SOURCE: Wiley Systems, Inc.

October 14, 2008 14:23 ET

Danish Study Validates Combined Cyclical Hormone Replacement Therapy (HRT) With Monthly Menstrual Bleed

Study Finds a Combined Cyclic Regiment With Monthly Bleeding Creates a Lower Cardiovascular Risk for Women Than Continuous-Combined Estrogen/Progesterone Therapy, Which Does Not Cause a Menstrual Bleed

SANTA BARBARA, CA--(Marketwire - October 14, 2008) - Wiley Systems, Inc. (www.thewileyprotocol.com) announced that a new Danish study featured in Europe's leading cardiovascular journal suggests that women taking hormone replacement therapy (HRT) should cycle their hormones to have a menstrual bleed. A combined cyclic regiment with monthly bleeding creates a lower cardiovascular risk for women than continuous-combined estrogen/progesterone therapy, which does not cause a menstrual bleed. The study also found that overall there was no increased risk of heart attacks in current users of HRT compared to women who had never taken it.

T.S. Wiley, developer of the Wiley Protocol® and author of two books on women's health believes this research is significant validation of the value of cyclical (estrogen, followed by a combination of estrogen and progesterone) hormone therapy and that biomimetic hormone restoration therapy (BHRT) could actually be safer than statically dosed continuous-combined alternatives. Wiley is available to media for further comment on the study results as well as to answer questions about BHRT.

According to the leader of this research, *Dr Ellen Løkkegaard, a gynecologist at the Rigshospitalet in Copenhagen, Denmark, "The main message is that when hormone therapy is indicated for a woman, then a cyclic combined regimen should be preferred, and that application via the skin or the vagina is associated with a decreased risk of myocardial infarction." The observational study, the largest to look at the effects of HRT since the Women's Health Initiative (WHI) trial in 1991, followed 698,098 healthy Danish women, aged 51-69.

Løkkegaard continued, "From the previous studies on HRT we have no reason to believe that these recommendations increase the risk of other diseases influenced by hormone therapy, such as breast cancer, venous thromboembolism and stroke. Actually, we believe they could reduce the risk."

Wiley is the developer of the Wiley Protocol, a trademarked patent pending delivery system consisting of biomimetic, bio-identical estradiol and progesterone, restoration therapy. The Wiley Protocol uses the rhythm of production found in nature to establish the proper doses of estradiol and progesterone. The Wiley Protocol allows women a more accurate form of hormone restoration for lost endocrine function that may be proven to be safer as well as more reliably effective.

"This study indicates that it's better for your heart to take hormones and stay on them. It may also confirm that the Wiley Protocol products based on biomimetic hormone restoration therapy could actually be safer than statically dosed continuous-combined alternatives," said Wiley. "Bio-identical hormones are only natural if they are biomimetic. Mounting evidence from the Wiley Protocol indicates that it mimicking the body's natural rhythm may be the missing key in other regimens."

The Wiley Protocol hormones are derived from plant sources and mimic the natural undulating or wavelike rhythms of the hormone blood levels in a normal menstrual cycle in a healthy young woman. It is this natural rhythm that is missing from all other bio-identical and synthetic hormone replacement therapies.

The components of the Wiley Protocol and their amounts vary throughout the 28-day cycle to mimic the hormone levels of youth. The Wiley Protocol is the only biomimetic hormone restoration therapy that features plant derived hormones in a biomimetic way, or that has ever been developed under the scrutiny of a practicing oncologist.

Additional Wiley Protocol rhythmic dosing schedules include: the Wiley Protocol for Men™, a biomimetic DHEA and testosterone restoration program; Wiley Protocol Thyroid™ for Women, biomimetic transdermals thyroid hormone restoration; Wiley Protocol Testosterone™ for Women, biomimetic testosterone restoration; and Wiley Protocol Face Crème™, which promotes a more youthful appearance by re-inflating fine lines with nature's own filler -- fat.

Wiley is a medical theorist in Darwinian medicine and environmental endocrinology. She is a noted writer, researcher and lecturer on the science and use of hormones, particularly in menopausal women. As an accepted expert in chronobiology and circadian rhythmicity, in the practice of endocrinology, Wiley's CME accredited seminars are attended by physicians from all over the world. Wiley is the author of "Sex, Lies & Menopause," Harper Collins, 2005 and "Lights Out: Sleep, Sugar and Survival," Simon & Schuster, Inc., 2000.

About Wiley Systems, Inc. and the Wiley Protocol

Wiley Systems, Inc. was founded in 2005 in Santa Barbara, California by T.S. Wiley, who is the developer of the Wiley Protocol®, a trademarked patent pending delivery system consisting of biomimetic, bio-identical estradiol and progesterone (Biomimetic Hormone Restoration Therapy.) Wiley Systems began as a project to fund the union of doctors and pharmacists in a common goal to standardize bio-identical hormones for academic research.

The Wiley Protocol is only available at compounding pharmacies that have joined the project for future NHI study and have contractually agreed to the standardized methods, materials, packaging and recommended pricing. In exchange, Wiley Systems provides intellectual property and sells 28WP logo-bearing packaging consisting of bags and syringes in the branded colors of purple and green. The Wiley Protocol name assures customers that they are receiving authentic Wiley Protocol dosing rhythms based on original research.

*Ellen Løkkegaard, Anne Helms Andreasen, Rikke Kart Jacobsen, Lars Hougaard Nielsen, Carsten Agger, and Øjvind Lidegaard. Hormone therapy and risk of myocardial infarction: a national register study. European Heart Journal, 2008; DOI: 10.1093/eurheartj/ehn408

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