Kenicer 2001.

Study characteristics
Methods	Design: randomised, double‐blind, placebo‐controlled Duration: 16 weeks Interval of assessment: start, 4 weeks
Participants	Number randomised: 66 (32 in the active group and 34 in the placebo group) Sex (M/F): both Age of participants: between 10 and 70 years of age Unit of allocation: whole body Country and setting: UK at Ninewells Hospital, Dundee or Hull Royal Infirmary Inclusion criteria of the study Diagnosis: satisfying previously defined and published criteria for atopic eczema (Hanifin 1980) Informed consent Active disease No severe intercurrent disease Exclusion criteria of the study Not pregnant, lactating Child‐bearing age and not on contraception Non‐compliant Epileptic Taking phenothiazines or immunosuppressive drugs Receiving UV treatments
Interventions	Treatment group: 8 capsules daily, with 400 mg GLA and 11 mg vitamin A in each capsule Placebo group: 8 capsules daily, with 500 mg olive oil in each capsule
Outcomes	Participant assessment of itch Participant assessment of dermatology (global score) Physician assessment of dermatology (global score) Physician assessment of redness (method of assessment: all participant and dermatological assessment were done on a VAS and scoring system used as 0 = no lesion to 100 = worse lesion)
Notes	Concomittent treatment: previous treatment with moderate to potent topical steroids, emollients continued for first 8 weeks of study, or both Next 8 weeks' steroids discontinued Compliance to treatment: Although the protocol called for pill counting and cream weighing to determine use of treatments, the final report did not include any evaluation of these measures Quote (page 29): "34% of Active and 32% of placebo participants did not satisfy the inclusion criterion" The results were evaluated ‐ by other individuals ‐ 6 years after the study completed There were a large number of dropouts
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was by computer‐generated sequence in blocks of 4, which was adequate
Allocation concealment (selection bias)	Low risk	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	Quote (page 29): "34% of Active and 32% of placebo participants did not satisfy the inclusion criterion" Quote (page 3): "For the purpose of this report the primary and secondary objectives have been re‐defined" The results were evaluated 6 years after the completion of the study; other individuals evaluated the results
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote (page 19): "There was no evidence in the protocol that the study was performed under blind conditions"