Hormone Therapy Study Has Doctors Buzzing
(ORLANDO, Fla.) -- Medical experts are buzzing about a new hormone therapy study that shows short-term estrogen and progesterone treatment is safe for some menopausal women -- and the study data isn't even out yet.
Results from the Kronos Early Estrogen Prevention Study, or KEEPS, will be presented Wednesday night at the North American Menopause Society's annual meeting in Orlando. Researchers reported finding that hormone pills and patches relieved patients' symptoms, such as hot flashes and night sweats, but didn't necessarily increase their risk of heart problems, as other studies have shown.
"We're so excited about results that are going to be released in just a few hours," NAMS Executive Director Dr. Margery Gass said from Orlando. She said the KEEPS data is preliminary and the paper hasn't been written yet, but doctors all around her are talking about the summary they've seen. "This study, however, is looking more at the immediate effects of hormones on quality of life issues and then markers of chronic disease... It's not the final results, such as broken bone, a heart attack or a stroke because those things don't really happen that much in this age group."
Findings released to the media this week in a press release include that the hormone therapy did not affect blood pressure or hardening of the arteries, and it had a neutral or positive effect on cholesterol. However, when ABC News requested the data behind these conclusions, KEEPS officials said it was not available.
Although some doctors are convinced KEEPS results will change current guidelines, which recommend as little hormone therapy as possible, others think the study is too different from previous studies to confirm hormone therapy is safe -- particularly in the long run.
Most notably, KEEPS follows the ongoing Women's Health Initiative study, nicknamed WHI, which looked at 160,000 women ages 50 to 79, but was halted in 2002 when researchers found that patients taking progestin and estrogen were more likely to develop aggressive breast cancer. Researchers released follow-up results of WHI as recently as 2010. By contrast, KEEPS was a four-year study of 727 women between the ages of 42 and 58.
"The results are not surprising, particularly as they contrasted to the results of the WHI," said Dr. William White, president of the American Society of Hypertension. "The dose of estrogen is lower than what was used in WHI, the patient population is younger and at low [cardiovascular] risk. Hence, it is good news that low dose estrogen replacement can be safe and effective for women recently undergoing the menopause for up to four years of treatment."
Dr. JoAnn Mason, chief of preventative medicine at Brigham and Women's Hospital in Boston, was one of the KEEPS authors. She said KEEPS does not challenge WHI, but "addresses entirely different questions." She said the trial was too small to make conclusions about whether hormone therapy increases patients' risk of heart problems or cancer.
"The WHI tested the role of hormone therapy in predominantly older women," Mason said. "In KEEPS, women were much younger… and many favorable effects of hormone therapy were found in the newly menopausal women participating in KEEPS."
Medical experts said they are comfortable prescribing hormone therapy in the short term, but the long term still caries cardiovascular risks.
"I would stick with the recommendation that short term HT is a reasonable option to consider if she had moderate to severe symptoms up to five years," said Dr. Jacques Rossouw, chief of the Women's Health Initiative branch of the National Heart, Lung, and Blood Institute. "[It] should not be considered longer term or in older women for prevention of cardiovascular disease."
Several doctors said the study is reassuring to women already on hormone therapy. There were 38 million women in 2010, according to IMS Health. Most prescriptions, 26 million, were for estrogen-only products, but 5.2 million were for progestin-estrogen products, and 5.3 million were for progestin-only products.
"These findings WILL change guidelines," Dr. Katherine Sherif, director of the Drexel Center for Women's Health, wrote in an email. "The pendulum is swinging back to the middle, partly due to women who benefit from hormones."
Wolf Utian, who founded and heads the National American Menopause Society, called the study the "foil to consistent negative statements" on hormone therapy, and emphasized the quality of life data in the study.
The preliminary findings are being announced in Orlando.
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