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Cited by 19Ear Surgery and Otitis MediaSinusitis and nasal conditionsEar and Head Tumors

Effectiveness of mometasone furoate nasal spray on tympanometric results and hearing loss in children with otitis media with effusion

Open access
Ahmed, Mohamed Rifaat, Eldeeb, Wael Elshahat·2022·The Egyptian Journal of Otolaryngology
DOI 10.1186/s43163-022-00225-x
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Abstract

Background: Otitis media with effusion (OME) is one of the commonest causes of hearing loss in children. Oral and nasal topical steroids alone or combined with antibiotics lead to its quicker resolution. The aim of this study was the assessment of the efficacy of mometasone furoate nasal spray in conjunction with oral antibiotics for management of OME in children. One hundred sixty-eight children aged (4–12 years old) diagnosed with bilateral OME for at least 3 months were randomly allocated into two equal groups: the 1st group received mometasone furoate aqueous nasal spray plus oral amoxicillin–clavulanate for 4 weeks, and the 2nd group received amoxicillin–clavulanate alone for the same period. Results: The tympanometric results after 1 month of medical treatment was much better in the 1st group compared to the 2nd group with 60% of patients of the 1st group having type A tympanogram versus 16% of patients of the 2nd group having this type (p = 0.0001). However, the average air-bone gap was not statistically different between the two groups. Conclusion: Mometasone furoate nasal spray is effective in OME as adjunctive treatment when combined with antibiotics as it helps to normalize the Eustachian tube function and middle ear status.

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Registry

Crossref · 10.1186/s43163-022-00225-x

Cites

18 of 18 references verified0 citation errors · 0 not checkable

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  • In the Ahmed 2022 trial, blinding of participants and personnel was judged at high risk of performance bias because no blinding was used.

    “No blinding was used in this study.”

    From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Ahmed 2022

    The ‘Randomization to treatment groups’ section says one group received nasal spray plus antibiotics while the other received antibiotics alone; parents were instructed in spray use, and the first dose was given in clinic. This supports the inference that parents and treating personnel were not blinded, but the paper does not explicitly state that no blinding was used anywhere or assess performance-bias risk. (LLM, conf=0.79)

    Experimental — accuracy not yet measured

  • In the Ahmed 2022 trial, allocation concealment was judged at unclear risk of selection bias.

    “See quote above.If the random number table was open and accessible, then treatment allocation would have been easily accessible.However, it is not clear if this was the case.”

    From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Ahmed 2022

    The “Randomization to treatment groups” section says a computer-generated random-number table determined assignments, but does not say who could access the table or how allocation was concealed. This supports the citing sentence’s uncertainty about accessibility; the paper itself does not judge allocation concealment to be at unclear risk of selection bias. No page number is available in our copy. (LLM, conf=0.83)

    Experimental — accuracy not yet measured

  • In the Ahmed 2022 trial, blinding of outcome assessment was judged at high risk of detection bias because outcome assessors were not blinded.

    “There is no statement to indicate that outcome assessors were blinded.As study participants were not blinded to treatment allocation, we assume this was also the case for outcome assessors.”

    From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Ahmed 2022

    The Randomization to treatment groups section describes parents being instructed to administer a nasal spray in one arm, while the other arm received only antibiotics; this supports the citing authors’ inference that participants knew their allocation. The paper does not state whether outcome assessors were blinded or judge detection-bias risk. Those are the citing authors’ assumptions and assessment, not findings reported by the trial. (LLM, conf=0.78)

    Experimental — accuracy not yet measured

  • In the Ahmed 2022 trial, sequence generation used a computer-generated table of random numbers, judged at low risk of selection bias.

    “The subjects were randomly divided into two equal groups.A computer-generated table of random numbers was used for group assignment; if the last digit of the random number was from 0 to 4, assignment was to the 1st group (study group), and if the last digit was from 5 to 9, assignment was to the 2nd group (control group).”

    From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Ahmed 2022

    The “Randomization to treatment groups” section states that a computer-generated table of random numbers determined group assignment. Our copy does not give a low-risk-of-selection-bias judgment; that appears to be the citing authors’ assessment rather than a finding reported by Ahmed et al. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • In the Ahmed 2022 trial, incomplete outcome data was judged at low risk of attrition bias because full follow-up was reported.

    “Full follow-up was reported.”

    From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Ahmed 2022

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Cites

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Research works printed but not linked: 1

  1. Robb PJ (2007) Otitis media with effusion. In: Graham JM, Scadding GK, Bull PD (eds) Pediatric ENT. Springer, Heidelberg, pp 413-420

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Authors
Ahmed, M. R., & Eldeeb, W. E.
Affiliations
Suez Canal University (EG)
Corresponding author
Ahmed, Mohamed Rifaat
ORCID
Ahmed, Mohamed Rifaat
Venue
The Egyptian Journal of Otolaryngology
Publisher
Springer Science and Business Media LLC
Published
2022-02-23
Volume
38
Issue
1
ISSN
  • 1012-5574 (ISSN-L)
  • 2090-8539
DOI
10.1186/s43163-022-00225-x
OpenAlex
W4214613452
Cited by
19
References
18
Citations by year
2024: 17 · 2023: 2
FWCI
4.19
Type
journal article
Language
en
Open access
Licence
Locations
  • The Egyptian Journal of Otolaryngology (publishedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Health Sciences › Medicine › Otorhinolaryngology › Ear Surgery and Otitis Media
  • Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
  • Health Sciences › Medicine › Oncology › Ear and Head Tumors
Keywords
otitis media with effusion, mometasone furoate nasal spray, amoxicillin-clavulanic acid, topical corticosteroids, tympanometry, hearing loss, Eustachian tube function, air-bone gap, children, adjunctive antibiotic therapy

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