PRESCRIPTION FOR UNCERTAINTY QUESTIONS, WORRIES PLAGUE WOMEN ON HORMONE REPLACEMENT THERAPY.

Byline: Mariko Thompson Staff Writer

TIRED OF NIGHT SWEATS and mood swings, Fae Lipeles reluctantly made an appointment with her doctor to begin a hormone replacement therapy regimen. Then on July 9 came the startling announcement that a major study of the drug was halted prematurely when a small but significant increase of breast cancer was discovered.

Lipeles canceled her appointment.

``I'm absolutely not starting hormones because of that study,'' said Lipeles, 52, of Northridge. ``I was prepared to start. Now I'm not going to do it. I've lost two friends to breast cancer and have more friends that have it.''

Like Lipeles, many women have feared adverse effects from hormone replacement therapy, but the medical community has long minimized the risks and touted the benefits. Now the study, part of the Women's Health Initiative funded by the National Institutes of Health, has determined that the medication popped for decades alongside daily vitamins confers more risks than benefits.

Though the findings have women and their doctors reevaluating treatment options, hormone replacement therapy won't be disappearing any time soon. Los Angeles-area physicians say the study will lead to a more individualized approach to treating menopausal symptoms and even greater emphasis on the importance of diet and exercise.

Millions affected

An estimated 6 million women nationwide take a combination of estrogen and progestin to ease menopausal symptoms, which include night sweats, hot flashes, mood swings and vaginal dryness. Doctors also had recommended hormone replacement therapy to reduce the risk of heart disease and to prevent osteoporosis.

The study, conducted at 40 centers nationwide, including UCLA, and the most comprehensive to date, ended five years into its eight-year run. The 16,608 participants - half taking estrogen-progestin and half taking a placebo - received letters instructing them to stop taking their pills. Of those taking the estrogen-progestin pills, the data showed eight more incidences of invasive breast cancer per 10,000 women, as well as seven more heart attacks, eight more strokes and eight more lung blood clots. On the benefits side, the study reported six fewer events of colorectal cancer and five fewer of hip fracture.

``I've been involved in menopause research for 30 years, and up until now we have not had firm answers,'' said Dr. Howard Judd, principal investigator for the Women's Health Initiative at UCLA Medical Center. ``All we could say is, 'It may.' It may increase your risk for this, it may decrease your risk for that. This study, at least for this product, now gives us firm, reliable information.''

So why not toss the pills? Though the findings discourage long-term use, Judd says short-term use while women make the transition through menopause poses little threat. The breast cancer risk didn't appear until more than three years into the study. He advises women concerned about hormone replacement therapy to talk to their doctors.

``A woman's doctor has the most information about the individual in regard to the pros and cons of using hormones,'' he says. ``A woman taking estrogen for a limited period of time to relieve her symptoms probably will not increase her risk much at all.''

Sexism in research?

How did hormone replacement therapy, available since the 1940s, become so entrenched without rigorous testing? For one, the medical community didn't view menopause as a serious area of study.

``There probably was some sexism in that decision,'' Judd said. ``Menopause wasn't considered important.''

In 1966, estrogen received a big boost when Dr. Robert Wilson, a gynecologist, published ``Feminine Forever.'' The best-selling book promoted long-term estrogen use for postmenopausal women. By the mid-'70s, however, concerns grew over the link between estrogen and endometrial cancer, leading to the addition of progestin for women who had not undergone hysterectomy. Since then, hormone replacement drugs have ranked among the most prescribed medications in America.

The questions that dogged the safety of hormone replacement finally became the focus on a major study in the early 1990s. A government review found a dearth of research studies on women's health issues. Congress approved $625 million for the Women's Health Initiative, launched by the NIH in 1991.

Though the Women's Health Initiative estrogen-progestin study has been halted, a separate study on estrogen only with women who underwent hysterectomies continues. However, another study conducted by the National Cancer Institute reported last week that women taking estrogen-only medications for 10 or more years incurred an increased risk of ovarian cancer, fueling more fears about hormone replacement therapy.

Two Los Angeles-area women who participated in the Women's Health Initiative estrogen-progestin study said they were not surprised by the outcome.

