Oprah and Bioidentical Hormones: FAQ

Oprah Winfrey says menopause caught her "off guard"
and that she's taking bioidentical hormones that have made a big improvement in
how she feels.

Bioidentical hormones are one form of therapy for menopausal symptoms.
Winfrey, who turns 55 this month, writes in February's edition of O, The
Oprah Magazine that she felt "out of kilter" and had
"issues" for two years that she suspected were hormonal. Upon a
friend's recommendation, Winfrey went to a doctor who specializes in
hormones.

Winfrey writes that the hormone specialist told her that her "hormonal
tank was empty" and gave her a prescription for bioidentical estrogen .

"After one day on bioidentical estrogen, I felt the veil lift,"
Winfrey writes. "After three days, the sky was bluer, my brain was no
longer fuzzy, my memory was sharper. I was literally singing and had a skip in
my step."

Winfrey isn't recommending bioidentical hormones for every menopausal woman.
Instead, she urges women to "take charge of your health" and says it's
time to "start the conversation" about menopause and bioidentical
hormones.

Oprah writes that bioidentical hormone therapy is controversial and
confusing to many people.

What's the controversy about? Are bioidentical hormones better or safer than
other hormone therapy? WebMD has answers from experts.

What Are Bioidentical Hormones?

"There is enormous confusion about the meaning of the term
'bioidentical,'" JoAnn Manson, MD, DrPH, tells WebMD via email.

"Bioidentical hormone preparations are medications that contain hormones that are an exact
chemical match to those made naturally by humans," says Manson, who is
chief of preventive medicine at Brigham and Women's Hospital in Boston and the
Elizabeth F. Brigham Professor of Women's Health at Harvard Medical School.

Some bioidentical hormones are made by drug companies, are approved by the
FDA, and are sold in standard doses. Other bioidentical hormone preparations
are made at special pharmacies called compounding pharmacies, which make the
preparations on a case-by-case basis for each patient. Those
"custom-made" preparations aren't approved by the FDA.

Why Aren't Compounded Bioidentical Hormones FDA approved?

The FDA doesn't approve any compounded products, for any condition, because
those products aren't standardized.

That doesn't mean that compounding is bad. Compounding can be useful for
patients who are allergic to an additive in an FDA-approved product, says
Kathleen Uhl, MD, the FDA's assistant commissioner for women's health.

But "the purpose of compounding is to do it on a patient-by-patient
basis, so there's nothing that's submitted to FDA to evaluate, so they're not
FDA approved," Uhl explains.

And because compounded products don't go through the FDA approval process,
they don't bear the same warnings as other hormone therapy.

A woman who gets a prescription for an FDA-approved hormone therapy for
menopausal symptoms is "going to get a lot of warning information," but
if she gets a compounded product instead, "you don't get any of those
warnings," Uhl says. "There's no requirement for them to provide that
because those products are not FDA approved."

L.D. King, executive director of the International Academy of Compounding
Pharmacists, suggests that patients look for accredited compounding pharmacies
listed on the web site of the Pharmaceutical Compounding Accreditation Board
(PCAB).

"They make sure those accredited pharmacies are adhering to a very high
level of practice, which would include pretty extensive quality control,"
King tells WebMD. He also suggests that because there aren't a lot of
PCAB-accredited compounding pharmacies, patients should ask compounding
pharmacies what types of quality assurance procedures are in place.

Manson points out that with FDA-approved "bioidentical" drugs
available, "mos women interested in bioidentical formulations do not need
to take custom-compounded products (exceptions would be women with allergies to ingredients, or
intolerances to doses, in commercially available products)."

Does That Mean Compounded Bioidentical Hormones Are Safer?

"There is no reason to think that these bioidentical compounded
[products] would have a different safety profile than the FDA-approved
ones," Uhl says. She points out that some compounded pharmacies have gotten
warning letters from the FDA for false and misleading claims about safety and
other benefits.

Isaac Schiff, MD, chief of obstetrics and gynecology at Massachusetts
General Hospital, agrees.

Schiff led an American College of Obstetrics and Gynecology (ACOG) committee
that reviewed the scientific evidence on compounded bioidentical hormone
therapy in 2005. That committee concluded that there wasn't scientific evidence
to support claims of increased efficacy or safety for compounded estrogen or
progesterone regimens. The North American Menopause Society (NAMS) and the
Endocrine Society have issued similar statements.

