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著者: Takeda T, Shiina M, Chiba Y.
雑誌名: BMJ Open. 2018 Jul 18;8(7):e023314. doi: 10.1136/bmjopen-2018-023314. Epub 2018 Jul 18.
Abstract/Text
INTRODUCTION: 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.
METHODS AND ANALYSIS: 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).
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: UMIN000031815.
© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PMID 30021756 BMJ Open. 2018 Jul 18;8(7):e023314. doi: 10.1136/bmjopen-2018-023314. Epub 2018 Jul 18.
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