Bio-identical hormones can only be truly bio-identical if the hormones for replacement mimic not only those chemically found in the body, but also mimic the natural biological process as well.

New research shines bright light on healthy hormone replacement therapy (HRT), suggesting that women must cycle their hormones and have a menstrual bleed to be truly safe from cardiovascular events. According to a recent Danish study, a combined cyclic regimen with monthly bleeding creates a lower cardiovascular risk for women than continuous-combined estrogen/progesterone/progestin 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 hormones.

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) may actually be safer than statically dosed continuous-combined alternatives, whether bio-identical or synthetic.

According to the principal investigator 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.

More women are turning back to Hormone Replacement Therapy (HRT) every day, however, there are a myriad of products on the market that make the right choice challenging. As a result women are looking to their doctors for help.

Uncertainty about HRT began when The National Institute of Health (NIH) sponsored the WHI, a study of more than 161,000 women, which was designed to identify the benefits and risks of using hormone restoration therapy to prevent chronic diseases such as heart disease, breast cancer and osteoporosis in postmenopausal women.

The study was ended mid-stream in 2002 when WHI investigators found that the risks of this approach using synthetic therapy exceeded the safety limits established at the beginning of the study.

The results of WHI study dealt with only women over 65 who were taking only synthetic hormone replacement therapy which consisted of the drugs PremPro and Premarin only. The WHI proved that dosing synthetic HRT in a static, low-dose regimen was harmful to woman over 65, particularly in regard to stroke and cardiac events. After 14 years and nearly $800 million taxpayer dollars, the overly emphasized negative results of the WHI were released in May 2002.

The media spin caused millions of women to immediately stop taking their Premarin or Prempro, or any other product deemed a hormone by their doctors, thus leaving millions of symptomatic women without any reasonable clinical guidance.

Interestingly, the WHI never looked at hormones, only drugs with “hormone-like” effects that were dosed in a regimen far from that of human replacement. This study has led us to believe that conjugated equine estrogens (from pregnant mare urine) and a synthetic progestin (Prempro) dosed on a daily basis in static doses is clearly very harmful to women after only a few years, and yet, in contradictory reports from the same agency, PremPro seemed to have had positive effects as well. The other drug studied, daily Premarin, seemed to show substantially less harmful effects. Compounded bio-identical hormones in static doses were not included in the study because they are prescribed and dosed too many different ways.

Now, in the wake of the WHI, acquiring hormones is difficult. Doctors are leery of even the “Standard of Care” approved synthetics. Finding legitimate insurance-covered mainstream physicians to prescribe even bio-identical hormones is a challenge.

History of HRT

Since 1900, in the developed countries, the life expectancy of women has increased from age 47 to well over age 80. The average onset of menopause has been recorded at 50 years old for the last 150 years. That means most women are living at least thirty years longer than they did at the turn of the century, and about one third of their lives after menopause. It is estimated that 80 percent of women experience a variety of transiently debilitating symptoms in menopause and 30 percent of those are classified as severe.

About ten years before women ever have a hot flash or a migraine, they tend to experience negative and unpredictable changes in their menstrual periods. Sleeplessness, exhaustion and anxiety contribute to the aging process. Aching joints and plummeting sex hormones can often create a life in constant distress.

Symptoms of menopause can begin as early as the late thirties – yet they are the same miserable disabilities that the elderly face. When hormones plummet, the aging process begins to accelerate. Aging often brings pathology in many forms such as cancer, diabetes, heart disease, glaucoma, depression, and Alzheimer’s. If hormone fall-off signals the body that it is growing older, then is it possible that menopause is a trigger for the same diseases attributed to aging?

The burst of Baby Boomers becoming menopausal has challenged doctors from a variety of specialties to come to the forefront to answer this health crisis. Almost none, however, have the accurate information on how to prescribe hormones.

Unfortunately, a lack of understanding has led many doctors to prescribe synthetic drugs with hormone-like effects. Besides the danger of synthetics, as shown by the WHI results, these hormones are prescribed in static dosing format, which is not natural to the body.

What if many of the threatening diseases associated with aging could be alleviated by accurately replacing the hormones youthful hormone levels that are missing?

What is Natural Hormone Replacement Therapy?

Women are beginning to realize that living without their hormones is unnecessary at best and miserable and dangerous at worst.

What if hormone replacement could really mimic youthful hormone levels, not just mask a few symptoms? After all, logic dictates that young women aren’t susceptible to glaucoma, cancer and heart disease, to name a few. The main difference between young women and old women is reproductive capacity and the attendant hormones. Medicine bears witness that the majority of women with normal hormones do not have those diseases.

Common sense dictates that natural hormone replacement (not synthetic drugs with hormone-like effects), in and of itself, does not cause cancer. If estrogen and progesterone, or even testosterone, caused cancer, all young women would be dead. If logic like that tells us that estrogen doesn’t actually cause cancer in and of itself, then there must be more to the story—like what kind of estrogen, how much and when to take it.

