- A Takwale, research fellow1,
- E Tan, research fellow1,
- S Agarwal, research fellow1,
- G Barclay, research fellow1,
- I Ahmed, research fellow1,
- K Hotchkiss, research nurse1,
- J R Thompson, professor2,
- T Chapman, technical director3,
- J Berth-Jones, consultant dermatologist ()1
- 1Department of Dermatology, George Eliot Hospital, Nuneaton CV10 7DJ
- 2Department of Health Sciences, University of Leicester, Leicester LE1 6TP
- 3Essential Nutrition Ltd, Bank House, Saltgrounds Road, Brough, East Yorkshire HU15 1EF
- Correspondence to: J Berth-Jones
- Accepted 10 October 2003
Objective To study the efficacy and tolerability of borage oil, which contains a high concentration of γ linolenic acid, in children and adults with atopic eczema.
Design Single centre, randomised, double blind, placebo controlled, parallel group trial.
Setting Acute district general hospital in Nuneaton, England.
Participants 151 patients, of whom 11 failed to return for assessment, leaving an evaluable population of 140 (including 69 children).
Intervention Adults received four capsules of borage oil twice daily (920 mg γ linolenic acid), and children received two capsules twice daily, for 12 weeks.
Main outcome measures Change in total sign score at 12 weeks measured with the six area, six sign, atopic dermatitis (SASSAD) score (primary endpoint); symptom scores, assessed on visual analogue scales; topical corticosteroid requirement, assessed on a five point scale; global assessment of response by participants; adverse events and tolerability.
Results The mean SASSAD score fell from 30 to 27 in the borage oil group and from 28 to 23 in the placebo group. The difference between the mean improvements in the two groups was 1.4 (95% confidence interval −2.2 to 5.0) points in favour of placebo (P = 0.45). No significant differences occurred between treatment groups in the other assessments. Subset analysis of adults and children did not indicate any difference in response. The treatments were well tolerated.
Conclusion γ linolenic acid is not beneficial in atopic dermatitis.
Contributors JB-J, TC, and JRT designed the protocol. JB-J, AT, ET, SA, GB, IA, and KH recruited patients and conducted the study. All authors contributed to analysis and interpretation of the data and production of the manuscript. JRT provided statistical advice on the design and analysis of the trial. JB-J is the guarantor.
Funding This study was sponsored by Essential Nutrition Ltd.
Competing interests TC is a director of Essential Nutrition Ltd.
Ethical approval Warwickshire Research Ethics Committee approved the protocol.