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Three years after HRT findings, navigating menopause has become a personal journey
Wednesday, December 21, 2005

Joei Smith, 58, has made peace with life without hormone replacement therapy. She says she survives hot flashes, insomnia, and what she delicately describes as a tendency towards "oversensitivity," with a daily dose of Vitamin E.

Robin Elson remains unsure of what to do. At 55, she's suffering symptoms of menopause, but is reluctant to fill her HRT prescription "because I'd like to try to get through this without drugs."

Finally, Barb Pionati, 50, vows she will part with her HRT only when "they pry it out of my cold, dead hands."

Like millions of other women, these four have had to personalize their approach to managing menopausal symptoms in the wake of a blockbuster announcement three and a half years ago.

Then, scientists at the National Institute of Health's Women's Health Inititative abruptly stopped part of a federally funded study of the hormones estrogen and progestin -- long the gold standard combo for menopause symptoms -- after finding slightly increased risks of breast cancer, stroke and heart attack.

The move prompted widespread consternation -- even panic -- among tens of millions of women who had been taking HRT. Subsequent reviews noted flaws in the findings, and continuing discord in the medical community leaves women on the outside looking in.

For example, gynecologists noted that the study, which was designed by cardiologists, looked at only one type and dose of HRT -- and a relatively high dose at that, compared to what is prescribed today. While younger, healthier women participated in the study, the average participant was 63, long past menopause, and had problems like hypertension and diabetes.

"WHI was a study group full of older, overweight women who were half-reformed smokers," said Dr. Mary Jane Minkin, a clinical professor at Yale Medical School. Skeptics, like Dr. Minkin's Yale colleague Frederic Naftolin, did their own analysis of the WHI data and found that the 50- to 59-year-old participants in the group were, on average, 12 years past menopause and comprised a relatively small number of the total. That's significant, she said, because other, smaller studies show estrogen is mostly beneficial to younger women who have just entered menopause, not women who have been out of it for a dozen years.

But Dr. Lewis Kuller, a co-author of the WHI study, a nationally known expert on heart disease and a professor at the University of Pittsburgh Graduate School of Public Health, questioned why so many gynecologists had trouble accepting WHI's findings.

"You should ask how much money they're getting from the drug industry to dispense these hormones," he said. "We hurt their business, frankly."

The notion that the women participating in the WHI clinical trial were, on average, older and with more health problems is "totally ridiculous," he said. "There were women age 50 to 59 in WHI who showed no evidence of any benefits."

Help is on the way

As women wonder who to believe, two new studies will pick up where WHI left off, addressing the impact of HRT on women in their 40s and early 50s.

Eight centers are enrolling participants in a five-year study funded by the Kronos Foundation, a private Arizona group. The relatively small Kronos Early Estrogen Prevention Study (KEEPS) will look at the cardiovascular effects of estrogen taken by menopausal women ages 44 to 55. While the KEEPS study of 720 women won't be able to measure effects on mortality from heart attacks, since they aren't common in women those ages, researchers will use ultrasound to measure the carotid artery's thickness and monitor calcium deposits in the coronary artery.

If there are indications of a protective effect, "this may be a door opening to a larger clinical trial to definitively resolve the question," said Dr. Mitchell Harman, director of the KEEPS study. A second study is under way at the University of Southern California, dubbed the Early versus Late Intervention Trial with Estradiol (ELITE). The three-year study of 504 women will compare estrogen's effects in women who are six or fewer years past menopause to its effects in women 10 years or more beyond menopause. Half will take a daily dose of the HRT drug estradiol, the rest will take a placebo, supplemented by progesterone 10 days a month.

Is more research needed?

Dr. Kuller doesn't think so.

"For some people, when they don't like the results of something, they just keep calling for more studies until they get a result they do like."

The new studies are too small and too short to provide any meaningful insights, even if they are designed as a possible stepping stone to a larger clinical trial.

And, he notes, the WHI's findings have been widely accepted in the medical establishment. While the FDA, for example, still allows sales of HRT, it urges women with severe symptoms to get on and off hormones as quickly as possible, which indicates "they know there's an increased risk of stroke."

"There are women who, without any question, have hot flashes or other symptoms who need hormone therapy." But, he said, prior to the WHI study, doctors were "giving it to the ladies and saying, 'this is a fountain of youth, take it and you'll live forever.' Sixty percent were on hormone therapy for absolutely no reason."

The bottom line? "If you keep women on hormone therapy for lengthy periods of time, you double or triple their risk of stroke."

What women are doing

It's this kind of talk that resonates with Joei Smith, who experienced regular periods that "stopped on a dime when I turned 50, and then came the night sweats, the tossing and the turning."

Ms. Smith, of Indiana Township, was given a low dose of the HRT drug Prempro, "and the symptoms stopped, one, two, three, like that."

But then she read about the WHI study. With a family history of breast cancer, she knew she didn't want to increase her risk of getting the disease, no matter how slight.

So instead of HRT, "which scares me," Ms. Smith now takes 1,000 milligrams a day of Vitamin E, which she believes help alleviate her symptoms.

As Ms. Smith found, it comes down to balancing risk versus quality of life.

"I think you have to work with a patient's belief structure, her personal mythology," Dr. Minkin said. "I'm perhaps a little fringe-ier than most, but I just give them all the pros and cons and let them make the decision."

"HRT does work the best, but the key idea here is, it's not the only option," said Dr. Minkin.

Indeed, for people like Barb Pionati, HRT remains the only game in town. An oncology nurse who experienced menopause in her mid-thirties, Ms. Pionati was startled to read the results of the WHI study. After her gynecologist laid out the data in more detail, she decided to stay on HRT.

"I felt it was worth the risks in terms of quality of life issues," said Ms. Pionati, of Point Breeze. She has stayed with hormones "because with them, I have a brain, and I have a sex life."

That's an attitude that Dr. Portman encounters frequently in her practice among women who have been told by other doctors they won't prescribe HRT.

"They say, 'If you tell me you're not going to prescribe this, I'm going to find someone else who will.' "

And so Dr. Portman does, without much hesitation, because after three and a half years, she is fairly convinced that the WHI study, while valuable for the information it did provide about older women, estrogen and heart disease, didn't tell the whole story.

"We've learned that if we're considering starting someone on hormones, we have to make sure they have a healthy lifestyle," Dr. Portman said. "We have to look at their lipids or their family history of clotting. And we know that when we start patients on hormone therapy, we have to do it in very low doses and move up from there until we have control of their symptoms."

There are those, however, who continue to resist what some critics have described as the "medicalization" of menopause.

Robin Elson, 55, of Squirrel Hill, still hasn't filled the prescription for HRT that her gynecologist gave her six months ago. Never much of a medicine taker anyway -- "I barely take vitamins" -- Ms. Elson hesitated about taking hormones even before the WHI findings. She tried an herbal remedy, Black Cohosh, but it didn't alleviate her hot flashes, so for now, she's going without anything.

She admits her symptoms are fairly mild, although she also says, only half-jokingly, that it's early yet. "My mother is 81 and she still has hot flashes, so who knows?"

But her nightly bouts of insomnia have a benefit: Her husband keeps her company.

"This morning we were up at 4:30 trying to figure out the plot of the movie 'Syriana,'" she laughed. "I figured, if I can get through this with some bad days and some good days, but not much beyond just inconvenience, why not?"

First published on December 21, 2005 at 12:00 am
Mackenzie Carpenter can be reached at mcarpenter@post-gazette.com or 412-263-1949.