Currently many believe that if a hormone is found in nature or created in a lab and it is chemically identical to the hormone in the body, it is natural. End of story. What if it’s not the end of the story? What if it is important that the body can actually recognize the substance coming in as a hormone? Look-alike (bio-identical) hormone molecules that are chemically derived and synthesized in a laboratory and trigger the activity of hormone receptors produced in the body, so they may be called “natural” but they differ, not only in structure from naturally occurring hormones, but in potential synergistic mechanisms.

Bio-identical Hormone Replacement Therapy (BHRT)

The term bio-identical has basically become a catch-all phrase for anything that is not a synthetic hormone. Scientifically, the term bio-identical means that look-alike molecules synthesized from plants are substituted for our own endogenously-produced hormone molecules. Bio-identical hormone products are created from natural sources of plant hormones which match the chemical structure of hormones produced by the human body. The premise is that the body can’t distinguish created bio-identical hormones from the ones the female ovaries produce naturally.

Many bio-identical HRT products are developed at compounding pharmacies from plant derived raw materials such as wild yams or soybeans that have an ability to mimic the molecules found in nature.

Biomimetic: The “How” of Replacing Hormones

It may not just be the molecule that matters. The way the hormone molecule is received at the receptor site and the way receptors are provoked may play a critical role in the effectiveness of HRT.

The Wiley Protocol, for example, is based on the premise that hormones can be accurately “bio-identical” only if they are biomimetic – this means that they must mimic those found in the body as well as mimic the natural biological process. A woman’s body does not produce hormones statically (the same amount every day) but in a undulating and changing rhythm throughout a 28 day cycle. It follows that natural plant derived hormones can accurately be termed bio-identical only when they are dosed in a biomimetic fashion.

It is this natural, wave-like rhythm of the hormone blood levels in a normal menstrual cycle of a healthy young woman that is missing from all other bio-identical and synthetic hormone replacement therapies.

A woman’s body has a rhythm and so does her menstrual cycles. Other bio-identical and synthetic hormone replacement therapies are missing the consideration of the circadian clock that measures the biological rhythms occurring at approximately 24-hour intervals. This natural rhythm follows one 24 hour spin of the planet. For 28 days the moon tracks the repeat of that cycle – and so does the body.

So what is meant by “the rhythm”? The body has rhythms that are governed by a master clock that works much like a conductor, striking up one section of the body's orchestra as another quiets down, and taking its main cue from light signals in the environment to stay in sync with the 24-hour day. Our hormones surge and ebb to this maestro's baton, controlling all endocrine function, predominantly a woman’s health for reproduction.

Bio-identical hormones can only be accurately bio-identical if the hormones for replacement mimic, not only those found in the body, but mimic the natural biological process as well. This approach may open the door for a new look at the possible decline or disappearance of the symptoms and disease states associated with menopause and aging.

The Wiley Protocol uses these natural rhythms in nature to establish the proper doses of estradiol and natural progesterone that mimic the natural hormones which would be produced by a younger body.

A Clinical Study

Women deserve hormone restoration that is proven to be safe and reliable. A new study, Bio-identical Hormones On Trial, or B.H.O.T., will soon begin at the College of Nursing and Health Sciences at the University of Texas, Tyler. The principal objective of the study will be to examine clinical outcomes and quality of life indicators of patients receiving BHRT at 10 to 12 primary care provider's practices. This study will be the first of its kind to track and quantify outcomes based on dosing and patterns of administration of BHRT.

Biomimetic Hormone Restoration and Healthcare Costs

Using a true biomimetic hormone restoration therapy, relief from many menopausal symptoms, such as improved sleep could allow women to live happier and more productive lives. Medicare and other insurance reimbursements for constant doctor visits and endless prescriptions and procedures would be reduced. Quality of life would improve for most symptomatic women and many more women would never have to experience the debilitating effects of being without their hormones.

Every day, forward thinking doctors, now frightened of the “Standard of Care” approved synthetics, are choosing safe, effective, biomimetic hormone restoration. By 2030 there will be 57.8 million baby boomers between the ages of 66 and 84 living with many of these health issues. There’s a chance that those who choose rhythmic replacement, the Wiley Protocol, could age to a healthier more graceful tune. Think about it…

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T.S. Wiley is a medical theorist in Darwinian medicine and environmental endocrinology. She is a noted writer and researcher, and lecturer on the effects of hormones, particularly in menopausal women. As an accepted expert in chronobiology and circadian rhythmicity, in endocrinology, Wiley’s CME accredited seminars, “Two Days Back on Earth,” are attended by physicians from all over the world. Wiley is also the developer of The Wiley Protocol, a trademarked patent pending delivery system consisting of bio-identical estradiol and progesterone in topical cream preparations dosed in a rhythm to mimic the natural cyclic hormone levels replicated in serum blood produced by a twenty year-old woman.

Wiley is the author with Dr. Julie Taguchi of “Sex, Lies & Menopause,” Harper Collins, 2005 and “Lights Out: Sleep, Sugar and Survival,” Simon & Schuster, Inc., 2000. Visit www.thewileyprotocol.com, or for more information about the Wiley Protocol Physicians Training and Certification, contact Caren Abdela at 805.565.7508, or email This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .

*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