Hormone Replacement Therapy: Debatable Choices 

Let’s Start at the Beginning

Uncertainty about HRT began when The National Institute of Health (NIH) sponsored the Women’s Health Initiative (WHI), a study of more than 161,000 women, designed to address the most common causes of death, disability, and impaired quality of life in postmenopausal women. What was not made clear to women is that the negative results of the study were, for the most part, due to the study group of women being over 65 and, of course, using synthetic hormone therapy drugs such as Permarin and PremPro only. The study started in 1991 and ended mid-stream in 2002 when WHI investigators found that the possible risks of this Big Pharma therapy exceeded the safety limits established at the beginning of its inception. The government’s response to their ill-conceived trial and abrupt ending was that women should not have any form of HRT ever again.

That was not an answer—even they knew it. In 2012, the WHI and 14 other medical organizations released a joint statement reinforcing the benefits of hormone replacement therapy for menopausal symptoms. Obviously, the same premise would apply to Testosterone for men. So, now that they have recanted, many men and women are still looking to relieve the symptoms of menopause and andropause or, in simple English: aging.  The well-known diseases of aging—heart disease, diabetes, cancer and Alzheimer’s—are preceded by declining sleep duration, eyesight, muscular strength, endurance, weight gain, foot and joint pain, as well as hot flashes, night sweats and losing your keys. Menopause and andropause are not just tedious times in everyone’s lives that you can live through like your ancestors—they are states of being that are, in fact, the beginning of the end. The right hormone replacement choice can not only relieve a myriad of symptoms, but may actually be prophylactic with respect to the far deadlier possibilities. After all, the major watershed moment in aging is the loss of sex hormones.  There are many options available, but these Hormone Replacement Therapies (HRT) are very confusing and often outright misleading.

The goal of hormone replacement therapy is to restore the hormone activity in brains, bones, breasts or prostate and heart that your body is no longer able to produce. The key to success just might be replacing these hormone levels and responses in the same template—timing and delivery system—as your body used to. None of these therapies, except The Wiley Protocol, acknowledge, let alone address these issues.

We refer here to the Standard of Care products provided by Big Pharma companies and the less-than-scientifically-based offerings from the Alternative/Complimentary “Medicine” community, copiously represented on the internet by groups like BodyLogic and HysterSisters, for example. Some therapies take the position that the body can’t distinguish bio-identical hormones from the ones that your body used to produce naturally. These bio-identical hormones are synthesized from yams or soy beans and the plant’s hormone molecules are, in fact, identical to human hormone molecules.

THAT’S WHERE THE “NATURAL” APPROACH ENDS, AND WE COME IN.

Although research has led to some novel choices that ostensibly provide a safer hormone profile for women to use hormone replacement, we believe that The Wiley Protocol, which is based on the premise that in order for bio-identical hormones to really be natural, they must be biomimetic, or mimic the innate and natural rhythms of reproductive youth. The Wiley Protocol’s dosing systems and manufacturing processes address the scientific aspects missing in other hormone therapies.

Below is a discussion of other approaches you may come across in your searches:

• Standard of Care Hormones
• Natural Hormone Replacement Therapy–What Is It?
• Bio-identical Hormone Replacement Therapy (BHRT)
• Compounded Pharmaceutical Products
• Pellet therapy
• Biomimetic: The “How” of Replacing Hormones

Standard of Care Hormones

This is a term used to describe the traditional HRT approach. Standard of Care hormones are most often made up of lab-created not-quite-the same hormone molecules that are chemically derived. Some Big Pharma products use bio-identical compounds in their mix, like Climera, Vivelle and CombiPatch, as well as Vagifem, Estrasorb, Estring, Prochieve and Prometrium. Subsequently, while they may be called “natural,” they differ in molecular structure from naturally occurring hormones.

The FDA has approved several substances that have been chemically derived and altered in a laboratory. These types of Estradiol and Progesterone Franken-molecules are the substances known as Standard of Care HRT. The problem is that many of these drug therapies contain hormone-like molecules that are completely foreign to the human body.

