Women have quit hormone
therapy in droves since a major study in July declared the pills
far riskier than once thought - but federal scientists seeking to
ease confusion over just who should ever take post-menopausal hormones
acknowledge they have lots of questions still to answer.
One clear recommendation, scientists told a meeting at the National
Institutes of Health on Wednesday, is that women shouldn't start
hormone therapy in hopes of preventing age-related diseases - one
big reason that estrogen-progestin pills were prescribed to some
6 million U.S. women.
"We can't take a pill for the rest of our life to make us young
again. Disappointing but true," said Dr. Susan Hendrix of Wayne
State University, a co-investigator in the NIH's Women's Health
Initiative, the biggest study ever done of hormone therapy.
Still, hormones are the mainstay treatment for hot flashes and other
menopause symptoms - and there lie the biggest quandaries: Which
women are at such high risk from the pills' side effects that they
shouldn't use them even to briefly ease menopause symptoms? And
for women who do try the pills to ease hot flashes, how long are
they safe to use?
Nobody yet knows. But Hendrix offered herself as an example, saying
her own hot flashes aren't bad enough for her to risk taking hormones,
but that she might reconsider if they were especially severe.
"There's still a place for this product," said Dr. Ginger
Constantine of Wyeth Pharmaceuticals, maker of the best-selling
hormone brands. She noted that lower doses than were used in the
Women's Health Initiative study can bring menopause relief - although
there's no proof they'll also bring fewer side effects.
The study that set off the controversy found women who take the
estrogen-and-progestin combination are at significantly higher risk
of heart disease and cancer than previously thought. For every 10,000
women taking the pills, every year there will be eight more breast
cancers, seven more heart attacks, eight more strokes and eight
more life-threatening blood clots in the lungs than if they hadn't
taken the pills, the study found.
For an individual, those
are small risks - although with millions of users they add up. But
the study concluded they far outweigh the pills' few benefits -
preventing five hip fractures and six cases of colorectal cancer
a year for every 10,000 users - especially as there are other ways
to fight bone loss and colon cancer.
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That's only half the story: Researchers are continuing to study
whether using estrogen alone - only possible for women who have
had hysterectomies - is safe.
The news has prompted many women to abandon hormones. Sales of Preempro,
the brand used in the study, are down 40 percent, Wyeth says. Also,
632,000 fewer prescriptions for all estrogen-progestin brands were
filled the month after the study was announced than the 2.2 million
filled the month before the bad headlines, according to IMS Health,
a company that tracks drug sales.
Estrogen-only sales are down by 15 percent for the top brand, Premarin,
Wyeth said. For all estrogen brands, 426,000 fewer prescriptions
were filled in August than the 5.5 million filled in June, says
IMS Health. There are no good alternatives to estrogen for menopause
symptoms, said Dr. Lorraine Anne Fitzpatrick of the Mayo Clinic.
The most promising are antidepressants in the Prozac family, called
SSRIs, but they need more study and pose their own side effects,
The often-touted herbs soy and evening primrose have failed in menopause
studies. But for women who refuse any drugs, Fitzpatrick called
black cohosh promising, noting that the German government, which
regulates herbs more rigorously than other nations, has approved
its use for hot flashes.
NIH researchers are working to tease out of the Women's Health Initiative
data whether certain characteristics make women more prone to hormone
dangers and how the therapy affected their quality of life, points
that may ultimately help women decide whether to try it.