 Looking For The Truth
Regarding
Natural Bio-identical
Hormones
in the Treatment of Women
Click on the links below
to go to the topic in this article.
Mivagawa and Frank- The Monkey Tests
Synthetic Hormones Versus
Natural bio-identical Hormones
Summary of
Available Literature on Estrogen
In July of 2002 a very important study was suddenly halted by
the Data and Safety Monitoring Board of the United States. In the mid 1990's The
Women's Health Initiative (WHI) began a study that was sponsored by the National
Institute of Health. This study was on the drug Premarin .625 combined with
Provera 2.5 mg (synthetic progestin). The study was to run until the year 2005,
but was suddenly stopped after only five years of the study.
Sixteen thousand,
six hundred and eight women in all were put through a double blind placebo
study. The double blind placebo study is a study where both the patients and the
physicians are unaware of the medication that the patient is receiving. In other
words half the patients received placebo (nothing) and the other half of the
patients received .625 mg of Premarin (pregnant mare's urine) and Provera 25 mg
(synthetic progestin), also know as Hormone Replacement Therapy (HRT).
The reason that the Data and Safety Monitoring Board (DSMB)
stopped the study after only 5.2 years was because the group of patients that
were receiving the synthetic Premarin and Provera had a higher incidence of
complications than the patients receiving the placebo. In fact, calculated out
to ten thousand women years, (in other words, two thousand women using the synthetic HRT
for five years), the study showed that patients who took the synthetic HRT had a
higher incidence of the following complications of 10,000 women using synthetic
HRT in 1 year.
-
Breast cancer- - eight more
cases
-
Heart attacks - seven more cases
-
Strokes- - eight more
cases
-
Thromboembolic phenomena - eight more
cases
-
Colon cancer- - six less
cases
-
Fractures- five less cases
In other words if 30 women had breast cancer taking a placebo or nothing,
then 38 women would be expected to get breast cancer if they were taking
synthetic HRT. For every 30 women who had a heart attack 37 women would have
heart attacks if they took synthetic HRT and so on throughout the study.
In fact, taking a synthetic HRT was more dangerous than
not taking it. (except for bowel cancer and osteoporosis)
This study however, should not have been a surprise if one had looked
at the literature over the past several years comparing synthetic
progestin and natural bio-identical progesterone. The problem really
has been that most of the studies over
the last 40 years, have always been with Premarin and
Provera and very few studies, except the PEPI trial in the early 1990's and the
Oregon Trial, had taken the time to compare synthetic
progestins, such as Provera to Natural bio-identical Progesterone, such as Prometrium or
Progesterone transdermal Cream.
Provera (synthetic progestin) is a synthetic hormone made to look like
progesterone, but it is not in fact progesterone and the body knows it.
Provera has a half life of 30 hours and therefore, has no biological pathway to
break it down and remove it from the body, and in fact, I believe that these
biological break down products are more potent than the product Provera itself.
As listed in the Medical Compendium, Provera has any of 150 side effects, many of which are side
effects that are already the complaints that the patient comes to a physician
for during menopause. These side effects are, for example: weight gain,
depression, insomnia, anxiety, water retention and many, many more.
In the 1950's, a man by the name of Willard Allan
extracted estrogens from the urine of horses and a huge international
pharmaceutical company (Wyeth-Ayerst) bought
the patent for the process and produced it under the name Premarin. In my
opinion, Premarin (pregnant mare's urine) belongs in a 1200 pound horse and
certainly in my mind, is far more potent than the natural bio-identical hormones
that belong in a woman that weighs between 100 and 150 pounds. Also, 80% of
Premarin is estrone and we know that this is the most oncogenic (cancer
producing) of the 3 estrogens.
Since there was no competition for the hormone replacement therapy
plus the fact that the Premarin had a tremendous amount of money invested in it
and a tremendous amount of advertising, the company flooded the market with this
wonderful new drug to keep women young forever.
As doctors prescribed Premarin
to their patients and a few years went by, some of those patients returned
to their doctors with uterine cancer.
