Efficacy and tolerability of borage oil in adults and children with atopic eczema: randomised, double blind, placebo controlled, parallel group trial.

OBJECTIVE

To study the efficacy and tolerability of borage oil, which contains a high concentration of gamma 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 gamma 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

Gamma linolenic acid is not beneficial in atopic dermatitis.