NEW YORK (Reuters Health) - A follow up of participants in the Women's Health Initiative (WHI) study suggests that those who stopped using combined estrogen plus progestin when the study was terminated in 2002 appear to be at increased risk of cancer subsequently, compared with those who received placebo in the study.
The WHI trial was intended to run for 8 to 9 years, but it was stopped after an average of 5.6 years after estrogen/progestin use was linked to an increased risk of breast cancer and appeared to yield no overall health benefit. The goal of the present study, reported in the Journal of the American Medical Association March 5, was to determine the health outcomes of 15,730 participants 3 years after the intervention had stopped.
"The follow-up after stopping estrogen plus progestin use confirms the trial's main conclusion that combination hormone therapy should not be used to prevent disease in healthy, postmenopausal women," Dr. Gerardo Heiss, from the University of North Carolina School of Public Health in Chapel Hill, said in a statement.
"The most important message to women who have stopped this hormone therapy is the need for continued prevention and screening activities through their physicians, for all important preventable conditions," Heiss added.
As noted, women who had received hormone therapy were more likely to develop cancer during the postintervention phase than were women who had received placebo, with annualized rates of 1.56 percent and 1.26 percent, respectively.
Breast cancers were more common in ex-hormone users than in ex-placebo users. However, the relative risk seen was lower than that noted during the trial.
The risk of cardiovascular events in ex-hormone and ex-placebo users was comparable in the follow up study, with annualized rates of 1.97 percent and 1.91 percent, respectively. This suggests, say the researchers, that the increased risks seen in women assigned to estrogen plus progestin during the trial period weakened after the study drugs were stopped.
"The WHI investigators did not expect to find an increased overall risk of cancer after stopping the estrogen plus progestin," Heiss said. "The increased risk is small, but the follow up did indicate there are higher levels of breast cancer, lung cancer, stroke and death among those who had taken this therapy."
"Thus, there is a need for prevention efforts through healthy lifestyle choices, risk factor control and regular screening activities as recommended by health care practitioners. This is good advice for everyone though, whether they have taken estrogen plus progestin for 3.5 to 8.5 years -- as in this study -- or not," Heiss added.
SOURCE: Journal of the American Medical Association, March 5, 2008.
The Women's Health Initiative (WHI) was a very large study that had more than 15,000 participants. The WHI helped doctors understand the relationship between increased breast cancer risk and using combination hormone replacement therapy (HRT) to manage menopausal side effects. Combination HRT has both estrogen and progesterone.
The WHI results reviewed here show that the women who took combination HRT were more likely to be diagnosed with breast and lung cancer after they quit taking the HRT than women who got a placebo (a sugar pill).
The WHI also found that women who took combination HRT had a higher risk of having a heart attack or stroke while on HRT. After the women stopped taking combination HRT, their risk for heart problems was similar to the women who took a placebo instead of the combination HRT.
Menopausal side effects can dramatically reduce some women's quality of life. These women have to weigh the benefits of HRT against the risks. If you're having severe hot flashes or other menopausal side effects and are considering taking HRT, talk to your doctor about how you can minimize your breast cancer risk. Be sure to discuss the pros and cons of different types of HRT and how you can take HRT for the shortest time possible.
Two points that you might want to discuss with your doctor:
Together, you and your doctor can decide if HRT or another treatment for the side effects of menopause might be right for you. If you do decide to use HRT, try to make healthy lifestyle choices that can lower your breast cancer risk. During and after HRT, make sure to follow the recommendations for breast cancer screening, including monthly breast self-exams, annual mammograms, and physical examinations by your doctor.
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