title: Double-blind, multicentre analysis of the efficacy of borage oil in patients with atopic eczema.
abstract: 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.
authors.affiliation: Department of Dermatology, Virchow Clinic, Free University Berlin, Augustenburgerplatz 1, 13344 Berlin, Germany.
authors.forename: B M
authors.initials: BM
authors.lastname: Henz
authors.forename: S
authors.initials: S
authors.lastname: Jablonska
authors.forename: P C
authors.initials: PC
authors.lastname: van de Kerkhof
authors.forename: G
authors.initials: G
authors.lastname: Stingl
authors.forename: M
authors.initials: M
authors.lastname: Blaszczyk
authors.forename: P G
authors.initials: PG
authors.lastname: Vandervalk
authors.forename: R
authors.initials: R
authors.lastname: Veenhuizen
authors.forename: R
authors.initials: R
authors.lastname: Muggli
authors.forename: D
authors.initials: D
authors.lastname: Raederstorff
mesh_terms: D015126:8,11,14-Eicosatrienoic Acid / Q000097:blood; D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D015415:Biomarkers / Q000097:blood; D003876:Dermatitis, Atopic / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010938:Plant Oils / Q000627:therapeutic use*; D014280:Triglycerides / Q000627:therapeutic use; D017965:gamma-Linolenic Acid / Q000097:blood
chemical_list: D015415:Biomarkers; D010938:Plant Oils; D014280:Triglycerides; C022834:miglyol 812; D017965:gamma-Linolenic Acid; C079363:borage oil; D015126:8,11,14-Eicosatrienoic Acid