NEW YORK (Reuters Health) – Oral propranolol given for 6 months stops the growth of infantile hemangiomas and decreases their volume and coloration, according to the results of a randomized trial reported in the August issue of Pediatrics.
As the authors point out, propranolol has been shown to produce dramatic involution of infantile hemangiomas in several case series (see Reuters Health reports “Propranolol a good first-line therapy for infantile hemangioma” on May 17 2011; “Propranolol useful for periocular infantile hemangiomas” on April 5, 2011; and “Propranolol useful for severe infantile hemangiomas” on August 10, 2009.) Indeed, many physicians are prescribing propranolol as first-line treatment.
To assess safety and efficacy in a double-blind, randomized trial, Dr. Marcia Hogeling and colleagues at Sydney Children’s Hospital, Australia, recruited 40 children between the ages of 11 weeks and 4 years who had hemangiomas at potentially disfiguring sites. The children were randomly assigned to receive oral propranolol 2 mg/kg/day or placebo solution for 24 weeks.
Response to therapy was measured by blinded volume estimation every 4 weeks and by blinded scoring of photographs for color and elevation at baseline, 12 weeks and 24 weeks.
“IH (infantile hemangioma) growth abruptly stopped for all patients who were treated with propranolol before week 4,” the team found.
Thereafter, mean volume declined steadily in the propranolol group, while it increased initially and then dropped in the placebo group. At 24 weeks the change in volume from baseline in the propranolol group was -60.0% compared with -14.1% in the placebo group, a significant difference (p=0.01)
Redness and elevation decreased significantly more over the study period in the propranolol group that the placebo group, according to the report. By week 24, redness had cleared in 23.5% of the children treated with propranolol but in none of those given placebo while 11.8% and 35.7% in the two groups, respectively, still had significant coloration.
As for safety, blood pressure, heart rate and blood glucose levels were carefully monitored during the trial, but the researchers observed no episodes of hypotension, bradycardia or hypoglycemia.
Dr. Hogeling and colleagues conclude, “Propranolol is a safe and effective medication for treating IHs.”
They add, “Even with small numbers and a heterogeneous group, the P values show significant volume reduction and redness/elevation reduction sufficient to justify the use of propranolol as the first-line option for potentially disfiguring or complicated IHs.”
A Randomized Controlled Trial of Propranolol for Infantile Hemangiomas