Malik 2013.

Methods	Design: parallel, 3 arms Country: India Method of randomisation: computer program Blinding: double‐blind/assessors Location: Department of Pediatric Surgery, Advanced Pediatric Centre Length of follow‐up: 18 months
Participants	Diagnosis: IHs Sex: male: not stated; female: not stated Age: 1 week to 8 months Inclusion criteria: 1 week to 8 months of either sex and problematic IHs, with potentially disfiguring lesions in the face or functionally threatening lesions of the limbs, genitalia, or natural orifices Exclusion criteria: uncomplicated lesions of trunk, extremities; presence of heart disease, cardiac arrhythmia; broncho‐obstructive disease; history of hypoglycaemia; diabetes mellitus; hypertension; hypotension; liver failure; visceral lesions; and prematurity Number of randomised children: 30
Interventions	Group A (10 children): oral propranolol alone, 1 mg/kg per day, in 2 divided doses and increased to 2 mg/kg/day on the second day (max: 3 mg/kg/day) Group B (10 children): oral prednisolone alone; 1 mg/kg/day in 2 divided doses after feeding for a period of 3 weeks; discontinued for 3 weeks and then restarted in a similar on/off fashion to reduce drug side effects Group C (10 children): combination of both drugs as per above protocol
Outcomes	Primary outcome Complete or nearly complete resolution of the target haemangioma (with nearly complete resolution defined as a minimal degree of telangiectasis, erythema, skin thickening, soft‐tissue swelling, and distortion of anatomical landmarks), haemangioma evolution (improvement, stabilisation, or worsening), and changes in haemangioma size and colour were assessed centrally. Secondary outcomes Centralised assessments of the target IH Investigator on‐site qualitative assessments of the target IH at each postbaseline visit vs baseline Investigator on‐site qualitative assessments of the target IH at paired consecutive patient visits (each scheduled postbaseline visit compared to the previous scheduled visit) Other investigator on‐site qualitative assessments at each scheduled postbaseline visit Parent(s) or guardian(s) on‐site qualitative assessments of the target IH at each scheduled postbaseline visit compared to the previous scheduled visit Intake of IH treatment (outside that assigned in the trial) during follow‐up (systemic/local beta blockers, systemic/local corticoids, and laser)
Notes	Trial registration: not stated Funder: not stated Role of funder: not stated A priori sample size estimation: not stated 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: “Random sequence was generated using a computer program in a 1:1:1 ratio.” Page 2454 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 images were evaluated by two independent blinded examiners who scored the improvement (...)." Page 2454 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)	High risk	The primary outcome was not clearly reported in the Results section.
Other bias	Low risk	No other biases were detected.