Summary of findings for the main comparison. Summary of findings: oral steroids versus control.
| Oral steroids compared with inactive control for otitis media with effusion in children | ||||||
|
Patient or population: Children with otitis media with effusion Settings: Hospital (secondary or tertiary care) Intervention: Oral steroids for the treatment of OME Comparison: Inactive control | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Inactive control | Oral steroids | |||||
|
Hearing loss [6 weeks] |
Medium‐risk population | RR 1.09 (0.8 to 1.49) | 44 (1) | +++O moderate | Single RCT with small sample size | |
| 739 per 1000 | 806 per 1000 (591 to 1101) | |||||
|
OME resolution at short‐term follow up (2 weeks) [< 1 month] |
Medium‐risk population | RR 3.80 (0.93 to 15.52) | 108 (3) | +++O moderate1 | ||
| 50 per 1000 | 190 per 1000 (47 to 776) | |||||
|
OME resolution at intermediate‐term follow up (4 to 6 weeks) [1 to < 6 months] |
Medium‐risk population | RR 1.54 (0.76 to 3.14) | 106 (3) | +++O moderate2 | ||
| 111 per 1000 | 169 per 1000 (84 to 345) | |||||
|
OME resolution at long‐term follow up [≥ 6 months] |
See comment | See comment | Not estimable | See comment | See comment | No studies reported long‐term outcome data |
| Symptoms | See comment | See comment | Not estimable | See comment | See comment | No studies reported data on symptoms |
|
Adverse effects [4 to 6 weeks] |
See comment | See comment | Not estimable | 143 (3) | See comment3 | There were no serious adverse effects3 |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OME: otitis media with effusion; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1 Risk of bias in studies low, but overall sample size small and wide confidence interval.
2 Risk of bias fairly low, but overall sample size is small.
3 Two studies reported that there were no significant adverse effects, but did not give actual data (or description of adverse effects). One study only reported on haematological complications. The study also reported that there was a transient drop in serum cortisol levels in 14 steroid‐treated patients.