Hormone Replacement, Women’s Health Initiative, and Individual Patient Care

Scientists at the 2004 AAAS Annual Meeting argued that women facing severe menopause symptoms should demand that their doctors take the time to help them balance the risks versus the benefits of hormone replacement therapy (HRT).

“We're saying that physicians have to learn more about their patients' risk profile,” said Susan Johnson, a gynecologist who is an investigator in the Women's Health Initiative study clinical trials. One of the WHI clinical trials, which studied the effects of a combination of estrogen and progestin on the prevention of chronic diseases, was ended in July 2002, after researchers found that combined HRT was putting women at risk for heart attacks, breast cancer, strokes and blood clots. “There are many women for whom HRT continues to be an excellent choice for the treatment of menopause related symptoms,” Johnson said. “In my clinical practice, I'm putting a lot of women back on HRT.”

With the release of the results of the high profile WHI study, many physicians and their women patients have been struggling to weigh contradictory evidence from several studies, while balancing the advantages and disadvantages of various treatment options. Johnson and several of her colleagues who participated in a panel at the AAAS Meeting have been among those the doctors are turning to for guidance.

Johnson noted that in the past clinicians could recommend HRT for the treatment of menopause and several diseases. In that sense, the WHI is transforming the practice of gynecology, she said. “Now, several therapeutic options need to be presented to women who prefer not to use hormones, and more time must be spent in considering risk factors and prevention options for osteoporosis, heart disease, and other conditions.”

Nonetheless, Johnson said, based on the WHI study, the risks exceed the benefits for asymptomatic women who are using HRT for prevention of conditions such as osteoporosis. Furthermore, WHI researcher Garnet Anderson noted, women might want to consider that the results released to the public were often the most conservative ones, particularly regarding breast cancer.

“In releasing these results in July 2002, a generally conservative statistical view of the data was given through use of unweighted statistics and inclusion of adjusted confidence intervals,” said Anderson, a statistician with the Fred Hutchinson Cancer Research Center. “I'm going to explain how the assumptions behind the analyses and try to show how these led to the decision to end the study.”

It's a familiar role for Anderson, who has received emails and faxes from physicians around the country who are struggling to understand the WHI results.

“The gynecological community's reaction to the WHI results was something akin to finding out that the world was round, and not flat,” Johnson said. “The public health benefit of HRT had been so ingrained in training and practice that the understandable initial reaction of many gynecologists was skepticism, disbelief and for some, anger at and distrust of the scientific community.”

Johnson and Anderson were among a group of epidemiologists, clinicians, and statisticians on a panel entitled, “HRT and WHI: How Science Informs Individuals’ Health Decisions.”

—Coimbra Sirica

27 February 2004