| Methods |
Design: parallel, 3 arms Country: China Method of randomisation: random number table Blinding: single‐blind/the physician test packet inspection blinded Duration of trial: from July 2010 to October 2011 Location: Hubei Maternal and Child Health Hospital, China Length of follow‐up: 24 weeks |
| Participants |
Diagnosis: all diagnosed as haemangioma surface, all cases had not received treatment. Sex: male: 28; female: 69 Age: between 1 and 4 months Inclusion criteria: 1 to 4 months of age, signed consent for Exclusion criteria: refusal to participate; age > 4 months; children with chronic diseases of cardiovascular, respiratory, and other systems; merger vascular malformations; maximum tumour diameter < 1.0 cm Number of randomised children: 97 |
| Interventions |
Intervention A (number of children: 32): propranolol, laser combined treatment. 1064 nm Nd:YAG laser therapy, once every 6 weeks; the first 2 days after laser treatment start propranolol 0.5 mg/kg/day, twice daily; increased dosage 2 weeks later to 0.8 mg/kg/day, 4 weeks later increased to 1.0 mg/kg/day Intervention B (number of children: 35): 1064 nm Nd:YAG laser treatment, once every 6 weeks Intervention C (number of children: 30): propranolol 0.5 mg/kg/day, orally twice daily; increased dosage 2 weeks later to 0.8 mg/kg/day, 4 weeks later increased to 1.0 mg/kg/day |
| Outcomes |
Primary outcome: clearance of lesions, measured by visual analogue scale score Clinical response rate: (the number of recovery cases + the number of obvious improvement cases + the number of improvement cases)/total number of cases in each group *100% Obvious improvement rate: (the number of recovery cases + the number of obvious improvement cases)/total number of cases in each group *100% Adverse events |
| Notes |
Trial registration: unclear Funder: not stated Role of funder: not stated A priori sample size estimation: not stated Conducted: from July 2010 to October 2011 Declared conflicts of interest: not reported |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "randomly assigned based on random number table.” Page 165
Comment: Authors reported information about adequate random sequence generation. |
| Allocation concealment (selection bias) |
Unclear risk |
There was insufficient information to assess this item as low or high. |
| Blinding of participants (Performance bias) |
Unclear risk |
There was insufficient information to assess this item as low or high. |
| Blinding of personnel (performance bias) |
Unclear risk |
There was insufficient information to assess this item as low or high. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "The outcome assessor was blinded." Page 165
Comment: Authors reported information about adequate blinding of outcome assessment. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
5 (16%) children in the propranolol group left the study early; no intention‐to‐treat analysis was conducted. |
| Selective reporting (reporting bias) |
Low risk |
Selective reporting was not detected. |
| Other bias |
Low risk |
No other biases were identified. |
