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Hormone restoration
Henry lindner, md
Menopause Q&A
Contrary to what most doctors think, transdermal estradiol combined with progesterone and testosterone do not have the cardiovascular and breast cancer risks seen with Premarin and Provera -- PremPro.
Since Menopause is Natural, Why should Women Replace their Estrogen?
The human lifespan has been dramatically extended. In the recent past, women rarely lived long beyond the age of 60.
Nowthey routinely live for 30 or 40 years after menopause--in a hormone-deficient state. Is this deficiency of estradiol,
progesterone and testosterone somehow beneficial for women? Far from it. Menopause is one consequence of the
universal disease we call aging--and aging is definitely not good for us. Menopause is both natural and bad for a
woman's health and quality of life. Interestingly, the brain knows that menopause is not a good thing. After natural
menopause or surgical removal of the ovaries, for as long as a woman lives, the pituitary gland continues to secrete very
high amounts of follicle stimulating hormone (FSH) in an attempt to stimulate eggs in the ovaries to produce estrogen.
Nobody told the brain that menopause is good. The cause of menopause is depletion of functional eggs in the woman's
ovaries. This leads to an almost complete loss of estrogen, progesterone, and testosterone. Menopausal women live in
state of severe steroid hormone deprivation--they have lower estrogen levels than men! The consequences of losing
estrogen include hot flashes, insomnia, poor memory and concentration, dementia, depression, increased
thinning and wrinkling of the skin, vaginal dryness and atrophy, incontinence, increased blood pressure, and
increased blood sugar. Sexual interest is often lost and intercourse can become difficult if not impossible. A woman
loses 25% of her bone mass in the first 5 years after menopause. The risk of heart attacks, strokes, and Alzheimer’s
disease is increased. The bulk of the evidence shows that bioidentical estradiol and progesterone restoration helps
prevent these problems and improves overall health and well-being.
What is Perimenopause? Why do Women need Progesterone?
Menopause is the end stage of ovarian failure. The years leading up to menopause are called perimenopause. This is
when ovarian function is altered but has not ceased. When women are in the 40s, the ovaries start making less
progesterone. Often women don't ovulate at all and the ovaries make no progesterone. Perimenopause can be a time of
very high estrogen levels with low progesterone, causing fatigue, insomnia, bloating, heavy bleeding, allergies, and
headaches. These symptoms can all be well-controlled by adequate progesterone supplementation--and many
hysterectomies prevented. Progesterone appears to be safe at any dose--levels in pregenancy are extremely high for 9
months. Progesterone has a sedative quality--reducing anxiety and mood swings. Progesterone balances estrogen in the
female reproductive cycle. Whereas estradiol promotes proliferation in the uterus and breasts, progesterone reduces
proliferation and promotes maturation and differentiation of these tissues in preparation for pregnancy. Differentiated cells
are less likely to be cancer cells. Progesterone directly deactivates estradiol in these organs. (Provera® instead increases
breast stimulation and the risk of breast cancer.) The loss of progesterone early in perimenopause increases the
risk of uterine and breast cancers. After menopause the female breasts continue to make their own estradiol but
cannot make progesterone, further increasing the risk of breast cancer. Breast cancer incidence begins to rise in the
perimenopausal period, and continues to rise throughout menopause! Due to its ability to prevent uterine and breast
cancer, (see powerpoint) progesterone must be restored to adequate levels in both perimenopause and menopause,
whether or not a woman is on estrogen replacement therapy, and whether or not she has a uterus.
How are Bioidentical Estradiol and Progesterone Produced? What about Compounding Pharmacies?
“Bioidentical” is the term that signifies that the molecule is exactly the same as the one in our bodies. Yams,
soy, and other plants contain a molecule called diosgenin that has no hormonal effects, but it is similar to cholesterol and is
easily converted by chemical processes into bioidentical estradiol, progesterone, testosterone, cortisol, and DHEA.
However, all the alien steroid substitutes are also made from diosgenin. The issue is not whether the molecule is natural or
synthetic--the source does not matter--it's the chemical structure that makes a hormone right or not. Also, the route of
delivery is very important as bioidentical estradiol can cause problems if swallowed. The body accepts and metabolizes
bioidentical hormones as if it made them. There are FDA-approved bioidentical estradiol and progesterone products, but
they are often expensive and hard to individualize. They are often not in the best form for delivery. There isn't any FDA-
approved testosterone for women (The drug companies are trying to fix that!) Therefore many physicians prefer to
prescribe compounded estradiol, progesterone, and testosterone. A compounding pharmacy uses USP-certified
bioidentical hormones (the same raw products used in FDA-approved products). They simply combine carefully measured
amounts of the hormone powder into a delivery vehicle--a cream, gel, tablet, or capsule. Nothing could be simpler.