The patients asked their physicians if their cancer comes from taking the
Premarin? The answer, unfortunately, of course was, "YES". It is interesting that
nature's own natural
estrogens never caused cancers, but when man began to manipulate things by using
synthetic drugs to replace natural bio-identical hormones, suddenly uterine cancer increased
by 15 times the usual incidence.
The drug companies reacted to these adverse results by creating a new drug called Provera
(synthetic progestin) to be taken along with the Premarin to in fact protect the
uterus. This drug with many, many adverse known side effects itself, was given to treat the
adverse side effects of the first drug given to the patient. Aggressively
marketed, promoted and advertised together, Premarin and Provera
became the so-called "Golden Standard" of hormone replacement therapy for the next
40 years (most of the last half of the 20th century).
During this time however, several other companies began to produce products
from natural sources such as soy and yam, which were to compete with Premarin
and Provera. Sadly however, because physicians had become so comfortable using
Premarin and Provera, many physicians were reluctant to transfer their patients
over to Prometrium, for example, which is a natural oral progesterone made from yam
and is by far superior to the synthetic Provera.
Other bio-identical estrogen products were
made from soy and were slowly getting into the market place, but also having a
difficult time replacing the standard Premarin and therefore, reaching patients. These
natural bio-identical estrogen products made
from soy are, in my mind, far safer to the patient, albeit they were for the most
part 100% Estradiol, the most potent estrogen (CES, Estrace, Estragel,
Estraderm, etc.)
The Heart
and Estrogen Progestin Replacement Study)
In 1994, a large-scale study was begun at 20 medical centers across the
United States called the HERS (The Heart and Estrogen Progestin Replacement
Study). It was the second largest study of its type ever attempted and because
of the cost factors involved, it
was funded by the producers of Premarin, none other than the giant
pharmaceutical company, Wyeth-Ayerst, with every preconceived expectation that
the HERS project would prove that synthetic hormones would prevent heart attacks
in post-menopausal women with heart disease.
Two thousand women with heart disease were put on a combination of
synthetic estrogen and progestin. By 1998, the results in the hormone
replacement therapy were as follows:
(a) Substantially increased heart attacks the first year in the synthetic
HRT group.
(b) Had no effect on decreasing heart attacks in subsequent years. (Note:
This is only for synthetics)
(c) Affected blood clots with a three times higher incidence in the group
that took synthetic hormone therapy (Note: Oral hormones increase thrombosis)
(d) HRT synthetic caused an increase in gallbladder disease.
Once again a large scale controlled medical study shows that synthetic HRT does not belong in
the human body and that all of the promotion that was given to the drug replacement
therapy as being a wonder drug providing the fountain of youth, was not the case
with synthetic hormone replacement therapy (HRT).
There is another side to the story of Hormone Replacement Therapy. What bothers me tremendously is that
it is only recently in medical history that an attempt has been made to
scientifically study the overall balances of the female human body. Had those
studies been made earlier, it would have been evident that the best
hormone replacement therapy which might be offered by medicine to women would
be those natural bio-identical hormones which matched most closely the ones put
there by nature and God in the first place, rather than synthetic drugs.
When science, relatively recently, looked at the estrogen levels of all
human females, it was found that no matter what time in her monthly hormone cycle, the ratio of
the three estrogens present in the female body, would always be the same (i) 10% estrone
(E1); (ii) 10% estradiol (E2), and (iii) 80% estriol (E3). The latter, estriol,
is the weakest estrogen but also, measurably, by far
the most protective estrogen of the three.
In fact, estriol is the hormone
of pregnancy produced by the adrenals during pregnancy and we now know that the sooner the
patient has a pregnancy in her life, the less likely she is to have breast
cancer. Studies done in the past by Lemon and Fathergil proved that the use of
estriol, the "forgotten estrogen" should be looked at very seriously.
However,
until only recently very few physicians have begun to look at estriol as a
possible hormone replacement substitute.
