Randomised controlled studies using beta blockers for treatment of IH
| Study (Ref.) | Type | Inclusion criteria | Intervention Duration | Age at start Preterm inf. | Sample size | Primary outcome time | Result | Comment |
|---|---|---|---|---|---|---|---|---|
| Abarzua-Araya et al45 | RCT dbl Non-inferiority | Functional impairment Aesth. disfigurement Ulcerated or loc. on folds | Atenolol 1 mg/kg SD vs Propr. 2 mg/kg 6 m | 1–15 m No preterms mentioned | 13:10 Not calculated | Complete response Partial response 6 m | 54%:60% ns 46%:40% ns | Small sample size. Atenolol less side effects? |
| Bauman et al46 | RCT bl Phase II | Sympt. IH: impaired function Ulcerating Pain Cosmetically sensitive | Propr. 2 mg/kg/d vs Predn. 2 mg/kg/d At least 4 m | 2 w to 6 m No preterms mentioned | 11:8 calculated 55 | Surface area 4 m | 64%:41% ns | Stopped prior due to SAE in predn. group |
| Malik et al47 | RCT Not bl | Functionally threatening Potentially disfiguring | Propr. vs predn. vs both propr. and predn. Combined Mean 11/13/10 m | 1–8 m No preterms mentioned | 10:10:10 | Size Visual Analogue Scale Satisfaction After 18 m observation | Geom. red.: 36:22:32%, ns VAS size reduction 90:67:83% p<0.05 | Propr. favoured, combined not superior |
| Zaher et al48 | RCT bl | Rapidly progressive Function threatening Cosmetic disfigurement | Propr. Oral 2 mg/kg/d vs topical 1% twice/d vs. intrales. 1 mg/wk Mean 5.1/7.5/7.9 m | 1–18 m No preterms mentioned | 15:15:15 | Efficacy Safety 6 m after end of treatment | Excellent result 60:20:13% Treatment time shortest for propr. (p=0.002) | Intralesional application not recommended |
| Chan et al49 | RCT dbl Placebo controlled | IH superficial not requiring systemic therapy | Timolol topic. 0.5% vs placebo 1 drop rub in twice/d 24 wk | 5–24 wk No preterms mentioned | 19:22 | Colour Volume 24 wk | p=0.003 p=0.002 | Treatment favoured |
| Leaute-Labreze et al50 | RCT dbl Pilot Placebo controlled | IH>1 cm Non-threatening, no steroids required | Propr. 3 mg/kg/d for 15 d and 4 mg/kg/d for add. 15 d vs placebo 30 d | <16 wk No preterms mentioned | 7:7 | Thickness Size After 30 d treatment | −45% vs +11% p=0.004 −16% vs +9% p=0.041 | Early treatment favoured |
| Hogeling et al51 | RCT bl Placebo controlled | Pediatric Dermatol. Clinic Age 9 wk–5 years IH with deep component, could impair function, too late for corticosteroids | Propr. 2 mg/kg/d vs placebo 6 m | 11 wk–4 years No preterms mentioned | 20:20 | Volume Redness Blueness Elevation After 24 wk therapy | −60% vs −14% p=0.01 p=0.04 p=0.17 p=0.01 | Treatment favoured. Limitations: heterogeneous, small numbers, age at incl. >6 m |
add, additional; bl, blind; d, day; dbl, double blind; geom. red., geometric reduction; IH, infantile haemangioma; incl., inclusion; loc., location; m, month; ns, not significant; predn., prednisolone; propr., propranolol; RCT, randomised controlled trial; SAE severe adverse event; sympt., symptomatic; topic., topical; VAS, Visual Analogue Scale; vs, versus; wk, weeks.