HRT, Hot Flashes
NAMS Releases Updated Position Statement on HT 2/15/07
MICHELE G. SULLIVAN (Mid-Atlantic Bureau)
Article Outline
The benefits of hormone therapy outweigh its risks in healthy perimenopausal and early-postmenopausal women with menopause-related symptoms and a low baseline risk of stroke, according to the revised position statement released by the North American Menopause Society.
However, the paper cautioned, HT should not be prescribed for the prevention of any disease, with the exception of postmenopausal osteoporosis.
The statement is based on an expert panel’s review of HT studies published subsequent to the group’s 2004 position paper, said Dr. Wulf Utian, executive director of the North American Menopause Society (NAMS).
“In this day and age, the life span of any position statement is a maximum of 2 or 3 years,” Dr. Utian said in an interview. “In the face of so much new information, we felt an update was due.”
The clinical impacts of HT’s short- and long-term effects are becoming clearer, especially as additional subanalyses of the Women’s Health Initiative (WHI) and the Heart and Estrogen/Progestin Replacement Study (HERS) emerge, he said. Results of these and other studies enabled more expert consensus in the new paper than was previously possible—most significantly, Dr. Utian said, in the area of cardiovascular disease risk.
“We have modified our stance on level of risk from 2004. Apart from the increased risk of stroke in the older woman [taking HT], the absolute risk of stroke and heart attack is rare, and we agreed that any evidence of an increase in heart attack in the perimenopausal woman was poor. We have concluded that for the symptomatic woman without a contraindication, the benefits of HT outweigh the riks, and that these women have less cause to fear than the popular perception.”
Two well-publicized, large studies have precipitated much of the current confusion over the safety of HT, appropriate treatment populations, and timing of therapy, the statement said.
“The results of WHI and HERS should not be extrapolated to symptomatic postmenopausal women younger than 50 years of age, who initiate HT at that time, as these women were not studied in those trials.”
Reporting risks in relative terms further confuses the issue, the paper said. A more helpful way of understanding those risks is to view them as rare (10 or fewer events/10,000 women per year) or very rare (1 or fewer events/10,000 women per year).
The attributable risk of coronary heart disease in women taking HT in both studies falls into the “rare” category, the paper said, but was higher in older women than among women aged 50–59 years. In fact, the paper noted, some data show a trend toward reduction of heart disease in women who begin HT less than 10 years after menopause.
Despite these data, HT cannot be recommended as a primary prevention therapy for coronary heart disease, Dr. Utian said. “We did, however, agree that this suggestion of a protective effect in women who start in close proximity to menopause should be investigated.”
The expert panel also agreed that stroke and venous thromboembolism are significantly elevated in postmenopausal women who use HT.
The risk of blood clot is small (13 excess events/10,000 women per year in WHI), lower in women aged 50–59 years, and concentrated in the first 2 years after therapy initiation. Lower doses of oral estrogens may be safer than higher doses with regard to clots, the paper said.
Stroke was also less common in women aged 50–59 years in WHI (one additional stroke/10,000 women per year) than in older women. Nevertheless, the paper said, HT should be avoided altogether in women who have an elevated baseline risk of stroke.
The increased incidence of breast cancer associated with HT is also rare (four to six more invasive cancers/10,000 women per year in women using estrogen/progestogen therapy). In women using estrogen alone, there is some evidence of a decreased incidence of
invasive breast cancer, with eight fewer cases/10,000 women per year. Despite this finding, hormones should not be prescribed for prevention of breast cancer.
Although HT may elevate mood in some women, there is no evidence that hormones can prevent depression in postmenopausal women. Likewise, no study has ever established a preventive role for HT in dementia, cognitive decline, or Alzheimer’s disease.
The paper did find limited evidence that early initiation of HT is associated with a 21% reduction in the rate of diabetes mellitus, compared with the rate in nontreated women (see related article below).
“We encourage more research in this area, but the evidence is not strong enough for prescribing hormones for this sole indication,” Dr. Utian said.
However, HT can be prescribed for the prevention of postmenopausal osteoporosis in women who require drug therapy to maintain bone.
“There is strong evidence of the efficacy of [HT] in reducing the risk of postmenopausal osteoporotic bone fracture,” the paper said. For women at risk of a fracture during the next 5–10 years, HT can be an option—but only after a careful risk/benefit analysis.
That sort of analysis should be the cornerstone of every visit that involves HT counseling, Dr. Utian stressed. “We state very clearly there is no cookbook recipe. Each woman has her own potential indications and risk factors and only a comprehensive evaluation and discussion is going to decide what is most appropriate for that individual.”
Dr. Jan Leslie Shifren, director of the Vincent menopause program at Massachusetts General Hospital, Boston, is glad that the position statement has been updated. But the NAMS statement won’t be the final word on HT, she added.
“Clearly, recommendations for HT remain moving targets as new data emerge. In fact, since the time the published studies were reviewed for this statement, we heard a report of the largest-ever annual decrease in breast cancer incidence [a 7% decline in 2003, compared with annual declines of 1% since 1998], which many experts believe may have to do with the dramatic drop in HT use.”
The findings still need to be reviewed and published, Dr. Shifren said, but they illustrate the difficulty of issuing guidelines for HT use.
“Caring for women is also a moving target,” she said. “Our goal as researchers and clinicians is to constantly review the data and give our patients the best information available so we can work together to make informed treatment decisions.”
The NAMS statement is available at www.menopause.org/aboutmeno/consensus.htm.
PII: S0029-7437(07)70097-6
doi:10.1016/S0029-7437(07)70097-6
© 2007 Elsevier Inc. All rights reserved.