As a society, we have a tendency to think of menopause as a
uniform experience. We generally suppose that all menopausal women have hot
flashes, mood swings and require the same kind of treatment. But that's not
accurate. Just as different women have different types of menstrual cycles in
their younger years, different women experience different menopausal symptoms.
Some may reach menopause early—or late. Some may have minimal symptoms while
others experience severe changes. So just as every woman is unique, so her
treatment should be.
This acknowledgement that one-size-does-not-fit-all is not a new concept to women and their physicians. Fortunately,
the experts are now coming around to this reality, too—especially as it
pertains to hormone replacement therapy (HRT). The
North American Menopause Society (NAMS), the preeminent voice on menopause treatments,
recently came out with a position statement recommending that HRT be prescribed
on an individualized basis. "Current evidence supports the use of HRT
... when the balance of potential benefits and risks is favorable for the
individual woman," the statement said.
This is a 180 degree turn from their recommendations after
the results of the Women’s Health Initiative were announced in 2002.
HRT's Turbulent
History
The
Women's Health Initiative (WHI) was the largest, most frequently referenced women's health study
conducted in the 1990s and early 2000s. It was abruptly discontinued in 2002 when higher rates of
breast cancer, heart disease, stroke and deep vein thrombosis and pulmonary
emboli were found in women who were using Prempro, a conjugated equine estrogen
and progestogen combination drug (EPT).
The second arm of WHI using Premarin alone continued. The
results of this study were overshadowed by the Prempro study. And it too showed
a slight increase in coronary heart disease, strokes and clotting problems. But
it did not show a significant increase in invasive breast cancer.
Initially, the more the WHI study was reviewed, the less physicians
prescribed any kind of HRT. In fact,
both women and physicians began believing that all forms of HRT were dangerous—even
bio-identical hormones. As a result, many conventional physicians stopped
prescribing Prempro and other HRT. This left many women with serious symptoms
that compromised the quality of their lives. Physicians tried antidepressants,
anti-hypertensives and sedatives to control hot flashes, night sweats, insomnia
and other symptoms.
There were several problems with the initial interpretation of the data from WHI:
- The media’s pronouncement that all HRT was dangerous wasn’t accurate for all women across all ages using different kinds of HRT. WHI included women aged 50-79. All participants were treated the same and lumped together following a cookie cutter model...one size fits all. But, some of the participants were just entering menopause. Most were older and had never been on HRT or had been off it for a long time. This skewed the results. The majority of women were older aged 70-79; so the study results mirrored their experience. Increased risk of breast cancer, increased risk of heart attacks, increased risk of strokes and deep vein thrombosis. What physician would prescribe a drug for menopausal symptoms that had this profile of side effects? None that I know; so the safety review board appropriately halted the study before its completion. Unfortunately the entire world read headlines stating “HRT is bad for women.”
- The headlines should have said “Prempro is bad for women.
- The route of administration of these drugs was oral. Any time an estrogenic drug is swallowed there is an increased risk of deep vein thrombosis and pulmonary emboli. Think of the complications of birth control pills. Heart attacks, blood clots and phlebitis. This is also true for conjugated equine (horse) estrogens like Premarin or natural estradiol like Estrace. Mother Nature never delivered estrogen through the stomach then processed it through the liver. Mother Nature released women’s natural estrogens directly from the ovary or fat into the bloodstream. So some of the complications at all ages simply had to do with the medications being administered orally. Topical low dose estrogens used in menopause, applied to the skin or vagina, have not been found to increase the tendency to clot. On the other hand, contraceptive rings and patches that are used for birth control with 50 times the estrogenic effect of HRT can still increase a younger woman's chances of phlebitis and pulmonary emboli.
- Older women who have not been on hormones have much older cardiovascular systems. When a woman has her last period at age 51, on average, she has caught up to a man's risk of heart disease by age 65. Generally younger women are protected from strokes and heart attacks by their higher levels of estrogen. Once the estrogen levels drop, arteries lose their elasticity, cholesterol plaques progress more quickly, and cells including heart cells lose some of their vitality. If one then adds an oral estrogenic drug that enhances clotting to this significantly older cardiovascular system, there is predictably a greater risk of heart attacks, strokes and deep vein thrombosis. One out of two women currently dies of heart disease.
