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AJN, American Journal of Nursing:
doi: 10.1097/01.NAJ.0000365169.24837.b6
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Hormone Replacement Therapy: Is the Risk Overestimated?

Potera, Carol

Section Editor(s): Kennedy, Maureen Shawn MA, RN

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E-mail: shawn.kennedy@wolterskluwer.com

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Abstract

As HRT use has plummeted, use of untested, herbal replacements has risen.

Women experiencing menopausal symptoms since 2002 may have missed out on the short- and long-term benefits of hormone replacement therapy (HRT), such as cardioprotection and relief from hot flashes, according to Alastair MacLennan, head of obstetrics and gynecology at the University of Adelaide, Australia, and author of a recent review of the literature. When the National Institutes of Health halted the Women's Health Initiative (WHI) trial of estrogen plus progestin in July 2002 because of an increased risk of heart disease and breast cancer in the HRT arm, many women abandoned HRT or were denied prescriptions by physicians who considered it dangerous. The WHI study of estrogen alone was stopped in 2004, although the risks were not as clearly defined. The latest data on HRT, however, suggest that it may not warrant the fear created by the WHI trials.

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MacLennan's review points out that the women in the discontinued WHI studies were in their mid-60s and had cardiovascular disease risk factors, and therefore were not representative of women who start HRT to treat menopausal symptoms. Further, women with menopausal symptoms who were looking to replace HRT often turned to unproven therapies, such as black cohosh, phytoestrogens, and bioidentical hormones. Such remedies are said to help the hot flashes, night sweats, irritability, joint pain, and vaginal dryness experienced by 80% of menopausal women.

The Health Omnibus Survey is an oral survey conducted annually since 1991 in South Australia to gather data on a wide variety of health-related topics. Subject matter covered varies from year to year according to who's sponsoring that year's survey. MacLennan and colleagues, in a separate study, used the results of several of the surveys to compare the use of HRT and alternative treatments among women over 50 since the WHI studies were stopped. The comparisons showed that in 2004, 19.8% used HRT but use of alternative therapies was rare. By 2008 HRT use dropped to 11.8%, whereas the proportion of women taking alternative therapies had risen to 4%. More specifically, among women ages 50 to 59, 13.4% used HRT, and 7.7% used alternative therapies. MacLennan believes that women switched to alternative therapies because the risks of HRT were overstated in 2002 and, as a result, sellers of alternative therapies began to target menopausal women.

Wulf Utian, executive director of the North American Menopause Society (NAMS), agrees. "There's still a high degree of fear and confusion fueled by the alternative-product industry," he says.

Promoters of alternative therapies, writes MacLennan in the review, often claim a 50% improvement yet fail to provide data from placebo-controlled trials. In addition, large placebo effects are standard in evaluations of alternative therapies. For instance, according to data from a 2002 Cochrane review published by MacLennan and colleagues, in high-quality randomized, controlled trials comparing the frequency of hot flashes and night sweats with HRT or placebo, placebo groups improved 58% on average, compared with 90% with HRT.

MacLennan's review found that black cohosh, phytoestrogens, and herbal and homeopathic medicines all fail the placebo test. He further maintains that there is no published high-quality evidence that bioidentical hormones are better or safer than HRT. Placebo-controlled studies show that HRT reduces hot flashes, improves vaginal dryness and painful intercourse, decreases joint pain and sleeplessness, and slows plaque buildup in arteries. He concludes that, overall, HRT is effective and safe when taken around menopause and before age 60 to control menopausal symptoms. HRT "is clearly the best therapy for oestrogen deficiency symptoms," writes MacLennan, "if [it's] given from near menopause. . . ." The latest position paper by NAMS on HRT (www.menopause.org/PSHT08.pdf) concurs, stating that the benefit–risk ratio "is favorable close to menopause but decreases with aging and with time since menopause in previously untreated women." The National Association of Nurse Practitioners in Women's Health, the American Medical Women's Association, and the Endocrine Society, among others, endorse the position taken by NAMS.

Despite the relative safety and effectiveness of HRT, says Stacie Geller, professor of obstetrics and gynecology at the University of Illinois at Chicago, "women will continue to take alternatives, regardless of what the science says, so we need to study them." In a new study comparing black cohosh and red clover with HRT and placebo in preventing hot flashes in menopausal women, Geller found that after 12 months, the average number of hot flashes decreased by 34% with the use of black cohosh, 57% with red clover, 94% with HRT—and 63% with placebo. Liver enzymes and other tests also confirmed that the botanicals were as safe as placebo. "This is important," says Geller, because "women want more options than hormones or nothing." The powerful placebo effect of safe alternatives may take the edge off menopausal symptoms in women who won't or can't take hormones.

Carol Potera

MacLennan AH. International Journal of Evidence-Based Healthcare 2009;7(2):112–23
MacLennan AH, et al. Climacteric 2009;12(2):122–30
Geller SE, et al. Menopause 2009;16(6). Epub ahead of print.

© 2009 Lippincott Williams & Wilkins, Inc.

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