Sunday, December 15, 2002
Last modified at 5:05 p.m. on Thursday, December 12, 2002
© 2002 - The Lubbock Avalanche-Journal

Dr. Kellie Flood-Shaffer

Decisions about HRT must be individualized

For millions of women in the United States, there were a few certainties in life. One was the inevitable arrival of meno pause, and another was the probability that with menopause, they would be prescribed hormone replacement therapy.

On July 9, the National Heart, Lung and Blood Institute of the National Institutes of Health announced it was halting the arm of the Women's Health Initiative study evaluating combined estrogen and progestin use in postmenopausal women. This announcement shattered the most widely accepted conventional wisdom of the past 50 years concerning women's health care.

Physicians had wholeheartedly endorsed HRT for peri- and postmenopausal women for a number of maladies associated with the menopause.

These maladies included heart disease, osteoporosis, hot flashes, genital tract dryness, Alzheimer's disease, colon cancer and macular degeneration. The WHI study had a simple objective: to evaluate the major health benefits and risks of the most commonly used hormone preparation in the United States, which is conjugated equine estrogen and medroxyprogesterone acetate, or Prempro. A total of 16,608 postmenopausal women ages 50 to 79 with an intact uterus were recruited from 40 medical research centers from 1993 through 1998. The study was designed to continue through 2005.

On May 31, the Data and Safety Monitoring Board recommended stopping the trial because, for invasive breast cancer, the risk outweighed the benefit of HRT. In fact, the study showed that the increase in the risk for invasive breast cancer in women on HRT was 26 percent. The increased risk of coronary heart disease was 22 percent. The increased risk of stroke was 41 percent.

The good news is that the news is not all bad. Hormone replacement therapy is still the best therapy for hot flashes. There was a decrease in the incidence of colorectal cancer at a rate of 6 fewer cases per 10,000 women. The risk of osteoporosis was decreased with a rate of 5 fewer hip fractures per 10,000 women.

It is important to note that the arm of the study in women who have undergone hysterectomy and are on estrogen alone is ongoing. There is no indication that this portion of the study will end early.

There are still some unanswered questions: Since the estrogen alone portion is ongoing, could the progesterone therapy be the culprit? What about other forms of estrogen and progesterone? What is the appropriate amount of time to be on HRT? What do we do now?

The most important thing a woman can do is to keep up to date on health maintenance: get her routine physical exam including pap smear, pelvic exam, clinical breast exam, mammogram, lab work, colonoscopy and cardiac exam on a regular and/or yearly basis. In the meantime, women have treatment choices where her menopausal symptoms are concerned.

For the prevention and treatment of osteoporosis there are alternatives to HRT. These include medications called bisphosphonates. The drawback to these drugs can be gastrointestinal side effects. Another therapy for osteoporosis is selective estrogen receptor modulators. Alternative therapies to help prevent cardiovascular diseases include aspirin, statins or cholesterol lowering agents, and blood pressure medications. For hot flashes, medications in a variety of classes can help. A blood pressure medication called clonidine has been shown helpful in 20 percent to 30 percent of patients, and an anti-depressant such as venlafaxine is effective in up to 60 percent of patients.

Herbal and over-the-counter preparations such as soy, black cohosh, and dong quai, although not tested or approved by the Food and Drug Administration, have shown some efficacy. There are several national pharmacies that specialize in customized hormonal cream preparations, but these also remain largely untested. There are also over-the-counter non-hormonal creams and gels that provide temporary relief from vaginal dryness and itching.

The WHI study had created what amounts to a paradigm shift in women's health care, and although no medical study is definitive and no medical advice fits all cases, women must discuss this issue at length with their physician and make an individualized and informed decision about their hormonal choices after menopause.

Dr. Kellie Flood-Shaffer is interim chairwoman of the obstetrics and gynecology department at Texas Tech University Health Sciences Center.