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2014

Daily 10 milligram dose of S-equol reduces menopausal symptoms effectively without impacting thyroid and sex hormones

S-equol alleviated hot flashes and neck or shoulder muscle stiffness without disturbing hormone levels in trial of Japanese postmenopausal, non-equol producing women

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NORTHRIDGE, Calif., June 15, 2013 /PRNewswire-USNewswire/ -- Consuming 10 milligrams (mg) daily of S-equol delivered via a new fermented soy-based nutritional supplement alleviated menopausal symptoms, particularly the frequency of hot flashes and severity of neck or shoulder muscle stiffness, without impacting thyroid and certain sex hormone levels, according to clinical data presented at the annual meeting of The Endocrine Society, (ENDO) 2013.

"This study provides evidence that the daily 10 mg doses of S-equol, a metabolite of the soy isoflavone daidzein, reduced hot flash frequency and relieved muscle stiffness without affecting sex or thyroid hormone levels of Japanese postmenopausal women. The findings confirm and expand on other studies in Japanese and U.S. women documenting the ability of S-equol to help relieve menopausal symptoms," said Belinda H. Jenks, Ph.D., coauthor of the study and director of Scientific Affairs & Nutrition Education at Pharmavite LLC. Development and ongoing research of a supplement containing S-equol is conducted by the Saga Nutraceuticals Research Institute of Otsuka Pharmaceutical Co., Ltd. Pharmavite LLC, the makers of Nature Made® vitamins and minerals, is a subsidiary of Otsuka, which supported the study.

The data presented at ENDO 2013 include results of a dose-finding study and larger confirmation study, both of which were randomized, double-blind and placebo-control trials examining 12 weeks of treatment using a supplement containing S-equol in Japanese postmenopausal women who could not produce S-equol themselves.

S-equol [7-hydroxy-3-(4'-hydroxyphenyl)-chroman] is a compound resulting from the natural metabolism, or conversion, of daidzein, an isoflavone found in whole soybeans. Not everyone can produce S-equol after soy consumption, as the production depends on the types of bacteria present in the large intestine and may be influenced by the amount of soy consumed. About 50 percent of Asians and 20 to 30 percent of North Americans and Europeans, who in general consume less soy than Asians, produce S-equol. Preliminary evidence from observational studies is emerging that suggests that women who are S-equol producers may experience fewer menopausal symptoms compared to non-producers.

Hormones Remain Steady, While Menopausal Symptoms Improve in Confirmation Study
Measurement of the sex hormones estradiol (estrogen), follicle stimulating hormone (FSH) and testosterone as well as of the thyroid hormones thyroid stimulating hormone (TSH), Free T4 (thyroxine) and Free T3 (triiodothyronine) documented no significant difference after 12 weeks of treatment in 77 women receiving 10 mg/daily of S-equol compared to 83 women receiving a placebo (p values ranged from 0.2092 to 0.3942).

Researchers assessed the effects of S-equol using the Climacteric Symptom Evaluation Form Checklist, which contains 22 menopausal symptoms. The women reported significant decreases in the severity of hot flashes as well as of muscle stiffness of the neck and shoulder after 12 weeks of treatment with S-equol compared to a placebo (p=0.015 for both).  Frequency of hot flash measures were also significantly reduced after 12 weeks of treatment, with hot flashes declining on average by 58.7 percent (-1.9 ± 1.8 episodes daily) with S-equol compared to 34.5 percent (-1.0 ± 2.0 episodes daily) with a placebo (p=0.009).

A separate measure using the Visual Analog Scale for menopausal symptoms documented a significant change in muscle stiffness of neck and shoulder after the 12-week treatment period for those receiving S-equol compared to a placebo (p=0.007).

The confirmation study evaluated 160 women aged 45 to 60 years, who had scored 25 or more on the Simplified Menopausal Index (SMI), a rating scale for menopausal symptoms.   Women who had a greater than 50 percent response on the SMI scale while using a placebo during a four-week screening period prior to the treatment phase were excluded from the study.  The use of the 10 mg daily dose of S-equol was based on the data from the prior pilot dose-finding study, which determined that 10 mg of S-equol was the active dose needed to alleviate menopausal symptoms.

Some of the data presented at ENDO 2013 were previously published in The Journal of Women's Health, Online Ahead of Print: March 12, 2012 doi:10.1089 and The Journal of Nutrition July 2010 supplement doi:10.3945.   More information about the supplement containing S-equol, including results of other studies, is at http://www.naturalequol.com.

About Equol
S-Equol has the ability to bind to the same estrogen receptors as natural estrogen, with a stronger affinity to the estrogen receptor beta than the estrogen receptor alpha. On binding to these receptors, S-equol mimics some, but not all, activities of estrogen. Because of these actions at the receptor, it has been proposed that S-equol may alleviate some of the symptoms caused by diminished estrogen production during menopause.

The supplement is the product of fermentation of whole soy germ by lactic acid bacteria "Lactococcus 20-92" using a patented and proprietary process by the Otsuka Pharmaceutical Co., Ltd. The process results in the conversion of the daidzein to S-equol. The supplement containing S-equol is created under current Good Manufacturing Practices. Following fermentation, the bacteria undergo heat denaturation and are deactivated. The process is designed to produce an S-equol rich product, or nutraceutical ingredient. The ingredient has self-affirmed GRAS (Generally Recognized As Safe) status.

ENDO 2013 Presentation
Saturday, June 15, 2013 Poster Presentation SAT-509 
S-equol: Evaluation of dosage for management of menopausal symptoms. 
Soh Iwashita, Global Science, Pharmavite LLC, Northridge, CA, Belinda H Jenks, Scientific Affairs, Pharmavite LLC, Northridge, CA, Tomomi Ueno, Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd., Saga, Japan and Shigeto Uchiyama, Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd., Saga, Japan

About Pharmavite LLC:
For 40 years, Pharmavite has earned and maintained the trust of healthcare professionals, consumers, and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. Nature Made is the #1 selling national vitamin brand in traditional retail scanning outlets.[1] The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states.

About Otsuka Pharmaceutical Co., Ltd.:
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment. Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has business operations in 25 countries and regions around the world, with consolidated sales of approximately USD 13 billion for fiscal year 2012 (4/1/2012-3/31/2013.)  Visit Otsuka Pharmaceutical Co., Ltd. at http://www.otsuka.co.jp/en/

[1] Nielsen Scan Track Scanning Data for U.S. xAOC channels, dollar sales for the 52 week period ending [05/11/13]

SOURCE Pharmavite LLC



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