"It may be safer, but that study hasn't been done yet," Schiff tells
WebMD. He says he would like to see a large, lengthy, rigorously designed study
on the topic.

"I'm not inherently negative about it," Schiff says. "I hope
they'd be good ... and if it turns out to be safer, fabulous. I would like, as
a physician, to prescribe the safest hormones to my patients who want to be
treated."

Erika Schwartz, MD, a New York doctor who prescribes FDA-approved
biodentical hormones and compounded bioidentical hormones, says there have been
studies that support the safety of bioidentical hormones, compared to other
hormone therapy.

Schwartz asks, "If NAMS or ACOG says there are not enough studies, well,
why haven't you done the studies if you think you need more? If this had been
men's health , would we be having
this conversation, or would we have answers?"

Schwartz says she has long wanted to see large, government-sponsored studies
compare bioidentical and other hormone therapies head to head.

"She's allowed to have her opinions," Uhl says. "The evidence
that FDA has seen and what's available in the medical literature leads us to
believe that there are the same concerns" with bioidentical and other
hormone therapy for menopausal symptoms.

Uhl adds that "the FDA is
not prohibiting the compounding of bioidentical hormones. There is
definitely a niche for them and certain patients do need this, but it's not for
everybody, and the people who are taking it need to realize that the risks are
probably the same for the FDA-approved drugs as they are for the [compounded]
bioidentical."

Can You Take Bioidentical Hormones Indefinitely?

Hormone therapy has been linked to increased risk of breast cancer , so most health
experts recommend that women take the lowest dose for the shortest time, if
they need it.

That research wasn't done on bioidentical hormones. But that doesn't
necessarily mean that it's safe to take them for a longer time, Schiff
says.

"If you have the exact same estrogen as one's own body makes, it doesn't
mean it's any safer," says Schiff.

Schwartz counters that bioidentical hormones are chemically different from
the hormone therapy drugs that were linked to health risks, saying "there
is no reason to compare recommendations because they're not the same
product."

Schwartz says she's been prescribing bioidentical hormones for 14 years and
takes them herself, having switched from other hormone therapy years ago.
"I feel great and the women I work with feel great," she says. "I
have no complaints."

Schiff doesn't dismiss bioidentical hormones. "If I have a patient who
says she wants a bioidentical ... then I personally would prescribe a hormone
like estradiol, which is what her ovares made, and I would give it to her in a
skin patch by one of the drug
companies that I know; it has oversight by the FDA and it has the exact dose
that I want her to have," says Schiff, who has no ties to any drug
companies. If a patient is already on a bioidentical hormone, "I try to
find out exactly what she's taking and try to make sure that it's a safe dose
and that she could be followed carefully," Schiff says.

Schwartz says she gives her patients a choice between standardized
bioidentical hormones or compounded products made by a lab she has vetted. She stresses
the importance of doctors being trained about bioidentical hormones by other
physicians who are knowledgeable about bioidenticals. "The physician has to
work with the patient and the compounder," Schwartz says.

Are Saliva and Blood Tests FDA Approved?

Yes, those tests are FDA approved for diagnostic purposes -- but not to
tailor hormone treatment.

"The tests are not approved for use to measure hormone levels to adjust
hormone therapy," says Uhl, who points out that hormone levels can
fluctuate throughout the day.

Schwartz says she doesn't believe saliva testing is appropriate and only
uses blood tests with her patients.

What About Oprah's Experience?

"I'm happy that Oprah feels better," Schiff says. "Every
experience is an important experience ... but everybody's individual and they
have to work that out with their doctor."

Some women, Schiff notes, feel better when they start hormone therapy, but
he's not sure if bioidentical hormone therapy would give them an additional
boost.

Compounded or not, bioidentical hormones are only part of the picture,
Schwartz says.

"A lot of people just want to follow the celebrity," she says.
"Sometimes people come in and what they really need is to address their diet , their exercise , their lifestyle."

"I think bioidentical hormones are great," Schwartz says. "But
if you don't address them in the context of the whole person -- with her diet,
her exercise, her lifestyle, with her relationships , with her stresses
-- and you don't work with everything, you're not really going to be able to
come up with the results that women would like to see."

By Miranda Hitti
Reviewed by Louise Chang
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