No Scientific Evidence Supporting
Effectiveness or Safety of Compounded Bioidentical Hormone Therapy
Washington, DC -- There is no scientific
evidence to support claims of increased efficacy or safety for
individualized estrogen or progesterone regimens prepared by compounding
pharmacies, according to a new Committee Opinion released today by The
American College of Obstetricians and Gynecologists (ACOG). Furthermore,
hormone therapy does not belong to a class of drugs with an indication for
individualized dosing. ACOG's opinion also points out that salivary
hormone level testing used by proponents to 'tailor' this therapy isn't
meaningful because salivary hormone levels vary within each woman
depending on her diet, the time of day, the specific hormone being tested,
and other variables.
Compounded "bioidentical hormones" are plant-derived
hormones that are prepared, mixed, assembled, packaged, and labeled as a
drug by a pharmacist. These preparations can be custom made for patients
according to a physician's specifications. "Bioidentical hormones" refer
to hormones that are biochemically similar or identical to those produced
by the ovaries or body.
According to ACOG, most compounded products, including
bioidentical hormones, have not undergone rigorous clinical testing for
either safety or efficacy. Also, there are concerns regarding the purity,
potency, and quality of compounded products. In 2001, the FDA analyzed a
variety of 29 product samples from 12 compounding pharmacies and found
that 34% of them failed one or more standard quality tests. Additionally,
9 of the 10 failing products failed assay or potency tests, with all
containing less of the active ingredient than expected. In contrast, the
testing failure rate for FDA-approved drug therapies is less than 2%.
The FDA requires manufacturers of FDA-approved products
that contain estrogen and progestogen to include a black box warning that
reflects the findings of the Women's Health Initiative. However,
compounded products, including bioidentical hormones, are not approved by
the FDA and therefore, compounding pharmacies are exempt from including
warnings and contraindications required by the FDA in class labeling for
Given the lack of well-designed and well-conducted
clinical trials of these compounded hormones, ACOG recommends that all of
them should be considered to have the same safety issues as those hormone
products that are approved by the FDA and may also have additional risks
unique to the compounding process.
Committee Opinion #322, "Compounded
Bioidentical Hormones," is published in the November 2005 issue of
Obstetrics & Gynecology.
The American College of Obstetricians and Gynecologists is the national
medical organization representing over 49,000 members who provide health
care for women.
Frequently Asked Questions About Hormone Therapy
New Recommendations based on
ACOG's Task Force Report on Hormone Therapy
If you're a woman navigating the transition through menopause, it may
seem as though these are the best of times and the worst of times. On the
bright side, solid research is finally providing long-awaited answers to
crucial women's health questions that researchers and women have been asking
for years. Some of that research has led to a broader range of treatment
options for the management of menopausal symptoms and some of the long-term
health risks associated with menopause, such as osteoporosis.
On the down side, sometimes the long-awaited answers aren't what anyone
expected, as was the case with the Women's Health Initiative (WHI), which
made headlines in 2002 and again in 2004 when two arms of the federally
funded study were halted prematurely after finding that hormone therapy
(estrogen and progestin, or HT) and estrogen alone (ET) did not protect
against heart disease, as was once believed.
Even before the WHI study results were announced, The American College of
Obstetricians and Gynecologists (ACOG) in early 2002 had created a task
force of 21 national experts to look at questions surrounding the use of HT
and ET. The Task Force met over the next two years to evaluate all of the
studies to date, including new research published since the WHI results were
released, and to develop guidelines for the appropriate use of hormone
therapies based on the most current research.
One of the most significant achievements of the Task Force was to put
into perspective - for both doctors and patients - the results of the WHI
and their relevance to the way hormones are prescribed in the management of
menopause. Indeed, as important as the WHI was in advancing our knowledge
about the use of hormones for the prevention of chronic illness and in
clarifying some of the risks of hormones, it's important to keep in mind
that the WHI was designed to investigate whether or not HT or ET could
prevent disease - not whether they relieve menopausal symptoms. In fact,
most of the women in the WHI were 10 years older than women who use hormones
to relieve menopausal symptoms, and most of the WHI study participants had
no menopausal symptoms while they were enrolled in the study. So although
the WHI clearly showed that hormones should not be used for disease
prevention, they are still appropriate as a treatment for the relief of
menopausal symptoms. As with all medications, the decision to use HT or ET
is a personal one based on a review of the individual woman's health needs.
