Further evidence that propranolol is effective in the treatment of infantile hemagiomas

Article Outline

• Question
• Design
• Setting
• Participants
• Intervention
• Outcomes
• Main Results
• Conclusions
• Commentary
• Reference
• Copyright

Hogeling M, Adams S, Wargon O. A randomized controlled trial of propranolol for infantile hemangiomas. Pediatrics 2011;128:e259-e66.

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Question 

Among children with infantile hemangiomas (IHs), does propranolol (compared with placebo) result in more rapid resolution?

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Design 

Randomized controlled trial.

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Setting 

Single tertiary center (pediatric dermatology, pediatric surgery, and multidisciplinary vascular anomalies clinics) in Australia.

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Participants 

40 children (age 9 weeks to 5 years) with facial IHs or IHs in sites with the potential for disfigurement.

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Intervention 

Propranolol or placebo oral solution 2 mg/kg per day divided 3 times daily for 6 months.

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Outcomes 

Change in the lesion as assessed by 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.

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Main 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.

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Conclusions 

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.

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Commentary 

IH usually pose no medical risk, but a significant number do require therapeutic intervention. Until recently, available options (eg, systemic steroids, interferon, vincristine) posed their own significant medical risks, limiting their usefulness. Options improved in 2008 when Leaute-Labreze et al published a small case series documenting the rapid and dramatic effect of propranol on IH.¹ Many clinicians subsequently chose to empirically utilize this therapy, and more than 100 publications have attested to the efficacy of this drug. Propranolol is now the “drug of first choice” for most problematic IH, but one might question if evidence-based data supports this approach. The randomized, controlled trial by Hogeling et al documenting the efficacy of propranol for IH is a move in the right direction. However, the authors admit to several shortcomings of the trial. The study is small and only represents one institution's experience. Children were of varying age at onset of intervention, and the IHs evaluated were at different proliferative stages of development, and of differing type (focal vs segmental; superficial vs deep). Given the small size of the study, such variability in the patient population does not allow us to draw specific conclusions relating to efficacy at any one time in development for any particular type of IH. The authors also admit that the 5 largest volume lesions were in the treated group, perhaps skewing results. Photographic assessments always allow for subjectivity, and IH, by their very nature, improve over time. Nonetheless, this small study provides useful confirmation of the utility of the drug. Further information, particularly regarding dose-response and toxicity, will most likely come from a large multinational study that is currently in progress. Until then, we can be reassured data by Hogeling et al regarding the utility of propranolol for IH.

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Reference 

1. Léauté-Labrèze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taïeb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008;358:2649–2651
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