Natural (Bio-identical, Body-identical) HRT
I specialize in treating hormonal problems, in both men and women, and of all ages. I use Bio-identical Hormones – also known as body-identical.
What is meant by Natural? (Bio-identical)
It is fairly obvious that different women require a different dose of hormones, by a different route, of different combinations of different hormones, for different symptoms. This cannot be done by the standard medical treatment of hormone problems, which is the wrong amount of the wrong hormones, for the wrong person for the wrong reason, and in the wrong way. Most HRT given by doctors is synthetic and very different to what the body actually produces.
The term NATURAL when describing BHRT refers to the molecule of the drug that is used in the preparation of these products. The Progesterone, Estrogen and DHEA are all derived from either wild yam, clover leaf, soy beans or other plants and herbs. The drug is extracted and then converted into a bio-identical hormone. A bio-identical hormone is a hormone that is exactly the same structure as the hormone the body produces. This means that when it enters the body it acts exactly the same as the human derived hormone. Because the body recognizes and is familiar to it, you do not get the side effects that you get from synthetic hormones.
Most prescription hormones used over the years, are derived from the hormones of pregnant mares, and therefore act similarly in our body but are not identical. Others are synthesized in a laboratory ( such as Livial). This is why BHRT is viewed as a natural treatment as the hormones are exactly the same as our own. The example of sugar is appropriate. Sugar is extracted from sugar cane, a process of crushing the plants and treating them in a factory to extract the pure product. Sugar is pure and natural, but does not grow on trees. However, it is very different from saccharine or aspartame, which are synthetic and artificial. The same applies to the hormones I use – they are mostly extracted from plants. However, the end results are hormones identical to that produced by our bodies, and a structure that has evolved over millions of years.
It is very important to tailor the dose to be correct – known as ” Tailor-made ” hormones. Or also as Designer hormones – made to measure. As humans are all different, it becomes very important to make sure the body is comfortable with the amount given. Compare this with standard HRT, where “one size fits all” is the rule eg. Mirena, Livial.
This will be done individually for each person by a blood test, as I find this more accurate than a saliva test (See FAQ – Saliva tests)
The usual hormones I test for are: Estrogen, Progesterone, testosterone, DHEA, FSH and sometimes thyroid tests. FSH is a fertility hormone made by the pituitary which reveals if someone is menopausal, and how deeply menopausal they are.
DHEA is an adrenal hormone, known as the “Mother” of all hormones, as it has so many actions in the body. Its main actions are to boost the immune system, as an anti-aging hormone, anti-depressant and youth restoring hormone.
The WHI study worked on the assumption that one dose would fit all asymptomatic post menopausal women. The investigators therefore often used the wrong dose, of the wrong hormones on the wrong patients and therefore came to many wrong conclusions. Different combinations of different hormones are necessary for different symptoms and different age groups. HRT may be commenced in the peri-menopausal phase, the early post menopause, the late post menopause or after hysterectomy and bilateral salpingo-oophorectomy or a premature menopause. These all require different treatments. Similarly various indications such as vasomotor symptoms, sexual problems, depression or the treatment/prevention of osteoporosis all need different combinations of oestradiol and possibly progestogen and testosterone according to the specific requirements of the patient.
For more information about the research and evidence in favor of this form of treating hormone problems, read “Safety of BHRT” and “evidence for BHRT” under the heading above.
What is a bioidentical hormone?
First of all, let us look at the definition of a bioidentical hormone, and how they differ from the synthetic hormones offered by the mainstream medical system.
Left Image: Natural Redhead courtesy of Wikimedia Commons
How is a Synthetic Hormone Different from A Bioidentical Hormone?
Bioidentical hormones are the hormones that exist in the human body naturally. Synthetic hormones are these very same human hormones that are chemically altered.
Why Chemically Alter a Human Hormone?
The drug company hires chemists to alter the structure of human hormones in the laboratory so the drug company can obtain a patent on the new chemical structure, which is a new drug. This alteration is required in order for the drug company to obtain a patent which gives exclusive marketing rights to the drug company. The patent is necessary to protects profits. Because of a quirk in our patent laws, only chemically altered substances can be patented. Natural substances like human hormones cannot be patented, and are therefore generally not as profitable to manufacture.