What does this mean for you? Essentially, HT and ET can still play a role
in the treatment of menopause, provided you use the medications for
appropriate reasons and after weighing the benefits and risks.
To help you evaluate the benefits and risks, here are answers to some of
the most frequently asked questions about HT and ET, based on ACOG's new
Hormone Therapy report.
Background: Hormone Therapy Then and Now
If you're not already familiar with ET, it is a form of drug therapy in
which you're given estrogen to supplement the estrogen your body makes much
less of after menopause. If you haven't had a hysterectomy and therefore
still have your uterus, you should also be given a progesterone-like agent
(synthetic forms are called progestins) to help reduce the risk of uterine
cancer, which is referred to as hormone therapy, or HT. Sometimes, androgens
(male reproductive hormones) may be prescribed, either alone or in
combination with estrogen (and progestin, if needed) for certain women who
are having problems with sexual desire -- although studies are still ongoing
as to whether androgens are effective for treating women's sexual libido.
Estrogen comes in the form of pills, patches, gels, and emulsions, and,
for women who have vaginal dryness, vaginal creams, tablets, and a flexible
vaginal ring. For women with a uterus who also need progestin, there are
progestin-only and combination (estrogen-progestin) pills and patches, as
well as a vaginal progesterone gel. Most formulations of estrogen also come
in varying strengths, or dosages.
For more than 60 years, hormone therapy (HT) has been a mainstay in the
treatment of menopausal symptoms, such as hot flashes and vaginal dryness.
When, in the mid-1980s, estrogen was found to retard (or slow) bone loss in
postmenopausal women, the FDA approved it for the treatment of osteoporosis.
At the same time, other observational studies suggested that HT might
prevent heart disease - the groups of women in these studies who used
estrogen had about half the number of heart attacks as those who didn't use
estrogen. This research was buoyed by evidence that estrogen lowered levels
of the 'bad' LDL cholesterol and raised levels of the 'good' HDL cholesterol
in postmenopausal women. Lower cholesterol levels are associated with a
reduced risk of heart disease. Other research had suggested that HT might
help prevent the onset of Alzheimer's disease.
Even so, questions remained about HT, in spite of the fact that it is one
of the most thoroughly studied drugs on the market today. Was the heart
protection found among estrogen users due to the estrogen, or did those
women simply take better care of their health than other women enrolled in
those studies? Would adding progestin to estrogen, necessary for reducing
the known risk of uterine cancer, cancel out estrogen's heart protection?
What about an increased risk of breast cancer?
Because so many questions about HT and ET remained unanswered, in 1993
the National Institutes of Health decided to look for definitive answers.
The result was a randomized controlled study involving a total of 161,809
women nationwide known as the Women's Health Initiative. The main thrust of
the WHI was to determine the exact degree to which hormone therapies
presumably protected the heart, and to investigate the degree to which some
of the known and potential risks of hormone therapies, such as breast cancer
and blood clots, cancelled out any benefits. The WHI also explored whether
hormone therapies prevented fractures, colon cancer and dementia, including
Alzheimer's disease. Still other parts of the study looked at the effects of
HT and ET on quality of life and cognitive function, energy levels, sleep
The main reason the study results carried so much weight had to do with
the way the study was designed and carried out. First, the sheer number of
study participants was huge. Many of the earlier studies on HT and ET
involved small groups of women. Having large numbers of women participating
in the study increases the accuracy of the statistics on which the
researchers base their conclusions.
Second, the study was designed to take place over a number of years. Many
of the questions researchers had about HT and ET - particularly their role
in the prevention of heart disease and osteoporosis - involved the use of
hormones over many years' time.
Finally, the study was designed to compare women using HT with those
taking a placebo, or inactive tablet. Neither the researchers nor the study
participants knew for sure until after the study was over which women were
taking HT and which were taking a placebo. This type of study design gives
the most definitive and objective results - in essence, by comparing apples
to apples. In effect, one of the things the WHI did best was to clarify some
of the risks involved with the use of hormone therapy.