Pharmacists are certified experts. They take their responsibilities seriously. Any slight batch to-batch differences in
concentration or delivery that may occur are insignificant to hormone replacement. Compounded hormones work
perfectly well, are very convenient, and are less expensive in most cases. The scare-mongering lies about
compounded hormones that you are hearing are just drug-company propaganda passed on through drug company-
funded professional organizations like ACOG and NAMS straight to your local OB/GYN. (ACOG=American College of
Obstetrics and Gynecology, NAMS=North American Menopause Society)
What of the Recent Studies proving that "HRT" is Dangerous?
Replacement implies the use of the same molecules. “Hormone replacement therapy” was never hormone
replacement at all, it was hormone substitution. The Women’s Health Initiative study (WHI) reported in 2002 looked
only at the effects of pregnant mare's urine estrogens (Premarin®, yes, from horses) and a test-tube progestin (Provera®).
A progestin is not progesterone, it is an alien molecule with a different chemical structure. It has only some
progesterone-like effects. Progestins do not raise serum progesterone levels nor support pregnancy. Likewise, any
molecule with estradiol-like effects is called “estrogen”. The arm of the WHI study using combined Premarin® and Provera® (PremPro®) was discontinued early because an increased risk of breast cancer was detected. This risk was attributed to Provera. Provera® also caused a large increase in heart attacks and strokes. There is no evidence that bioidentical progesterone increases the risk of breast cancer, heart disease or strokes! Prior and subsequent reviews and
clinical studies indicate that natural progesterone does not increase the risk of breast cancer (Campagnoli, 2005), nor
does bioidentical estradiol and progesterone supplementation increase a woman's risk of breast cancer. (Fournier, 2005,
E3N-EPIC). The arm of the WHI study using Premarin®-only was discontinued because of an increased incidence of blood
clots and strokes in older women--a complication that we know is caused by taking any estrogens by mouth. Oral estrogens
affect the liver in an unnatural way and increase the production of clotting factors and the risk of blood clots. However,
estradiol delivered transdermally ( through the skin) does not increase a woman's risk of blood clots, heart
attacks, or strokes at all. Unfortunately, the pharmaceutically-funded media and professional organizations have
misrepresented this and other studies and are implying that all “hormones” are equally dangerous. This is an
understandable legal strategy given the thousands of pending and potential lawsuits over the diseases and deaths caused
by PremPro®. Many women can’t even tolerate alien hormones, suffering side effects such as bloating, bleeding, breast
tenderness, weight gain, and mood swings. Women do tolerate the correct hormones when given by the correct route,
since this is just the restoration of their youthful hormonal state.
What About Birth Control Pills?
Ethinyl estradiol (EE) is the estrogen in birth control pills (BCPs). It is an acetylene molecule attached to estradiol, making it
almost impossible for the body to metabolize and eliminate. It is a super-potent estrogen. EE increases the risk of blood
clots. It does not even affect one of the female estrogen receptors. BCPs combine EE with one of the 30+ progestins that
drug companies have created. BCPs shut down a woman's ovaries so that they do not produce any estradiol,
progesterone, or testosterone. These three natural hormones are replaced by two alien molecules. The woman's
testosterone level declines reducing her libido, sexual function, and muscle strength. (Female athletes should avoid BCPs!)
BCPs increase blood pressure and blood sugar. Women on BCPs should get off them and use an alternative contraceptive
method. If BCPs are being used to control irregular or painful periods, then the cause of the hormonal problem should be
found and corrected. For birth control, the current copper intra-uterine devices (IUDs) are very safe and rarely cause the
problems seen with earlier IUDs. IUD's can be used by young women who have not been pregnant. (Speroff) It's best to
avoid IUDs that dispense artificial hormones, but they are better than BCPs.
So Why doesn’t my Gynecologist Prescribe Bioidentical Hormones?
Naturally-occuring molecules such as vitamins and hormones cannot be patented. Pharmaceutical corporations are
interested only in patentable drugs (new, alien molecules) that are exclusive and profitable. If it’s natural, drug companies
aren’t interested. Drug companies now control most medical information that reaches your doctor, deciding what
gets studied, what is published in journals, and what your doctor's professional organizations tell him/her about hormones.
Drug companies are promoting their own products and attempting to suppress compounding pharmacies and the growing
compounded bioidentical hormone industry. So your doctor is told to use alien/synthetic hormone substitutes and to avoid
bioidentical hormones--believe it or not! Doctors are unaware of the benefits and safety of hormone restoration, and simply
don't know how to do it. For a physician to get at the truth, he/she must take the time to educate him/herself. Most likely,
he/she has just never thought much about bioidenticals, doesn't have the time for independent study, and has no desire to
stray from the drug-company promoted “standard of care” and thus endanger his/her career.
What about Evista® and Fosamax®?
