Hormone Therapy (HT) Concepts by MedicineNet.com

Doctor’s Archive

Medical Author: Carolyn J. Crandall, MD,
MS, FACP

Medical Editor: William C. Shiel, Jr., MD, FACP, FACR

Well women, here we go again…Estrogen Therapy (ET) Confusion!

July 2002 brought a confusing mass of media reports for
the public and the physicians, owing to publication of the results of the
Women’s Health
Initiative” (WHI).

First of all, it’s interesting to notice what we ALREADY knew before the
recent, highly publicized Women’s Health Initiative:

  1. Hormone
    therapy (HT) probably does not protect against heart disease or
    stroke, contrary to what many researchers used to think several years ago.
  2. Hormone therapy (HT) probably does protect
    against colon cancer and hip fractures, but scientists were not really
    positive prior to WHI.
  3. Hormone therapy (HT), particular Estrogen/Progesterone Therapy (EPT), over the longer term
    probably increased the risk of
    breast cancer (but only after 5 years
    of continuous treatment), and the progesterone that is used with estrogen is
    probably bad for the breast
    also.
  4. Hormone therapy (HT) increases the risk of vein clots in the legs and
    lungs.

If we already suspected these facts, then why did we need
the Women’s Health Initiative? Because the Women’s Health Initiative (WHI) was
the first study ever strictly designed to empirically (factually) show the
effects of hormone therapy (HT) on the heart, colon, breast, and bone. To date, no single study had ever been done on
these topics in a reliable fashion. In addition, the hormones in the study were
conjugated equine estrogens (CEE,
otherwise known as Premarin, 0.625mg daily) and medroxyprogesterone acetate
(MPA, otherwise known as Provera, 2.5mg daily),
thus the results would apply to many women in the U.S. who use this common
combination of hormones.




Menopause & Perimenopause: Symptoms, Signs


Furthermore, the study compared the hormones to an
identical looking placebo (sugar pill),
so that neither the participants nor the researchers knew which women were
taking the estrogen therapy (ET) pills, or the placebo pills (double blind study). This type of
study lends strength to the reliability and results of the study. Finally, the
study involved a very large number of women (16,608), which also lends
credibility to the results. The study included 16,608 menopausal women aged
50-79 years and was meant to continue for 8.5 years, but instead it was halted
after only 5.2 years because the overall health risks of CEE/MPA (Premarin,
0.625mg/Provera, 2.5 mg daily) of breast cancer appeared to
exceed the possible health benefits.

Here is what we now know, from the results of the WHI:

  • Colon cancer: The WHI showed that colon cancer is
    probably prevented by estrogen/progesterone therapy (EPT), but maybe not by
    estrogen therapy , in otherwise healthy women.
  • Hip fracture: The WHI was the first study that conclusively showed that
    estrogen therapy 
    (CEE alone) and estrogen/progesterone therapy  (combined CEE/MPA) each protect against osteoporotic
    fractures in generally healthy women. Both estrogen therapy  and
    estrogen/progesterone therapy  appear to decrease the
    risk of hip fracture and vertebral (spine) fracture. In WHI, CEE/MPA therapy
    decreased the risk of hip fracture by about 30% and decreased total risk of
    fracture (all types combined) by about 25%. Hip and vertebral fracture risks
    were each reduced about 40% in the women taking CEE alone in WHI. For more,
    see the review of osteoporosis.
  • Breast cancer: The WHI also confirmed what we already
    suspected, that use of estrogen/progesterone therapy  (combined CEE/MPA), but not
    estrogen therapy  (CEE alone)
    increases the risk of breast cancer. As was already suspected, the increased
    risk of breast cancer with estrogen/progesterone therapy  was only noted after about 4-5 years of use.
  • Heart disease: In WHI, estrogen/progesterone therapy  raised the risk of coronary
    heart disease, whereas estrogen therapy  probably did not noticeably affect coronary heart
    disease risk compared to a placebo pill.
  • Stroke: In WHI, estrogen/progesterone therapy  (CEE/MPA) appeared to be
    associated with increased risk of stroke, whereas estrogen therapy  (CEE alone) may
    not have
    noticeably increased stroke risk.
  • Blood clots in the lungs (pulmonary emboli) and leg
    veins (deep vein thrombosis or
    DVT
    ):
    Blood clots in the lungs and blood clots
    in the leg veins were each noted more frequently in both the estrogen therapy  (CEE alone)
    and estrogen/progesterone therapy  (CEE/MPA) groups, although
    estrogen/progesterone therapy  use seemed to be more strongly linked
    with increased risk than estrogen therapy  use.
  • Uterine cancer: CEE/MPA combination therapy did not
    increase the risk of uterine cancer (which is proof that the progesterone MPA
    was doing it’s job of protecting the uterus from the potential harm of
    estrogen). It did not alter the general overall risk for cancer as a whole. It
    did not alter the risk of death due to other causes.


