Could Biomimetic Dosing be the Answer to

Hormone Replacement Therapy?

By T.S. Wiley

It may be time to recognize that the peak is the point and relief is in the rhythm.

Bio-identical hormones can only be termed bio-identical if they mimic not only those chemically found in the
body, but also imitate the natural biological process as well. 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. In
order to be biomimetic and truly natural, new findings show that the therapy should produce a menstrual cycle.

New research sheds fresh light on healthy hormone replacement therapy (HRT), suggesting that women must
cycle their hormones and have a menstrual bleed to be truly safe from negative 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 because it
reliably produces a healthy menstrual bleed.

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 Women's Health
Initiative (WHI). This study of more than 161,000 women 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.
Apparently, using synthetic therapy exceeded the safety limits established at the beginning of the study.

Of course, 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 without concomment progesterone
or progestins. What the WHI did prove was that dosing a 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 without
a clear explanation to the nation’s doctors or women.
The media spin of fear mongering 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 point should be made that the WHI never looked at hormones, only drugs with “hormone-like”
effects that were dosed in a regimen far from that of human replacement. The WHI study has led us to believe
that HRT of any kind is dangerous. When, in fact, only the study substance - conjugated equine estrogens
(from pregnant mare urine) and a synthetic progestin (Prempro) - dosed on a daily basis in static doses clearly
can be deemed very harmful to women after only a few years. Compounded bio-identical hormones in static
doses were not included in the study because they are prescribed and dosed too many different ways. And of
course, Wiley’s biomimetic, bioidenticals didn’t even make the radar scope.

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 % of women experience a variety of transiently
debilitating symptoms in menopause and 30 % 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. Very few, 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 imitate youthful hormone levels, not just mask a few symptoms?
What if replacing hormones has the potential to alleviate many diseases associated with aging? After all,
history has shown 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),
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

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must be more to the story more to the story. Synthetic drugs with hormone-like effects, however, are not the
answer. The solution lies with the kind estrogen, how much and when to take it.

Currently many believe that a hormone is natural if it is found in nature or created in a lab and it is chemically
identical to the hormone in the body. It is important to note that if the substance or structure is changed in a
laboratory, then it becomes a synthetic hormone. It may trigger the activity of hormone receptors produced in
the body – alluding to a natural occurring result, however, synthetics differ not only in structure but in the
synergistic actions they have on the mechanisms of the body. What if it is important for the body to actually
recognize the substance coming in as a hormone?

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 are substituted for our own endogenously
produced hormone molecules. Many bio-identical hormone products are created from plant-derived raw
materials such as wild yams or soybeans. These sources of plant hormones mimic 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.

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 to mimic the
natural biological process. Since a woman’s body does not produce hormones statically but in an undulating
rhythm throughout a 28 day cycle, it follows that natural plant derived hormones must be dosed according to
this rhythm to be biomimetic and thus correctly called bio-identical.

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.

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.

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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 leery 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 possibility that those who choose rhythmic
replacement, the Wiley Protocol, could age to a healthier more graceful tune.

**************
T.S. Wiley is a medical theorist in environmental endocrinology and Darwinian medicine. 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 caren@thewileyprotocol.com.

*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

**Accreditation: The Medical Educator Consortium, is accredited by the Accreditation Council for Continuing Medical Education to
provide continuing medical education for physicians.
Credit Hours: The Medical Educator Consortium, designates this educational activity for a maximum of 17 AMA PRA Category 1
TM
Credit(s) . Physicians should only claim credit commensurate with the extent of their participation in the activity.

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