Premarin is an animal-derived product made from a “natural” mixture of estrogens secreted by a pregnant mare. Beyond animal estrogen, Premarin also contains many lab-created types of estrogen-like substances that are not found in the human body. These faux estrogens are more potent and more persistent at the estrogen receptor site than human “17-beta estradiol,” creating dangerous and unbearable side-effects.

These Big Pharma drugs are patented molecules. Legally, it is impossible to patent a natural substance for which a molecular construct already exists in nature such as water, or human hormones. Therefore, the invented molecules found in Standard of Care treatments must be architected to be unique, non-natural forms in order to be able to be patented.

Natural Hormone Replacement Therapy—What Does That Even Mean?

Many men and women are beginning to realize that living without their hormones is miserable and dangerous. But, what if there was a kind of hormone replacement that could actually imitate youthful hormone levels, not just mask a few random symptoms? What if replacing hormones has the potential to alleviate many degenerative diseases associated with aging? After all, history has shown that young individuals aren’t susceptible to osteoporosis, Alzheimer’s, glaucoma, cancer, and heart disease to name a few. The main difference between young men and women and older men and women is their reproductive capacity and the attendant hormones associated with reproductive youth. Medicine bears witness that most men and 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 people would be dead. If logic like that tells us that estrogen doesn’t cause cancer in and of itself, then there must be more to the story. Synthetic drugs with hormone-like effects, however, are not the answer. The solution lies with the kind of hormone, how much, and when it is administered.

Currently, many believe that a hormone is natural if it is found in nature or created in a lab and it is chemically suitable to do the job in the body. It is important to note that if the substance or structure is changed in a laboratory, it no longer does the same job that our hormones do. These hormone-like pharmaceutical drugs can trigger a variety of activities at the receptor site. However, Big Pharma hormones differ not only in structure, but in the synergistic actions they have on every mechanism in the body.

Bio-identical Hormone Replacement Therapy (BHRT)

The term bio-identical has become a catch-all phrase for anything that is not from a lab. It is commonly applied to look-alike molecules derived from “natural” plants that are substituted for the hormone molecules we produce in the body. “Natural,” or bio-identical hormones are made by converting natural plant hormone compounds from wild yams and soybeans into chemical molecules identical to those made in the human body for 17-beta estradiol, progesterone, or testosterone.

These sources of plant hormones mimic only the “chemical structure” of human hormones. The purveyors of this premise—that the body can’t distinguish created bio-identical hormones from our own—has never been accepted by the Standard of Care unless used in an FDA product. Bio-identical HRT is available in standardized tablets, patches, compounded creams, gels and injectable prescriptions in very low static doses. Taking more than one kind together every day is termed “continuous combined” therapy. Taking one, say estradiol, and adding in progesterone for some part of the cycle is referred to as “sequential” dosing.

Compounded Pharmaceutical Products

Hormone Replacement Therapy (HRT) products from compounding pharmacies are made with the same plant-derived raw materials developed for their ability to mimic the hormone molecules found humans used in Big Pharma products. In compounded BHRT, the raw materials known as 17 beta-estradiol, testosterone, cortisol, and progesterone have been FDA approved in the same sense that they are as ingredients in FDA products. These compounded forms are the ones most commonly called BHRT. The HRT made using this methodology provide very little actual hormone in a dose that is static (administering the same amount each day).

Pellet therapy as BHRT

Pellets aren’t really pellets. They are tiny rice-sized “capsulettes” filled with bio-identical hormones in in a water-soluble vinyl polymer called polyvinylpyrrolidone USP.  Your physician of choice will cut a slit in your upper buttock to insert these pellets.  The amount and how many kinds of pellets are administered at once may vary, and the process is repeated after they ostensibly release their contents into your blood stream and then dissolve. So, you get stabbed, and risk infection every 3-4 months, too.

