Diagnosis and Management of Infantile Hemangioma

Table 7. Key resolution outcomes in studies comparing methylprednisolone and prednisolone
Age at
Resolution Rebound Growth/
Initiation,
Outcomes Recurrence, n
Months Location
Author, Year
Comparison
Groups (n)
Quality
Akyuz et al.
2001 40
G1:
Prednisolone,
oral
2mg/kg/day
(26)
G2:
Methylpredniso
lone, oral low
dose
10mg/kg/day
tapered to 2
mg/kg/day (11)
G3:
Methylpredniso
lone, oral low
dose
30mg/kg/day
tapered to 5
mg/kg/day (8)
Quality: Fair
Type
Age, mean
(range)
G1: 5 (2-72)
G2: 4 (2-11)
G3: 6 (1-36)
Type
Capillary, n
(%)
G1: 11 (42.3)
G2: 2 (18)
G3: 4 (50)
Cavernous
(Deep)
G1: 8 (30.8)
G2: 4 (36.4)
G3: 4 (50)
Mixed
G1: 7 (27)
G2: 5 (45.5)
G3: 0
G1+G2+
G3:
multiple
Methods and
Measures of
Resolution/ Response
• Change in
dimension,
lightening of color,
and softening of
texture
• Response graded
as:
Excellent: 75-100%
Good: 50-75%
Fair: 25-50%
Poor: < 25%
• Blinded assessment:
NR
Response, n
(%)
G1+G2+G3:
Good or
excellent: 16
(36)
Fair: 15 (33)
Poor: 14 (31)
G1 vs. G2 vs.
G3: p=ns
G = group; kg = kilogram; mg = milligram; n = number; NR = not reported; ns = not significant
Harms of Steroids
Other Outcomes
Rebound Growth
G1: 4
G2+G3: 8
G1 vs. G2+G3:
p=0.045
Effect Modifiers
• No significant
association
between
response to
treatment and
sex, age, lesion
type, size,
location, and
age at
treatment
initiation in
univariate
analyses
• In multivariate
analyses,
younger age
and smaller
lesion size
associated with
better response
Harms Reported in Studies Included in This Review
Two comparative studies that addressed steroids explicitly defined harms and were
considered good quality for harms reporting. 107,108 Another RCT (good quality for harms
reporting) that compared prednisolone and propranolol also predefined harms. 98 Studies included
a limited number of participants and may not have been adequately powered to detect harms.
One RCT that compared harms reported in the prednisolone arm with those reported in the
methylprednisolone arm noted no significant differences in harms between groups, 107 as did an
RCT comparing prednisolone, triamcinolone, and conservative management. 108 One child
receiving oral prednisolone discontinued the study due to persistent vomiting. 107 Another RCT
comparing oral propranolol alone, prednisolone alone, and propranolol plus prednisolone noted
significantly more complications in the steroid arms compared with propranolol alone (p values
not clearly reported). 100 Complications in the combination arm and prednisolone only arm
included Cushingoid appearance (n=6/10 in combination , 5/10 in prednisolone arms) and
gastrointestinal upset (n=4/10 in combination arm and 3/10 in prednisolone). One child in the
prednisolone arm discontinued the study due to ulceration and infection. 100 A final RCT reported
harms using a general classification. 98 The frequency of harms between the prednisolone and
propranolol groups did not differ significantly (44 vs. 32, respectively), and harms associated
29