Peer-Reviewed, Placebo-Controlled Studies Show Standardized Red Clover Supplement Offers Women Dramatic Relief from Symptoms Associated with Menopause
STAMFORD, Conn., Aug. 13 /PRNewswire/ -- Two new studies offer women who are looking for natural relief from symptoms associated with menopause clinical proof that Promensil(TM) is effective at reducing the frequency and severity of hot flashes. The studies were published in the current issues of The Female Patient and Maturitas/The European Menopause Journal.
Promensil is a high quality dietary supplement made from red clover and standardized according to pharmaceutical grade Good Manufacturing Practice (GMP) procedures.
The Female Patient Study
This study shows that the commercially available dose (40 mg per day) of Promensil reduced hot flashes by nearly 50 percent (48.5), while a placebo (dummy pill) used in a control group of patients reduced hot flashes by only about 10 percent (10.5).
"This study demonstrates that dietary supplementation with red-clover derived isoflavones (Promensil) is an effective alternative for symptomatic relief of vasomotor symptoms in postmenopausal women, reducing both the average daily frequency and severity of hot flushes," said Arturo Jeri, MD, director, climacteric unit, Institute of Gynaecology and Reproduction, Lima, Peru, and author of the study. "Many botanical and nutritional therapies are offered for use during menopause, however Promensil has the clinical evidence supporting a favorable risk-benefit profile."
The double-blinded study reviewed data on 30 healthy, non-vegetarian women who had been postmenopausal for more than one year. The patients had not used Hormone Replacement Therapy (HRT), soy, or other estrogen-active plant products for at least 16 weeks prior to the study. The group was divided into two equal groups of 15 patients.
The study used non-vegetarian women to avoid potential biasing from higher than usual consumption of soy and other legumes, often seen in vegetarian women. Severity of symptoms was self-measured by patients on a scale of zero (no symptoms) to three (severe, interferes with normal activities.)
The Maturitas Study
Thirty women participated in this double blind, randomized placebo- controlled trial. The women, all of whom had more than five incidents of hot flashes per day, were given a list of isoflavone-rich foods and supplements to avoid.
All the women received placebo tablets for four weeks and were subsequently randomized to either placebo or 80 mg isoflavones for a further 12 weeks. During the first four weeks of placebo the frequency of hot flashes for all the women decreased by an average of 16 percent. During the subsequent double-blind phase, a further, statistically significant decrease of 44 percent was seen in isoflavones group, whereas no further reduction occurred within the placebo group. A quality of life score improved in the active group by 13 percent and remained unchanged in the placebo group. The study authors concluded that the difference in reduction of hot flashes between the two groups "demonstrates the effectiveness of Promensil in the management of hot flashes."
"While isoflavones can be consumed in the diet, it would be extremely difficult for Western women to consume the variety of legume food plants necessary to match this supplement," said Ronald Barentsen, MD, Department of Obstetrics and Gynecology, Vrije Universiteit Medical Centre, Amsterdam, The Netherlands, co-author of the study.
In addition to containing the two isoflavones found in soy known to have significant estrogenic properties, genistein and daidzein, Promensil contains two additional isoflavones, formononetin and biochanin, which have been shown to bind to estrogen receptors to produce estrogen-like effects.*
"Although a range of isoflavone dietary supplements are now available, those produced from red clover offer the benefit of containing all four important isoflavones and Promensil provides these in a form standardized with respect to concentration and ratio," said Dr. Barentsen.
Promensil Safety Also Studied
Phytoestrogens (compounds from plants) work differently than the estrogens used in HRT. Authors of the study published in Maturitas add that there has been no evidence of adverse estrogenic effects on the endometrium with red clover isoflavones, "alleviating concerns of undesirable side effects associated with (Hormone Replacement Therapy)."
"Published studies indicate that phytoestrogens work similarly to the class of medications known as selective estrogen receptor modulators -- that is, they stimulate some cells but not others -- and they don't stimulate cells that contribute to hormone-dependent cancers," said Mark Blumenthal, founder and executive director of the nonprofit American Botanical Council in Austin, Texas.
"The Asian populations that consume a high volume of the same isoflavones found in red clover and soy have lower rates of hormone-dependent cancer," said Blumenthal.
Over a dozen clinical trials on Promensil have been conducted and reported, making it not only the most studied isoflavone supplement, but one of the most studied of all dietary supplements available for relief of menopause associated symptoms.
Reprints of other Promensil clinical trials are available by dialing 1- 877-417-7663 or by visiting http://www.promensil.com/ . Promensil is available in health food stores and in the supplement section of drug stores throughout the U.S. and Canada.
Novogen Limited is a pharmaceutical company based in Sydney, Australia with offices in Stamford, Connecticut. Novogen is involved in the development of isoflavone supplements and drug discovery for disorders that are commonly associated with aging. Over the past five years, Novogen has conducted the largest and most comprehensive isoflavone clinical testing program in the world. Current products include Promensil, Rimostil(TM) and Trinovin(TM) -- a midlife health range of natural products, scientifically developed for menopause, post-menopause and prostate health. Novogen is also researching and developing compounds for the treatment of cancer, cardiovascular disease and inflammatory bowel disease. http://www.novogen.com/
* Eden J. Phytoestrogens and the menopause. Baillieres Clin Endocrinol Metab. 1998; 12:581-587