Summary of findings 3. Oral propranolol compared to topical timolol for infantile haemangiomas of the skin.
Oral propranolol compared to topical timolol maleate for infantile haemangiomas (strawberry birthmarks) of the skin | ||||||
Patient or population: infantile haemangiomas (strawberry birthmarks) of the skin Setting: all settings (outpatient care) Intervention: oral propranolol Comparison: topical timolol maleate | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with topical timolol maleate | Risk with oral propranolol | |||||
Clearance, as assessed by a clinician at any follow‐up ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | We did not identify any studies reporting this outcome. |
A subjective measure of improvement, as assessed by the parent or child, at any follow‐up ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | We did not identify any studies reporting this outcome. |
Adverse events experienced at short or long term ‐ general adverse events 24 weeks' follow‐up |
See comment | See comment | RR 7.00 (0.40 to 123.35) | 26 (1 RCT) | ⊕⊝⊝⊝ VERY LOW1 | There were 3 events in the oral propranolol group and no events in the topical timolol maleate group. Due to no events in the control group, absolute events could not be calculated. |
Other measures of resolution, as assessed by a clinician, at any follow‐up ‐ size reduction ≥ 50% 24 weeks' follow up |
615 per 1000 | 695 per 1000 (394 to 1000) | RR 1.13 (0.64 to 1.97) | 26 (1 RCT) | ⊕⊕⊝⊝ LOW2 | |
Proportion of parents who consider their child still has a problem, at any follow‐up ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | We did not identify any studies reporting this outcome. |
Proportion of children who consider they still have a problem, at any follow‐up ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | We did not identify any studies reporting this outcome. |
Aesthetic appearance as assessed by physician, child, or parent, at any follow‐up ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | We did not identify any studies reporting this outcome. |
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group (the event rate in the single study) and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio | ||||||
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. |
1Downgraded by three levels: one level due to unclear risk of selection and performance bias and two levels for imprecision (wide confidence interval around the estimate of the effect and low number of participants and events). 2Downgraded by two levels: one level due to unclear risk of selection and performance bias and one level for imprecision (small sample size).