``I always felt like the drug companies really pushed us,'' said Susan Sullivan, 57, of Topanga Canyon. ``If you get half the population to take a drug for the rest of their lives, you've got a good thing going.''

``Had I swallowed the propaganda, I'd be very upset,'' agreed Sandra Wagner, 64, of Pasadena. ``There are some ladies here in my condominium complex that are scared. They've got calls into their doctors. They want to know how to undo the risk.''

Wagner is convinced she was taking the placebo. Because of a side effect that she had suffered, Sullivan is certain she took the medication. Over the next few months, all participants will meet with researchers to learn which group they were in, have any questions answered and provide follow-up information.

To participate in the study, women ages 50 to 79 had to be in good health, with no history of cancer or heart disease and lacking severe menopausal symptoms (in case they were assigned the placebo). Both Sullivan and Wagner avoided hormone replacement therapy before the study. They participated in it out of a sense of duty.

``I thought the study would answer a lot of concerns and questions, maybe not for us but for our daughters,'' Wagner said.

Don't forget benefits

The study gives women and doctors a clearer understanding of the risks involved. But the question of whether to take hormones or not remains. What has changed is that doctors can no longer take a one-size-fits-all approach.

``I tell patients this didn't overnight become a bad medication,'' said Dr. Christopher Tarnay, an obstetrician and gynecologist at Kaiser Permanente in Woodland Hills. ``It's just not all it was cracked up to be. It's important for patients not to panic. They need to look at why they're on it and re-evaluate those reasons with their providers.''

Dr. Robert Boostanfar, a reproductive endocrinologist at the Huntington Reproductive Centers in Pasadena and Westlake Village, worries patients will stop taking their medication without consulting their doctors and find themselves suffering from hot flashes and other symptoms.

``I can tell you, I didn't take my mother off hormone replacement therapy,'' he said. ``The way I treat patients is how I would treat my family members.''

Women placed on the drug as a preventive measure for osteoporosis and heart disease likely will be moved to other medications and to natural remedies such as diet and exercise. Whether women decide to take hormones for menopausal symptoms or not, a more holistic approach should be stressed, said Dr. Michael Hirt, director of the Center for Integrative Medicine at Encino-Tarzana Regional Medical Center.

A diet rich in soy, vegetables and whole grains and low in processed foods is the easiest way to improve one's cancer odds. For women taking hormones, Hirt suggests eating plenty of cruciferous vegetables, such as broccoli, kale, cauliflower and cabbage, to assist the liver in processing estrogen.

As an alternative to hormones, Hirt suggests natural estrogens such as kudzu and black cohosh to ease some menopausal symptoms, though many doctors remain skeptical of herbal remedies.

Doctors predict more emphasis will be placed on designing doses that are specific to each patient. More research will be done on how estrogen is administered, dose levels, and different forms of estrogen or progestin than used in the Women's Health Initiative study.

``There are so many items we need to look at,'' said Dr. Marlon Brooks, director of the maternity center at Providence Holy Cross Medical Center in Mission Hills. ``If someone weighs 300 pounds and someone else weighs 90 pounds, it doesn't make sense to give the same dose.''

Hirt believes one day all seniors, men and women, will take hormone replacements designed to individual specifications. The driving force will be quality of life, including the ability to enjoy sex and to participate in sporting and recreational activities.

``One can argue that we weren't designed to live this long,'' Hirt said. ``The human body functions best when hormones are balanced. A lot of women will continue to take the hormones with a better understanding, more than just swallowing them and hoping for best. Life without hormones is a quality-of-life issue, and women are not going to be willing to make that trade-off.''

Staff writer Linda Hutchinson contributed to this story.

CAPTION(S):

2 photos, chart

Photo:

(1 -- cover -- color) WEIGHING THE OPTIONS

Recent warning about hormone replacement therapy has left women wondering what to do

Layne Smith/Knight Ridder Newspapers

(2) UCLA's Dr. Howard Judd thinks short-term use of HRT poses little threat.

Chart:

HORMONE REPLACEMENT THERAPY

Source: Women's Health Initiative

Graphic: Martha Thierry, Detroit Free Press 

Knight Ridder Tribune