.org/10.1186/s40814-020-00671-5
    29. 29. National Institute for Health and Care Excellence (NICE). Antimicrobial Stewardship: Systems and Processes for Effective Antimicrobial Medicine Use; NICE: London, UK, 2015.
    30. 30. Castelli Gattinara, G.; Bergamini, M.; Simeone, G.; et al. Antibiotic Treatment of Acute and Recurrent Otitis Media in Children: An Italian Intersociety Consensus. Ital. J. Pediatr. 2025, 51, 50. DOI: https://doi.org/10.1186/s13052-025-01894-z
    31. 31. Rosenfeld, R.M.; Shin, J.J.; Schwartz, S.R.; et al. Clinical Practice Guideline: Otitis Media with Effusion (Update). Otolaryngol. Head Neck Surg. 2016, 154, S1–S41. DOI: https://doi.org/10.1177/0194599815623467
    32. 32. Allen, D.B. Systemic Effects of Inhaled Corticosteroids in Children. Curr. Opin. Pediatr. 2004, 16, 440–444. DOI: https://doi.org/10.1097/01.mop.0000129597.48138.e7
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