True
confession time again: Just when I thought I had
made peace with the Great Post-Menopausal Hormone
Decision -- in my case, sticking with very low dose
oral hormones, despite the risks revealed in a 2002
study -- I have plunged into the murk again.
This
time, my curiosity and my game plan are focused on
''bioidentical hormones," which are synthesized from
soy and yams. They are made to be very similar to
the hormones your body already produces -- much more
similar, for instance, than the hormones
post-menopausal woman swallowed in pills like
Prempro and Premarin.Proponents argue
that such similarity means bioidentical hormones
won't have the side effects of oral hormones, like
Prempro, which the 2002 study found to modestly
increase the risk of breast cancer, heart disease,
stroke, and, blood clots.
But some
mainstream researchers are leery. Dr. JoAnn Manson,
chief of preventive medicine at Brigham and Women's
Hospital, called the research on bioidentical
hormones ''very, very sparse," and warned that women
should not flock to them.
''We need to be
cautious about not repeating the debacle that
occurred with conventional hormone therapy," said
Manson, a leader in the 2002 research on standard
hormone replacement therapy. In a September
newsletter, doctors from the Mayo Clinic similarly
warned that ''hormones aren't safer or better just
because they're labeled natural or bioidentical."
So why am I even
considering replacing oral hormones with something
''bioidentical"?
Because I like
the way they're delivered. The only way to get a
''bioidentical" substance -- that is, an exact
chemical match to something the body already makes
-- into the system is non-orally, chiefly through
the skin, via patches, creams, lotions, or gels.
Medicines taken orally don't enter the bloodstream
in the same form that you take them because they
pass first through the liver, where their chemical
structure is altered. Medicines taken transdermally
do not pass through the liver en route to the
bloodstream, and hence are not altered.
When a woman
takes oral estradiol, the hormone that declines
precipitously at menopause, it is converted in the
liver to estrone, a weaker hormone, said Dr. Alan
Altman, a menopause specialist in private practice
in Brookline. By contrast, when estradiol is taken
transdermally, it gets right into the bloodstream --
as estradiol.
The transdermal
form appears not to increase certain cardiovascular
risk factors, such as blood clotting proteins,
triglycerides, and C-reactive protein, as oral
estradiol does, hormone specialists say. And, there
may also be another advantage to taking transdermal
estradiol. Research suggests that oral estradiol
reduces the amount of available testosterone and
therefore sex drive, while the transdermal form does
not.
For the moment,
at least, ''non-oral is the way to go," said Dr.
Carolyn Shaak , medical director of WomanWell in
Needham and a longtime proponent of bioidentical
hormones. ''If you want to duplicate the function of
the ovary, you want to use a non-oral delivery
system."
Bioidentical
hormones can either be made by drug companies or --
as proponents prefer -- on a patient-by-patient
basis by a ''compounding" pharmacist, who follows a
doctor's prescription to deliver a precise dose. The
compounded versions, because they're more similar to
the body's own hormones, are safer and more
effective than the hormone pills cooked up by Big
Pharma, proponents insist.
Dr. Steven F.
Hotze, who owns a compounding pharmacy in Houston
and has treated thousands of patients with
bioidentical hormones, has no doubts about the
superiority of these products. His patients, he
said, ''come in on Premarin and [don't feel well].
We put them on bioidentical hormones and they get
well. Hello? Come talk to my patients!"
Compelling words,
to be sure. But there's no hard proof that
compounded hormones, which are not approved by the
US Food and Drug Administration, are safe and
effective.
In late October,
a review committee of the American College of
Obstetricians and Gynecologists found that ''there
is no scientific evidence to support claims of
increased efficacy or safety for individualized
estrogen or progesterone regimens prepared by
compounding pharmacies." The group cited a
government analysis of 29 product samples (not all
of them hormones) from 12 compounding pharmacies; it
found that one-third of the products flunked quality
tests, with many not even containing the proper
amount of the active ingredients.
You don't have to
go to a compounding pharmacy to get many of these
products. There have long been FDA-approved
estradiol patches on the market. And in the last
year or so, one FDA-approved cream (Estrasorb) and
an FDA-approved gel (Estrogel) have also become
available.
There are also
FDA-approved vaginal rings that deliver estradiol,
one called Estring which only combats vaginal
dryness; and another called Femring, which addresses
more menopausal symptoms.
For progesterone,
which women who still have a uterus must take to
offset the risk of uterine cancer from estrogen, a
good solution is a type of progesterone sold as
Prometrium -- which, studies suggest, may carry less
cardiovascular risk than the synthetic progesterone
sold as Provera.
Needless to say,
the growing popularity of non-oral approaches to
hormone replacement is not lost on big drug
companies, some of which make patches and creams.
Wyeth
Pharmaceuticals, which makes the pill Premarin, went
so far as to file a citizens' petition to the FDA in
October to address what a company spokeswoman called
''the growing and unlawful manufacture and marketing
of so-called bioidentical hormone replacement
therapy."
The reaction to
that in the bioidentical world is also no surprise.
As Hotze put it: ''They're putting pressure on the
FDA to drive us little guys out of business. It's a
big monopoly push."
As for me, my
path through the murk is getting clearer. I'm
switching from Premarin to an estrogen patch to keep
feeling good. I could have switched to a compounded
cream, but I feel safer with an FDA-approved
product.
But, as we all
know by now, hormone therapy is a moving target. So
stay tuned!
Judy Foreman is a
freelance columnist who can be contacted at foreman@globe.com.

Note: Picture
courtesy of
Jack Gallagher Ueland Illustration Co.
www.uelandillustration.com
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