Harper 1990.

Study characteristics
Methods	Design: randomised, double‐blind, placebo‐controlled, parallel Duration of trial: 16 weeks Interval of assessment: first weekly, then 4 weeks
Participants	Number randomised: 20 (9 in the active group and 11 in the placebo group) Sex (M/F): 1/8 in the active group and 4/7 in the placebo group Age of participants: active group = 7.0, placebo group = 4.3 Unit of analysis: whole person Country and setting: patients from single centre dermatology in UK, no other specifications Inclusion criteria of the study "Moderate to severe atopic eczema requiring constant treatment with mild to moderate potent steroids, emollients or antihistamines" Aged 6 months to 12 years No trial treatment to be started in hospital setting, none to be discontinued, if hospitalised. May enter study immediately after leaving hospital Diagnostic criteria: clinical Exclusion criteria of the study Other cause of itch Any other inflammatory disorder Any severe intercurrent illness, including renal liver failure or cancer Epilepsy Phenothiazines
Interventions	Treatment (active) group: 8 capsules daily, each with 500 mg EPO, for children between 6 months to 2 years; 12 capsules daily, each with 500 mg EPO, for children between 2 years to 12 years Placebo group: capsules each with 500 mg olive oil, divided into 2 groups as above Duration: 16 weeks' treatment and 8 weeks' off therapy
Outcomes	Parent evaluation of itch (method: VAS, from none to worst ever) Parental assessments of the participant's skin dryness, scaling, redness, and overall impression (method of assessment: VAS) Dermatologist assessments of the patient's skin dryness, scaling, redness, and overall impression (method of assessment: VAS) Adverse events
Notes	Previous treatment not stopped ("no limitations regarding other treatment were required") Asessment of compliance: "Insufficient data were available to evaluate compliance" Compliance treatment of the children's eczema was permitted to continue as usual The results were evaluated ‐ by other individuals ‐ 6 years after the study completed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The trial used computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Quote (page 15): "A listing of the randomization schedule and code is not available. Appendix 4 contains a listing of children with their randomised assigned treatment" Comment: This was adequate
Incomplete outcome data (attrition bias) All outcomes	Low risk	The trial undertook ITT analysis
Selective reporting (reporting bias)	Low risk	There was no selective reporting
Other bias	High risk	Pharmacia sponsored the trial
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (page 15): "Securicontainer #1 was given out by physician or pharmacist to the first patient entered in the trial" Comment: This was adequate