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Novogen - News Article

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    http://www.novogen.com.au/news/news0501.cfm?mainsection=05&subsection=01&newsid=87

    EVIDENCE BASED NATURAL ALTERNATIVES FOR MENOPAUSAL AND POST-MENOPAUSAL WOMAN
    Friday, 12 July 2002

    Information and answers are what women are demanding from their health practitioners in the wake of the release of findings from the Women’s Health Initiative study published in The Journal of American Medicine Association (10 July 2002).

    Since the recent HRT scare, the number of women seeking information about alternative therapies has grown dramatically.

    Novogen the Australian biotechnology company has received significant numbers of calls from women wanting to know about Promensil and Rimostil

    Promensil, for the relief of menopause symptoms and Rimostil, to maintain bone strength and cholesterol health for postmenopausal women are the only natural products supported by randomised clinical trials proving safety and efficacy.

    Professor Alan Husband, Research Director for Novogen said: “Even prior to the Women’s Health Initiative study, women have been demanding more information about menopause and natural products. But now more so than ever, women are becoming more involved in the management of menopause symptoms and post-menopause health.”

    Promensil and Rimostil are made from red clover isoflavones (a member of the phytoestrogen family). Red clover has been found to have a much higher level of isoflavone content than soy. Novogen also has a strict manufacturing process to ensure that each tablet of Promensil and Rimostil is standardised to ensure product stability and that isoflavone activity meets the specifications as claimed on the label.”

    Over the past five years, Novogen has conducted the largest and most comprehensive isoflavone clinical testing program in the world. Importantly, Promensil and Rimostil have not been associated with any significant side effects either in clinical trials or during consumer usage since 1997.

    The facts:
    PROMENSIL

    Promensil is designed to assist in the natural relief of menopausal symptoms, such as hot flushes and night sweats.2,3,4

    Efficacy
    Clinical trials have shown that Promensil reduces the symptoms of menopause naturally with 75% of women experiencing a significant improvement with an average of 50% reduction in hot flushes and 47% reduction in the incidence of night sweats. Women have also reported an easing of mood swings and no weight gain.2,3,4


    Cardiovascular benefits
    A recent study showed Promensil resulted in a reduction in total cholesterol of 10.2%, a reduction in LDL-cholesterol of 13.8% and an improved LDL/HDL ratio of 14.3 %5. No adverse effects were reported. Dr Arturo Jeri, who presented the study findings, said: “The 10% reduction of total cholesterol may translate to a possible 20% reduction in cardiovascular health disease events.”12

    Another study published in The Journal of Clinical Endocrinology and Metabolism found Promensil improves systemic arterial compliance – an indicator of reduced risk of cardiovascular disease.6

    Breast Health
    · The recent trial conducted by Professor Sheila Bingham and Dr Charlotte Atkinson in Cambridge found that in contrast with the effects of HRT, Promensil did not increase breast density. Research has found women with predominantly dense breasts have a four- to six-fold increased risk of breast cancer compared to women with little or no densities. Breast density may mask cancer detection and their appearance is indicative of an oestrogenic effect which may promote cancer.7

    · A case controlled study of breast cancer found a substantial reduction in the risk of breast cancer among women with a high intake of isoflavones.8

    · In vitro and animal evidence14 suggests that dietary isoflavones may be protective against the development of breast cancer, and this has been supported in a small scale study in women using Promensil according to a paper published in The Journal of British Menopause Society.9

    RIMOSTIL

    Rimostil addresses the long-term needs of women after menopause to maintain bone strength and cholesterol health10 in the face of oestrogen deficiency.

    Efficacy
    Clinical trials in postmenopausal women showed improvement in bone density of 4% after six months.10 This bone effect complements previous data in which peri-menopausal women using Promensil reported a 50% reduction in the rate of bone loss over a 12-month period.11

    Additionally the trial showed an improvement in HDL (good) cholesterol of 21%. Based on epidemiological studies this could translate to as much as a 30% reduction in risk of cardiovascular disease. (Each 1 mg/dL improvement in HDL = 3% reduction in risk of CV death in women.13 The 21% improvement in HDL is equivalent to ~10 mg/dL and thus could translate to a 30% risk reduction.)

    Both of these results are comparable to some prescription medicines.10

    SAFETY

    Safety monitoring over the course of clinical trials as well as post marketing monitoring indicates no endometrial changes4,10 and no other significant adverse effects.

    Promensil and Rimostil are sold in pharmacies, health food stores and Woolworths nationally. For further information about menopause, red clover isoflavones and Novogen products, log onto www.novogen.com or contact Novogen on the Medical Information Help line: 1300 789 709.


    Novogen is the Australian biotechnology company which has patented isoflavones technology for the treatment and prevention of degenerative diseases and disorders. 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 and Trinovin – 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 and osteoarthritis.

    References
    1. Writing Group for the Women’s Health Initiative Investigators. Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women. JAMA. 2002;288:321-333.
    2. A.R. Jeri, c. d Romana. The effect of isoflavone phytoestrogens in relieving hot flushes in Peruvian post menopausal women. The Female Patient (In Press), 2002.
    3. Van de Weijer P, Barentsen R. Isoflavones from red clover (Promensil) significantly reduce hot flashes compared with placebo. Presented at The North American Menopause Society’s 12th Annual Meeting, New Orleans, October 4-6, 2001.
    4. Natchigall LB et al. The effects of isoflavones derived from red clover on vasomotor symptoms and endometrial thickness. 9th International Menopause Society World Congress on the Menopause, Yokohama, Japan, October 1999.
    5. Jeri AR. Effects of isoflavone phytoestrogens on lipid profile in postmenopausal Peruvian women. Presented at the 10th World Congress on the Menopause, Berlin, Germany, June 2002.
    6. Nestel PJ et al. Isoflavones from Red Clover Improves Systemic Arterial Compliance but not Plasma Lipids in Menopausal Women. The Journal of Clinical Endocrinology and Metabolism. Vol 84, No 3; 895-898.
    7. Atkinson C et al. Effects of Isoflavones on Breast Density, Oestradiol, and Gonadotrophins: A double blind randomised placebo-controlled trial. Presented at ENDO 2001, Denver, Colorado, June 2001.
    8. Ingram D et al. Case-control phyto-oestrogens and breast cancer. The Lancet, Vol 350, Oct 1997; 990-972.
    9. Woodside JV, Campbell MJ. Isoflavones and breast cancer. Journal of the British Menopause Society, Supplement S1, 2001.
    10. P.B Clifton-Bligh, R.J. Baber, G.R. Fulcher, M.L. Nery and T. Moreton. The effect of isoflavones extracted from red clover (Rimostil) on lipid and bone metabolism. Menopause 8 (4): 259-265, 2001
    11. Atkinson C et al The Effects of Isoflavone Phytoesotrogens on Bone: Preliminary Results from a large, randomised, controlled study. Presented at ENDO 2000, Toronto, Canda, June 2000.
    12. Fager and O. Wiklund. Cholesterol reduction and clinical benefit. Are there limits to our expectations? Arterioscler.Thromb.Vasc.Biol. 17 (12):3527-3533, 1997
    13. Gordon et al, High-density lipoprotein cholesterol and CV disease. Four prospective American studies. Circ. 79 (1):8-15, 1989
    14. C. A. Lamartiniere, J. B. Moore, N. M. Brown, R. Thompson, M. J. Hardin, and S. Barnes. Genistein suppresses mammary cancer in rats. Carcinogenesis 16 (11):2833-2840, 1995
 
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