Efficacy and cost-effectiveness analysis of steroid in treatment of otitis media with effusion (OME) in children: a randomized trial
Open accessAbstract
Background: Otitis media with effusion (OME) is a common disorder in children and lacks international consensus for its treatment. Out of various treatment options, few studies have show promising benefits of steroids for this condition. The objective of this study was to find the efficacy of steroid in treatment of OME and compare effectiveness of various modalities of treatment for OME. Also, we conducted their cost-effectiveness analysis. Methods: In this experimental study, 160 children between one and 12 years of age having OME between September 2018 and January 2020 were randomized into four parallel groups and were managed with antibiotics-antihistamines-decongestant combination, nasal steroid spray, oral steroid, and watchful observation respectively. They were re-evaluated in one-month period for improvement in OME and appearance of any adverse effects. Improvement was compared with Chi-square test. Results: A total of 160 participants were randomly divided into four groups by block randomization. The group treated with nasal steroid spray showed statistically significant improvement. The group treated with oral steroid showed improvement but was not statistically significant. Improvement was significantly lower in observation group. Cost of treatment was in the decreasing order in antibiotics-combination, nasal steroid spray, oral steroid and observation groups respectively. Conclusions: Topical nasal steroid was the only efficacious treatment among the four modalit…
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Acharya 2020 and Hussein 2017 stated that no adverse effects of oral steroids were reported in study participants; Choung 2008 did not report on adverse events.
“Both Acharya 2020 and Hussein 2017 stated that no adverse effects of oral steroids were reported in study participants.Choung 2008 did not report on adverse events.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Acharya 2020
In the Acharya 2020 trial, blinding of participants and personnel was judged at high risk of performance bias because no placebo was used.
“Comment: no placebo was used.Participants and study personnel would have been aware of treatment allocation.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Acharya 2020
In the Acharya 2020 trial, allocation concealment was judged at high risk of selection bias because of the small block size (blocks of four) and the unblinded design.
“Comment: small block size (blocks of 4, therefore 1:1 ratio for allocation) and an unblinded trial, therefore recruitment to different groups would have been predictable.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Acharya 2020
In the Acharya 2020 trial, blinding of outcome assessment was judged at high risk of detection bias because outcome assessors were unblinded.
“Comment: open-label trial with no placebo.No description of blinding of outcome assessors, therefore we assume that outcome assessors were unblinded.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Acharya 2020
In the Acharya 2020 trial, selective reporting was judged at low risk of reporting bias because results are reported in accordance with the trial registration.
“Comment: results are reported in accordance with the trial registration.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Acharya 2020
In the Acharya 2020 trial, incomplete outcome data was judged at low risk of attrition bias because full follow-up is reported.
“Comment: full follow-up is reported.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Acharya 2020
In the Acharya 2020 trial, other bias was judged at high risk because follow-up was inadequate to allow appropriate comparison of steroids and no intervention.
“Comment: follow-up is inadequate to allow appropriate comparison of steroids and no intervention.Outcomes reported at this stage may be more likely to favour the active intervention, as insufficient time has elapsed to allow for spontaneous resolution.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Acharya 2020
In the Acharya 2020 trial, sequence generation used computer-generated random numbers, judged at low risk of selection bias.
“The children who fulfilled the selection criteria were randomly divided into four parallel groups by block randomization, with blocks of four by a resident not involved in the study.The blocks were generated randomly by an author, who was not directly involved in treatment of patient, according to computer generated random numbers”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Acharya 2020
Cites
Hussein, A., Fathy, H., Amin, S. M., & Elsisy, N. (2017) · The Journal of Laryngology & Otology · doi:10.1017/s0022215117001700 · Cited by 13 · see citing works
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Topical and oral steroids for otitis media with effusion (OME) in children
Mulvaney, C. A., Galbraith, K., Webster, K. E., Rana, M., Connolly, R., Tudor-Green, B., Marom, T., Daniel, M., Venekamp, R. P., Schilder, A. G., et al. (2023) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd015255.pub2 · Cited by 18 · see citing works
- Authors
- Acharya, A., Pokharel, B., Pandit, S. B., & Bartaula, S.
- Affiliations
- Universal College of Medical Sciences (NP)
- Lumbini Medical College (NP)
- Venue
- Journal of Gandaki Medical College-Nepal
- Publisher
- Nepal Journals Online (JOL)
- Published
- 2020-12-25
- Volume
- 13
- Issue
- 2
- Pages
- 111-115
- ISSN
- 2070-4240 (ISSN-L)
- 2070-4259
- OpenAlex
- W3115334019
- Cited by
- 3
- References
- 1
- Citations by year
- 2025: 1 · 2023: 1 · 2022: 1
- FWCI
- 0.40
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- Locations
- Journal of Gandaki Medical College-Nepal (publishedVersion, cc-by-nc)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Topics
- Health Sciences › Medicine › Otorhinolaryngology › Ear Surgery and Otitis Media
- Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
- Health Sciences › Health Professions › Emergency Medical Services › Pediatric health and respiratory diseases
- Keywords
- otitis media with effusion, oral corticosteroids, expectant management, children, treatment efficacy, cost-effectiveness, adverse effects
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