USPSTF Recommends Against Hormone Therapy to Prevent Chronic Conditions in Postmenopausal Women

Health Letter, July 2018

By Azza AbuDagga, M.H.A., Ph.D.

Menopause, the permanent cessation of a woman’s menstrual cycle, is associated with a natural decrease in estrogen levels. U.S. women reach menopause at a median age of 51 and are expected to live an average of approximately 30 years afterwards.[1]

The years following menopause coincide with increased rates of preventable chronic conditions, such as heart disease, stroke, diabetes, dementia, cancer and osteoporosis (and subsequent fractures).

It is not clear whether menopause itself contributes to the increased risk of these conditions. Yet some doctors prescribe hormone therapy, also called “hormone replacement therapy,” to postmenopausal women who do not have chronic conditions in order to prevent the occurrence of these conditions. This is known as “primary prevention.”[2]

The U.S. Preventive Services Task Force (USPSTF), a volunteer panel of experts working independently of the drug and medical device industries, examined the scientific evidence for this use of hormone therapy and issued a final statement recommending against its use.

The USPSTF published its statement and the evidence that supported its recommendation in the Dec. 12, 2017, issue of the Journal of the American Medical Association.[3],[4]

About hormone therapy [5]

Hormone therapy is the use of female hormone medications (either estrogen alone or estrogen in combination with a progestin). These medications are available in a variety of approved formulations and doses, which can be injected or taken orally. Other options for administration include nasal spray, implant, skin patch, cream and gel. Estrogen is used in combination with a progestin in women who still have a uterus because taking estrogen alone increases the risk of uterine cancer.

Approved formulations of estrogen for postmenopausal women include conjugated estrogens (PREMARIN); esterified estrogens (MENEST); estradiol tablets, transdermal systems, patches, gels, creams, nasal sprays or implants (ALORA, CLIMARA, DIVIGEL, ELESTRIN, ESTRACE, ESTRASORB, ESTRING, ESTROGEL, EVAMIST, FEMRING, MENOSTAR, MINIVELLE, VAGIFEM, VIVELLE); and estradiol injection (DELESTROGEN, DEPOESTRADIOL).

Estrogen-progestin combinations include conjugated estrogens with medroxyprogesterone (PREMPHASE, PREMPRO), estradiol with drospirenone (ANGELIQ) and ethinyl estradiol with norethindrone (ACTIVELLA, AMABELZ, COMBIPATCH, FEMHRT). Another estrogen-containing combination drug approved for postmenopausal symptoms and prevention of postmenopausal osteoporosis is conjugated estrogen with bazedoxifene (DUAVEE), which Public Citizen’s Health Research Group has designated as Do Not Use.

Approved uses of hormone therapy are limited to relief of menopausal symptoms (including hot flashes and night sweats), treatment of vaginal or vulvar atrophy and prevention (but not treatment) of osteoporosis. Not all hormone therapy products are approved for all three of these uses.

More harm than benefit

The USPSTF’s evidence review relied on 18 randomized clinical trials that compared the effects of hormone therapy with placebo on the prevention of chronic conditions in postmenopausal women.[6] The USPSTF defined hormone therapy as the use of oral or transdermal formulations, during or after menopause, of combined estrogen and progestin in women who still have a uterus or estrogen alone in women who have had a hysterectomy (removal of the uterus).

The review found that both types of hormone therapy are associated with a decreased risk of fractures and diabetes. Combined estrogen and progestin also is associated with a decreased risk of colorectal cancer, whereas estrogen use alone is associated with a decreased risk of invasive breast cancer.

However, both types of hormone therapy increase the risk of blood clots, stroke, gallbladder disease, dementia and urinary incontinence. Combined estrogen and progestin also increase the risk of coronary artery disease and invasive breast cancer.

Therefore, the USPSTF concluded with moderate certainty that hormone therapy has no net benefit for the primary prevention of chronic conditions in average postmenopausal women.

USPSTF recommendations

Based on the aforementioned evidence, the USPSTF recommended against the use of hormone therapy in postmenopausal women who are considering hormone therapy to prevent chronic health conditions (see table below).

As an alternative to hormone therapy, the USPSTF recommended behavioral counseling to promote a healthful diet and physical activity for the prevention of cardiovascular disease in women who are overweight or obese and have other risk factors for heart or blood vessel diseases.

It also recommended daily lowdose aspirin to decrease the risk of colorectal cancer and cardiovascular disease in certain postmenopausal women. Finally, it recommended tamoxifen (SOLTAMOX) or raloxifene (EVISTA) to lower the risk of breast cancer in women who have an increased risk of breast cancer, have no contraindications for these medications and are at low risk of adverse effects from these drugs.

U.S. Preventive Services Task Force 2017 Recommendations

Population Recommendation*
Postmenopausal women Do not use combined estrogen and progestin for the primary prevention of chronic conditions.
Postmenopausal women who have had a hysterectomy Do not use estrogen for the primary prevention of chronic conditions.

* The recommendations do not apply to women who are considering hormone therapy to manage menopausal symptoms or those with early menopause due to a disease or surgical removal of the ovaries.

What You Can Do

If you are transitioning into menopause or life after menopause, do not use hormone therapy to prevent any chronic disease, including osteoporosis.[7] If you use hormone therapy to control menopausal symptoms, use the lowest dose for the shortest time possible.


References

[1] US Preventive Services Task Force. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force recommendation statement. JAMA. 2017;318(22):2224-2233.

[2] Gartlehner G, Patel SV, Feltner C, et al. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: Evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2017;318(22):2234-2249.

[3] Ibid.

[4] US Preventive Services Task Force. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force recommendation statement. JAMA. 2017;318(22):2224-2233.

[5] More evidence linking hormone therapy to cardiovascular harm in postmenopausal women. Worst Pills, Best Pills News. October 2015. https://www.worstpills.org/member/newsletter.cfm?n_id=994. Accessed March 13, 2018.

[6] US Preventive Services Task Force. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force recommendation statement. JAMA. 2017;318(22):2224-2233.

[7] A guide to treatments for osteoporosis. Worst Pills, Best Pills News. May 2015. http://www.worstpills.org/member/newsletter.cfm?n_id=960. Accessed March 13, 2018.