Skip to main content
. 2018 Apr 18;2018(4):CD006545. doi: 10.1002/14651858.CD006545.pub3

Li 2016.

Methods
  • Design: 2 arms

  • Country: China

  • Method of randomisation: randomly divided into experimental and control groups using a randomised number table

  • Blinding: double‐blind

  • Location: Department of Oral and Maxillofacial Surgery, China Medical University Stomatologic Hospital

  • Length of follow‐up: 8 months

Participants
  • Diagnosis: children with mixed IHs in the oral and maxillofacial regions

  • Sex: 18 female, 13 male

  • Age: between 2 and 11 months

  • Inclusion criteria: patients of less than 1 year of age, and the presence of mixed haemangioma (located in the papillary dermis, reticular dermis, and subcutaneous tissue) with functional or cosmetic deformity

  • Exclusion criteria: history of previous treatment for IHs (such as laser or steroid), heart disease, cardiac arrhythmia, asthma, broncho‐obstructive disease, PHACE syndrome, and prematurity

  • Number of randomised children: 31

Interventions Intervention A (number of children: 14): oral propranolol in combination with topical timolol maleate
Intervention B (number of children: 17): oral propranolol treatment alone
Outcomes Primary
Outcome A: Changes of size and colour of the haemangioma were assessed by B‐ultrasound and photographs at the onset of treatment, between treatment intervals, and at the conclusion of treatment.
Secondary
Outcome B: The visual analogue scale was compared with the response to treatment.
Notes
  • Trial registration: not stated

  • Funder: not stated

  • Role of funder: not stated

  • A priori sample size estimation: not stated

  • Conducted: March 2013 to June 2014

  • Declared conflicts of interest: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomly divided into experimental and control groups using a randomised number table." Page 56
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 Despite participants being aware of intervention group assigned, it is unclear whether this had an impact or not on the trial results.
Blinding of personnel (performance bias) Unclear risk Despite researchers being aware of intervention group assigned, it is unclear whether this had an impact or not on the trial results.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Three independent surgeons blind to the patients assessed the efficacy by analysing the clinical photograph at baseline and the end of the treatment." Page 57
Comment: Authors reported information about adequate blinding of outcome assessment.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No children were lost at follow‐up.
Selective reporting (reporting bias) Low risk Selective reporting was not detected.
Other bias Low risk No other biases were identified.