Chemically Altered Hormones are Monster Hormones.
Left Image: Boris Karlof in Frankenstein 1931 Courtesy of Wikimedia Commons. Respresents Monster Hormones
Hormones fit onto their receptors just like a “lock and key”, so any slight alteration of their chemical structure creates a “monster hormone”. These resulting “monster hormones” are never found in the human body or anywhere else in nature. The reality is that these synthetically altered monster hormones should never have been approved for marketing and sale to the Australian and American People, and yet that is exactly what your mainstream medical doctor will offer you if you ask for hormones..
Examples of a chemically altered hormone
Bioidentical Progesterone Above Right: Chemical alteration (see red side group) creates a monster hormone called Provera, a synthetic altered version of progesterone.
Why do we use the word bio-identical to describe natural human hormones?
You are probably wondering why do we use the word, “bioidentical”? That’s an excellent question. I can remember back when I was in first year medical school learning biochemistry at the University of Illinois in Chicago. Our class used Lehninger’s classic textbook of biochemistry. Lehninger never used the word, bio-identical hormones, because all hormones are by definition, bioidentical hormones. They simply used the word, “hormone”. Using a word like “bioidentical” was simply redundant and unnecessary for a biochemistry textbook, as it should be today.
The Information War and Terminology
Years ago, after the invention of synthetic monster hormones, an information war was launched by the drug industry creating confusion in the public and even among medical professionals about the difference between natural human hormones and synthetic monster hormones. Because of this information war, we must now use the terminology, “bioidentical” hormones which really means human hormones in order to different these from the monster altered hormones.
So it is an embarrassment to medical science that we are forced to use the word “bio-identical” for natural hormones found in the human body. We shouldn’t feel that we are forced to do this. It should be sufficient to use the same old names in the biochemistry text books. The simple word “hormone” should suffice. Yet here we are again finding ourselves using the word “bio-identical hormone” thanks to the “Information War” going on between natural medicine and the drug industry.
How do Hormones Work?
Hormones are messengers that attach directly on to the DNA of trillions of our cells and influence gene expression.
See diagram below showing hormone attaching to DNA in the Nucleus:
Hormones Bind to DNA and Turn on Protein Synthesis
The hormone enters the cell, attached to a receptor, and then enters the nucleus of the cell where it binds directly to the DNA. Once bound to the DNA, the hormone messenger turns on DNA expression of protein synthesis. DNA contains the source code for the manufacture of proteins. The Hormone is a messenger that tells the DNA to produce these proteins.
Why Are Proteins Important ?
Proteins are the major building block for the human body, and all life for that matter. Proteins serve a variety of functions. For example, “structural” proteins make up the structural elements of the body such as bones, skin, arteries, hair, connective tissue, ligaments, tendons, muscles. Other proteins called enzymes are involved in energy production. There are proteins involved in communication, neurological function, and cognition called neurotransmitters. There are proteins involved in the immune system called antibodies, and the list goes on. The types of proteins are a very important part of the makeup of the organism.
Regenerative and Reparative Proteins
We need a constant supply of proteins to repair the body’s wear and tear. A marathon runner, for example, suffers wear and tear on the tendons, ligaments and muscles used in the marathon run. Recovery time after a marathon depends on the speed of repair of these injuries. During recovery, new proteins and new cells are manufactured and used for repair.
Diagram below shows the hormone (red molecule at upper left) entering cell, attaching to the DNA, and turning on protein synthesis.(see below)
New Cell Layers Needed for Life
In order to live, we need to make new cells. As our older cells and cell layers age and eventually die, we must have the ability to manufacture new cells. Examples are blood cells that must be replaced by the bone marrow every 90 days, the skin cells that slough off as the outer layer to be replaced by new layers of cells underneath. The gastrointestinal lining is generated at the basal cell layer. These basal cells mature as they migrate to the surface where they eventually live out their life span, die and slough off.