Jonathon Wright, (an admirable pioneering doctor who has proven he thinks
for himself)
began to formulate Tri-Est. This formula is compounded in a compounding pharmacy* in the
exact ratio of 10% Estradiol (E1), 10% estrone (E2) and 80% estriol (E3) and put
together entirely from a soy
or yam base. The dose of Tri-Est is .625 mgm used twice a day (or 1.25 mg used twice a day)
because Tri-Est is found to 50% metabolize within a 12- hour interval. Initially I
prescribed Tri-Est
in a transdermal form. (*compounding pharmacy such as York Downs Pharmacy
1-800-564-5020)
Dr David T. Zava, in his excellent advice in the
International Journal of Pharmaceutical Compounding (volume 6, No.4 July/ August
2002) has listed 53 references when referring to the estrogen matrix and I refer
this excellent article for the consideration of both physicians and patients in the handouts that are
available. Dr. David T. Zava and Dr. George Gilson have recently published an
excellent paper with 71 medical references comparing synthetic hormones to
natural bio-identical hormones.
Along with this article, I would suggest reading Boomsna
and Pauletti, also quoted in the International Journal of Pharmaceutical
Compounding (volume 6, No.4 July/August 2002) with 35 references, an article
which is a superb review from the medical literature to illustrate that
natural bio-identical progesterone is, in fact, a protective hormone
against breast cancer. The references throughout the literature appear to be now
quite solid. However, more studies are needed.
In fact,
natural bio-identical estrogen tells the body "grow" and
natural bio-identical progesterone tells it to "stop growing."
It is like the Ying and the Yang, the natural balancing halves. It is my opinion that the best natural
bio-identical hormone replacement would appear to be
natural bio-identical Bi-Est or Tri-Est (.625, 1.25mg twice a
day or 2.5mg twice a day, along with a natural bio-identical progesterone
transdermal cream, either 3% or 6%
transdermal cream. If the patient is having trouble sleeping, the use of oral
Prometrium, 100 or 200 mg at night, is indicated.
It is recommended that patients take the first five days of each
month off from medication, to clear their receptors. Some patients find that
taking the five days of rest does not change how they feel. Other patients who
take five days off report they are bothered by menopausal symptoms and choose to
continue in an uninterrupted manner. Medically, I am more comfortable having a
patient take 5 days off.
Difficulty came when this large mass of women were suddenly faced with the
problems of Premarin and Provera and suddenly ceased the Premarin and Provera because of the
results of the study. When the study ceased, they were simply taken straight off
the drugs, causing many to return to previous troublesome menopausal symptoms
without relief. What should have been done, in my opinion, was to slowly wean
these patients off Premarin and Provera, placing them gradually on a soy-based estrogen, such as Estragel, along
with a yam based natural bio-identical progesterone such as Prometrium, 100mg during the time they are
coming off of Premarin and Provera.
This would have allowed patients to transfer over to soy
based and yam based natural bio-identical progesterone and estrogen
which would have continued to provide them with benefits, (although the estrogens in
these products are 100% Estradiol). It is my intention to have patients in my
practice who are on
the combination Premarin and Provera gradually come off the estrogen and progesterone and move
towards the natural bio-identical Tri-Est or Bi-Est
and natural bio-identical progesterone in the
transdermal cream form, which I believe is far safer for long tern use.
Another presenting issue which I have encountered over many years, are the patients who
have had a
hysterectomy and who have then
been placed on unopposed estrogen. Studies are now showing that if a patient
does receive unopposed estrogens for many years, that there may be an increased incidence of
breast and ovarian cancer in patients who are not protected from
the side effects of the estrogen with the use of a natural bio-identical
progesterone along with natural bio-identical estrogen.
Over the last 10 years, I have always prescribed natural bio-identical progesterone
to these patients, despite
the fact they do not have a uterus. I have had other physicians call my office and ask
why I would place someone on natural bio-identical progesterone who does not have a uterus.
My
answer to them usually, is that it is my belief that God and nature did not put progesterone in the
body just only to protect one organ. Progesterone is in the body to protect all reactive
tissue that have progesterone receptors (such as brain receptors and breast receptors).
