Pharmacotherapy focusing on for the management of otitis media with effusion in children: Systematic review and meta-analysis

Published:March 24, 2022DOI:



      To examine the evidence for treating children with otitis media with effusion with pharmacotherapy.

      Data Sources

      For the systematic review, data were retrieved from PubMed, Cochrane database, and the Japan Medical Abstracts Society Database (1st January 1995 through 31th May 2019).

      Study Selection

      Articles addressing pharmacotherapy for the management of otitis media with effusion in children were selected in English.

      Data Extraction

      The database was searched using the keywords “Otitis Media with effusion or secretory otitis media” and the following medical agents: carbocysteine, antihistamines, leukotriene receptor antagonist, and steroid nasal spray.

      Data Synthesis

      After a critical review of 18 studies, studies addressing steroid nasal spray were eligible for quantitative synthesis. Intranasal steroids for OME showed no benefit with OR 1.155 (95% CI 0.834-1.598) within one month. Conversely, intranasal steroids have effects for OME with OR 1.858 (95% CI 1.240-2.786) for more than one month.


      We found evidence of benefit from treatment of OME in children with intranasal steroids and S-carboxymethylcysteine at longer-term follow-up.


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        • Ito M
        • Takahashi H
        • Iino Y
        • Kojima H
        • Hashimoto S
        • Kamide Y
        • et al.
        Clinical practice guidelines for the diagnosis and management of otitis media with effusion (OME) in children in Japan, 2015.
        Auris Nasus Larynx. 2017; 44: 501-508
        • Rosenfeld RM
        • Shin JJ
        • Schwartz SR
        • Coggins R
        • Gagnon L
        • Hackell JM
        • et al.
        Clinical Practice Guideline: Otitis Media with Effusion (Update).
        Otolaryngol Head Neck Surg. 2016; 154: S1-S41
        • Tos M.
        Epidemiology and natural history of secretory otitis.
        Am J Otol. 1984; 5: 459-462
        • Kogan MD
        • Overpeck MD
        • Hoffman HJ
        Casselbrant ML. Factors associated with tympanostomy tube insertion among preschool-aged children in the United States.
        Am J Public Health. 2000; 90: 245-250
        • Williamson IG
        • Dunleavey J
        • Bain J
        • Robinson D.
        The natural history of otitis media with effusion–a three-year study of the incidence and prevalence of abnormal tympanograms in four South West Hampshire infant and first schools.
        J Laryngol Otol. 1994; 108: 930-934
        • Heidemann CH
        • Lous J
        • Berg J
        • Christensen JJ
        • Hakonsen SJ
        • Jakobsen M
        • et al.
        Danish guidelines on management of otitis media in preschool children.
        Int J Pediatr Otorhinolaryngol. 2016; 87: 154-163
        • Blanc F
        • Ayache D
        • Calmels MN
        • Deguine O
        • Francois M
        • Leboulanger N
        • et al.
        Management of otitis media with effusion in children. Societe francaise d'ORL et de chirurgie cervico-faciale clinical practice guidelines.
        European annals of otorhinolaryngology, head and neck diseases. 2018; 135: 269-273
        • Lee HJ
        • Park SK
        • Choi KY
        • Park SE
        • Chun YM
        • Kim KS
        • et al.
        Korean clinical practice guidelines: otitis media in children.
        Journal of Korean medical science. 2012; 27: 835-848
        • Venekamp RP
        • Burton MJ
        • van Dongen TM
        • van der Heijden GJ
        • van Zon A
        • Schilder AG.
        Antibiotics for otitis media with effusion in children.
        Cochrane Database Syst Rev. 2016; CD009163
        • Higgins JPTGS
        Cochrane handbook for systematic reviews of interventions, version 5.0.1.
        Wiley–Blackwell, Oxford, UK2009
        • Cumpston M
        • Li T
        • Page MJ
        • Chandler J
        • Welch VA
        • Higgins JP
        • et al.
        Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions.
        Cochrane Database Syst Rev. 2019; 10ED000142
        • Lildholdt T
        • Kortholm B.
        Beclomethasone nasal spray in the treatment of middle-ear effusion - a double-blind study.
        Int J Pediatr Otorhinolaryngol. 1982; 4: 133-137
        • 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: 81-85
        • 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: official publication of the American College of Allergy.
        Asthma, Immunol. 1998; 80: 198-206
        • Cengel S
        • Akyol MU.
        The role of topical nasal steroids in the treatment of children with otitis media with effusion and/or adenoid hypertrophy.
