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

Ehsani 2014.

Methods
  • Design: parallel, 2 arms

  • Country: Iran

  • Method of randomisation: randomised number table

  • Blinding: single‐blind

  • Location: Razi Hospital

  • Length of follow‐up: 16 weeks

Participants
  • Diagnosis: superficial or mixed IH

  • Sex: female: 16; male: 3

  • Age: less than 2 years of age

  • Inclusion criteria: less than 2 years of age, having haemangioma in non‐vital parts of the body including eyelids, ears, lips, and nose, and no previous treatment with systemic steroids or other modalities over the last 3 months

  • Exclusion criteria: patients with congenital heart or renal disease

  • Number of randomised children: 19

Interventions
  • Intervention A (number of children: 9): pulsed dye laser therapy (spot size 7 mm, fluence 12 J/cm², pulse duration 1.5 ms, dynamic cooling device 40/40)

  • Intervention B (number of children: 10): pulsed dye laser therapy + topical propranolol 1%, twice a day for at least 12 weeks

Outcomes Outcomes were not classified as primary or secondary:
  • Clinical response: 0% to 25% = no response, 25% to 50% = poor response, 50% to 75% = good response, 75% to 100% = excellent response

  • Side effects reported by parents

Notes
  • Trial registration: IRCT 201110137787N1

  • Funder: not reported

  • Role of funder: not reported

  • A priori sample size estimation: no

  • Conducted: from January 2011 to July 2012

  • Declared conflicts of interest: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "(...) and randomly divided into two treatment groups using a randomised number table." Page 658
Comment: Authors reported information about adequate random sequence generation.
Allocation concealment (selection bias) Unclear risk There was insufficient information to classify this item as high or low risk of bias.
Blinding of participants (Performance bias) Unclear risk It is highly probable that participants were aware of intervention group assigned, but it is unclear whether this had an impact or not on the trial results.
Blinding of personnel (performance bias) Unclear risk It is highly probable that researchers were aware of intervention group assigned, but 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: “The clinical improvements of IH lesions were quantified using a visual score system after comparing pre‐ and post‐treatment lesion photographs by two dermatologists who were blind to treatment regimens”. Page 659
Comment: Authors reported information about adequate blinding of outcome assessment.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: “All the 19 patients who were included to the study completed the treatment course.” Page 659
Comment: Authors reported complete data for all included children.
Selective reporting (reporting bias) Unclear risk In the protocol, the authors specified an outcome called “improvement of overall health of patient”. However, this outcome is not reported in the manuscript.
Other bias Low risk No other biases were identified.