title: Low-dose isoflavone aglycone alleviates psychological symptoms of menopause in Japanese women: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  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.
authors: Department of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
authors: Asuka
authors: A
authors: Hirose
authors: Department of Women's Health, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan. teragyne@tmd.ac.jp.
authors: Masakazu
authors: M
authors: Terauchi
authors: Department of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
authors: Mihoko
authors: M
authors: Akiyoshi
authors: Department of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
authors: Yoko
authors: Y
authors: Owa
authors: Department of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
authors: Kiyoko
authors: K
authors: Kato
authors: Department of Obstetrics and Gynecology, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo, Tokyo, 113-8510, Japan.
authors: Toshiro
authors: T
authors: Kubota
mesh_terms: D000328:Adult; D001007:Anxiety / Q000188:drug therapy* / Q000523:psychology; D003863:Depression / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage* / Q000494:pharmacology; D007564:Japan; D008593:Menopause / Q000187:drug effects* / Q000208:ethnology / Q000523:psychology*; D008875:Middle Aged; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D007529:Isoflavones
keywords: Depression; Flavonoids; Insomnia; Mood; Sleep