If you’re a woman taking hormones to ease the symptoms of menopause, the latest news from the largest-ever government trial on the issue shouldn’t change a thing.
That’s the view of doctors, researchers and the leader of one of the nation’s largest menopause education and support groups, who hope to avoid the mass panic that occurred when the infamous clinical trial was halted six years ago.
“The original message was a little bit inflamed,” acknowledged Garnet Anderson, a co-principal investigator of the landmark trial, known as the Women’s Health Initiative, and co-author of a follow-up study released Tuesday.
The new study of nearly 16,000 women, published in the Journal of the American Medical Association, reports a higher risk of cancer, particularly lung cancer, in women who took a combination of estrogen and progestin hormones than in those who didn’t, even after stopping the drugs. The number of breast cancer cases remained elevated, too, although the difference in risk wasn’t significant.
That could alarm women using or considering the hormones, especially if the only take-away message they hear is: “more cancer,” said Dr. Leon Speroff, a professor of obstetrics and gynecology at the Oregon Health Sciences University and a member of the board of the American Menopause Association. But they need to remember that the original study included women much older than typical hormone users — and that the results may not apply to typical women seeking treatment.
“This publication is not a reason to change what you are doing,” said Speroff. “It is not strong enough to make a change in clinical practice.”
Instead, women should recognize that the chance of cancer being caused by the hormones is very small, even as reported in the study. Of 8,052 women taking the drugs, 281 got cancer during the three-year follow-up, compared to 218 of the 7,678 women taking placebos. That amounts to about three more cases a year for every 1,000 women on hormone pills.
While the trend indicates there might be some long-term effects on cancer, the research is still not clear, Anderson added.
“We had to test 16,000 women to see these risks,” she said. “It is a really small risk."
Future studies likely will clarify the enduring cancer risk, which was "a little bit surprising," said Dr. Nanette Santoro, director of the division of reproductive endocrinology at the Albert Einstein College of Medicine in New York.
In the meantime, women should remember that the new study applied only to women who took estrogen and progestin, not to women who took estrogen alone. She expects the rate of cancer to fall in the future and noted that the overall rate of new breast cancer cases in the U.S. has been declining.
While women may want more clear-cut answers about hormones, the issue requires careful consideration of new research and individual risk, Anderson added. She urged women to talk to their doctors and, in general, to heed advice recommending low-doses of the drug for short terms to relieve symptoms.
Other effects faded
The lingering effects for cancer didn’t hold for the worst cardiovascular problems that stopped the WHI clinical trial, nor for the benefits, including protection against bone fractures, the study showed. Differences in those conditions disappeared after the hormones were stopped, according to the study, which followed women for three years after the trial was stopped.
Still, researchers concluded that overall risks remained higher for those who took hormones than for those who didn’t.
That draws the ire of doctors like Speroff and Dr. Wulf Utian, executive director of the North American Menopause Society, who said WHI researchers “have always looked to the dark side.”
“The facts are clear and that is there is a non-statistical difference in events and no difference in mortality,” he said. “For women in the age range 45 to 65 on hormones for two to three years for menopausal symptoms, these results are actually quite reassuring.”
Speroff and Utian say the best advice for hormone users remains the same: Low doses, early in menopause, for a limited period of time, can help relieve the most serious symptoms of menopause, including hot flashes, mood swings and irregular bleeding.
That’s good news for Karen Giblin, the founder of Red Hot Mamas, a menopause education and support group with chapters in 60 hospitals in the United States and Canada and a quarter-million Web site visits a month.
After the WHI trial was stopped, she was flooded with calls and e-mails from frantic women who didn’t want to risk their health, but didn’t want to give up the drugs that gave them relief from hot flashes, mood swings and irregular bleeding.
“When a bombshell is dropped, women start to become frantic,” she said.
Her agency urges women not to be “passive consumers” and to realize that the decision to use hormones is very individual. Drug therapy is only one option, she said. Exercise, diet and natural remedies can also offer relief, but only if women find out exactly what works best for them.
It’s worth the effort, said Giblin, 57, who has taken low doses of estrogen for years.
“I know my quality of life is definitely better on it,” she said.