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. 2018 Apr 18;2018(4):CD006545. doi: 10.1002/14651858.CD006545.pub3

Lu 2016.

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

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
  • Change in lesions: scores from 0 to 10 points

  • Total treatment time

  • Medication time

  • Laser treatment times

  • Side effects

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.