Progesterone is a major
protective hormone for the breast. This is where the dialogue becomes very
interesting. It is now recognized by science that if you take a synthetic
progestin along with estrogen, that you increase the incidence of breast
cancer. As a result, many physicians advise their patients who have
hysterectomies not to use progesterone along
with estrogen.
A major
issue is that many physicians are mixing and matching progestin and progesterone
as if they were the same, but, in fact, they are as different in their effects
on the body as night and day. The fact is that the female human body knows
the difference between progestin and real progesterone.
Mivagawa and Frank- The Monkey Tests
Synthetic Hormones Versus
Natural bio-identical Hormones
To prove this point, in an Oregon study done by Mivagawa and Frank, a
study was combined with the USC School of Medicine This study compared the
use of synthetic progestin along with estrogen, versus a natural bio-identical progesterone
along with estrogen, in monkeys that had been given surgical menopause. In other
words, 18 surgically altered monkeys were divided into two test groups.
One group of monkeys were lucky enough to receive natural bio-identical progesterone and
estrogen and the other group were unlucky enough to receive progestin
and estrogen. The two groups were then given a drug which was going to produce
a vasospasm- in other words, a heart attack in the animal. The group of monkeys
that had received estrogen and (synthetic) progestin all required a reversing drug to save
their lives.
However, the group of monkeys who had received natural bio-identical progesterone and estrogen-
and then received the vasospastic drug- all survived the episode
without any need of a reversing drug.
Therefore, it is clear that progestin allows vasospasm, but progesterone causes vaso relaxation.
Current pathological science now proves that some women who have had fatal heart attacks
have some arteries
that contain very little plaque compared to men who die of atherosclerotic heart
disease and myocardial infarction. I believe that it is vasospasm
that produces heart attacks in females and therefore, progestin is one of
the worst possible drugs to be taken by any patient who has an increased risk of heart disease,
specifically and women past menopause age generally.
I believe that, in years to come, natural bio-identical
progesterone will be shown to help protect a female patient's uterus and heart,
but also protect her from cardiovascular disease. Until the age of 50 to 54 (or
approximate usual onset of menopause), female patients statistically have far
fewer heart
attacks than men.
After the age of 50, however, women suddenly begin to be at increased risk
of heart attacks and their risk factor catches up to and suddenly equals that of men.
For this reason, it is my opinion,
that giving natural bio-identical estrogen and
natural bio-identical progesterone may well provide protection for the
cardiovascular systems of female patients over the age of 50 or past menopause.
The error that is commonly made is that patients SHOULD NOT receive
synthetic estrogen or progesterone, but SHOULD receive natural
bio-identical estrogen and natural bio-identical progesterone. For patient's
protection, I recommend natural bio-identical Bi-Est or Tri-Est (estrogen
hormones) or
the natural combination of natural bio-identical estrogens and natural
bio-identical progesterone in transdermal cream form. Patients in my practice who receive
natural bio-identical progesterone transdermal cream are not
given 100% estradiol preparations. If patients use 100% Estradiol (or
Estragel), I prescribe Prometrium. If my patient uses natural
bio-identical transdermal Bi-Est or Tri-Est, I prescribe natural bio-identical progesterone
transdermal cream.
Summary of
Available Literature on Estrogen
Some people believe that it is only Estradiol
component that is the major hormone protecting patient's heart and bones.
However, Dr.
Maida Taylor from the University of California wrote an excellent paper in The Clinical Obstetrics and Gynecology (volume 44, No.4 December 2001) in
which she reviews all hormones.
The title of the article is "Unconventional Estrogens: Estriol, Bi-Est and Tri-Est." I believe that
Dr. Taylor has given a very balanced summary of the available literature on
estrogen and that physicians can make
their own decision based on the information that she has provided.
In my own
practice, I have been overwhelmed with the success of natural bio-identical Tri-Est
and Bi-Est estrogen hormone made from soy
and natural bio-identical progesterone hormone made from wild yam, in
combination.
