Jan. 6, 2004 -- New research confirms that millions of women in the U.S. have abandoned menopausal hormone therapy, but other recent studies suggest that many are having a difficult time coping without it.
Stanford University researchers report that prescriptions for the estrogen-plus-progestin drug Prempro declined by two-thirds in the year following the early termination of a large prevention trial linking Prempro's use in postmenopausal women to an increased risk of heart attacks, blood clots, and breast cancer.
Roughly 2 1/2 million women in the U.S. still take estrogen-plus-progestin combinations like Prempro, compared with 6 million who took the hormone therapy before July of 2002, says lead investigator Randall S. Stafford, MD, PhD, of the Stanford Prevention Research Center. That is when government health officials announced plans to halt the Women's Health Initiative (WHI) study evaluating the combination treatment for the prevention of heart disease and other diseases associated with aging.
A WHI trial evaluating estrogen therapy alone, which is given to women who have had hysterectomies, is scheduled to end in 2005. But the new findings also show a steep decline in its use. Prescriptions for the estrogen-alone drug Premarin dropped by one-third in the year following the cessation of the Prempro trial.
Stafford and colleagues used two national databases to assess trends in menopausal hormone therapy usage between January 1995 and July 2003. Annual prescriptions for these drugs increased from 58 million in 1995 to 90 million in 1999, then remained relatively stable until the WHI trial was stopped in July of 2002. A year later, HRT prescriptions had dropped to roughly 57 million. The findings are reported in the Jan. 7 issue of The Journal of the American Medical Association.
Last month, University of California researchers reported that about a quarter of the women in their study who stopped taking menopausal hormone therapy ended up going back on the treatment to relieve hot flashes and other menopausal symptoms. Other studies have also shown that many women who abandoned these medications are going back to it. It is estimated that 10 million women in the U.S. now take either estrogen alone or estrogen plus progestin.
"We are beginning to see a backlash against the backlash," North American Menopause Society president Wulf H. Utian, MD, PhD, tells WebMD. "When the news hit, women got the message that all hormone therapy was bad. Now the pendulum is beginning to swing back toward the middle."
Government health guidelines now call for hormone therapy to be used only for the management of menopausal symptoms, like hot flashes and vaginal dryness, and in the lowest effective dosage for the shortest possible time. Prempro and Premarin manufacturer Wyeth Pharmaceuticals has introduced low-dose versions of both drugs. The company is aggressively marketing the low-dose preparations as alternatives to traditional hormone therapy.
"Women who need hormone therapy are going back to it, but they are also having very educated discussions with their health-care providers about the risks vs. benefits," Utian says.
Public Debate Drives Policy
Stafford says the dramatic decline in hormone therapy in menopausal women, in the wake of news reports following the WHI announcement, show that the health-care system can respond quickly to clinical trial results under the right circumstances.
In the same issue of JAMA, the researchers reported a smaller, but still significant, decline in the use of a class of hypertension drugs known as alpha-blockers after they were linked to an increased risk of heart failure. Both stories received significant media attention.
"A main message from these two experiences is that sometimes for clinical trial results to really have an impact, they need to leave the professional arena and become part of the public consciousness and conversation," Stafford says. "This is an idea that scientists are often uncomfortable with. But we have to recognize that there are social forces that are very important for determining whether clinical trial results really make a difference."