        Int J Pediatr Otorhinolaryngol. 2006; 70: 639-645
        • 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. 2009; 339: b4984
        • Barati B
        • Omrani MR
        • Okhovat AR
        • Kelishadi R
        • Hashemi M
        • Hassanzadeh A
        • et al.
        Effect of nasal beclomethasone spray in the treatment of otitis media with effusion.
        J Res Med Sci. 2011; 16: 509-515
        • Bhargava R
        • Chakravarti A.
        A double-blind randomized placebo-controlled trial of topical intranasal mometasone furoate nasal spray in children of adenoidal hypertrophy with otitis media with effusion.
        Am J Otolaryngol. 2014; 35: 766-770
        • 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: 298-301
        • Simpson SA
        • Lewis R
        • van der Voort J
        • Butler CC.
        Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children.
        Cochrane Database Syst Rev. 2011; CD001935
        • Chohan A
        • Lal A
        • Chohan K
        • Chakravarti A
        • Gomber S.
        Systematic review and meta-analysis of randomized controlled trials on the role of mometasone in adenoid hypertrophy in children.
        Int J Pediatr Otorhinolaryngol. 2015; 79: 1599-1608
        • Roditi RE
        • Caradonna DS
        • Shin JJ.
        The Proposed Usage of Intranasal Steroids and Antihistamines for Otitis Media with Effusion.
        Current allergy and asthma reports. 2019; 19: 47
        • Combs JT.
        The effect of montelukast sodium on the duration of effusion of otitis media.
        Clin Pediatr (Phila). 2004; 43: 529-533
        • Schoem SR
        • Willard A
        • Combs JT.
        A prospective, randomized, placebo-controlled, double-blind study of montelukast's effect on persistent middle ear effusion.
        Ear Nose Throat J. 2010; 89: 434-437
        • Ertugay CK
        • Cingi C
        • Yaz A
        • San T
        • Ulusoy S
        • Erdogmus N
        • et al.
        Effect of combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial.
        Acta Otolaryngol. 2013; 133: 1266-1272
        • Moore RA
        • Commins D
        • Bates G
        • Phillips CJ.
        S-carboxymethylcysteine in the treatment of glue ear: quantitative systematic review.
        BMC family practice. 2001; 2: 3
        • Simon F
        • Haggard M
        • Rosenfeld RM
        • Jia H
        • Peer S
        • Calmels MN
        • et al.
        International consensus (ICON) on management of otitis media with effusion in children.
        European annals of otorhinolaryngology, head and neck diseases. 2018; 135: S33-SS9
        • Stroup DF
        • Berlin JA
        • Morton SC
        • Olkin I
        • Williamson GD
        • Rennie D
        • et al.
        Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group.
        JAMA. 2000; 283: 2008-2012
        • Scadding G.
        Non-surgical treatment of adenoidal hypertrophy: the role of treating IgE-mediated inflammation.
        Pediatric allergy and immunology: official publication of the European Society of Pediatric Allergy and Immunology. 2010; 21: 1095-1106
        • Goldbart AD
        • Veling MC
        • Goldman JL
        • Li RC
        • Brittian KR
        • Gozal D.
        Glucocorticoid receptor subunit expression in adenotonsillar tissue of children with obstructive sleep apnea.
        Pediatric research. 2005; 57: 232-236
        • Goodrich T
        • Rubio F
        • Cutler JL.
        Otitis media and antihistamines.
        Current allergy and asthma reports. 2009; 9: 456-459
        • Griffin GH
        • Flynn C
        • Bailey RE
        • Schultz JK.
        Antihistamines and/or decongestants for otitis media with effusion (OME) in children.
        Cochrane Database Syst Rev. 2006; CD003423
        • Griffin G
        • Flynn CA.
        Antihistamines and/or decongestants for otitis media with effusion (OME) in children.
        Cochrane Database Syst Rev. 2011; CD003423
        • Bonney AG
        • Goldman RD.
        Antihistamines for children with otitis media.
        Can Fam Physician. 2014; 60: 43-46
        • Feng Y
        • Meng YP
        • Dong YY
        • Qiu CY
        • Cheng L.
        Management of allergic rhinitis with leukotriene receptor antagonists versus selective H1-antihistamines: a meta-analysis of current evidence.
        Allergy Asthma Clin Immunol. 2021; 17: 62
        • Kuhle S
        • Hoffmann DU
        • Mitra S
        • Urschitz MS
        Anti-inflammatory medications for obstructive sleep apnoea in children.
        Cochrane Database Syst Rev. 2020; 1CD007074
        • Hooper C
        • Calvert J.
        The role for S-carboxymethylcysteine (carbocisteine) in the management of chronic obstructive pulmonary disease.
        Int J Chron Obstruct Pulmon Dis. 2008; 3: 659-669