As I grow further into the process of learning about hormones and
experience more results in their use, I am
very impressed with the use of natural bio-identical progesterone used alone. Peri-menopause should be treated only with
natural bio-identical progesterone because it is the first hormone to be lost by the patient and the patient's
adverse symptoms
are often very quickly reversed with natural bio-identical progesterone
transdermal cream.
I do believe the late, great
Dr. John Lee was correct when he stated that two out of every three patients
could be treated successfully through menopause with natural bio-identical progesterone
transdermal cream alone.
I would add that, in some cases, a vaginal estriol along with a transdermal progesterone, would be
highly beneficial in some patients who experience vaginal dryness and atrophy
and urethritis symptomatology. For patients who do not receive adequate
cessation of adverse symptoms on natural bio-identical progesterone alone, I feel very comfortable adding
natural bio-identical Tri-Est or Bi-Est to their
prescription regime.
Many of my patients ask why there are not more studies
being done on natural bio-identical hormones. The answer is very clear. Drug companies can
only make money by selling drugs and you cannot patent natural products.
It would not be economically desirable for a drug company to prove that
natural bio-identical hormones
were more beneficial than synthetic drugs, because that would destroy their own
market for synthetic drugs.
However, compounding pharmacies are
now becoming a stronger voice in the medical community and many papers are
being produced through the compounding society by investigators who have
revealed that it makes eminent sense to use natural bio-identical hormones
versus synthetic, especially in
light of the fact that they appear to be far more protective against
other medical problems and less
dangerous by far than synthetic drugs.
Many women do not require any
hormone supplementation to travel through the third of their lives called menopause. The issue
was raised initially only because of the fact that many women are now living
longer lives and therefore now live one third of
their life in menopause. Many of them experience substantial, uncomfortable and
debilitating symptoms during this period.
We need to sort out for the future whether or
not we should stand back and accept the natural aging process taking place after
menopause, or
whether it would be beneficial to have the protection of the natural
bio-identical hormones
that women produce up to the approximate age of 50 by themselves continued by
the use of natural bio-identical hormone supplementation.
While we are discussing hormones, let
me point out emphatically that natural bio-identical estrogen and natural
bio-identical progesterone are not the only hormones
that have to be considered in a menopausal patient. The other forgotten hormone
is natural bio-identical testosterone. Naturally occurring testosterone levels lower as the
patient's progesterone levels lower.
When a woman ovulates, she is more
interested in sexual intercourse. A man looks better to her than he usually does
throughout the rest of her monthly cycle. That is because progesterone is the precursor to testosterone,
which is the hormone of
desire.
Susan Rako wrote an excellent book called, "The Hormone of
Desire" about her experience with the use of testosterone. I found
that taking a free testosterone level in a patient who states that she has a
lowered libido will usually prove that the testosterone level is indeed
extremely low. My preference is to prescribe a natural bio-identical testosterone
transdermal cream to be
rubbed ¼ tsp. twice a day on the pubic hair, inner thighs and clitoris. This
will
enhance the patient's ability to not only enjoy intercourse, but to have the
thought processes that are required to enjoy the amount of intimacy. Dosages
range from 2.5 mgm, up to 5 mgm. The other advantages of using natural
testosterone are increased energy, muscle strength and mental clarity.
Testosterone is a
very strong anabolic hormone and men have five times the amount of
testosterone that is present in women. That is why I tell my patients very often that most men don't need a reason
to fool around- they just need a place! Other hormones that have to be
considered during menopause are DHEA and Pregnenalone. I prescribe
methyltestosterone for breast cancer patients. Usual doses are .25 mgm to .5 mgm
twice daily.
In summary, hormone replacement during and after menopause appears to be a
very complicated subject. However, in my mind it is becoming increasingly clear
that the closer we stay to the original plan -nature's way- the better off
patients and their doctors will be. The education of the physician shouldn't end
at medical school. It should just begin at that point. I thank my patients
for helping me with my education about the wisdom of their menopause.
   
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