- These were drugs. Drugs are not bio-identical. The estrogens were equine conjugated estrogens, Premarin. It was not estradiol, estrone, and estriol--our natural hormones. The progestin or progestogen or progestational drug employed was medroxyprogesterone acetate (MPA). The brand name drugs containing this are PremPRO and PROvera. This is not natural progesterone. It does not do what natural progesterone does. It is designed to protect the uterus from uterine cancer when a woman is on HRT. It's great for the uterus, but it's not healthy for the rest of a woman's body. In WHI and earlier studies MPA reversed the beneficial effects of estrogen on the cardiovascular system and cholesterol. Natural progesterone does not interfere with the benefits of natural estrogens on the cardiovascular system. Natural progesterone also protects the uterus and reduces a woman's risk of both breast cancer and uterine cancer.
In February 2004, the
Premarin arm of WHI was terminated due to an excessive number of strokes
overall. (Remember the tendency for oral estrogens to increase clotting in all
women.) Even so studies began to be
published which separated the absolute risk of various complications and
benefits by age group. That's when things got very
interesting.
- In the Prempro group, EPT, there were still increased numbers of women with coronary heart disease, breast cancer, stroke and thrombotic disease across all age groups compared to placebo. Ranging from 5 additional heart attacks in women aged 50-59/10,000 women/year to older women aged 70 - 79 with 23 additional heart attacks/10,000 women/year. Breast cancer was similar: 5 additional cases of invasive breast cancer/10,000 younger women/year compared to placebo; 13 additional in the older cohort. While none of these numbers are that large given the fact that this is per 10,000 women per year, there was still a very clear trend.
- On the other hand, in the Premarin only group, ET, there was an unexpected reduction in heart attacks and breast cancer relative to placebo when women started Premarin shortly after going through menopause, i.e., in their 50s. Ten fewer cases of heart disease and breast cancer/10,000 women/year. Women who started Premarin in their 70s still had an increased risk of heart disease and breast cancer but it was a much smaller increase than the Prempro group. This was the first major finding which showed that not all postmenopausal women are the same. “Cookie cutter medicine dies...one size does not fit all.”
- Another WHI follow-up study published in April 2007 showed that women who started Premarin, ET, within 10 years of menopause had no increased risk of heart attack, breast cancer or stroke. This resulted in a 30% decline in all cause mortality. That means there were fewer deaths in the group that took Premarin alone.
This past spring follow-up studies covering an almost 12-year
span of women who participated in WHI demonstrated even more interesting
results. These studies reflected what happened to women after they stopped
Prempro and Premarin.
Women who took
Premarin alone, ET, in their 50’s reduced their risk of heart disease and
breast cancer while on Premarin and
after they discontinued it. The
risk of breast cancer was reduced by 23-25% in women in their 50’s compared to
the placebo group and this reduced risk continued after stopping Premarin. Furthermore,
if these same women did develop
breast cancer, they had a 63% reduction in deaths from the disease compared to
placebo.
The risk of heart
disease was decreased by 40-50% for women on Premarin compared with placebo for
these women aged 50-59. Older women did not fare so well. They had more heart
attacks. For
example, for every 10,000 women/year taking CEE, there were 12 fewer heart
attacks, 13 fewer deaths, and 18 fewer adverse events for women ages 50 to 59.
In contrast, for every 10,000 women/year ages 70 to 79, there were 16 extra
heart attacks, 19 extra deaths, and 48 extra adverse events for women taking
CEE.
Since Premarin is an
oral estrogen, there was a slight increase in strokes and deep vein thrombosis
while taking Premarin, which decreased after stopping the Premarin.
The lower risk of
breast cancer was restricted to women without a history of benign breast
disease or a strong family history of breast cancer. The researchers
noted: “The
continued post intervention effect of estrogen on breast cancer incidence is
akin to that reported for other hormone-targeted drugs shown to reduce breast
cancer incidence.” That’s tamoxifen
they are referencing.
Three years after the
Prempro arm was halted due to increased heart disease and breast cancer, follow
up studies showed that the
increased cardiovascular risks while on Prempro normalized after they stopped
Prempro. Unfortunately, the greater risk of fatal and nonfatal breast cancer which
occurred while on Prempro carried forward even after the women stopped Prempro.
Summarizing all the above
Women who
are experiencing hot flashes, night sweats cognitive dysfunction, fatigue and
other quality of life symptoms
will get their lives back and live longer with less cardiovascular disease and
breast cancer, not to mention osteoporosis and Alzheimer’s Disease if they
start estrogen replacement therapy within 10 years of their last period or in
their 50s. Topical or vaginal estrogen virtually eliminates the risk of excess
clotting found with oral Premarin or any oral estrogen. Conventional doctors
use any one of many topical estradiol products now available; Vivelle Dot is
the most commonly prescribed. It is bio-identical.
Conventional
doctors prescribe a progestin for women to protect the uterus from uterine
cancer. Most see no reason for a woman to take progesterone or a progestin if
the woman has had a hysterectomy.