What the WHI Found
One part of the WHI, an 8-year trial involving some 16,608 healthy women
with a uterus, was designed to explore whether hormone therapy (estrogen and
progestin) protected against heart disease and osteoporosis. But when
researchers analyzed the data they had collected after only 5.2 years, they
concluded that the risks for the study group on combined HT outweighed the
benefits. Moreover, the risks, although small, were outside of the safety
standards set for the study, which led to early termination of the study.
Risks included a small but significant increased risk of breast cancer (38
women out of 10,000 women per year compared to 30 women taking placebo),
heart attacks (37 women out of 10,000 women per year compared to 30 women
taking placebo), strokes (29 women out of 10,000 women per year compared to
21 women taking placebo) and blood clots (34 women out of 10,000 women per
year compared to 16 women taking placebo) for the group of women on HT.
To be sure, HT offered health benefits as well. HT users had a lower risk
of spine and hip fractures. In the HT group, there was a 24 percent
reduction in total fractures, and a 34 percent reduction in hip fractures.
On average, per year, there were 10 cases of hip fracture per 10,000 women
on HT compared to 15 per 10,000 women on placebo.
The WHI also reported a reduced risk of colon cancer among HT users,
which was down by 37 percent (or 10 cases of colorectal cancer per 10,000
women per year on HT compared to 16 cases per 10,000 women per year on
placebo). But given the risks for breast cancer and cardiovascular problems
shown in the study, the risks of using HT for prevention of heart disease
outweighed these benefits for most women.
Another part of the WHI, involving 11,000 healthy postmenopausal women
who were using estrogen alone, continued for two more years after the
estrogen-progestin part of the study was halted. But early in 2004, that arm
of the study was halted as well. Researchers discovered that ET did not
prevent cardiovascular disease and appeared to increase the risk of stroke
at about the same rate as HT did. That is, women using ET had about 12 more
strokes per year for every 10,000 women than did those who took a placebo
(44 on ET vs. 32 on placebo). ET also increased the risk of blood clots (21
on ET vs. 15 on placebo).
The good news: ET did not appear to increase or decrease a woman's risk
of breast cancer during the seven years the women took it. And the women on
ET had a lower risk of hip fractures.
Although ET appears to pose fewer risks to women than HT, the researchers
decided to halt the study a year early because after seven years of follow
up, the results were unlikely to change in the one year remaining in the ET
study to answer the primary question: is ET effective in reducing heart
disease in women? There was also concern that the increased risk of stroke
was no longer acceptable in healthy women participating in a research study
on a drug that's supposed to prevent disease.
I'm confused. Do the findings of the WHI mean
that menopausal women should never take hormones because the drugs are too
No. Remember: The WHI was designed to determine whether HT and ET were
effective in preventing illnesses such as cardiovascular disease and
osteoporosis, and not their usefulness in the treatment of menopausal
symptoms. What's more, all medications have side effects, and the WHI helped
to clarify and quantify what some of those side effects were for hormone
In fact, for as much good information as the WHI provided about HT and
ET, many physicians and researchers believe many more questions about
hormone therapy have yet to be answered. For instance, do the results of the
WHI study, which involved the use of a certain formulation of estrogen and
progestin taken together daily, apply to the numerous other brands of
estrogen and progestin on the market? What about lower doses of estrogen and
progestin? Do estrogen-containing skin patches, vaginal creams and the new
vaginal ring carry the same risks? Equally important are questions about the
safety and effectiveness of over-the-counter products, which are not
stringently regulated by the U.S. Food and Drug Administration (FDA) and,
more often than not, have not been as rigorously tested for safety and
effectiveness as prescription medications.
It does mean, however, that when considering hormones for relief of
menopausal symptoms, you and your physician must carefully evaluate the
benefits and risks of HT or ET as they apply to you as an individual.
So how do I weigh the risks?
First, it's important to distinguish between individual risk and public
health risk. In the WHI trial, the size of the health risks for each
individual woman was actually quite small. For instance, a woman's risk
of developing breast cancer while using combination HT was 8 per 10,000
women taking HT per year - in other words, less than one tenth of one
percent a year, according to the study authors. (There's a caveat,
however: Although the increase was small, it was cumulative over time. In
other words, the longer a woman stayed on HT, the more her risk for breast
cancer increased, at a higher rate than would normally occur with advancing
The National Institutes of Health stopped the study both in fairness to
the group of women on HT and because the researchers were looking at the
increased risks for an entire population of women over time. While the rate
of increased breast cancer risk may not sound huge - only 8 additional cases
of breast cancer diagnosed per 10,000 women per year in the HT group - the
numbers become unacceptably large when you factor in the millions of women
who take the drug over many years' time.
