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Dear Patient:
It is
understandable if you are confused or concerned regarding the recent
news reports regarding Hormone Replacement Therapy (HRT). These
reports are about a study done on a very particular type of estrogen
and progesterone combination known as Prempro. The study was
conducted by the Women’s Health Initiative of the National
Institutes of Health. As your physician I want t6o do what is best
for you. The topic of hormone replacement therapy is not simple or
black and white. Treatment decisions must be individualized for each
woman, depending on family health history, personal health history,
lifestyle and personal belief systems and preferences. New research
is being done each day that will undoubtedly change the known risks
and benefits of this therapy. Below is a summary sheet of this
newest research. We encourage you to be an active participant in
your health maintenance.
Below are important
points for you to consider:
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If you are
taking the particular daily hormone replacement therapy known as
Prempro purely as a preventive measure against heart disease, it
is recommended you stop taking the drug gradually. This particular
study showed Prempro increases the risk of heart disease, blood
clots in your lungs or large veins, and stroke after long-term
use. Please contact me or another physician for an appointment to
discuss other methods of prevention (such as lifestyle changes) of
heart disease.
-
If you are
taking Prempro as a preventive measure for osteoporosis, it may be
time to reevaluate your options. Your current health, health
history, family health history, and lifestyle all must be
considered in making your decision. You should consult with me or
another physician and weigh the benefits against your personal
risks for heart attack, stroke, blood clots, and breast cancer.
Alternate treatments also are available to help prevent
osteoporosis and fractures.
-
As always, you
should keep up with your regular schedule of breast
self-examinations and mammograms.
-
If you are
taking Prempro for relief of the symptoms of menopause, whether or
not to continue the medication is a person decision you must make
with the information available to you. You must weigh the benefits
against the risks. Your specific health risks as well as the
degree this medication benefits your quality of life must be taken
into account.
-
If you do wish
to continue with Prempro, you really need to schedule an
appointment with me or another physician. You need to discuss the
options that are available to you.
-
This particular
study reminds us there is no magic pill for health benefits and
that the flied of medicine is constantly changing. A healthy diet,
lifestyle and regular exercise are some of the things known to be
helpful for your good health and in general, do not have bad side
effects.
As you can imagine,
the media coverage of this study has increased the number of calls
to our office dramatically. We appreciate your patients during this
time.
Sincerely,
Randy A. Birken, MD
Recent Prempro Study Facts
The Study
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Over 16,600
healthy menopausal women ages 50 – 79 participated in a study
-
The federal
government, rather than a company that may stand to gain from good
results, conducted the study.
-
The study
specifically involved the trail of only one type of hormone
replacement therapy that combines 0.625 mg conjugated estrogens
plus 2.5 mg medroxyprogesterone acetate daily. This
combination is sold in one form as a medication called Prempro.
Different doses and combinations are available and my have
different risks and benefits.
-
The researchers
ended the trail 5.2 years into the anticipated 8-year study to
protect the participants.
-
The study of
Prempro was halted, but the study on estrogen-only was not halted
and is ongoing.
-
The study was
not designed to look at the short –term benefits for menopausal
symptoms but long-term use of Prempro.
The Risks Identified
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The study
suggests that Prempro raises the risk of developing breast cancer.
-
The results of
the study show that Prempro does not protect against heart disease
as was previously thought. In fact, it probably increases the risk
of heart disease.
-
The trial of
Prempro indicates small increases also in the risk of stroke and
clots in deep veins and the lungs.
-
The data
indicate that if 10,000 women take Prempro for more than 5 years,
then in any one particular year, 8 more women will develop breast
cancer, 7 more will have a heart problem, 8 more will have a
stroke, and 8 more will have blood clots in the lungs, as compared
to 10,000 women who are not taking any Estrogen replacement
therapy.
The Benefits Identified
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The Prempro
study showed benefits including reduced rates of hip fractures
(due to osteoporosis) and reduced rates of colon cancer.
-
Prempro may
still be appropriate for short-term use to ease menopause
symptoms.
-
Prempro still
remains an effective treatment for menopause symptoms such as
night sweats, hot flashes, and mood swings in women who are
menopausal and have not undergone hysterectomy.
Your Response
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Even if you have
been taking Prempro for a long period of time, do not panic. Call
and discuss hormone replacement therapy with your physician.
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A decision to
take or quit using Prempro is a decision each woman should make
with education and input from her physician. Consideration should
include individual health, preferences, family history, and
possible alternatives.
