Methods |
Design: 2 arms
Country: China
Method of randomisation: unclear
Blinding: unclear
Location: Department of Dermatology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China
Length of follow‐up: unclear
|
Participants |
Diagnosis: complicated infantile haemangiomas
Sex: 46 female, 15 male
Age: mean age of 3.55 (range 1 to 6 months)
Inclusion criteria: 1. the lesion in question had a distinct proliferative phase; 2. physicians determined topical treatment alone would not control the progression of the disease; 3. the thickness of lesions was ≥ 1 cm and confirmed by ultrasound
Exclusion criteria: patients who had taken or were taking systemic corticosteroids, as well as patients with a family history of asthma
Number of randomised children: 61
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Interventions |
Intervention A (number of children: 30): local dual‐wavelength laser therapy after discontinuation of oral propranolol (1 to 2 mg/kg/day). Propranolol treatment was stopped when maximised treatment effect was achieved.
Intervention B (number of children: 31): oral propranolol (1 to 2 mg/kg/day) for 1 week before laser therapy was added concurrently
|
Outcomes |
|
Notes |
Trial registration: not stated
Funder: Natural Science Foundation of Hunan Province and Bureau of Changsha Science and Technology
Role of funder: provision of grants
A priori sample size estimation: not stated
Conducted: 2009 to 2011
Declared conflicts of interest: yes
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "the patients were randomised into two groups.” Page 16,135 Comment: There was insufficient information to rate this item as low or high risk of bias. |
Allocation concealment (selection bias) |
Unclear risk |
There was insufficient information to rate this item as low or high risk of bias. |
Blinding of participants (Performance bias) |
Unclear risk |
There was insufficient information to rate this item as low or high risk of bias. |
Blinding of personnel (performance bias) |
Unclear risk |
There was insufficient information to rate this item as low or high risk of bias. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
There was insufficient information to rate this item as low or high risk of bias. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No children were lost at follow‐up. |
Selective reporting (reporting bias) |
Low risk |
Selective reporting of information was not detected. |
Other bias |
Low risk |
No other biases were detected. |