You may decide that the relief you get from your symptoms with HT may be
well worth the slight individual risks. The decision is yours to make, as
long as you have discussed the risks and benefits with your doctor.
Do the risks apply to other forms of hormone
therapy, such as the skin patch?
The women in the hormone therapy arm of the WHI study used a combination
form of HT containing .625 milligrams of conjugated equine estrogens and 2.5
milligrams of medroxyprogesterone acetate (brand name Prempro®) in the form
of a daily pill. For now, experts advise doctors and patients to assume that
all formulations carry the same risks as those reported in the WHI. But in
fact, until more research is conducted, it's impossible to say whether other
formulations or types of hormones will carry the same risks.
Some of that research is already under way. In August 2003, for instance,
the Million Women Study, a large observational survey investigating the link
between hormone use and breast cancer, confirmed the results of the WHI but
also looked at which kinds of HT are associated with the greatest risk. In
that study, women taking combinations of estrogen and progestin had four
times as many breast cancers as those using estrogen alone. The study found
that for every 10,000 women taking estrogen for 10 years, there would be
five extra breast cancers; for those using combined HT, there would be 19.
The results were similar for estrogen and progestin combinations in pills
and patches, when taken daily or in cycles, and at higher and lower doses.
The researchers also found that the increased risk falls to that of nonusers
five years after HT is stopped.
In another small study, French researchers found that women who took
estrogen pills were more likely to develop blood clots in the legs than
those who used an estrogen patch. One reason may be that pills are broken
down in the liver, where proteins involved in the formation of blood clots
are activated. The estrogen in skin patches is released directly into the
bloodstream, bypassing the liver completely.
Your best bet, regardless of the type or dosage of HT you use, is simply
to be aware of the increased risks found in the WHI trial and, until we know
more about your particular regimen, to factor those risks into your
Is it safe to take hormones for the treatment of
hot flashes and night sweats?
If you have hot flashes, night sweats, sleep disruptions or other
symptoms, the Task Force found that HT and ET still are the most effective
therapies, reducing hot flashes by up to 90 percent. In fact, for severe hot
flashes, nothing works better. Numerous studies have shown that, in addition
to oral estrogens, transdermal estrogen patches effectively alleviate hot
For the majority of women, hot flashes dissipate on their own within an
average of four years. If you have mild to moderate hot flashes, a number of
lifestyle changes can help you cope, such as wearing layers of light
clothing, setting the thermostat to a lower temperature and avoiding spicy
foods and caffeinated beverages and alcohol, which may help reduce the
severity of hot flashes. Relaxation exercises or biofeedback may also help
control temperature fluctuations.
If those or other measures don't work or if symptoms are severe and you
have no family or personal history of blood clots, premature cardiovascular
disease, or breast cancer, talk to your doctor about using hormones.
If you do use estrogen alone or with progestin for relief of hot flashes,
the Task Force recommends that you use the lowest effective dose for the
shortest possible time. Be sure to reassess your need for hormones with your
doctor at least on an annual basis.
Can hormone therapy improve my sex life?
It depends. If the chief complaint is painful intercourse as a result of
vaginal dryness, then the answer may be yes. When estrogen levels fall after
menopause, vaginal lubrication is diminished and vaginal tissues may become
dry and irritated, especially during and right after intercourse. Vaginal
estrogen creams, the vaginal estrogen ring, and even low doses of estrogen
in the form of pills or patches can help relieve vaginal dryness and improve
lubrication. It doesn't take much estrogen to do this, either, so the risks
associated with the use of hormone therapy can be minimized. Still, many
women find that over-the-counter vaginal lubricants and moisturizers work
just as well.
Although vaginal dryness is one of the most common contributors to a
decline in sexual activity after menopause, it is by no means the only one.
In fact, sexual problems are complex issues that may stem from any number of
physical, emotional and social factors. In a woman, physical changes,
including a decline in estrogen and testosterone (yes, even women produce
small amounts of this 'male' hormone) can contribute to the problem, as can
emotional conflict, certain drugs, and depression.
