A Call for More Flexibility in Prescribing Postmenopausal Hormone Therapy
Approximately 10 years ago, the first results emerged from the Women’s Health Initiative linking postmenopausal hormone therapy (HT) to an increased risk of heart disease, stroke, thrombotic events, and breast cancer. Since then, many healthcare providers have adopted a strategy of providing “the lowest dose for the shortest possible time.” However, hormone therapy remains the most effective treatment available for menopausal hot flashes and night sweats, and there is a growing body of evidence that formulation, route of administration, timing of therapy, and duration of therapy may produce different effects on different women.
Therefore, new guidelines published by the North American Menopause Society (NAMS)— updating those previously published in 2010—suggest that healthcare providers take a flexible approach in making the decision to use HT. This approach should incorporate the woman’s health and quality-of-life priorities as well as her personal risk factors, such as risk of blood clots, heart disease, stroke, and breast cancer. There is a growing body of evidence suggesting that while long-term HT or starting HT in older women is associated with greater risk, for healthy women ages 50 through 59, the absolute risks of using HT are low.
In discussing whether or not to provide HT, the guidelines suggest that you and your patients consider the following:
- Her individual risk for heart disease, stroke, and breast cancer
- Route of administration and dosing (transdermal and low-dose oral estrogen are associated with lower venous thromboembolism and stroke risks than standard oral estrogen doses)
- Type of symptoms—with low dose, local administration of estrogen when only vaginal symptoms are present
In addition, the guidelines also offer the following recommendations based on data from randomized clinical trials:
- The primary indication for HT is the treatment of moderate-to-severe vasomotor symptoms.
- The recommendation for duration of therapy differs for estrogen-progestogen therapy (EPT) in women with a uterus and estrogen therapy (ET) in women who have had a hysterectomy.
- Duration of EPT is limited by the increased risk of breast cancer associated with more than 3 to 5 years of use. ET has a more favorable benefit-risk profile with no apparent increase in risk of breast cancer during an average of 7 years of use, a finding that allows more flexibility in duration of therapy.
- For relief of hot flashes, women with a uterus should take EPT so that a progestogen will protect the lining of the uterus from the cancer-promoting effects of estrogen alone.
- Low-dose vaginal ET is advised when symptoms are limited to vaginal dryness or discomfort with intercourse.
- Neither ET nor EPT appears to increase the risk of heart disease in healthy women younger than 60 years old or within 10 years of menopause. The risk of stroke can be increased but is considered rare in a woman in her 50s.
- Women with premature or early menopause who are otherwise appropriate candidates can use HT until the average age of natural menopause (age 51). Longer duration of treatment can be considered if needed for symptom management.
- There is a lack of safety data supporting the use of HT in women with a history of breast cancer.
- Both ET delivered as a patch and low-dose oral ET have been associated with lower risks of blood clots and stroke than standard doses of oral estrogen, but confirmation of benefits in randomized trials is not yet available.
As this paper focuses mainly on the safety of HT, there are no recommendations to guide women who may choose alternative treatments to relieve their symptoms, except for a caveat about the use of “bioidentical hormones.” Also note that NAMS receives financial support from the pharmaceutical industry and many of the authors of the statement provided extensive financial disclosures.
Jill Shuman, MS, ELS
Published March 6, 2012
- Rossouw JE, Anderson GL, Prentice RL, et al; Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333.
- Barnabei VM, Cochrane BB, Aragaki AK, et al; Women’s Health Initiative Investigators. Menopausal symptoms and treatment-related effects of estrogen and progestin in the Women’s Health Initiative. Obstet Gynecol. 2005;105(5 Pt 1):1063-1073.
- The North American Menopause Society. The 2012 Hormone Therapy Position Statement of The North American Menopause Society. Menopause. 2012;19(3):257-271.
- Rossouw JE, Prentice RL, Manson JE, et al. Postmenopausal hormone therapy and risk of cardiovascular disease by age and years since menopause. JAMA. 2007;297(13):1465-1477.