Diagnosis and Management of Infantile Hemangioma

Table 10. Key resolution outcomes in RCTs comparing propranolol and placebo or observation
(continued)
Author, Year
Methods and Resolution Rebound Growth/
Age
Comparison
Measures of Outcomes Recurrence, n (%)
Location
Groups (n)
Resolution/
Type
Quality
Response
Other Outcomes
Leaute-Labreze
et al. 2013 99
G1: Propranolol,
oral 3-4
mg/kg/day for 1
month (7)
G2: Placebo (7)
Age, weeks
mean±SD
G1: 12.5 ± 2.1
G2: 12.4 ± 2.6
Type:
NR
G1+G2:
multiple
• Change in
thickness as
measured by
ultrasound
• Double-blinded
assessment of
change
Mean change
in thickness, 5
[95% CI]
G1: -44.9%
[36-76.2p
G2: +11.3%
G1 vs G2:
p=0.004
• NR
Quality: Fair
Percentage
change in size
G1: -15.8
G2: +8.9
G1 vs G2:
p=0.041
Hogeling et al.
2011 17
G1: Propranolol
oral,
2mg/kg/day in 3
daily doses (19)
G2: Placebo
(20)
Quality: Good
Mean weeks,
n
G1: 67
G2: 71
Type
Focal, n
G1: 16
G2: 17
Segmental
G1: 3
G2: 3
G1+G2:
multiple
• Photographs
and serial
hemispheric
measurements
of tumor
volume
assessed by
blinded
investigators
Percent
change in
volume at 24
weeks
G1: -60%
(n=18)
G2: -14.1%
(n=15)
Difference
between group
-45.9 (95% CI:
-80.3, -11.4)
p=0.01
• NR
40