A double-blind randomized placebo-controlled trial of topical intranasal mometasone furoate nasal spray in children of adenoidal hypertrophy with otitis media with effusion
Abstract
Purpose To study the effects of topical intranasal mometasone furoate nasal spray for management of otitis media with effusion in children aged 2-12 years with adenoidal hypertrophy and its impact on change in quality of life. Method A prospective randomized double blind interventional placebo control study was conducted. Hundred patients of endoscopic grade 3 or 4 adenoidal hypertrophy aged 2-12 years were enrolled in this study. Among these sixty two patients had persistent bilateral otitis media with effusion more than three months. These were randomly divided into two groups, group A and group B. Group A received mometasone nasal spray for six months and group B received saline nasal spray for the same period. Patients were evaluated with symptom, pure tone audiometry wherever possible, pneumatic otoscopic examination and tympanogram at 0, 8 and 24 weeks. Results Resolution of otitis media with effusion in study group (28 out of 30) was significantly higher as compared control group (16 out of 32) (p value 0.0004). A significant improvement in hearing and symptoms was seen in the study group (p Conclusion Mometasone nasal spray appears to be effective for the treatment of otitis media with effusion in patients of adenoidal hypertrophy.
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Bhargava 2014 at 24 weeks reported a significant difference in pure tone average hearing threshold, with mean 5.2 dB HL in steroids versus 11.6 dB HL in placebo (1 study, 62 participants; very low-certainty evidence).
“The authors' own analysis indicated that there was a significant difference between the two groups, with a mean hearing threshold of 5.2 dB HL in those receiving steroids and 11.6 dB HL for those receiving placebo (1 study, 62 participants; very low-certainty evidence).”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Bhargava 2014
Bhargava 2014 found persistence reduced with nasal mometasone furoate for 24 weeks (50% placebo versus 7% steroids; RR 0.13, 95% CI 0.03 to 0.53; 1 study, 62 participants).
“Persistence was reduced for those who had received nasal mometasone furoate for 24 weeks (50% of those receiving placebo, compared to 7% of those receiving steroids; RR 0.13, 95% CI 0.03 to 0.53; 1 study, 62 participants; Analysis 3.13).”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Bhargava 2014
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References 21 · Cited by 50
- Authors
- Bhargava, R., & Chakravarti, A.
- Affiliations
- Lady Hardinge Medical College (IN)
- Corresponding author
- Bhargava, Rahul
- Venue
- American Journal of Otolaryngology
- Publisher
- Elsevier BV
- Published
- 2014-11
- Volume
- 35
- Issue
- 6
- Pages
- 766-770
- ISSN
- 0196-0709 (ISSN-L)
- OpenAlex
- W1989833273
- Cited by
- 50
- References
- 21
- Citations by year
- 2025: 5 · 2024: 4 · 2023: 4 · 2022: 5 · 2021: 3 · 2020: 2 · 2019: 5 · 2018: 4 · 2017: 11 · 2016: 5 · 2015: 2
- FWCI
- 5.39
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Otolaryngology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Otorhinolaryngology › Ear Surgery and Otitis Media
- Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
- Health Sciences › Medicine › Surgery › Nasal Surgery and Airway Studies
- Keywords
- mometasone furoate, nasal spray, adenoid hypertrophy, otitis media with effusion, children, quality of life, hearing, topical corticosteroids
- MeSH terms
- Mometasone Furoate, Adenoids, Administration, Topical, Anti-Inflammatory Agents, Child, Child, Preschool, Double-Blind Method, Female, Humans, Hypertrophy, Male, Otitis Media with Effusion, Pregnadienediols, Quality of Life, Treatment Outcome, Nasal Sprays
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