Evista® (raloxifene) is in a class of non-bioidentical hormone-like drugs known as selective estrogen receptor modifiers or
designer estrogens. Studies show that these compounds are somewhat effective in increasing bone mass although
nowhere near as effective as estrogen, progesterone, and testosterone. They are given to postmenopausal women
because doctors are afraid to replace the lost natural hormones, and because they are more profitable for drug
companies. Designer estrogens do not relieve the other negative effects of menopause and sometimes increase them.
Fosamax® is a one of a number of biphosphonate drugs given to reduce bone mineral loss in menopause.
Bisphosphonates are soap-like molecules that poison osteoclasts, thus interfering with normal bone resorption. This does
cause a short-term increase in bone strength and mineral density. However, bone formation is eventually inhibited,
disrupting the natural process of bone turnover and producing bone that is essentially dead. There are increasing
reports of unusual fractures in persons on long-term bisphosphonates (Odvina, 2005). They have also been associated
with a number of side effects including gastrointestinal problems, severe muscle and joint pain, and eye inflammation. They
reduce normal bone remodeling after long-bone fractures and tooth extractions. Orthodontists have noticed that teeth will
not move if the person is on a bisphosphonate. It’s really very simple: postmenopausal osteoporosis is a hormone-
deficiency disease. The proper way to prevent and treat osteoporosis is hormone restoration (including the hormone we
call Vit. D).
How Long should I Stay on Hormones?
Women are being told that they should take hormones for menopause only if they have unbearable symptoms and for only
5 years. However, this recommendation is based on the known dangers of Prempro® and other hormone substitutes as
revealed in the WHI and other studies. Combined bioidentical transdermal estradiol and oral/sublingual progesterone have
never been show to increase the risk of breast cancer or heart disease. Indeed, these diseases are rare in premenopausal
women who have high levels of both hormones. Estradiol-progesterone restoration brings many known health benefits.
Therefore women should replace these hormones for the rest of their lives in order to maintain their health
and vitality.
Do I Need to have Periods the Rest of my Life?
The complex female organs and hormonal system exists to make babies and breastfeed them. Menstrual cycles are not
for a woman's health, they are for making babies. The fact that women have this complex reproductive hormonal
system is why they have so many more hormonal problems than men do. There is no health requirement for periods,
however, if a woman wants to menstruate, she can be made to bleed regularly with cyclical use of estradiol and
progesterone. This is not a real period though, but just the building up and the sloughing off of the uterine lining, just as
occurs with birth control pills. It is just an imitation of a menstrual cycle. The goal of menopausal hormone replacement
is to provide adequate amounts of estradiol and progesterone for health needs. When estradiol and
progesterone are taken together daily and in proper balance, there is no build-up of the uterine lining, so there is no need
to have a period to shed the lining.
What about Over-The-Counter Creams and Saliva Tests?
Over-the-counter non-prescription progesterone cream is beneficial to women in perimenopause and menopause, but it
has a low concentration and its absorption is variable. The usual dose is not sufficient, though, for women who are on
estrogen replacement. A prescription progesterone cream with a higher progesterone concentration is more cost-effective
and convenient. For many women, sublingual progesterone tablets made by a compounding pharmacy are the best choice.
Saliva tests are generally good for assessing sex hormone levels before supplementation, but they grossly overreact to
even minimal amounts of hormones applied to the skin, so they can't be used to adjust replacement doses. Practitioners
who use saliva tests to determine the dose of transdermal hormones are underdosing their patients. On the other hand,
serum blood tests (with the red cells removed) can underestimate the actual blood delivery of transdermal progesterone,
causing the practitioner to overdose the patient. The Wiley Protocol for bioidentical hormone replacement used serum
levels to guide transdermal hormone replacement and ended up grossly overdosing women with progesterone and
estradiol creams. A landmark study showed that 80mg/day of progesterone in a cream produces significant whole-blood
progesterone levels, equal to 200mg of Prometrium, but the cream did not produce much increase in the usual serum
progesterone test. (Hermann 2005). Labs only test for serum progesterone and this has caused doctors to erroneously
conclude that progesterone creams have no effect. The prescribing physician needs to be aware of all these issues
surrounding hormone delivery and testing.
Are there other Hormones that a Woman Needs?
Yes, most women should also restore their testosterone and DHEA to youthful levels. These hormones decline with age,
yet are essential for overall health and particularly for mood, muscle strength, and sexual desire and response. In women
with fatigue, fibromyalgia, or depression, there is often a need to optimize thyroid and/or cortisol levels as well. The female
hormonal system produces lower cortisol levels and effects which in many women can lead to a partial adrenal
insufficiency causing aches and pains, fatigue, insomnia, hypoglycemia, PMS, anxiety, irritable bowel syndrome, and other
problems. Many women cannot even tolerate estradiol and progesterone replacement after menopause without cortisol
supplementation because these hormones antagonize cortisol's effects. Hormone restoration requires balance among all
the significant hormones.