S-equol: Evaluation of dosage for management of menopausal symptoms

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SAT 498-531-Female Repro Endocrinology & Case Reports
Clinical
Saturday, June 15, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SAT-509
Soh Iwashita*1, Belinda H Jenks1, Tomomi Ueno2 and Shigeto Uchiyama2
1Pharmavite LLC, Northridge, CA, 2Otsuka Pharmaceutical Co., Ltd., Yoshinogari-cho, Japan
S-equol (EQ), a metabolite of the soy isoflavone daidzein, was evaluated to assess for dose efficacy in postmenopausal women. Past research has evaluated isoflavone supplements for menopausal management with mixed efficacy results. The discrepancy of the results could be attributed to whether women had EQ producing capacity. Only people who host EQ producing bacteria can make EQ after soy consumption. Therefore, we have developed a dietary supplement with EQ, a fermented soy germ by lactic acid bacterium Lactococcus 20-92. This research investigated the dosage of EQ needed to alleviate menopausal symptoms. Two double blind placebo controlled studies were conducted with Japanese postmenopausal EQ non-producing women.

105 subjects (40-60 yrs) were randomly assigned to either 2mg/d (EQ-2), 6mg/d (EQ-6) or 10mg/d (EQ-10) EQ supplement groups or placebo (P) for 12 wks. Subjects completed the simplified menopausal index (SMI), which is a rating scale for menopausal symptoms including hot flashes (HF) and shoulder stiffness, at 0, 6 and 12 wks. The subjects had ≥25 of SMI score, in which they were categorized as “mild” to “severe” symptomatic. The changes in SMI score at 12 wks were -49.3% in P, -54.1% in EQ-2, -52.8% in EQ-6 and -68% in EQ-10 (P vs EQ-10, p<0.05). Reduction of shoulder stiffness showed EQ dose dependency, with a difference between P vs. EQ-10 for 6 wks (0±0. 4 vs -0.5±0.7, p<0.05) and for 12 wks (-0.3±0.4 vs -1.0±0.9, p=0.06). Thus, EQ-10 was decided to be used as the dosage for the confirmation study.

Since treatment of menopausal symptoms have many placebo effects, over 50% placebo responders in SMI during the 4 wks of screening period were excluded from the treatment period in the confirmation study. 160 subjects (45-60 yrs), who were ≥25 in SMI and ≥1/day in HF, were assigned either P or EQ-10 group for 12 wks. Menopausal symptoms were assessed by multiple instruments including HF frequency record and subscales of the Greene Climacteric Scale. Both severity of HF and neck and muscle stiffness were more improved in EQ-10 vs in P at 12 wks (p<0.05 and p<0.05, respectively). In addition, irritability was reduced by EQ-10 vs. P (p=0.076). HF frequency was reduced in EQ-10 than P (-58.7% vs -34.5%, p<0.01).

These results suggest that 10mg/day EQ supplement alleviates menopausal symptoms, especially in HF and neck/shoulder and muscle stiffness, in EQ non-producing post menopausal Japanese women.

Disclosure: SI: Researcher, Otsuka. BHJ: Researcher, Otsuka. TU: Researcher, Otsuka. SU: Researcher, Otsuka.

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm