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JAMA Dermatol. 2017 Jun 1;153(6):529-536. doi: 10.1001/jamadermatol.2017.0250.

Comparison of Efficacy and Safety Between Propranolol and Steroid for Infantile Hemangioma: A Randomized Clinical Trial.

Author information

1
Department of Dermatology, Seoul National University College of Medicine, Seoul, Republic of Korea2Institute of Human-Environment Interface Biology, Seoul National University Medical Research Center, Seoul, Republic of Korea3Laboratory of Cutaneous Aging and Hair Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea.
2
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, Seoul National University College of Medicine, Seoul, Republic of Korea.
3
Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
4
Department of Dermatology, Seoul National University College of Medicine, Seoul, Republic of Korea.
5
Department of Plastic and Reconstructive Surgery, Seoul National University Hospital, Seoul, Republic of Korea.
6
Department of Radiology, Seoul National University College of Medicine, Seoul, Republic of Korea.
7
Department of Medicine, Seoul National University School of Medicine (Master Course), Seoul, Republic of Korea.
8
Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University Children's Hospital, Seoul, Republic of Korea.
9
Department of Plastic and Reconstructive Surgery, Seoul National University Bundang Hospital, Gyeonggi, Republic of Korea.

Abstract

Importance:

There are limited data from randomized clinical trials comparing propranolol and steroid medication for treatment of infantile hemangioma (IH).

Objective:

To determine the efficacy and safety of propranolol compared with steroid as a first-line treatment for IH.

Design, Setting, and Participants:

This randomized clinical noninferiority trial tested the efficacy and safety of propranolol vs steroid treatment for IH at a single academic hospital. All participants were diagnosed with IH between June 2013 and October 2014, had normal heart function, and had not been previously treated for IH.

Interventions:

The participants were randomly assigned to either the propranolol group or the steroid group. In the propranolol group, the patients were admitted, observed for adverse effects for 3 days after treatment initiation, and then released and treated as outpatients for 16 weeks (2 mg/kg/d). In the steroid group, the patients were seen as outpatients from the beginning and were also treated for 16 weeks (2 mg/kg/d).

Main Outcomes and Measures:

The primary efficacy variable was the response to treatment at 16 weeks, which was evaluated by the hemangioma volume using magnetic resonance imaging before and at 16 weeks after treatment initiation. While comparing the effect of medication between the groups, we monitored the adverse effects of both drugs.

Results:

A total of 34 patients (15 boys, 19 girls; mean age, 3.3 months; range, 0.3-8.2 months) were randomized to receive either propranolol or steroid treatment (17 in each treatment group). Guardians for 2 patients in the steroid group withdrew their consent, and 1 patient in the propranolol group did not complete the efficacy test. The intention-to-treat analysis, applying multiple imputations, found the treatment response rate in the propranolol group to be 95.65%, and that of the steroid group was 91.94%. Because the difference in response rate between the groups was 3.71%, propranolol was considered noninferior. We found that there was no difference between the groups in safety outcomes.

Conclusions and Relevance:

Our trial demonstrated that propranolol was not inferior to steroid with respect to therapeutic effects in IH.

Trial Registration:

clinicaltrials.gov Identifier: NCT01908972.

PMID:
28423174
PMCID:
PMC5817616
DOI:
10.1001/jamadermatol.2017.0250
[Indexed for MEDLINE]
Free PMC Article

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