Sometimes, the discomforts of menopause, such as hot flashes, night
sweats, sleep problems, and irritability, can contribute to sexual problems.
But so far, there's little evidence to support the use of systemic hormone
therapy (pills, patches) to improve sexual libido.
Some research has suggested that women who have had their ovaries
surgically removed may benefit from high dose transdermal androgen in
addition to estrogen. But androgen can raise harmful blood lipids, which may
increase a woman's risk of heart disease.
The Task Force concluded that, at this time, there are too few studies in
the scientific literature to say that the use of estrogen or androgen
improves sex drive in postmenopausal women.
What about urinary incontinence?
There's no evidence to support treating urinary incontinence with
estrogen. In fact, some studies suggest that hormone therapy may actually
contribute to a worsening of symptoms in some women.
Can hormone therapy lift depression?
The majority of women do not develop depression during menopause,
although some studies do suggest that perimenopausal women may be somewhat
more susceptible to depressive symptoms during this biologically tumultuous
Before beginning any medication for depression, you should undergo a
thorough physical evaluation, including a check for thyroid problems, which
can often mimic depressive symptoms. Although a couple of small studies have
found estrogen to have antidepressive effects in perimenopausal women, the
Task Force recommends trying antidepressant medications first. Selective
serotonin re-uptake inhibitors (SSRIs), such as Prozac®, Paxil® and Effexor®,
have the added benefit of helping to relieve hot flashes. If you don't want
to or can't take antidepressants, talk with your doctor about trying
estrogen for mild to moderate depression, particularly if you also suffer
from hot flashes or other symptoms of menopause. Short-term use of HT or ET
may facilitate the action of antidepressants in some women.
I'm at high risk for osteoporosis. Can I
continue on HT?
If you are also taking HT for treatment of menopausal symptoms, it may be
appropriate. If you are taking HT solely for the prevention of osteoporosis,
consider stopping it, because there are other medications that can help
prevent osteoporosis and fractures that appear to carry lower risks for
conditions such as breast cancer.
Other preventive drug therapies include the family of drugs known as
bisphosphonates, which can reduce the breakdown of bone. Still other options
are the selective estrogen receptor modulators, or SERMs, which are a new
class of synthetic estrogens that act like estrogen in certain parts of the
body (such as the bone) while leaving other body tissues unaffected. Studies
have shown that some SERMs may actually protect against breast cancer.
Some women with heartburn or ulcer problems may be unable to take
bisphosphonates, and each of the medications discussed here has its own side
effects. Although these medications appear to have a different ratio of
benefits to risks compared to HT, it's not clear yet whether they're better.
Studies are continuing to investigate the effects of these drugs.
To protect their bones, all peri- and postmenopausal women should be sure
to consume 1,200 to 1,500 milligrams of calcium per day, a multi-vitamin
containing vitamin D, and engage in regular weight-bearing exercise such as
So, if I'm taking HT just to protect against
heart disease, should I stop?
Yes. The WHI did not show any benefit to the heart. Lifestyle changes can
help prevent heart disease - particularly regular exercise, smoking
cessation and weight control. And, for certain women at high risk for heart
disease, other medications have been shown to be effective. Medications such
as statins can help reduce high cholesterol levels, and hypertension
medications can help reduce high blood pressure. You'll want to discuss with
your doctor the specific type of medication that may be right for you, along
with any risks and side effects associated with those drugs.
Does hormone therapy prevent Alzheimer's disease
and other types of dementia?
The ACOG Task Force on Hormone Therapy found no evidence that hormone
therapy prevents cognitive decline in older women. Nor does it appear to
improve cognition in women who already have Alzheimer's disease or other
forms of dementia. However, more research needs to be conducted to determine
whether the age at which a woman begins taking hormones has any bearing on
Is it true that women who take hormones gain
No. The Task Force found no evidence that using hormones leads to weight
gain. The cause is more likely to be associated with your diet and activity
level than with hormone therapy.
The weight gain that occurs during this time in a woman's life appears to
be related to aging, not menopause or HT. In one three-year study involving
485 women ranging in age from 42 to 50, researchers found the women gained
an average of about 5 pounds. This weight gain occurred even among women who
did not experience menopause during the study period.
