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用阔叶十大功劳提取物Reliéva治疗轻至中度银屑病——一项双盲、安慰剂对照研究。

Treatment of mild to moderate psoriasis with Reliéva, a Mahonia aquifolium extract--a double-blind, placebo-controlled study.

作者信息

Bernstein Steve, Donsky Howard, Gulliver Wayne, Hamilton Douglas, Nobel Sion, Norman Robert

机构信息

Dermatology and Cosmetic Center, 1665 East Ridge Road, Rochester, New York 14621, USA.

出版信息

Am J Ther. 2006 Mar-Apr;13(2):121-6. doi: 10.1097/00045391-200603000-00007.

DOI:10.1097/00045391-200603000-00007
PMID:16645428
Abstract

Psoriasis is usually treated with local and systemic medications that have varying degrees of efficacy and safety profiles. We investigated the efficacy and safety of an alternative treatment from natural sources, Mahonia aquifolium, for the management of mild to moderate psoriasis. Two hundred subjects participated in a randomized, double-blind, placebo-controlled study using either the topical cream Reliéva (a homeopathic product containing a proprietary M. aquifolium extract) or control (placebo) twice a day for 12 weeks. Efficacy and safety were assessed using the Psoriasis Area Severity Index (PASI) and the Quality of Life Index (QLI) questionnaires at different times throughout the 12-week study. The PASI was evaluated by the physician at the beginning (week 0) and end (week 12) of the study. The QLI was assessed by patients at weeks 0, 4, 8, and 12. The results indicate statistically significant (P < 0.05) improvements in PASI and QLI in the Mahonia-treated group, compared with the control group. The side effects reported were infrequent, < 1% and minor; the most frequent side effects were rash, a burning sensation when applying the cream, and clothing stain. These data indicate that Reliéva, a proprietary form of M. aquifolium, is effective and well tolerated in patients with mild to moderate psoriasis.

摘要

银屑病通常采用局部和全身用药治疗,这些药物的疗效和安全性各不相同。我们研究了一种天然来源的替代疗法——阔叶十大功劳,用于治疗轻至中度银屑病的疗效和安全性。200名受试者参与了一项随机、双盲、安慰剂对照研究,他们每天两次外用乳膏Reliéva(一种含有专利阔叶十大功劳提取物的顺势疗法产品)或对照(安慰剂),持续12周。在为期12周的研究过程中的不同时间,使用银屑病面积和严重程度指数(PASI)和生活质量指数(QLI)问卷评估疗效和安全性。在研究开始时(第0周)和结束时(第12周)由医生评估PASI。在第0、4、8和12周由患者评估QLI。结果表明,与对照组相比,阔叶十大功劳治疗组的PASI和QLI有统计学意义的改善(P < 0.05)。报告的副作用很少见,<1%且轻微;最常见的副作用是皮疹、涂抹乳膏时的烧灼感和衣物染色。这些数据表明,阔叶十大功劳的专利制剂Reliéva对轻至中度银屑病患者有效且耐受性良好。

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