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New Soy-Based Natural S-equol Supplement Reduces Menopausal Hot Flashes, Muscle and Joint Pain in First Study Among U.S. Women
Date:10/7/2010

s: psychological, somatic (physical) and vasomotor.

"Together these data document that a minimum daily dose of 10 mg Natural S-equol would provide the benefit of both reducing the frequency of moderate to severe hot flashes as well as decreasing muscle and joint pain associated with menopause," explained Jenks.

The trial also noted treatment-emergent adverse effects in participants of all the treatment groups.  Such effects occurring in more than 5 percent of each group included abdominal distention, constipation and endometrial hypertrophy, the thickening of the lining of the uterus.  The endometrial hypertrophy was identified by transvaginal ultrasounds and assessed by the Medical Monitor, and any changes observed were not considered to be clinically significant.  No trends or clinically meaningful changes were identified in laboratory blood or urine tests, electrocardiographs, physical examinations or vital signs among the participants.

The trial enrolled women aged 45 to 65 years, who had levels of follicle stimulating hormone (FSH) of 40 or more milli international units/microliter, a marker of menopause.  Investigators randomized the women into four groups to receive either the isoflavone (26 women) or one of the three doses of the Natural S-equol supplement (24 in the 10 mg, 27 in the 20 mg and 25 in the 40 mg groups), in the form of daily tablets taken with breakfast and dinner meals for 12 weeks.  The women had diets controlled for soy foods, isoflavone and lignans, compounds found in certain plants that are known as phytoestrogens because of their estrogen-like properties.  The study included a period before the treatment weeks to allow for elimination of any women who responded to a placebo.  Women also were tested to determine their ability to produce S-equol after eating soy.  The study included 70 percent equol nonproducers and 30 percent equol producers.  

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