HRT for Menopausal Symptoms Allowed in New Consensus

Laurie Barclay, MD

July 16, 2012

July 16, 2012 — Short-term hormone replacement therapy (HRT) is acceptable and relatively safe for healthy, symptomatic, recently postmenopausal women, according to a new consensus statement endorsed by 15 leading medical organizations involved in women's health.

The new guidelines and rationale were issued jointly by the North American Menopause Society (NAMS), the American Society for Reproductive Medicine, and the Endocrine Society.

Risks for HRT Reiterated

More than a decade ago, on July 9, 2002, findings from the Women's Health Initiative (WHI) stirred up controversy by showing that for the prevention of chronic disease, risks for HRT outweighed the benefits.

Use of conjugated equine estrogen and medroxyprogesterone acetate in postmenopausal women was associated with an increased risk for cardiovascular events.

"The WHI has saved thousands of lives by debunking conventional wisdom and allowing millions of women and their doctors to make key health decisions based on scientific evidence," Carolyn M. Clancy, MD, director of HHS's Agency for Healthcare Research and Quality, was quoted by Public Health Newswire as saying in an expert panel discussion held July 9 at the George Washington University Hospital in Washington, DC.

Dr. Clancy, who declined interview requests from Medscape Medical News, was further quoted as saying: "In virtually every institution, important findings...have made people uncomfortable. You can't do it alone as researchers; you need clinicians, advocates, and policymakers behind you. The WHI showed us this is possible. What we need to do now is make sure this isn't a one-hit wonder."

Highlighted at the expert panel meeting on July 9, the 10-year anniversary of the publication of the WHI results, were findings of increased risk for heart disease and stroke beginning during the first year of menopausal HRT use, with persistence of elevated risks up to 5 years after use. Using combination HRT for several years was associated with a 29% increase in myocardial infarction, a 41% increase in strokes, and nearly double the risk for serious thromboembolic disease.

In addition, the panelists emphasized, women at least 65 years of age were at higher risk for dementia if they had received HRT. According to findings from the WHI, the US Food and Drug Administration therefore recommended that HRT not be prescribed for preventative cardiovascular health.

Despite Risks, HRT Safe for Symptoms

"The results of the WHI and the conflicting reports that followed led many women to believe hormone therapy may not be a safe treatment for menopausal symptoms," Janet E. Hall, MD, immediate past president of the Endocrine Society, said in a news release. "We want women to know that there are options out there for relief of their menopausal symptoms. The level of risk depends on the individual, her health history, age, and the number of years since her menopause began."

In the aftermath of the WHI report, some clinicians may have erred on the side of caution, hesitating to provide even short-term HRT to appropriately selected patients for relief of perimenopausal symptoms. Although HRT is widely thought to be effective in this setting, the reluctance of physicians to prescribe it may have led symptomatic women to seek unproven alternative treatments.

"Many women can safely take hormone therapy for relief of menopausal symptoms when they work closely with their provider to assess their personal risks and benefits," NAMS Executive Director Margery Gass, MD, said in a news release. "Women and clinicians have been frustrated by the many conflicting recommendations during the last 10 years. This statement should be reassuring to all."

The joint statement aimed to present evidence-based key concepts about appropriate use of HRT to facilitate informed decision-making by women and their physicians.

"Physicians can help patients determine, based on their own particular characteristics and history, whether or not they are good candidates for hormone therapy and what type of [therapy] will provide them the greatest relief at the lowest risk," said Roger Lobo, MD, past president of the American Society for Reproductive Medicine. "A decade of research and analysis has shown us that the generalized conclusions of the WHI do not apply to younger women at the beginning of the menopausal transition."

Specific recommendations in the consensus statement include the following;

  • The decision to use HRT must be individualized based on specific patient factors and anticipated risks and benefits. These include quality-of-life priorities, age, time since menopause, and risk for blood clots, heart disease, stroke, and breast cancer.

  • For healthy, relatively young women (younger than 59 years or within 10 years of menopause) with moderate to severe menopausal symptoms, systemic HRT is an acceptable option and is the most effective treatment.

  • Low-dose vaginal estrogen is the preferred treatment for women who have only vaginal dryness or discomfort with intercourse.

  • To prevent uterine cancer in women who still have a uterus, HRT should include progesterone or a similar progestogen, as well as estrogen. Women who have undergone hysterectomy can be given only estrogen.

  • Estrogen-only and estrogen-progestogen HRT are associated with increased risk for stroke and of venous thromboembolism (deep venous thrombosis and pulmonary embolus), as are hormone-based contraceptives. However, the risk is rare in women aged 50 to 59 years.

  • Use of continuous estrogen with progestogen therapy for at least 5 years, and possibly even for shorter duration, is associated with an increased risk for breast cancer. When HRT is discontinued, this risk decreases.

Endorsed by 15 Medical Organizations

In addition to the North American Menopause Society, the American Society for Reproductive Medicine, and the Endocrine Society, which collaborated on the joint statement and published it in their journals, 12 other medical organizations endorsed the consensus guidelines.

These are the Academy of Women's Health, the American Academy of Family Physicians, the American Academy of Physician Assistants, the American Association of Clinical Endocrinologists, the American Medical Women's Association, the Asociación Mexicana para el Estudio del Climaterio, the Association of Reproductive Health Professionals, the National Association of Nurse Practitioners in Women's Health, the National Osteoporosis Foundation, the Society for the Study of Reproduction, the Society of Obstetricians & Gynaecologists of Canada, and the SIGMA Canadian Menopause Society.

Notably absent from this list is the American College of Obstetricians and Gynecologists.

"The college participated in the initial writing stages of the document's development, but because of the specifics of our formal review process, we were not able to fully participate in, and thus endorse, the final document," Gerald J. Joseph Jr, MD, the college's vice president for practice activities, told Medscape Medical News in an email interview.

"Please see the college's current guidance on hormone therapy in postmenopausal women," Dr. Joseph said when asked whether or not the college was in agreement with the consensus statement.

The College's Committee Opinion cites recent evidence suggesting that women in early menopause who are in good cardiovascular health are at low risk for adverse cardiovascular outcomes.

"[These women] should be considered candidates for the use of conjugated equine estrogen or conjugated equine estrogen and medroxyprogesterone acetate for relief of menopausal vasomotor symptoms," the opinion states.

"Hormone therapy use should be limited to the treatment of menopausal symptoms at the lowest effective dosage over the shortest duration possible and continued use should be reevaluated on a periodic basis. Some women may require extended therapy because of persistent symptoms."

Some of the consensus statement authors report various financial relationships with the European Society of Human Reproduction and Embryology, KEEPS Study of Hormone Therapy, Journal Watch Women's Health, Novogyne, and/or Pharmavite.

"A Decade After the Women's Health Initiative — The Experts Do Agree." Full text

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