As you grow older, your body's metabolism (the rate at which you burn
calories) declines. When combined with a lower activity level, the result is
added pounds. What's more, when you gain weight in the middle and later
years, it's more likely to accumulate around your abdomen, rather than the
hips and thighs. Abdominal weight is associated with a greater risk of heart
disease, high blood pressure and diabetes.
The good news is that you can help stave off so-called middle-aged spread
with a sensible low-fat diet and plenty of physical activity (a minimum of
30 minutes of activity, such as brisk walking, on most days of the week).
I have Type 2 diabetes. Will hormone therapy
interfere with my ability to control my blood sugar?
No. According to the Task Force, long-term control of blood sugar in
women with Type 2 diabetes doesn't appear to be adversely affected by
hormone therapy. In fact, women who use HT have been found to have a lower
risk of Type 2 diabetes than women who don't take hormones.
If you have diabetes and choose to use hormone therapy to relieve hot
flashes and other symptoms, you need to be aware of the slightly increased
risk of heart disease and stroke associated with its use, since you already
face an elevated risk of cardiovascular disease by virtue of having
Does hormone therapy increase the risk of
developing ovarian cancer?
The Task Force concluded that hormone therapy doesn't appear to increase
the risk of developing ovarian cancer. Although a few observational studies
suggest the risk may be increased after 10 years of use, other studies found
no such association.
Since the WHI found that hormone therapy reduces
the risk of colon cancer, should I take hormones to prevent colon cancer?
No. Although a number of studies have associated hormone therapy use with
a decreased risk of colon cancer, the Task Force does not recommend its use
to prevent colon cancer.
How does my family health history factor into my
Since many chronic conditions, such as heart disease and certain cancers,
appear to have hereditary links, it's crucial that you and your doctor
factor any potential hereditary health problems into your decision to use
hormones. If you have a family or personal history of heart disease, stroke,
blood clots, or breast cancer, you'll need to carefully consider those risk
factors when making a decision to use HT. If, on the other hand, you have a
family history of osteoporosis or colon cancer along with severe menopausal
symptoms, HT or ET may provide added protection while you use it for
short-term relief of your symptoms. But hormones should not be taken just
for these benefits.
Is a woman ever too young or too old to use
Unfortunately, there are no good studies to answer this question
definitively. If you're perimenopausal (you're still menstruating) and are
experiencing mood swings, insomnia, and even hot flashes, you may find
temporary relief with low-dose oral contraceptives or a low-dose estrogen
patch, as long as you don't smoke. Risks appear to be relatively low,
possibly because your body is still producing its own estrogen and
progestin. (Cigarette smoking greatly increases the cardiovascular risks
among cigarette smokers who are over 35 and who use birth control pills or
After menopause (when you haven't had a period for at least 12 months),
ET or HT can help extinguish hot flashes and relieve vaginal dryness. In
fact, estrogen is the single most effective treatment for hot flashes. It's
not understood why some women have mild menopausal symptoms for only a short
time, while others have severe symptoms for years at a time. If you're in
the latter group, just remember that your natural risks for conditions such
as breast cancer and heart disease rise as you age. You'll want to keep that
in mind as you assess the benefits and risks of HT for an older woman.
If you're past menopause and are no longer having hot flashes or other
symptoms of menopause, the WHI clearly shows that there really aren't many
good reasons to continue taking hormones. But there appear to be several
convincing reasons (slightly increased risks of heart disease, stroke, blood
clots and breast cancer) to stop.
If ET is safer than HT, why can't all women just
use estrogen alone?
If you have a uterus, the added progestin protects against an increased
risk of endometrial cancer that occurs when taking estrogen alone.
It's also not clear that progestin is the sole factor that affected
breast cancer risk among the women in the WHI who took HT instead of ET.
Women who used estrogen alone had had a hysterectomy. They also were more
likely to have high blood pressure and be overweight than the women who took
HT. Any one of those differences might also have affected the study outcome.
What other risks and side effects are associated
with hormone therapy?
About 10 percent of all women who take HT experience breast tenderness,
fluid retention and pelvic cramping. Those who take progestin along with
estrogen occasionally may have periodic bleeding similar to menstruation.
