McLean, VA (written by Kim Painter/Special for USA Today) -- Women who start low-dose hormone therapy in the first few years of menopause get relief from hot flashes and improve their mood and sexual health, without raising their blood pressure or harming their arteries, a much-awaited new study shows.
The study offers some reassurance to women who want that symptom relief, researchers say, but it was too short and too small to answer some big questions, including how the therapy affects risks for breast cancer, stroke and heart attack.
And it did not find evidence that early hormone use actually helps prevent hardening of the arteries - something the researchers thought possible.
The bottom line is that the now-standard advice still stands: Hormones should be used only by women with moderate to severe symptoms, at the lowest dose and for the shortest time needed, say several experts, including those behind the new study.
The era of widespread, long-term hormone use ended a decade ago when the landmark Women's Health Initiative linked higher-dose estrogen-progestin pills with increased risks of cardiovascular disease and breast cancer. Hormone use has since plunged.
The new study, which included 727 women in the first three years of menopause, is much smaller, but the patients, with an average age of 52, are younger and healthier than the average women in the WHI, and are more like typical hormone users today, says JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital, Boston. She was among researchers presenting the new data at a meeting of the North American Menopause Society on Wednesday in Orlando.
"Many women will be using hormone therapy for only four to five years, so these findings will have great relevance to them," Manson says.
Women in the trial used estrogen pills or patches, combined with natural progesterone pills taken 12 days a month. They were compared with women using placebo patches and pills. After four years, researchers found:
- No effect on blood pressure
- No significant differences in the buildup of deposits in coronary or carotid arteries.
- Increases in HDL "good" cholesterol and decreases in LDL "bad" cholesterol, but also increases in triglycerides, a potentially harmful blood fat, in estrogen pill users - and none of those effects in patch users.
- Eased depression and anxiety symptoms among estrogen users, especially those who took pills, and no adverse effects on thinking abilities - which were impaired among women over age 65 in the WHI.
- Improvements in hot flashes, night sweats, mood, sexual function and bone density in pill and patch users.
The main study - dubbed KEEPS, for Kronos Early Estrogen Prevention Study - was funded by the Kronos Longevity Research Institute, a non-profit organization without drug-industry ties. The cognitive arm was funded by the National Institutes of Health.
The findings on mood and sexual function are new and "somewhat encouraging for short-term use," says Jacques Rossouw, who oversees WHI activities at the National Heart, Lung and Blood Institute. However, he says the finding that hormones don't slow hardening of the arteries is "a severe blow" to the theory that early hormone use might actually enhance heart health.
Although the study found some positive cardiovascular signs, "women should not be overly reassured by these findings," Rossouw says. Young women may still face elevated risks for strokes due to blood clots, he says.
For many women considering hormone therapy, the biggest fear is breast cancer, says Andrea LaCroix, a researcher at Fred Hutchinson Cancer Research Center in Seattle. The new study doesn't address those fears, she says, but "does provide new information that will help women make good decisions."
LaCroix is presenting data at the conference on some alternatives, including anti-depressants that have shown promise against hot flashes. Yoga, aerobic exercise and other approaches may help relieve other symptoms, she says.
For women who do want to use hormones, the new study provides new information on the differences between patches and pills and different formulations of estrogen, says Margery Gass, executive director of the Menopause Society. Doctors may recommend different combinations to women with differing health profiles, she says.
Studies show that about 75% of women experience hot flashes and other bothersome symptoms around the time of menopause, Gass says. Just 25% have severe symptoms, she says, but "they are quite disruptive and annoying to those who have them."