"There are some vocal people going around ... trying to convince people that the Women's Health Initiative results are not true," said Andrea LaCroix, an epidemiologist at the Fred Hutchinson Cancer Research Center and a principal investigator on the research project that has yielded most of the alarming information. "I think it's a tremendous disservice and I think women pay the price."
Women who are struggling to understand what it all means for them say they're confused and frustrated.
"I feel so good right now, I don't want to swing a bat at a hornet's nest," said 51-year-old Penny Clifton of Burien, who has been taking Prempro for several years. "But every morning, I pop that pill and wonder: Is this like a ticking time bomb?"
A growing rift
It was a year ago that initial reports from the Women's Health Initiative rocked the medical world with the news that women who took Prempro had a higher risk of heart attack, breast cancer, stroke and blood clots than women who took dummy pills. Two months ago, Alzheimer's disease was added to the list of problems linked with the drugs.
But critics of the studies argue their findings may not be relevant to the women who are most likely to be grappling with menopause symptoms.
"I think people are misinterpreting the data, trying to apply it to all women," said Tacoma gynecologist Dr. John Lenihan, also a menopause researcher.
The average age of participants in the Women's Health Initiative was 63. Because they could be randomly assigned to a group taking dummy pills, few women with severe menopause symptoms volunteered. In the dementia study, all participants were 65 or older.
The average age of women entering menopause is 51, said Dr. Barbara Levy, a noted Federal Way gynecologist. Like many of her colleagues, Levy believes the early stage of menopause is a critical window during which women can benefit most from hormone therapy, and are in the least jeopardy for side effects.
The overall odds of heart disease, breast cancer, dementia and stroke are much lower for younger women, so the added risks from taking hormones are also lower, Levy said.
Evidence from previous studies suggested hormones could protect menopausal women from heart attacks, but only if they started taking the drugs early. And a large study published late last year found that elderly women who had taken hormone replacement drugs early in menopause, then stopped, had a lower risk of Alzheimer's disease than those who didn't take the drugs or took them later in life.
"For younger women, the risk of taking hormones is lower and the benefits are higher," Levy said.
Arguments like those anger LaCroix.
The medical profession, which for decades encouraged women to take hormones to prevent heart disease, fuzzy memory, brittle bones and loss of libido, is now loath to accept that much of its advice was dead wrong, she said.
The evidence from the Women's Health Initiative is much more solid than any previous studies, she added. Researchers tracked nearly 17,000 women, who were randomly assigned to take either hormones or a placebo.
And though the average age was 63, women as young as 50 were included. Younger women do have lower risks of side effects than older women, but the risks were definitely elevated for those who took hormones.
"There are still women in their 50s who are having heart attacks because they are taking hormones," LaCroix said. "There's absolutely no evidence that they are somehow protected."
Experts agree combination hormones remain the most effective treatment for menopausal symptoms. (Combination drugs are prescribed for women who still have their uteruses, because estrogen alone can cause uterine cancer. Women who have had their uteruses removed can take estrogen-only pills, which have so far not been linked with most of the serious problems caused by combination drugs.)
In addition to hot flashes and night sweats, women coping with menopause report problems that range from fuzzy-headedness to irritability, anxiety, sleeplessness, vaginal dryness and loss of sex drive, most of which can be alleviated with hormones. Many also are convinced the drugs help them look and feel younger, warding off wrinkles and boosting vitality.
"When it came down to how absolutely dreadful my menopause symptoms made me feel, all that research went right out the window," said Nancy Boland-Tabor, a 51-year-old nurse who lives in Federal Way. She resumed her hormones two months after quitting cold turkey.
"No sleep, back to hot flashes, feeling like I wanted to cry all the time," she ticked off her symptoms.
"Don't even try to talk me out of HRT."
'Playing Russian roulette'
When 55-year-old Cindy Black of North Seattle gave up Prempro, she started getting thigh cramps on the ski slopes, along with papery skin, dry eyes and memory problems. Even though she's already suffered one bout of breast cancer, she resumed the drugs.
"Here I am back playing Russian roulette, but I don't want to watch myself decline," she said. "It totally speaks to quality of life."
Reviewing the new data, the U.S. Food and Drug Administration recommends women take hormone drugs for the shortest possible time, and at the lowest possible dose. Symptoms typically diminish two years after menopause, but it's highly variable.
Many women who don't want to quit completely are trying to cut back.
Charlotte Stanford of West Seattle tried to get by with a Prempro pill every three days, but her night sweats got so bad she frequently had to roust her husband out of bed to change the sheets. After several months of experimentation, the 60-year-old woman is now doing well on a lower-dose drug, which she takes every other day.
Others are trying alternative treatments, ranging from extracts of black cohosh root, cherry bark tea, soy milk, calcium supplements and vitamin E to customized hormone combinations produced by specialized pharmacies.
Just as with conventional therapy, results are mixed, and there's even less research to validate the options. But there's no reason to believe "natural" hormones, many of which are derived from yams or other plants, are any less dangerous than the versions used in drugs like Prempro, LaCroix said.
Many women, like 80-year-old Catherine Bell, prefer the completely natural approach — using no drugs at all.
Either as a result of luck or her "mind over matter" approach, the Stanwood woman suffered few problems with menopause.
"Medication is not the only answer," she said. "Positive thinking is a marvelous thing."
Risk vs. quality of life
Putting the risks into perspective is key to helping women decide whether to resume hormone therapy, said Lenihan, the Tacoma gynecologist.
The Women's Health Initiative concluded Prempro raises the risk of breast cancer 26 percent. Though the number sounds high, the actual risk that a woman will get breast cancer remains low, even among women who use hormones. Out of 10,000 women who take combination hormones for one year, 38 would be expected to develop breast cancer compared to 30 out of a group of 10,000 women who do not take the drugs.
By comparison, out of 100,000 women who smoke one to two packs of cigarettes a day, about 240 will develop lung cancer compared to 12 in a group of non-smokers. That's nearly a 2,000 percent increase in relative risk.
One message that's clear from the new studies is that women shouldn't take on even the small additional risk if they aren't bothered by menopausal symptoms.
"There's ample evidence to say they're not good for you," Levy said.
It can be hard for women to know whether symptoms will surface until they try giving up the drugs. Even women well past the onset of menopause can be hit with hot flashes and night sweats when they stop the drugs after taking them for a long time, which is why most doctors recommended gradual withdrawal.
For women facing hot flashes that force them to flee business meetings or insomnia that keeps them up all night, the risk-benefit calculation is one they have to make for themselves — and is the reason many are turning back to hormones, Levy said.
"These women are saying: My quality of life is so bad without hormones, I'm willing to tolerate the (small) risk of breast cancer."
For 55-year-old Tina Hendricks of Seattle, it's a tradeoff worth making.
When she tried to give up the drugs, her hot flashes were so intense that she started dressing in layers, shedding the excess clothing on downtown sidewalks or in crowded theater lobbies. Herbal remedies offered no relief.
Finally, her nurse practitioner suggested she reconsider the drugs she had given up.
"I'm back on the HRT bandwagon, but this time I'm trying a reduced dose of estrogen," she said. "I decided that if HRT shortens my life, at least it will have been a life lived in reasonable comfort." |