There are 2 ways to think about decision-making regarding
hormone therapy (HT). In general terms, we can group the “good things” together and the “bad
things” together and compare them. The way scientists do this is to multiply the
numbers of women by the number of years that they are taking the hormone
therapy. This measure is called “person-years”. In the WHI, the numbers of
expected good things (protection against colorectal cancer and hip fracture, were less than the
number of expected bad things (heart disease, stroke, blood clots in the lungs,
and breast cancer) – specifically, 11 extra “good things” as compared to 31 extra
“bad things” per 10,000 person-years for the women taking estrogen/progesterone
therapy compared to taking
placebo. For the women taking estrogen therapy, the corresponding numbers are 18 extra “good
things” and 15 extra “bad things”. Each individual woman will have a different
opinion about whether the 31 extra “bad things” per 10,000 women taking
estrogen/progesterone therapy for
a year is enough to make her avoid hormone therapy. Because of this, the
decision whether to initiate hormone therapy is a highly personal decision.

If this is too confusing, consider the following seven possible scenarios:

  1. A woman just recently becomes menopausal. She had her last menstrual
    period a year ago and is began taking CEE/MPA due to bothersome hot flashes.
    What should she do with the CEE/MPA she is taking?

If she is at otherwise low risk for stroke, heart
disease, or blood clots (which she will determine with her physician), she can
consider continuing her CEE/MPA to control her hot flashes. Although this is a highly personal decision,
the otherwise healthy woman who takes the hormone therapy for a short-term
period (fewer than 4 or 5 years) to relieve hot flashes is in fact currently the
best candidate for hormone therapy. The “risk and benefit” is likely to be in
her favor because she is otherwise healthy, she will only use the hormone
therapy for a short period, and hormone therapy is an the most effective therapy (the only
FDA-approved therapy) for reducing hot flashes.

  1. A woman has been taking hormone therapy for 2 years due to hot flashes,
    but a different hormone preparation, not CEE/MPA. She wants to know how to
    apply the results of the WHI in her own case.

The WHI did not include any preparation other than
CEE/MPA. Therefore, we cannot make firm conclusions. It is probably reasonable
to say that similar overall risks and benefits apply as in the woman in example
1 above. Again, each women has to carefully consider her individual health
profile and balance of risk versus benefit, optimally with her physician. If her
overall health is good (no particular risk of heart disease, stroke, blood
clots, or breast cancer prior to starting therapy); if she is going to use the
therapy for only a few years; and if her hot flashes are bothersome enough that
she wants to take therapy; she can reasonably opt to continue the therapy with
an generally low risk of complication. Again, as mentioned above, each individual woman has to
decide what level is increased risk is “acceptable.”

  1. A woman has been taking hormone therapy for 8 years.
    She feels great and is afraid of stopping because her mother has terrible osteoporosis. She
    needs to know what to do about her family history of osteoporosis. Her
    mother had a hip fracture.





This answer is relatively clear and established even before the WHI results:
A logical plan is to check bone density results. If the woman has low bone
density, or has already experienced an osteoporosis-related fracture, there are
other non-hormone options for her bones that she can try. If she does not have
low bone density, she can just continue bone monitoring at appropriate
intervals.

