Although
gamma-linolenic acid (GLA) has been shown to correct deficiencies in skin
lipids associated with reduced
delta-6-desaturase activity which should result in improvement of dysregulation of
inflammation and immunity in
atopic eczema, clinical studies with
evening primrose oil containing 10% GLA have yielded contradictory results. We have therefore examined the effect of a higher percentage (at least 23%) GLA-containing
borage oil in adults with stable
atopic eczema of moderate severity in a double-blind, multicentre study. One hundred and sixty patients were randomized to take daily either 500 mg of
borage oil-containing capsules or the bland
lipid miglyol as a placebo over a 24-week period. Use of topical diflucortolone-21-valerate cream was allowed as rescue medication, with the amount used until response being defined as primary, and clinical improvement as secondary efficacy criteria. Although several clinical symptoms improved compared with placebo, the overall response to
borage oil did not reach statistical significance. Significant differences in favour of
borage oil were, however, observed in a subgroup excluding patients who failed to show increased erythrocyte
dihomo-gamma-linolenic acid levels and in whom adherence to inclusion criteria and the study protocol were questionable. GLA metabolites increased in
borage oil-treated patients only, and serum
IgE showed a trend to decrease on overall and subgroup analysis. No substance-related adverse effects were observed. This study shows no overall efficacy of GLA-containing
borage oil in
atopic eczema, with
steroid use being the primary response parameter, although it suggests that a subgroup of patients may benefit from this well-tolerated treatment.