Some women who are prone to migraine headaches find they develop more
headaches when using hormones, but others have fewer headaches when taking
Another long-term complication is a slightly increased risk of
gallbladder problems. If you experience any problems, talk to your ob/gyn.
Often, the form of HT or the dosage of your medication can be changed to
alleviate any side effects.
What else is available for relief from hot
flashes if I can't or don't want to take hormones?
Other medications that have been found to help relieve hot flashes are a
class of antidepressant medications known as selective-serotonin re-uptake
inhibitors, or SSRIs (Prozacâ, Paxilâ, Effexorâ).
What about alternative therapies, such as black
cohosh or phytoestrogens?
The Task Force found that few nutritional supplements have been
rigorously studied and tested for safety and effectiveness. Ongoing research
should help shed some light on the subject, but the results from these
studies are still a number of years away. Here's a roundup of some of the
more common over-the-counter remedies that are frequently recommended for
the treatment of menopause, and what researchers now know about them.
Soy Foods, Beverages and Supplements. Soybeans are made up of two
primary components, soy protein and isoflavones, plant chemicals that have
estrogen-like properties. The isoflavones genistein and diadzein
in soy are thought to be responsible for relieving menopause symptoms, such
as hot flashes. But the effectiveness of soy foods and supplements on hot
flashes and other menopause symptoms isn't clear. In one or two studies, soy
protein supplements were found to reduce the incidence of hot flashes by up
to 45 percent. Other reports, however, have found that soy was no more
effective than a placebo.
Soy protein in foods does lower blood cholesterol levels and,
theoretically, may reduce the risk of heart disease. However, some research
suggests that when isoflavones are removed from soy protein and ingested
alone, as they are in soy supplements, they may not be effective for
reducing cholesterol. Ongoing research should help shed some light on the
Soy's effect on bone loss is unclear, too. Women who take soy protein
supplements while they are experiencing menopause and still having menstrual
periods on their own appear to lose bone mass while taking soy supplements.
But there may be a role for soy products in preventing further bone loss
after menopause. Current studies are not entirely consistent. For this
reason, soy is not recommended to help prevent bone loss.
As for safety, more research is needed before scientists know for sure
whether the plant estrogens in soy are safer than prescription estrogens.
But one recent study suggested that the use of soy supplements for up to
five years may possibly increase a woman's risk of endometrial cancer, just
as estrogen does in women with a uterus who don't also take progestin. In a
2004 randomized, placebo-controlled study involving 376 postmenopausal
women, those who took soy phytoestrogen for up to five years had an
increased rate of endometrial hyperplasia - an overgrowth of cells in the
Black Cohosh. This plant, also known as snakeroot, "squaw" root
and bugbane, has been used for centuries in the treatment of women's
reproductive disorders, although no one knows exactly how - or even if - it
works. For the past 40 years, black cohosh has been prescribed in Germany
where it is regulated and used by women for hot flashes, depression, and
sleep disturbances common during perimenopause.
Because no large, controlled studies of black cohosh have yet been
conducted, no recommended doses have been established, nor have specific
claims been allowed regarding the herb's effectiveness. Black cohosh does
not appear to have any effect on bone density or cardiovascular health. Some
researchers recommend that you limit its use to six months.
Topical Progesterone, Testosterone and other 'Natural' Hormones.
These topical creams are sold in health food stores and via the Internet as
an alternative to synthetic forms of progesterone (progestins) and
testosterone (also known as androgen), amid claims that these products can
build bone, increase sexual desire, prevent endometrial and breast cancer,
and substitute for hormone therapy.
At this point, no formal studies have been conducted to determine the
safety and/or effectiveness of these products. Many so-called 'natural'
progesterone creams do not contain substances that the human body can use as
progesterone. These products are often derived from wild yam extracts and
contain a substance, diosgenin, that only plants can metabolize into active
progesterone. Other such products contain these plant extracts plus
chemically synthesized progesterone, which is added to the plant extract in
the cream. It is not always possible for a woman to tell exactly how much
progesterone is available to her body by using these creams. And there's no
evidence to date that progesterone creams can prevent the over-stimulation
of the uterine lining by estrogen or reduce the risk of endometrial cancer.
There's even less information about the safety and effectiveness of
testosterone creams, which have been studied only in men.
