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草药提取物(EstroG-100)对绝经前、围绝经期和绝经后妇女的影响:一项随机、双盲、安慰剂对照研究。

The effect of herbal extract (EstroG-100) on pre-, peri- and post-menopausal women: a randomized double-blind, placebo-controlled study.

机构信息

Shady Canyon Medical Group, 16300 Sand Canyon, Suite 909, Irvine, CA 92618, USA.

出版信息

Phytother Res. 2012 Apr;26(4):510-6. doi: 10.1002/ptr.3597. Epub 2011 Sep 2.

DOI:10.1002/ptr.3597
PMID:21887807
Abstract

This clinical research study was designed to evaluate the efficacy of a new herbal product, EstroG-100, containing a mixture of standardized extracts of Cynanchum wilfordii, Phlomis umbrosa and Angelica gigas, on menopausal symptoms. This randomized double-blind, placebo-controlled trial was performed for 12 weeks with 64 pre-, peri- and postmenopausal White Hispanic, White non-Hispanic and African American women who were randomly allocated to either the EstroG-100 group (n = 31) or the placebo group (n =  33). Primary end-points were the mean change in scores of the Kupperman menopause index (KMI) that evaluates 11 symptoms, and the mean change in scores of vaginal dryness. The mean KMI score was significantly reduced in the EstroG-100 group from 29.5 ± 7.4 at baseline to 11.3 ± 5.8 (p < 0.01) compared with change of the placebo group (29.2 ± 6.6 at baseline vs 23.7 ± 7.7 at week 12). The constituting symptoms of vasomotor, paresthesia, insomnia, nervousness, melancholia, vertigo, fatigue and rheumatic pain were significantly improved in the EstroG-100 group in comparison with the placebo group (p < 0.05). Statistically significant improvement in vaginal dryness in the EstroG-100 group was also observed compared with that of the placebo group (p < 0.05). In conclusion, EstroG-100 significantly improved the menopausal symptoms of pre-, peri- and post-menopausal women without weight gain or any serious side effects.

摘要

这项临床研究旨在评估一种新的草药产品 EstroG-100 的疗效,该产品含有标准化的蒺藜、兔耳草和当归提取物混合物,用于治疗更年期症状。这是一项为期 12 周的随机双盲、安慰剂对照试验,共有 64 名白种西班牙裔、白种非西班牙裔和非裔美国绝经前、围绝经期和绝经后妇女参与,她们被随机分配到 EstroG-100 组(n = 31)或安慰剂组(n = 33)。主要终点是库珀曼绝经指数(KMI)评分的平均变化,该评分评估 11 种症状,以及阴道干燥评分的平均变化。与安慰剂组相比,EstroG-100 组的 KMI 评分从基线时的 29.5 ± 7.4 显著降低至 11.3 ± 5.8(p < 0.01)。与安慰剂组相比,EstroG-100 组在血管舒缩、感觉异常、失眠、神经质、忧郁、眩晕、疲劳和风湿痛等症状方面有显著改善(p < 0.05)。与安慰剂组相比,EstroG-100 组阴道干燥的改善也具有统计学意义(p < 0.05)。总之,EstroG-100 显著改善了绝经前、围绝经期和绝经后妇女的更年期症状,且无体重增加或任何严重的副作用。

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