Don 2003.

Study characteristics
Methods	Design: double‐blind, randomised, placebo‐controlled, parallel Duration: 12 weeks Interval of evaluation: 4 weeks and 12 weeks
Participants	Number randomised: 20 (10 each in the active and placebo groups) Sex (M/F): 8/1 in the active group and 5/4 in the placebo group Age of participants: 20 children aged 7 to 48 months (mean age = 22.9) Unit of allocation: whole person Country and setting: Italy, 1 centre Duration of eczema: placebo = 9.44 years, borage = 9.66 years (averages) Inclusion criteria of the study Severity of condition: SCORAD figures at start = 39.44 for borage group, 44.93 for placebo group Diagnostic criteria: Hanifin Rajka's criteria Exclusion criteria of the study Not specified Number: 20
Interventions	Treatment group: 60 drops daily of BO Control group: 60 drops daily of olive oil
Outcomes	SCORAD (method of assessment: standard method) Quality of life (parents' evaluation) (method of assessment: scores of calm = 4, slightly distressed = 3, moderately distressed = 2, very distressed = 1)
Notes	Concomittent treatment: allowed continued emollients and low‐dose steroids Compliance to treatment: undertaken by parental information and serum level changes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (page 428): "Patients were assigned to two groups on the basis of a randomised list created by suitable statistical software"
Allocation concealment (selection bias)	Low risk	The BO group was identified by letter A; the olive oil (placebo) group, by letter B. Investigators were unaware of this classification before and during the study. Comment: It is unclear if allocation was adequately concealed
Incomplete outcome data (attrition bias) All outcomes	Low risk	9/10 participants in the borage oil group completed the study, and 9/10 in the olive oil group completed the study
Selective reporting (reporting bias)	Low risk	The trial reported all prespecified outcomes
Other bias	Low risk	We contacted the author; there was no other bias
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Oils were dispensed in dark unlabelled bottles. Interventions had a different taste, smell, and colour Quote: "None of the investigators was aware of (...the A vs B...) classification before or during the study." (Methods section) Comment: Attempts were made to blind both participants and personnel, but it was unclear if this was adequate