The bottom line: The Task Force's review of studies to date has found no
evidence that treatment with alternative therapies, such as wild yam
extract, black cohosh, or dietary phytoestrogen supplements derived from red
clover extracts has any significant effect on hot flashes.
If you decide to use alternative therapies, be sure to tell your
physician. Some treatments have the potential to cause drug interactions
with other medications you are using. Your doctor may recommend that you be
monitored more closely for safety's sake while using alternative or
complementary therapies. Remember, too, that dietary supplements, including
herbal products, are not as strictly regulated by the federal government as
are prescription and over-the-counter drugs. As a result, potency may vary
from product to product, or even from batch to batch of the same product.
Bear in mind that just because alternative therapies are referred to as
'natural' remedies doesn't mean they're without risks or side effects. For
this reason, you should take the same care when using alternative
supplements or products as you would when using any over-the-counter or
prescription medication. Be sure to inform your physician that you are using
these therapies, as well as any prescription medications, during medical
I've been taking hormones to treat hot flashes
for the past two years. How long is "too long?"
Again, there are no good studies to tell us precisely what constitutes
safe short-term use. In the past, hormone therapy of five years or less was
believed to be associated with little or no risk. However, the WHI study
found an increase in the incidence of blood clots and stroke during the
first year of use, and a rise in the diagnosis of breast cancer after 4
years, suggesting that even the first four years of use may not be
risk-free. The estrogen-only arm did not show an increased risk for breast
cancer after nearly seven years, but did find similar small increases in
blood clots and stroke after just one or two years' use.
Keep in mind that the risks are low. If you don't already have a
hereditary risk of blood clots, strokes, heart disease or breast cancer, you
and your doctor may decide that the slightly elevated risks associated with
the use of hormone therapy are perfectly acceptable to you when you factor
in the relief you get from hot flashes. Again, you'll also want to reassess
on an annual basis whether you still need relief for hot flashes.
What do I do when I'm ready to stop taking
So far, there aren't many good studies to guide you. You and your
physician will have to discuss whether it's better for you to go "cold
turkey" and simply stop taking hormones one day, or whether you might
benefit from a more gradual approach.
Not all women can comfortably quit using hormone therapy. Some women
experience heavy vaginal bleeding for several days after they stop taking
hormones. Hot flashes and other menopausal symptoms may return, too,
especially if you stop abruptly. A recent survey of patients from the
Northern California Kaiser Permanente group suggests that one in four women
who stopped using hormone therapy following the publication of the WHI
results have re-initiated therapy because of persistent bothersome symptoms.
If you experience any of these problems, talk with your doctor about how
you might taper off the dosage over time.
If I stop taking hormone therapy, will the
elevated risks associated with its use go down?
There's no evidence to suggest that the slightly increased risks
associated with using hormones - blood clots, strokes, heart attacks and
breast cancer - remain elevated after you stop taking hormones. In fact,
observational studies suggest that these risks do decline after you stop
taking hormones. WHI researchers are monitoring their study participants to
answer this question definitively.
Making a Decision
Only you, working together with your physician, can decide whether the
benefits of using HT for relief of menopause symptoms are worth the small
risks that have been identified. Start with a thorough medical evaluation to
assess your current health status. You'll also want to learn as much as you
can about the options available to you. This way, the choices you make will
be informed ones, tailored to your individual needs.
If you do choose HT, the Task Force recommends that you use the smallest
effective dose for the shortest time you can, and that you see your doctor
at least once a year to discuss whether you are ready to stop, and what new
information may be available that might influence your decision to stop or
continue using hormones. Of course, you'll want to continue to get regular
breast cancer screenings, including annual physician breast exams and
periodic mammograms (which ACOG recommends every one to two years during
your forties, and annually thereafter).
As with most issues concerning your health, the decision to use hormones
is a very personal one that rests with you. Just make sure it's a
well-informed one with which you feel comfortable.
An Important Note: Research Continues, Recommendations May Change
ACOG's statements here are for general information purposes and should
not be construed as medical advice. Before making a decision about HT,
consult with your physician for individualized advice that takes into
account your personal needs and your medical and family history.
# # #
The American College of Obstetricians and Gynecologists is the national
medical organization representing over 47,000 members who provide health
care for women.
Copyright © October 2004, The American College of
Obstetricians and Gynecologists, 409 12th Street, SW, Washington, DC