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Low-dose isoflavone aglycone alleviates psychological symptoms of menopause in Japanese women: a randomized, double-blind, placebo-controlled study
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Low-dose isoflavone aglycone alleviates psychological symptoms of menopause in Japanese women: a randomized, double-blind, placebo-controlled study
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Low-dose isoflavone aglycone alleviates psychological symptoms of menopause in Japanese women: a randomized, double-blind, placebo-controlled study
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Journal Article
Low-dose isoflavone aglycone alleviates psychological symptoms of menopause in Japanese women: a randomized, double-blind, placebo-controlled study
2016
Overview
Purpose
Many studies have demonstrated the effectiveness of isoflavones on menopausal symptoms; however, these mostly used high dosages. Because high-dose isoflavone may result in endometrial hyperplasia, we investigated whether low-dose isoflavone aglycone alleviates menopausal symptoms similarly to high dosages.
Methods
We conducted a randomized, double-blind, placebo-controlled study in 90 healthy women aged 40–60 years who had at least one menopausal symptom on the Menopausal Symptom Scale (MSS). The participants were randomized to receive active tablets containing ultralow-dose (12.5 mg/day;
n
= 30) or low-dose (25 mg/day;
n
= 30) isoflavone aglycone, or placebo (
n
= 30) tablets, for 8 weeks. Their menopausal symptoms were evaluated using MSS, Hospital Anxiety and Depression Scale (HADS), and Athens Insomnia Scale (AIS) before, and 4 and 8 weeks after treatment.
Results
Eighty-seven women (97 %) completed the 8-week treatment. In the low-dose group, significant improvement was observed from baseline, in the following parameters: (1) HADS-depression subscale score, (2) AIS score, (3) MSS-somatic symptom score after 4 and 8 weeks of treatment, and (4) MSS-vasomotor symptom score after 8 weeks of treatment. The changes in scores on HADS-depression subscale and AIS from baseline to 8 weeks were significantly higher in the low-dose group than in the placebo group.
Conclusions
Low-dose (25 mg/day) isoflavone aglycone significantly alleviated symptoms of depression and insomnia in Japanese middle-aged women.
Clinical Trial Registration
UMIN-CTR UMIN000011876.
Publisher
Springer Science and Business Media LLC,Springer Berlin Heidelberg,Springer Nature B.V
Subject
/ Anxiety
/ Dose-Response Relationship, Drug
/ Female
/ Humans
/ Insomnia
/ Isoflavones - administration & dosage
/ Japan
/ Medicine
/ Obstetrics/Perinatology/Midwifery
/ Sleep Initiation and Maintenance Disorders
/ Sleep Initiation and Maintenance Disorders - drug therapy
