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Not all women will need HRT

Tuesday, July 16, 2002

By Deborah Mendenhall, Post-Gazette Staff Writer

When menopause hit Adele Puff 16 years ago, she didn't even know it.

Adele Puff was part of the study of hormone replacement therapy. (Martha Rial, Post-Gazette)
Unlike most women, she didn't have mental confusion, didn't wake up drenched from night sweats and hot flashes didn't send her on unexpected tropical vacations in her own living room.

"I got none of that," she said. "People told me I was very lucky."

Even so, the Lincoln resident enrolled in the nation's largest study of the long-term benefits of Prempro, a popular estrogen-progestin combination drug widely prescribed by doctors to control menopause symptoms.

Last Monday, she learned that the small, white football-shaped pill that she took every day may have caused her harm.

  Related story

There are plenty of alternatives to hormone therapy


Many were stunned last week when government researchers warned that women who took Prempro were at greater risk for heart disease, stroke, blood clots and breast cancer, and halted a component of the Women's Health Initiative three years early.

But University of Pittsburgh researchers weren't among them.

"Since the 1980s, the medical group here that worked on the Women's Health Study have argued very strongly that the observational evidence that hormone replacement therapy prevents heart disease was highly suspect," said Dr. Lewis Kuller, principal investigator of the Pitt study site where Puff was enrolled.

Wyeth's Prempro, which contains a synthetic progesterone called medroxyprogesterone acetate, is used by 6 million women to control menopause symptoms. It's the most widely prescribed pharmaceutical drug for women.

"We used to call this the greatest uncontrolled experiment on women in the United States," said Kuller, who is also chairman of Pitt's department of epidemiology.

So what do women do now?

Not all women need medication, said Dr. Mary Ann Portman, a gynecological specialist at Magee-Womens Hospital,

Menopause hits hard in about 15 percent of women, 70 percent are moderately to mildly affected, and 15 percent are symptom free, she said. There is no way to tell how a woman will fare, but generally, she will follow her mother's path.

In light of the study results, she is advising her patients to take Prempro for a maximum five years.


Public sessions on HRT

Magee-Womens Hospital in Oakland has scheduled two free community meetings to discuss hormone replacement therapy. They'll be held 6 to 8 p.m. on July 17 and 18 in the conference center. You can attend either meeting. Reservations are required and can be made by calling the Magee education department at 412-641-4492.

The Western Pennsylvania Hospital in Bloomfield will hold a free HRT seminar at 7 p.m. July 23 in the hospital's auditorium. Free parking available in the hospital garage at corner of Liberty and South Millvale avenues. To register, call 412-578-5644.

Post-Gazette health editor Virginia Linn writes about alternatives to hormone replacement therapy in her Healthwise column this week.


"We have known for a while that the medroxyprogesterone acetate is not a very woman-friendly drug and causes a lot of side effects."

Other options are available, such as FemHRT and Activella, a combination pill that derives estrogen and progesterone from plants. But the drugs haven't been studied for long-term effects either, she said.

Some doctors treat menopause symptoms with anti-depressants such as Effexor, Clonidine, Prozac and Paxil after a Mayo Clinic study showed that they reduce hot flashes by up to 60 percent.

But others are wary of the side effects of those drugs, such as Dr. Eugene Scioscia, chairman of Allegheny General Hospital's department of obstetrics and gynecology.

Scioscia said he has no plans to stop prescribing Prempro, and believes most gynecologists will continue to prescribe it. The decision to use the drug must be made individually by each patient, he said.

"But our discussions today will differ greatly from discussions we had with patients five or 10 years ago," he said.

A decade ago, doctors advised patients to remain on Prempro and other HRT drugs all their lives because they thought it would prevent heart disease and osteoporosis.

Today, better drugs are available for those diseases, and Prempro will more likely be used short term.

"But there are probably more questions than answers," he said. "No one knows how long is too long, or how long is sufficient."

Neither Scioscia and Portman cared to comment on the bio-identical plant hormones that are mixed individually for each woman at compounding pharmacies, saying they had not been scientifically studied.

Large multi-clinic trials are expensive and participants are often wary of taking an unknown drug, but the results of this study show that they are necessary, Kuller said.

"This trial should have been done 20 years ago. Anytime you have a widely used drug, you'd better be damned sure that it works."

Agreeing with him is Dr. Victor Vogel, director of the Magee/UPCI Breast Program, who is a member of the initiative's Data and Safety Monitoring Board and helped make the decision to call off the study.

"What we thought we knew about the benefits of hormones turned out to be wrong," Vogel said. "Even the smartest people were wrong and the only way to get smarter is to do this kind of study."

Kuller said the study participants deserve credit for enrolling. They were told they were foolish to risk their health by taking a placebo because the drug was highly beneficial, he said.

Puff enrolled primarily because she is health-conscious and wanted the benefit of the study's bone density tests, mammograms, cardiograms and blood tests.

In fact, Puff, who didn't want her age used, said she is taking medication for high blood pressure that was detected in early screenings. She doesn't know whether she was taking Prempro or a placebo, and won't find out until next month.

Puff has stopped taking the pill, as researchers have advised, but even though she took Prempro for years, she isn't alarmed. Her overall health is good, she watches her diet, meditates, does yoga and weight-bearing exercises regularly, and the routine screening tests conducted in the study indicate she's healthy.

"It was scary when I first heard, but I never felt sick taking the pill," she said. "I'm feeling positive that everything is fine and that I'm one of the lucky ones."

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