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A randomized controlled trial of propranolol for infantile hemangiomas
Marcia Hogeling1, Susan Adams, Orli Wargon
1Department Pediatric Dermatology, Sydney Children's Hospital, Randwick, New South Wales 2031, Australia. hogelingm@yahoo.ca
Insights
Propranolol hydrochloride effectively treats infantile hemangiomas (IHs) by reducing their size, color, and height. This study confirms its safety and efficacy in young children, offering a valuable therapeutic option.
Area of Science:
- Pediatric Dermatology
- Vascular Anomalies
- Pharmacology
Background:
- Infantile hemangiomas (IHs) are common benign vascular tumors in infants.
- Treatment options for IHs, especially those with cosmetic or functional concerns, are continuously evolving.
- Propranolol has emerged as a promising therapeutic agent for IHs.
Purpose of the Study:
- To evaluate the efficacy and safety of oral propranolol hydrochloride in treating infantile hemangiomas.
- To assess the impact of propranolol on IH volume, color, and elevation.
- To compare outcomes between propranolol and placebo groups.
Main Methods:
- A randomized, placebo-controlled trial involving 40 children aged 9 weeks to 5 years with IHs.
- Participants received either propranolol (2 mg/kg/day) or placebo for 6 months.
- Efficacy was measured by blinded volume assessments and photographic scoring; safety was monitored through vital signs and laboratory tests.
Main Results:
- Propranolol significantly halted IH growth by week 4 and reduced IH volume, redness, and elevation by weeks 12 and 24.
- The largest volume reduction difference between groups was observed at week 12.
- No significant adverse events like hypoglycemia, hypotension, or bradycardia were noted; common side effects were mild.
Conclusions:
- Oral propranolol hydrochloride at 2 mg/kg/day is a safe and effective treatment for infantile hemangiomas in infants and children up to 5 years.
- The medication demonstrably reduces IH volume, color, and elevation.
- Propranolol offers a beneficial treatment for focal and segmental IHs.
Objective:
Propranolol hydrochloride is a safe and effective medication for treating infantile hemangiomas (IHs), with decreases in IH volume, color, and elevation.
Methods:
Forty children between the ages of 9 weeks and 5 years with facial IHs or IHs in sites with the potential for disfigurement were randomly assigned to receive propranolol or placebo oral solution 2 mg/kg per day divided 3 times daily for 6 months. Baseline electrocardiogram, echocardiogram, and laboratory evaluations were performed. Monitoring of heart rate, blood pressure, and blood glucose was performed at each visit. Children younger than 6 months were admitted to the hospital for monitoring after their first dose at weeks 1 and 2. Efficacy was assessed by performing blinded volume measurements at weeks 0, 4, 8, 12, 16, 20, and 24 and blinded investigator scoring of photographs at weeks 0, 12, and 24.
Results:
IH growth stopped by week 4 in the propranolol group. Significant differences in the percent change in volume were seen between groups, with the largest difference at week 12. Significant decrease in IH redness and elevation occurred in the propranolol group at weeks 12 and 24 (P = .01 and .001, respectively). No significant hypoglycemia, hypotension, or bradycardia occurred. One child discontinued the study because of an upper respiratory tract infection. Other adverse events included bronchiolitis, gastroenteritis, streptococcal infection, cool extremities, dental caries, and sleep disturbance.
Conclusion:
Propranolol hydrochloride administered orally at 2 mg/kg per day reduced the volume, color, and elevation of focal and segmental IH in infants younger than 6 months and children up to 5 years of age.