All of the parts of our bodies are require new cells to replace old ones. These new cells are made of proteins , so regeneration of new cell layers requires the DNA to be “turned on” to make these new proteins and cells.
Hormone Levels Decline with Age
We know from observational studies that hormones levels decline with age. Starting around age 50, hormones levels decline to low levels. In women, this is sudden decline in hormone levels is called menopause around age 50 with cessation of ovulation. In men, hormonal decline after age 50 is called andropause, with a gradual in testosterone levels.
Chart of Life Span from 1600 to 2010. (see below)
Above chart courtesy of : Broken Limits to Life Expectancy Jim Open and James W.Vaupel
Starting around 1820, the time of the Industrial Revolution, we see a linear increase in life span. I suspect this is due to the improved living standards, better nutrition and mass production of goods and services. Before 1900, most people did not live past 50, so hormonal decline was not an issue. However, after 1900, an increasing population was living longer after the age of 50 with hormonal decline. This is an even greater trend now, with the largest over 50 population in the history of western civilization. All of these people are living with hormonal decline, and the accompanying degenerative diseases associated with hormonal decline.
Lack of Reparative Proteins Leads to Degenerative Diseases of Aging
Without the hormone message attached to the DNA, which turns on DNA expression and protein synthesis, we all begin to suffer from the lack of reparative and regenerative proteins leading to the degenerative diseases of aging.
Natural Medicine will provide bioidentical hormone replacement which will serve to prevent or reverse these degenerative diseases of aging. Here is a list with the mainstream drug treatment offered.
List of the Degenerative Diseases Drugs Used
|Immune System Dysfunction||Cipro, Z-pack|
|Loss of Libido||Viagra|
Degenerative Disease Means Great Profits for Drug Companies
The major drug companies make most of their profits on blockbuster drugs aimed at one of the above degenerative diseases of aging.
BioIdentical Hormones Prevent Degenerative Diseases of Aging
Since all of these degenerative diseases are directly caused by hormonal decline, they can be prevented or reversed (at least partially reversed) with the use of bio-identical hormones, representing direct economic competition with the drug industry which sells a drug for each degenerative disease (see above chart).
Natural Medicine Means Lost Profits for the Drug Industry
If bio-identical hormones were widely used, this would mean massive lost sales and lost profits for the drug industry. It is not difficult to understand why there is animosity and competition between the drug industry and natural medicine, and especially between the drug industry and natural bioidentical hormones, with a raging information war going on.
There seems to be a view that the use of bioidentical hormones is a clever American development that is a vital advance on orthodox HRT. It is important to realise that bioidentical hormones in the form of oestradiol, testosterone and progesterone has been used in Europe, particularly France for at least 20 year and I have used nothing else during this time. Meanwhile our American colleagues had been obsessed by the use of oestrogens extracted from urine of pregnant mares; conjugated equine estrogens (Premarin) and were most reluctant to move on to the more appropriate preparations of human hormones. Premarin contains about 64 different equine hormones and 20% of Godknowswhat. In contrast, oestradiol is the natural human oestrogen that is the most active in the body.
There is also good evidence that oestradiol through the skin is safer and probably more effective than when taken by mouth. If oestradiol is taken as an oral tablet it is changed in the gut and the liver to a less effective oestrogen Oestrone, whereas the transdermal route of oestradiol whether by gels, patches or implants produces the appropriate level of oestradiol in the blood stream.
There is also clear evidence that by using transdermal oestradiol stimulation of coagulation factors from the liver is avoided whereas this does occur as the result of the first pass effect with the ingestion of oral oestrogens.
Testosterone is a normal female hormone and is present in 5-10 times the amount in the adult female as oestradiol. It is a vital hormone necessary for mood, energy and libido and it is certainly best given through the skin as gels or implants. There is a license to use testosterone patches in women who have had a hysterectomy. In my view gels or implants are preferable.
