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Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children.

Abstract

BACKGROUND

OME is common and may cause hearing loss with associated developmental delay. Treatment remains controversial. The effect of both systemic and intra-nasal steroids on effusions has been assessed by randomised controlled trials.

OBJECTIVES

To examine evidence for or against treating children with hearing loss associated with OME with systemic or topical nasal steroids.

SEARCH STRATEGY

Searches were conducted in February 2000. We searched the Cochrane Controlled Trials Register using the terms 'otitis-media', 'otitis media with effusion', 'glue ear', or 'OME', and 'steroids', 'glucocorticoids, synthetic', 'glucocorticoids, topical', 'anti-inflammatory agents, steroidal'. EMBASE and MEDLINE were also searched for additional information.

SELECTION CRITERIA

Randomised controlled trials of oral and topical nasal steroids, either alone or in combination with another agent such as an antibiotic, were included.

EXCLUSIONS

publications in abstract form only since adequate appraisal was not possible; uncontrolled, non-randomised or retrospective studies; studies reporting outcomes with ears (rather than children) as the unit of analysis.

DATA COLLECTION AND ANALYSIS

Data were extracted from the published reports by the two authors independently (CCB and JH van der V) using standardised data extraction forms and methodology. The methodological quality of the included studies were independently assessed by the two authors using the scheme described in the Cochrane Handbook. Dichotomous results were expressed as an odds ratio using a fixed effects model together with the 95% confidence intervals. Continuous data were analysed using the weighted mean difference in a fixed effects model. Tests for heterogeneity between studies were performed using a Mantel-Haenszel approach. In trials with a cross over design, post-crossover treatment data were not used.

MAIN RESULTS

No study prospectively documented hearing loss associated with OME prior to randomisation. Follow up was short term. No serious or lasting side effects were reported in the four studies that did mention side effects. Most comparisons involved small numbers of subjects. The odds ratio for OME persisting after short term follow up for children treated with oral steroids plus antibiotic compared to control plus antibiotic was 0.32 (95% CI 0.20 to 0.52). However there was significant heterogeneity between studies (p<0.01). Trends favoured steroids for most other comparisons, but confidence intervals included unity. There was no evidence of benefit for steroid treatment in the longer term, and no study assessed effect of steroid treatment on language development.

REVIEWER'S CONCLUSIONS

There is evidence that steroids combined with an antibiotic lead to a quicker resolution of OME in the short term. However, there is not evidence for long term benefit from treating hearing loss associated with OME with either oral or topical nasal steroids. These treatments are therefore not recommended at the present time. Future studies should document hearing loss associated with OME before the start of study treatment. Follow up should be longer and ideally include symptom, audiometry and developmental outcomes. Data should not be presented with ears as the unit of analysis.

Authors+Show Affiliations

Department of General Practice, University of Wales College of Medicine, Llanedeyrn Health Centre, Llanedeyrn, Cardiff, South Galmorgan, UK, CF3 7PN. butlercc@cf.ac.ukNo affiliation info available

Pub Type(s)

Journal Article
Review
Systematic Review

Language

eng

PubMed ID

11034736

Citation

Butler, C C., and van Der Voort JH. "Oral or Topical Nasal Steroids for Hearing Loss Associated With Otitis Media With Effusion in Children." The Cochrane Database of Systematic Reviews, 2000, p. CD001935.
Butler CC, van Der Voort JH . Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2000.
Butler, C. C., & van Der Voort JH, . (2000). Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. The Cochrane Database of Systematic Reviews, (4), CD001935.
Butler CC, van Der Voort JH . Oral or Topical Nasal Steroids for Hearing Loss Associated With Otitis Media With Effusion in Children. Cochrane Database Syst Rev. 2000;(4)CD001935. PubMed PMID: 11034736.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. AU - Butler,C C, AU - van Der Voort JH,, PY - 2000/10/18/pubmed PY - 2001/8/3/medline PY - 2000/10/18/entrez SP - CD001935 EP - CD001935 JF - The Cochrane database of systematic reviews JO - Cochrane Database Syst Rev IS - 4 N2 - BACKGROUND: OME is common and may cause hearing loss with associated developmental delay. Treatment remains controversial. The effect of both systemic and intra-nasal steroids on effusions has been assessed by randomised controlled trials. OBJECTIVES: To examine evidence for or against treating children with hearing loss associated with OME with systemic or topical nasal steroids. SEARCH STRATEGY: Searches were conducted in February 2000. We searched the Cochrane Controlled Trials Register using the terms 'otitis-media', 'otitis media with effusion', 'glue ear', or 'OME', and 'steroids', 'glucocorticoids, synthetic', 'glucocorticoids, topical', 'anti-inflammatory agents, steroidal'. EMBASE and MEDLINE were also searched for additional information. SELECTION CRITERIA: Randomised controlled trials of oral and topical nasal steroids, either alone or in combination with another agent such as an antibiotic, were included. EXCLUSIONS: publications in abstract form only since adequate appraisal was not possible; uncontrolled, non-randomised or retrospective studies; studies reporting outcomes with ears (rather than children) as the unit of analysis. DATA COLLECTION AND ANALYSIS: Data were extracted from the published reports by the two authors independently (CCB and JH van der V) using standardised data extraction forms and methodology. The methodological quality of the included studies were independently assessed by the two authors using the scheme described in the Cochrane Handbook. Dichotomous results were expressed as an odds ratio using a fixed effects model together with the 95% confidence intervals. Continuous data were analysed using the weighted mean difference in a fixed effects model. Tests for heterogeneity between studies were performed using a Mantel-Haenszel approach. In trials with a cross over design, post-crossover treatment data were not used. MAIN RESULTS: No study prospectively documented hearing loss associated with OME prior to randomisation. Follow up was short term. No serious or lasting side effects were reported in the four studies that did mention side effects. Most comparisons involved small numbers of subjects. The odds ratio for OME persisting after short term follow up for children treated with oral steroids plus antibiotic compared to control plus antibiotic was 0.32 (95% CI 0.20 to 0.52). However there was significant heterogeneity between studies (p<0.01). Trends favoured steroids for most other comparisons, but confidence intervals included unity. There was no evidence of benefit for steroid treatment in the longer term, and no study assessed effect of steroid treatment on language development. REVIEWER'S CONCLUSIONS: There is evidence that steroids combined with an antibiotic lead to a quicker resolution of OME in the short term. However, there is not evidence for long term benefit from treating hearing loss associated with OME with either oral or topical nasal steroids. These treatments are therefore not recommended at the present time. Future studies should document hearing loss associated with OME before the start of study treatment. Follow up should be longer and ideally include symptom, audiometry and developmental outcomes. Data should not be presented with ears as the unit of analysis. SN - 1469-493X UR - https://www.unboundmedicine.com/medline/citation/11034736/Oral_or_topical_nasal_steroids_for_hearing_loss_associated_with_otitis_media_with_effusion_in_children_ L2 - https://doi.org/10.1002/14651858.CD001935 DB - PRIME DP - Unbound Medicine ER -