MacKie Child 1990.

Study characteristics
Methods	Design: double‐blind, randomised, placebo‐controlled Duration: 24 weeks (16 weeks' intervention, 8 weeks off treatment) Interval of assessment: 4 weeks
Participants	Number randomised: 19 (10 in the active group and 9 in the placebo group) Sex (M/F): 10/10 total (3/7 in the active group and 7/3 in the placebo group) Age of participants: active group = 6.2, placebo group = 5.8 (means) Unit of allocation: whole person Country and setting: Glasgow, UK; single dermatology centre Inclusion criteria of the study Participants of either sex Participants < 12 years Participants with moderate to severe atopic eczema, as defined by extensive body involvement Diagnosis: severity of condition: moderate to severe eczema defined as extensive body involvement with regular need for moderately potent or potent steroid or frequent need for systemic steroids, cytotoxic therapy, combined with other measures, particularly antipruritic agents or antibiotics as required Exclusion criteria of the study Pruritis of any other cause Any other inflammatory skin disorder or any systemic disorder Any severe intercurrent illness, including liver failure, renal failure, malignancy Participants pregnant or trying to conceive Participants with epilepsy Participants on phenothiazines
Interventions	Treatment group: 8 capsules daily, each with 40 mg GLA and 11 mg vitamin E Placebo group: 8 capsules daily, each with 500 mg olive oil
Outcomes	Participant assessment of itching (method of assessment: VAS 0 to 100; none to worst ever) Participant assessment of all other signs and symptoms of eczema except itch (method of assessment: VAS) Skin assessments by the dermatologist (method of assessment: Glasgow method and skin profilimetry) EFA levels Adverse events (mild, moderate, severe)
Notes	Previous treatment not stopped Assessment of compliance: "There were no details relating to any assessments of compliance in the protocol. All unused capsules were returned to Scotia Pharmaceuticals at the end of the study" Concommitant 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	Randomisation was computer‐generated
Allocation concealment (selection bias)	Low risk	The trial used sealed envelopes
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were no withdrawals, but defaults: 4/10 in the active group and 2/9 in the placebo group
Selective reporting (reporting bias)	Low risk	This was low risk
Other bias	High risk	The results were evaluated 6 years after the completion of the study; other individuals evaluated the results. 1 child was included against protocol (age 12)
Blinding of participants and personnel (performance bias) All outcomes	Low risk	This was adequately blinded