Double-blind, multicentre analysis of the efficacy of borage oil in patients with atopic eczema
Double-blind, multicentre analysis of the efficacy of borage oil in patients with atopic eczema
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DOI：
10.1046/j.1365-2133.1999.02771.x
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发表时间：
1999-04-01
影响因子：
10.3
通讯作者：
Raederstorff, D
中科院分区：
文献类型：
--
作者：
Henz, BM;Jablonska, S;Raederstorff, D
尽管γ-亚麻酸（GLA）已被证明可纠正与δ-6-去饱和酶活性降低相关的皮肤脂质缺陷，这应导致特应性湿疹中炎症和免疫失调的改善，但使用含有10%GLA的月见报春花油的临床研究产生了矛盾的结果。因此，我们在一项双盲多中心研究中，研究了较高百分比（至少23%）含GLA的琉璃苣油对中度稳定性特应性湿疹成人的影响。160名患者被随机分为两组，一组每天服用500毫克琉璃苣油胶囊，另一组在24周内服用温和的脂质米格列醇作为安慰剂。允许使用局部二氟可托龙-21-戊酸酯乳膏作为急救药物，将缓解前的用量定义为主要疗效标准，将临床改善定义为次要疗效标准。尽管与安慰剂相比，几种临床症状得到改善，但琉璃苣油的总体反应没有达到统计学显著性。然而，在排除患者的亚组中观察到有利于琉璃苣油的显著差异，这些患者未能显示红细胞二高-γ-亚麻酸水平升高，并且对入选标准和研究方案的依从性存在疑问。GLA代谢物仅在琉璃苣油治疗的患者中增加，血清IgE在总体和亚组分析中显示出下降的趋势。未观察到与供试品相关的不良反应。这项研究表明，含GLA的琉璃苣油在特应性湿疹中没有总体疗效，类固醇使用是主要反应参数，尽管它表明一个亚组的患者可能受益于这种耐受性良好的治疗。
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.