Takeda Takashi, Shiina Masami, Chiba Yasutaka
Division of Women's Health, Research Institute of Traditional Asian Medicine, Kindai University, Osaka-Sayama, Japan.
Clinical Research Center, Kindai University Hospital, Osaka-Sayama, Japan.
BMJ Open. 2018 Jul 18;8(7):e023314. doi: 10.1136/bmjopen-2018-023314.
Premenstrual syndrome (PMS) comprises a range of mood, behavioural and physical symptoms, and impairs many women's quality of life. Isoflavones are expected to stabilise the natural fluctuation of the oestrogen cycle through their selective oestrogen receptor modulator-like activities that alleviate PMS symptoms. Equol, a metabolite of a soy isoflavone converted from daidzein by specific gut bacteria, has a greater bioavailability compared with other soy isoflavones. We aim to examine the effect of natural S-equol supplements on premenstrual symptoms.
This study will enrol 124 women (aged 20-45 years) who have PMS symptoms and are non-equol producers in a double-blind, parallel, randomised, placebo-controlled trial, in which they will receive natural S-equol supplement (equol 10 mg a day) or placebo, orally, twice daily, for three menstrual cycles. The primary outcome measure (Daily Record of Severity of Problems total score) will be assessed during intervention cycles. To compare the primary outcomes between the S-equol group and the placebo group, the mean differences in the Daily Record of Severity of Problems total score between the two groups will be determined. The p values will be determined using Student's t-test, where the significance level is 5% (two-sided).
The institutional review board at Kindai University approved the study. The findings of this trial will be submitted to an international peer-reviewed journal. Abstracts will be submitted to national and international conferences.
UMIN000031815.
经前综合征（PMS）包括一系列情绪、行为和身体症状，会损害许多女性的生活质量。异黄酮有望通过其类似选择性雌激素受体调节剂的活性来稳定雌激素周期的自然波动，从而缓解经前综合征症状。雌马酚是大豆异黄酮的一种代谢产物，由特定肠道细菌将大豆苷元转化而来，与其他大豆异黄酮相比，其生物利用度更高。我们旨在研究天然S-雌马酚补充剂对经前症状的影响。
本研究将招募124名有经前综合征症状且不产生雌马酚的20至45岁女性，进行一项双盲、平行、随机、安慰剂对照试验。在试验中，她们将口服天然S-雌马酚补充剂（每日10毫克雌马酚）或安慰剂，每日两次，持续三个月经周期。主要结局指标（问题严重程度每日记录总分）将在干预周期内进行评估。为比较雌马酚组和安慰剂组之间的主要结局，将确定两组问题严重程度每日记录总分的平均差异。p值将使用学生t检验确定，显著性水平为5%（双侧）。
近畿大学的机构审查委员会批准了该研究。本试验的结果将提交给一份国际同行评审期刊。摘要将提交给国内和国际会议。
UMIN000031815。