Information
gathered from The American College of Obstetricians and
Gynecologists
ACOG News Release
July 9, 2002
The information
contained in this information regarding HRT and in our online site
is solely intended to provide broad consumer understanding and
knowledge of health care topics. This service is for educational
purposes only and should in no way be taken to be the provision or
practice of medical, nursing or professional healthcare advice or
services. The information should not be considered complete and
should not be used in place of a visit, call, consultation or advice
of your physician or other health care provider. The information
obtained from GYNFO.COM is not exhaustive and does not cover all
diseases, ailments, physical conditions or their treatments. Should
you have any health care-related questions, please call or see your
physician or other health care provider promptly.
Dr. Birken would like to take
this opportunity to respond to the Houston Chronicle Article dated
July 10, 2002 on Prempro. This article can be viewed at "Click for
more information" below.
Understanding the Issues from the Recently Released
Study Information Regarding Hormone Replacement Therapy
The National Heart, Lung, and Blood Institute
of the National Institutes of Health stopped a major clinical trial
on the risks and benefits of combination hormone therapy (estrogen
and progestin) in healthy menopausal women due to an increased risk
of invasive breast cancer.
The trial, part of the Women’s Health Initiative (WHI), also found a
small increase in coronary artery disease, stroke, and pulmonary
embolism.
The investigators reported a decrease rate of both hip fractures and
colon cancers in the study group.
It is important to note that no increase in breast cancer was found
among those women who were taking estrogen alone without the
addition of progestin.
Here is another way of interpreting the results:
If 10,000 women taking the combined hormone therapy for one year
were compared to 10,000 not taking HRT, you would see:
8 more cases of invasive breast cancer
7 more cases of heart attacks
8 more cases of stroke
8 more cases of blood clots in the lungs
6 less cases of colorectal cancer
5 less cases of hip fracture
The increased breast cancer risk did not appear in the first four
years of HRT, risks for blood clots were greatest in the first two
years of use, and the reduced risk of colorectal cancer was seen
after three years of hormone use.
An American College of Obstetricians and Gynecologists Task Force
will decide on clinical recommendations within the near future.
Until then, my patients have the following options based on these
clinical scenarios:
For those patients taking Prempro 2.5 or Prempro 5:
1. May stop this HRT without a need for tapering the medication
2. Switch to another estrogen/progestin (although we have no
clinical data on these hormones exist at this time)
3. Stop HRT and switch to soy/black cohosh herbal product
4. Stop HRT and continue to eat nutritional well, exercise, and take
Calcium 1200-1500 mg./day with Vitamin D 400 I.U./day
For those patients taking another estrogen/progestin product:
1. Continue on this product until further data is available
2. Stop this product without tapering the medication
3. Switch to a soy/black cohosh product
4. Continue with good nutrition, exercise, and calcium and vitamin D
For those patients taking estrogen only:
1. Continue on ERT until further data is available
2. Stop ERT without tapering the medication
3. Switch to a soy/black cohosh product
4. Continue with good nutrition, exercise, and calcium and vitamin D
For those patients who have been on HRT or ERT less than four years:
1. Continue on this product and stop at four years
2. Stop the product without tapering the medication
3. Switch to a soy/black cohosh product
4. Continue with good nutrition, exercise, and calcium and vitamin D
Remember, no conclusive studies have shown that an herbal product
such as soy/black cohosh gives one the assumed benefits of HRT
without the risk. Some patients have experienced less hot flashes
and night sweats when on these products. Please choose products that
are from a reputable source. If you like, there is a link on my home
page on Vitamins and Herbs that will take you to Rexall/Unicity, a
company that produces excellent products. Look up either Meno-basics
or Meno-Essentials and read about these products before purchasing
them.
Every patient must be managed on an individual basis since every
patient is unique. If you have further questions or concerns, please
call the office to schedule a consultation with me. And please
remember, don’t panic! These new findings must be analyzed and
interpreted by experts before specific guidelines are available to
our patients!
The information contained in this information regarding HRT and in
our online site is solely intended to provide broad consumer
understanding and knowledge of health care topics. This service is
for educational purposes only and should in no way be taken to be
the provision or practice of medical, nursing or professional
healthcare advice or services. The information should not be
considered complete and should not be used in place of a visit,
call, consultation or advice of your physician or other health care
provider. The information obtained from GYNFO.COM is not exhaustive
and does not cover all diseases, ailments, physical conditions or
their treatments. Should you have any health care-related questions,
please call or see your physician or other health care provider
promptly.
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