Pellet therapies were used in Europe in the 1930s. Brought to America by Dr. Robert Greenblatt in 1939, the immediate problems identified were those of absorption rates. Cortisol is gone in 27 days, estrogen in 51 days, and testosterone in 61 days alone. Dosing is remarkably inaccurate because of the previous fact and the variability among patient metabolism. Aetna, in their study of pellets for men, concluded six testosterone pellets (450 mg), plus injections of 50 mg a week was adequate to six months-worth of replacement.  But that study was done because Aetna is an insurance company and the only FDA-approved testosterone pellet was Testopel, which is now facing a class-action law suit. As for women and pellets, in 1992, Dr. Geno Tutero founded the SottoPelle Center for Hormonal Balance and Wellbeing. He realized progesterone just didn’t work like that and opted for estrogen and testosterone pellets combined with sequential (part of the month) progesterone creams or pills. While Dr.Tutero died in 2015, his legacy lives on though his franchises and though the facilities who knocked off his treatments such as BioTE, Amore Vie, and BodyLogic.

In countless blogs and chat sites, women report lasting sciatica pain, persistent infections, growing unwanted hair in unappealing places, acne, hot flashes, sleep loss, and massive abdominal weight gain. The most distressing clinical problem is the inability to adjust the dose or remove the active agent. In fact, on August 26th, 2011, a Dr. Donovitz was sued and brought before the Texas Medical Board in a law suit brought by a patient complaining he failed to perform an intake exam and prescribed testosterone pellets with no laboratory evidence that she needed it. She claimed substantial damage, including but not limited to: hair loss, facial hair and cystic acne.

Biomimetic: The Key to Restoring Not Replacing Hormones

Chronobiology, the study of the patterns of time and environmental effects on human biological systems, shows us that the patterns in nature control the actions of our genes in every cell of our body. Sun up. Sun down. Every trip around the Sun. All living beings are regulated by biological cycles. These cycles have a rhythm and are commonly called circadian rhythms or referred to as the circadian clock. This ‘clock’ in our cells measures the rhythm of a 24-hour spin of the planet. For 28 days, the moon tracks the repeat of that cycle — and so does the body.

Those environmental cues are reported right down to genes with hormone rhythms—the same hormones that dissipate at midlife. So, the same dose of whatever hormone—even those made by plants—taken everyday, not only doesn’t register as hormone messages in the body (hormones move in wave-like patterns), but causes great harm. Thanks to the same mechanism causing insulin (a hormone) resistance, statically dosed bioidenticals also stop working within about three to five months. Research done by T. S. Wiley shows that it may not, in fact, just be the molecule that matters. The way the hormone is administered and when the hormone molecule is received at the receptor site, as well as the way receptors are provoked may be as important, if not more. After all, the WHI proved that dosing synthetic HRT in a static, low-dose regimen was harmful to woman over 65, particularly with regard to stroke and cardiac events.

The Wiley Protocol’s hormone restoration therapies are distinguished from other BHRT programs because they are biomimetic as well as bio-identical. The Wiley Protocol is based on the premise that “bio-identical” hormones can only be truly and accurately bio-identical if the hormones for replacement not only mimic those found in the body, but mimic the natural biological processes associated with them as well. In other words, natural plant derived hormones can accurately be termed bio-identical only when they are dosed in a biomimetic fashion which must include a natural, cyclical rhythm.

The Wiley Protocol uses the natural rhythms found in reproductive youth to establish the proper doses of estradiol and progesterone for women, and DHEA and testosterone for men. The Wiley Protocol is a multi-phasic rhythmic dosing regimen, meaning that the topical creams and their amounts vary throughout the 28-day cycle to restore the hormone levels of a man or woman in their prime.

It is this natural, wave-like rhythm of application that is missing from all other bio-identical and synthetic hormone replacement therapies. This approach opens the door for a new look at the possible decline or disappearance of the symptoms and disease-states associated with menopause, andropause, and aging.