DHEA (Dehydroepiandrosterone) is often considered a bioidentical hormone and is freely available in many countries. It is a precursor of testosterone and has only one fiftieth of the potency of testosterone. Although it is useful it is more sensible to use transdermal testosterone which is clearly bioidentical than taking tablets of DHEA and more effective.
The problem with bioidentical hormones comes with the progestogen components. The much heralded expensive progesterone cream available on the internet with exaggerated claims of increase in bone density and improvement of depression, hot flushes, sweats, etc is in fact virtually ineffective as it is hardly absorbed. My team have spent more than £100,000 studying this preparation over the last few years and it has no effect whatsoever on bone density, no effect upon mood and no effect upon the symptoms of flushes, sweats and headaches which are the common symptoms of the menopause. It might have a tranquilising and sedating effect if it is absorbed. These results have been published in Menopause International (Benster et al)
It is therefore necessary to give an effective progesterone/progestogen to protect the lining of the womb in patients receiving oestrogens. Most gynaecologists would use a synthetic progesterone such as Norethisterone or Medroyxprogesterone which certainly protects the uterus and produces regular scanty periods. Unfortunately, it often reproduces PMS symptoms in those women who are progesterone intolerant and therefore there is a move to use a more natural progesterone such as Utrogestan 100 mgs(Not available in Australia -Dr Holloway’s comment) for 7 days of each calendar month. This is in contrast to the orthodox management of 14 days of progestogen a month because of the frequent problems of depression, breast discomfort and loss of energy that occurs with a longer course of progestogen in those women with PMS and progestogen intolerance.
The best method of taking bioidentical hormones would in my view be Oestrogel 2-3 measures daily with the possible addition of transdermal testosterone gel and then Utrogestan 100 mgs daily for the first 7 days of each calendar month. This would bring about a regular scanty bleed on about the 10th day of each calendar month. You will find more details of this treatment for menopausal symptoms, hormone responsive depression and osteoporosis in this web site but please remember that it is not a recent American discovery. That would be too much to bear!
Read my daily blog for frequent updates on all matters hormonal and Health.
Here is a very recent study showing that natural hormones are much safer than synthetic hormones:
17β-Estradiol and natural progesterone for menopausal hormone therapy: REPLENISH phase 3 study design of a combination capsule and evidence review.
Several formulations combining estrogens and progestins for hormone therapy (HT) have been approved worldwide for the treatment of menopausal symptoms, yet recent data indicate a decline in their use and an increase in compounded bioidentical HT. Up to now, no single product combining natural 17β-estradiol and progesterone has been approved by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). A phase 3 trial (REPLENISH) is underway to study a novel oral formulation of solubilized 17β-estradiol and natural progesterone combined in a single gelatin capsule (TX-001HR; TherapeuticsMD, Inc, Boca Raton, FL) for treating vasomotor symptoms (VMS) in postmenopausal women. The REPLENISH trial evaluates the efficacy and safety of TX-001HR (4 doses) versus placebo for the reduction of moderate to severe VMS frequency and severity at 4 and 12 weeks and evaluates the endometrial safety of the combinations at 1 year. TX-001HR contains hormones that are molecularly identical to endogenous estradiol and progesterone and is intended as an option for women who prefer bioidentical hormones; further, it does not contain peanut oil, a common allergen. The constituents of TX-001HR, in a pharmacokinetic report, showed similar bioavailability and safety compared with reference estradiol tablets and micronized progesterone capsules administered together.
Published data suggest a safer profile of estradiol and natural progesterone compared with HT containing conjugated equine estrogens and progestins.
This report summarizes the methodology of the REPLENISH trial and reviews the evidence suggesting clinical differences between HT containing progesterone or progestins, and estradiol or conjugated equine estrogens.
Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.
The effects of compounded bioidentical transdermal hormone therapy on hemostatic, inflammatory, immune factors; cardiovascular biomarkers; quality-of-life measures; and health outcomes in perimenopausal and postmenopausal women.
