Department of Obstetrics and Gynecology, Tokyo Medical and Dental University School of Medicine, Tokyo, Japan.
J Womens Health (Larchmt). 2012 Jan;21(1):92-100. doi: 10.1089/jwh.2011.2753. Epub 2011 Oct 12.
The objective of this clinical trial was to examine the efficacy of a supplement containing natural S-(-)equol, a daidzein metabolite, in reducing menopausal symptoms.
In this multicenter, double-blind placebo-controlled trial, 160 equol nonproducing, postmenopausal Japanese women who experienced at least 1 hot flush/day were randomly assigned to consume 10 mg/day S-(-)equol (n=77 women) or placebo (n=83 women) for 12 weeks. Participants completed a standardized menopausal symptom checklist and rated five common menopause symptoms by a visual analog scale at baseline, week 12, and week 18 (6-week postintervention). Physical, blood, and urine examinations were conducted. One hundred twenty-six women completed the study.
At baseline, daily hot flush frequency was 2.9±2.1 for the S-(-)equol group and 3.2±2.4 for the placebo group. After the 12-week intervention, the S-(-)equol group had a greater decrease from baseline in hot flush frequency compared with the placebo group (-1.9±1.8/day, -58.7%, vs. -1.0±2.0/day, -34.5%, p=0.009). The severity of hot flushes and neck or shoulder muscle stiffness significantly decreased in the S-(-)equol group compared with the placebo group. No changes in clinical parameters or serious adverse effects were reported.
This is the first trial to show beneficial effects of a 10-mg natural S-(-)equol supplement consumed daily for 12 weeks on major menopausal symptoms, specifically, hot flushes and neck or shoulder muscle stiffness, in postmenopausal Japanese women. This supplement offers a promising alternative for management of menopausal symptoms.
本临床试验旨在研究一种含有天然 S-(-)雌马酚的补充剂对减轻更年期症状的疗效,S-(-)雌马酚是大豆异黄酮的代谢产物。
在这项多中心、双盲、安慰剂对照试验中,160 名绝经后、不能产生雌马酚的日本女性,每日至少经历 1 次热潮,她们被随机分配每天服用 10 毫克 S-(-)雌马酚(77 名女性)或安慰剂(83 名女性),共 12 周。参与者在基线、第 12 周和第 18 周(干预后 6 周)时使用标准化更年期症状检查表和视觉模拟量表评估 5 种常见的更年期症状。进行了体格检查、血液和尿液检查。126 名女性完成了研究。
在基线时,S-(-)雌马酚组的每日热潮发生频率为 2.9±2.1,安慰剂组为 3.2±2.4。经过 12 周的干预后,与安慰剂组相比,S-(-)雌马酚组的热潮发生频率从基线下降更多(-1.9±1.8/天,-58.7%,与-1.0±2.0/天,-34.5%,p=0.009)。S-(-)雌马酚组的热潮严重程度和颈部或肩部肌肉僵硬明显低于安慰剂组。未报告临床参数或严重不良事件的变化。
这是第一项显示每日服用 10 毫克天然 S-(-)雌马酚补充剂 12 周对主要更年期症状(特别是热潮和颈部或肩部肌肉僵硬)有有益影响的试验,在绝经后日本女性中。这种补充剂为管理更年期症状提供了一种有前途的选择。