  1. A woman has been taking hormone therapy for 8 years because she was
    already found to have osteoporosis when she was 58 years old.

In this case, she wouldn’t need to have a bone density
test because we already know she has osteoporosis. She needs to consider and
discuss with her physician the possibility of switching to a non-hormone
osteoporosis medication.
The irony is that the WHI actually did show us for the first time ever,
conclusive proof that hormone therapy prevents osteoporosis fractures; however,
the problem is the balance of risk and benefit would lead us to avoid long-term
hormone therapy because of the possible risks of breast cancer, heart disease
and vein clots, and because there are safer non-hormonal options available.

  1. A woman has been taking hormone therapy for 8 years. Several 1st
    degree relatives had heart attacks at an early age. She has never had any heart
    trouble herself, and she does not have hot flashes.

Although we used to think hormone therapy reduced heart disease risk,
we recently began to realize (even before WHI) that hormone therapy (either
estrogen therapy or estrogen/progesterone therapy) does
not prevent heart disease, and indeed may actually increase coronary heart
disease risk in otherwise healthy women, i.e., women who are not taking hormone
therapy to
reduce hot flashes. Neither estrogen/progesterone therapy nor estrogen therapy should be used primarily for protection
from, or therapy of, coronary heart disease. The WHI results provided additional
sound proof for this recommendation. The woman with a strong family history of
coronary heart disease should generally be recommended to avoid hormone therapy for any
purpose.

  1. A woman was diagnosed with a heart attack about 9
    years ago. Two years after her heart attack her doctor recommended CEE/MPA due to her
    osteoporosis, and because at the time her physician felt it might prevent
    recurrence of heart events in the future. What should she do?

The WHI did not specifically address the effects of hormone therapy
on heart disease in women who already had heart disease. However, pre-WHI
studies specifically carried out in women with known heart disease had already
provided unequivocal proof that hormone therapy does not protect against, and may actually
increase risk of, heart disease recurrence in women who already have coronary
heart disease. Neither CEE/MPA nor CEE alone should be continued long-term for
the purpose of treating heart disease. In this case, The hormones may actually
be increasing her cardiac risk, and possibly increasing breast cancer risk.
Most experts would recommend that she stop
the hormone therapy. Again, the irony is that the hormone therapy was probably doing a
good job at preventing her from osteoporosis-related fractures, as proven by
the WHI. A different osteoporosis medication would have to be substituted in
place of the hormone therapy.

Summary

How should a woman stop
hormone therapy? There is not a strict guideline, nor is there any reliable
clinical study, telling physicians how to discontinue hormone therapy, however, it is clear
that many woman have temporary unpleasant symptoms with stopping the hormones
suddenly. Most menopause experts currently
recommend that women “taper” or “wean” hormone therapy.

Each woman will have to continue speaking with her physician face-to-face in
a calm and thoughtful way, so she can make the decision that is right for her.
Different women will continue to come to different conclusions depending on
their individual circumstances.

It is comforting to have a well-done large and comprehensive research study
available for reference. The WHI was long overdue and necessary. Although the
WHI confirmed many things we had already suspected, its new findings and the
findings of prior studies can help guide womens’ decisions about hormone
therapy. The decisions are difficult and will likely remain difficult for the
next several years.

One more word of caution: It is critical to remember that
people who do not conduct research may report study results accurately, but they
are usually not able to accurately report the quality of a study, or how
a study should fit into the actual day-to-day health of women.
Fortunately, in the case of the WHI, the study was very well performed, but in
general, women would do well to discuss any worries they have regarding media
reports with a caring physician who feels qualified to discuss the quality of
the research. Often a woman will be relieved to know the research may not even
apply to her particular health concerns.

For information about “HT” and “ET,” please read Dr.
Crandall’s Doctor’s View, “HT/ET, Making Sense of It!”




Menopause & Perimenopause: Symptoms, Signs


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