The problem
with this is that no one knows the optimum way to prescribe a progestin since MPA,
PROvera in PremPRO, caused all the problems discussed above. What about Provera
every three months? What about norethindrone, another progestin? Nobody knows.
Some
conventional doctors are using natural progesterone, brand name Prometrium. But
it is still not accepted as quite as good at protecting the uterus as the progestins.
How can we make this better? Safer?
There are
physicians, like Dr. Jonathan Wright, who first
studied the use of bio-identical hormones therapy (BHRT) in 1982. They have
used combinations of topical estriol (an anti-cancer estrogen), estradiol and
sometimes estrone combined with cyclical natural progesterone for 30 years and
they haven’t seen the rate of breast cancer and heart disease that conventional
medicine sees.
BHRT
It’s
topical--no increased clotting complications. It’s low
dose--usually no periods. It’s
bio-identical estrogens--has to be better than horse estrogens at reducing
heart disease and breast cancer. And the estriol is a SERM. A selective
estrogen receptor modulator. Flax seeds, the drug Evista, and soy are other
SERMS that reduce the risk of breast cancer.
It’s
natural progesterone which a woman’s body has produced month after month after
month since she went through puberty. It’s not just good for uteruses; it’s
great for breast and most other body tissues. Every month it helps a woman not
have PMS and have a normal, pain free, cramp free period. It protects the
breasts from over stimulation by estradiol. And it doesn’t negate the positive
effects of estradiol like MPA. It also does a search and destroy mission every
month routing out wayward cells or early cancer cells. It also keeps breast
cancer from metastasizing. Progesterone is a good hormone. Better than any
progestin. Thank you to the late Dr. John Lee who brought the public’s
attention to progesterone.
Physicians using BHRT report a 50% lower rate of breast cancer in
women who cycle progesterone instead of taking it daily. On the other
hand, the U.S. Food and
Drug Administration (FDA) and The Endocrine Society want further studies on
BHRT. NAMS in its 2012 position statement “confirm(ed) its support of the
US Food and Drug Administration (FDA) and other scientific organizations that
have warned women about the potential harm from these bio-identical hormones,” meaning custom compounded hormones. Vivelle Dot and Prometrium are OK.
Randomized, controlled trials would be great. But all of
these bio-identical hormones are natural. They can’t be patented so there isn’t
a potential high profit motivating individuals or companies to do these
studies. And we already have 30 years of observational studies from pioneering
physicians who have treated patients for many years. BHRT should be the
standard of care for HRT for men and women until someone proves that it damages
patients. (Oh... men already use bio-identical testosterone. Men have always used bio-identical testosterone
for replacement therapy. Not horse testosterone.)
A Tailored Approach
Lastly, are these lower rates of cancer and heart disease
documented by BHRT prescribing physicians just due to BHRT vs HRT, including ET
and EPT? No. Physicians who
prescribe bio-identical hormone replacement therapy usually take a very
holistic approach to patient evaluation and care. They address diet, weight optimization, exercise, blood
sugar control, stress management, other hormones, nutritional status, and the
ability to detoxify and eliminate the many pollutants in our bodies and reduce
our exposure to those in the world.
Each woman is different. Some will sail through menopause
without any symptoms. Others may find that they can take herbs, flax seeds or
soy to control minor symptoms. Then, there are women whose lives fall apart due
to incapacitating hot flashes, disturbed sleep, memory problems and inability
to think clearly. These are the women who will benefit from BHRT.
However, before beginning any kind
of BHRT, you and your doctor should consider the following:
- Your current conditions and personal health history—particularly related to cardiovascular disease and breast cancer.
- Family health history related to cardiovascular disease and breast cancer.
- Your exposure to toxins.
- How long it has been since you started menopause.
- The severity of your menopausal symptoms.
- What type of HRT you may already be on, and for how long.
- Your response to any HRT you may be on.
- CRP
- Hormone levels
- Adrenal function
- Thyroid function
- Vitamin D level
- Iodine level
- Thermography to assess breast health
While NAMS does not endorse getting or monitoring levels of
sex hormones, a former president of NAMS, Dr. Lila Nachtigall, said in a recent
talk that women must have an estradiol level of 21 pcg/ml to maintain bone
health. Higher to build bone. BHRT prescribing physicians, routinely monitor
sex hormone levels.
If you'd like to explore bio-identical hormones or get advice
on a personalized BHRT treatment plan, contact Vaughan Integrative Medicine at
(336) 808-3627, extension 13, to make an appointment with Dr. Vaughan.
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