CHATSWORTH, Calif., Apr 14, 2008 (BUSINESS WIRE) -- Natrol, Inc., the exclusive U.S. licensee for Promensil(R) and a premier marketer and manufacturer of nationally branded nutritional products, announces the results of a large, three-year study -- published last month in the journal Menopause International ( http://www.rsmpress.co.uk/mi.htm) -- reinforcing the safety of this red clover isoflavone supplement for managing hot flashes and other menopausal symptoms.(1)(a)
Furthermore, this new study shows that Promensil, containing a standardized supplement of red clover isoflavones, has a neutral effect on breast density in women with a family history of breast cancer. This is in contrast to studies showing that some conventional hormone replacement therapies (HRT) increase mammographic breast density.(2) Mammographic breast density has consistently been associated with risk for breast cancer.(a)
Professor Trevor Powles ( http://www.breastcanceruk.com/), consultant oncologist and the study's lead investigator, said, "Reassuringly for women, this study shows that these phytoestrogens don't cause any estrogenic increase in breast density in women with a family history of breast cancer. This indicates that they are unlikely to cause an increased risk of breast cancer. This three-year study confirms similar findings from previous, shorter-term studies."(a)
Tens of thousands of women around the world use Promensil daily. Promensil has been recommended by menopause experts as a natural alternative to help control hot flashes and other symptoms associated with menopause, used alongside lifestyle changes.(3)(a)
According to Michael Yatcilla, Ph.D., Vice President of Research and Development for Natrol, "We have long had confidence in the significant body of clinical research indicating Promensil provides benefits for menopausal women by offering a unique isoflavone ratio that is a safe alternative to help relieve the frequency and severity of hot flashes, and promote breast and heart health, as well as emotional well-being."(a)
In addition, two systematic reviews and meta-analyses of seventeen randomized controlled trials of supplementation with red clover or soy isoflavones demonstrate a significant reduction in menopausal hot flash frequency with red clover isoflavone use, particularly in women with frequent flashes.(4)(5)(a)
Nick Panay ( http://www.nickpanay.com/), Consultant Gynaecologist, Queen Charlotte's Hospital, London, said, "This three-year data has exciting findings that add to a broader evidence base, showing that standardized, quality-controlled supplements of red clover isoflavones have a good safety profile. I recommend isoflavones derived from red clover as an effective option to women." Dr. Panay also stressed the importance of choosing a well-researched product that provides a minimum daily intake of 40mg of isoflavones.(a)
Isoflavones are phytoestrogens, which literally means "plant estrogens." They occur naturally in the diet in foods such as peas, lentils, soy, chickpeas, and other beans, and red clover. With a chemical structure similar to the body's own estrogen, isoflavones -- when consumed in adequate amounts during menopause -- can mimic some of the effects of the body's own estrogen to help support health and well-being, particularly hormonal balance when hormone levels are declining.(a)
This red clover isoflavone breast cancer safety study took place in the UK, and has implications for women worldwide. Over 400 healthy women with at least one first-degree relative with breast cancer were studied. The women received a standardized supplement of 40mg red clover isoflavones (Promensil) or placebo for three years in a randomized, double-blind, placebo-controlled trial. Results showed that Promensil did not adversely affect breast density, skeletal strength, or cardiovascular status. In post-menopausal women, endometrial status was not adversely affected. The adverse event profile was similar between Promensil and placebo groups.(a)
Carried out at the Royal Marsden Hospital ( http://www.royalmarsden.nhs.uk/rmh) and the University Hospital of South Manchester ( http://www.uhsm.nhs.uk/Pages/Home.aspx), this study was led by Prof. Trevor Powles, Parkside Oncology Clinic in London ( http://www.parksideoncologyclinic.co.uk/index0.asp), and Prof. Anthony Howell ( http://www.breastcentre.manchester.ac.uk/groups/howell/), University Hospital of South Manchester. The study received funding support from the breast cancer charity Breakthrough Breast Cancer ( http://www.breakthrough.org.uk/).
About Promensil(R) and Novogen
In October, 2006, Natrol acquired the licensing rights to market Promensil(R) in the U.S. Promensil was developed by Novogen Limited, which launched the product in Australia in 1997. Today, Promensil has a global presence, including Europe, Asia, Africa, and North America. For more information, visit www.PromensilUSA.com.
Novogen Limited (NVGN) is an Australian biotechnology company that holds an extensive portfolio of patents related to isoflavones and isoflavone technology for the treatment and prevention of degenerative diseases and disorders. Over the past ten years, Novogen has conducted one of the largest and most comprehensive isoflavone clinical testing programs in the world. Novogen is involved in drug discovery and product development for disorders that are commonly associated with aging, and coordinates an international clinical research and development program with external collaborators, hospitals, and universities. For more information, visit www.novogen.com.
About Natrol - Nourishing the Potential of Mind and Body SM
Natrol, Inc., headquartered in Chatsworth, CA, is a wholly owned subsidiary of Plethico Pharmaceuticals Limited. Plethico Pharmaceuticals Limited (BSE: 532739.BO: PLETHICO), an herbal/nutraceutical-focused Indian Company, engages in the manufacture, marketing, and distribution of pharmaceutical and allied healthcare products in India and internationally.
Natrol, Inc. has a portfolio of health and wellness brands representing quality nutritional supplements, functional herbal teas, and sports nutrition products. Established in 1980, Natrol's portfolio of brands includes: Natrol(R), MRI, Prolab(R), BioSil(TM), Laci Le Beau(R), Promensil(R), Trinovin(R), Nu Hair(R), and Shen Min(R). The company also manufactures supplements for its own brands and on behalf of third parties.
Natrol distributes products nationally through more than 54,000 retailers, as well as internationally in over 40 other countries through distribution partners and subsidiaries in the UK and Hong Kong. For more information, call 1-800-2-NATROL (1-800-262-8765) or visit www.Natrol.com.
1 Powles TJ et al. Menopause Int. 2008 Mar;14(1):6-12
2 Atkinson C et al. Breast Cancer Res 2004;6:170-179
3 Nachtigall L et al. J Obstet Gyn Can 2006;28(4):279-289
4 Howes L et al. Maturitas 2006;55:203-211
5 Thompson Coon J et al. Phytomed 2007;14:153-159
(a) These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.