Menopause impacts 25 million women world wide each year, and the World Health Organization estimates 1.2 billion women will be postmenopausal by 2030. Menopause has been associated with symptoms of hot flashes, night sweats, dysphoric mood, sleep disturbance, and conditions of cardiovascular disease, depression, osteoporosis, osteoarthritis, depression, dementia, and frailty. Conventional hormone replacement therapy results in increased thrombotic events, and an increased risk of breast cancer and dementia as evidenced in large prospective clinical trials including Heart and Estrogen/Progestin Replacement Study I and the Women’s Health Initiative. A possible mechanism for these adverse events is the unfavorable net effects of conjugated equine estrogens and medroxyprogesterone acetate on the hemostatic balance and inflammatory and immune factors.
Physiologic sex steroid therapy with transdermal delivery for peri/postmenopausal women may offer a different risk/benefit profile, yet long-term studies of this treatment model are lacking. The objective of this study was to examine the long-term effects of compounded bioidentical transdermal sex steroid therapy including estriol, estradiol, progesterone, DHEA, and testosterone on cardiovascular biomarkers, hemostatic, inflammatory, immune signaling factors; quality-of-life measures; and health outcomes in peri/postmenopausal women within the context of a hormone restoration model of care. A prospective, cohort, closed-label study received approval from the Human Subjects Committee. Recruitment from outpatient clinics at an academic medical center and the community at large resulted in three hundred women giving signed consent. Seventy-five women who met strict inclusion/exclusion criteria were enrolled. Baseline hormone evaluation was performed along with baseline experimental measures. Following this, women received compounded transdermal bioidentical hormone therapy of BiEst (80%Estriol/20%Estradiol), and/or Progesterone for eight weeks to meet established physiologic reference ranges for the luteal phase in premenopausal women. The luteal phase hormone ratios were selected based on animal and epidemiologic studies demonstrating favorable outcomes related to traumatic, ischemic, or neuronal injury. Follow-up testing was performed at eight weeks and adjustment to hormone regimens were made including addition of androgens of DHEA and Testosterone if indicated. Experimental subjects were monitored for 36 months. Baseline, 2-month, and annual values were obtained for: blood pressure, body mass index, fasting glucose, Homeostasis Metabolic Assessment of Insulin Resistance (HOMA-IR), fasting triglycerides, total Factor VII, Factor VIII, fibrinogen, Antithrombin III, Plasminogen Activator Inhibitor1(PAL-1), C-reactive protein (CRP), Interleukin-6 (IL-6), Matrix Metalloproteinase-9 (MMP-9), Tumor Necrosis Factor-alpha (TNF), Insulin-like Growth Factor (IGF-1), and sex steroid levels. Psychosocial measures included: Greene Climacteric Scale, Visual Analog Pain Scale, Hamilton Anxiety Scale, Hamilton Depression Scale, Holmes Rahe Stress Scale, Job Strain, and Home Strain. Health outcome measures included the number of prescribed medications used, number of co-morbidities, and endometrial thickness in postmenopausal women with intact uteri. Subjects receiving compounded transdermal bioidentical hormone therapy showed significant favorable changes in: Greene Climacteric Scale scores, Hamilton Anxiety Scale, Hamilton Depression Scale, Visual Analog Pain Scale, fasting glucose, fasting triglycerides, MMP-9, C-reactive Protein, fibrinogen, Factor VII, Factor VIII, Insulin-Like Growth Factor 1, and health outcomes of co-morbidities and a number of prescribed medications. Antithrombin III levels were significantly decreased at 36 months. All other measures did not exhibit significant effects.
Administration of compounded transdermal bioidentical hormone therapy in doses targeted to physiologic reference ranges administered in a daily dose significantly relieved menopausal symptoms in peri/postmenopausal women. Cardiovascular biomarkers, inflammatory factors, immune signaling factors, and health outcomes were favorably impacted, despite very high life stress, and home and work strain in study subjects. The therapy did not adversely alter the net prothrombotic potential, and there were no associated adverse events. This model of care warrants consideration as an effective and safe clinical therapy for peri/postmenopausal women especially in populations with high perceived stress and a history of stressful life events prior to, or during the menopausal transition.