SE5-OH containing Natural S-equol, a novel soy germ-based ingredient in a supplement, improved menopausal symptoms, including significantly reducing hot flash frequency by nearly 59 percent, according to a peer-reviewed study in Japanese women. This key study was presented in an oral presentation at the North American Menopause Society (NAMS) 20th annual meeting.
A second oral presentation reported peer-reviewed data that documented for the first time the pharmacokinetics, or absorption and distribution in the body, in U.S. menopausal women of S-equol when taken as a supplement using SE5-OH containing Natural S-equol. Development and ongoing research of SE5-OH containing Natural S-equol is conducted by the Saga Nutraceuticals Research Institute of Otsuka Pharmaceutical Co., Ltd. Pharmavite LLC, the makers of NatureMade- vitamins and minerals and a subsidiary of Otsuka Pharmaceutical Co., Ltd., is studying SE5-OH containing Natural S-equol in supplement form for management of menopausal symptoms.
"Natural S-equol, a soy-derived compound that is thought to interact with specific estrogen receptors, has been studied for its benefits in relieving menopausal symptoms in both U.S. and Japanese women. The data presented at NAMS adds to this research and illustrates the potential that SE5-OH containing Natural S-equol has for management of menopausal symptoms. Pharmavite LLC and Otsuka Pharmaceutical Co., Ltd. have a rigorous program, including additional clinical studies, to develop a SE5-OH containing Natural S-equol supplement," said Belinda H. Jenks, Ph.D., director of Scientific Affairs & Nutrition Education at Pharmavite LLC.
Soybeans contain a compound daidzein that certain bacteria living within the digestive tract of some individuals can metabolize, or convert, into Natural S-equol [7-hydroxy-3-(4'-hydroxyphenyl)-chroman], a compound thought to act as a selective estrogen receptor modulator (SERM). SERMs can bind to the body's receptors for estrogen, the naturally occurring female sex hormone, and Natural S-equol has a selective affinity for the estrogen receptor beta. Not everyone can produce Natural 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, have the ability to produce equol. Studies in Japan have documented an association between milder menopausal symptoms in equol producers as compared to non-producers, but efficacy studies of S-equol, and of SE5-OH containing Natural S-equol, have been limited.
Investigational SE5-OH Containing Natural S-equol Supplement Improves Menopause Symptoms
In the study of Japanese postmenopausal women who were equol non-producers and reported at the NAMS annual meeting, a supplement whose active ingredient was SE5-OH containing Natural S-equol had significant effects on improving several menopausal symptoms.
"Our clinical trial of SE5-OH containing Natural S-equol in Japanese post-menopausal women documented a significant reduction of their menopausal symptoms as measured in several ways, and the compound appears to have a promising future role in the management of women's menopausal symptoms," said study author Takashi Aso, M.D., Ph.D., of the Department of Obstetrics and Gynecology, Faculty of Medicine, Tokyo Medical and Dental University and past president of the Japanese Menopause Society. "Safe and effective alternatives to hormone replacement therapy are needed to help women who suffer from menopause symptoms."
In the study, women taking a daily oral dose of 10 milligrams (mg) of Natural S-equol via the supplement reduced their frequency of hot flashes by 58.7 percent after 12 weeks of treatment, significantly more than the 34.5 percent reduction experienced in women receiving a placebos primary endpoint was individual menopause symptom scores after 12 weeks of treatment.
SE5-OH containing Natural S-equol also yielded positive improvements of other menopause symptoms, as measured by the study's several secondary endpoints, including total scores on menopausal symptom evaluations as assessed by a physician-administered 22-item menopausal symptom questionnaire and by a validated tool called the Visual Analogue Scale of five symptoms (hot flashes, sweating, light sleep insomnia, depression and shoulder muscle stiffness). Women in Japan in general experience less hot flashes than women in the United States but experience more neck and shoulder stiffness, the investigators noted.
The trial also evaluated safety and adverse treatment-related effects. No adverse events were reported in this study and the supplement was well tolerated. A complete report of the study data will be submitted for peer-review publication.
The trial, a randomized, double-blind, placebo-controlled, parallel-group study, evaluated 230 post-menopausal Japanese women aged 45 to 60 years. At enrollment, the women had at least one hot flash per day, did not produce equol after eating soy products, and did not take hormonal drugs or menopause symptom treatments. The postmenopausal enrollment criteria included estrogen levels of less than 21 picograms per milliliter (ml) and follicle stimulating hormone (FSH) values greater than 30 million international units/ml. Investigators randomized the women into two groups to receive either the placebo or the supplement, in the form of two daily tablets taken for 12 weeks.
The Natural S-equol used in this study and the pharmacokinetic study was in the form of SE5-OH containing Natural S-equol. The supplement tablets each contained 5 mg of Natural S-equol. The SE5-OH is the product of fermentation of soy germ by the bacterial strain Lactococcus garvieae 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. SE5-OH is created under current Good Manufacturing Practices. Following fermentation, the bacteria undergoes heat denaturation and is deactivated. The process is designed to produce a Natural S-equol rich product, or nutraceutical ingredient. SE5-OH Containing Natural S-equol Supplements Provide Very High Systemic Bioavailability
The S-equol in SE5-OH containing Natural S-equol supplement tablets was rapidly absorbed from the tablets and attained optimal concentrations in the blood stream, providing very high systemic bioavailability when given to healthy postmenopausal women. These findings were from a single-center, open-label, randomized, two-period crossover study conducted in white, non-Hispanic women. Bioavailability is a calculation of how much of a given dose of a test compound reaches the blood stream to circulate within the body, has a potential therapeutic effect and then is excreted in urine.